Shorter treatment showed no difference in outcomes, including in black patients, and could allow more patients access to highly effective medications to treat hepatitis C
Oakland, Calif.— Current hepatitis C treatment guidelines state that black patients should not be treated with a shorter 8-week course of direct-acting antiviral agents, even if they are otherwise eligible, and instead should be given the full 12-week regimen.
A new study from the Kaiser Permanente Northern California Division of Research shows that a treatment regimen of 8 weeks for hepatitis C may be just as effective as 12 weeks in black patients. The study also showed that more people overall can take advantage of the shorter treatment durations, which has important implications for access given the medication’s high cost. The study, “No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients,” was published online March 12 in the journal Clinical Gastroenterology and Hepatology.
“We found that treatment was equally effective for black patients who were treated for 8 and 12 weeks. The 8-week regimen was also generally underused for all patients, with 26 percent of those eligible for 8 weeks receiving 12 weeks of therapy,” said senior author Michael J. Silverberg, PhD, MPH, of the Division of Research.
Treatments for hepatitis C have come a long way, and the debilitating illness is now being cured with highly effective, direct-acting antiviral agents. The most common type of hepatitis C infection in the United States can be eliminated with a combination of ledipasvir and sofosbuvir for 12 weeks.
According to clinical guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America, a shorter, 8-week course of ledipasvir/sofosbuvir can be considered for patients who meet certain clinical criteria, but the recommendation excludes black patients. Shorter courses are less costly and allow health care systems to increase the number of patients that receive the treatment.
In this new study, researchers from Kaiser Permanente Northern California, a large integrated healthcare system, compared the effectiveness of 8- and 12-week courses of hepatitis C treatment among those who were eligible to receive 8 weeks of ledipasvir/sofosbuvir. The study found that the effectiveness of 8 or 12 week regimens of ledipasvir/sofosbuvir was over 95% in most subgroups evaluated, including black patients. These findings implied that shorter courses should be strongly considered for all patients, including black patients, who meet other eligibility criteria for 8-week regimens.
“Our findings do not support current hepatitis C treatment guidelines that recommend against the use of a shorter course of treatment in black patients,” said the paper’s lead author, Julia L. Marcus, PhD, MPH, now at Harvard Medical School and Harvard Pilgrim Health Care Institute but formerly of the Division of Research where she initiated this work.
The study authors also suggest that clinicians should consider using 8-week courses of ledipasvir/sofosbuvir in more patients who are otherwise eligible for shorter courses of therapy, which can benefit patients, providers, and healthcare systems.
“We have known for some time that a shorter treatment duration is effective, but these data highlight that we could offer this option to more patients,” said co-author, David J. Witt, MD, at Kaiser Permanente San Rafael Medical Center. “Given the high cost of these medications, more widespread use of shorter courses could result in more patients receiving treatment without compromising treatment effectiveness.”
This work was supported by the Kaiser Permanente Delivery Science Research Program and the National Institute of Allergy and Infectious Diseases.
Other contributors on the paper included Leo B. Hurley, MPH, Jennifer O. Lam, PhD, MPH, and Charles P. Quesenberry, Jr., PhD, all of the Division of Research; and co-authors Scott Chamberland, PharmD, Kaiser Permanente Regional Pharmacy, Oakland; Jamila H. Champsi, MD, and Varun Saxena, MD, Kaiser Permanente South San Francisco Medical Center; Laura C. Gittleman, RN, MBA, Kaiser Permanente Northern California, Medical Group Support Services; Daniel G. Korn, MD, Kaiser Permanente Oakland Medical Center; Jennifer B. Lai, MSc, PharmD, Kaiser Permanente San Rafael Medical Center; Mary Patricia Pauly, MD, Kaiser Permanente Sacramento Medical Center; Joanna Ready, MD, Kaiser Permanente Santa Clara Medical Center; and Suk Seo, MD, Kaiser Permanente Antioch Medical Center.
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About the Kaiser Permanente Division of Research
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being, and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 550-plus staff is working on more than 350 epidemiological and health services research projects. For more information, visit divisionofresearch.kaiserpermanente.org or follow us @KPDOR.
About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 11.8 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.