Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients

NCT03250910 | Completed Phase 4

• 1 other identifier: 201602026RINC
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus

Keywords

hepatitis C virus; human immunodeficiency virus; Direct acting antiviral agent

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response

  HCV RNA \< LLOQ 12 weeks off therapy

  24 weeks

Study Arms (4)

HIV/HCV compensated liver disease

EXPERIMENTAL

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.

Drug: Sofosbuvir and Velpatasvir

HIV/HCV decompensated liver disease

EXPERIMENTAL

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.

Drug: Sofosbuvir and Velpatasvir; Drug: Ribavirin

HCV compensated liver disease

ACTIVE COMPARATOR

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.

Drug: Sofosbuvir and Velpatasvir

HCV decompensated liver disease

ACTIVE COMPARATOR

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.

Drug: Sofosbuvir and Velpatasvir; Drug: Ribavirin

Interventions

Sofosbuvir and Velpatasvir DRUG

All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.

Also known as: Sofosvel

HCV compensated liver disease; HCV decompensated liver disease; HIV/HCV compensated liver disease; HIV/HCV decompensated liver disease

Ribavirin DRUG

Patients with decompensated cirrhosis (Child-Pugh B or C), received 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.

Also known as: Robatrol

HCV decompensated liver disease; HIV/HCV decompensated liver disease

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic kidney disease (CKD) stage ≥ 4,
• Organ transplantation
• Prior DAA exposure
• Refusal to provide written informed consent.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome

Interventions

sofosbuvir-velpatasvir drug combination; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Chen-Hua Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 16, 2017
• Study Start: August 1, 2016
• Primary Completion: July 15, 2017
• Study Completion: October 31, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)