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Bemnifosbuvir-ruzasvir versus sofosbuvir-velpatasvir for adults with chronic hepatitis C

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

Phase 3 Interventional Atea Pharmaceuticals, Inc. · NCT07037277

This will test whether the oral combination bemnifosbuvir-ruzasvir works as well and is as safe as sofosbuvir-velpatasvir for adults with chronic hepatitis C who have never received direct-acting antiviral treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment880 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorAtea Pharmaceuticals, Inc. Industry-sponsored
Locations106 sites (Nice, Alpes Maritimes and 105 other locations)
Trial IDNCT07037277 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares the efficacy and safety of bemnifosbuvir-ruzasvir (BEM/RZR) against the established regimen sofosbuvir-velpatasvir (SOF/VEL) in adults with chronic hepatitis C. Eligible participants are DAA‑treatment‑naïve and may have no cirrhosis or compensated cirrhosis; people with controlled HIV on a stable antiretroviral regimen may also join under specified criteria. Enrolled participants receive one of the two oral regimens and are followed for virologic response and adverse events over the planned treatment and follow‑up periods. The trial is conducted at Atea study sites in France.

Who should consider this trial

Good fit: Adults with chronic hepatitis C who have never received a DAA, are not pregnant or breastfeeding, do not have hepatitis B co‑infection, and can attend one of the study sites—people with compensated cirrhosis or well‑controlled HIV on a stable ARV regimen may qualify.

Not a fit: People previously treated with any HCV DAA, those with decompensated liver disease, hepatitis B co‑infection, pregnant or breastfeeding individuals, or those taking prohibited medications are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BEM/RZR could become an effective alternative oral treatment option for DAA‑naïve adults with chronic HCV, expanding choices for patients and clinicians.

How similar studies have performed: Sofosbuvir‑velpatasvir is a well‑established, highly effective pan‑genotypic regimen, while bemnifosbuvir‑ruzasvir is a newer combination currently being tested in later‑phase trials against that standard.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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-1 RNA \<LLOQ
  2. Suitable ARV treatment and not taking any contraindicated medications

Key Exclusion Criteria:

* Pregnant or breastfeeding
* Co-infected with hepatitis B virus
* Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
* Prior exposure to any HCV DAA
* Requirement of any prohibited medications
* Use of other investigational drugs within 30 days of dosing
* 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

Where this trial is running

Nice, Alpes Maritimes and 105 other locations

+56 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HEPATITIS C VIRUS CHRONIC INFECTIONHepatitis C, ChronicHepatitis C Virus InfectionHepatitis C
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.