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Background: Ombitasvir, paritaprevir co-administered with ritonavir, and dasabuvir (OBV/PTV/r+DSV) comprise the 3 direct-acting antiviral (DAA; 3D) regimen ± ribavirin (RBV) approved for HCV genotype (GT) 1 infection. Here we investigate the safety and efficacy of 3D±RBV for GT1, and the 2 DAA (2D) regimen of OBV+PTV/r approved for GT4, in HIV-1 co-infected patients with or without compensated cirrhosis.
Methods: TURQUOISE-I, Part 2 is a phase 3 multicenter study. Eligible patients were HCV treatment-naïve or RBV/interferon-experienced, on an HIV-1 antiretroviral regimen containing atazanavir, raltegravir, dolutegravir, or darunavir (for GT4 only), and had plasma HIV-1 RNA < 40 copies/mL at screening. Patients received OBV/PTV/r (25/150/100 mg) ± DSV (250mg) ± weight-based RBV for 12 or 24 weeks per label guidelines. Interim safety and efficacy data are presented.
Results: Table 1 presents baseline demographics on 227 treated patients as of 4/21/2016. Of the 194 GT1- and 26 GT4-infected patients with available data, 98% and 100% achieved sustained virologic response at post-treatment week (PTW) 4 (SVR4), respectively. Three patients experienced virologic failure: one GT1a patient relapsed at PTW4, a second relapsed at PTW12, and one GT1b patient experienced breakthrough at week 10. No patients discontinued treatment due to adverse events (AEs). Most AEs were mild to moderate in severity, and key lab abnormalities were rare (Table 2).
Conclusions: The 2D and 3D regimens were well-tolerated and yielded high SVR4 rates in patients with HCV GT1 or GT4/HIV-1 co-infection. OBV+PTV/r±DSV±RBV is a potent HCV treatment option for patients with HIV-1 co-infection, regardless of treatment-experience or presence of compensated cirrhosis.

Table 1. Baseline Demographics and Disease Characteristics
[Table 1. Baseline Demographics and Disease Characteristics]



Table 2. Safety & Post-baseline Laboratory Abnormalities
[Table 2. Safety & Post-baseline Laboratory Abnormalities]