Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019
Hepatitis C Treatment: Study Finds No Liver, Kidney or Cardiovascular Adverse Effects
MedicalResearch.com Interview with:
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Dr. McGlynn[/caption]
Elizabeth A. McGlynn, PhD
Vice President for Kaiser Permanente Research
Executive Director
Kaiser Permanente Center for Effectiveness and Safety
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue. We found no evidence of increased risks of significant side effects associated with taking these drugs. In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.
Dr. McGlynn[/caption]
Elizabeth A. McGlynn, PhD
Vice President for Kaiser Permanente Research
Executive Director
Kaiser Permanente Center for Effectiveness and Safety
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue. We found no evidence of increased risks of significant side effects associated with taking these drugs. In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.












Dr. Andrea Wickremasinghe[/caption]
Andrea C. Wickremasinghe, MD
Neonatologist
Kaiser Santa Clara California
MedicalResearch.com: What is the background for this study?
Response: Neonatal jaundice is common and is often treated with phototherapy. Phototherapy is typically considered to be benign. In the past decade, phototherapy use has increased and it is sometimes started at bilirubin levels below recommended treatment thresholds. Beginning in the 1970’s, in-vitro and in-vivo studies have shown phototherapy to be associated with cellular changes implicated in the pathogenesis of cancer. Epidemiologic studies have yielded mixed results, with some studies showing associations between phototherapy and leukemia and other studies failing to show this association. In this study, we used a large statewide administrative dataset to investigate the relationship between neonatal phototherapy and cancer in the first year after birth.
Dr. Anny Xiang[/caption]
Anny H. Xiang, PhD
Kaiser Permanente Southern California Department of Research & Evaluation
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Xiang: Previous studies have identified a link between maternal obesity, diabetes and/or excessive gestational weight gain and long-term obesity risk in children. Our study examined the interplay among all four factors associated with childhood obesity: pre-pregnancy obesity, gestational weight gain, gestational diabetes and breastfeeding. To our knowledge, the interplay among these factors and their independent contributions to childhood obesity with data from a large and multi-ethnic cohort under current standard clinical care had not been previously studied.
The study included 15,710 women who delivered babies at Kaiser Permanente medical facilities in Southern California in 2011. The key findings were:
Dr. Reina Haque[/caption]
Reina Haque, PhD MPH
Research scientist
Kaiser Permanente Southern California Department of Research & Evaluation
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Haque: The study fills an important knowledge gap about the long-term association of aromatase inhibitors on cardiovascular disease risk in breast cancer survivors.
This was a retrospective cohort study that included a cohort of 13,273 postmenopausal breast cancer survivors who were diagnosed with breast cancer, either estrogen or progesterone receptor positive, from 1991 to 2010. The patients were followed through 2011, or a maximum of 21 years. The study participants were divided into four groups based on the drugs they received: 31.7 percent were treated only with tamoxifen; 28.6 percent only with aromatase inhibitors; 20.2 percent used both; and 19.4 percent did not use any of these drugs. These oral drugs are used to combat breast cancer recurrence, but may have long-term side effects on other organs.
The study determined that the risk of cardiac ischemia (which can lead to a heart attack) and stroke were not elevated in patients who only took aromatase inhibitors compared to those who only took tamoxifen. These results provide reassurance that aromatase inhibitors may not increase risk of the potentially fatal cardiovascular outcomes compared to tamoxifen.




Dr. Gunderson[/caption]
MedicalResearch.com Interview with:
Erica P. Gunderson, PhD, MPH, MS, RD
Senior Research Scientist, Division of Research, Cardiovascular and Metabolic Conditions Section
Kaiser Permanente Northern California
Oakland, CA 94612
Medical Research: What is the background for this study?
Dr. Gunderson: Gestational diabetes mellitus (GDM) is a disorder of glucose tolerance affecting 5-9 percent of all U.S. pregnancies (approximately 250,000 annually), with a 7-fold higher risk of progression to type 2 diabetes. Strategies during the postpartum period for prevention of diabetes focus on modification of lifestyle behaviors, including dietary intake and physical activity to promote weight loss.
Lactation is a modifiable postpartum behavior that improves glucose and lipid metabolism, and increases insulin sensitivity, with favorable metabolic effects that persist post-weaning. Despite these metabolic benefits, evidence that lactation prevents type 2 diabetes remains inconclusive, particularly among women with 

