Article: Glecaprevir/Pibrentasvir for Hepatitis C Virus Genotype 3 Patients with Cirrhosis and/or Prior Treatment Experience: A Partially Randomized Phase 3 Clinical Trial—D. Wyles, et. al.
SOURCE: Hepatology. 2017 Sep 19. doi: 10.1002/hep.29541. [Epub ahead of print]
Study Aims and Results: A study of Mavyret (glecaprevir/pibrentasvir co-formulated into one pill) taken once-a-day was conducted to find out the cure rates of hepatitis C (HCV) genotype 3 treatment-naïve and treatment-experienced patients with and without cirrhosis. There were 131 patients enrolled in the study. These were patients without serious HCV disease progression. The treatment length, prior treatment information, liver disease status, and cure rates are listed below:
Conclusions: The combination of glecaprevir— an HCV protease inhibitor—plus pibretasvir— an NS5A inhibitor—produced up to 98% cure rates. Of note, people who did not achieve a cure in this trial (6 people) were invited to enroll in www.clinicaltrials.gov #NCT02939989. The study includes HCV DAA’s Mavyret plus sofosbuvir.
Editorial Comments: This study has three of the most difficult disease characteristics to treat—HCV genotype 3, treatment experienced and cirrhosis. You will note that the difference in cure rates between the 12 and 16-week treatment- experienced groups without cirrhosis was minimal. The current study proved that the vast majority of patients treated with Mavyret could overcome these difficult treatment obstacles. It will be interesting to find out if the addition of sofosbuvir— an HCV polymerase inhibitor—a different HCV viral protein can cure the remaining six patients. I know this study is a scientific endeavor, but I wonder if just adding ribavirin would be as effective (and cheaper) alternative than adding another expensive drug. Perhaps the study participants were offered ribavirin in the new study protocol.
Treatment Duration Patient Population Cure Rate
12 weeks TE without cirrhosis 91% (20 of 22 pts)
16 weeks TE without cirrhosis 95% (21 of 22 pts)
12 weeks TN with cirrhosis 98% (39 of 40 pts)
6 weeks TE with cirrhosis 96% (45 of 47 pts)
* TE = treatment experience; TN = treatment naïve
There were no serious side effects or treatment discontinuations.
Alan Franciscus is the Executive Director of the Hepatitis C Support Project and the Editor-in-Chief of the HCV Advocate Website.
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