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COVID cases rising in about half of states

Article Type
Changed
Tue, 04/12/2022 - 10:41

Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

A version of this article first appeared on WebMD.com.

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Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

A version of this article first appeared on WebMD.com.

Though overall COVID-19 case counts continue to drop nationally, that’s not the story in every U.S. state.

About half the states have reported increases in COVID cases fueled by the Omicron subvariant, Axios reported. Alaska, Vermont, and Rhode Island had the highest increases, with more than 20 new cases per 100,000 people.

Nationally, the statistics are encouraging, with the 7-day average of daily cases around 26,000 on April 6, down from around 41,000 on March 6, according to the Centers for Disease Control and Prevention. The number of deaths has dropped to an average of around 600 a day, down 34% from 2 weeks ago.

National health officials have said some spots would have a lot of COVID cases.

“Looking across the country, we see that 95% of counties are reporting low COVID-19 community levels, which represent over 97% of the U.S. population,” CDC Director Rochelle Walensky, MD, said April 5 at a White House news briefing.

“If we look more closely at the local level, we find a handful of counties where we are seeing increases in both cases and markers of more severe disease, like hospitalizations and in-patient bed capacity, which have resulted in an increased COVID-19 community level in some areas.”

Meanwhile, the Commonwealth Fund issued a report April 8 saying the U.S. vaccine program had prevented an estimated 2.2 million deaths and 17 million hospitalizations.

If the vaccine program didn’t exist, the United States would have had another 66 million COVID infections and spent about $900 billion more on health care, the foundation said.

The United States has reported about 982,000 COVID-related deaths so far with about 80 million COVID cases, according to the CDC.

“Our findings highlight the profound and ongoing impact of the vaccination program in reducing infections, hospitalizations, and deaths,” the Commonwealth Fund said.

“Investing in vaccination programs also has produced substantial cost savings – approximately the size of one-fifth of annual national health expenditures – by dramatically reducing the amount spent on COVID-19 hospitalizations.”

A version of this article first appeared on WebMD.com.

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Protease inhibitors increase small-for-gestational-age but not other pregnancy risks

Article Type
Changed
Fri, 04/08/2022 - 10:43

Pregnant women with HIV can be reassured that protease inhibitors are safer than previously thought in terms of risk to the fetus, according to research from the National Perinatal Epidemiology Unit (NPEU) at Oxford Population Health, a research institute based at the University of Oxford (England).

Antiretroviral therapy (ART) is recommended for all pregnant women living with HIV and plays a crucial role both in improving maternal health and in reducing transmission of HIV from mother to child. However, there has been a critical lack of evidence about the effects of ART on the risk of adverse pregnancy outcomes, with particular concern about protease inhibitors.

Current guidelines recommend that protease inhibitor-based therapies should be used in pregnancy only if first-line treatments (such as integrase and reverse-transcriptase based treatments) are either unsuitable or unavailable. These guidelines also often advise against the use of a specific protease inhibitor, lopinavir/ritonavir, citing an increased risk of preterm birth. However, such advice may restrict treatment options for pregnant women with HIV on the basis of limited evidence.
 

Largest review to date

The NPEU researchers, therefore, conducted the largest systematic review to date of adverse perinatal outcomes after a range of antiretroviral therapies. It included 34 cohort studies published between 1980 and 2020 and involving over 57,000 pregnant women with HIV in 22 different countries. The review, published in eClinicalMedicine, looked for evidence of 11 perinatal outcomes:

  • Preterm birth, very preterm birth, and spontaneous preterm birth
  • Low birth weight, very low birth weight, term low birth weight, and preterm low birth weight
  • Small for gestational age and very small for gestational age
  • Stillbirth, and neonatal death

Using pairwise random-effects meta-analyses, researchers compared protease inhibitor versus non-protease inhibitor-based ART, as well as specifically looking at the comparative risks associated with different protease inhibitor regimens.

They found that protease inhibitor-based ART significantly increased the risk of small or very small for gestational age babies, with relative risks of 1.24 (95% confidence interval, 1.08-1.43; I2 = 66.7%) and 1.40 (95% CI, 1.09-1.81; I2 = 0.0%), respectively. However there were no significant differences in other adverse pregnancy outcomes for protease inhibitors, compared with other therapies.

In addition, researchers found no significant differences in perinatal outcomes between ART regimens containing lopinavir/ritonavir, atazanavir/ritonavir, or darunavir/ritonavir, which are the most frequently used protease inhibitors.
 

No increased risk of preterm birth

Senior author Dr. Joris Hemelaar, senior clinical research fellow at the NPEU and honorary consultant in obstetrics at the John Radcliffe Hospital, Oxford (England), said: “Antiretroviral therapy in pregnancy has clear benefits for maternal health and prevention of HIV transmission to the child, but our study has shown for the first time that protease inhibitors are associated with babies being small or very small for their gestational age.”

“However, there was no increased risk of preterm birth, or any other adverse pregnancy outcomes. This means protease inhibitors remain an important option for pregnant women living with HIV if other treatments are unsuitable, for example due to drug resistance, or unavailable. The evidence presented here indicates that the commonly used protease inhibitors atazanavir, lopinavir, and darunavir are comparable with regard to perinatal outcomes, which should inform international treatment guidelines.”

Over 70% of the studies assessed were conducted in high-income countries, and Dr. Hemelaar added that there is an urgent need for more research on pregnancy outcomes after different ART in low- to middle-income countries, where the burden of HIV is highest.

Professor Yvonne Gilleece, a spokesperson for the British HIV Association (BHIVA) and immediate past chair of the BHIVA guidelines on the management of HIV in pregnancy and the postpartum period commented: “Pregnancy is a unique life situation in which we must consider the safety of both the birthing parent and the baby. Due to ongoing under-representation of all women in clinical trials, but particularly pregnant women, we do not have enough evidence on which to base all our management decisions. This systematic review includes large numbers of pregnant women living with HIV and can, therefore, improve an informed discussion regarding the safety of the use of protease inhibitors during pregnancy.”

Dr. Hemelaar told Medscape UK: “Many international treatment guidelines cite adverse pregnancy outcomes, in particular preterm birth, associated with protease inhibitor (PI)-drugs as a reason for caution for their use in pregnancy. However, PI drugs are not associated with preterm birth in our analysis. This suggests that PI drugs may not be as detrimental as previously thought (and we found no differences between different PI drugs used), and, hence, these drugs may have a more favourable profile for use in pregnancy.

“However, many other aspects of treatment, including the extent to which the virus can be suppressed, adverse drug effects, adherence to drug prescriptions, antiretroviral drug resistance, drug interactions, drug cost, and availability, should also be taken into account by clinicians and guideline development committees.”

A version of this article first appeared on Medscape UK.

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Pregnant women with HIV can be reassured that protease inhibitors are safer than previously thought in terms of risk to the fetus, according to research from the National Perinatal Epidemiology Unit (NPEU) at Oxford Population Health, a research institute based at the University of Oxford (England).

Antiretroviral therapy (ART) is recommended for all pregnant women living with HIV and plays a crucial role both in improving maternal health and in reducing transmission of HIV from mother to child. However, there has been a critical lack of evidence about the effects of ART on the risk of adverse pregnancy outcomes, with particular concern about protease inhibitors.

Current guidelines recommend that protease inhibitor-based therapies should be used in pregnancy only if first-line treatments (such as integrase and reverse-transcriptase based treatments) are either unsuitable or unavailable. These guidelines also often advise against the use of a specific protease inhibitor, lopinavir/ritonavir, citing an increased risk of preterm birth. However, such advice may restrict treatment options for pregnant women with HIV on the basis of limited evidence.
 

Largest review to date

The NPEU researchers, therefore, conducted the largest systematic review to date of adverse perinatal outcomes after a range of antiretroviral therapies. It included 34 cohort studies published between 1980 and 2020 and involving over 57,000 pregnant women with HIV in 22 different countries. The review, published in eClinicalMedicine, looked for evidence of 11 perinatal outcomes:

  • Preterm birth, very preterm birth, and spontaneous preterm birth
  • Low birth weight, very low birth weight, term low birth weight, and preterm low birth weight
  • Small for gestational age and very small for gestational age
  • Stillbirth, and neonatal death

Using pairwise random-effects meta-analyses, researchers compared protease inhibitor versus non-protease inhibitor-based ART, as well as specifically looking at the comparative risks associated with different protease inhibitor regimens.

They found that protease inhibitor-based ART significantly increased the risk of small or very small for gestational age babies, with relative risks of 1.24 (95% confidence interval, 1.08-1.43; I2 = 66.7%) and 1.40 (95% CI, 1.09-1.81; I2 = 0.0%), respectively. However there were no significant differences in other adverse pregnancy outcomes for protease inhibitors, compared with other therapies.

In addition, researchers found no significant differences in perinatal outcomes between ART regimens containing lopinavir/ritonavir, atazanavir/ritonavir, or darunavir/ritonavir, which are the most frequently used protease inhibitors.
 

No increased risk of preterm birth

Senior author Dr. Joris Hemelaar, senior clinical research fellow at the NPEU and honorary consultant in obstetrics at the John Radcliffe Hospital, Oxford (England), said: “Antiretroviral therapy in pregnancy has clear benefits for maternal health and prevention of HIV transmission to the child, but our study has shown for the first time that protease inhibitors are associated with babies being small or very small for their gestational age.”

“However, there was no increased risk of preterm birth, or any other adverse pregnancy outcomes. This means protease inhibitors remain an important option for pregnant women living with HIV if other treatments are unsuitable, for example due to drug resistance, or unavailable. The evidence presented here indicates that the commonly used protease inhibitors atazanavir, lopinavir, and darunavir are comparable with regard to perinatal outcomes, which should inform international treatment guidelines.”

Over 70% of the studies assessed were conducted in high-income countries, and Dr. Hemelaar added that there is an urgent need for more research on pregnancy outcomes after different ART in low- to middle-income countries, where the burden of HIV is highest.

Professor Yvonne Gilleece, a spokesperson for the British HIV Association (BHIVA) and immediate past chair of the BHIVA guidelines on the management of HIV in pregnancy and the postpartum period commented: “Pregnancy is a unique life situation in which we must consider the safety of both the birthing parent and the baby. Due to ongoing under-representation of all women in clinical trials, but particularly pregnant women, we do not have enough evidence on which to base all our management decisions. This systematic review includes large numbers of pregnant women living with HIV and can, therefore, improve an informed discussion regarding the safety of the use of protease inhibitors during pregnancy.”

Dr. Hemelaar told Medscape UK: “Many international treatment guidelines cite adverse pregnancy outcomes, in particular preterm birth, associated with protease inhibitor (PI)-drugs as a reason for caution for their use in pregnancy. However, PI drugs are not associated with preterm birth in our analysis. This suggests that PI drugs may not be as detrimental as previously thought (and we found no differences between different PI drugs used), and, hence, these drugs may have a more favourable profile for use in pregnancy.

“However, many other aspects of treatment, including the extent to which the virus can be suppressed, adverse drug effects, adherence to drug prescriptions, antiretroviral drug resistance, drug interactions, drug cost, and availability, should also be taken into account by clinicians and guideline development committees.”

A version of this article first appeared on Medscape UK.

