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Doctors Conclude Majority of Both HCV & Coinfected Not Elgible for IFN/RBV
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"NATIONAL MULTICENTER STUDY OF ELIGIBILITY FOR INTERFERON AND RIBAVIRIN THERAPY IN PATIENTS COINFECTED WITH HIV AND HCV"
This study was presented in a poster at DDW 2004 (May, New Orleans, LA) by Edmund J Bini, Sue Currie, Hui Shen, Norbert Brau, Warren Schmidt, Teresa L Wright, VA HCV-001 Research Group
HIV and HCV coinfected patients progress to cirrhosis faster and more commonly than those with HCV monoinfection. However, many coinfected patients are not treated for HCV.
The aim of this study was to determine the proportion of HIV/HCV coinfected patients that were eligible for interferon (IFN) and ribavirin (RBV) therapy.
Data were prospectively collected in 4,364 HCV RNA positive patients undergoing evaluation for HCV therapy from 24 geographically diverse medical centers throughout the U.S. Treatment candidacy was determined by 2 methods (established inclusion/exclusion criteria and the opinion of the treating clinician). Information collected included demographics, determination of treatment candidacy, and reasons for non-candidacy.
HIV status was known in 3,238 patients (72.6%), and 280 (8.6%) were coinfected with HIV. There were no significant differences in age or gender between the two groups, but coinfected patients were more likely to be African American (51.8% vs. 29.0%, p < 0.001).
Coinfected patients were significantly less likely to be eligible for IFN/RBV therapy according to established criteria (25.0% vs. 32.5%; OR 0.7, 95% CI 0.5 - 0.9; p = 0.01) and in the opinion of the treating clinician (34.3% vs. 41.8%; OR 0.7, 95% CI 0.6 - 0.9; p = 0.02) compared to those with HCV monoinfection.
Among coinfected patients, multivariate analysis identified ongoing or recent substance abuse (OR 26.0; 95% CI 5.2 - 128.8), comorbid medical disease (OR 19.4; 95% CI 6.4 - 58.9), albumin < 3.2 g/dl (OR 15.2; 95% CI 1.5 - 157.2), psychiatric disease (OR 5.7; 95% CI 1.2 - 26.6), and annual income < $10,000 (OR 2.6; 95% CI 1.0 - 6.4) as independent predictors of not being a treatment candidate according to the opinion of the clinician.
Of those offered treatment, only 69.3% of coinfected and 75.9% of HCV monoinfected patients agreed to treatment (p = 0.16). The primary reasons for declining treatment in both groups included concerns over potential side-effects and deferring treatment until better therapies are available.
The authors concluded that the majority of HCV infected patients are not suitable candidates for IFN and RBV therapy, and HIV/HCV coinfected individuals were even less likely to be eligible for therapy than those with HCV monoinfection. Multidisciplinary collaboration and better tolerated HCV therapies are needed to improve treatment candidacy in HIV/HCV coinfected patients. This study was funded in part by a grant from Schering Plough Corporation.
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