HEPATITIS C VIRUS CHRONIC INFECTIONPhase 3NCT06868264

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

A Phase 3 study testing Bemnifosbuvir-Ruzasvir (BEM/RZR) and Sofosbuvir-Velpatasvir (SOF/VEL) in people with HEPATITIS C VIRUS CHRONIC INFECTION, run by Atea Pharmaceuticals, Inc. at 105 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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
What is being tested?: Bemnifosbuvir-Ruzasvir (BEM/RZR) and Sofosbuvir-Velpatasvir (SOF/VEL)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 940 participants
Where: 105 sitesin 2 countries
Study dates: 7 Apr 2025to 9 Sep 2026
Phase: Phase 3
Are there results?: None posted in the registry

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
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

Trial locations and contacts

105 sites in 2 countries.

Country

City, postcode or hospital

105 sites in 2 countries

United States96 sites

Atea Study Site
Allentown, Pennsylvania, 18103
Atea Study Site
Arlington, Texas, 76012
Atea Study Site
Asheville, North Carolina, 28801
Atea Study Site
Bakersfield, California, 93301
Atea Study Site
Baltimore, Maryland, 21201
Atea Study Site
Baltimore, Maryland, 21287
Atea Study Site
Beavercreek, Ohio, 45440
Atea Study Site
Birmingham, Alabama, 35215
Atea Study Site
Boston, Massachusetts, 02114
Atea Study Site
Boston, Massachusetts, 02118
Atea Study Site
Brooklyn, New York, 11215
Atea Study Site
Camden, New Jersey, 08103
Atea Study Site
Chandler, Arizona, 85225
Atea Study Site
Charleston, South Carolina, 29425
Atea Study Site
Charlotte, North Carolina, 28204
Atea Study Site
Chattanooga, Tennessee, 37421
Atea Study Site
Chesapeake, Virginia, 23320
Atea Study Site
Chicago, Illinois, 60613
Atea Study Site
Cincinnati, Ohio, 45267
Atea Study Site
Colorado Springs, Colorado, 80907
Atea Study Site
Coral Gables, Florida, 33134
Atea Study Site
Cordova, Tennessee, 38018
Atea Study Site
Coronado, California, 92118
Atea Study Site
Dallas, Texas, 75203
Atea Study Site
Dallas, Texas, 75242
Atea Study Site
DeLand, Florida, 32720
Atea Study Site
Denison, Texas, 75020
Atea Study Site
Detroit, Michigan, 48201
Atea Study Site
Dothan, Alabama, 36301
Atea Study Site
DuBois, Pennsylvania, 15801
Atea Study Site
Escondido, California, 92025
Atea Study Site
Fairway, Kansas, 66205
Atea Study Site
Fayetteville, North Carolina, 28304
Atea Study Site
Flagstaff, Arizona, 86001
Atea Study Site
Fort Lauderdale, Florida, 33308
Atea Study Site
Fresno, California, 93711
Atea Study Site
Ft. Pierce, Florida, 34982
Atea Study Site
Gainesville, Florida, 32610
Atea Study Site
Grosse Pointe Woods, Michigan, 48236
Atea Study Site
Hackensack, New Jersey, 07601
Atea Study Site
Hillsborough, New Jersey, 08844
Atea Study Site
Houston, Texas, 77030
Atea Study Site
Inverness, Florida, 34452
Atea Study Site
Jackson, Tennessee, 38301
Atea Study Site
Jupiter, Florida, 33458
Atea Study Site
Lauderdale Lakes, Florida, 33313
Atea Study Site
Little Rock, Arkansas, 72204
Atea Study Site
Long Beach, California, 98015
Atea Study Site
Los Angeles, California, 90048
Atea Study Site
Los Angeles, California, 90067
Atea Study Site
Louisville, Kentucky, 40218
Atea Study Site
Macon, Georgia, 31201
Atea Study Site
Maitland, Florida, 32751
Atea Study Site
Marietta, Georgia, 30060
Atea Study Site
Mesa, Arizona, 85210
Atea Study Site
Miami, Florida, 33125
Atea Study Site
Miami Lakes, Florida, 33014
Atea Study Site
New Albany, Indiana, 47150
Atea Study Site
New Iberia, Louisiana, 70560
Atea Study Site
New Orleans, Louisiana, 70112
Atea Study Site
New York, New York, 10016
Atea Study Site
Newark, New Jersey, 07102
Atea Study Site
Newark, New Jersey, 07103
Atea Study Site
Norfolk, Virginia, 23502
Atea Study Site
Novi, Michigan, 48377
Atea Study Site
Ogden, Utah, 84405
Atea Study Site
Orange, California, 92868
Atea Study Site
Orlando, Florida, 32803
Atea Study Site
Pasadena, California, 91105
Atea Study Site
Pembroke Pines, Florida, 33024
Atea Study Site
Philadelphia, Pennsylvania, 19104
Atea Study Site
Philadelphia, Pennsylvania, 19107
Atea Study Site
Phoenix, Arizona, 85006
Atea Study Site
Phoenix, Arizona, 85015
Atea Study Site
Plano, Texas, 75093
Atea Study Site
Richmond, Virginia, 23226
Atea Study Site
Richmond, Virginia, 23298
Atea Study Site
Sacramento, California, 95817
Atea Study Site
San Antonio, Texas, 78215
Atea Study Site
Sarasota, Florida, 34237
Atea Study Site
Seattle, Washington, 98101
Atea Study Site
Springfield, Massachusetts, 01105
Atea Study Site
Temple, Texas, 76508
Atea Study Site
Topeka, Kansas, 66606
Atea Study Site
Torrance, California, 90502
Atea Study Site
Tucson, Arizona, 85745
Atea Study Site
Tulsa, Oklahoma, 74104
Atea Study Site
Tupelo, Mississippi, 38801
Atea Study Site
Valencia, California, 91355
Atea Study Site
Waco, Texas, 76710
Atea Study Site
Washington D.C., District of Columbia, 20017
Atea Study Site
Washington D.C., District of Columbia, 20037
Atea Study Site
West Palm Beach, Florida, 33407
Atea Study Site
Worcester, Massachusetts, 01655
Atea Study Site
Wyoming, Michigan, 49519
Atea Study Site
Yonkers, New York, 10701