Pregnant women with HIV can be reassured that protease inhibitors are safer than previously thought in terms of risk to the fetus, according to research from the National Perinatal Epidemiology Unit (NPEU) at Oxford Population Health, a research institute based at the University of Oxford (England).

Antiretroviral therapy (ART) is recommended for all pregnant women living with HIV and plays a crucial role both in improving maternal health and in reducing transmission of HIV from mother to child. However, there has been a critical lack of evidence about the effects of ART on the risk of adverse pregnancy outcomes, with particular concern about protease inhibitors.

Current guidelines recommend that protease inhibitor-based therapies should be used in pregnancy only if first-line treatments (such as integrase and reverse-transcriptase based treatments) are either unsuitable or unavailable. These guidelines also often advise against the use of a specific protease inhibitor, lopinavir/ritonavir, citing an increased risk of preterm birth. However, such advice may restrict treatment options for pregnant women with HIV on the basis of limited evidence.
 

Largest review to date

The NPEU researchers, therefore, conducted the largest systematic review to date of adverse perinatal outcomes after a range of antiretroviral therapies. It included 34 cohort studies published between 1980 and 2020 and involving over 57,000 pregnant women with HIV in 22 different countries. The review, published in eClinicalMedicine, looked for evidence of 11 perinatal outcomes:

  • Preterm birth, very preterm birth, and spontaneous preterm birth
  • Low birth weight, very low birth weight, term low birth weight, and preterm low birth weight
  • Small for gestational age and very small for gestational age
  • Stillbirth, and neonatal death

Using pairwise random-effects meta-analyses, researchers compared protease inhibitor versus non-protease inhibitor-based ART, as well as specifically looking at the comparative risks associated with different protease inhibitor regimens.

They found that protease inhibitor-based ART significantly increased the risk of small or very small for gestational age babies, with relative risks of 1.24 (95% confidence interval, 1.08-1.43; I2 = 66.7%) and 1.40 (95% CI, 1.09-1.81; I2 = 0.0%), respectively. However there were no significant differences in other adverse pregnancy outcomes for protease inhibitors, compared with other therapies.

In addition, researchers found no significant differences in perinatal outcomes between ART regimens containing lopinavir/ritonavir, atazanavir/ritonavir, or darunavir/ritonavir, which are the most frequently used protease inhibitors.
 

No increased risk of preterm birth

Senior author Dr. Joris Hemelaar, senior clinical research fellow at the NPEU and honorary consultant in obstetrics at the John Radcliffe Hospital, Oxford (England), said: “Antiretroviral therapy in pregnancy has clear benefits for maternal health and prevention of HIV transmission to the child, but our study has shown for the first time that protease inhibitors are associated with babies being small or very small for their gestational age.”

“However, there was no increased risk of preterm birth, or any other adverse pregnancy outcomes. This means protease inhibitors remain an important option for pregnant women living with HIV if other treatments are unsuitable, for example due to drug resistance, or unavailable. The evidence presented here indicates that the commonly used protease inhibitors atazanavir, lopinavir, and darunavir are comparable with regard to perinatal outcomes, which should inform international treatment guidelines.”

Over 70% of the studies assessed were conducted in high-income countries, and Dr. Hemelaar added that there is an urgent need for more research on pregnancy outcomes after different ART in low- to middle-income countries, where the burden of HIV is highest.

Professor Yvonne Gilleece, a spokesperson for the British HIV Association (BHIVA) and immediate past chair of the BHIVA guidelines on the management of HIV in pregnancy and the postpartum period commented: “Pregnancy is a unique life situation in which we must consider the safety of both the birthing parent and the baby. Due to ongoing under-representation of all women in clinical trials, but particularly pregnant women, we do not have enough evidence on which to base all our management decisions. This systematic review includes large numbers of pregnant women living with HIV and can, therefore, improve an informed discussion regarding the safety of the use of protease inhibitors during pregnancy.”

Dr. Hemelaar told Medscape UK: “Many international treatment guidelines cite adverse pregnancy outcomes, in particular preterm birth, associated with protease inhibitor (PI)-drugs as a reason for caution for their use in pregnancy. However, PI drugs are not associated with preterm birth in our analysis. This suggests that PI drugs may not be as detrimental as previously thought (and we found no differences between different PI drugs used), and, hence, these drugs may have a more favourable profile for use in pregnancy.

“However, many other aspects of treatment, including the extent to which the virus can be suppressed, adverse drug effects, adherence to drug prescriptions, antiretroviral drug resistance, drug interactions, drug cost, and availability, should also be taken into account by clinicians and guideline development committees.”

A version of this article first appeared on Medscape UK.

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Study suggests keto diet increases tumor growth in ovarian cancer

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Fri, 04/08/2022 - 14:33

A ketogenic diet fed to mice with epithelial ovarian cancer led to significantly increased tumor growth and gut microbiome alterations, according to study recently presented at the annual meeting of the Society of Gynecologic Oncology.

“The keto diet is very popular, especially among patients who believe it may treat cancer by starving tumors of the fuel they need to grow, altering the immune system, and other anticancer effects,” said study leader Mariam AlHilli, MD, of the Cleveland Clinic.

The findings are surprising because in other studies the high-fat, zero-carb ketogenic diet has demonstrated tumor-suppressing effects. It has been under study as a possible adjuvant therapy for other cancers, such as glioblastoma, colon cancer, prostate cancer, and pancreatic cancer.

“While we don’t know yet whether these findings extend to patients, the results in animals indicate that instead of being protective, the keto diet appears to promote ovarian cancer growth and progression,” Dr. AlHilli said. In the present study, tumor bearing mice were fed a keto diet consisting of 10% protein, 0% carbohydrates, and 90% fat, while the high-fat diet was 10% protein, 15% carbohydrates, and 75% fat. The control diet consisted of 10% protein, 77% carbohydrates, and 13% fat. Epithelial ovarian cancer tumor growth was monitored weekly.

Over the 6- to 10-week course of study, a 9.1-fold increase from baseline in tumor growth was observed in the keto diet-fed mice (n = 20). Among mice fed a high-fat diet (n = 20) that included some carbohydrates, tumor growth increased 2.0-fold from baseline, and among control group mice (n = 20) fed a low-fat, high carbohydrate diet, tumor growth increased 3.1-fold.

The investigators observed several hallmarks of tumor progression: tumor associated macrophages were enriched significantly, activated lymphoid cells (natural killer cells) were significantly reduced (P < .001), and M2:M1 polarization trended higher. Also, in keto diet–fed mice, gene set enrichment analysis revealed that epithelial ovarian cancer tumors had increased angiogenesis and inflammatory responses, enhanced epithelial-to-mesenchymal transition phenotype, and altered lipid metabolism. Compared with high-fat diet–fed mice, the keto-fed mice had increases in lipid catalytic activity and catabolism, as well as decreases in lipid synthesis.

“The tumor increase could be mediated by the gut microbiome or by gene alterations or by metabolite levels that influence tumor growth. It’s possible that each cancer type is different. The composition of the diet may be a factor, as well as how tumors metabolize fat and ketones,” Dr. AlHilli said.

The results need to be confirmed in preclinical animal studies and in additional models, she added.

The study was funded by a K12 Grant and internal funding from Cleveland Clinic. Dr. AlHilli declared no relevant disclosures.

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A ketogenic diet fed to mice with epithelial ovarian cancer led to significantly increased tumor growth and gut microbiome alterations, according to study recently presented at the annual meeting of the Society of Gynecologic Oncology.

“The keto diet is very popular, especially among patients who believe it may treat cancer by starving tumors of the fuel they need to grow, altering the immune system, and other anticancer effects,” said study leader Mariam AlHilli, MD, of the Cleveland Clinic.

The findings are surprising because in other studies the high-fat, zero-carb ketogenic diet has demonstrated tumor-suppressing effects. It has been under study as a possible adjuvant therapy for other cancers, such as glioblastoma, colon cancer, prostate cancer, and pancreatic cancer.

“While we don’t know yet whether these findings extend to patients, the results in animals indicate that instead of being protective, the keto diet appears to promote ovarian cancer growth and progression,” Dr. AlHilli said. In the present study, tumor bearing mice were fed a keto diet consisting of 10% protein, 0% carbohydrates, and 90% fat, while the high-fat diet was 10% protein, 15% carbohydrates, and 75% fat. The control diet consisted of 10% protein, 77% carbohydrates, and 13% fat. Epithelial ovarian cancer tumor growth was monitored weekly.

Over the 6- to 10-week course of study, a 9.1-fold increase from baseline in tumor growth was observed in the keto diet-fed mice (n = 20). Among mice fed a high-fat diet (n = 20) that included some carbohydrates, tumor growth increased 2.0-fold from baseline, and among control group mice (n = 20) fed a low-fat, high carbohydrate diet, tumor growth increased 3.1-fold.

The investigators observed several hallmarks of tumor progression: tumor associated macrophages were enriched significantly, activated lymphoid cells (natural killer cells) were significantly reduced (P < .001), and M2:M1 polarization trended higher. Also, in keto diet–fed mice, gene set enrichment analysis revealed that epithelial ovarian cancer tumors had increased angiogenesis and inflammatory responses, enhanced epithelial-to-mesenchymal transition phenotype, and altered lipid metabolism. Compared with high-fat diet–fed mice, the keto-fed mice had increases in lipid catalytic activity and catabolism, as well as decreases in lipid synthesis.

“The tumor increase could be mediated by the gut microbiome or by gene alterations or by metabolite levels that influence tumor growth. It’s possible that each cancer type is different. The composition of the diet may be a factor, as well as how tumors metabolize fat and ketones,” Dr. AlHilli said.

The results need to be confirmed in preclinical animal studies and in additional models, she added.

The study was funded by a K12 Grant and internal funding from Cleveland Clinic. Dr. AlHilli declared no relevant disclosures.

A ketogenic diet fed to mice with epithelial ovarian cancer led to significantly increased tumor growth and gut microbiome alterations, according to study recently presented at the annual meeting of the Society of Gynecologic Oncology.

“The keto diet is very popular, especially among patients who believe it may treat cancer by starving tumors of the fuel they need to grow, altering the immune system, and other anticancer effects,” said study leader Mariam AlHilli, MD, of the Cleveland Clinic.

The findings are surprising because in other studies the high-fat, zero-carb ketogenic diet has demonstrated tumor-suppressing effects. It has been under study as a possible adjuvant therapy for other cancers, such as glioblastoma, colon cancer, prostate cancer, and pancreatic cancer.

“While we don’t know yet whether these findings extend to patients, the results in animals indicate that instead of being protective, the keto diet appears to promote ovarian cancer growth and progression,” Dr. AlHilli said. In the present study, tumor bearing mice were fed a keto diet consisting of 10% protein, 0% carbohydrates, and 90% fat, while the high-fat diet was 10% protein, 15% carbohydrates, and 75% fat. The control diet consisted of 10% protein, 77% carbohydrates, and 13% fat. Epithelial ovarian cancer tumor growth was monitored weekly.

Over the 6- to 10-week course of study, a 9.1-fold increase from baseline in tumor growth was observed in the keto diet-fed mice (n = 20). Among mice fed a high-fat diet (n = 20) that included some carbohydrates, tumor growth increased 2.0-fold from baseline, and among control group mice (n = 20) fed a low-fat, high carbohydrate diet, tumor growth increased 3.1-fold.

