TY - JOUR
T1 - Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy
AU - Crismale, James F.
AU - Martel-Laferrière, Valérie
AU - Bichoupan, Kian
AU - Schonfeld, Emily
AU - Pappas, Alexis
AU - Wyatt, Christina
AU - Odin, Joseph A.
AU - Liu, Lawrence U.
AU - Schiano, Thomas D.
AU - Perumalswami, Ponni V.
AU - Bansal, Meena
AU - Dieterich, Douglas T.
AU - Branch, Andrea D.
PY - 2014/8
Y1 - 2014/8
N2 - 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. Methods: 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. Results: 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. Conclusions: 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.
AB - 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. Methods: 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. Results: 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. Conclusions: 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.
KW - Anaemia
KW - Diabetes mellitus
KW - Hepatitis C virus
KW - Pegylated-interferon
KW - Ribavirin
KW - Telaprevir
KW - Triple therapy
UR - http://www.scopus.com/inward/record.url?scp=84904501123&partnerID=8YFLogxK
U2 - 10.1111/liv.12342
DO - 10.1111/liv.12342
M3 - Article
C2 - 24118693
AN - SCOPUS:84904501123
SN - 1478-3223
VL - 34
SP - 1018
EP - 1024
JO - Liver International
JF - Liver International
IS - 7
ER -