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

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

Official Title
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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

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

Intervention / Treatment
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* Drug: Bemnifosbuvir
* Drug: Ruzasvir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bemnifosbuvir and Ruzasvir<br>Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules | Drug: Bemnifosbuvir<br>* 550 mg administered orally once a day (QD) for 8 weeks<br>* Other names: AT-527;Drug: Ruzasvir<br>* 180 mg administered orally once a day (QD) for 8 weeks<br>* Other names: AT-038;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects experiencing treatment-emergent adverse events |  | Day 1 through 4 weeks after end of treatment | 
| Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12) |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects experiencing virologic failure |  | Day 1 thru 12 weeks after end of treatment | 
| Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24) |  | Day 1 thru 24 weeks after end of treatment |