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Title: Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.
Authors: Montes, Maria Luisa
Nelson, Mark
Girard, Pierre-Marie
Sasadeusz, Joe
Horban, Andrzej
Grinsztejn, Beatriz
Zakharova, Natalia
Rivero, Antonio
Durant, Jacques
Ortega-Gonzalez, Enrique
Lathouwers, Erkki
Janssen, Katrien
Ouwerkerk-Mahadevan, Sivi
Witek, James
González-García, Juan
metadata.dc.subject.mesh: Adolescent
Antiviral Agents
Drug-Related Side Effects and Adverse Reactions
HIV Infections
Hepatitis C, Chronic
Middle Aged
Polyethylene Glycols
Recombinant Proteins
Treatment Outcome
Young Adult
Issue Date: 19-Oct-2015
Abstract: INSIGHT ( NCT01513941) evaluated the efficacy, safety and pharmacokinetics of telaprevir-based therapy and specific antiretroviral agents in hepatitis C virus genotype 1 (HCV-1)/HIV-1-coinfected patients. Open-label, Phase IIIb, multicentre study of telaprevir with pegylated-IFN (Peg-IFN) α2a and ribavirin in treatment-naive or -experienced HCV-1/HIV-1-coinfected patients on stable HIV HAART comprising efavirenz, atazanavir/ritonavir, darunavir/ritonavir, raltegravir, etravirine or rilpivirine with two nucleos(t)ide analogues. Patients received 750 mg telaprevir (1125 mg, if on efavirenz) every 8 h plus 180 μg/week Peg-IFNα2a and 800 mg/day ribavirin for 12 weeks, followed by Peg-IFNα2a and ribavirin alone for 12 weeks (HCV treatment naive and relapsers without cirrhosis, with extended rapid virological response) or 36 weeks (all others). Overall, 162 patients (median age of 46 years, 78% male, 92% Caucasian and mean CD4 count of 687 cells/mm(3)) were treated; 13% had cirrhosis. One-hundred-and-thirty-two patients (81%) completed telaprevir; 14 (9%) discontinued due to an adverse event (AE). Sustained virological response (SVR) 12 rates ( In treatment-naive/-experienced HCV-1/HIV-1 patients there were significantly higher SVR rates with telaprevir-based therapy compared with pre-specified historical controls, and safety comparable to that in HCV-monoinfected patients.
metadata.dc.identifier.doi: 10.1093/jac/dkv323
Appears in Collections:Producción 2020

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