HEPATITIS C VIRUS CHRONIC INFECTIONPhase 3NCT07037277

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

A Phase 3 study testing Bemnifosbuvir-Ruzasvir and Sofosbuvir-Velpatasvir in people with HEPATITIS C VIRUS CHRONIC INFECTION and Hepatitis C, Chronic, run by Atea Pharmaceuticals, Inc. at 107 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: HEPATITIS C VIRUS CHRONIC INFECTION, Hepatitis C, Chronic, Hepatitis C Virus Infection
What is being tested?: Bemnifosbuvir-Ruzasvir and Sofosbuvir-Velpatasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 880 participants
Where: 107 sitesin 17 countries
Study dates: 2 Jun 2025to Mar 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

107 sites in 17 countries.

Country

City, postcode or hospital

107 sites in 17 countries

India19 sites

Atea Study Site
Agra, Uttar Pradesh, 282002
Atea Study Site
Belagavi, Karnataka, 590010
Atea Study Site
Chandigarh, Punjab, 151001
Atea Study Site
Hyderabad, Andhra Pradesh, 500082
Atea Study Site
Kanpur, Uttar Pradesh, 208002
Atea Study Site
Kochi, Kerala, 682041
Atea Study Site
Kolkata, West Bengal, 700020
Atea Study Site
Lucknow, Uttar Pradesh, 226010
Atea Study Site
Ludhiana, Punjab, 141001
Atea Study Site
Mumbai, Maharashtra, 400008
Atea Study Site
Mumbai, Maharashtra, 400012
Atea Study Site
Nagpur, Maharashtra, 440010
Atea Study Site
Patna, Bihar, 800014
Atea Study Site
Pune, Maharashtra, 411004
Atea Study Site
Pune, Maharashtra, 411023
Atea Study Site
Rajkot, Gujarat, 360005
Atea Study Site
Shimla, Himachal Pradesh, 171006
Atea Study Site
Surat, Gujarat, 395002
Atea Study Site
Varanasi, Uttar Pradesh, 221005

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Pakistan11 sites

Atea Study Site
Islamabad, 44000
Atea Study Site
Islamabad, 45600
Atea Study Site
Karachi, 74800
Atea Study Site
Karachi, 75190
Atea Study Site
Karachi, 75300
Atea Study Site
Karachi, 75600
Atea Study Site
Lahore, 53100
Atea Study Site
Lahore, 54700
Atea Study Site
Lahore, 54800
Atea Study Site
Peshawar, 25000
Atea Study Site
Rawalpindi, 0000

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Romania10 sites

Atea Study Site
Bucharest, 020125
Atea Study Site
Bucharest, 021105
Atea Study Site
Bucharest, 022328
Atea Study Site
Bucharest, 030303
Atea Study Site
Constanța, 900709
Atea Study Site
Craiova, 200642
Atea Study Site
Galati, 800179
Atea Study Site
Iași, 700503
Atea Study Site
Sibiu, 550245
Atea Study Site
Suceava, 720201

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Turkey (Türkiye)9 sites

Atea Study Site
Adana, 01790
Atea Study Site
Ankara, 06100
Atea Study Site
Ankara, 06800
Atea Study Site
Bursa, 16310
Atea Study Site
Denizli, 20070
Atea Study Site
Diyarbakır, 2128
Atea Study Site
Istanbul, 34785
Atea Study Site
Kayseri, 38080
Atea Study Site
Samsun, 55270

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South Africa8 sites

Atea Study Site
Bloemfontein, Free State, 9301
Atea Study Site
Brits, North West, 0250
Atea Study Site
Johannesburg, Gauteng, 1827
Atea Study Site
Johannesburg, Gauteng, 2092
Atea Study Site
Johannesburg, Gauteng, 2193
Atea Study Site
Port Elizabeth, Eastern Cape, 6001
Atea Study Site
Pretoria, Gauteng, 0152
Atea Study Site
Somerset West, Western Cape, 7130

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France6 sites

Atea Study Site
Clermont-Ferrand, Puy De Dome, 63003
Atea Study Site
Clichy, Hauts De Seine, 92110
Atea Study Site
Créteil, Val De Marne, 94010
Atea Study Site
Montpellier, Herault, 34295
Atea Study Site
Nice, Alpes Maritimes, 06202
Atea Study Site
Strasbourg, Bas Rhin, 67091

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Malaysia6 sites

Atea Study Site
Ampang, Kuala Lumpur, 68000
Atea Study Site
Kota Bharu, Kelantan, 15586
Atea Study Site
Kota Bharu, Kelantan, 16150
Atea Study Site
Kota Kinabalu, Sabah, 88586
Atea Study Site
Kuala Lumpur, 50586
Atea Study Site
Kuantan, Pahang, 25100

