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

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ClinicalTrials.gov Identifier: NCT05904470
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Hepatitis C, Chronic Hepatitis C Hepatic Cirrhosis HCV Drug: Bemnifosbuvir Drug: Ruzasvir Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 30, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bemnifosbuvir and Ruzasvir

Bemnifosbuvir (BEM; AT-527) Tablets

Ruzasvir (RZR; AT-038) Capsules

 Drug: Bemnifosbuvir
550 mg administered orally once a day (QD) for 8 weeks
Other Name: AT-527

Drug: Ruzasvir
180 mg administered orally once a day (QD) for 8 weeks
Other Name: AT-038


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 1 through 4 weeks after end of treatment ]
  2. Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12) [ Time Frame: Day 1 through12 weeks after end of treatment ] SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment ]

Secondary Outcome Measures :
  1. Proportion of subjects experiencing virologic failure [ Time Frame: Day 1 thru 12 weeks after end of treatment ]
  2. Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24) [ Time Frame: Day 1 thru 24 weeks after end of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05904470


Contacts
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Contact: Clinical Trials Administrator 1(857)284-8891 ateaclinicaltrials@ateapharma.com

Locations
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Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
More Information
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Responsible Party: Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05904470    
Other Study ID Numbers: AT-01B-004
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Chronic Disease
Disease Attributes
Pathologic Processes
Fibrosis
Ruzasvir
Antiviral Agents
Anti-Infective Agents