Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir.

BACKGROUND: Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients. AIM: To investigate adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting. METHODS: Data on 174 hepatitis C-infected patients initiating telaprevir-based therapy at Mount Sinai and Montefiore medical centres were collected. Biopsy data and FIB-4 scores identified patients with advanced fibrosis. Multivariable fully adjusted models were built to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event. RESULTS: Patients with (n = 71) and without (n = 103) advanced fibrosis were similar in BMI, ribavirin exposure, gender, prior treatment history, haemoglobin and creatinine, but differed in race. Overall, 47% of patients completed treatment and 40% of patients achieved SVR. Treated patients with and without advanced fibrosis or cirrhosis had similar rates of adverse events; advanced fibrosis, however, was independently associated with ano-rectal discomfort (P = 0.03). Three patients decompensated and had advanced fibrosis. The discontinuation of all treatment medications due to an adverse event was significantly associated with older age (P = 0.01), female gender (P = 0.01) and lower platelets (P = 0.03). CONCLUSIONS: Adverse events were common, but were not significantly related to the presence of advanced fibrosis or cirrhosis. More critical monitoring in older and female patients with low platelets throughout treatment may reduce adverse event-related discontinuations.

Efficacy of inferior vena cava filters in anticoagulated patients.

BACKGROUND AND OBJECTIVES: The benefit of an inferior vena cava (IVC) filter in addition to standard anticoagulation regimens is unknown. METHODS: We examined data for patients who received IVC filters with anticoagulation (AC-Filter) after an episode of venous thromboembolism (VTE) and compared them with data for those who received anticoagulation only (AC-Only). Outcome measures were new pulmonary embolism (PE), recurrent deep vein thrombosis (DVT), and mortality at 90 days and at 5 years. Demographic data included age, gender, and ethnicity/race, prior thromboembolic history, cancer, serum albumin, and time in therapeutic range. In addition, subsets matched for age, gender and race/ethnicity were examined in detail. RESULTS: AC-Filter patients (n = 251), when compared to AC-Only patients (n = 1377), did not differ significantly with regard to gender or cancer status, but white males in general had better outcomes. AC-Filter patients were more likely to have had a previous history of PE or VTE (P < 0.001). In comparison to AC-Only patients, AC-Filter patients had lower mean serum albumin levels (3.1 +/- 0.8 vs. 3.6 +/-0.8 mg dL(-1), P < 0.001) and were older (65 +/- 16.1 years vs. 60 +/- 17.5 years, P < 0.001). After stratification according to previous history of PE or VTE prior to the index VTE event, no differences in the outcome measures of new PE, recurrent DVT or mortality were identified between groups, but patients with a prior history of PE from either group were more likely to have a new PE (hazard ratio 1.9, P < 0.001). CONCLUSIONS: These data suggest that IVC filters may not provide any substantial additional benefit for patients who can tolerate anticoagulant therapy.