Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection, Response to Therapy of focused on measuring hepatitis C virus, human immunodeficiency virus, Direct acting antiviral agent
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Hospital, Yun-Lin Branch
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
HIV/HCV compensated liver disease
HIV/HCV decompensated liver disease
HCV compensated liver disease
HCV decompensated liver disease
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) received a generic version of Sofosbuvir and Velpatasvir fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Patients with decompensated cirrhosis (Child-Pugh B or C) received Sofosvel® 1 tablet per day in combination with weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.
Patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) received a generic version of Sofosbuvir and Velpatasvir fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
Patients with decompensated cirrhosis (Child-Pugh B or C) received Sofosvel® 1 tablet per day in combination with weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.