title: Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital.
abstract: BACKGROUND
  The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients.
  
  
  OBJECTIVE
  The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects.
  
  
  METHODS
  Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale.
  
  
  RESULTS
  Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were 'probable' and 33.96% were 'possible'.
  
  
  CONCLUSIONS
  Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.
authors: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors: Anshu Kumar
authors: AK
authors: Jha
authors: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors: Akash
authors: A
authors: Gadgade
authors: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors: Ashok K
authors: AK
authors: Shenoy
authors: Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors: Mukta N
authors: MN
authors: Chowta
authors: Department of Medicine, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
authors: John T
authors: JT
authors: Ramapuram
keywords: Adverse events; HIV; anti-retroviral therapy
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