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Knobel Hernando; Miró, José M.; Domingo, Pere; Rivero, Antonio; Márquez, Manuel; Force, Luis; González, Alicia; De Miguel, Verónica; Sanz, José; Boix, Vicente; Blanco, José Luis; Locutura, Jaime; the GESIDA 0999 Study Group
JAIDS Journal of Acquired Immune Deficiency Syndromes: September 1st, 2001
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Objectives:Rash is the most frequent adverse event associated with nevirapine. The use of prednisone has been controversial in this setting. A double-blind placebocontrolled study was performed to evaluate its efficacy in nevirapine-induced rash prevention.

Design:Multicentered, randomized, double-blind, placebo-controlled clinical trial with prednisone (30 mg/day × 2 weeks). Inclusion criteria: HIV-1 infection; CD4 count >200 cells/mm3; plasma viral load (PVL) <5 log10 copies/ml; nevirapine (200 mg/day × 2 weeks, followed by 200 mg twice daily) plus stavudine and didanosine. Clinical follow-up was performed at 15, 30, and 60 days and thereafter every 2 months.

Results:In all, 75 evaluable patients were enrolled (39 prednisone/36 placebo). Median baseline CD4+ cell count was 390 cells/mm3 and PVL, 20,200 copies/ml. Overall, nine cases of rash (12.5%) were detected, seven (18%) in the prednisone group and two (5.5%) in the placebo group (odds ratio [OR], 3.85; 95% confidence interval [CI], 0.65-29.3; p = .11). Incidence of moderate-to-severe rashes leading to nevirapine withdrawal was 13.5% (5 of 37) in the prednisone group and 3% (1 of 35) in the placebo group (p = .2). Median time to rash in both groups was 16 days. Adverse events that motivated withdrawal of therapy appeared in 6 patients from the prednisone group (15.4%) and 3 from the placebo group (8.3%) (p = .3).

Conclusion:Short-term prednisone administration does not prevent nevirapine rash, but might even increase its incidence.

Address correspondence and reprint requests to Hernando Knobel, Department of Internal Medicine-Infectious Diseases, Hospital del Mar, Paseo Maritimo 25-29, 08003 Barcelona, Spain; e-mail: hernando@intercom.es

Presented in part at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), American Society for Microbiology, Toronto, Ontario, Canada, September 17-20, 2000 [Late breaker abstract L-15].

Manuscript received May 5, 2001; accepted June 28, 2001.

© 2001 Lippincott Williams & Wilkins, Inc.