Abstract

SANGRADOR PELLUZ, C.; MAIQUES LLACER, F. J.  and  SOLER COMPANY, E.. Safety in the clinical practica of the triple teraphy with telaprevir in chronic hepatitis C. Farm Hosp. [online]. 2013, vol.37, n.6, pp.489-493. ISSN 2171-8695.  https://dx.doi.org/10.7399/FH.2013.37.6.1067.

Purpose: To study the safety of triple therapy with telaprevir and the time of appearance of the RAM in the treatment of hepatitis C. Method: A retrospective observational study (January 2012-June 2013) of patients with HCV genotype 1 who had completed 12 weeks of triple therapy with telaprevir. The following variables were needed to characterize patients, and those relating to the treatment received. The classification of ADR was performed according to criteria of the SIDA Division 1.0. Results: We included 88 patients (78% male), 75% cirrhotic patients. 40.9% were coinfected with HIV. The main ADR (incidence > 40%) including all grades: haematological toxicity, fatigue, hyperuricemia, hyperbilirubinemia and pruritus. Serious ADR (incidence > 15%): thrombocytopenia, anemia and neutropenia. 3.4% had severe toxicodermia. 51.1% required ribavirin dose adjustment, blood transfusions 13.6%, and 28.4% exogenous erythropoietin. The 8% required hospitalization motivated by treatment toxicity. The treatment was stopped for toxicity in 6.8% of patients: 3 severe toxicodermia, 2 severe haematological toxicity, and 1 severe emesis. Thrombocytopenia and hyperbilirubinemia occurred at an early stage in its higher degree of toxicity, while the other ADR presented progression longer periods. Conclusions: The study shows a superior toxicity profile to that described in clinical trials, mainly with regard to hematologic toxicity, and predicts a time range of highest probability of occurrence of ADR.

Keywords : Telaprevir; Safety; Triple therapy; Adverse drug reaction (ADR); Hepatitis C.

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