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Poland6 sites

Atea Study Site
Kłodzko, 57-300
Atea Study Site
Krakow, 30-901
Atea Study Site
Lublin, 20-582
Atea Study Site
Mysłowice, 41-400
Atea Study Site
Warsaw, 00-124
Atea Study Site
Wroclaw, 51-162

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Thailand6 sites

Atea Study Site
Bangkok, 10330
Atea Study Site
Hat Yai, Changwat Songkhla, 90110
Atea Study Site
Mueang Nonthaburi, Changwat Khon Kaen, 40002
Atea Study Site
Mueang Nonthaburi, Chiang Mai, 50200
Atea Study Site
Pathum Wan, Bangkok, 10330
Atea Study Site
Ratchathewi, Bangkok, 10400

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Greece5 sites

Atea Study Site
Alexandroupoli, 68100
Atea Study Site
Athens, 10676
Atea Study Site
Athens, 11527
Atea Study Site
Heraklion, 71110
Atea Study Site
Rhodes, 85100

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South Korea5 sites

Atea Study Site
Busan, 47392
Atea Study Site
Busan, 49241
Atea Study Site
Seoul, Gyeonggi-do, 120-752
Atea Study Site
Seoul, 05505
Atea Study Site
Yangsan, Gyeongsangnam-do, 626-770

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Vietnam5 sites

Atea Study Site
Haiphong, 180000
Atea Study Site
Hanoi, 10000
Atea Study Site
Ho Chi Minh City, 700000
Atea Study Site
Ho Chi Minh City, 70000
Atea Study Site
Ho Chi Minh City, 748806

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Spain4 sites

Atea Study Site
Barcelona, 08035
Atea Study Site
Málaga, Malaga, 29010
Atea Study Site
Santander, Cantabria, 39008
Atea Study Site
Vigo, Pontevedra, 36211

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Germany3 sites

Atea Study Site
Frankfurt am Main, Hesse, 60590
Atea Study Site
Hamburg, 20246
Atea Study Site
Leipzig, Saxony, 04103

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Ukraine2 sites

Atea Study Site
Kyiv, 08173
Atea Study Site
Lviv, 79000

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Egypt1 site

Atea Study Site
Cairo, 11796

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Moldova1 site

Atea Clinical Study Site
Chisinau, 2025

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About this study

Official title: 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

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, Chronic, Hepatitis C Virus Infection, Hepatitis C
Being tested: Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bemnifosbuvir-RuzasvirDrug
Also called (BEM/RZR)
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)
Sofosbuvir-VelpatasvirDrug
Also called (SOF/VEL)
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Study groups in NCT07037277
Study group	Role	What they receive
Bemnifosbuvir - Ruzasvir (BEM/RZR)	Experimental	Not described Receives: Drug: Bemnifosbuvir-Ruzasvir
Sofosbuvir-Velpatasvir (SOF/VEL)	Active comparator	Not described Receives: Drug: Sofosbuvir-Velpatasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
Measured: Day 1 through Week 24

Secondary outcomes (2)

Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs
Measured: Day 1 through 12 weeks after the end of treatment
Proportion of subjects experiencing virologic failure as measured by HCV RNA RT-qPCR
Measured: Day 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 2025Mar 2027

First posted25 Jun 2025
Study start2 Jun 2025
Primary completionDec 2026 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HEPATITIS C VIRUS CHRONIC INFECTIONStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 880 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07037277
Sponsor's protocol ID: AT-01B-008
Status last verified: Jun 2026
First submitted: 10 Jun 2025
Last updated: 29 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All HEPATITIS C VIRUS CHRONIC INFECTION trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07037277
Acronym / sponsor ID: AT-01B-008
Conditions: HEPATITIS C VIRUS CHRONIC INFECTION, Hepatitis C, Chronic, Hepatitis C Virus Infection, Hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 880 participants (estimated)
Lead sponsor: Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 2 Jun 2025 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 25 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bemnifosbuvir - Ruzasvir (BEM/RZR)	Experimental	Drug: Bemnifosbuvir-Ruzasvir
Sofosbuvir-Velpatasvir (SOF/VEL)	Active comparator	Drug: Sofosbuvir-Velpatasvir

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bemnifosbuvir-RuzasvirAlso: (BEM/RZR)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	Bemnifosbuvir - Ruzasvir (BEM/RZR)
Sofosbuvir-VelpatasvirAlso: (SOF/VEL)SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks	Drug	Sofosbuvir-Velpatasvir (SOF/VEL)

Primary outcome

Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
Time frame: Day 1 through Week 24

2 secondary outcomes

Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs
Time frame: Day 1 through 12 weeks after the end of treatment
Proportion of subjects experiencing virologic failure as measured by HCV RNA RT-qPCR
Time frame: Day 1 through Week 24

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Individual participant dataSharing planned: Undecided

Related trials for HEPATITIS C VIRUS CHRONIC INFECTION

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

107 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in India, Pakistan, Romania, Turkey (Türkiye), South Africa and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24 (time frame: Day 1 through Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.