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Diabetes Therapy Improves Peg/RBV Response
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Diabetes Mellitus is a Predictor of Treatment Failure in hepatitis C Patients Treated with Peg IFN and RBV
Reported by Jules Levin
DDW, May 19-24, 2007, Wash DC
H. M. Elgouhari1; I. Hanouneh1; C. O. Zein2; A. E. Feldstein3; N. N. Zein1
1. Gastroenterology and Hepatology, Cleveland Clinic foundation, Cleveland, OH, USA.
2. Gastroenterology and Hepatology, Case Western Reserve University, Louis Stokes VAMC, Cleveland, OH, USA.
3. Pediatric Gastroenterology and Cell Biology, Cleveland Clinic Foundation, Cleveland, OH, USA.
Background: Insulin resistance is a major feature of type II Diabetes mellitus (DM) and has recently been linked to treatment failure in HCV. However, there is paucity of data on treatment outcome in diabetic HCV patients. Aims: 1) To determine the rate of SVR in HCV patients with DM compared to those without DM; 2) To assess the safety of combining insulin sensitizing agents (ISA) with Peg IFN/RBV in HCV patients.
Methods: Case-controlled retrospective assessment of prospectively collected data. All HCV+DM patients (n=61) that were treated with standard doses of Peg IFN/RBV between 2002 and 2004 were identified. A 1:1 control group of non-DM HCV patients (n=61) matched for genotype and ethnicity treated during the same time period at the same institution was identified. Descriptive statistics were performed to characterize both groups. Univariate analysis was performed to compare variables of interest. Logistic regression was performed to identify independent factors associated with treatment failure. Safety measures included the occurrence of any serious adverse events (SAE), early withdrawals or ALT flares during therapy.
Results: Patients with DM had higher BMI than non-DM (32.4 + 6.0 vs 28.5 + 6.6, p=0.0009) and were more likely to have advanced fibrosis (56% vs 28%, p=0.003). SVR was observed in 14/61 (23%) of HCV+DM patients compared to 31/61 (51%) of non-DM patients (p=0.001). By univariate analysis, DM (p=0.001), genotype 1 (p=0.005), and African American ethnicity (p=0.03) were associated with lack of SVR. Multivariate logistic regression identified DM [OR=3.9, 95% CI 1.7-9.3; p=0.001] and genotype 1 [OR=3.7, 95% CI 1.2-12.3; p=0.02] as independent predictors of treatment failure in patients with HCV. This association remained significant after adjusting for other relevant variables including presence of advanced fibrosis and ethnicity. Among patients with DM, SVR was higher in patients who were on therapy with ISA (29%) compared to those who were not on ISA (20%). However, this difference in SVR did not reach statistical significance. The rates of SAE, early discontinuation and ALT flares were similar between HCV+DM patients receiving ISA (21 patients) and HCV+DM not receiving ISA (40 patients).
Conclusions: 1) DM is a predictor of treatment failure in HCV patients treated with Peg IFN/RBV. 2) Based on this limited assessment, ISA appear to be safe when combined with Peg IFN/RBV in diabetic HCV patients.
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