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

PREVENTION OF NEVIRAPINE-ASSOCIATED EXANTHEMA USING SLOW DOSE ESCALATION, ANTIHISTAMINICS OR CORTICOSTEROIDS

P. Barreiro, V. Soriano, E. Casas², M. Tellez¹, V. Estrada¹, R. Hoetelmans³, I. Jiménez-Nácher⁴ and J. González-Lahoz
Service of Infectious Diseases and ⁴ Pharmacy, Instituto de Salud Carlos III, ¹ Hospital Clinco and ² Hospital Principe de Asturias, Madrid, Spain; ³ Department of Pharmacy and Pharmacology, Slotervaart Hospital, Amsterdam, The Netherlands

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.2
AIDS 2000, Oct 22-26;14(Suppl. 4); S12

The appearance of a rash is one of the most frequent and limiting side effects during the first 4 weeks of treatment with nevirapine (NVP). We explored the efficacy and safety of four different strategies for reducing the incidence of this complication.

Five-hundred and sixty-two patients were randomly assigned to accomplish the induction phase of NVP following either the standard (std) recommendation of 200 mg daily during the first 2 weeks (n=166), or any of four new strategies: i) adding loratadine 10 mg/12h during the first 2 weeks (n=93), ii) adding prednisone 50 mg each other day during the first 2 weeks (n=93), iii) using an slow escalating dosing, beginning with 100 mg daily the first week, and increasing the dose 100 mg weekly up to the full daily dose of 400 mg (n=107), and iv) combining both the addition of prednisone with the slow escalating dosing (n=103). A pharmacokinetic substudy was performed in 8 patients receiving 100 mg of NVP during the first week.

The incidence of rash and NVP discontinuation standard recommendation and the alternative approaches was:

Table PL9.2.

P values compare the standard induction of NVP with the different new interventions. NVP plasma concentrations within the first week of treatment using 100 mg daily were above the IC₉₀ for wild type HIV-1 in all instances.

In conclusion, the incidence of rash complicating the first few weeks of treatment with NVP can be diminished adding corticosteroids or antihistaminics for two weeks to the standard recommendation, or using a slow escalating dosing. This third approach is proven to be pharmacokinetically safe.

Presenting author: P. Barreiro

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2000-10-22
PL9-2

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