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Sixth International Congress

Drug Therapy in HIV Infection


17-21 November, 2002
Glasgow, UK


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Risk factors for hepatic decompensation in cirrhotic patients with HIV-HCV coinfection treated with PEG interferon a or interferon a and ribavirin or placebo

S Mauss1, D Larrey2, W Valenti3, F J Torriani4, D Dieterich5, S Passe, J Solsky, L Cupelli, J DePamphilis, and the APRICOT Study Group, USA6
Int Cong Drug Therapy HIV 2002 Nov 17-21;6:Abstract No. PL12.4


Hepatic decompensation is a rare event during treatment of HCV infection with interferon a ± ribavirin in compensated cirrhotic patients. In an ongoing, controlled, randomized, partially-blinded HCV-treatment study of PEG-IFN alfa-2a ± ribavirin/placebo or IFN alfa-2a + ribavirin in 868 HIV/HCV-coinfected patients with (n=133) and without (n=735) liver cirrhosis, 14 hepatic decompensations were observed. All occurred in cirrhotic patients (14/133, 10.5%); 13 within 24 weeks after initiating HCV treatment. Baseline Child-Pugh score was ≥6 in 11 of the 14 patients and 5 in 3 of the 14 patients. Our purpose was to identify risk factors associated with hepatic decompensation. A univariate analysis compared baseline variables (demographics, laboratory parameters, antiretroviral treatment) in the 13 cirrhotic patients who decompensated within 24 weeks vs. the 120 other cirrhotics. Multiple logistic regression analysis was performed with all variables reaching p<0.2. Variables associated with hepatic decompensation in univariate analysis were: higher total bilirubin and alkaline phosphatase; lower albumin, hemoglobin and platelets; and didanosine treatment (p<0.05). In multivariate analyses, two four-variable models including bilirubin, hemoglobin, didanosine and either alkaline phosphatase or platelets had the highest likelihood score (chi-square) statistic. Age, sex, pretreatment weight, HIV or HCV viral loads, CD4+ count, and histological inflammation score did not exhibit predictive value. In conclusion, the risk associated with didanosine suggests a possible interaction with HCV treatment. The majority of risk factors associated with hepatic decompensation, however, are biological markers for advanced cirrhosis. Therefore, patients with early stage cirrhosis may not be at high risk of decompensation and should be considered for HCV treatment.

Presenting author: S Mauss

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1 Center for HIV and Hepatogastroenterology, Dusseldorf, Germany

2 University of Montpellier, France

3 Community Health Network, Rochester, NY

4 University of California, San Diego, CA

5 Mt. Sinai Medical Center, New York

6 Hoffmann-LaRoche Inc., Nutley, NJ, USA

2002-11-17
PL12-4

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