safety, tolerability, and efficacy of 12-weeks of sovaprevir, ach-3102, and ribavirin in treatment-naive gt-1 hcv participants

Conditions: Hepatitis C, Chronic

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.

Keywords: chronic hepatitis c genotype 1 hepatitis c liver diseases hepatitis ribavirin antiviral agents anti-infective agents protease inhibitors ns5a inhibitors viral