A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

NCT05904470 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AT-01B-004
• Study Type: interventional
• Target: 275
• Locations: 12 countries
• Sites: 51

Brief Summary

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

Conditions

Chronic Hepatitis C Virus; Hepatitis C, Chronic; Hepatitis C; Hepatic Cirrhosis; HCV

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1 through 12 weeks after end of treatment

Secondary Outcomes (2)

• Percentage of Subjects Experiencing Virologic Failure

  Day 1 through 12 weeks after end of treatment

• Percentage of Subjects Achieving Sustained Virologic Response at 24 Weeks Post-treatment (SVR24)

  Day 1 through 24 weeks after end of treatment

Study Arms (1)

Bemnifosbuvir and Ruzasvir

EXPERIMENTAL

Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules

Drug: Bemnifosbuvir; Drug: Ruzasvir

Interventions

Bemnifosbuvir DRUG

550 mg administered orally once a day (QD) for 8 weeks

Also known as: AT-527

Bemnifosbuvir and Ruzasvir

Ruzasvir DRUG

180 mg administered orally once a day (QD) for 8 weeks

Also known as: AT-038

Bemnifosbuvir and Ruzasvir

Eligibility Criteria

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

You may qualify if:

• 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
• Liver disease staging assessment as follows:
• Absence of cirrhosis (F0 to F3)
• Compensated cirrhosis (F4)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (51)

Atea Study Site

San Antonio, Texas, 78215, United States

Location

Atea Study Site

Manaus, Amazonas, 69040-000, Brazil

Location

Atea Study Site

Salvador, Estado de Bahia, 41920-900, Brazil

Location

Atea Study Site

Brasília, Federal District, 70200-730, Brazil

Location

Atea Study Site

Rio de Janeiro, Rio Do Janeiro, 04037-030, Brazil

Location

Atea Study Site

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

Location

Atea Study Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Atea Study Site

Porto Velho, Rondônia, 78918-791, Brazil

Location

Atea Study Site

Boa Vista, Roraima, 69304-015, Brazil

Location

Atea Study Site

Botucatu, São Paulo, 18618-970, Brazil

Location

Atea Study Site

Ijuí, São Paulo, 98700-000, Brazil

Location

Atea Study Site

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Atea Study Site

São Paulo, São Paulo, 04119-001, Brazil

Location

Atea Study Site

São Paulo, São Paulo, 05403-000, Brazil

Location

Atea Study Site

Sorocaba, São Paulo, 18052-210, Brazil

Location

Atea Study Site

Vancouver, British Columbia, V6Z 2C7, Canada

Location

Atea Study Site

Toronto, Ontario, M5G 2C4, Canada

Location

Atea Study Site

Rajkot, Gujarat, 360005, India

Location

Atea Study Site

Surat, Gujarat, 395002, India

Location

Atea Study Site

Belagavi, Karnataka, 590010, India

Location

Atea Study Site

Nagpur, Maharashtra, 440010, India

Location

Atea Study Site

Kolkata, West Bengal, 700020, India

Location

Atea Study Site

Quatre Bornes, 72218, Mauritius

Location

Atea Study Site

Chisinau, 2025, Moldova

Location

Atea Study Site

Karachi, 74800, Pakistan

Location

Atea Study Site

Karachi, 75600, Pakistan

Location

Atea Study Site

Baguio City, 35100, Philippines

Location

Atea Study Site

Iloilo City, 5000, Philippines

Location

Atea Study Site

Mabalacat, 2023, Philippines

Location

Atea Study Site

Bucharest, BUC, 022328, Romania

Location

Atea Study Site

Bucharest, BUC, 30303, Romania

Location

Atea Study Site

Constanța, CON, 900709, Romania

Location

Atea Study Site

Craiova, DOL, 200073, Romania

Location

Atea Study Site

Bucharest, 21105, Romania

Location

Atea Study Site

Bloemfontein, Free State, 9301, South Africa

Location

Atea Study Site

Johannesburg, Gauteng, 2193, South Africa

Location

Atea Study Site

Randburg, Gauteng, 2087, South Africa

Location

Atea Study Site

Somerset West, Western Cap, 7130, South Africa

Location

Atea Study Site

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

Location

Atea Study Site

Yangsan, Gyeongsangnam, 626-770, South Korea

Location

Atea Study Site

Busan, 47392, South Korea

Location

Atea Study Site

Busan, 49241, South Korea

Location

Atea Study Site

Seoul, 5505, South Korea

Location

Atea Study Site

Seoul, 6351, South Korea

Location

Atea Study Site

Adana, 1130, Turkey (Türkiye)

Location

Atea Study Site

Ankara, 6100, Turkey (Türkiye)

Location

Atea Study Site

Ankara, 6230, Turkey (Türkiye)

Location

Atea Study Site

Ankara, 6800, Turkey (Türkiye)

Location

Atea Study Site

Denizli, 20070, Turkey (Türkiye)

Location

Atea Study Site

Izmir, 35100, Turkey (Türkiye)

Location

Atea Study Site

Kayseri, 38010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Liver Cirrhosis

Interventions

AT-511; ruzasvir

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; Fibrosis

Limitations and Caveats

This was a single arm study. Results will need to be confirmed in larger, controlled randomized trials.

Results Point of Contact

• Title: Atea Clinical Trials
• Organization: Atea Pharmaceuticals, Inc.

ateaclinicaltrials@ateapharma.com

1-857-284-8891

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: May 30, 2023
• Primary Completion: December 9, 2024
• Study Completion: January 28, 2025
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Locations

KR (6); BR (14); US (1); PH (3); IN (5); CA (2); MO (1); ZA (4); MA (1); TU (7); PA (2); RO (5)