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The Centers for Disease Control and Prevention is expected to announce this week that new data show people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, The New York Times reported late on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the Times said. The bottom line is that the CDC data show people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on July 29 that the CDC’s updated mask guidance followed an outbreak in Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

The Centers for Disease Control and Prevention is expected to announce this week that new data show people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, The New York Times reported late on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the Times said. The bottom line is that the CDC data show people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on July 29 that the CDC’s updated mask guidance followed an outbreak in Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

The Centers for Disease Control and Prevention is expected to announce this week that new data show people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, The New York Times reported late on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the Times said. The bottom line is that the CDC data show people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on July 29 that the CDC’s updated mask guidance followed an outbreak in Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

Adult women with acne describe significant impacts on their lived experience of acne, including concerns about appearance, mental and emotional health consequences, and disruption to their personal and professional lives, results from a qualitative study demonstrated.

“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”

For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.

The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).

More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.

In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.

“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”

In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”

Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”

In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”

A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”

For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”

This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.

[email protected]

Adult women with acne describe significant impacts on their lived experience of acne, including concerns about appearance, mental and emotional health consequences, and disruption to their personal and professional lives, results from a qualitative study demonstrated.

“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”

For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.

The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).

More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.

In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.

“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”

In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”

Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”

In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”

A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”

For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”

This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.

[email protected]

Adult women with acne describe significant impacts on their lived experience of acne, including concerns about appearance, mental and emotional health consequences, and disruption to their personal and professional lives, results from a qualitative study demonstrated.

“Nearly 50% of women experience acne in their 20s, and 35% experience acne in their 30s,” the study’s corresponding author, John S. Barbieri, MD, MBA, formerly of the department of dermatology at the University of Pennsylvania, Philadelphia, told this news organization. “While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail and prior studies have included relatively few patients. As a result, we conducted a series of semistructured interviews among adult women with acne to examine the lived experience of adult acne and its treatment.”

For the study, published online July 28, 2021, in JAMA Dermatology, Dr. Barbieri and colleagues conducted voluntary, confidential phone interviews with 50 women aged between 18 and 40 years with moderate to severe acne who were recruited from the University of Pennsylvania Health System and from a private dermatology clinic in Cincinnati. They used free listing and open-ended, semistructured interviews to elicit opinions from the women on how acne affected their lives; their experience with acne treatments, dermatologists, and health care systems; as well as their views on treatment success.

The mean age of the participants was 28 years and 48% were white (10% were Black, 8% were Asian, 4% were more than one race, and the rest abstained from answering this question; 10% said they were Hispanic).

More than three-quarters (78%) reported prior treatment with topical retinoids, followed by spironolactone (70%), topical antibiotics (43%), combined oral contraceptives (43%), and isotretinoin (41%). During the free-listing part of interviews, where the women reported the first words that came to their mind when asked about success of treatment and adverse effects, the most important terms expressed related to treatment success were clear skin, no scarring, and no acne. The most important terms related to treatment adverse effects were dryness, redness, and burning.

In the semistructured interview portion of the study, the main themes expressed were acne-related concerns about appearance, including feeling less confident at work; mental and emotional health, including feelings of depression, anxiety, depression, and low self-worth during acne breakouts; and everyday life impact, including the notion that acne affected how other people perceived them. The other main themes included successful treatment, with clear skin and having a manageable number of lesions being desirable outcomes; and interactions with health care, including varied experiences with dermatologists. The researchers observed that most participants did not think oral antibiotics were appropriate treatments for their acne, specifically because of limited long-term effectiveness.

“Many patients described frustration with finding a dermatologist with whom they were comfortable and with identifying effective treatments for their acne,” the authors wrote. “In contrast, those who thought their dermatologist listened to their concerns and individualized their treatment plan reported higher levels of satisfaction.”

In an interview, Dr. Barbieri, who is now with the department of dermatology at Brigham and Women’s Hospital, Boston, said that he was surprised by how many patients expressed interest in nonantibiotic treatments for acne, “given that oral antibiotics are by far the most commonly prescribed systemic treatment for acne.”

