engleski

Triple therapy for chronic hepatitis C: real life clinical experience in Croatia

OBJECTIVE: Boceprevir-based and telaprevir-based triple therapy for HCV genotype 1 infection have markedly improve the overall response to therapy in many patients. The purpose of this study was to assess the validity of large clinical trial data with respect to efficacy and side effects in the real-life setting. METHODS: A retrospective study was performed by reviewing the charts of 41 chronic HCV patients who were started on triple therapy from January 2012, representing the first clinical experience in Croatia. RESULTS: 25 patients were treated with boceprevir and 16 with telaprevir- based therapy. 35 patients were treatment-experienced (21 relapser, 8 non-responder, 6 partial-responders). 76% had CT and 7% TT IL28 genotype. Baseline median fibrosis score was 4 (IQR 3-5), histological activity index of 8 (IQR 5-11), ALT 65 (IQR 43-163). 15% of patients had compensated cirrhosis and 1 hepatocellular carcinoma. Early virological response (EVR) and end of treatment response (ETR) was attained by 90% and 70% of patients treated with telaprevir, respectively, and 80% and 76% of patients treated with boceprevir. Sustained virologic response (SVR) was attained by 68% of patients treated with boceprevir and 75% of patients treated with telaprevir, respectively. Our clinical experience with telaprevir demonstrates that SVR rates are compatible with published literature values. Rates of SVR were also similar to those reported in cirrhotic patients - 50%. The side effect profiles were similar to the literature values except more frequent anemia (96%). 56% of patients developed leukopenia (25% of those received G-CSF, and 1 patient developed agranulocytosis with life-threatening MSSA sepsis), 80% thrombocytopenia. Almost all of the patients on telaprevir developed rash. 8% of patients stopped therapy due to the severity of side-effects. CONCLUSION: Although incomplete, our study demonstrates that clinical trial data are largely compatible with the outcomes obtained in our community setting.

Triple therapy; Chronic hepatitic C

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