Clinical trial NCT01849562 (phase 2, status: completed)
Conditions: hepatitis c, chronic
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: sovaprevir, ach-3102, rbv, placebo
SMILES: COC1=CC2=NC(=CC(O[C@@H]3C[C@H](N(C3)C(=O)[C@@H](CC(=O)N3CCCCC3)C(C)(C)C)C(=O)N[C@@]3(C[C@H]3C=C)C(=O)NS(=O)(=O)C3CC3)=C2C=C1)C1=CC=CC=C1, COC(=O)N[C@@H](C(C)C)C(=O)N1[C@@H](C[C@@H]2CCCC[C@H]12)C1=NC2=CC=C(C=C2N1)C1=CC2=CC=C1CCC1=CC=C(CC2)C(=C1)C1=CC=C2N=C(NC2=C1)[C@@H]1C[C@@H]2CCCC[C@@H]2N1C(=O)[C@@H](NC(=O)OC)C(C)C, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females between ages 18 and 65

          -  Chronic HCV infection

          -  HCV genotype 1

          -  HCV RNA > 10,000 IU/mL at screening.

          -  Female patients must be willing to use two effective methods of contraception, one of
             which must be barrier method, during dosing period and six months after last dose of
             ribavirin. Females of childbearing potential must have a negative pregnancy test at
             screening and baseline.

          -  Male patients must be willing to use an effective barrier method of contraception
             throughout the dosing period and for six months.

          -  Signed and dated written informed consent form.

          -  Willing to participate in all study activities and all study requirements (including
             effective contraception) during study period.

          -  Treatment naïve subjects defined as subjects 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 (BMI) > 36.0

          -  Pregnant or nursing (lactating) females, confirmed by a positive human chorionic
             gonadotropin (HCG) laboratory test or females contemplating pregnancy

          -  Participation in any interventional clinical trial within 35 days prior to first study
             medication dose administration on Day 1

          -  Known HIV-1 or HIV-2 infection/serology and/or positive Hepatitis B Surface Antigen
             (HBsAg)

          -  Use of dietary supplements, grapefruit juice, herbal supplements, CYP2C8 substrates,
             CYP3A4 inducers and inhibitors, PGP inducers and substrates, OATP inhibitors and
             substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing
             through 7 days following completion of study meds.

          -  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)

          -  ECG with any clinically significant abnormality.

          -  Structural or functional cardiac abnormalities (specified in protocol)

          -  History of COPD, emphysema, or other chronic lung disease.

          -  Subjects currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol
             abuse in the judgement of the investigator