The investigators observed several hallmarks of tumor progression: tumor associated macrophages were enriched significantly, activated lymphoid cells (natural killer cells) were significantly reduced (P < .001), and M2:M1 polarization trended higher. Also, in keto diet–fed mice, gene set enrichment analysis revealed that epithelial ovarian cancer tumors had increased angiogenesis and inflammatory responses, enhanced epithelial-to-mesenchymal transition phenotype, and altered lipid metabolism. Compared with high-fat diet–fed mice, the keto-fed mice had increases in lipid catalytic activity and catabolism, as well as decreases in lipid synthesis.

“The tumor increase could be mediated by the gut microbiome or by gene alterations or by metabolite levels that influence tumor growth. It’s possible that each cancer type is different. The composition of the diet may be a factor, as well as how tumors metabolize fat and ketones,” Dr. AlHilli said.

The results need to be confirmed in preclinical animal studies and in additional models, she added.

The study was funded by a K12 Grant and internal funding from Cleveland Clinic. Dr. AlHilli declared no relevant disclosures.

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AI model predicts ovarian cancer responses

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Fri, 04/08/2022 - 14:34

An artificial intelligence (AI) model successfully predicted which high-grade serous ovarian cancer patients would have excellent responses to laparoscopic surgery. The model, using still-frame images from pretreatment laparoscopic surgical videos, had an overall accuracy rate of 93%, according to the pilot study’s first author, Deanna Glassman, MD, an oncologic fellow at the University of Texas MD Anderson Cancer Center, Houston.

Dr. Glassman described her research in a presentation given at the annual meeting of the Society of Gynecologic Oncology.

While the AI model successfully identified all excellent-response patients, it did classify about a third of patients with poor responses as excellent responses. The smaller number of images in the poor-response category, Dr. Glassman speculated, may explain the misclassification.

Researchers took 435 representative still-frame images from pretreatment laparoscopic surgical videos of 113 patients with pathologically proven high-grade serous ovarian cancer. Using 70% of the images to train the model, they used 10% for validation and 20% for the actual testing. They developed the AI model with images from four anatomical locations (diaphragm, omentum, peritoneum, and pelvis), training it using deep learning and neural networks to extract morphological disease patterns for correlation with either of two outcomes: excellent response or poor response. An excellent response was defined as progression-free survival of 12 months or more, and poor response as PFS of 6 months or less. In the retrospective study of images, after excluding 32 gray-zone patients, 75 patients (66%) had durable responses to therapy and 6 (5%) had poor responses.

The PFS was 19 months in the excellent-response group and 3 months in the poor-response group.

Clinicians have often observed differences in gross morphology within the single histologic diagnosis of high-grade serous ovarian cancer. The research intent was to determine if AI could detect these distinct morphological patterns in the still frame images taken at the time of laparoscopy, and correlate them with the eventual clinical outcomes. Dr. Glassman and colleagues are currently validating the model with a much larger cohort, and will look into clinical testing.

“The big-picture goal,” Dr. Glassman said in an interview, “would be to utilize the model to predict which patients would do well with traditional standard of care treatments and those who wouldn’t do well so that we can personalize the treatment plan for those patients with alternative agents and therapies.”

Once validated, the model could also be employed to identify patterns of disease in other gynecologic cancers or distinguish between viable and necrosed malignant tissue.

The study’s predominant limitation was the small sample size which is being addressed in a larger ongoing study.

Funding was provided by a T32 grant, MD Anderson Cancer Center Support Grant, MD Anderson Ovarian Cancer Moon Shot, SPORE in Ovarian Cancer, the American Cancer Society, and the Ovarian Cancer Research Alliance. Dr. Glassman declared no relevant financial relationships.

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An artificial intelligence (AI) model successfully predicted which high-grade serous ovarian cancer patients would have excellent responses to laparoscopic surgery. The model, using still-frame images from pretreatment laparoscopic surgical videos, had an overall accuracy rate of 93%, according to the pilot study’s first author, Deanna Glassman, MD, an oncologic fellow at the University of Texas MD Anderson Cancer Center, Houston.

Dr. Glassman described her research in a presentation given at the annual meeting of the Society of Gynecologic Oncology.

While the AI model successfully identified all excellent-response patients, it did classify about a third of patients with poor responses as excellent responses. The smaller number of images in the poor-response category, Dr. Glassman speculated, may explain the misclassification.

Researchers took 435 representative still-frame images from pretreatment laparoscopic surgical videos of 113 patients with pathologically proven high-grade serous ovarian cancer. Using 70% of the images to train the model, they used 10% for validation and 20% for the actual testing. They developed the AI model with images from four anatomical locations (diaphragm, omentum, peritoneum, and pelvis), training it using deep learning and neural networks to extract morphological disease patterns for correlation with either of two outcomes: excellent response or poor response. An excellent response was defined as progression-free survival of 12 months or more, and poor response as PFS of 6 months or less. In the retrospective study of images, after excluding 32 gray-zone patients, 75 patients (66%) had durable responses to therapy and 6 (5%) had poor responses.

The PFS was 19 months in the excellent-response group and 3 months in the poor-response group.

Clinicians have often observed differences in gross morphology within the single histologic diagnosis of high-grade serous ovarian cancer. The research intent was to determine if AI could detect these distinct morphological patterns in the still frame images taken at the time of laparoscopy, and correlate them with the eventual clinical outcomes. Dr. Glassman and colleagues are currently validating the model with a much larger cohort, and will look into clinical testing.

“The big-picture goal,” Dr. Glassman said in an interview, “would be to utilize the model to predict which patients would do well with traditional standard of care treatments and those who wouldn’t do well so that we can personalize the treatment plan for those patients with alternative agents and therapies.”

Once validated, the model could also be employed to identify patterns of disease in other gynecologic cancers or distinguish between viable and necrosed malignant tissue.

The study’s predominant limitation was the small sample size which is being addressed in a larger ongoing study.

Funding was provided by a T32 grant, MD Anderson Cancer Center Support Grant, MD Anderson Ovarian Cancer Moon Shot, SPORE in Ovarian Cancer, the American Cancer Society, and the Ovarian Cancer Research Alliance. Dr. Glassman declared no relevant financial relationships.

An artificial intelligence (AI) model successfully predicted which high-grade serous ovarian cancer patients would have excellent responses to laparoscopic surgery. The model, using still-frame images from pretreatment laparoscopic surgical videos, had an overall accuracy rate of 93%, according to the pilot study’s first author, Deanna Glassman, MD, an oncologic fellow at the University of Texas MD Anderson Cancer Center, Houston.

Dr. Glassman described her research in a presentation given at the annual meeting of the Society of Gynecologic Oncology.

While the AI model successfully identified all excellent-response patients, it did classify about a third of patients with poor responses as excellent responses. The smaller number of images in the poor-response category, Dr. Glassman speculated, may explain the misclassification.

Researchers took 435 representative still-frame images from pretreatment laparoscopic surgical videos of 113 patients with pathologically proven high-grade serous ovarian cancer. Using 70% of the images to train the model, they used 10% for validation and 20% for the actual testing. They developed the AI model with images from four anatomical locations (diaphragm, omentum, peritoneum, and pelvis), training it using deep learning and neural networks to extract morphological disease patterns for correlation with either of two outcomes: excellent response or poor response. An excellent response was defined as progression-free survival of 12 months or more, and poor response as PFS of 6 months or less. In the retrospective study of images, after excluding 32 gray-zone patients, 75 patients (66%) had durable responses to therapy and 6 (5%) had poor responses.

The PFS was 19 months in the excellent-response group and 3 months in the poor-response group.

Clinicians have often observed differences in gross morphology within the single histologic diagnosis of high-grade serous ovarian cancer. The research intent was to determine if AI could detect these distinct morphological patterns in the still frame images taken at the time of laparoscopy, and correlate them with the eventual clinical outcomes. Dr. Glassman and colleagues are currently validating the model with a much larger cohort, and will look into clinical testing.

“The big-picture goal,” Dr. Glassman said in an interview, “would be to utilize the model to predict which patients would do well with traditional standard of care treatments and those who wouldn’t do well so that we can personalize the treatment plan for those patients with alternative agents and therapies.”

Once validated, the model could also be employed to identify patterns of disease in other gynecologic cancers or distinguish between viable and necrosed malignant tissue.

The study’s predominant limitation was the small sample size which is being addressed in a larger ongoing study.

Funding was provided by a T32 grant, MD Anderson Cancer Center Support Grant, MD Anderson Ovarian Cancer Moon Shot, SPORE in Ovarian Cancer, the American Cancer Society, and the Ovarian Cancer Research Alliance. Dr. Glassman declared no relevant financial relationships.

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Postpartum HCV treatment rare in infected mothers with opioid use disorder

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Fri, 04/15/2022 - 08:57

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

Dr. Marian P. Jarlenski

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Dr. Mishka Terplan

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

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Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

Dr. Marian P. Jarlenski

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Dr. Mishka Terplan

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

Dr. Marian P. Jarlenski

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Dr. Mishka Terplan

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

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About 19% of COVID-19 headaches become chronic

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Approximately one in five patients who presented with headache during the acute phase of COVID-19 developed chronic daily headache, according to a study published in Cephalalgia. The greater the headache’s intensity during the acute phase, the greater the likelihood that it would persist.

The research, carried out by members of the Headache Study Group of the Spanish Society of Neurology, evaluated the evolution of headache in more than 900 Spanish patients. Because they found that headache intensity during the acute phase was associated with a more prolonged duration of headache, the team stressed the importance of promptly evaluating patients who have had COVID-19 and who then experience persistent headache.
 

Long-term evolution unknown

Headache is a common symptom of COVID-19, but its long-term evolution remains unknown. The objective of this study was to evaluate the long-term duration of headache in patients who presented with this symptom during the acute phase of the disease.

Recruitment for this multicenter study took place in March and April 2020. The 905 patients who were enrolled came from six level 3 hospitals in Spain. All completed 9 months of neurologic follow-up.

Their median age was 51 years, 66.5% were women, and more than half (52.7%) had a history of primary headache. About half of the patients required hospitalization (50.5%); the rest were treated as outpatients. The most common headache phenotype was holocranial (67.8%) of severe intensity (50.6%).
 

Persistent headache common

In the 96.6% cases for which data were available, the median duration of headache was 14 days. The headache persisted at 1 month in 31.1% of patients, at 2 months in 21.5%, at 3 months in 19%, at 6 months in 16.8%, and at 9 months in 16.0%.

“The median duration of COVID-19 headache is around 2 weeks,” David García Azorín, MD, PhD, a member of the Spanish Society of Neurology and one of the coauthors of the study, said in an interview. “However, almost 20% of patients experience it for longer than that. When still present at 2 months, the headache is more likely to follow a chronic daily pattern.” Dr. García Azorín is a neurologist and clinical researcher at the headache unit of the Hospital Clínico Universitario in Valladolid, Spain.

“So, if the headache isn’t letting up, it’s important to make the most of that window of opportunity and provide treatment in that period of 6-12 weeks,” he continued. “To do this, the best option is to carry out preventive treatment so that the patient will have a better chance of recovering.”

Study participants whose headache persisted at 9 months were older and were mostly women. They were less likely to have had pneumonia or to have experienced stabbing pain, photophobia, or phonophobia. They reported that the headache got worse when they engaged in physical activity but less frequently manifested as a throbbing headache.
 

