PMID- 29665069 OWN - NLM STAT- MEDLINE DCOM- 20190916 LR - 20220321 IS - 1365-2036 (Electronic) IS - 0269-2813 (Linking) VI - 47 IP - 12 DP - 2018 Jun TI - Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection. PG - 1690-1698 LID - 10.1111/apt.14647 [doi] AB - 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 (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 (RASs) in HCV NS5A and NS5B regions, but the SVR(12) 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 SVR(12) rates for HCV infection in patients with and without HIV coinfection. CI - (c) 2018 John Wiley & Sons Ltd. FAU - Liu, C-H AU - Liu CH AUID- ORCID: 0000-0003-3622-9707 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Department of Internal Medicine, National Taiwan University Hospital, Douliou, Taiwan. FAU - Sun, H-Y AU - Sun HY AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. FAU - Liu, C-J AU - Liu CJ AUID- ORCID: 0000-0002-6202-0993 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. FAU - Sheng, W-H AU - Sheng WH AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. FAU - Hsieh, S-M AU - Hsieh SM AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. FAU - Lo, Y-C AU - Lo YC AD - Centers for Disease Control, Taipei, Taiwan. FAU - Liu, W-C AU - Liu WC AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. FAU - Su, T-H AU - Su TH AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. FAU - Yang, H-C AU - Yang HC AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Department of Microbiology, National Taiwan University College of Medicine, Taipei, Taiwan. FAU - Hong, C-M AU - Hong CM AD - Department of Traumatology, National Taiwan University Hospital, Taipei, Taiwan. FAU - Tseng, T-C AU - Tseng TC AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. FAU - Chen, P-J AU - Chen PJ AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. FAU - Chen, D-S AU - Chen DS AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Genomics Research, Center, Academia Sinica, Taipei, Taiwan. FAU - Hung, C-C AU - Hung CC AUID- ORCID: 0000-0001-7345-0836 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Department of Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan. AD - Department of Medical Research, China Medical University Hospital, Taichung, Taiwan. FAU - Kao, J-H AU - Kao JH AUID- ORCID: 0000-0002-2442-7952 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180417 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - 0 (Antiviral Agents) RN - 0 (Carbamates) RN - 0 (Drug Combinations) RN - 0 (Heterocyclic Compounds, 4 or More Rings) RN - 0 (sofosbuvir-velpatasvir drug combination) RN - 49717AWG6K (Ribavirin) RN - 99YXE507IL (Tenofovir) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM MH - Adult MH - Aged MH - Antiviral Agents/*administration & dosage/therapeutic use MH - Carbamates/*administration & dosage MH - Coinfection MH - Drug Combinations MH - Female MH - HIV Infections/drug therapy MH - Hepacivirus/isolation & purification MH - Hepatitis C/*drug therapy MH - Heterocyclic Compounds, 4 or More Rings/*administration & dosage MH - Humans MH - Male MH - Middle Aged MH - Ribavirin/therapeutic use MH - Sofosbuvir/*administration & dosage MH - Sustained Virologic Response MH - Taiwan MH - Tenofovir/therapeutic use MH - Treatment Outcome EDAT- 2018/04/18 06:00 MHDA- 2019/09/17 06:00 CRDT- 2018/04/18 06:00 PHST- 2017/11/22 00:00 [received] PHST- 2017/12/18 00:00 [revised] PHST- 2018/03/12 00:00 [accepted] PHST- 2018/04/18 06:00 [pubmed] PHST- 2019/09/17 06:00 [medline] PHST- 2018/04/18 06:00 [entrez] AID - 10.1111/apt.14647 [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2018 Jun;47(12):1690-1698. doi: 10.1111/apt.14647. Epub 2018 Apr 17.