Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients.
Dr Bichoupan and colleagues from New York, USA investigated adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting.
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.
|47% of patients completed treatment |
|Alimentary Pharmacology & Therapeutics|
The research team built multivariable fully adjusted models to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event.
The team reported that patients with and without advanced fibrosis were similar in BMI, ribavirin exposure, gender, prior treatment history, hemoglobin 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.
The team noted that advanced fibrosis was independently associated with ano-rectal discomfort.
The researchers found that 3 patients decompensated and had advanced fibrosis.
The discontinuation of all treatment medications due to an adverse event was significantly associated with older age, female gender, and lower platelets.
Dr Bichoupan's team concludes, "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."