Resumen de Safety of the triple therapy with boceprevir in chronic hepatitis c

Cristina Sangrador Pelluz, Enrique Soler Company, F. J. Maiques Llácer, Carmen García Muñoz, M. Monzó Rausell

• Purpose: To study the safety of triple therapy with boceprevir and the time of appearance of the ADR in the treatment of hepatitis C.

  Method: A retrospective observational study (January 2012 - February 2014) of patients with HCV genotype 1 who had completed treatment with boceprevir.

  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 50 patients (68% male), 48% with cirrhosis. 10% were coinfected with HIV. The main ADR including all grades: neutropenia, thrombocytopenia,fatigue, anaemia, lymphopenia, anorexia, fever, and dysgeusia. The most serious ADR [grade (G) 3 or higher]: anaemia (16% G3, G4 2%), neutropenia (18% G3, G4 8%), thrombocytopenia (16% G3, G4 2%), lymphopenia (2% G3, G4 4%) and increased creatinine (2% G3). 72% required dose adjustment of ribavirin and/or peginterferon, 16% required blood transfusions, exogenous erythropoietin 42% and 8% granulocyte colony stimulating factors. Treatment was discontinued because of toxicity in 8% of patients.

  Conclusions: The study shows a different toxicity profile to that described in clinical trials, in particular, it highlights a higher incidence of anaemia and thrombocytopenia, and lower rates of neutropenia, and predicts a time range of highest probability of occurrence of ADR