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Aliment Pharmacol Ther. 2018 Jun;47(12):1690-1698. doi: 10.1111/apt.14647. Epub 2018 Apr 17.

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

Liu CH1,2,3, Sun HY1, Liu CJ1,2,4, Sheng WH1, Hsieh SM1, Lo YC5, Liu WC1, Su TH1,2, Yang HC1,2,6, Hong CM7, Tseng TC1,2, Chen PJ1,2,4, Chen DS1,2,8, Hung CC1,9,10, Kao JH1,2,4.

Author information

1
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
2
Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
3
Department of Internal Medicine, National Taiwan University Hospital, Douliou, Taiwan.
4
Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
5
Centers for Disease Control, Taipei, Taiwan.
6
Department of Microbiology, National Taiwan University College of Medicine, Taipei, Taiwan.
7
Department of Traumatology, National Taiwan University Hospital, Taipei, Taiwan.
8
Genomics Research, Center, Academia Sinica, Taipei, Taiwan.
9
Department of Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan.
10
Department of Medical Research, China Medical University Hospital, Taichung, Taiwan.

Abstract

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 (AEs) were compared between the two groups. The characteristics potentially related to sustained virological response 12 weeks off therapy (SVR12 ) were analysed.

RESULTS:

The SVR12 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 SVR12 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 (RASs) in HCV NS5A and NS5B regions, but the SVR12 rates were not affected by the presence or absence of RASs. One (1.4%) and five (3.1%) patients in the HIV/HCV-coinfected and HCV-monoinfected groups had serious AEs. No patient died or discontinued treatment due to AEs. 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 SVR12 rates for HCV infection in patients with and without HIV coinfection.

PMID:
29665069
DOI:
10.1111/apt.14647

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