Moreover, he added, “although I have experienced many patients being hesitant about isotretinoin, I was surprised by how strong patients’ concerns were about isotretinoin side effects. Unfortunately, there are many misconceptions about isotretinoin that limit use of this treatment that can be highly effective and safe for the appropriate patient.”

In an accompanying editorial, dermatologists Diane M. Thiboutot, MD and Andrea L. Zaenglein, MD, with Penn State University, Hershey, and Alison M. Layton, MB, ChB, with the Harrogate Foundation Trust, Harrogate, North Yorkshire, England, wrote that the findings from the study “resonate with those recently reported in several international studies that examine the impacts of acne, how patients assess treatment success, and what is important to measure from a patient and health care professional perspective in a clinical trial for acne.”

A large systematic review on the impact of acne on patients, conducted by the Acne Core Outcomes Research Network (ACORN), found that “appearance-related concerns and negative psychosocial effects were found to be a major impact of acne,” they noted. “Surprisingly, only 22 of the 473 studies identified in this review included qualitative data gathered from patient interviews. It is encouraging to see the concordance between the concerns voiced by the participants in the current study and those identified from the literature review, wherein a variety of methods were used to assess acne impacts.”

For his part, Dr. Barbieri said that the study findings “justify the importance of having a discussion with patients about their unique lived experience of acne and individualizing treatment to their specific needs. Patient reported outcome measures could be a useful adjunctive tool to capture these impacts on quality of life.”

This study was funded by grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Barbieri disclosed that he received partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. Dr. Thiboutot reported receiving consultant fees from Galderma and Novartis outside the submitted work. Dr. Layton reported receiving unrestricted educational presentation, advisory board, and consultancy fees from Galderma Honoraria; unrestricted educational presentation and advisory board honoraria from Leo; advisory board honoraria from Novartis and Mylan; consultancy honoraria from Procter and Gamble and Meda; grants from Galderma; and consultancy and advisory board honoraria from Origimm outside the submitted work.

[email protected]

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

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

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

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

Administering hyperimmune globulin to pregnant women who tested positive for cytomegalovirus did not reduce CMV infections or deaths among their fetuses or newborns, according to a randomized controlled trial published online July 28 in the New England Journal of Medicine.

Up to 40,000 infants a year have congenital CMV infections, which can lead to stillbirth, neonatal death, deafness, and cognitive and motor delay. An estimated 35%-40% of fetuses of women with a primary CMV infection will develop an infection, write Brenna Hughes, MD, an associate professor of ob/gyn and chief of the division of maternal fetal medicine at Duke University, Durham, N.C., and colleagues.

Previous trials and observational studies have shown mixed results with hyperimmune globulin for the prevention of congenital CMV infection.

“It was surprising to us that none of the outcomes in this trial were in the direction of potential benefit,” Dr. Hughes told this news organization. “However, this is why it is important to do large trials in a diverse population.”

The study cohort comprised 206,082 pregnant women who were screened for CMV infection before 23 weeks’ gestation. Of those women, 712 (0.35%) tested positive for CMV. The researchers enrolled 399 women who had tested positive and randomly assigned them to receive either a monthly infusion of CMV hyperimmune globulin (100 mg/kg) or placebo until delivery. The researchers used a composite of CMV infection or, if no testing occurred, fetal/neonatal death as the primary endpoint.

The trial was stopped early for futility when data from 394 participants revealed that 22.7% of offspring in the hyperimmune globulin group and 19.4% of those in the placebo group had had a CMV infection or had died (relative risk = 1.17; P = .42).

When individual endpoints were examined, trends were detected in favor of the placebo, but they did not reach statistical significance. The incidence of death was higher in the hyperimmune globulin group (4.9%) than in the placebo group (2.6%). The rate of preterm birth was also higher in the intervention group (12.2%) than in the group that received placebo (8.3%). The incidence of birth weight below the fifth percentile was 10.3% in the intervention group and 5.4% in the placebo group.

