Combination HCV Treatment Effective for Various Genotypes

The combination of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin appeared to be effective and well tolerated and could potentially reduce the duration of treatment for many individuals with hepatitis C infection, according to a recent study.

The randomized open-label clinical trial included 676 participants who were chronically infected with HCV genotypes 1-6 with or without compensated cirrhosis from 15 countries. Participants were randomly assigned to received fixed-dose combination of grazoprevir, ruzasvir, and uprifosbuvir with ribavirin or without ribavirin for 8, 12, or 16 weeks. The proportion of participants who achieve sustained virological response 12 weeks after the end of the study (SVR12) was assessed as the primary endpoint. Final analysis included data from 675 participants who received at least 1 dose of the study drug.
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Of the participants who received the 8-week regimen of grazoprevir, ruzasvir, and uprifosbuvir with and without ribavirin, SVR12 was achieved in 39 of the 42 participants with genotype 1a (93%), 45 of the 46 participants with genotype 1b (98%), 54 of the 63 participants with genotype 2 (86%), 98 of the 103 participants with genotype 3 (95%), and all 7 participants with genotype 4 (100%). SVR12 for the 12-week regimen with and without ribavirin was achieved by 87 of the 88 participants with genotype 1 (99%), 61 of the 62 participants with genotype 2 (98%), and all 4 participants with genotype 6 (100%).

Among participants with genotype 3 and cirrhosis who received the 12-week regimen with and without ribavirin, SVR12 was achieved by 28 of the 29 participants who had not received prior HCV treatment (97%), and was achieved by all 29 participants who had received prior treatment (100%).

For those who received the 16-week regimen with and without ribavirin, all 26 participants with genotype 2 (100%) and 72 of the 75 participants with genotype 3 (96%) achieved SVR12.

Common adverse events observed in 664 participants included headache (22%), fatigue (19%), and nausea (13%). In addition, 16 of 664 participants experienced serious adverse events.

“The combined regimen of grazoprevir (100 mg/day), ruzasvir (60 mg/day), and uprifosbuvir (450 mg/day) has the potential to provide a simplified treatment for HCV that is effective and well tolerated in most individuals infected with HCV, as well as a shorter duration of treatment in many individuals,” the researchers concluded.

—Melissa Weiss

Reference:

Lawitz E, Buti M, Vierling JM, et al. Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, part B): two randomised, phase 2, open-label trials [published online August 9, 2017]. Lancet Gastroenterol Hepatol. http://dx.doi.org/10.1016/S2468-1253(17)30163-2.