Background: Efavirenz (EFV) is one of the latest antiretroviral compounds appeared in the market. Its toxicity profile is not well known.
Patients and 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.
Conclusion: 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