One woman who received hyperimmune globulin experienced a severe allergic reaction to the first infusion. Additionally, more women in the hyperimmune globulin group experienced headaches and shaking chills during infusions than did those who received placebo. There were no differences in maternal outcomes between the groups. There were no thromboembolic or ischemic events in either group.

“These findings suggest CMV hyperimmune globulin should not be used for the prevention of congenital CMV in pregnant patients with primary CMV during pregnancy,” Dr. Hughes said in an interview.

“A CMV vaccine is likely to be the most effective public health measure that we can offer, and that should be at the forefront of research investments,” she said. “But some of the other medications that work against CMV should be tested on a large scale as well,” she said. For example, a small trial in Israel showed that high-dose valacyclovir in early pregnancy decreased congenital CMV, and thus the drug merits study in a larger trial, she said.

Other experts agree that developing a vaccine should be the priority.

“The ultimate goal for preventing the brain damage and birth defects caused by congenital CMV infection is a vaccine that is as effective as the rubella vaccine has been for eliminating congenital rubella syndrome and that can be given well before pregnancy,” said Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine and pediatrician-in-chief at New York–Presbyterian/Weill Cornell Medical Center and the New York–Presbyterian Komansky Children’s Hospital in New York.

“While trials of vaccines are ongoing, there is a need to have a therapeutic option, especially for the high-risk setting of a mother acquiring the virus for the first time during pregnancy,” Dr. Permar said in an interview.

Dr. Permar was not involved in this study but is involved in follow-up studies of this cohort and is conducting research on CMV maternal vaccines. She noted the need for safe, effective antiviral treatments and for research into newer immunoglobulin products, such as monoclonal antibodies.

Both Dr. Permar and Dr. Hughes highlighted the challenge of raising awareness about the danger of CMV infections during pregnancy.

“Pregnant women, and especially those who have or work with young children, who are frequently carriers of the infection, should be informed of this risk,” Dr. Permar said. She hopes universal testing of newborns will be implemented and that it enables people to recognize the frequency and burden of these infections. She remains optimistic about a vaccine.

“After 60 years of research into a CMV vaccine, I believe we are currently in a ‘golden age’ of CMV vaccine development,” she said. She noted that Moderna is about to launch a phase 3 mRNA vaccine trial for CMV. “Moreover, immune correlates of protection against CMV have been identified from previous partially effective vaccines, and animal models have improved for preclinical studies. Therefore, I believe we will have an effective and safe vaccine against this most common congenital infection in the coming years.”

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Dr. Hughes has served on Merck’s scientific advisory board. Various coauthors have received personal fees from Medela and nonfinancial support from Hologic; personal fees from Moderna and VBI vaccines, and grants from Novavax. Dr. Permar consults for Pfizer, Moderna, Merck, Sanofi, and Dynavax on their CMV vaccine programs, and she has a sponsored research program with Merck and Moderna on CMV vaccines.

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

Rana et al published a cost-effectiveness analysis in the British Journal of Obstetrics and Gynecology that evaluated the cost-effectiveness of uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. The analysis was conducted along the FEMME randomized control trial, that examined the quality of life of menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Over a 2-year time period, UAE was associated with higher mean costs and lower quality-adjusted life years compared with myomectomy. Similar results were observed over the 4-year time period. The authors concluded that myomectomy is a cost-effective option for the treatment of uterine fibroids.

A third study by Moor et al evaluated the impact of herpes simplex type 2 (HSV-2) infection on incidence and growth of ultrasound-diagnosed uterine fibroids in a large group of African American women. As reproductive tract infections have long been suspected as risk factors for fibroid development, this is a key study. In this prospective study analyzing data from the Study of Environment, Lifestyle and a large cohort of 25-35 year-old African American women with uterine fibroids were monitored by ultrasound over a 5-year period. A key finding was that fibroid HSV-2 positive status was not associated with fibroid incidence.

Rana et al published a cost-effectiveness analysis in the British Journal of Obstetrics and Gynecology that evaluated the cost-effectiveness of uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. The analysis was conducted along the FEMME randomized control trial, that examined the quality of life of menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Over a 2-year time period, UAE was associated with higher mean costs and lower quality-adjusted life years compared with myomectomy. Similar results were observed over the 4-year time period. The authors concluded that myomectomy is a cost-effective option for the treatment of uterine fibroids.

