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
1 other identifier
interventional
880
16 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2025
CompletedFirst Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 13, 2026
April 1, 2026
1.5 years
June 10, 2025
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
Day 1 through Week 24
Secondary Outcomes (2)
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
Study Arms (2)
Bemnifosbuvir - Ruzasvir (BEM/RZR)
EXPERIMENTALSofosbuvir-Velpatasvir (SOF/VEL)
ACTIVE COMPARATORInterventions
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)
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Eligibility Criteria
You may qualify if:
- 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:
- Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ
- Suitable ARV treatment and not taking any contraindicated medications
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Atea Study Site
Nice, Alpes Maritimes, 06202, France
Atea Study Site
Strasbourg, Bas Rhin, 67091, France
Atea Study Site
Clichy, Hauts De Seine, 92110, France
Atea Study Site
Montpellier, Herault, 34295, France
Atea Study Site
Clermont-Ferrand, Puy De Dome, 63003, France
Atea Study Site
Créteil, Val De Marne, 94010, France
Atea Study Site
Frankfurt am Main, Hesse, 60590, Germany
Atea Study Site
Leipzig, Saxony, 04103, Germany
Atea Study Site
Hamburg, 20246, Germany
Atea Study Site
Alexandroupoli, 68100, Greece
Atea Study Site
Athens, 10676, Greece
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Athens, 11527, Greece
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Heraklion, 71110, Greece
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Rhodes, 85100, Greece
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Hyderabad, Andhra Pradesh, 500082, India
Atea Study Site
Patna, Bihar, 800014, India
Atea Study Site
Rajkot, Gujarat, 360005, India
Atea Study Site
Surat, Gujarat, 395002, India
Atea Study Site
Shimla, Himachal Pradesh, 171006, India
Atea Study Site
Belagavi, Karnataka, 590010, India
Atea Study Site
Kochi, Kerala, 682041, India
Atea Study Site
Mumbai, Maharashtra, 400008, India
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Mumbai, Maharashtra, 400012, India
Atea Study Site
Nagpur, Maharashtra, 440010, India
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Pune, Maharashtra, 411004, India
Atea Study Site
Pune, Maharashtra, 411023, India
Atea Study Site
Chandigarh, Punjab, 151001, India
Atea Study Site
Ludhiana, Punjab, 141001, India
Atea Study Site
Agra, Uttar Pradesh, 282002, India
Atea Study Site
Kanpur, Uttar Pradesh, 208002, India
Atea Study Site
Lucknow, Uttar Pradesh, 226010, India
Atea Study Site
Varanasi, Uttar Pradesh, 221005, India
Atea Study Site
Kolkata, West Bengal, 700020, India
Atea Study Site
Kota Bharu, Kelantan, 15586, Malaysia
Atea Study Site
Kota Bharu, Kelantan, 16150, Malaysia
Atea Study Site
Ampang, Kuala Lumpur, 68000, Malaysia
Atea Study Site
Kuantan, Pahang, 25100, Malaysia
Atea Study Site
Kota Kinabalu, Sabah, 88586, Malaysia
Atea Study Site
Kuala Lumpur, 50586, Malaysia
Atea Clinical Study Site
Chisinau, 2025, Moldova
Atea Study Site
Islamabad, 44000, Pakistan
Atea Study Site
Islamabad, 45600, Pakistan
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Karachi, 74800, Pakistan
Atea Study Site
Karachi, 75190, Pakistan
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Karachi, 75300, Pakistan
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Karachi, 75600, Pakistan
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Lahore, 53100, Pakistan
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Lahore, 54700, Pakistan
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Lahore, 54800, Pakistan
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Peshawar, 25000, Pakistan
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Rawalpindi, 0000, Pakistan
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Krakow, 30-901, Poland
Atea Study Site
Kłodzko, 57-300, Poland
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Lublin, 20-582, Poland
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Mysłowice, 41-400, Poland
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Warsaw, 00-124, Poland
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Wroclaw, 51-162, Poland
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Bucharest, 020125, Romania
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Bucharest, 021105, Romania
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Bucharest, 022328, Romania
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Bucharest, 030303, Romania
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Constanța, 900709, Romania
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Craiova, 200642, Romania
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Galati, 800179, Romania
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Iași, 700503, Romania
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Sibiu, 550245, Romania
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Suceava, 720201, Romania
Atea Study Site
Port Elizabeth, Eastern Cape, 6001, South Africa
Atea Study Site
Bloemfontein, Free State, 9301, South Africa
Atea Study Site
Johannesburg, Gauteng, 1827, South Africa
Atea Study Site
Johannesburg, Gauteng, 2092, South Africa
Atea Study Site
Johannesburg, Gauteng, 2193, South Africa
Atea Study Site
Pretoria, Gauteng, 0152, South Africa
Atea Study Site
Brits, North West, 0250, South Africa
Atea Study Site
Somerset West, Western Cape, 7130, South Africa
Atea Study Site
Seoul, Gyeonggi-do, 120-752, South Korea
Atea Study Site
Yangsan, Gyeongsangnam-do, 626-770, South Korea
Atea Study Site
Busan, 47392, South Korea
Atea Study Site
Busan, 49241, South Korea
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Seoul, 05505, South Korea
Atea Study Site
Santander, Cantabria, 39008, Spain
Atea Study Site
Málaga, Malaga, 29010, Spain
Atea Study Site
Vigo, Pontevedra, 36211, Spain
Atea Study Site
Barcelona, 08035, Spain
Atea Study Site
Pathum Wan, Bangkok, 10330, Thailand
Atea Study Site
Ratchathewi, Bangkok, 10400, Thailand
Atea Study Site
Mueang Nonthaburi, Changwat Khon Kaen, 40002, Thailand
Atea Study Site
Hat Yai, Changwat Songkhla, 90110, Thailand
Atea Study Site
Mueang Nonthaburi, Chiang Mai, 50200, Thailand
Atea Study Site
Bangkok, 10330, Thailand
Atea Study Site
Adana, 01790, Turkey (Türkiye)
Atea Study Site
Ankara, 06100, Turkey (Türkiye)
Atea Study Site
Ankara, 06800, Turkey (Türkiye)
Atea Study Site
Bursa, 16310, Turkey (Türkiye)
Atea Study Site
Denizli, 20070, Turkey (Türkiye)
Atea Study Site
Diyarbakır, 2128, Turkey (Türkiye)
Atea Study Site
Istanbul, 34785, Turkey (Türkiye)
Atea Study Site
Kayseri, 38080, Turkey (Türkiye)
Atea Study Site
Samsun, 55270, Turkey (Türkiye)
Atea Study Site
Kyiv, 08173, Ukraine
Atea Study Site
Lviv, 79000, Ukraine
Atea Study Site
Haiphong, 180000, Vietnam
Atea Study Site
Hanoi, 10000, Vietnam
Atea Study Site
Ho Chi Minh City, 700000, Vietnam
Atea Study Site
Ho Chi Minh City, 70000, Vietnam
Atea Study Site
Ho Chi Minh City, 748806, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 25, 2025
Study Start
June 2, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04