Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
BACKGROUND & AIMS:
Adding telaprevir to pegylated-interferon and ribavirin increased both response rates and side effects of hepatitis C virus (HCV) treatment. We identified variables associated with severe anaemia during telaprevir-based triple therapy.
An observational study was performed on 142 HCV-infected patients between June 2011 and March 2012. All subjects completed 12 weeks of telaprevir-based triple therapy or discontinued early because of anaemia. Severe anaemia was defined by a haemoglobin ≤8.9 g/dl; advanced fibrosis was determined by Fib-4 ≥3.25.
The 47 (33%) patients who developed severe anaemia were similar to those who did not in sex, race, and prior response to dual therapy, but they were more likely to have diabetes (23.4% vs. 6.3%, P < 0.01), advanced fibrosis (46.8% vs. 29.5%, P = 0.04) and a history of anaemia during previous dual therapy (29.7% vs. 11.4%, P = 0.02). Patients developing severe anaemia were older (59 vs. 56 years, P = 0.02), had lower baseline platelet counts (134 vs. 163 × 109 /L, P = 0.04), haemoglobin (14.0 vs. 15.0 g/dl, P < 0.01), estimated glomerular filtration rate (79 vs. 90 ml/min/1.73 m2 , P = 0.03) and a higher median ribavirin/weight ratio (14.9 vs. 13.2 mg/kg, P < 0.01). In multivariable logistic regression, presence of diabetes (OR = 5.61, 95% CI: 1.59-19.72), Fib-4 ≥3.25 (OR = 3.09, 95% CI: 1.28-7.46), higher ribavirin/weight ratio (OR = 1.31 per mg/kg, 95% CI: 1.13-1.52) and lower baseline haemoglobin (OR = 0.57 per g/dl, 95% CI, 0.41-0.80) were independently associated with developing severe anaemia.
Severe anaemia occurred in one-third of patients receiving telaprevir-based triple therapy. Risk was greater in patients with diabetes, advanced liver fibrosis, higher ribavirin/weight ratio and lower baseline haemoglobin.