Other trials in United States

Canada9 sites

Atea Study Site
Brampton, Ontario, L6R 3J7
Atea Study Site
Moncton, New Brunswick, E1C6Z8
Atea Study Site
Montreal, Quebec, H4A3J1
Atea Study Site
Ottawa, Ontario, K1H8L6
Atea Study Site
Québec, Quebec, G1V 4T3
Atea Study Site
Québec, Quebec, G1V4G2
Atea Study Site
St. John's, Newfoundland and Labrador, A1B3V6
Atea Study Site
Toronto, Ontario, M5G2C4
Atea Study Site
Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

About this study

Official title: Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects With Chronic Hepatitis C Virus (HCV) Infection

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
Being tested: Bemnifosbuvir-Ruzasvir (BEM/RZR), Sofosbuvir-Velpatasvir (SOF/VEL)

What participants receive

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

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

Study groups in NCT06868264
Study group	Role	What they receive
Bemnifosbuvir-Ruzasvir (BEM/RZR)	Experimental	Not described Receives: Drug: Bemnifosbuvir-Ruzasvir (BEM/RZR)
Sofosbuvir-Velpatasvir (SOF/VEL)	Active comparator	Not described Receives: Drug: Sofosbuvir-Velpatasvir (SOF/VEL)

What is being measured

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

Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study 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.
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.

7 Apr 20259 Sep 2026

First posted10 Mar 2025
Study start7 Apr 2025
Primary completion18 Jun 2026
Study completion9 Sep 2026

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: 940 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06868264
Sponsor's protocol ID: AT-01B-007
Status last verified: Nov 2025
First submitted: 7 Mar 2025
Last updated: 29 Oct 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects With Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov ID: NCT06868264
Acronym / sponsor ID: AT-01B-007
Conditions: HEPATITIS C VIRUS CHRONIC INFECTION
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 940 participants (actual)
Lead sponsor: Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 7 Apr 2025 (actual)
Primary completion: 18 Jun 2026 (actual)
Study completion: 9 Sep 2026 (actual)
First posted: 10 Mar 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 (BEM/RZR)
Sofosbuvir-Velpatasvir (SOF/VEL)	Active comparator	Drug: Sofosbuvir-Velpatasvir (SOF/VEL)

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 (8 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
Requirement of any prohibited medications
Use of other investigational drugs within 30 days of dosing

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-Ruzasvir (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-Velpatasvir (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

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.

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
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

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.

105 sites in 2 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 8 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: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study 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 NCT06868264.

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 Oct 2026.