C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

Atea Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: HEPATITIS C VIRUS CHRONIC INFECTION

Treatments: Drug: Sofosbuvir-Velpatasvir (SOF/VEL); Drug: Bemnifosbuvir-Ruzasvir (BEM/RZR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06868264

AT-01B-007

Details and patient eligibility

About

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

Enrollment: 880 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Use of adequate contraception for females of childbearing potential

• Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)

• Documented medical history compatible with chronic HCV

• Either no liver cirrhosis or with compensated liver cirrhosis

• If HIV-1-positive, must meet the following 2 criteria:

  1. Antiretroviral (ARV) regimen for >8 weeks prior to screening visit, with CD4 T-cell count >200 cells/mm3 and plasma HIV-1 RNA <LLOQ
  2. Suitable ARV treatment and not taking any contraindicated medications

Key Exclusion Criteria:

• Pregnant or breastfeeding
• Co-infected with hepatitis B virus
• Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
• Requirement of any prohibited medications
• Use of other investigational drugs within 30 days of dosing
• History or signs of decompensated liver disease (decompensated cirrhosis)
• History of hepatocellular carcinoma (HCC)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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880 participants in 2 patient groups

Bemnifosbuvir-Ruzasvir (BEM/RZR)

Experimental group

Treatment:

Drug: Bemnifosbuvir-Ruzasvir (BEM/RZR)

Sofosbuvir-Velpatasvir (SOF/VEL)

Active Comparator group

Treatment:

Drug: Sofosbuvir-Velpatasvir (SOF/VEL)