Image by Difu Wu

The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel^®).

The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This approval was granted under priority review, and the drug received orphan designation for this indication.

The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.

The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.

For more details, see the full prescribing information.

Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Pediatric studies

The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.

There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.

Ninety-one patients received dasatinib at 60 mg/m² once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.

The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.

The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).

At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.

At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.

The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.

Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).

Image by Difu Wu

The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel^®).

The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This approval was granted under priority review, and the drug received orphan designation for this indication.

The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.

The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.

For more details, see the full prescribing information.

Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Pediatric studies

The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.

There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.

Ninety-one patients received dasatinib at 60 mg/m² once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.

The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.

The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).

At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.

At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.

The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.

Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).

Image by Difu Wu

The US Food and Drug Administration (FDA) has expanded the approved use of dasatinib (Sprycel^®).

The drug is now approved to treat children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This approval was granted under priority review, and the drug received orphan designation for this indication.

The recommended starting dosage for dasatinib in pediatric patients with chronic phase, Ph+ CML is based on body weight.

The recommended dose should be administered orally once daily, and the dose should be recalculated every 3 months based on changes in body weight or more often if necessary.

For more details, see the full prescribing information.

Dasatinib is also approved by the FDA to treat adults with newly diagnosed chronic phase, Ph+ CML; chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Pediatric studies

The approval of dasatinib in pediatric CML patients was supported by 2 studies. Results from the phase 1 study (NCT00306202) were published in the Journal of Clinical Oncology in 2013. Phase 2 (NCT00777036) results were presented at the 2017 ASCO Annual Meeting.

There were 97 patients in the 2 studies who had chronic phase CML and received oral dasatinib—17 from phase 1 and 80 from phase 2. Fifty-one of the patients had newly diagnosed CML, and 46 patients were resistant or intolerant to previous treatment with imatinib.

Ninety-one patients received dasatinib at 60 mg/m² once daily (maximum dose of 100 mg once daily for patients with high body surface area). Patients were treated until disease progression or unacceptable toxicity.

The median duration of treatment was 51.1 months, or 4.3 years (range, 1.9 to 99.6 months). The median follow-up was 4.5 years in the newly diagnosed patients and 5.2 years in patients who had previously received imatinib.

The efficacy endpoints were complete cytogenetic response (CCyR), major cytogenetic response (MCyR), and major molecular response (MMR).

At 12 months, the CCyR rate was 96.1% in newly diagnosed patients and 78.3% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 56.9% and 39.1%, respectively.

At 24 months, the CCyR rate was 96.1% in newly diagnosed patients and 82.6% in patients who had prior treatment with imatinib. The MCyR rate was 98.0% and 89.1%, respectively. And the MMR rate was 74.5% and 52.2%, respectively.

The median durations of CCyR, MCyR and MMR could not be estimated, as more than half of the responding patients had not progressed at the time of data cut-off.

Drug-related serious adverse events were reported in 14.4% of dasatinib-treated patients. The most common adverse events (≥15%) were headache (28%), nausea (20%), diarrhea (21%), skin rash (19%), pain in extremity (19%), and abdominal pain (16%).

TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.

While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.

Debra Beck/Frontline Medical News

Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).

Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.

“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported. Specifically, asthma exacerbations numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.

Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.

Postbronchodilator FEV₁ at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV₁ was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.

Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.

Adverse events were consistent with the known safety profile of omalizumab.

“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.

Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.

TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.

While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.

Debra Beck/Frontline Medical News

Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).

Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.

“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported. Specifically, asthma exacerbations numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.

Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.

Postbronchodilator FEV₁ at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV₁ was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.

Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.

Adverse events were consistent with the known safety profile of omalizumab.

“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.

Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.

TORONTO – Omalizumab (Xolair, Genentech) decreased asthma exacerbations and improved symptom control to a similar extent in patients with asthma chronic obstructive pulmonary disease (ACO) overlap as seen in patients with asthma but no COPD, in a study presented at the CHEST annual meeting.

While patients with COPD typically experience annual declines in lung function, at least some of the ACO patients in this study, which included one of the largest observational cohorts to date of patients with ACO, showed preserved lung function after 48 weeks of omalizumab treatment.

Debra Beck/Frontline Medical News

Dr. Hanania presented data from the “real-world” PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab), which unlike many asthma studies, did not exclude patients with comorbid COPD. PROSPERO was a prospective, multicenter, observational, 48-week study of patients (n = 806) who were 12 years of age and older who were initiating omalizumab treatment for moderate to severe allergic asthma. Asthma control was assessed monthly using the Asthma Control Test (ACT).

Participants were identified as having ACO based on two approaches: 1. A positive medical history of asthma and COPD, or 2. A medical history of asthma (but not COPD), at least a 10-pack per year smoking history, and an forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) of less than 0.7. From the 728 study participants included in this secondary analysis, 56 were classified as ACO according to the first definition (ACO cohort A) and 59 according to the second (ACO cohort B). Thirty-seven patients fell into both groups.

“All groups had a reduction in their exacerbation rates through 12 months, and it didn’t differ whether they had ACO in cohort A or cohort B, or no ACO,” Dr. Hanania reported. Specifically, asthma exacerbations numbers were reduced from baseline levels though month 12, from 3 or more exacerbations in both ACO and non ACO groups to 1.1 or less.

Additionally, all three groups showed clinically meaningful improvements in their ACT scores, with mean improvements of 4.1, 4.7, and 4.4 units for ACO cohort A, ACO cohort B, and non-ACO patients, respectively.

