Failure of a short-term prednisone regimen to prevent nevirapine-associated rash: a double-blind placebo-controlled trial: the GESIDA 09/99 study.
OBJECTIVE
Rash is the most frequent adverse event associated with nevirapine. The use of prednisone has been controversial in this setting. A double-blind placebo-controlled study was performed to evaluate its efficacy in nevirapine-induced rash prevention.


METHODS
Multicentered, randomized, double-blind, placebo-controlled clinical trial with prednisone (30 mg/day x 2 weeks).


METHODS
HIV-1 infection; CD4 count >200 cells/mm3; plasma viral load (PVL) <5 log10 copies/ml; nevirapine (200 mg/day x 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).


CONCLUSIONS
Short-term prednisone administration does not prevent nevirapine rash, but might even increase its incidence.
Knobel
H
H
Department of Internal Medicine-Infectious Diseases, Hospital del Mar, Barcelona, Spain. hernando@intercom.es
Miró
J M
JM
Domingo
P
P
Rivero
A
A
Márquez
M
M
Force
L
L
González
A
A
De Miguel
V
V
Sanz
J
J
Boix
V
V
Blanco
J L
JL
Locutura
J
J
D000328:Adult; D004311:Double-Blind Method; D004342:Drug Hypersensitivity / Q000517:prevention & control*; D005076:Exanthema / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects*; D010919:Placebos; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects*
D010919:Placebos; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D011241:Prednisone