C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV

NCT07037277 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: AT-01B-008
• Study Type: interventional
• Target: 880
• Locations: 17 countries
• Sites: 107

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.

Conditions

HEPATITIS C VIRUS CHRONIC INFECTION; Hepatitis C; Hepatitis C, Chronic; Hepatitis C Virus Infection

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)

EXPERIMENTAL

Drug: Bemnifosbuvir-Ruzasvir

Sofosbuvir-Velpatasvir (SOF/VEL)

ACTIVE COMPARATOR

Drug: Sofosbuvir-Velpatasvir

Interventions

Bemnifosbuvir-Ruzasvir DRUG

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)

Also known as: (BEM/RZR)

Bemnifosbuvir - Ruzasvir (BEM/RZR)

Sofosbuvir-Velpatasvir DRUG

SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Also known as: (SOF/VEL)

Sofosbuvir-Velpatasvir (SOF/VEL)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (107)

Atea Study Site

Cairo, 11796, Egypt

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Nice, Alpes Maritimes, 06202, France

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Strasbourg, Bas Rhin, 67091, France

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Clichy, Hauts De Seine, 92110, France

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Montpellier, Herault, 34295, France

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Clermont-Ferrand, Puy De Dome, 63003, France

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Créteil, Val De Marne, 94010, France

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Frankfurt am Main, Hesse, 60590, Germany

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Leipzig, Saxony, 04103, Germany

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Hamburg, 20246, Germany

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Alexandroupoli, 68100, Greece

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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

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Patna, Bihar, 800014, India

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Rajkot, Gujarat, 360005, India

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Surat, Gujarat, 395002, India

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Shimla, Himachal Pradesh, 171006, India

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Belagavi, Karnataka, 590010, India

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Kochi, Kerala, 682041, India

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Mumbai, Maharashtra, 400008, India

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Mumbai, Maharashtra, 400012, India

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Nagpur, Maharashtra, 440010, India

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Pune, Maharashtra, 411004, India

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Pune, Maharashtra, 411023, India

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Chandigarh, Punjab, 151001, India

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Ludhiana, Punjab, 141001, India

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Agra, Uttar Pradesh, 282002, India

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Kanpur, Uttar Pradesh, 208002, India

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Lucknow, Uttar Pradesh, 226010, India

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Varanasi, Uttar Pradesh, 221005, India

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Kolkata, West Bengal, 700020, India

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Kota Bharu, Kelantan, 15586, Malaysia

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Kota Bharu, Kelantan, 16150, Malaysia

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Ampang, Kuala Lumpur, 68000, Malaysia

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Kuantan, Pahang, 25100, Malaysia

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Kota Kinabalu, Sabah, 88586, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Chisinau, 2025, Moldova

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Islamabad, 44000, Pakistan

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Islamabad, 45600, Pakistan

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Karachi, 74800, Pakistan

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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

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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

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Bloemfontein, Free State, 9301, South Africa

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Johannesburg, Gauteng, 1827, South Africa

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Johannesburg, Gauteng, 2092, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Pretoria, Gauteng, 0152, South Africa

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Brits, North West, 0250, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Seoul, Gyeonggi-do, 120-752, South Korea

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Yangsan, Gyeongsangnam-do, 626-770, South Korea

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Busan, 47392, South Korea

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Busan, 49241, South Korea

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Seoul, 05505, South Korea

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Santander, Cantabria, 39008, Spain

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Málaga, Malaga, 29010, Spain

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Vigo, Pontevedra, 36211, Spain

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Barcelona, 08035, Spain

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Pathum Wan, Bangkok, 10330, Thailand

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Ratchathewi, Bangkok, 10400, Thailand

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Mueang Nonthaburi, Changwat Khon Kaen, 40002, Thailand

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Hat Yai, Changwat Songkhla, 90110, Thailand

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Mueang Nonthaburi, Chiang Mai, 50200, Thailand

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Bangkok, 10330, Thailand

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Adana, 01790, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Ankara, 06800, Turkey (Türkiye)

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Bursa, 16310, Turkey (Türkiye)

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Denizli, 20070, Turkey (Türkiye)

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Diyarbakır, 2128, Turkey (Türkiye)

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Istanbul, 34785, Turkey (Türkiye)

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Kayseri, 38080, Turkey (Türkiye)

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Samsun, 55270, Turkey (Türkiye)

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Kyiv, 08173, Ukraine

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Lviv, 79000, Ukraine

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Haiphong, 180000, Vietnam

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Hanoi, 10000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Ho Chi Minh City, 70000, Vietnam

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Ho Chi Minh City, 748806, Vietnam

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MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: June 29, 2026

Record last verified: 2026-06

Locations

KR (5); MY (6); TU (9); ZA (8); IN (19); FR (6); VN (5); UA (2); ES (4); PL (6); TH (6); DE (3); GR (5); PA (11); RO (10); EG (1); MO (1)