TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir.

Academic Article

Abstract

  • Background: Ombitasvir/paritaprevir/ritonavir with dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV) is approved for hepatitis C virus (HCV) genotype 1 (GT1) treatment in HIV-1 coinfected patients. In healthy controls, coadministration of OBV/PTV/r + DSV + darunavir (DRV) lowered DRV trough concentration (Ctrough) levels. To assess the clinical significance of this change, TURQUOISE-I, Part 1b, evaluated the efficacy and safety of OBV/PTV/r + DSV + RBV in coinfected patients on stable, DRV-containing antiretroviral therapy (ART). Methods: Patients were HCV treatment-naive or interferon-experienced, had CD4+ lymphocyte count ≥200 cells/µL or ≥14%, and plasma HIV-1 RNA suppression on once-daily (QD) DRV-containing ART at screening. Patients were randomized to maintain DRV 800 mg QD or switch to twice-daily (BID) DRV 600 mg; all received OBV/PTV/r + DSV + RBV for 12 weeks. Results: Twenty-two patients were enrolled and achieved SVR12. No adverse events led to discontinuation. Coadministration had minimal impact on DRV maximum observed plasma concentration and area under the curve; DRV Ctrough levels were slightly lower with DRV QD and BID. No patient experienced plasma HIV-1 RNA >200 copies/mL during treatment. Conclusions: HCV GT1/HIV-1 coinfected patients on stable DRV-containing ART achieved 100% SVR12 while maintaining plasma HIV-1 RNA suppression. Despite DRV exposure changes, episodes of intermittent HIV-1 viremia were infrequent.
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    Keywords

  • HCV, HIV, TURQUOISE, co-infection, darunavir, direct-acting antiviral, ART, Adolescent, Adult, Aged, Anilides, Anti-Retroviral Agents, Body Mass Index, CD4 Lymphocyte Count, Carbamates, Coinfection, Darunavir, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, HIV-1, Hepacivirus, Hepatitis C, Humans, Macrocyclic Compounds, Male, Middle Aged, Ribavirin, Ritonavir, Sulfonamides, Uracil, Young Adult
  • Digital Object Identifier (doi)

    Author List

  • Wyles D; Saag M; Viani RM; Lalezari J; Adeyemi O; Bhatti L; Khatri A; King JR; Hu YB; Trinh R
  • Start Page

  • 599
  • End Page

  • 605
  • Volume

  • 215
  • Issue

  • 4