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J Infect Dis. 2017 Feb 15;215(4):599-605. doi: 10.1093/infdis/jiw597.

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

Author information

1
University of Colorado School of Medicine, Denver, USA.
2
Center for AIDS Research, University of Alabama, Birmingham, USA.
3
AbbVie Inc, North Chicago, Illinois, USA.
4
Quest Clinical Research, San Francisco, California, USA.
5
Ruth M. Rothstein CORE Center, Chicago, Illinois, USA.
6
AIDS Healthcare Foundation, Beverly Hills, California, USA.
7
Ruane Medical & Liver Health Institute, Los Angeles, California, USA.

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.

KEYWORDS:

HCV; HIV; TURQUOISE; co-infection; darunavir; direct-acting antiviral; ART

PMID:
28329334
DOI:
10.1093/infdis/jiw597
[Indexed for MEDLINE]

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