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


METHODS
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.


CONCLUSIONS
As the developing world increasingly uses generic ART, the clinician must be constantly vigilant for treatment-related adverse events.
Jena
Anupam
A
Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Sachdeva
Ravinder K
RK
Sharma
Aman
A
Wanchu
Ajay
A
D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000480:Alkynes; D001066:Appetite / Q000187:drug effects; D048588:Benzoxazines / Q000008:administration & dosage / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D003521:Cyclopropanes; D004244:Dizziness / Q000139:chemically induced; D004325:Dreams / Q000187:drug effects; D004359:Drug Therapy, Combination; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D006987:Hypesthesia / Q000139:chemically induced; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D012894:Sleep Stages / Q000187:drug effects; D018119:Stavudine / Q000008:administration & dosage / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects
D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine; C098320:efavirenz