Abstract
Background There are limited data that tackle safety and effectiveness of the triple treatment based on protease inhibitors (telaprevir or boceprevir) in liver transplant patients. Purpose To describe effectiveness and safety of the triple treatment used by liver transplant patients. Material and methods We performed an observational retrospective study, from November 2012 to September 2014. Transplant patients who started triple treatment before May 2013 were included. Baseline variables included demographic data, treatment and infection related data, and laboratory data. The effectiveness outcome was sustained virological response (SVR). Safety outcomes included haematological toxicity and skin toxicity. Moreover, we recorded the requirements to treat those side effects. Results Seven patients were included; 100% were male. The average age of patients was 57.5 (standard deviation 4.2). Telaprevir was used in 3 (42.9%) patients and boceprevir in 4 (57.1%). As far as grade of fibrosis was concerned, 6 (85.7%) patients were cirrhotic or F4 and 1 (14.3%) patient was F2. Median fibroscan value was 16.6 Kpa (IQR 12.1–28.6 Kpa). Two (28.6%) patients were treatment-naive, 1 (14.3%) patient was a null responder and 4 (57.1%) patients were relapsers from previous treatment. At the beginning of treatment the median haemoglobin level was 13.6 g/dL (IQR 12.1–16.4 g/dL), the median neutrophil count was 3.0/mL (1.2–4.8/mL) and the median platelet count, 164/mL (126–197/mL). Four (66.7%) patients achieved SVR. One patient died during treatment. Haematological toxicity included anaemia (85.7%), neutropenia (28.6%) and thrombocytopenia (42.9%). Skin rash was present in 2 (28.6%) patients. Five (71.4%) patients required ribavirin dose reductions, erythropoietin and blood transfusions. The median number of red blood units administered was 28 (IQR 3–31). Conclusion Despite the severe disease of the included patients, we found that response rates to triple treatment exceeded 60%. As the treatment-related anaemia was considerable, most of the patients required supportive care. References and/or acknowledgements Conflict of interest.
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