Adverse drug reactions to nonnucleoside reverse transcriptase inhibitor-based antiretroviral regimen: a 24-week prospective study

Abstract

Background: Few studies have addressed the issue of adverse drug reactions with non-protease inhibitor (PI)-based antiretroviral therapy (ART) in resource-constrained settings. We studied prospectively the incidence of adverse drug reactions with generic ART among our patients.

Methodology: A total of 100 HIV-infected individuals were recruited. Patients received nevirapine (NVP) or efavirenz (EFV) with lamivudine (3TC) and zidovudine (ZDV)/stavudine (d4T). They were followed for 6 months for evidence of adverse drug reactions.

Results: The mean CD4 count was 114.09 +/- 60.07 cells/mm(3) (range, 12-232 cells/mm(3)). Transient gastrointestinal symptoms were most frequent. Fourteen individuals (12 receiving ZDV/d4T, 3TC, NVP and 2 receiving ZDV/d4T, 3TC, EFV) developed skin rash. Among patients receiving NVP, 25.7% developed grade 1 hepatotoxicity. Three patients had numbness in both lower limbs. Among those individuals who received EFV, 32.3% individuals had central nervous system (CNS) symptoms in the form of insomnia, vivid dreams, dizziness, and drowsiness.

Conclusion: As the developing world increasingly uses generic ART, the clinician must be constantly vigilant for treatment-related adverse events.