5th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 8–11 July 2003, Le Meridien Montparnasse, Paris, France

RISK FACTORS FOR HEPATIC DECOMPENSATION IN CIRRHOTIC PATIENTS WITH HIV/HCV CO-INFECTION TREATED WITH PEGYLATED INTERFERON-α OR INTERFERON-α AND RIVBAVIRIN, OR PLACEBO

Antiviral Therapy 2003; 8:L4 (abstract W2)

S Mauss¹, D Larrey², W Valenti³, F Torriani⁴, D Dieterich⁵, S. Passe, L Cupelli⁶, J Solsky⁶, J DePamphilis⁶ and the APRICOT Study Group
¹Private Practice, Duesseldorf, Germany; ²University Montpelier, Montpelier, France; ³Community Health Network, Rochester, NY, USA; ⁴University of California at San Diego, San Diego, CA, USA; ⁵New York University, New York, NY, USA; and ⁶Hoffmann-La Roche, Inc., Nutley, NJ, USA

Hepatic decompensation is a rare event during treatment of HCV infection with interferon alpha (IFN-α) ±ribavirin in compensated cirrhotic patients. In an ongoing controlled, randomized, partly-blinded HCV treatment study of pegylated (PEG)-IFN-α-2a ±ribavirin/ placebo or IFN-α-2a+ ribavirin in 868 HIV/HCV co-infected patients with (n=133) and without (n=735) liver cirrhosis, 14 hepatic decompensations were observed. All occurred in cirrhotic patients (14/133, 10.5%) and 13/14 within 24 weeks after initiating HCV treatment. Baseline Child-Pugh score was ≥6 in 11/14 patients and 5 in 3/14 patients. Our purpose was to identify risk factors associated with hepatic decompensation. A univariate analysis compared baseline variables (demographics, laboratory parameters and 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, haemoglobin and platelets; and didanosine treatment (P<0.05). In multivariate analysis, two four-variable models including bilirubin, haemoglobin, didanosine and either alkaline phosphatase or platelets had the highest likelihood score (chi-square) statistic. Age, sex, pre-treatment 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

2003-07-08
W2

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