Thirty-eight of 40 volunteers with hepatitis C virus (HCV) infections who received a combination of three direct-acting oral drugs for six weeks were cured in a clinical trial conducted at the National Institutes of Health (NIH). A six-week course of therapy is half the length of time previously shown to achieve a similar cure rate using two direct-acting oral HCV drugs only. The trial findings appear in The Lancet.
A group of 20 volunteers received the recently licensed drug sofosbuvir (trade name Sovaldi) along with two other direct-acting oral therapies, ledipasvir and an experimental drug named GS-9669, for six weeks. A second group of 20 volunteers received sofosbuvir, ledipasvir and a different experimental drug, GS-9451, for six weeks. None of the volunteers had been treated previously for their HCV infections, and all tolerated the drug regimens well. In the first group, one volunteer relapsed two weeks after completing therapy, but the remaining 19 people had no detectable HCV when tested 12 weeks after the end of therapy and were deemed cured. In the second group, one volunteer was lost to follow-up, but the remaining 19 had no detectable HCV 12 weeks after the end of therapy and were also deemed cured. A third group of 20 volunteers received just two oral drugs-sofosbuvir and ledipasvir-for 12 weeks. All 20 were cured with that drug regimen.
"This short duration, simple therapy for HCV may prove relevant for the global elimination of hepatitis C, where simple, well-tolerated therapy of short duration is required to ensure adherence," the study authors write.
The trial was led by Shyam Kottilil, M.D., Ph.D., formerly of the NIH National Institute of Allergy and Infectious Diseases, and included researchers from the NIH Clinical Center and the National Cancer Institute. The study was also supported by the NIH Office of AIDS Research and was conducted in collaboration with the D.C. Partnership for AIDS Research.
A Kohli et al. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. The Lancet DOI: 10.1016/S0140-6736(14)61228-9 (2015).
NIAID Director Anthony S. Fauci, M.D., a study co-author, is available to discuss the findings. Dr. Kottilil is also available for comment.