Secondary tension headaches

On the other hand, Jaime Rodríguez Vico, MD, head of the headache unit at the Jiménez Díaz Foundation Hospital in Madrid, said in an interview that, according to his case studies, the most striking characteristics of post–COVID-19 headaches “in general are secondary, with similarities to tension headaches that patients are able to differentiate from other clinical types of headache. In patients with migraine, very often we see that we’re dealing with a trigger. In other words, more migraines – and more intense ones at that – are brought about.”

He added: “Generally, post–COVID-19 headache usually lasts 1-2 weeks, but we have cases of it lasting several months and even over a year with persistent daily headache. These more persistent cases are probably connected to another type of pathology that makes them more susceptible to becoming chronic, something that occurs in another type of primary headache known as new daily persistent headache.”
 

Primary headache exacerbation

Dr. García Azorín pointed out that it’s not uncommon that among people who already have primary headache, their condition worsens after they become infected with SARS-CoV-2. However, many people differentiate the headache associated with the infection from their usual headache because after becoming infected, their headache is predominantly frontal, oppressive, and chronic.

“Having a prior history of headache is one of the factors that can increase the likelihood that a headache experienced while suffering from COVID-19 will become chronic,” he noted.

This study also found that, more often than not, patients with persistent headache at 9 months had migraine-like pain.

As for headaches in these patients beyond 9 months, “based on our research, the evolution is quite variable,” said Dr. Rodríguez Vico. “Our unit’s numbers are skewed due to the high number of migraine cases that we follow, and therefore our high volume of migraine patients who’ve gotten worse. The same thing happens with COVID-19 vaccines. Migraine is a polygenic disorder with multiple variants and a pathophysiology that we are just beginning to describe. This is why one patient is completely different from another. It’s a real challenge.”

Infections are a common cause of acute and chronic headache. The persistence of a headache after an infection may be caused by the infection becoming chronic, as happens in some types of chronic meningitis, such as tuberculous meningitis. It may also be caused by the persistence of a certain response and activation of the immune system or to the uncovering or worsening of a primary headache coincident with the infection, added Dr. García Azorín.

“Likewise, there are other people who have a biological predisposition to headache as a multifactorial disorder and polygenic disorder, such that a particular stimulus – from trauma or an infection to alcohol consumption – can cause them to develop a headache very similar to a migraine,” he said.
 

Providing prognosis and treatment

Certain factors can give an idea of how long the headache might last. The study’s univariate analysis showed that age, female sex, headache intensity, pressure-like quality, the presence of photophobia/phonophobia, and worsening with physical activity were associated with headache of longer duration. But in the multivariate analysis, only headache intensity during the acute phase remained statistically significant (hazard ratio, 0.655; 95% confidence interval, 0.582-0.737; P < .001).

When asked whether they planned to continue the study, Dr. García Azorín commented, “The main questions that have arisen from this study have been, above all: ‘Why does this headache happen?’ and ‘How can it be treated or avoided?’ To answer them, we’re looking into pain: which factors could predispose a person to it and which changes may be associated with its presence.”

In addition, different treatments that may improve patient outcomes are being evaluated, because to date, treatment has been empirical and based on the predominant pain phenotype.

In any case, most doctors currently treat post–COVID-19 headache on the basis of how similar the symptoms are to those of other primary headaches. “Given the impact that headache has on patients’ quality of life, there’s a pressing need for controlled studies on possible treatments and their effectiveness,” noted Patricia Pozo Rosich, MD, PhD, one of the coauthors of the study.

“We at the Spanish Society of Neurology truly believe that if these patients were to have this symptom correctly addressed from the start, they could avoid many of the problems that arise in the situation becoming chronic,” she concluded.

Dr. García Azorín and Dr. Rodríguez Vico disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Approximately one in five patients who presented with headache during the acute phase of COVID-19 developed chronic daily headache, according to a study published in Cephalalgia. The greater the headache’s intensity during the acute phase, the greater the likelihood that it would persist.

The research, carried out by members of the Headache Study Group of the Spanish Society of Neurology, evaluated the evolution of headache in more than 900 Spanish patients. Because they found that headache intensity during the acute phase was associated with a more prolonged duration of headache, the team stressed the importance of promptly evaluating patients who have had COVID-19 and who then experience persistent headache.
 

Long-term evolution unknown

Headache is a common symptom of COVID-19, but its long-term evolution remains unknown. The objective of this study was to evaluate the long-term duration of headache in patients who presented with this symptom during the acute phase of the disease.

Recruitment for this multicenter study took place in March and April 2020. The 905 patients who were enrolled came from six level 3 hospitals in Spain. All completed 9 months of neurologic follow-up.

Their median age was 51 years, 66.5% were women, and more than half (52.7%) had a history of primary headache. About half of the patients required hospitalization (50.5%); the rest were treated as outpatients. The most common headache phenotype was holocranial (67.8%) of severe intensity (50.6%).
 

Persistent headache common

In the 96.6% cases for which data were available, the median duration of headache was 14 days. The headache persisted at 1 month in 31.1% of patients, at 2 months in 21.5%, at 3 months in 19%, at 6 months in 16.8%, and at 9 months in 16.0%.

“The median duration of COVID-19 headache is around 2 weeks,” David García Azorín, MD, PhD, a member of the Spanish Society of Neurology and one of the coauthors of the study, said in an interview. “However, almost 20% of patients experience it for longer than that. When still present at 2 months, the headache is more likely to follow a chronic daily pattern.” Dr. García Azorín is a neurologist and clinical researcher at the headache unit of the Hospital Clínico Universitario in Valladolid, Spain.

“So, if the headache isn’t letting up, it’s important to make the most of that window of opportunity and provide treatment in that period of 6-12 weeks,” he continued. “To do this, the best option is to carry out preventive treatment so that the patient will have a better chance of recovering.”

Study participants whose headache persisted at 9 months were older and were mostly women. They were less likely to have had pneumonia or to have experienced stabbing pain, photophobia, or phonophobia. They reported that the headache got worse when they engaged in physical activity but less frequently manifested as a throbbing headache.
 

Secondary tension headaches

On the other hand, Jaime Rodríguez Vico, MD, head of the headache unit at the Jiménez Díaz Foundation Hospital in Madrid, said in an interview that, according to his case studies, the most striking characteristics of post–COVID-19 headaches “in general are secondary, with similarities to tension headaches that patients are able to differentiate from other clinical types of headache. In patients with migraine, very often we see that we’re dealing with a trigger. In other words, more migraines – and more intense ones at that – are brought about.”

He added: “Generally, post–COVID-19 headache usually lasts 1-2 weeks, but we have cases of it lasting several months and even over a year with persistent daily headache. These more persistent cases are probably connected to another type of pathology that makes them more susceptible to becoming chronic, something that occurs in another type of primary headache known as new daily persistent headache.”
 

Primary headache exacerbation

Dr. García Azorín pointed out that it’s not uncommon that among people who already have primary headache, their condition worsens after they become infected with SARS-CoV-2. However, many people differentiate the headache associated with the infection from their usual headache because after becoming infected, their headache is predominantly frontal, oppressive, and chronic.

“Having a prior history of headache is one of the factors that can increase the likelihood that a headache experienced while suffering from COVID-19 will become chronic,” he noted.

This study also found that, more often than not, patients with persistent headache at 9 months had migraine-like pain.

As for headaches in these patients beyond 9 months, “based on our research, the evolution is quite variable,” said Dr. Rodríguez Vico. “Our unit’s numbers are skewed due to the high number of migraine cases that we follow, and therefore our high volume of migraine patients who’ve gotten worse. The same thing happens with COVID-19 vaccines. Migraine is a polygenic disorder with multiple variants and a pathophysiology that we are just beginning to describe. This is why one patient is completely different from another. It’s a real challenge.”

Infections are a common cause of acute and chronic headache. The persistence of a headache after an infection may be caused by the infection becoming chronic, as happens in some types of chronic meningitis, such as tuberculous meningitis. It may also be caused by the persistence of a certain response and activation of the immune system or to the uncovering or worsening of a primary headache coincident with the infection, added Dr. García Azorín.

“Likewise, there are other people who have a biological predisposition to headache as a multifactorial disorder and polygenic disorder, such that a particular stimulus – from trauma or an infection to alcohol consumption – can cause them to develop a headache very similar to a migraine,” he said.
 

Providing prognosis and treatment

Certain factors can give an idea of how long the headache might last. The study’s univariate analysis showed that age, female sex, headache intensity, pressure-like quality, the presence of photophobia/phonophobia, and worsening with physical activity were associated with headache of longer duration. But in the multivariate analysis, only headache intensity during the acute phase remained statistically significant (hazard ratio, 0.655; 95% confidence interval, 0.582-0.737; P < .001).

When asked whether they planned to continue the study, Dr. García Azorín commented, “The main questions that have arisen from this study have been, above all: ‘Why does this headache happen?’ and ‘How can it be treated or avoided?’ To answer them, we’re looking into pain: which factors could predispose a person to it and which changes may be associated with its presence.”

In addition, different treatments that may improve patient outcomes are being evaluated, because to date, treatment has been empirical and based on the predominant pain phenotype.

In any case, most doctors currently treat post–COVID-19 headache on the basis of how similar the symptoms are to those of other primary headaches. “Given the impact that headache has on patients’ quality of life, there’s a pressing need for controlled studies on possible treatments and their effectiveness,” noted Patricia Pozo Rosich, MD, PhD, one of the coauthors of the study.

“We at the Spanish Society of Neurology truly believe that if these patients were to have this symptom correctly addressed from the start, they could avoid many of the problems that arise in the situation becoming chronic,” she concluded.

Dr. García Azorín and Dr. Rodríguez Vico disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Approximately one in five patients who presented with headache during the acute phase of COVID-19 developed chronic daily headache, according to a study published in Cephalalgia. The greater the headache’s intensity during the acute phase, the greater the likelihood that it would persist.

The research, carried out by members of the Headache Study Group of the Spanish Society of Neurology, evaluated the evolution of headache in more than 900 Spanish patients. Because they found that headache intensity during the acute phase was associated with a more prolonged duration of headache, the team stressed the importance of promptly evaluating patients who have had COVID-19 and who then experience persistent headache.
 

Long-term evolution unknown

Headache is a common symptom of COVID-19, but its long-term evolution remains unknown. The objective of this study was to evaluate the long-term duration of headache in patients who presented with this symptom during the acute phase of the disease.

Recruitment for this multicenter study took place in March and April 2020. The 905 patients who were enrolled came from six level 3 hospitals in Spain. All completed 9 months of neurologic follow-up.

Their median age was 51 years, 66.5% were women, and more than half (52.7%) had a history of primary headache. About half of the patients required hospitalization (50.5%); the rest were treated as outpatients. The most common headache phenotype was holocranial (67.8%) of severe intensity (50.6%).
 

Persistent headache common

In the 96.6% cases for which data were available, the median duration of headache was 14 days. The headache persisted at 1 month in 31.1% of patients, at 2 months in 21.5%, at 3 months in 19%, at 6 months in 16.8%, and at 9 months in 16.0%.

“The median duration of COVID-19 headache is around 2 weeks,” David García Azorín, MD, PhD, a member of the Spanish Society of Neurology and one of the coauthors of the study, said in an interview. “However, almost 20% of patients experience it for longer than that. When still present at 2 months, the headache is more likely to follow a chronic daily pattern.” Dr. García Azorín is a neurologist and clinical researcher at the headache unit of the Hospital Clínico Universitario in Valladolid, Spain.

