Bemnifosbuvir-Ruzasvir for Hepatitis C

Recruiting at 18 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Atea Pharmaceuticals, Inc.

Disqualifiers: Pregnant, Hepatitis B, Alcohol abuse, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot take any prohibited medications. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of the drug Bemnifosbuvir-Ruzasvir for Hepatitis C?

The drug Sofosbuvir-Velpatasvir (SOF/VEL), which is part of the treatment being studied, has been shown to be highly effective in treating Hepatitis C, with high rates of success in various studies. This suggests that the combination with Bemnifosbuvir-Ruzasvir may also be effective. ^{1 2 3 4 5}

Is Bemnifosbuvir-Ruzasvir (BEM/RZR) safe for humans?

The combination of Sofosbuvir and Velpatasvir (SOF/VEL), which is similar to Bemnifosbuvir-Ruzasvir, has been shown to be safe in studies involving over 1800 people with Hepatitis C. It is generally well-tolerated and has a good safety profile. ^{2 3 4 6 7}

What makes the drug Bemnifosbuvir-Ruzasvir unique for treating Hepatitis C?

The combination of Bemnifosbuvir-Ruzasvir (BEM/RZR) is unique because it offers a new treatment option for Hepatitis C, potentially differing in its mechanism or components compared to the well-established Sofosbuvir-Velpatasvir (SOF/VEL), which is known for its high efficacy and once-daily dosing for various genotypes of the virus. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for adults with chronic Hepatitis C Virus (HCV) who are also on stable antiretroviral therapy for HIV, have a CD4 T-cell count over 200 cells/mm3, undetectable HIV-1 RNA levels, and no previous treatments with direct-acting antivirals. Participants must not have severe liver cirrhosis and women able to bear children must use effective contraception.

Inclusion Criteria

Key

I have never been treated with drugs specifically for hepatitis C.

I have a history of chronic hepatitis C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BEM/RZR or SOF/VEL to compare efficacy and safety in adults with chronic HCV

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bemnifosbuvir-Ruzasvir (BEM/RZR)
• Sofosbuvir-Velpatasvir (SOF/VEL)

Trial Overview The study compares two drug combinations for treating chronic HCV: Bemnifosbuvir-Ruzasvir (BEM/RZR) versus Sofosbuvir-Velpatasvir (SOF/VEL). The goal is to determine which treatment is more effective and safer for patients.

Participant Groups

Group I: Bemnifosbuvir-Ruzasvir (BEM/RZR) Experimental Treatment 1 Intervention

Group II: Sofosbuvir-Velpatasvir (SOF/VEL) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Atea Pharmaceuticals, Inc.

Lead Sponsor

Trials

29

Recruited

4,600+

References

1. England pubmed.ncbi.nlm.nih.gov

Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: Results from ASTRAL-1 placebo-controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in patients co-infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL-5 study. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection. [2020]

5. England pubmed.ncbi.nlm.nih.gov

High efficacy of sofosbuvir/velpatasvir and impact of baseline resistance-associated substitutions in hepatitis C genotype 3 infection. [2022]

6. Romania pubmed.ncbi.nlm.nih.gov

Real World Efficacy and Safety of Sofosbuvir + Velpatasvir + Voxilaprevir in Romanian Patients with Genotype 1b HCV Infection Non-reponders to DAAs Therapy. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Real-world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2: A nationwide multicenter study by the Japanese Red Cross Liver Study Group. [2020]