Fifth International Congress Drug Therapy in HIV Infection 22-26 October, 2000 Glasgow, UK

NEVIRAPINE-INDUCED LIVER TOXICITY: A PROSPECTIVE COHORT STUDY

E. Martínez¹, J.A. Arnaiz², A. Cruceta¹, J.B. Pérez-Cuevas¹, A. Mocroft³, X. Carné² and J.M. Gatell^1
1Dept. of Infectious Diseases, Hospital Clinic, Barcelona, Spain; ²Clinical Pharmacology Unit-Hospital Clínic, Barcelona, Spain; ³HIV Research Unit, Royal Free Medical School, London, UK

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.5
AIDS 2000, Oct 22-26;14(Suppl. 4);S11

BACKGROUND: Nevirapine (NVP) is a potent and reasonably well tolerated NNRTI. Recently, a warning has been added to the product information advising to monitor liver function tests (LFT) during first weeks of therapy.

OBJECTIVE: To assess the incidence of LFT abnormalities and clinical hepatitis associated with NVP-containing HAART within a prospectively followed cohort of HIV-infected patients.

METHODS: All consecutive patients who initiated a NVP-containing HAART from 9/97 to 5/00. The databases with clinical data and laboratory results (ASAT, ALAT, GGT, alkaline phosphatase (AP), bilirubin, serology for HBV and HCV) were matched.

RESULTS: NVP was prescribed to 706 of the 4352 patients of the clinical database. 610 had baseline information, underwent at least one further clinical laboratory evaluation and were included in the study. Median follow-up and exposure to NVP were 12 and 9 months respectively. Twelve patients (2%) died, 32 (5.2%) were lost to follow-up while on NVP and 239 (39%) stopped NVP before the end of the study. 13/610 patients (2%) stopped NVP for liver toxicity and the remaining for other reasons, mainly virological failure (13%) or skin toxicity (9%). The number and proportions of patients with a 3-fold increase in ALAT, ASAT or GGT and Kaplan–Meier estimates at different time points are shown in Table PL8.5.

There were seven cases of clinical hepatitis (incidence rate: 1.2 cases per 100 person-years), 6 of them in patients with chronic liver disease due to HCV, developing from 20 to 270 days (median 60) after initiating NVP. There were no cases of fulminant hepatitis or deaths due to liver failure. Independent risk factors for 3-fold increase of ALAT or ASAT were elevated baseline ALAT (P = 0.013), seropositivity for HCV (P = 0.0024) and duration of exposure to antiretrovirals (P = 0.022).

CONCLUSIONS: NVP was generally well tolerated. Clinical hepatitis seldom appeared and other underlying factors might be related. Abnormalities in ALAT or ASAT increased steadily along first year of therapy, but they were mainly asymptomatic. LFT monitoring during first 1–2 months of therapy does not seem to be justified.

Presenting author: E. Martínez

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2000-10-22
PL8-5

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