“So, if the headache isn’t letting up, it’s important to make the most of that window of opportunity and provide treatment in that period of 6-12 weeks,” he continued. “To do this, the best option is to carry out preventive treatment so that the patient will have a better chance of recovering.”

Study participants whose headache persisted at 9 months were older and were mostly women. They were less likely to have had pneumonia or to have experienced stabbing pain, photophobia, or phonophobia. They reported that the headache got worse when they engaged in physical activity but less frequently manifested as a throbbing headache.
 

Secondary tension headaches

On the other hand, Jaime Rodríguez Vico, MD, head of the headache unit at the Jiménez Díaz Foundation Hospital in Madrid, said in an interview that, according to his case studies, the most striking characteristics of post–COVID-19 headaches “in general are secondary, with similarities to tension headaches that patients are able to differentiate from other clinical types of headache. In patients with migraine, very often we see that we’re dealing with a trigger. In other words, more migraines – and more intense ones at that – are brought about.”

He added: “Generally, post–COVID-19 headache usually lasts 1-2 weeks, but we have cases of it lasting several months and even over a year with persistent daily headache. These more persistent cases are probably connected to another type of pathology that makes them more susceptible to becoming chronic, something that occurs in another type of primary headache known as new daily persistent headache.”
 

Primary headache exacerbation

Dr. García Azorín pointed out that it’s not uncommon that among people who already have primary headache, their condition worsens after they become infected with SARS-CoV-2. However, many people differentiate the headache associated with the infection from their usual headache because after becoming infected, their headache is predominantly frontal, oppressive, and chronic.

“Having a prior history of headache is one of the factors that can increase the likelihood that a headache experienced while suffering from COVID-19 will become chronic,” he noted.

This study also found that, more often than not, patients with persistent headache at 9 months had migraine-like pain.

As for headaches in these patients beyond 9 months, “based on our research, the evolution is quite variable,” said Dr. Rodríguez Vico. “Our unit’s numbers are skewed due to the high number of migraine cases that we follow, and therefore our high volume of migraine patients who’ve gotten worse. The same thing happens with COVID-19 vaccines. Migraine is a polygenic disorder with multiple variants and a pathophysiology that we are just beginning to describe. This is why one patient is completely different from another. It’s a real challenge.”

Infections are a common cause of acute and chronic headache. The persistence of a headache after an infection may be caused by the infection becoming chronic, as happens in some types of chronic meningitis, such as tuberculous meningitis. It may also be caused by the persistence of a certain response and activation of the immune system or to the uncovering or worsening of a primary headache coincident with the infection, added Dr. García Azorín.

“Likewise, there are other people who have a biological predisposition to headache as a multifactorial disorder and polygenic disorder, such that a particular stimulus – from trauma or an infection to alcohol consumption – can cause them to develop a headache very similar to a migraine,” he said.
 

Providing prognosis and treatment

Certain factors can give an idea of how long the headache might last. The study’s univariate analysis showed that age, female sex, headache intensity, pressure-like quality, the presence of photophobia/phonophobia, and worsening with physical activity were associated with headache of longer duration. But in the multivariate analysis, only headache intensity during the acute phase remained statistically significant (hazard ratio, 0.655; 95% confidence interval, 0.582-0.737; P < .001).

When asked whether they planned to continue the study, Dr. García Azorín commented, “The main questions that have arisen from this study have been, above all: ‘Why does this headache happen?’ and ‘How can it be treated or avoided?’ To answer them, we’re looking into pain: which factors could predispose a person to it and which changes may be associated with its presence.”

In addition, different treatments that may improve patient outcomes are being evaluated, because to date, treatment has been empirical and based on the predominant pain phenotype.

In any case, most doctors currently treat post–COVID-19 headache on the basis of how similar the symptoms are to those of other primary headaches. “Given the impact that headache has on patients’ quality of life, there’s a pressing need for controlled studies on possible treatments and their effectiveness,” noted Patricia Pozo Rosich, MD, PhD, one of the coauthors of the study.

“We at the Spanish Society of Neurology truly believe that if these patients were to have this symptom correctly addressed from the start, they could avoid many of the problems that arise in the situation becoming chronic,” she concluded.

Dr. García Azorín and Dr. Rodríguez Vico disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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FDA to decide by June on future of COVID vaccines

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Fri, 04/08/2022 - 10:33

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

 

 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

A version of this article first appeared on WebMD.com.

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The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

 

 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

A version of this article first appeared on WebMD.com.

The next generation of COVID-19 vaccines should be able to fight off a new strain and be given each year, a panel of experts that advises the Food and Drug Administration said April 6.

But members of the panel also acknowledged that it will be an uphill battle to reach that goal, especially given how quickly the virus continues to change.

The members of the Vaccines and Related Biological Products Advisory Committee said they want to find the balance that makes sure Americans are protected against severe illness and death but doesn’t wear them out with constant recommendations for boosters.

“We don’t feel comfortable with multiple boosters every 8 weeks,” said committee chairman Arnold Monto, MD, professor emeritus of public health at the University of Michigan, Ann Arbor. “We’d love to see an annual vaccination similar to influenza but realize that the evolution of the virus will dictate how we respond in terms of additional vaccine doses.”

The virus itself will dictate vaccination plans, he said.

The government must also keep its focus on convincing Americans who haven’t been vaccinated to join the club, said committee member Henry H. Bernstein, DO, given that “it seems quite obvious that those who are vaccinated do better than those who aren’t vaccinated.”

The government should clearly communicate to the public the goals of vaccination, he said.

“I would suggest that our overall aim is to prevent severe disease, hospitalization, and death more than just infection prevention,” said Dr. Bernstein, professor of pediatrics at Hofstra University, Hempstead, N.Y.

The FDA called the meeting of its advisers to discuss overall booster and vaccine strategy, even though it already authorized a fourth dose of the Pfizer and Moderna vaccines for certain immune compromised adults and for everyone over age 50.

Early in the all-day meeting, temporary committee member James Hildreth, MD, the president of Meharry Medical College, Nashville, Tenn., asked why that authorization was given without the panel’s input. Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that suggested immunity from a third shot was already waning.

Dr. Marks later said the fourth dose was “authorized as a stopgap measure until we could get something else in place,” because the aim was to protect older Americans who had died at a higher rate than younger individuals.

“I think we’re very much on board that we simply can’t be boosting people as frequently as we are,” said Dr. Marks.
 

Not enough information to make broader plan

The meeting was meant to be a larger conversation about how to keep pace with the evolving virus and to set up a vaccine selection and development process to better and more quickly respond to changes, such as new variants.

But committee members said they felt stymied by a lack of information. They wanted more data from vaccine manufacturers’ clinical trials. And they noted that so far, there’s no objective, reliable lab-based measurement of COVID-19 vaccine effectiveness – known as a correlate of immunity. Instead, public health officials have looked at rates of hospitalizations and deaths to measure whether the vaccine is still offering protection.

“The question is, what is insufficient protection?” asked H. Cody Meissner, MD, director of pediatric infectious disease at Tufts Medical Center in Boston. “At what point will we say the vaccine isn’t working well enough?”

Centers for Disease Control and Prevention officials presented data showing that a third shot has been more effective than a two-shot regimen in preventing serious disease and death, and that the three shots were significantly more protective than being unvaccinated.

In February, as the Omicron variant continued to rage, unvaccinated Americans aged 5 years and older had an almost three times higher risk of testing positive, and nine times higher risk of dying, compared with those who were considered fully vaccinated, said Heather Scobie, PhD, MPH, a member of the CDC’s COVID-19 Emergency Response team.

But only 98 million Americans – about half of those aged 12 years or older – have received a third dose, Dr. Scobie said.

It’s also still not clear how much more protection a fourth shot adds, or how long it will last. The committee heard data on a just-published study of a fourth dose of the Pfizer vaccine given to some 600,000 Israelis during the Omicron wave from January to March. The rate of severe COVID-19 was 3.5 times lower in the group that received a fourth dose, compared with those who had gotten only three shots, and protection lasted for at least 12 weeks.

Still, study authors said, any protection against infection itself was “short lived.”


 

 

 

More like flu vaccine?

The advisers discussed the possibility of making COVID-19 vaccine development similar to the process for the flu vaccine but acknowledged many difficulties.

The flu predictably hits during the winter in each hemisphere and a global surveillance network helps the World Health Organization decide on the vaccine strains each year. Then each nation’s regulatory and public health officials choose the strains for their shot and vaccine makers begin what is typically a 6-month-long manufacturing process.

COVID outbreaks have happened during all seasons and new variants haven’t always hit every country in a similar fashion. The COVID virus has mutated at five times the speed of the flu virus – producing a new dominant strain in a year, compared with the 3-5 years it takes for the flu virus to do so, said Trevor Bedford, PhD, a professor in the vaccine and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle.

Global COVID surveillance is patchy and the WHO has not yet created a program to help select strains for a COVID-19 vaccine but is working on a process. Currently, vaccine makers seem to be driving vaccine strain selection, said panelist Paul Offit, MD, professor of paediatrics at Children’s Hospital of Philadelphia. “I feel like to some extent the companies dictate the conversation. It shouldn’t come from them. It should come from us.”

“The important thing is that the public understands how complex this is,” said temporary committee member Oveta A. Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan. “We didn’t get to understand influenza in 2 years. It’s taken years to get an imperfect but useful process to deal with flu.”

A version of this article first appeared on WebMD.com.

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Preterm C-sections, induced deliveries dropped during COVID-19 pandemic

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Changed
Thu, 12/15/2022 - 14:33

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

Dr. Daniel Dench

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

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Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

Dr. Daniel Dench

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

Dr. Daniel Dench

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

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‘Outbid on three houses!’ Doc frustrated by crazy market

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Fri, 04/08/2022 - 08:28

After more than a decade of moving because of medical school, residencies, and international fellowships, Abhi Kole, MD, PhD, is ready to put down roots. But he’s learning that buying a house in today’s housing market is easier said than done.

In the past 6 months, Dr. Kole, an internist at Grady Hospital in Atlanta, put in offers on three houses. None resulted in a purchase. Dr. Kole says he’s learned how to be more competitive with each subsequent offer, starting out with a bid significantly above the asking price and waiving his right to an appraisal or financing contingencies.

The experience has been surprising and disappointing.

“I knew the market was bad when I started looking and that home prices had gone up,” Dr. Kole says. “What I didn’t realize was that it would still be so hard for me. I have a good job, no debt, and great credit.”

Another frustration for Dr. Kole: He’s been approved for a physician’s loan (a type of mortgage that requires a lower down payment and does not count student loans in debt-to-income calculations) from a national bank, but sellers seem to prefer buyers who work with local lenders. Dr. Kole has been willing to waive the appraisal and mortgage contingency on the right home, but he draws the line at waiving the inspection, a trend that some other buyers in his area are going along with.

“With each house, I learn more about how this works and what amount of risk I can safely assume,” Dr. Kobe says. “There are certain things I definitely wouldn’t give up.”

Dr. Kole’s experience mirrors that of millions of other would-be homebuyers navigating a strong seller’s market.

