Chronic Hepatitis C VirusPhase 2NCT05904470
A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
A Phase 2 study testing Bemnifosbuvir and Ruzasvir in people with Chronic Hepatitis C Virus and Hepatitis C, Chronic, run by Atea Pharmaceuticals, Inc. at 51 sites in 12 countries.
Trial summary
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Hepatitis C Virus, Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- Bemnifosbuvir and Ruzasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 51 sitesin 12 countries
- Study dates
- 30 May 2023to 28 Jan 2025
- Phase
- Phase 2
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
- Willing and able to provide written informed consent
- Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age
- Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception
- Females must have a negative pregnancy test at Screening and at Day 1 prior to dosing
- Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV
- Documented medical history compatible with chronic HCV
Show all 9Show fewer
- Liver disease staging assessment as follows:
- Absence of cirrhosis (F0 to F3)
- Compensated cirrhosis (F4)
Who cannot join
- Female subject is pregnant or breastfeeding
- Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
- 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
- Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
- Subject with known allergy to the study medications or any of their components
Show all 10Show fewer
- History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
- Cirrhotic and has a Child-Pugh score >6, corresponding to a Child-Pugh Class B or C
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible 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
51 sites in 12 countries.
51 sites in 12 countries
Brazil14 sites
Atea Study Site
Boa Vista, Roraima, 69304-015
Atea Study Site
Botucatu, São Paulo, 18618-970
Atea Study Site
Brasília, Federal District, 70200-730
Atea Study Site
Ijuí, São Paulo, 98700-000
Atea Study Site
Manaus, Amazonas, 69040-000
Atea Study Site
Porto Alegre, Rio Grande do Sul, 90035-074
Atea Study Site
Porto Alegre, Rio Grande do Sul, 90035-903
Atea Study Site
Porto Velho, Rondônia, 78918-791
Atea Study Site
Rio de Janeiro, Rio Do Janeiro, 04037-030
Atea Study Site
Salvador, Estado de Bahia, 41920-900
Atea Study Site
São José do Rio Preto, São Paulo, 15090-000
Atea Study Site
São Paulo, São Paulo, 04119-001
Atea Study Site
São Paulo, São Paulo, 05403-000
Atea Study Site
Sorocaba, São Paulo, 18052-210
Turkey (Türkiye)7 sites
Atea Study Site
Adana, 1130
Atea Study Site
Ankara, 6100
Atea Study Site
Ankara, 6230
Atea Study Site
Ankara, 6800
Atea Study Site
Denizli, 20070
Atea Study Site
Izmir, 35100
Atea Study Site
Kayseri, 38010
South Korea6 sites
Atea Study Site
Busan, 47392
Atea Study Site
Busan, 49241
Atea Study Site
Seoul, Gyeonggi-do, 120-752
Atea Study Site
Seoul, 5505
Atea Study Site
Seoul, 6351
Atea Study Site
Yangsan, Gyeongsangnam, 626-770
India5 sites
Atea Study Site
Belagavi, Karnataka, 590010
Atea Study Site
Kolkata, West Bengal, 700020
Atea Study Site
Nagpur, Maharashtra, 440010
Atea Study Site
Rajkot, Gujarat, 360005
Atea Study Site
Surat, Gujarat, 395002
Romania5 sites
Atea Study Site
Bucharest, BUC, 022328
Atea Study Site
Bucharest, BUC, 30303
Atea Study Site
Bucharest, 21105
Atea Study Site
Constanța, CON, 900709
Atea Study Site
Craiova, DOL, 200073
South Africa4 sites
Atea Study Site
Bloemfontein, Free State, 9301
Atea Study Site
Johannesburg, Gauteng, 2193
Atea Study Site
Randburg, Gauteng, 2087
Atea Study Site
Somerset West, Western Cap, 7130
Philippines3 sites
Atea Study Site
Baguio City, 35100
Atea Study Site
Iloilo City, 5000
Atea Study Site
Mabalacat, 2023
Canada2 sites
Atea Study Site
Toronto, Ontario, M5G 2C4
Atea Study Site
Vancouver, British Columbia, V6Z 2C7
About this study
Official title: A Phase 2, Open-label Study to Assess the Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic Hepatitis C Virus (HCV) Infection
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
- Being tested
- Bemnifosbuvir, Ruzasvir
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemnifosbuvirDrug
Also called AT-527
550 mg administered orally once a day (QD) for 8 weeks
RuzasvirDrug
Also called AT-038
180 mg administered orally once a day (QD) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bemnifosbuvir and Ruzasvir | Experimental | Bemnifosbuvir (BEM; AT-527) Tablets
Ruzasvir (RZR; AT-038) Capsules Receives: Drug: Bemnifosbuvir; Drug: Ruzasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Achieving Sustained Virologic Response at 12 Weeks Post-treatment (SVR12)
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (<LLOQ) at 12 weeks post-treatment
Measured: Day 1 through 12 weeks after end of treatment
Secondary outcomes (2)
Percentage of Subjects Experiencing Virologic Failure
Virologic failure defined as a confirmed 1 log10 increase in HCV RNA from post-baseline nadir, or confirmed increase in HCV RNA ≥ LLOQ in any subject who achieved HCV RNA < LLOQ.
Measured: Day 1 through 12 weeks after end of treatment
Percentage of Subjects Achieving Sustained Virologic Response at 24 Weeks Post-treatment (SVR24)
SVR24 defined as plasma HCV RNA less than the lower limit of quantitation (<LLOQ) at 24 weeks post-treatment
Measured: Day 1 through 24 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start30 May 2023
- Primary completion9 Dec 2024
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis C VirusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904470
- Sponsor's protocol ID
- AT-01B-004
- Status last verified
- Oct 2025
- First submitted
- 6 Jun 2023
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No