Do
Sex and CD4 Count Predict Risk of Nevirapine (Viramune) Side Effects?
Boehringer Ingelheim has issued a warning about the use of its non-nucleoside
reverse transcriptase inhibitor nevirapine
(Viramune), advising that the drug should not be prescribed for
patients with increased risk of toxicity based on sex and CD4 cell count cut-offs.
According to current
U.S. treatment guidelines, nevirapine is not recommended
for women with a CD4 count above 250 cells/mm3 or men with more than
400 cells/mm3. It is thought that individuals with stronger immunity
are more prone to nevirapine-induced hypersensitivity reactions such as skin rash
and liver toxicity.
The aim of the present study, published in the January issue of HIV Medicine, was to determine whether
these recommendations are of use in
preventing nevirapine side effects.
The retrospective analysis included antiretroviral drug-naive patients
who started treatment with nevirapine. Patients were divided into 2 groups: those
with high CD4 counts (women >250 cells/mm3; men > 400 cells/mm3)
and those with low CD4 counts (women < 250 cells/mm3; men < 400
cells/mm3).
Results
- 142 patients
were included in the study, 61 in the high CD4 group and 81 in the low CD4 group.
- Skin rash
developed in 6.56% of patients in the high CD4 group and 14.81% of patients in
the low CD4 group (P = 0.18).
- Hepatotoxicity
developed in 4.92% and 6.17% of patients with high and low CD4 cell counts, respectively
(P = 1.0).
Conclusion
Based on their findings, the study authors concluded, “The recommendations not to use nevirapine in drug-naive patients
at increased risk of toxicity on the basis of gender and CD4 cell count do not
seem to be of use in preventing the occurrence of side effects.”
“However,” they added “[only] a small number of patients were included
in this study, and hence the possibility cannot be excluded that the recommendations are appropriate in another clinical practice
setting.”
Department
of Internal Medicine-Infectious Diseases and Department of Internal Medicine-Pharmacy,
Hospital del Mar, Barcelona, Spain.
02/01/08
Reference
H Knobel, A Guelar, M Montero, and others. Risk of
side effects associated with the use of nevirapine in treatment-naïve patients,
with respect to gender and CD4 cell count HIV
Medicine 9(1): 14-18. January 2008.
