RECRUITINGPhase 3INTERVENTIONAL
C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
About This Trial
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Bemnifosbuvir-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)
DRUG
Sofosbuvir-Velpatasvir
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Locations (20)
Atea Study Site
Nice, Alpes Maritimes, France
Atea Study Site
Strasbourg, Bas Rhin, France
Atea Study Site
Clichy, Hauts de Seine, France
Atea Study Site
Montpellier, Herault, France
Atea Study Site
Clermont-Ferrand, Puy de Dome, France
Atea Study Site
Créteil, Val de Marne, France
Atea Study Site
Hamburg, Hamburg, Germany
Atea Study Site
Frankfurt am Main, Hesse, Germany
Atea Study Site
Leipzig, Saxony, Germany
Atea Study Site
Alexandroupoli, Greece
Atea Study Site
Athens, Greece
Atea Study Site
Athens, Greece
Atea Study Site
Heraklion, Greece
Atea Study Site
Hyderabad, Andhra Pradesh, India
Atea Study Site
Patna, Bihar, India
Atea Study Site
Rajkot, Gujarat, India
Atea Study Site
Surat, Gujarat, India
Atea Study Site
Shimla, Himachal Pradesh, India
Atea Study Site
Belagavi, Karnataka, India
Atea Study Site
Kochi, Kerala, India