Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
Data are limited regarding the effectiveness and safety of generic velpatasvir plus
 sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus
 (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the
 effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected
 and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are
 compare between the two groups. The characteristics potentially related to sustained
 virologic response 12 weeks off therapy (SVR12) are analyzed.
Due to the lack of effective vaccination and the shared routes of transmission, hepatitis C
 virus (HCV) infection remains a challenging co-morbidity in patients with human
 immunodeficiency virus (HIV) infection. It is estimated that approximately 2.3 million people
 are coinfected with HIV and HCV (HIV/HCV) in the world. Compared to patients with HCV
 monoinfection, HIV/HCV-coinfected patients tend to have higher serum HCV viral loads, faster
 hepatic fibrosis progression, and higher risks of hepatic decompensation. Following the
 commencement of scale-up antiretroviral therapy (ART) that decreases the HIV-related
 opportunistic infections and malignancies, the liver-related complications have now become
 the leading cause of morbidity and mortality in HIV/HCV-coinfected patients. On the other
 hand, the survival rate is improved if these patients achieve sustained virologic response
 (SVR) by anti-HCV agents.

 On the basis of excellent efficacy and safety, treatment by interferon (IFN)-free direct
 acting antiviral agents (DAAs) has made a paradigm shift for HCV care. Velpatasvir (VEL) is
 an HCV non-structural protein 5A (NS5A) inhibitor and sofosbuvir (SOF) is an HCV NS5B
 nucleotide polymerase inhibitor. Both agents are active against HCV with pan-genotypic
 potency. A fixed-dose combination of VEL at a daily dosage of 100 mg and SOF at a daily
 dosage of 400 mg (VEL/SOF) with or without weight-based ribavirin (RBV) has been approved by
 U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to treat HCV
 genotype 1-6 patients with compensated and decompensated liver diseases, respectively.
 Recently, a phase 3 study of VEL/SOF to treat HCV infection in HIV-coinfected patients
 reveals that this regimen is safe and provides a high and comparable SVR rate to
 HCV-monoinfected patients.

 Although treatment of HCV by IFN-free DAAs is considered highly efficacious and well
 tolerated, numerous HCV-infected individuals have limited access to the brand-name agents due
 to the lack of universal governmental reimbursement or private insurance support. Therefore,
 allowing the generic version of patented DAAs for HCV through voluntary or compulsory
 licensing may provide patients with greater access to new HCV treatment, particularly in
 resource-constrained countries. Regarding the real-world experiences of generic IFN-free
 DAAs, a recent report from China evaluated the effectiveness of a generic version of
 ledipasvir (LDV) plus SOF (LDV/SOF) with or without RBV for 8-12 weeks in 192 HCV genotype 1b
 (HCV-1b) patients. The overall SVR rates were excellent (96.8%-96.9%) and most patients
 tolerated the treatment well. Based on the encouraging results, we aim to evaluate the
 effectiveness and safety of a generic version of pan-genotypic VEL/SOF-based therapy for HCV
 in HIV-coinfected patients, and compare the performance of such a regimen in HCV-monoinfected
 patients.
Inclusion Criteria:

 -  Age > or = 20 years

 -  Chronic HCV infection, defined as detectable HCV antibody (anti-HCV; Abbott HCV EIA
 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) and quantifiable serum HCV RNA
 (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, lower limit of
 quantification [LLOQ]: 25 IU/mL) for ≥ 6 months

 Exclusion Criteria:

 -  Chronic kidney disease (CKD) stage ≥ 4,

 -  Organ transplantation

 -  Prior DAA exposure

 -  Refusal to provide written informed consent.