Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

摘要

Summary Novel direct‐acting antivirals ( DAA s) are now the standard of care for the management of hepatitis C virus ( HCV ) infection. Branded DAA s are associated with high sustained virological response at 12?weeks post‐completion of therapy ( SVR 12), but are costly. We aimed to assess the efficacy of generic oral DAA s in a real‐life clinical scenario. Consecutive patients with known HCV infection who were treated with generic‐oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR 12 were documented. Four hundred and ninety patients (mean age: 38.9?±?12.7?years) were treated with generic DAA s in the study time period. Their clinical presentations included chronic hepatitis ( CHC ) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n?=?372, 75.9%) followed by genotype 1 (n?=?97, 19.8%). Treatment na?ve and treatment‐experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%), respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n?=?175), daclatasvir alone (n?=?149), ribavirin and peginterferon (n?=?80), ledipasvir alone (n?=?43), daclatasvir and ribavirin (n?=?37), and ledipasvir and ribavirin (n?=?6). Overall SVR 12 was 95.9% (470/490) for all treatment regimens. SVR 12 for treatment na?ve and experienced patients was 97.0% (419/432) and 87.9% (51/58), respectively, P ?=?.005. High SVR 12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR 12 with 12 or 24?weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAA s are associated with high SVR rates in patients with HCV infection in a real‐life clinical scenario.