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Risk
Factors and Occurrence of Rash in HIV-positive Patients with Low
CD4 levels (< 50) Not Receiving NNRTIs
Most of the studies evaluating rash in HIV-positive patients have
focused on non nucleoside reverse transcriptase inhibitors (NNRTI),
particularly nevirapine, and little is known about the occurrence
of rash and the risk factors for its development in patients receiving
regimens not based on NNRTI.
In this study, researchers evaluated all cases of rash observed during
a 48-week randomized multicentre trial in 1251 nucleoside-experienced
patients who started treatment with protease inhibitors (ritonavir
or indinavir) at CD4 counts below 50 cells/mL.
Incidence rates for rash were calculated according to gender, clinical
status, age, use of highly active antiretroviral therapy (HAART),
Pneumocystis carinii pneumonia (PCP) prophylaxis and use
of individual antiretroviral drugs at enrolment. Differences between
groups defined according to the above characteristics were tested
for statistical significance using the log-rank test in a Kaplan-Meier
survival analysis.
All factors that gave results in the univariate analyses below the
significance level of 0.05 were included in a multivariate analysis
using a Cox regression model.
Results
During a follow-up period of 9690 person-months, 66 patients (5.3%)
developed rash (0.68 events/100 person-months). In the univariate
analyses, risk of rash did not differ with trial treatment (indinavir
or ritonavir), clinical status, PCP prophylaxis, or age.
During follow-up, rash was observed in 7.5% of enrolled women and
in 4.5% of enrolled men (P=0.03). Serious rash occurred in
4.5% of enrolled women and in 1.6% of enrolled men (P=0.003).
Use of HAART (P<0.001) and inclusion of zidovudine and
of zalcitabine in the prescribed regimen (P=0.02) appeared
to be associated with a lower risk of rash. In the multivariate
analysis, the variables that remained significantly predictive of
rash were gender (risk for women compared to men: 1.65, 95% confidence
interval (CI): 1.00–2.72, P=0.048) and use of a non-HAART
regimen (risk for non-HAART patients compared to HAART: 2.73, 95%
CI: 1.49–5.02, P=0.001).
Conclusions
In this study, about 5% of HIV-positive patients who started treatment
with protease inhibitors at very low CD4 counts developed rash,
generally in the first few weeks after treatment.
Risk was significantly higher in women and in patients who did not
receive a HAART regimen. Our data indicate that women have a higher
risk of rash than men, also with regimens that do not include NNRTI.
03/29/04
Reference
M Floridia and others. Risk factors and occurrence of rash in
HIV-positive patients not receiving non nucleoside reverse transcriptase
inhibitor: data from a randomized study evaluating use of protease
inhibitors in nucleoside-experienced patients with very low CD4
levels (<50 cells/mµL). HIV Medicine 5(1): 1-10. January 1, 2004.
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