[53] SHORT-TERM TOLERANCE OF EFAVIRENZ IN HIV-INFECTED AFRICAN ADULTS PARTICIPATING IN THE TRIVACAN ANRS 1269 TRIAL, ABIDJAN, CÔTE D’IVOIRE

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] SHORT-TERM TOLERANCE OF EFAVIRENZ IN HIV-INFECTED AFRICAN ADULTS PARTICIPATING IN THE TRIVACAN ANRS 1269 TRIAL, ABIDJAN, CÔTE D’IVOIRE

[AUTHOR(S):] C Danel¹, R Moh¹, E Messou¹, A Minga¹, C Seyler¹, D Sauvageot¹, X Anglaret³, E Bissagnene² and R Salamon³ for the ANRS 1269 Study Group
¹Programme PAC-CI, Abidjan, Côte d’Ivoire; ²Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d’Ivoire; and ³INSERM U 593, Université Bordeaux 2, France

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 53
Antiviral Therapy 2003; 8(Suppl. 1):S196

[ABSTRACT:] Background: Adverse effects to efavirenz are frequent but mostly transitory. Data on efavirenz tolerance in sub-Saharan Africa are scarce.

Objective: To describe short-term tolerance of efavirenz in patients included in a therapeutic trial in Abidjan.

Methods: The Trivacan Structured Treatment Interruption (STI) trial started on December 26, 2002. 840 antiretroviral naïve HIV-infected adults with 150< CD4 <350/mm³ will be enrolled in a first phase of continuous treatment. After 6 months, patients with immuno-virological success will be randomised into three arms, including two different STI strategies. We describe data on efavirenz tolerance in patients participating in the first phase.

Results: As of March 4, 2003, 132 adults were enrolled. At inclusion 118 of them (67% women, baseline median CD4 count 237/mm³) were prescribed AZT-3TC-efavirenz. All patients enrolled for at least one month (n=46) had attended the first-month scheduled visit. The most frequent selfreported symptoms were dizziness (n=33 patients), nausea (n=32), headache (n=23), nightmare (n=20), and insomnia (n=16). Two patients spontaneously interrupted efavirenz because of dizziness (n=1) and nausea (n=1) but reintroduced it successfully thereafter. No grade 3 or 4 and only one transient grade 2 (facial oedema) adverse events were notified. There was no treatment modification.

Discussion: In these preliminary data from adult patients receiving efavirenz in trial conditions (counselling on compliance), subjective symptoms were frequently self-reported, but no severe adverse event was notified and no treatment modification decided. Data available on June 2003 (350 patients) will be presented at the conference.

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