Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Sovaprevir; ACH-3102; Ribavirin; Placebo
Intervention description: Nonstructural protein 3/4A protease inhibitor.; Nonstructural protein 5A inhibitor.
Intervention MeSH terms: Ribavirin; Odalasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Genotype 1; Hepatitis C; Liver Diseases; Hepatitis; Ribavirin; Antiviral Agents; Anti-infective Agents; Protease Inhibitors; NS5a Inhibitors; Viral

Summary:

      The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks
      of treatment with sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1),
      treatment-naive, hepatitis C virus (HCV) participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV infection.

          -  HCV GT-1.

          -  HCV ribonucleic acid > 10,000 international units/milliliter at screening.

          -  Female participants must be willing to use 2 effective methods of contraception, one
             of which must be a barrier method, during the dosing period and 6 months after the
             last dose of RBV. Females of childbearing potential must have a negative pregnancy
             test at screening and baseline.

          -  Male participants must be willing to use an effective barrier method of contraception
             throughout the dosing period and for 6 months.

          -  Signed and dated written informed consent form.

          -  Willing to participate in all study activities and all study requirements (including
             effective contraception) during the study period.

          -  Treatment-naïve participants were defined as those participants who have never
             received pegylated interferon, RBV, or a direct-acting anti-viral agent for the
             treatment of chronic HCV infection.

          -  A liver biopsy within the last 3 years without evidence of cirrhosis.

        Exclusion Criteria:

          -  Body mass index > 36.0 kilograms/meter squared.

          -  Pregnant or nursing (lactating) female participants confirmed by a positive human
             chorionic gonadotropin laboratory test or contemplating pregnancy.

          -  Participation in any interventional clinical trial within 35 days prior to first study
             medication dose administration on Day 1.

          -  Known human immunodeficiency virus (HIV)-1 or HIV-2 infection/serology and/or positive
             hepatitis B surface antigen.

          -  Use of dietary supplements, grapefruit juice, herbal supplements, cytochrome P450
             (CYP) 2C8 substrates, CYP3A4 inducers and inhibitors, P-glycoprotein inducers and
             substrates, organic-anion-transporting polypeptide inhibitors and substrates, and
             potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days
             following completion of study medications.

          -  Clinically significant laboratory abnormality at screening (specified in protocol).

          -  Other forms of liver disease.

          -  History of severe or uncontrolled psychiatric disease.

          -  History of malignancy of any organ system, treated or untreated within the past 5
             years.

          -  History of major organ transplantation.

          -  Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.

          -  History of seizure disorder requiring ongoing medical therapy.

          -  History of known coagulopathy including hemophilia.

          -  History of hemoglobinopathy, including sickle cell anemia and thalassemia.

          -  History of immunologically mediated disease (specified in protocol).

          -  History of clinical evidence of significant chronic cardiac disease ( specified in
             protocol).

          -  Electrocardiogram with any clinically significant abnormality.

          -  Structural or functional cardiac abnormalities (specified in protocol).

          -  History of chronic obstructive pulmonary disease, emphysema, or other chronic lung
             disease.

          -  Participants currently abusing amphetamines, cocaine or opiates, or with ongoing
             alcohol abuse in the judgement of the investigator.