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Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection
Author(s) -
Liu C.H.,
Sun H.Y.,
Liu C.J.,
Sheng W.H.,
Hsieh S.M.,
Lo Y.C.,
Liu W.C.,
Su T.H.,
Yang H.C.,
Hong C.M.,
Tseng T.C.,
Chen P.J.,
Chen D.S.,
Hung C.C.,
Kao J.H.
Publication year - 2018
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.14647
Subject(s) - medicine , coinfection , hepatitis c virus , sofosbuvir , ribavirin , adverse effect , hepatitis c , virology , gastroenterology , human immunodeficiency virus (hiv) , virus
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 generic VEL / SOF ‐based therapy for HCV infection in patients with or without HIV coinfection in Taiwan. Methods Sixty‐nine HIV / HCV ‐coinfected and 159 HCV ‐monoinfected patients receiving 12 weeks of generic VEL / SOF with or without ribavirin ( RBV ) for HCV were prospectively enrolled. The anti‐viral responses and the adverse events ( AE s) were compared between the two groups. The characteristics potentially related to sustained virological response 12 weeks off therapy ( SVR 12 ) were analysed. Results The SVR 12 was achieved in 67 HIV / HCV ‐coinfected patients (97.1%; 95% CI : 90.0%‐99.2%) and in 156 HCV ‐monoinfected patients (98.1%; 95% CI : 94.6%‐99.4%) receiving VEL / SOF ‐based therapy, respectively. The SVR 12 rates were comparable between HIV / HCV ‐coinfected and HCV ‐monoinfected patients, regardless of pre‐specified baseline characteristics. One hundred twenty‐two (53.5%) and seven (3.1%) patients had baseline resistance‐associated substitutions ( RAS s) in HCV NS 5A and NS 5B regions, but the SVR 12 rates were not affected by the presence or absence of RAS s. One (1.4%) and five (3.1%) patients in the HIV / HCV ‐coinfected and HCV ‐monoinfected groups had serious AE s. No patient died or discontinued treatment due to AE s. The eGFR remained stable throughout the course of treatment in HIV / HCV ‐coinfected patients receiving anti‐retroviral therapy containing tenofovir disoproxil fumarate ( TDF ). Conclusions Generic VEL / SOF ‐based therapy is well‐tolerated and provides comparably high SVR 12 rates for HCV infection in patients with and without HIV coinfection.