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Bemnifosbuvir-Ruzasvir

Phase 3

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

Bemnifosbuvir-Ruzasvir development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2025

Bemnifosbuvir-Ruzasvir target and mechanism

Molecular targetHCV
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,760

FDA Designations

No designations recorded

Bemnifosbuvir-Ruzasvir clinical trials

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 INFECTIONUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV
HEPATITIS C VIRUS CHRONIC INFECTIONUnlock trial analytics

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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Frequently asked questions about Bemnifosbuvir-Ruzasvir

What is Bemnifosbuvir-Ruzasvir used for?

Bemnifosbuvir-Ruzasvir is an investigational oral treatment being developed for chronic hepatitis C virus infection. It is a fixed-dose combination of two small molecule antivirals studied in adults aged 18 years and older. It has not been approved by the FDA and remains in Phase 3 clinical development.

What does Bemnifosbuvir-Ruzasvir target?

Bemnifosbuvir-Ruzasvir targets the hepatitis C virus. The combination pairs bemnifosbuvir, a nucleotide prodrug, with ruzasvir, an NS5A inhibitor, so the two components act on distinct HCV viral proteins. This dual mechanism is intended to suppress viral replication across HCV genotypes.

Who is developing Bemnifosbuvir-Ruzasvir?

Bemnifosbuvir-Ruzasvir is being developed by Atea Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker AVIR. Atea is running the Phase 3 program for the combination in chronic hepatitis C virus infection.

What phase is Bemnifosbuvir-Ruzasvir in?

Bemnifosbuvir-Ruzasvir is in Phase 3 development. Two Phase 3 trials are active and none have been completed. The drug is investigational and has not received FDA approval for chronic hepatitis C virus infection.

What clinical trials is Bemnifosbuvir-Ruzasvir in?

Bemnifosbuvir-Ruzasvir is being studied in two active Phase 3 trials, both comparing BEM/RZR with sofosbuvir/velpatasvir in adults with chronic HCV. NCT07037277, called C-Forward, enrolls 880 patients across Europe, Asia, Africa and the Middle East. NCT06868264, called C-BEYOND, enrolls 880 patients in the United States and Canada. Both are active and not recruiting.