A third study by Moor et al evaluated the impact of herpes simplex type 2 (HSV-2) infection on incidence and growth of ultrasound-diagnosed uterine fibroids in a large group of African American women. As reproductive tract infections have long been suspected as risk factors for fibroid development, this is a key study. In this prospective study analyzing data from the Study of Environment, Lifestyle and a large cohort of 25-35 year-old African American women with uterine fibroids were monitored by ultrasound over a 5-year period. A key finding was that fibroid HSV-2 positive status was not associated with fibroid incidence.

Rana et al published a cost-effectiveness analysis in the British Journal of Obstetrics and Gynecology that evaluated the cost-effectiveness of uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. The analysis was conducted along the FEMME randomized control trial, that examined the quality of life of menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Over a 2-year time period, UAE was associated with higher mean costs and lower quality-adjusted life years compared with myomectomy. Similar results were observed over the 4-year time period. The authors concluded that myomectomy is a cost-effective option for the treatment of uterine fibroids.

A third study by Moor et al evaluated the impact of herpes simplex type 2 (HSV-2) infection on incidence and growth of ultrasound-diagnosed uterine fibroids in a large group of African American women. As reproductive tract infections have long been suspected as risk factors for fibroid development, this is a key study. In this prospective study analyzing data from the Study of Environment, Lifestyle and a large cohort of 25-35 year-old African American women with uterine fibroids were monitored by ultrasound over a 5-year period. A key finding was that fibroid HSV-2 positive status was not associated with fibroid incidence.

Key clinical point: Pituitrin 2 units (2U) for laparoscopic uterine myomectomy could provide a satisfactory surgical field with minimal hemodynamic changes.

Major finding: There were no differences among 2U, 4U, and 6U groups in the surgical condition quality. Pituitrin 2U significantly reduced blood loss vs pituitrin 0U, and increasing the pituitrin dose beyond 2U did not reduce blood loss further.

Study details: In a prospective, double-blind trial, 118 patients undergoing laparoscopic myomectomy were randomly assigned to receive 0U, 2U, 4U, or 6U of pituitrin injected into the myometrium surrounding the myoma.

Disclosures: The study was supported by grants from the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Guo F et al. J Minim Invasive Gynecol. 2021 Jun 17. doi: 10.1016/j.jmig.2021.06.008.

Key clinical point: Pituitrin 2 units (2U) for laparoscopic uterine myomectomy could provide a satisfactory surgical field with minimal hemodynamic changes.

Major finding: There were no differences among 2U, 4U, and 6U groups in the surgical condition quality. Pituitrin 2U significantly reduced blood loss vs pituitrin 0U, and increasing the pituitrin dose beyond 2U did not reduce blood loss further.

Study details: In a prospective, double-blind trial, 118 patients undergoing laparoscopic myomectomy were randomly assigned to receive 0U, 2U, 4U, or 6U of pituitrin injected into the myometrium surrounding the myoma.

Disclosures: The study was supported by grants from the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Guo F et al. J Minim Invasive Gynecol. 2021 Jun 17. doi: 10.1016/j.jmig.2021.06.008.

Key clinical point: Pituitrin 2 units (2U) for laparoscopic uterine myomectomy could provide a satisfactory surgical field with minimal hemodynamic changes.

Major finding: There were no differences among 2U, 4U, and 6U groups in the surgical condition quality. Pituitrin 2U significantly reduced blood loss vs pituitrin 0U, and increasing the pituitrin dose beyond 2U did not reduce blood loss further.

Study details: In a prospective, double-blind trial, 118 patients undergoing laparoscopic myomectomy were randomly assigned to receive 0U, 2U, 4U, or 6U of pituitrin injected into the myometrium surrounding the myoma.

Disclosures: The study was supported by grants from the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Guo F et al. J Minim Invasive Gynecol. 2021 Jun 17. doi: 10.1016/j.jmig.2021.06.008.

