Active, not recruitingPhase 3
A Phase 3 Trial Comparing Whether BEM/RZR is Similar to SOF/VEL in Patients with Hepatitis C Virus Infection
Key facts
- Who runs it
- Atea Pharmaceuticals Inc.
- Where
- France, Germany, Greece, Poland, Romania, and Spain38 sites in 6 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 275 people, planned
- Started
- 2 Oct 2025
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional
- Record updated
- 20 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Use of adequate contraception for females of childbearing potential
- Must be direct-acting antiviral (DAA)-treatment naïve (never exposed to an approved or experimental DAA for HCV)
- Documented medical history compatible with chronic HCV
- Either no liver cirrhosis or with compensated liver cirrhosis
- If HIV-1 positive, must meet the following 2 criteria: 1. Antiretroviral (ARV) regimen for > 8 weeks prior to screening visit, with CD4 T-cell count > 200 cells/mm3 and plasma HIV-1RNA level < LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications
Who cannot take part
- Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
- Requirement of any prohibited medications
- Use of other investigational drugs within 30 days of dosing
- Co-infected with hepatitis B virus
- History or signs of decompensated liver disease (decompensated cirrhosis)
- History of hepatocellular carcinoma (HCC)
- Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Pregnant or breastfeeding
This trial has no sites in United States.
It has sites in 6 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD.
Data and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
- Record updated
- 20 July 2026