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

• Bemnifosbuvir-Ruzasvir (BEM/RZR) (Drug): BEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)
• Sofosbuvir-Velpatasvir (SOF/VEL) (Drug): SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Primary outcomes

• Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24. [Day 1 through Week 24]

Secondary outcomes

• Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs. [Day 1 through 12 weeks after the end of treatment]
• Proportion of subjects experiencing virologic failure. [Day 1 through Week 24]

Sex: All, ages: 18 Years to 85 Years

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

5 more sites not listed.