Key clinical point: Myomectomy is a cost-effective treatment option for uterine fibroids compared with uterine artery embolization (UAE).

Major finding: UAE was associated with higher mean costs (difference, £645; 95% confidence interval [CI], £−1,381 to £2,580) and lower quality-adjusted life years (difference, −0.09; 95% CI, −0.11 to −0.04) vs myomectomy over a 2-year follow-up period. Results were comparable over a 4-year follow-up period.

Study details: The data come from a cost-utility analysis of the FEMME trial. A total of 254 premenopausal women with symptomatic uterine fibroids were randomly assigned to either UAE (n=127) and myomectomy (n=127).

Disclosures: The study was supported by the National Institute of Health Research Health Technology Assessment programme. The authors declared no relevant conflicts of interest.

Source: Rana D et al. BJOG. 2021 May 30. doi: 10.1111/1471-0528.16781.

Key clinical point: Myomectomy is a cost-effective treatment option for uterine fibroids compared with uterine artery embolization (UAE).

Major finding: UAE was associated with higher mean costs (difference, £645; 95% confidence interval [CI], £−1,381 to £2,580) and lower quality-adjusted life years (difference, −0.09; 95% CI, −0.11 to −0.04) vs myomectomy over a 2-year follow-up period. Results were comparable over a 4-year follow-up period.

Study details: The data come from a cost-utility analysis of the FEMME trial. A total of 254 premenopausal women with symptomatic uterine fibroids were randomly assigned to either UAE (n=127) and myomectomy (n=127).

Disclosures: The study was supported by the National Institute of Health Research Health Technology Assessment programme. The authors declared no relevant conflicts of interest.

Source: Rana D et al. BJOG. 2021 May 30. doi: 10.1111/1471-0528.16781.

Key clinical point: Myomectomy is a cost-effective treatment option for uterine fibroids compared with uterine artery embolization (UAE).

Major finding: UAE was associated with higher mean costs (difference, £645; 95% confidence interval [CI], £−1,381 to £2,580) and lower quality-adjusted life years (difference, −0.09; 95% CI, −0.11 to −0.04) vs myomectomy over a 2-year follow-up period. Results were comparable over a 4-year follow-up period.

Study details: The data come from a cost-utility analysis of the FEMME trial. A total of 254 premenopausal women with symptomatic uterine fibroids were randomly assigned to either UAE (n=127) and myomectomy (n=127).

Disclosures: The study was supported by the National Institute of Health Research Health Technology Assessment programme. The authors declared no relevant conflicts of interest.

Source: Rana D et al. BJOG. 2021 May 30. doi: 10.1111/1471-0528.16781.

Key clinical point: Seroprevalence of herpes simplex virus (HSV)-2 was not associated with incidence and growth of ultrasound-diagnosed uterine fibroids in young African-American women.

Major finding: HSV-2 seropositivity had no significant association with fibroid incidence (adjusted hazard ratio, 0.88; 95% confidence interval [CI], 0.69-1.12) or growth 3.1% (95% CI, −5.8% to 13.0%).

Study details: A cohort study examined the associations of HSV-2 with fibroid incidence and growth among African-American women aged 23-35 years who underwent ultrasound fibroid screening.

Disclosures: This study was supported by the Intramural Research Program of the National Institute of Health, the National Institute of Environmental Health Sciences, and the American Recovery and Reinvestment Act funds designated for the National Institute of Health Research. The authors declared no conflicts of interest.

Source: Moore KR et al. Am J Epidemiol. 2021 May 27. doi: 10.1093/aje/kwab160.

Key clinical point: Seroprevalence of herpes simplex virus (HSV)-2 was not associated with incidence and growth of ultrasound-diagnosed uterine fibroids in young African-American women.

Major finding: HSV-2 seropositivity had no significant association with fibroid incidence (adjusted hazard ratio, 0.88; 95% confidence interval [CI], 0.69-1.12) or growth 3.1% (95% CI, −5.8% to 13.0%).

