Clinical trial NCT01667731 (phase 3, status: completed)
Conditions: hepatitis c, human immunodeficiency virus
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9, B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: sof, rbv
SMILES: CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection

          -  HCV RNA > 1 x 10^4 IU/mL at screening

          -  Infection with HCV genotype 1, 2 or 3 as determined at screening

          -  HIV-1 infection confirmed with positive ELISA or Western blot at screening

          -  Medical records must be sufficient to be categorized on interferon (IFN) eligibility
             or prior treatment history with PEG/RBV.

          -  Confirmation of chronic HCV infection

          -  Ability to determine presence/absence of cirrhosis.

          -  HIV antiretroviral therapy (ARV) criteria of one of the following:

               -  ARV untreated with a CD4 T-cell count > 500 cells/mm^3

               -  On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4
                  T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA
                  level for ≥ 8 weeks preceding the screening visit

          -  Approved HIV antiretroviral medications based on drug interaction studies

          -  Not been treated with any investigational drug or device within 30 days of the
             screening visit

          -  Females if confirmed that she is not pregnant or nursing of non-childbearing potential
             or of childbearing potential but has a negative serum pregnancy test at screening and
             agrees to use protocol approved method of birth control from screening through 6
             months after the last dose of RBV

          -  Males who agree to consistently and correctly use a condom while their female partner
             agrees to use protocol approved method of birth control from screening through 7
             months after the last dose of RBV

          -  Must be of generally good health as determined by the investigator.

          -  Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients
             only, to exclude hepatocellular carcinoma (HCC)

        Exclusion Criteria:

          -  Non-genotype 1/2/3 or mixed genotype at screening

          -  Genotype 1 with prior treatment for HCV

          -  Poor control with ARV regimen

          -  Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein
             (NS)5B polymerase

          -  Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1
             antitrypsin deficiency, cholangitis)

          -  A new AIDS-defining condition diagnosed within 30 days prior to screening

          -  Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics,
             antivirals or antifungals within 30 days prior to baseline

          -  Infection with hepatitis B virus (HBV)

          -  Contraindication to RBV therapy

          -  Chronic use of systemically administered immunosuppressive agents (eg, prednisone
             equivalent > 10 mg/day)

          -  History of solid organ transplantation or malignancy diagnosed or treated within 5
             years

          -  Current or prior history of clinical hepatic decompensation or other significant
             gastrointestinal disorder