Merck’s fixed-dose combination tablet, grazoprevir/elbasvir, given with or without ribavirin, cured over 90 percent of various subgroups of people with hepatitis C virus (HCV), including those coinfected with HIV, and those with or without cirrhosis. Data on the various arms of the C-EDGE trial, in which the participants were treated for 12 or 16 weeks with the NS3/4A protease inhibitor grazoprevir and the NS5A replication complex inhibitor elbasvir, with or without ribavirin, were presented at the 50th International Liver Congress in Vienna, Austria.
All the study arms included people with and without cirrhosis.
In the C-EDGE TN arm, 316 people with genotypes 1, 4 or 6 were treated for 12 weeks. Ninety-five percent (299) of them achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), with all the subgroups achieving at least a 92 percent cure rate except for those with genotype 6, of whom 80 percent (8 of 10) were cured.
In the C-EDGE Co-INFXN arm, 218 people with genotypes 1, 4 or 6 were treated for 12 weeks. Ninety-five percent (207) were cured, with all subgroups achieving at least a 94 percent cure rate.
The C-EDGE TE arm was divided into four subgroups: Two received 12 weeks of treatment with or without ribavirin (104 and 105 participants, respectively), and two received 16 weeks of treatment with or without ribavirin (106 and 105 participants, respectively). This arm included people with genotypes 1, 4 or 6, although the 12-week treatment subgroup did not include people with genotype 6. In the 12-week treatment subgroups, 94 percent (98 of 104) of those who took ribavirin were cured, as were 92 percent (97 of 105) of those who did not take ribavirin. In the 16-week treatment subgroups, 97 percent (103 of 106) of those who took ribavirin were cured, as were 92 percent (97 of 105) of those who did not take ribavirin.
All the various subcategories of people in C-EDGE TE, including those with cirrhosis, achieved at least a 92 percent cure rate, except for the following:
- Among those with cirrhosis who were treated for 12 weeks, 89 percent of both those who took ribavirin (31 of 35) and those who did not (33 of 37) were cured.
- Seventy-eight percent (7 of 9) of people with genotype 4 who did not take ribavirin and were treated for 12 weeks were cured.
- Sixty percent (3 of 5) of people with genotype 4 and 75 percent (3 of 4) of those with genotype 6 who did not take ribavirin and were treated for 16 weeks were cured.
To read the Merck press release about the study, click here.
To read the study abstract, click here.