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TURQUOISE-I Part 1b: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin for Hepatitis C Virus Infection in HIV-1 Coinfected Patients on Darunavir.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2017 Feb 15; Vol. 215 (4), pp. 599-605. - Publication Year :
- 2017
-
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).<br />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.<br />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.<br />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.<br /> (© The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
- Subjects :
- 2-Naphthylamine
Adolescent
Adult
Aged
Anilides therapeutic use
Body Mass Index
CD4 Lymphocyte Count
Carbamates therapeutic use
Coinfection drug therapy
Cyclopropanes
Dose-Response Relationship, Drug
Drug Therapy, Combination
Female
HIV-1 drug effects
HIV-1 isolation & purification
Hepacivirus drug effects
Hepacivirus isolation & purification
Humans
Lactams, Macrocyclic
Macrocyclic Compounds therapeutic use
Male
Middle Aged
Proline analogs & derivatives
Ribavirin therapeutic use
Ritonavir therapeutic use
Sulfonamides therapeutic use
Uracil analogs & derivatives
Uracil therapeutic use
Valine
Young Adult
Anti-Retroviral Agents therapeutic use
Darunavir therapeutic use
Hepatitis C drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6613
- Volume :
- 215
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 28329334
- Full Text :
- https://doi.org/10.1093/infdis/jiw597