Study details: A cohort study examined the associations of HSV-2 with fibroid incidence and growth among African-American women aged 23-35 years who underwent ultrasound fibroid screening.

Disclosures: This study was supported by the Intramural Research Program of the National Institute of Health, the National Institute of Environmental Health Sciences, and the American Recovery and Reinvestment Act funds designated for the National Institute of Health Research. The authors declared no conflicts of interest.

Source: Moore KR et al. Am J Epidemiol. 2021 May 27. doi: 10.1093/aje/kwab160.

Key clinical point: Seroprevalence of herpes simplex virus (HSV)-2 was not associated with incidence and growth of ultrasound-diagnosed uterine fibroids in young African-American women.

Major finding: HSV-2 seropositivity had no significant association with fibroid incidence (adjusted hazard ratio, 0.88; 95% confidence interval [CI], 0.69-1.12) or growth 3.1% (95% CI, −5.8% to 13.0%).

Study details: A cohort study examined the associations of HSV-2 with fibroid incidence and growth among African-American women aged 23-35 years who underwent ultrasound fibroid screening.

Disclosures: This study was supported by the Intramural Research Program of the National Institute of Health, the National Institute of Environmental Health Sciences, and the American Recovery and Reinvestment Act funds designated for the National Institute of Health Research. The authors declared no conflicts of interest.

Source: Moore KR et al. Am J Epidemiol. 2021 May 27. doi: 10.1093/aje/kwab160.

Key clinical point: A fifth of clinically stable patients receiving intermittent ulipristal acetate (UPA) treatment for uterine fibroids needed surgery after it was suspended by the European Medicines Agency in March 2020, because of safety concerns.

Major finding: Following the suspension of UPA, 20% of patients receiving intermittent UPA needed surgery and 80% needed other medical treatments.

Study details: The data come from an analysis of 85 women who received intermittent UPA treatment until it was suspended in March 2020.

Disclosures: No funding information was available. The authors declared no conflicts of interest.

Source: Nicolás I et al. Gynecol Endocrinol. 2021 May 28. doi: 10.1080/09513590.2021.1929152.

Key clinical point: A fifth of clinically stable patients receiving intermittent ulipristal acetate (UPA) treatment for uterine fibroids needed surgery after it was suspended by the European Medicines Agency in March 2020, because of safety concerns.

Major finding: Following the suspension of UPA, 20% of patients receiving intermittent UPA needed surgery and 80% needed other medical treatments.

Study details: The data come from an analysis of 85 women who received intermittent UPA treatment until it was suspended in March 2020.

Disclosures: No funding information was available. The authors declared no conflicts of interest.

Source: Nicolás I et al. Gynecol Endocrinol. 2021 May 28. doi: 10.1080/09513590.2021.1929152.

Key clinical point: A fifth of clinically stable patients receiving intermittent ulipristal acetate (UPA) treatment for uterine fibroids needed surgery after it was suspended by the European Medicines Agency in March 2020, because of safety concerns.

Major finding: Following the suspension of UPA, 20% of patients receiving intermittent UPA needed surgery and 80% needed other medical treatments.

Study details: The data come from an analysis of 85 women who received intermittent UPA treatment until it was suspended in March 2020.

Disclosures: No funding information was available. The authors declared no conflicts of interest.

Source: Nicolás I et al. Gynecol Endocrinol. 2021 May 28. doi: 10.1080/09513590.2021.1929152.

Key clinical point: Application of temporary uterine tourniquet may be effective in reducing perioperative bleeding in patients with multiple, large-sized uterine fibroids in close proximity of vascular structures.

Major finding: The tourniquet applied group vs not applied group had more favorable outcomes in terms of hemoglobin drop (P = .019), hematocrit drop (P = .023), transfusion amount (P = .012), operation time (P = .044), and duration of hospitalization (P = .036).

Study details: The data come from a retrospective study involving 84 patients who underwent abdominal myomectomy and were categorized into 2 groups according to the use (n=36) or nonuse (n=48) of a temporary uterine tourniquet.

