Bemnifosbuvir + Ruzasvir for Chronic Hepatitis C

No longer recruiting at 57 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Atea Pharmaceuticals, Inc.

Must not be taking: Investigational drugs

Disqualifiers: HIV, Hepatitis B, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combining two drugs, Bemnifosbuvir and Ruzasvir, to determine their safety and effectiveness in treating chronic Hepatitis C. The goal is to see if these medications can help individuals with this long-term liver infection who have not tried similar treatments before. This trial may suit those with a history of Hepatitis C who have never used direct-acting antiviral treatments and do not have advanced liver disease. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to important medical advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of bemnifosbuvir and ruzasvir is being tested for safety in treating chronic hepatitis C. In earlier studies, these drugs showed promise in stopping the virus. Patients who took these drugs did not report any serious side effects, and the treatment was generally well-tolerated. Some patients experienced mild reactions, but these were uncommon.

Previous tests with healthy participants also supported the safety of this drug combination. The data indicated that people did not encounter major issues when taking bemnifosbuvir and ruzasvir together. As the trial remains in an early phase, researchers are closely monitoring safety, continuing to gather information to ensure it is safe for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about bemnifosbuvir and ruzasvir because these treatments potentially offer a new approach to tackling chronic hepatitis C. Unlike traditional treatments like direct-acting antivirals (DAAs), which typically target specific proteins of the hepatitis C virus, bemnifosbuvir acts as a nucleotide polymerase inhibitor, interfering with the virus's ability to replicate its genetic material. This new mechanism could enhance treatment options, especially for patients who don't respond well to existing therapies. Additionally, when combined with ruzasvir, which targets different parts of the virus, there's potential for a more comprehensive attack against the virus, potentially leading to higher cure rates.

What evidence suggests that Bemnifosbuvir and Ruzasvir could be effective for chronic Hepatitis C?

Research has shown that the combination of Bemnifosbuvir and Ruzasvir, which participants in this trial will receive, effectively treats chronic Hepatitis C. One study reported that 98% of patients were free of the virus 12 weeks after completing just an 8-week treatment. These drugs work together to strongly inhibit the virus's growth and spread. Early studies suggest that this combination might outperform some current treatments, making it a promising option for those with chronic Hepatitis C. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with chronic Hepatitis C who haven't been treated with direct-acting antiviral drugs. They must not have severe liver damage or cirrhosis, no history of liver cancer, and can't be pregnant or breastfeeding. Participants should agree to use effective contraception if applicable.

Inclusion Criteria

I agree to not have sex or use effective birth control.

I have a history of chronic hepatitis C.

I have taken a pregnancy test and it was negative.

Exclusion Criteria

I am co-infected with hepatitis B and/or HIV.

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

Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bemnifosbuvir (BEM) and Ruzasvir (RZR) for the treatment of chronic HCV infection

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bemnifosbuvir
• Ruzasvir

Trial Overview The trial tests the safety and effectiveness of two medications, Bemnifosbuvir (BEM) and Ruzasvir (RZR), in treating chronic Hepatitis C virus infection. It's an open-label study where all participants know which treatment they're receiving.

How Is the Trial Designed?

Group I: Bemnifosbuvir and Ruzasvir Experimental Treatment 2 Interventions

Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules

Who Is Running the Clinical Trial?

Atea Pharmaceuticals, Inc.

Lead Sponsor

Trials

29

Recruited

4,600+

Published Research Related to This Trial

The combination of sofosbuvir and velpatasvir is highly effective in treating chronic hepatitis C, achieving a sustained virologic response (SVR12) rate of 98.3% in non-cirrhotic patients and 89.7% in cirrhotic patients, based on a study of 116 patients over 12 weeks.

While the treatment is generally safe, 46.5% of participants experienced adverse events, with a higher incidence in cirrhotic patients (63.8%) compared to non-cirrhotic patients (29.3%), primarily involving gastrointestinal issues and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Sofosbuvir and Velpatasvir Combination for the Treatment of Chronic Hepatitis C in Patients With or Without Cirrhosis. Shah, I., Ahmad, W., Qadir, A., et al.[2021]

Citations

1. ir.ateapharma.com ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-present-new-data-supporting-combination-0

News Release - Investor Relations | Atea Pharmaceuticals, Inc. Atea Pharmaceuticals to Present New Data Supporting Combination of Bemnifosbuvir and Ruzasvir as Potential Best-in-Class Regimen for Treatment ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06868264

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL ... The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV. Official Title. Phase 3, Randomized, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0166354225000634

Bemnifosbuvir and ruzasvir in combination exhibit potent ... Bemnifosbuvir and ruzavir are potent inhibitors of hepatitis C virus. These antiviral drugs act synergistically in vitro when combined.

4. ir.ateapharma.com ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-announces-full-results-phase-2-study

Atea Pharmaceuticals Announces Full Results from Phase 2 ... Full results from Phase 2 study confirmed 98% sustained virologic response at 12 weeks post-treatment (SVR12) after short 8-week treatment duration for regimen.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130360/

Results of a Phase 1 Study in Healthy Participants These results support the evaluation of the safety and efficacy of the bemnifosbuvir and ruzasvir combination for treating people with chronic HCV infections.

6. natap.org natap.org/2025/EASL/EASL_84.htm

Efficacy and Safety of Bemnifosbuvir and Ruzasvir After 8 ... Efficacy and Safety of Bemnifosbuvir and Ruzasvir After 8 Weeks of Treatment in Patients With Chronic Hepatitis C Virus (HCV) Infection.