Bemnifosbuvir-Ruzasvir for Hepatitis C
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for hepatitis C, a liver infection caused by the HCV virus. The goal is to compare the effectiveness of Bemnifosbuvir-Ruzasvir (BEM/RZR) with Sofosbuvir-Velpatasvir (SOF/VEL), an existing treatment. Participants should have a history of chronic hepatitis C, should not have tried similar treatments, and may have either no liver cirrhosis or early-stage liver cirrhosis. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of bemnifosbuvir and ruzasvir (BEM/RZR) is generally safe. Earlier studies reported no serious side effects from this treatment. These drugs effectively combat the hepatitis C virus, with strong results in lab tests. Specifically, one study found that 98% of patients had no detectable virus in their blood 12 weeks after treatment.
The comparison treatment, sofosbuvir-velpatasvir (SOF/VEL), is already used for hepatitis C, providing extensive safety information. It is generally safe, with only mild side effects reported in some cases.
Both treatments have demonstrated good safety records in previous studies, making them promising options for treating hepatitis C.12345Why are researchers excited about this trial's treatments?
Bemnifosbuvir-Ruzasvir (BEM/RZR) is unique because it combines two powerful antiviral agents that target different parts of the Hepatitis C virus, potentially leading to a more effective treatment. Unlike standard treatments like Sofosbuvir-Velpatasvir (SOF/VEL), which are also quite effective, BEM/RZR may offer a broader spectrum of action and could work faster or be more effective against resistant strains. Researchers are excited about these treatments because they could simplify the treatment regimen or improve outcomes for patients who don't respond well to current options.
What evidence suggests that this trial's treatments could be effective for Hepatitis C?
Research has shown that Bemnifosbuvir-Ruzasvir (BEM/RZR), which participants in this trial may receive, looks promising for treating hepatitis C. Earlier studies found that this combination achieved a 98% success rate in keeping the virus undetectable 12 weeks after treatment. Two lab studies demonstrated that BEM and RZR work well together to stop the virus without harming healthy cells. This suggests BEM/RZR could be a strong option for people with chronic hepatitis C.12345
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either BEM/RZR or SOF/VEL to compare efficacy and safety in adults with chronic HCV
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atea Pharmaceuticals, Inc.
Lead Sponsor
Citations
1.
ir.ateapharma.com
ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-presents-new-data-supporting-fixed-doseNews Release - Investor Relations | Atea Pharmaceuticals, Inc.
Conclusion: A resistance analysis from the Company's Phase 2 study of BEM and RZR demonstrated that SVR12 rates were not impacted by resistance ...
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, ...
Bemnifosbuvir and ruzasvir in combination exhibit potent ...
Two independent in vitro evaluations suggested that BEM and RZR act synergistically to inhibit HCV replication without accompanying cytotoxicity. Additionally, ...
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.
5.
ir.ateapharma.com
ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-announces-full-results-phase-2-studyAtea 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.
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