Bemnifosbuvir + Ruzasvir for Chronic Hepatitis C

Recruiting at 40 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

275 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two treatments, BEM and RZR, to see if they are safe and effective for patients with chronic hepatitis C infection. The treatments likely help to lower the amount of hepatitis C virus in the body and improve liver function. Grazoprevir (GZR) plus elbasvir is an approved treatment for chronic infection with hepatitis C virus (HCV) genotype 1 or 4.

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.

What data supports the effectiveness of the drug combination Bemnifosbuvir and Ruzasvir for treating chronic hepatitis C?

The combination of ruzasvir and another similar drug, uprifosbuvir, has shown promising results in treating hepatitis C, with high success rates in certain genotypes. Additionally, similar drug combinations like ledipasvir-sofosbuvir have been effective in treating hepatitis C, suggesting that combining direct-acting antiviral agents can be a successful approach. ^{1 2 3 4 5}

Is the combination of ruzasvir and uprifosbuvir safe for humans?

In clinical trials, the combination of ruzasvir and uprifosbuvir was generally well tolerated, with common side effects including fatigue and diarrhea. Serious side effects were rare and not considered related to the drugs. ^{1 2 6 7 8}

How is the drug Bemnifosbuvir + Ruzasvir different from other treatments for chronic hepatitis C?

The combination of Bemnifosbuvir and Ruzasvir is unique because it involves two direct-acting antiviral agents that target different parts of the hepatitis C virus, potentially offering a new option for patients with various genotypes. This combination may provide an alternative for those who have not responded well to other treatments, although its effectiveness can vary depending on the specific genotype of the virus. ^{1 2 4 5 9}

Eligibility Criteria

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 am between 18 and 85 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ruzasvir 60 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4 or 6 infection. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Combination ledipasvir-sofosbuvir for the treatment of chronic hepatitis C virus infection: a review and clinical perspective. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a fixed-dose combination regimen of grazoprevir, ruzasvir, and uprifosbuvir with or without ribavirin in participants with and without cirrhosis with chronic hepatitis C virus genotype 1, 2, or 3 infection (C-CREST-1 and C-CREST-2, part B): two randomised, phase 2, open-label trials. [2020]

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

Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Elevated serum uric acid level was a notable adverse event during combination therapy with sofosbuvir and ribavirin. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. [2023]

8. United States 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. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection. [2022]