Postbronchodilator FEV₁ at study end was improved by 36 mL in ACO cohort A and by 23 mL in the non-ACO cohort. But a 14 mL reduction in postbronchodilator FEV₁ was noted in ACO cohort B, “a reminder that the cohort B population was those patients with fixed airway obstruction and smoking history,” said Dr. Hanania.

Mean age in the non-ACO population was 50 years, rising to 57.6 years in ACO cohort A and 55 years in ACO cohort B. All three groups had three or more asthma exacerbations in the 12 months before starting omalizumab, and all groups had mean ACT scores of less than 15 at baseline, indicating that they were all symptomatic.

Adverse events were consistent with the known safety profile of omalizumab.

“The significance of this study [is that] it’s one of the largest ACO cohorts that we know of and I think it encourages all of us to look at or re-visit both COPD therapies and asthma therapies in populations [not included] in clinical trials because in real life, these are the patients we see … and we don’t have evidence,” Dr. Hanania said.

Dr. Hanania reported receiving research support from Roche/Genentech, among other companies. Three of the investigators are employees of Genentech, the study’s sponsor.

LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.

In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

[email protected]

LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.

In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

[email protected]

LAS VEGAS – Clinicians can offer patients with scarring the potential for more comprehensive improvement thanks to progress in light-based devices and technologies, Kristen M. Kelly, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Not only can we improve these scars from a cosmetic appearance ... but we can also greatly improve the symptoms that patients have,” such as scar-related stinging, discomfort, and movement restrictions or contractures, said Dr. Kelly of the University of California, Irvine.

In addition, combining light-based therapies with medications applied after the treatments can optimize results, she said.

Dr. Kelly disclosed relationships with multiple companies including Allergan, MundiPharma, Syneron-Candela, Light Sciences Oncology, Novartis, Sciton, and ThermiRF.

SDEF and this news organization are owned by the same parent company.

[email protected]

Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.

Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.

Surgeon Matthew A. Hutter, MD, FACS, discusses the first report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) focused on laparoscopic sleeve gastrectomy. The study (Ann Surg. 2016;264[3]:464-73) looked at outcomes, methods, and complications of this procedure based on a database of nearly 190,000 patients, more than 1,600 surgeons, and 720 centers. Dr. Hutter said that is high-quality data that offers surgeons good information on the procedure.

The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

[email protected]

The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

[email protected]

The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

[email protected]

Some children with HIV infection may not be receiving medical care frequently enough, according to researchers at the Centers for Disease Control and Prevention

The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.

However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).

In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.

The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.

In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.

For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.

Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”

[email protected]

Some children with HIV infection may not be receiving medical care frequently enough, according to researchers at the Centers for Disease Control and Prevention

The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.

However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).

In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.

The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.

In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.

For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.

Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”

[email protected]

Some children with HIV infection may not be receiving medical care frequently enough, according to researchers at the Centers for Disease Control and Prevention

The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.

However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).

In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.

The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.

In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.

For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.

Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”

[email protected]

The generic clofarabine injection for treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL) is now available on the U.S. market.

The generic version of the drug was approved by the Food and Drug Administration in May 2017 for children up to age 21 years with relapsed or refractory ALL after at least two prior regimens.

The injection, marketed by Mylan N.V., is available in 20 mg/20 mL (1 mg/mL) single-dose vials. It is a generic version of Genzyme’s Clolar.

[email protected]

On Twitter @maryellenny

The generic clofarabine injection for treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL) is now available on the U.S. market.

The generic version of the drug was approved by the Food and Drug Administration in May 2017 for children up to age 21 years with relapsed or refractory ALL after at least two prior regimens.

The injection, marketed by Mylan N.V., is available in 20 mg/20 mL (1 mg/mL) single-dose vials. It is a generic version of Genzyme’s Clolar.

[email protected]

On Twitter @maryellenny

The generic clofarabine injection for treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL) is now available on the U.S. market.

The generic version of the drug was approved by the Food and Drug Administration in May 2017 for children up to age 21 years with relapsed or refractory ALL after at least two prior regimens.

The injection, marketed by Mylan N.V., is available in 20 mg/20 mL (1 mg/mL) single-dose vials. It is a generic version of Genzyme’s Clolar.

[email protected]

On Twitter @maryellenny

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.

[email protected]

On Twitter @eaztweets

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.

[email protected]

On Twitter @eaztweets

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.

[email protected]

On Twitter @eaztweets

SAN DIEGO – The method of manufacturing can markedly influence the interaction of products containing red blood cells and lung cells, according to research presented at the annual meeting of the American Association of Blood Banks.

Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.

“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.

ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.

Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”

In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.

For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.

After 24 hours, the production of IL-8 and IL-6 was measured.

Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.

Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.

Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).

The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.

Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).

However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.

“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”

Dr. Wirtz had no disclosures.

[email protected]

SAN DIEGO – The method of manufacturing can markedly influence the interaction of products containing red blood cells and lung cells, according to research presented at the annual meeting of the American Association of Blood Banks.

Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.

“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.

ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.

Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”

In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.

For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.

After 24 hours, the production of IL-8 and IL-6 was measured.

Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.

Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.

Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).

The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.

Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).

However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.

“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”

Dr. Wirtz had no disclosures.

[email protected]

SAN DIEGO – The method of manufacturing can markedly influence the interaction of products containing red blood cells and lung cells, according to research presented at the annual meeting of the American Association of Blood Banks.

Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.

“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.

ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.

Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”

In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.

For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.

After 24 hours, the production of IL-8 and IL-6 was measured.

Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.

Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.

Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).

The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.

Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).

However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.

“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”

Dr. Wirtz had no disclosures.

[email protected]