Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection

Summary Background Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) for hepatitis C virus (HCV) in patients with or without human immunodeficiency virus (HIV) coinfection. Aim To evaluate the effectiveness and safety of genericVEL/SOF‐based therapy forHCVinfection in patients with or withoutHIVcoinfection in Taiwan. Methods Sixty‐nineHIV/HCV‐coinfected and 159HCV‐monoinfected patients receiving 12 weeks of genericVEL/SOFwith or without ribavirin (RBV) forHCVwere prospectively enrolled. The anti‐viral responses and the adverse events (AEs) were compared between the two groups. The characteristics potentially related to sustained virological response 12 weeks off therapy (SVR12) were analysed. Results TheSVR12was achieved in 67HIV/HCV‐coinfected patients (97.1%; 95%CI: 90.0%‐99.2%) and in 156HCV‐monoinfected patients (98.1%; 95%CI: 94.6%‐99.4%) receivingVEL/SOF‐based therapy, respectively. TheSVR12rates were comparable betweenHIV/HCV‐coinfected andHCV‐monoinfected patients, regardless of pre‐specified baseline characteristics. One hundred twenty‐two (53.5%) and seven (3.1%) patients had baseline resistance‐associated substitutions (RASs) inHCV NS5A andNS5B regions, but theSVR12rates were not affected by the presence or absence ofRASs. One (1.4%) and five (3.1%) patients in theHIV/HCV‐coinfected andHCV‐monoinfected groups had seriousAEs. No patient died or discontinued treatment due toAEs. TheeGFRremained stable throughout the course of treatment inHIV/HCV‐coinfected patients receiving anti‐retroviral therapy containing tenofovir disoproxil fumarate (TDF). Conclusions GenericVEL/SOF‐based therapy is well‐tolerated and provides comparably highSVR12rates forHCVinfection in patients with and withoutHIVcoinfection.