Efficacy and safety of 12?weeks of elbasvir?±?grazoprevir?± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C‐SCAPE study

摘要

Summary People with hepatitis C virus ( HCV ) infection other than genotype 1 represent a heterogeneous group. The aim of the phase 2 C‐ SCAPE study was to evaluate elbasvir/grazoprevir ( EBR / GZR ), with or without ribavirin ( RBV ), in participants with HCV genotype 2, 4, 5 or 6 infection. This was a part randomised, open‐label, parallel‐group study ( NCT 01932762; PN 047‐03) of treatment‐naive, noncirrhotic participants. Participants with HCV genotype 2 infection received GZR 100?mg?+? RBV ?±? EBR 50?mg for 12?weeks and those with genotype 4, 5 or 6 infection were randomized to receive EBR / GZR ?±? RBV for 12?weeks. The primary endpoint was sustained virological response 12 weeks after completion of treatment (SVR12; HCV RNA 25?IU/mL). Among participants with genotype 2 infection, SVR 12 was achieved by 80% (24/30) of those receiving EBR / GZR ?+? RBV and 73% (19/26) of those receiving GZR ?+? RBV . SVR rates were high in participants with HCV genotype 4 infection receiving EBR / GZR with and without RBV (100% [10/10] and 90% [9/10]; respectively). In contrast, the addition of RBV to EBR / GZR appeared to increase SVR 12 in participants with genotype 5 infection ( EBR / GZR , 25%; EBR / GZR ?+? RBV 100% [4/4]). In participants with genotype 6 infection, SVR 12 was 75% (3/4) in both those receiving EBR / GZR and those receiving EBR / GZR ?+? RBV . The safety profile was similar across treatment arms, with adverse events tending to occur more frequently among participants receiving RBV . In conclusion, these data support the inclusion of participants with genotype 4 or 6 infection in the EBR / GZR phase 3 studies. EBR / GZR ?±? RBV was unsatisfactory for participants with genotype 2 or 5 infection.