[Toxicity associated to efavirenz in HIV-infected persons enrolled in an expanded access program].
BACKGROUND
Efavirenz (EFV) is one of the latest antiretroviral compounds appeared in the market. Its toxicity profile is not well known.


METHODS
The rate of adverse events was examined in 250 subjects enrolled in the expanded access program in a single institution located in Madrid, Spain.


RESULTS
Adverse events grade >= 2 (WHO) were recorded in 33 (13.2%) persons. The most common were neuropsychiatric disorders (8.4%), cutaneous lesions (3.2%), and gastrointestinal problems (0.8%). The drug needed to be discontinued in 17 (6.8%) patients.


CONCLUSIONS
The rate of adverse events grade moderate-to-severe in patients receiving EFV is relatively low (13. 4%), without evidence of cross-toxicity (i.e., rash by nevirapine). Neuropsychiatric and dermatological conditions are the most common, and ten to resolve spontaneously in two
Dona
C
C
Servicios de Enfermedades Infecciosas y aFarmacia. Hospital Carlos III. Instituto de Salud Carlos III. Madrid.
Soriano
V
V
Barreiro
P
P
Jiménez-Náchera
I
I
González-Lahoz
J
J
D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects*; D048588:Benzoxazines; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010078:Oxazines / Q000009:adverse effects*
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; C098320:efavirenz