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

Autor: Jacob Lalezari, Amit Khatri, Peter Ruane, Jennifer R. King, Rolando M Viani, Michael S. Saag, Laveeza Bhatti, Roger Trinh, Oluwatoyin Adeyemi, David L. Wyles, Nancy S. Shulman, Yiran B Hu
Rok vydání: 2017
Předmět:
Cyclopropanes
Male
0301 basic medicine
Hepacivirus
Gastroenterology
Body Mass Index
chemistry.chemical_compound
0302 clinical medicine
2-Naphthylamine
Immunology and Allergy
Anilides
030212 general & internal medicine
Darunavir
Sulfonamides
Dasabuvir
Coinfection
virus diseases
Valine
Hepatitis C
Middle Aged
Infectious Diseases
Anti-Retroviral Agents
Drug Therapy
Combination
Female
medicine.drug
Adult
medicine.medical_specialty
Macrocyclic Compounds
Adolescent
Proline
Lactams
Macrocyclic
030106 microbiology
Young Adult
03 medical and health sciences
Ombitasvir/paritaprevir/ritonavir
Internal medicine
Ribavirin
medicine
Humans
Uracil
Aged
Ritonavir
Dose-Response Relationship
Drug
business.industry
medicine.disease
Ombitasvir
CD4 Lymphocyte Count
chemistry
Paritaprevir
HIV-1
Carbamates
business
Zdroj: The Journal of Infectious Diseases. 215:599-605
ISSN: 1537-6613
0022-1899
Popis: 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.
Databáze: OpenAIRE
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