Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants

Alexion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Placebo; Drug: ACH-3102; Drug: Ribavirin; Drug: Sovaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01849562

ACH102-007

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg

Active Comparator group

Description:

Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.

Treatment:

Drug: Sovaprevir

Drug: Ribavirin

Drug: ACH-3102

Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg

Active Comparator group

Description:

Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.

Treatment:

Drug: Sovaprevir

Drug: Ribavirin

Drug: ACH-3102

Placebo

Placebo Comparator group

Description:

Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks.

Treatment:

Drug: Placebo