Clinical trial NCT02707952 (phase 3, status: completed)
Conditions: chronic hepatitis c virus, hepatitis c virus
ICD codes: B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2, B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2
Drugs: abt-493/abt-530, obv/ptv/r
SMILES: [H][C@](C)(OC)[C@]([H])(N=C(O)OC)C(=O)N1CCC[C@@]1([H])C1=NC2=C(N1)C=C(F)C(=C2)[C@@]1([H])CC[C@@]([H])(N1C1=CC(F)=C(N2CCC(CC2)C2=CC=C(F)C=C2)C(F)=C1)C1=CC2=C(NC(=N2)[C@]2([H])CCCN2C(=O)[C@@]([H])(N=C(O)OC)[C@@]([H])(C)OC)C=C1F, CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Females were postmenopausal for at least 2 years; surgically sterile or had a
             vasectomized partner; or, if of childbearing potential and sexually active with a male
             partner, were currently using at least 1 effective method of birth control at the time
             of Screening and agreed to practice 1 effective method of birth control from Screening
             through 30 days after stopping study drug. Sexually active males were surgically
             sterile or, if sexually active with a female partner of childbearing potential, agreed
             to practice 1 effective form of birth control from Screening through 30 days after
             stopping study drug.

          -  Screening central laboratory result indicated HCV single genotype infection for the
             appropriate treatment arm, without co-infection of any other genotype.

          -  Chronic HCV infection is defined as one of the following:

               -  Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before
                  Screening.

               -  A liver biopsy consistent with chronic HCV infection.

          -  Agreed to voluntarily sign and date an informed consent form, approved by an
             Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the
             initiation of any screening or study specific procedures.

          -  Participants who were able to understand and adhere to the study visit schedule and
             all other protocol requirements.

          -  Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed
             tomography (CT) scan or magnetic resonance imaging (MRI).

        Exclusion Criteria:

          -  Females who were pregnant or planned to become pregnant, or breastfeeding or males
             whose partner was pregnant or planning to become pregnant during the study.

          -  Participants co-infected with hepatitis B virus or human immunodeficiency virus.

          -  Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if
             known), whichever was longer, prior to the first dose of any study drug.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Any cause of liver disease other than chronic HCV infection.

          -  Any current or past clinical evidence of Child-Pugh B or C classification or clinical
             history of decompensated liver disease.

          -  Consideration by the investigator, for any reason, that the participant is an
             unsuitable candidate to receive ABT-493/ABT-530.