Article: Safety and Efficacy of Elbasvir/Grazoprevir in Patients with Hepatitis C Virus Infection and Compensated Cirrhosis: an Integrated Analysis—Ira M. Jacobson et al.
Study Aims and Results
This was a retrospective study—looking back at prior studies—to analyze the results of Merck’s two drug combination of elbasvir plus grazoprevir (Zepatier) with or without ribavirin to treat patients infected with chronic hepatitis C who had compensated cirrhosis. The study combined data from 6 clinical studies.
The analysis of the studies included 402 patients with HCV genotype 1, 4, or 6. The patients were treated for 12 to 18 weeks. The goal of the study was to find the number of people who were cured of hepatitis C.
In those who received Zepatier (without ribavirin) 97.8% (135 of 138 patients) of treatment-naïve and 88.9% (48 of 54 pts) of treatment-experienced were cured of hepatitis C.
In those who received Zepatier for 12 weeks the addition of ribavirin did not increase the cure rates—treatment naïve-90.3% (28 of 31 pts) or treatment experienced -91.4% (74 of 81 pts).
All of the patients who received Zepatier and ribavirin for 16 or 18 weeks were cured, and 93.9% (46 of 49 pts) of patients were cured who received Zepatier without ribavirin treated for 16 or 18 weeks.
People with HCV genotype 1a infection and those who had not responded to a previous course of interferon therapy were less likely to be cured compared to those with HCV genotype 1b. Baseline testing for resistant associated variants was recommended to ascertain the best course of treatment duration and if the addition of ribavirin is needed for treatment of HCV genotype 1a. Patients with the baseline RAVs had a 73% (8 of 11 pts) cure rate compared to a 98% (96 of 98 pts) cure rate in those who did not have baseline RAVs. The patients who had HCV genotype 1a infection with baseline RAVs who received 16 or 18 weeks of Zepatier plus ribavirin were cured reinforcing the need for ribavirin to overcome baseline RAVs.
There were 3% of serious adverse events but they did not lead to a decompensated event.
The pooled analysis of Zepatier clinical studies of people with compensated cirrhosis showed very high cure rates, low side effect profile and in the vast majority of cases no ribavirin is needed. From this analysis the only cases that ribavirin may be of benefit is in patients with HCV genotype 1a baseline RAVs.
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Alan Franciscus is the Executive Director of the Hepatitis C Support Project and the Editor-in-Chief of the HCV Advocate Website.