“Potential homebuyers are really facing a triple threat right now,” says Clare Losey, an assistant research economist with the Texas Real Estate Research Center. “There’s high home appreciation, high mortgage rates, and low inventory of homes for sale.”

It’s still possible to find — and buy — your dream home, even in today’s market with all its challenges. Here are some important steps that can help you.
 

1. Do not low ball.

There may be some cases in which you can save money by making an offer significantly below the asking price on a property. However, with most housing areas across the country experiencing a seller’s market, you run the risk of offending the buyer or being dismissed as not having a serious offer.

In today’s market, a better strategy is to go in with close to your best and final offer from the start, realtors say. It can help to waive the appraisal or financing contingency as well, although it’s important to understand the risk associated with doing so. Last month, the average home sold for 103% of the list price, according to data compiled from Statista.
 

2. Get credit ready.

The better your credit, the easier time you’ll have getting a mortgage — and the lower the rate you’ll pay for the loan. The average first-time homebuyer has a credit score of 746, according to a recent paper by Fannie Mae. If you know you’re going to buy a home in the next few months, you can improve your credit by making sure to pay all your bills on time and by avoiding taking on any new debt.

This is also a good opportunity to check your credit report (get all three reports for free from AnnualCreditReport.com) to see whether there are any mistakes or other problems that you’ll need to clear up before applying for a loan. Also, take a look at your credit-utilization ratio (the amount of credit you use compared to the amount available to you). Experts recommend keeping this number below 30%.
 

3. Prepare to move quickly.

Among homes that closed in March, the average number of days on the market (the amount of time between listing and closing) was just 38 days, according to Realtor.com. In busy markets, homes are moving even faster, realtors say, with sellers commonly accepting offers within days of listing their house for sale.

“It’s crazy,” says Sarah Scattini, president of the Reno/Sparks Association of Realtors. “The market is moving extremely fast here. If you list your home, your sale is pending within 5 days.”

In addition to moving quickly to make your initial offer, do the same if a buyer counters with a negotiation. A speedy response will show the buyer that you’re very interested — and to beat out any other bidders who may have also received a counteroffer.
 

4. Shop around for mortgages.

Especially for first-time homebuyers, the process will go much more smoothly if you’ve got a team of professionals to help you. Look for a realtor and a mortgage lender who have experience working with first-time homebuyers and with physicians, if possible.

Since mortgage rates can vary wildly, you’ll want to shop around a bit before settling on a lender. Get quotes from a local lender, an online lender, and, potentially, a credit union or a mortgage broker to get a sense of the types of mortgages and rates available to you.

“With multiple offers on every single listing, you really want to align yourself with a great realtor who can negotiate for you on your behalf and navigate you through this very tricky market,” says Ms. Scattini.

For both your realtor and your lender, you’ll want to know up front how they get paid and how they calculate their fees. Typically, the real estate agents for buyers and sellers split a 6% commission on home sales, meaning that your realtor will likely take home 3% of the purchase price.
 

5. Get preapproved.

Once you’ve settled on a lender, getting preapproved for a mortgage can make your offer more appealing to potential buyers. Preapproval is an in-depth process in which lenders pull your credit and look at other financial factors, such as your income and assets, to tell you ahead of time how much you could borrow under their standards and how much that might cost you.

These days, a large number of buyers are coming in with a cash offer, which in former times was considered very appealing to sellers. However, preapproval helps equalize buyers, and as one seller noted, “I don’t care if it’s cash or mortgage, as long as I get the money.”

If, like most homebuyers, you need a mortgage to finance the purchase, having preapproval can provide some assurance to sellers that your offer won’t fall through because you can’t qualify for the mortgage you expected. Once you’ve received preapproval, don’t open any new credit accounts. If your credit score goes down, the amount you can borrow could decline as well.
 

 

 

6. Firm up your budget.

While the preapproval process will tell you how much a lender thinks you can afford, it typically makes sense to come up with your own budget as well. That’s because banks and other mortgage lenders may approve you for much more than you want or are able to pay for a home.

You’ll want to factor in future costs of homeowners as well as any other (current or future) expenses for which the lender may not have accounted. For example, if you’re planning to have children soon, you may want to lower your budget to factor in the cost of childcare.

Knowing your budget ahead of time, and looking only at houses that fall within it, will prevent you from falling in love with a house that you really can’t afford.
 

7. Stick with it.

Buying a house in today’s market is no easy task. The first part of the process requires simply looking at multiple houses to get a sense of how far your budget will go and whether there are homes that meet your requirements.

If you’re sure that purchasing a home is the best financial move for you, don’t give up. Instead, consider whether you can make adjustments that could widen your pool of potential homes. That may mean changing your budget, moving a little further out geographically, or opting for a house that needs a little more work than you expected.

That said, while the pace of price increases will likely moderate, it’s unlikely prices will go down significantly in the future.

“We might see home price appreciation subside to levels close to 10% to 15% [from 20% last year] or even just 5% to 10%,” Ms. Losey says. “When you do the math, home prices just can’t continue to go up 20% year over year.”

Dr. Kobe is planning to keep looking for his home for at least the next several months.

“Prices are still going up, but we are hearing that the inventory will increase over the summer,” he says. “I’m still out looking for the right house, and I’m ready to make an offer.”

A version of this article first appeared on Medscape.com.

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After more than a decade of moving because of medical school, residencies, and international fellowships, Abhi Kole, MD, PhD, is ready to put down roots. But he’s learning that buying a house in today’s housing market is easier said than done.

In the past 6 months, Dr. Kole, an internist at Grady Hospital in Atlanta, put in offers on three houses. None resulted in a purchase. Dr. Kole says he’s learned how to be more competitive with each subsequent offer, starting out with a bid significantly above the asking price and waiving his right to an appraisal or financing contingencies.

The experience has been surprising and disappointing.

“I knew the market was bad when I started looking and that home prices had gone up,” Dr. Kole says. “What I didn’t realize was that it would still be so hard for me. I have a good job, no debt, and great credit.”

Another frustration for Dr. Kole: He’s been approved for a physician’s loan (a type of mortgage that requires a lower down payment and does not count student loans in debt-to-income calculations) from a national bank, but sellers seem to prefer buyers who work with local lenders. Dr. Kole has been willing to waive the appraisal and mortgage contingency on the right home, but he draws the line at waiving the inspection, a trend that some other buyers in his area are going along with.

“With each house, I learn more about how this works and what amount of risk I can safely assume,” Dr. Kobe says. “There are certain things I definitely wouldn’t give up.”

Dr. Kole’s experience mirrors that of millions of other would-be homebuyers navigating a strong seller’s market.

“Potential homebuyers are really facing a triple threat right now,” says Clare Losey, an assistant research economist with the Texas Real Estate Research Center. “There’s high home appreciation, high mortgage rates, and low inventory of homes for sale.”

It’s still possible to find — and buy — your dream home, even in today’s market with all its challenges. Here are some important steps that can help you.
 

1. Do not low ball.

There may be some cases in which you can save money by making an offer significantly below the asking price on a property. However, with most housing areas across the country experiencing a seller’s market, you run the risk of offending the buyer or being dismissed as not having a serious offer.

In today’s market, a better strategy is to go in with close to your best and final offer from the start, realtors say. It can help to waive the appraisal or financing contingency as well, although it’s important to understand the risk associated with doing so. Last month, the average home sold for 103% of the list price, according to data compiled from Statista.
 

2. Get credit ready.

The better your credit, the easier time you’ll have getting a mortgage — and the lower the rate you’ll pay for the loan. The average first-time homebuyer has a credit score of 746, according to a recent paper by Fannie Mae. If you know you’re going to buy a home in the next few months, you can improve your credit by making sure to pay all your bills on time and by avoiding taking on any new debt.

This is also a good opportunity to check your credit report (get all three reports for free from AnnualCreditReport.com) to see whether there are any mistakes or other problems that you’ll need to clear up before applying for a loan. Also, take a look at your credit-utilization ratio (the amount of credit you use compared to the amount available to you). Experts recommend keeping this number below 30%.
 

3. Prepare to move quickly.

Among homes that closed in March, the average number of days on the market (the amount of time between listing and closing) was just 38 days, according to Realtor.com. In busy markets, homes are moving even faster, realtors say, with sellers commonly accepting offers within days of listing their house for sale.

“It’s crazy,” says Sarah Scattini, president of the Reno/Sparks Association of Realtors. “The market is moving extremely fast here. If you list your home, your sale is pending within 5 days.”

In addition to moving quickly to make your initial offer, do the same if a buyer counters with a negotiation. A speedy response will show the buyer that you’re very interested — and to beat out any other bidders who may have also received a counteroffer.
 

4. Shop around for mortgages.

Especially for first-time homebuyers, the process will go much more smoothly if you’ve got a team of professionals to help you. Look for a realtor and a mortgage lender who have experience working with first-time homebuyers and with physicians, if possible.

Since mortgage rates can vary wildly, you’ll want to shop around a bit before settling on a lender. Get quotes from a local lender, an online lender, and, potentially, a credit union or a mortgage broker to get a sense of the types of mortgages and rates available to you.

“With multiple offers on every single listing, you really want to align yourself with a great realtor who can negotiate for you on your behalf and navigate you through this very tricky market,” says Ms. Scattini.

For both your realtor and your lender, you’ll want to know up front how they get paid and how they calculate their fees. Typically, the real estate agents for buyers and sellers split a 6% commission on home sales, meaning that your realtor will likely take home 3% of the purchase price.
 

5. Get preapproved.

Once you’ve settled on a lender, getting preapproved for a mortgage can make your offer more appealing to potential buyers. Preapproval is an in-depth process in which lenders pull your credit and look at other financial factors, such as your income and assets, to tell you ahead of time how much you could borrow under their standards and how much that might cost you.

These days, a large number of buyers are coming in with a cash offer, which in former times was considered very appealing to sellers. However, preapproval helps equalize buyers, and as one seller noted, “I don’t care if it’s cash or mortgage, as long as I get the money.”

If, like most homebuyers, you need a mortgage to finance the purchase, having preapproval can provide some assurance to sellers that your offer won’t fall through because you can’t qualify for the mortgage you expected. Once you’ve received preapproval, don’t open any new credit accounts. If your credit score goes down, the amount you can borrow could decline as well.
 

 

 

6. Firm up your budget.

While the preapproval process will tell you how much a lender thinks you can afford, it typically makes sense to come up with your own budget as well. That’s because banks and other mortgage lenders may approve you for much more than you want or are able to pay for a home.

You’ll want to factor in future costs of homeowners as well as any other (current or future) expenses for which the lender may not have accounted. For example, if you’re planning to have children soon, you may want to lower your budget to factor in the cost of childcare.

Knowing your budget ahead of time, and looking only at houses that fall within it, will prevent you from falling in love with a house that you really can’t afford.
 

7. Stick with it.

Buying a house in today’s market is no easy task. The first part of the process requires simply looking at multiple houses to get a sense of how far your budget will go and whether there are homes that meet your requirements.

If you’re sure that purchasing a home is the best financial move for you, don’t give up. Instead, consider whether you can make adjustments that could widen your pool of potential homes. That may mean changing your budget, moving a little further out geographically, or opting for a house that needs a little more work than you expected.

That said, while the pace of price increases will likely moderate, it’s unlikely prices will go down significantly in the future.

