8th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV San Francisco, California - September 24 - 26, 2006

RISK OF HEPATOTOXICITY IN VIROLOGICALLY SUPPRESSED HIV PATIENTS SWITCHING TO NEVIRAPINE ACCORDING TO GENDER AND CD4 COUNT

Antiviral Therapy 2006; 11:L8 (abstract no. 9)

E De Lazzari, A León, JA Arnaiz, E Martinez, JM Mallolas, JL Blanco, M Laguno, M Larrousse, A Milinkovic, M Lonca and JM Gatell
University of Barcelona, Barcelona, Spain

BACKGROUND: There is an increased risk of hepatotoxicity in antiretroviral-naïve patients starting a nevirapine-containing combination antiretroviral therapy (NcART) with high CD4 counts. It is not known whether this higher risk also applies to virologically suppressed patients.

METHODS: Meta-analysis of all randomized studies in which virologically suppressed patients were switched to a NcART and have a follow-up = 3 months. CD4 was classified as high (HCD4) (≥400/mm³/250/mm³; male/female respectively) or low (LCD4). Main endpoint was hepatotoxicity defined as elevation of ALAT or ASAT above 200 if normal at baseline or ≥3 fold increase if abnormal at baseline within first 3 months. Mortality, symptomatic hepatitis and rash were also evaluated. The combined estimates were assessed by a random-effects meta-analysis.

RESULTS: Four studies with a pooled total of 410 patients were included (133 in the LCD4 and 277 in the HCD4 groups respectively. The risk of hepatotoxicity was 2% and 4% in the LCD4 and HCD4 groups, with an overall OR of 1.46 (95% CI: 0.43–4.98; P=0.54). The overall OR for hepatotoxicity or rash was 1.17 (95% CI: 0.56–2.42; P=0.68). No patients died and 2 patients (1%) in the HCD4 group developed a symptomatic hepatitis. Only a baseline elevation of transaminases was associated (P=0.08) with an increased risk of hepatotoxicity. The risk of hepatotoxicity at any moment during the evolution was also similar in both groups with a combined HR of 0.854 (95% CI 0.3–2.5; P=0.80). Differences in hepatotoxicity ≥8% would have been detected with a power of 80% and P<0.05 if existed.

CONCLUSIONS: Contrary to naïve patients, virologically suppressed patients do not have a higher risk of hepatotoxicity or rash when stratified by gender and CD4 count.

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2006-09-24
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