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Bemnifosbuvir-Ruzasvir

Phase 3

HEPATITIS C VIRUS CHRONIC INFECTION | Small molecule | Infectious Disease |Atea Pharmaceuticals, Inc.|Last Updated: Jun 29, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,760
FDA Designations
FAST_TRACK
Clinical trial landscape

Bemnifosbuvir-Ruzasvir · 2 trials · 4 indications

Phase 3 2
NCT07037277C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCVHEPATITIS C VIRUS CHRONIC INFECTION
ACTIVE NOT_RECRUITING880 Analytics
NCT06868264C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCVHEPATITIS C VIRUS CHRONIC INFECTION
ACTIVE NOT_RECRUITING880 Analytics
PHASE3ACTIVE NOT_RECRUITING
C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
HEPATITIS C VIRUS CHRONIC INFECTION
NCT07037277880
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PHASE3ACTIVE NOT_RECRUITING
C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV
HEPATITIS C VIRUS CHRONIC INFECTION
NCT06868264880
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Study Endpoints
Primary Endpoints
Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
Day 1 through Week 24
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
Day 1 through Week 24
Secondary Endpoints
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
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bemnifosbuvir - Ruzasvir (BEM/RZR)EXPERIMENTAL -
Sofosbuvir-Velpatasvir (SOF/VEL)ACTIVE_COMPARATOR -
Bemnifosbuvir-Ruzasvir (BEM/RZR)EXPERIMENTAL -
Interventions
NameTypeDescription
Bemnifosbuvir-RuzasvirDRUGBEM/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-VelpatasvirDRUGSOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Bemnifosbuvir-Ruzasvir (BEM/RZR)DRUGBEM/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)DRUGSOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
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Eligibility Criteria
Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites107

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 wi...

Countries:EgyptFranceGermanyGreeceIndiaMalaysiaMoldovaPakistanPolandRomaniaSouth AfricaSouth KoreaSpainThailandTurkey (Türkiye)UkraineVietnamUnited StatesCanada
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Recent Changes (Last 90 Days)
MEDIUMJun 29, 2026NCT07037277Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 29, 2026NCT07037277Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT07037277primaryCompletionDate: changed
LOWMay 26, 2026NCT06868264primaryCompletionDate: changed
LOWMay 24, 2026NCT07037277studyFirstPostDate: changed
LOWMay 24, 2026NCT06868264studyFirstPostDate: changed