“We might see home price appreciation subside to levels close to 10% to 15% [from 20% last year] or even just 5% to 10%,” Ms. Losey says. “When you do the math, home prices just can’t continue to go up 20% year over year.”

Dr. Kobe is planning to keep looking for his home for at least the next several months.

“Prices are still going up, but we are hearing that the inventory will increase over the summer,” he says. “I’m still out looking for the right house, and I’m ready to make an offer.”

A version of this article first appeared on Medscape.com.

After more than a decade of moving because of medical school, residencies, and international fellowships, Abhi Kole, MD, PhD, is ready to put down roots. But he’s learning that buying a house in today’s housing market is easier said than done.

In the past 6 months, Dr. Kole, an internist at Grady Hospital in Atlanta, put in offers on three houses. None resulted in a purchase. Dr. Kole says he’s learned how to be more competitive with each subsequent offer, starting out with a bid significantly above the asking price and waiving his right to an appraisal or financing contingencies.

The experience has been surprising and disappointing.

“I knew the market was bad when I started looking and that home prices had gone up,” Dr. Kole says. “What I didn’t realize was that it would still be so hard for me. I have a good job, no debt, and great credit.”

Another frustration for Dr. Kole: He’s been approved for a physician’s loan (a type of mortgage that requires a lower down payment and does not count student loans in debt-to-income calculations) from a national bank, but sellers seem to prefer buyers who work with local lenders. Dr. Kole has been willing to waive the appraisal and mortgage contingency on the right home, but he draws the line at waiving the inspection, a trend that some other buyers in his area are going along with.

“With each house, I learn more about how this works and what amount of risk I can safely assume,” Dr. Kobe says. “There are certain things I definitely wouldn’t give up.”

Dr. Kole’s experience mirrors that of millions of other would-be homebuyers navigating a strong seller’s market.

“Potential homebuyers are really facing a triple threat right now,” says Clare Losey, an assistant research economist with the Texas Real Estate Research Center. “There’s high home appreciation, high mortgage rates, and low inventory of homes for sale.”

It’s still possible to find — and buy — your dream home, even in today’s market with all its challenges. Here are some important steps that can help you.
 

1. Do not low ball.

There may be some cases in which you can save money by making an offer significantly below the asking price on a property. However, with most housing areas across the country experiencing a seller’s market, you run the risk of offending the buyer or being dismissed as not having a serious offer.

In today’s market, a better strategy is to go in with close to your best and final offer from the start, realtors say. It can help to waive the appraisal or financing contingency as well, although it’s important to understand the risk associated with doing so. Last month, the average home sold for 103% of the list price, according to data compiled from Statista.
 

2. Get credit ready.

The better your credit, the easier time you’ll have getting a mortgage — and the lower the rate you’ll pay for the loan. The average first-time homebuyer has a credit score of 746, according to a recent paper by Fannie Mae. If you know you’re going to buy a home in the next few months, you can improve your credit by making sure to pay all your bills on time and by avoiding taking on any new debt.

This is also a good opportunity to check your credit report (get all three reports for free from AnnualCreditReport.com) to see whether there are any mistakes or other problems that you’ll need to clear up before applying for a loan. Also, take a look at your credit-utilization ratio (the amount of credit you use compared to the amount available to you). Experts recommend keeping this number below 30%.
 

3. Prepare to move quickly.

Among homes that closed in March, the average number of days on the market (the amount of time between listing and closing) was just 38 days, according to Realtor.com. In busy markets, homes are moving even faster, realtors say, with sellers commonly accepting offers within days of listing their house for sale.

“It’s crazy,” says Sarah Scattini, president of the Reno/Sparks Association of Realtors. “The market is moving extremely fast here. If you list your home, your sale is pending within 5 days.”

In addition to moving quickly to make your initial offer, do the same if a buyer counters with a negotiation. A speedy response will show the buyer that you’re very interested — and to beat out any other bidders who may have also received a counteroffer.
 

4. Shop around for mortgages.

Especially for first-time homebuyers, the process will go much more smoothly if you’ve got a team of professionals to help you. Look for a realtor and a mortgage lender who have experience working with first-time homebuyers and with physicians, if possible.

Since mortgage rates can vary wildly, you’ll want to shop around a bit before settling on a lender. Get quotes from a local lender, an online lender, and, potentially, a credit union or a mortgage broker to get a sense of the types of mortgages and rates available to you.

“With multiple offers on every single listing, you really want to align yourself with a great realtor who can negotiate for you on your behalf and navigate you through this very tricky market,” says Ms. Scattini.

For both your realtor and your lender, you’ll want to know up front how they get paid and how they calculate their fees. Typically, the real estate agents for buyers and sellers split a 6% commission on home sales, meaning that your realtor will likely take home 3% of the purchase price.
 

5. Get preapproved.

Once you’ve settled on a lender, getting preapproved for a mortgage can make your offer more appealing to potential buyers. Preapproval is an in-depth process in which lenders pull your credit and look at other financial factors, such as your income and assets, to tell you ahead of time how much you could borrow under their standards and how much that might cost you.

These days, a large number of buyers are coming in with a cash offer, which in former times was considered very appealing to sellers. However, preapproval helps equalize buyers, and as one seller noted, “I don’t care if it’s cash or mortgage, as long as I get the money.”

If, like most homebuyers, you need a mortgage to finance the purchase, having preapproval can provide some assurance to sellers that your offer won’t fall through because you can’t qualify for the mortgage you expected. Once you’ve received preapproval, don’t open any new credit accounts. If your credit score goes down, the amount you can borrow could decline as well.
 

 

 

6. Firm up your budget.

While the preapproval process will tell you how much a lender thinks you can afford, it typically makes sense to come up with your own budget as well. That’s because banks and other mortgage lenders may approve you for much more than you want or are able to pay for a home.

You’ll want to factor in future costs of homeowners as well as any other (current or future) expenses for which the lender may not have accounted. For example, if you’re planning to have children soon, you may want to lower your budget to factor in the cost of childcare.

Knowing your budget ahead of time, and looking only at houses that fall within it, will prevent you from falling in love with a house that you really can’t afford.
 

7. Stick with it.

Buying a house in today’s market is no easy task. The first part of the process requires simply looking at multiple houses to get a sense of how far your budget will go and whether there are homes that meet your requirements.

If you’re sure that purchasing a home is the best financial move for you, don’t give up. Instead, consider whether you can make adjustments that could widen your pool of potential homes. That may mean changing your budget, moving a little further out geographically, or opting for a house that needs a little more work than you expected.

That said, while the pace of price increases will likely moderate, it’s unlikely prices will go down significantly in the future.

“We might see home price appreciation subside to levels close to 10% to 15% [from 20% last year] or even just 5% to 10%,” Ms. Losey says. “When you do the math, home prices just can’t continue to go up 20% year over year.”

Dr. Kobe is planning to keep looking for his home for at least the next several months.

“Prices are still going up, but we are hearing that the inventory will increase over the summer,” he says. “I’m still out looking for the right house, and I’m ready to make an offer.”

A version of this article first appeared on Medscape.com.

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Tebipenem pivoxil hydrobromide offers oral option for complex UTIs

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Wed, 04/13/2022 - 13:48

Oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) offers a safe and effective strategy for treating patients with complicated urinary tract infections, according to a new study.

“No new oral antibiotic alternative has emerged to treat these conditions in more than 25 years,” corresponding author Angela K. Talley, MD, said in an interview. The new research was published in the New England Journal of Medicine.

Courtesy Spero Therapeutics
Dr. Angela K. Talley

Patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), are often hospitalized and treated with intravenous therapy because of the lack of oral options, especially in cases of antibiotic-resistant pathogens, explained Dr. Talley, of Spero Therapeutics.

In their new phase 3, double-blind randomized trial, the researchers evaluated the safety and effectiveness of oral TBP-PI-HBr, compared with intravenous ertapenem in hospitalized patients with cUTIs or AP. Oral tebipenem is an investigational carbapenem with demonstrated activity against uropathogenic Enterobacterales, and it has shown effectiveness in animal models, the researchers noted in their paper.
 

Methods and results

The researchers randomized 1,372 adult patients. The microbiologic intent-to-treat population included 449 patients who received TBP-PI-HBr (600 mg every 8 hours) and 419 who received ertapenem (1 g every 24 hours) for 7-10 days or up to 14 days for patients with bacteremia.

The primary endpoint was a composite of clinical cure and favorable microbiologic response, assessed at a test-of-cure visit on day 19. Clinical cure was defined as “complete resolution or clinically significant alleviation of baseline signs and symptoms of complicated urinary tract infection or acute pyelonephritis and no new symptoms, such that no further antimicrobial therapy was warranted,” the researchers wrote. Microbiologic response was defined as a reduction to less than 103 CFU per milliliter in uropathogen levels from baseline at day 19.

Overall, the clinical response occurred in 58.8% of patients who received TBP-PI-HBr and 61.6% of those who received ertapenem at the test-of-cure visit.

Clinical cure rates were similar in the TBP-PI-HBr and ertapenem groups (93.1% vs. 93.6%) at the test-of-cure visit.

Both treatment groups showed similar responses to Enterobacterales pathogens at the test-of-cure visit (62.7% for TBP-PI-HBr and 65.2% for ertapenem).

Among patients with bacteremia at baseline, overall response rates were 72.3% and 66.0% for TBP-PI-HBr and ertapenem, respectively, at the test-of-cure visit, and 93.6% and 96.2%, respectively, at the end-of-treatment visit on or around day 25.

The overall incidence of adverse events was approximately 26% in both treatment groups. Most adverse events were mild or moderate in severity and did not limit treatment, the researchers wrote.

The mean age of the patients was 58.1 years; 46.1% were aged 65 and older, and 11.5% had bacteremia at baseline.

The study findings were limited by several factors, including the mandated 7- to 10-day course of antibiotics, which may not reflect the standard of care in other settings in the United States. The study’s trial sites were located in the United States, South Africa, and Europe. The study population was primarily White and from Central and Eastern Europe. Other limitations included the randomization of patients before confirming the baseline pathogen, although this was done to limit potential confounding from previous antibiotics, the researchers noted.
 

 

 

Safety and efficacy support application for approval

“To our knowledge, this is the first head-to-head evaluation of an IV vs. an oral drug for the treatment of cUTI and acute pyelonephritis,” Dr. Talley said in an interview.  

“The findings demonstrate that almost all patients in the study achieved complete resolution of the signs and symptoms of their infection,” she said.

TBP-PI-HBr has not been approved by the Food and Drug Administration, but a new drug application that included data from the current study was submitted to the FDA and is currently under review, Dr. Talley noted.

As for additional research, the current study was conducted in hospitalized patients, and the use of TBP-PI-HBr in the outpatient setting has not yet been evaluated, she said.
 

Approval and use of oral carbapenem will change practice

The current study is very important because it provides a viable and effective alternative form of antibiotic delivery for the patients with complicated UTI, Noel N. Deep, MD, emphasized in an interview.

Dr. Noel N. Deep

“Currently these patients have to be treated with IV carbapenem antibiotics either in a hospital or through a home health nurse,” Dr. Deep, a general internist in group practice in Antigo, Wisc., explained.

Current IV strategies also carry the inherent risk associated with the insertion of an IV catheter that is left in place for several days or replaced periodically. “The oral antibiotic eliminates these risks and higher health care costs and provides a safer and equally efficacious option,” Dr. Deep said.

