Background: Telaprevir based triple therapy for HCV (hepatitis C virus) infected genotype 1 patients is now the standard of care as recommended by AASLD. Aims: To evaluate the complexity & morbidity of telaprevir based triple therapy for treatment of HCV. Methods: A retrospective review of 105 pts with HCV genotype 1, treated with telaprevir based triple therapy in a community based practice. All patients completed at least 12 weeks of therapy unless treatment was discontinued per futility guidelines or due to adverse events. Patients with cirrhosis Child class B/C, HIV co-infection, and patients after liver transplantation were excluded from the study. Results: The demographic data of all patients are listed in table 1. A majority of patients were African-American, suffered from advanced fibrosis, hypertension and genotype 1a infection. 62% of all patients had received prior interferon based therapy for HCV. The on-treatment progress, viral loads, discontinuation rates and serious adverse events are listed in table 2. Since, the treatment outcomes of a significant number of patients remain pending; this study does not aim to evaluate the efficacy of the above therapy. Adverse events experienced during treatment included anemia (n=74, 70%), fatigue (n=57, 54%), skin rash (n=50, 48%), pruritus (n=34, 32%), depression and anxiety (n=30, 29%), anorectal discomfort (n=23, 22%) and retinopathy (n=4, 4%). The skin rash was noted to be mild (n=27, 26%), moderate (n=14, 13%) or severe (10, 10%), with 2 patients (2%) experiencing DRESS (drug rash with eosinophilia and systemic symptoms). Among patients that developed anemia (n=74), 16 (15%) were treated with erythropoietin stimulating agents (ESA), and 29 (28%) required ribavirin dose reductions. 14 (13%) patients discontinued telaprevir prematurely due to adverse events. Seventeen (16%) pts were hospitalized during treatment for anemia (n=9, 9%), rash (n=3, 3%), hepatic encephalopathy (n=1, 1%), hyponatremia (n=1, 1%), sepsis (n=1, 1%), and dehydration (n=2, 2%). 12 (11%) pts required blood transfusions with four patients requiring more than one transfusion. One patient died from septic shock during treatment. Conclusions: Real world community based treatment of HCVwith telaprevir based regimen carries a significantly higher rate ofmorbidity, relapse, treatment failure and serious adverse events than those published in the phase 3 trials. This can result in a considerable increase in treatment complexity and potentially higher costs. These data suggest that telaprevir based therapy should be implemented in a setting equipped to handle the complexity of current therapy for treatment of HCV genotype 1 patients. Table 1. Demographic Data (n=105)
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