What side effects are associated with this type of intervention?

Common treatments for Hepatitis C, particularly those involving direct-acting antivirals (DAAs) and ribavirin, are generally well-tolerated but can have several side effects. DAAs like sofosbuvir and simeprevir may cause fatigue, headache, and nausea. Ribavirin, which is similar to RZR, can lead to anemia, hyperbilirubinemia, and other hematologic abnormalities. Patients may also experience rash and photosensitivity with some DAA regimens. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several direct-acting antiviral agents (DAAs) for the treatment of Hepatitis C, which have revolutionized therapy by offering high cure rates with fewer side effects compared to older interferon-based treatments. Notable DAAs include sofosbuvir, a nucleotide analog polymerase inhibitor, and ledipasvir, an NS5A inhibitor, often combined in a single regimen (Harvoni). Other combinations include sofosbuvir-velpatasvir (Epclusa) and glecaprevir-pibrentasvir (Mavyret). These treatments target various stages of the viral lifecycle, similar to the mechanisms of BEM (an ATP citrate lyase inhibitor) and RZR (an RNA synthesis inhibitor) being studied in clinical trials.

What other types of research exist?

Promising, novel alternatives to BEM + RZR for Hepatitis C treatment in 2024 include combinations of direct-acting antivirals (DAAs) such as sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, and sofosbuvir/ledipasvir. These regimens offer high cure rates, shorter treatment durations, and are effective across multiple HCV genotypes.

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Anti-viral

Bemnifosbuvir + Ruzasvir for Chronic Hepatitis C

Phase 2

Waitlist Available

Research Sponsored by Atea Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from BEM and RZR may include typical drug reactions like nausea, headache, fatigue, possible allergic reactions to ingredients in the medication, as well as any specific risks associated with antiviral treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bemnifosbuvir and RuzasvirExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruzasvir

2016

Completed Phase 2

~910

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hepatitis C involve direct-acting antiviral agents (DAAs) that target specific steps in the viral life cycle. Protease inhibitors block the NS3/4A protease enzyme, preventing viral replication. Polymerase inhibitors, such as sofosbuvir, inhibit the NS5B polymerase enzyme, which is crucial for viral RNA synthesis. NS5A inhibitors disrupt the NS5A protein, essential for viral replication and assembly. These mechanisms are vital for Hepatitis C patients as they lead to a sustained virologic response (SVR), effectively curing the infection and reducing the risk of liver-related complications. Treatments like BEM (Bempedoic Acid) and RZR (Ribavirin) work similarly by inhibiting viral RNA synthesis, highlighting the importance of targeting viral replication in managing Hepatitis C.

2015 Philip S. Portoghese Medicinal Chemistry Lectureship. Curing Hepatitis C Virus Infection with Direct-Acting Antiviral Agents: The Arc of a Medicinal Chemistry Triumph.Hepatitis C viral kinetics with the nucleoside polymerase inhibitor mericitabine (RG7128).