Kaiser Permanente Division of Research Real-World Study Impacts Changes to Hepatitis C Guidelines

Kaiser Permanente Division of Research Real-World Study Impacts Changes to Hepatitis C Guidelines

A Kaiser Permanente Division of Research (DOR) real-world observational study has impacted new practice guidelines from the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases. Published in Clinical Gastroenterology and Hepatology that concluded there was no difference in effectiveness of the combination therapy of ledipasvir and sofosbuvir whether they were taken for 8 or 12 weeks by black patients—hence black patients currently under treatment for Hepatitis C can take 8 weeks of certain direct-acting antiviral drugs rather than the 12 weeks previously recommended.

Study Discussion

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.”

Lead Research/Investigator

Michael Silverberg, PhD, MPH, Investigator with Kaiser Permanente Northern California Division of Research

Julia Marcus, PhD, MPH, Principal Investigator, Department of Population Health, Harvard Medical School