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Comparing two treatments for chronic Hepatitis C

Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects With Chronic Hepatitis C Virus (HCV) Infection

PHASE3 · Atea Pharmaceuticals, Inc. · NCT06868264

This study is testing two different antiviral treatments for adults with chronic Hepatitis C to see which one works better and is safer for people who haven't been treated before.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment880 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorAtea Pharmaceuticals, Inc. (industry)
Locations40 sites (Birmingham, Alabama and 39 other locations)
Trial IDNCT06868264 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of two antiviral treatments, Bemnifosbuvir-Ruzasvir (BEM/RZR) and Sofosbuvir-Velpatasvir (SOF/VEL), in adults diagnosed with chronic Hepatitis C virus (HCV) infection. Participants will be randomly assigned to receive one of the two treatment regimens, and their health outcomes will be monitored to determine which treatment is more effective. The study focuses on treatment-naïve individuals, meaning they have not previously received direct-acting antiviral therapy for HCV. The trial will assess both the effectiveness in clearing the virus and the safety profile of the medications.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with chronic HCV who have never been treated with direct-acting antivirals and have either no liver cirrhosis or compensated liver cirrhosis.

Not a fit: Patients who are pregnant, breastfeeding, or co-infected with hepatitis B virus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with chronic Hepatitis C.

How similar studies have performed: Other studies have shown success with similar antiviral treatment approaches, indicating a promising avenue for chronic HCV management.

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
* 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

Birmingham, Alabama and 39 other locations

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 →

Conditions: HEPATITIS C VIRUS CHRONIC INFECTION

Last reviewed 2026-05-15 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.