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Tytuł:
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Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.
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Autorzy:
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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
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Temat:
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CHRONIC hepatitis C
HIV-positive persons
MIXED infections
TELAPREVIR
PHARMACOKINETICS
DRUG efficacy
RNA
HIV infection complications
HIV infection epidemiology
ANTIVIRAL agents
CLINICAL trials
COMPARATIVE studies
DRUG side effects
HIV infections
RESEARCH methodology
MEDICAL cooperation
OLIGOPEPTIDES
POLYETHYLENE glycol
PROTEINS
RECOMBINANT proteins
RESEARCH
RIBAVIRIN
EVALUATION research
TREATMENT effectiveness
ANTI-HIV agents
DISEASE complications
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Źródło:
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Journal of Antimicrobial Chemotherapy (JAC); Jan2016, Vol. 71 Issue 1, p244-250, 7p
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Objectives: INSIGHT (ClinicalTrials.gov 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.Patients and Methods: 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).Results: 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 (<25 IU/mL HCV RNA 12 weeks after the last planned treatment dose) in treatment-naive patients, relapsers and non-responders were 64% (41 of 64), 62% (18 of 29) and 49% (34 of 69), respectively. SVR12 rates ranged from 51% (33 of 65) (patients receiving efavirenz) to 77% (13 of 17) (patients receiving raltegravir). Most frequently reported AEs during telaprevir treatment were pruritus (43%) and rash (34%) special search categories. Anaemia special search category occurred in 15% of patients; 6% of patients reported a serious AE.Conclusions: 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. [ABSTRACT FROM AUTHOR]
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