In the current study, “I was definitely surprised at the effectiveness of the oral carbapenem,” Dr. Deep said. “I am absolutely delighted with this new treatment option that physicians can now add to their armamentarium [assuming FDA approval] as we provide care to our patients,” he said.

If approved, TBP-PI-HBr will definitely change the treatment spectrum for the multidrug-resistant bacterial UTIs, said Dr. Deep. “Carbapenems have continued to be effective and low antibiotic resistance to carbapenems has been recorded.”

As for additional research, “I would like to see studies done in other ethnicities and different countries to ascertain the effectiveness of this antibiotic in those populations and against other bacterial strains with potentially different resistance mechanisms,” Dr. Deep said.

The study was supported by Spero Therapeutics and the Department of Health and Human Services. Lead author Paul B. Eckburg, MD, of Stanford (Calif.) University, and Dr. Talley are employees of Spero Therapeutics. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.

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Oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) offers a safe and effective strategy for treating patients with complicated urinary tract infections, according to a new study.

“No new oral antibiotic alternative has emerged to treat these conditions in more than 25 years,” corresponding author Angela K. Talley, MD, said in an interview. The new research was published in the New England Journal of Medicine.

Courtesy Spero Therapeutics
Dr. Angela K. Talley

Patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), are often hospitalized and treated with intravenous therapy because of the lack of oral options, especially in cases of antibiotic-resistant pathogens, explained Dr. Talley, of Spero Therapeutics.

In their new phase 3, double-blind randomized trial, the researchers evaluated the safety and effectiveness of oral TBP-PI-HBr, compared with intravenous ertapenem in hospitalized patients with cUTIs or AP. Oral tebipenem is an investigational carbapenem with demonstrated activity against uropathogenic Enterobacterales, and it has shown effectiveness in animal models, the researchers noted in their paper.
 

Methods and results

The researchers randomized 1,372 adult patients. The microbiologic intent-to-treat population included 449 patients who received TBP-PI-HBr (600 mg every 8 hours) and 419 who received ertapenem (1 g every 24 hours) for 7-10 days or up to 14 days for patients with bacteremia.

The primary endpoint was a composite of clinical cure and favorable microbiologic response, assessed at a test-of-cure visit on day 19. Clinical cure was defined as “complete resolution or clinically significant alleviation of baseline signs and symptoms of complicated urinary tract infection or acute pyelonephritis and no new symptoms, such that no further antimicrobial therapy was warranted,” the researchers wrote. Microbiologic response was defined as a reduction to less than 103 CFU per milliliter in uropathogen levels from baseline at day 19.

Overall, the clinical response occurred in 58.8% of patients who received TBP-PI-HBr and 61.6% of those who received ertapenem at the test-of-cure visit.

Clinical cure rates were similar in the TBP-PI-HBr and ertapenem groups (93.1% vs. 93.6%) at the test-of-cure visit.

Both treatment groups showed similar responses to Enterobacterales pathogens at the test-of-cure visit (62.7% for TBP-PI-HBr and 65.2% for ertapenem).

Among patients with bacteremia at baseline, overall response rates were 72.3% and 66.0% for TBP-PI-HBr and ertapenem, respectively, at the test-of-cure visit, and 93.6% and 96.2%, respectively, at the end-of-treatment visit on or around day 25.

The overall incidence of adverse events was approximately 26% in both treatment groups. Most adverse events were mild or moderate in severity and did not limit treatment, the researchers wrote.

The mean age of the patients was 58.1 years; 46.1% were aged 65 and older, and 11.5% had bacteremia at baseline.

The study findings were limited by several factors, including the mandated 7- to 10-day course of antibiotics, which may not reflect the standard of care in other settings in the United States. The study’s trial sites were located in the United States, South Africa, and Europe. The study population was primarily White and from Central and Eastern Europe. Other limitations included the randomization of patients before confirming the baseline pathogen, although this was done to limit potential confounding from previous antibiotics, the researchers noted.
 

 

 

Safety and efficacy support application for approval

“To our knowledge, this is the first head-to-head evaluation of an IV vs. an oral drug for the treatment of cUTI and acute pyelonephritis,” Dr. Talley said in an interview.  

“The findings demonstrate that almost all patients in the study achieved complete resolution of the signs and symptoms of their infection,” she said.

TBP-PI-HBr has not been approved by the Food and Drug Administration, but a new drug application that included data from the current study was submitted to the FDA and is currently under review, Dr. Talley noted.

As for additional research, the current study was conducted in hospitalized patients, and the use of TBP-PI-HBr in the outpatient setting has not yet been evaluated, she said.
 

Approval and use of oral carbapenem will change practice

The current study is very important because it provides a viable and effective alternative form of antibiotic delivery for the patients with complicated UTI, Noel N. Deep, MD, emphasized in an interview.

Dr. Noel N. Deep

“Currently these patients have to be treated with IV carbapenem antibiotics either in a hospital or through a home health nurse,” Dr. Deep, a general internist in group practice in Antigo, Wisc., explained.

Current IV strategies also carry the inherent risk associated with the insertion of an IV catheter that is left in place for several days or replaced periodically. “The oral antibiotic eliminates these risks and higher health care costs and provides a safer and equally efficacious option,” Dr. Deep said.

In the current study, “I was definitely surprised at the effectiveness of the oral carbapenem,” Dr. Deep said. “I am absolutely delighted with this new treatment option that physicians can now add to their armamentarium [assuming FDA approval] as we provide care to our patients,” he said.

If approved, TBP-PI-HBr will definitely change the treatment spectrum for the multidrug-resistant bacterial UTIs, said Dr. Deep. “Carbapenems have continued to be effective and low antibiotic resistance to carbapenems has been recorded.”

As for additional research, “I would like to see studies done in other ethnicities and different countries to ascertain the effectiveness of this antibiotic in those populations and against other bacterial strains with potentially different resistance mechanisms,” Dr. Deep said.

The study was supported by Spero Therapeutics and the Department of Health and Human Services. Lead author Paul B. Eckburg, MD, of Stanford (Calif.) University, and Dr. Talley are employees of Spero Therapeutics. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.

Oral tebipenem pivoxil hydrobromide (TBP-PI-HBr) offers a safe and effective strategy for treating patients with complicated urinary tract infections, according to a new study.

“No new oral antibiotic alternative has emerged to treat these conditions in more than 25 years,” corresponding author Angela K. Talley, MD, said in an interview. The new research was published in the New England Journal of Medicine.

Courtesy Spero Therapeutics
Dr. Angela K. Talley

Patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), are often hospitalized and treated with intravenous therapy because of the lack of oral options, especially in cases of antibiotic-resistant pathogens, explained Dr. Talley, of Spero Therapeutics.

In their new phase 3, double-blind randomized trial, the researchers evaluated the safety and effectiveness of oral TBP-PI-HBr, compared with intravenous ertapenem in hospitalized patients with cUTIs or AP. Oral tebipenem is an investigational carbapenem with demonstrated activity against uropathogenic Enterobacterales, and it has shown effectiveness in animal models, the researchers noted in their paper.
 

Methods and results

The researchers randomized 1,372 adult patients. The microbiologic intent-to-treat population included 449 patients who received TBP-PI-HBr (600 mg every 8 hours) and 419 who received ertapenem (1 g every 24 hours) for 7-10 days or up to 14 days for patients with bacteremia.

The primary endpoint was a composite of clinical cure and favorable microbiologic response, assessed at a test-of-cure visit on day 19. Clinical cure was defined as “complete resolution or clinically significant alleviation of baseline signs and symptoms of complicated urinary tract infection or acute pyelonephritis and no new symptoms, such that no further antimicrobial therapy was warranted,” the researchers wrote. Microbiologic response was defined as a reduction to less than 103 CFU per milliliter in uropathogen levels from baseline at day 19.

Overall, the clinical response occurred in 58.8% of patients who received TBP-PI-HBr and 61.6% of those who received ertapenem at the test-of-cure visit.

Clinical cure rates were similar in the TBP-PI-HBr and ertapenem groups (93.1% vs. 93.6%) at the test-of-cure visit.

Both treatment groups showed similar responses to Enterobacterales pathogens at the test-of-cure visit (62.7% for TBP-PI-HBr and 65.2% for ertapenem).

Among patients with bacteremia at baseline, overall response rates were 72.3% and 66.0% for TBP-PI-HBr and ertapenem, respectively, at the test-of-cure visit, and 93.6% and 96.2%, respectively, at the end-of-treatment visit on or around day 25.

The overall incidence of adverse events was approximately 26% in both treatment groups. Most adverse events were mild or moderate in severity and did not limit treatment, the researchers wrote.

The mean age of the patients was 58.1 years; 46.1% were aged 65 and older, and 11.5% had bacteremia at baseline.

The study findings were limited by several factors, including the mandated 7- to 10-day course of antibiotics, which may not reflect the standard of care in other settings in the United States. The study’s trial sites were located in the United States, South Africa, and Europe. The study population was primarily White and from Central and Eastern Europe. Other limitations included the randomization of patients before confirming the baseline pathogen, although this was done to limit potential confounding from previous antibiotics, the researchers noted.
 

 

 

Safety and efficacy support application for approval

“To our knowledge, this is the first head-to-head evaluation of an IV vs. an oral drug for the treatment of cUTI and acute pyelonephritis,” Dr. Talley said in an interview.  

“The findings demonstrate that almost all patients in the study achieved complete resolution of the signs and symptoms of their infection,” she said.

TBP-PI-HBr has not been approved by the Food and Drug Administration, but a new drug application that included data from the current study was submitted to the FDA and is currently under review, Dr. Talley noted.

As for additional research, the current study was conducted in hospitalized patients, and the use of TBP-PI-HBr in the outpatient setting has not yet been evaluated, she said.
 

Approval and use of oral carbapenem will change practice

The current study is very important because it provides a viable and effective alternative form of antibiotic delivery for the patients with complicated UTI, Noel N. Deep, MD, emphasized in an interview.

Dr. Noel N. Deep

“Currently these patients have to be treated with IV carbapenem antibiotics either in a hospital or through a home health nurse,” Dr. Deep, a general internist in group practice in Antigo, Wisc., explained.

Current IV strategies also carry the inherent risk associated with the insertion of an IV catheter that is left in place for several days or replaced periodically. “The oral antibiotic eliminates these risks and higher health care costs and provides a safer and equally efficacious option,” Dr. Deep said.

In the current study, “I was definitely surprised at the effectiveness of the oral carbapenem,” Dr. Deep said. “I am absolutely delighted with this new treatment option that physicians can now add to their armamentarium [assuming FDA approval] as we provide care to our patients,” he said.

If approved, TBP-PI-HBr will definitely change the treatment spectrum for the multidrug-resistant bacterial UTIs, said Dr. Deep. “Carbapenems have continued to be effective and low antibiotic resistance to carbapenems has been recorded.”

As for additional research, “I would like to see studies done in other ethnicities and different countries to ascertain the effectiveness of this antibiotic in those populations and against other bacterial strains with potentially different resistance mechanisms,” Dr. Deep said.

The study was supported by Spero Therapeutics and the Department of Health and Human Services. Lead author Paul B. Eckburg, MD, of Stanford (Calif.) University, and Dr. Talley are employees of Spero Therapeutics. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.

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