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.

The efficacy of anal fistula plug in fistula-in-ano: a systematic review.

AIMS: To assess the efficacy of anal fistula plug (AFP) procedure for the treatment of fistula-in-ano especially the complex fistulas. METHOD: The database of PUBMED, MEDLINE, SCOPUS, EMBASE and COCHRANE LIBRARY for the period 1995-2009 was searched. A systematic analysis was carried to evaluate the success rate of AFP procedure in fistula-in-ano. RESULTS: A total of 25 studies were extracted and 12 (n = 317) were finally included in the systematic review. The follow-up period ranged from 3.5 to 12 months. The AFP procedure had a success rate (patient cure rate) ranging from 24% to 92%. In complex fistula-in-ano in prospective studies (8/12 studies), the success rate was 35-87%. The success rate in patients with Crohn's disease was 29-86%. The success rate in the patients with single tracts was 44-93% and in patients with multiple tracts, success ranged from 20% to 71%. The abscess formation/sepsis rate was 4-29% (11/108) and the plug extrusion rate was 4-41% (42/232-19%). CONCLUSION: Anal fistula plug procedure has a success rate ranging from 24% to 92% in different studies. In prospective studies of complex fistula-in-ano, there was a moderate success rate of 35-87%. As AFP is associated with low morbidity and sepsis, it appears to be a safe procedure. Further randomized controlled trials studying objective parameters of fistula healing are needed to substantiate these findings.