Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

Exclusion Criteria

• •1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
• •2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
• •3. Subjects with a history of clinically significant drug allergy
• •4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
• •5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
• •6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up
• •7. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection. Subjects provided they met stable treatment criteria. Subjects with HIV infection may be eligible for moderate impairment cohort provided they met stable treatment criteria.
• •1. Estimated creatinine clearance \<60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\] - Unless otherwise instructed by the Study Review Committee (SRC), CKD-EPI should not be corrected for subjects of African ancestry
• •2. Bilirubin (total, direct) \>1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)
• •3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 1.2×ULN
• •4. Grade ≥1 Hemoglobin
• •1. Subjects with advanced ascites (Grade 3)
• •2. Subjects with refractory encephalopathy as judged by the investigator.
• •3. Subjects with esophageal variceal bleeding within the past 6 months prior to screening.
• •4. Subjects with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.
• •5. Estimated creatinine clearance \<60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\] - Unless otherwise instructed by the SRC, CKD-EPI should not be corrected for subjects of African ancestry
• •6. ALT or AST level ≥5×ULN
• •7. Serum sodium ≤125 mmol/L
• •8. Platelets \<50×10\^9/L
• •9. Grade ≥2 Hemoglobin