Table 1. Study inclusion criteria, systematic review and meta-analysis of generic direct-acting agents for treating hepatitis C.
Characteristic | Inclusion criterion | Notes |
---|---|---|
Study population | People living with a chronic HCV infection | None |
Study intervention | Treatment of HCV infection using generic direct-acting agents | Table 2 lists eligible drugs and their licensed doses and Box 1 lists eligible treatment regimens |
Comparison treatment | Either: (i) brand-name direct-acting agents for HCV infection; or (ii) no comparator treatment | The following study types were excluded: (i) studies of HCV prevalence or screening; and (ii) clinical trials or cohort studies that evaluated the effectiveness of brand-name direct-acting agents only |
Study outcome | Sustained virological response 12 weeks after the end of treatment | The outcome used in intention-to-treat and per-protocol analyses was the eradication of HCV virus, as indicated by a sustained virological response 12 weeks after the end of treatment |
Study design | Randomized or open-label clinical trials and real-life cohort studies | The following study types were eligible for inclusion: (i) randomized or open label clinical trials that compared the effectiveness of generic and brand-name direct-acting agents for the treatment of HCV infection; and (ii) cohort studies that reported the effectiveness of generic direct-acting agents for HCV eradication |
HCV: hepatitis C virus.