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New hep c combo aims to match top therapy in phase 3 showdown

NCT ID NCT07037277

Disease control Sponsor: Atea Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests a new two-drug combination, BEM/RZR, against an approved treatment, SOF/VEL, in 880 adults with chronic hepatitis C. The goal is to see if BEM/RZR can clear the virus as effectively and safely. Participants must not have taken prior HCV drugs and may have compensated cirrhosis or well-controlled HIV.

Why investors are watching

ATEA Pharmaceuticals is running a phase 3 trial comparing its experimental hepatitis C drug combination, Bemnifosbuvir-Ruzasvir, against an approved standard treatment, Sofosbuvir-Velpatasvir, in 880 adults with chronic HCV. For a small company, this late-stage readout is the main test of whether its drug can match an existing therapy, and the result will largely determine the drug's commercial future.

If it works: If the trial shows BEM/RZR works as well as or better than the standard treatment, ATEA could gain a competitive product in the hepatitis C market. That outcome would give the company a path to seek regulatory approval and generate revenue from a new drug.

If it fails: If the trial fails to show non-inferiority or reveals safety problems, ATEA would likely abandon the drug, and the company, with few other products, would face a major setback. Clinical trials often fail, so investors should treat a negative result as a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 880 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 with compensated liver cirrhosis * If HIV-1-positive, must meet the following 2 criteria: 1. Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications Key Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis C virus infection hepatitis C virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis C Hepatitis C virus chronic infection Hepatitis C virus infection Hepatitis C, chronic

Contacts and locations

Locations

  • Atea Clinical Study Site

    Chisinau, 2025, Moldova

  • Atea Study Site

    Cairo, 11796, Egypt

  • 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

  • Atea Study Site

    Athens, 11527, Greece

  • Atea Study Site

    Heraklion, 71110, Greece

  • Atea Study Site

    Rhodes, 85100, Greece

  • Atea Study Site

    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

  • Atea Study Site

    Mumbai, Maharashtra, 400012, India

  • Atea Study Site

    Nagpur, Maharashtra, 440010, India

  • Atea Study Site

    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 Study Site

    Islamabad, 44000, Pakistan

  • Atea Study Site

    Islamabad, 45600, Pakistan

  • Atea Study Site

    Karachi, 74800, Pakistan

  • Atea Study Site

    Karachi, 75190, Pakistan

  • Atea Study Site

    Karachi, 75300, Pakistan

  • Atea Study Site

    Karachi, 75600, Pakistan

  • Atea Study Site

    Lahore, 53100, Pakistan

  • Atea Study Site

    Lahore, 54700, Pakistan

  • Atea Study Site

    Lahore, 54800, Pakistan

  • Atea Study Site

    Peshawar, 25000, Pakistan

  • Atea Study Site

    Rawalpindi, 0000, Pakistan

  • Atea Study Site

    Krakow, 30-901, Poland

  • Atea Study Site

    Kłodzko, 57-300, Poland

  • Atea Study Site

    Lublin, 20-582, Poland

  • Atea Study Site

    Mysłowice, 41-400, Poland

  • Atea Study Site

    Warsaw, 00-124, Poland

  • Atea Study Site

    Wroclaw, 51-162, Poland

  • Atea Study Site

    Bucharest, 020125, Romania

  • Atea Study Site

    Bucharest, 021105, Romania

  • Atea Study Site

    Bucharest, 022328, Romania

  • Atea Study Site

    Bucharest, 030303, Romania

  • Atea Study Site

    Constanța, 900709, Romania

  • Atea Study Site

    Craiova, 200642, Romania

  • Atea Study Site

    Galati, 800179, Romania

  • Atea Study Site

    Iași, 700503, Romania

  • Atea Study Site

    Sibiu, 550245, Romania

  • Atea Study Site

    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

  • Atea Study Site

    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

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