Disclosures: The study did not receive any financial support. The authors declared no conflicts of interest.

Source: Akbaba E et al. J Turk Ger Gynecol Assoc. 2021 Jun 8. doi: 10.4274/jtgga.galenos.2021.2020.0242.

Key clinical point: Application of temporary uterine tourniquet may be effective in reducing perioperative bleeding in patients with multiple, large-sized uterine fibroids in close proximity of vascular structures.

Major finding: The tourniquet applied group vs not applied group had more favorable outcomes in terms of hemoglobin drop (P = .019), hematocrit drop (P = .023), transfusion amount (P = .012), operation time (P = .044), and duration of hospitalization (P = .036).

Study details: The data come from a retrospective study involving 84 patients who underwent abdominal myomectomy and were categorized into 2 groups according to the use (n=36) or nonuse (n=48) of a temporary uterine tourniquet.

Disclosures: The study did not receive any financial support. The authors declared no conflicts of interest.

Source: Akbaba E et al. J Turk Ger Gynecol Assoc. 2021 Jun 8. doi: 10.4274/jtgga.galenos.2021.2020.0242.

Key clinical point: Application of temporary uterine tourniquet may be effective in reducing perioperative bleeding in patients with multiple, large-sized uterine fibroids in close proximity of vascular structures.

Major finding: The tourniquet applied group vs not applied group had more favorable outcomes in terms of hemoglobin drop (P = .019), hematocrit drop (P = .023), transfusion amount (P = .012), operation time (P = .044), and duration of hospitalization (P = .036).

Study details: The data come from a retrospective study involving 84 patients who underwent abdominal myomectomy and were categorized into 2 groups according to the use (n=36) or nonuse (n=48) of a temporary uterine tourniquet.

Disclosures: The study did not receive any financial support. The authors declared no conflicts of interest.

Source: Akbaba E et al. J Turk Ger Gynecol Assoc. 2021 Jun 8. doi: 10.4274/jtgga.galenos.2021.2020.0242.

Key clinical point: Ultrasound-guided microwave ablation (MWA) is a safe and effective minimally invasive treatment strategy for symptomatic uterine fibroids.

Major finding: In patients treated with MWA, uterine fibroid symptom scores decreased significantly (reduction rate, 65.9%; P less than .0001) and the quality of life scores (increasing rate, 72.0%; P less than .0001) and hemoglobin levels increased significantly (increasing rate, 30.3%; P less than .0001) from baseline to follow-up. No major adverse events were reported.

Study details: A meta-analysis of 10 studies involving 671 patients.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu L et al. J Minim Invasive Gynecol. 2021 Jun 28. doi: 10.1016/j.jmig.2021.06.020.

Key clinical point: Ultrasound-guided microwave ablation (MWA) is a safe and effective minimally invasive treatment strategy for symptomatic uterine fibroids.

Major finding: In patients treated with MWA, uterine fibroid symptom scores decreased significantly (reduction rate, 65.9%; P less than .0001) and the quality of life scores (increasing rate, 72.0%; P less than .0001) and hemoglobin levels increased significantly (increasing rate, 30.3%; P less than .0001) from baseline to follow-up. No major adverse events were reported.

Study details: A meta-analysis of 10 studies involving 671 patients.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu L et al. J Minim Invasive Gynecol. 2021 Jun 28. doi: 10.1016/j.jmig.2021.06.020.

Key clinical point: Ultrasound-guided microwave ablation (MWA) is a safe and effective minimally invasive treatment strategy for symptomatic uterine fibroids.

Major finding: In patients treated with MWA, uterine fibroid symptom scores decreased significantly (reduction rate, 65.9%; P less than .0001) and the quality of life scores (increasing rate, 72.0%; P less than .0001) and hemoglobin levels increased significantly (increasing rate, 30.3%; P less than .0001) from baseline to follow-up. No major adverse events were reported.

Study details: A meta-analysis of 10 studies involving 671 patients.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu L et al. J Minim Invasive Gynecol. 2021 Jun 28. doi: 10.1016/j.jmig.2021.06.020.