Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV

• INCLUSION CRITERIA

Subjects who meet the following criteria are eligible to enter the study:

• Eighteen years of age or older at screening
• Naive to treatment for hepatitis C or treatment experienced on previous IFN-containing treatment for chronic HCV infection. Patients who have been re-infected with HCV are excluded.
• Women are allowed to participate if they agree to always use at least two forms of birth control. One form must be barrier protection (i.e., condom or female condom) and the other is to meet one of the criteria below:
• Non-childbearing potential status (i.e., physiologically incapable of becoming pregnant)
• Has had a hysterectomy or
• Has had a bilateral oophorectomy or
• Is post-menopausal (age greater than or equal to 50 and a demonstration of a total cessation of menses for greater than or equal to 1 year) or
• Has had a bilateral tubal ligation or fallopian tube inserts
• Childbearing potential status women must have a negative serum pregnancy test at screening and agree to use an acceptable form of birth control, such as any of the following:
• Complete abstinence from sexual intercourse 2 weeks prior to administration of the study drug until completion of the follow-up procedures and at least 5 weeks (women) after the last dose of the study drugs.
• Vasectomized partner in reliably monogamous relationship.
• An intrauterine device (IUD) 2 weeks prior to administration of the study drugs continuously until completion of the follow-up procedures and at least 5 weeks after the last dose of the study drugs.
• Double contraceptive method (condom or occlusive cap [diaphragm or cervical/vault caps]; spermicidal foam/gel/film/cream/suppository).
• Oral, implantable, transdermal, or injectable or any other form of hormonal contraceptives are NOT an acceptable form of contraception for females on this study.
• Men are allowed to participate if they agree to use at least 2 forms of birth control. One form must be barrier protection (i.e., condom or female condom) and the other is to meet one of the criteria below:
• Are sterile or
• Agree to use at least one of the following approved methods of contraception 2 weeks prior to administration of the study drug until the completion of the followup procedures and at least 14 weeks after the last dose of the study drugs:
• A male condom with spermicide.
• A sterile sexual partner.
• A female sexual partner who has an IUD.
• A female sexual partner using a female condom with spermicide, intravaginal system (e.g., NuvaRing[registered]), diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives.
• Chronic GT1b (2DAA arm) or Chronic GT 1 (1a or 1b) (3DAA arm) infection as documented by one or more measurements of serum HCV RNA greater than or equal to 2,000 IU/mL during screening and at least one of the following:
• A positive anti-HCV antibody, HCV RNA, or HCV genotype test result greater than or equal to 12 months prior to the baseline (Day 0) visit together with current positive HCV RNA or anti-HCV antibody test results.

Or

b. Positive HCV RNA test and anti-HCV antibody test results together with a liver biopsy consistent with chronic HCV infection or a liver biopsy performed before Day 0 with evidence of chronic hepatitis C infection disease, such as the presence of fibrosis.

• HIV treatment status:
• Documented HIV infection (defined by positive Western blot result or detectable HIV viral load), ARV untreated for >8 weeks preceding dosing and having either:
• A CD4 T-cell count greater than or equal to 500 cells/mm3 within 8 weeks of Day 0 or
• An HIV viral load less than 500 copies/mL with a stable CD4 count for at least 3 months
• Documented HIV-1 (defined by positive western blot result or detectable HIV viral load) infection on a stable protocol-approved, ARV regimen for greater than or equal to 4 weeks prior to dosing and is expected to continue the current ARV regi