Hepatitis C, Hepatitis C, Chronic, HEPATITIS C VIRUS CHRONIC INFECTION, Hepatitis C Virus Infection
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
Interventions
DRUGBemnifosbuvir-Ruzasvir
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)
DRUGSofosbuvir-Velpatasvir
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion 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 * Prior exposure to any HCV DAA * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24 | Day 1 through Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 as measured by HCV RNA RT-qPCR | Day 1 through Week 24 |
Countries
Egypt, France, Germany, Greece, India, Malaysia, Moldova, Pakistan, Poland, Romania, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, Vietnam
Outcome results
None listed