title: Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study.
abstract: OBJECTIVE
  To identify the adverse drug reactions (ADRs) to antiretroviral therapy (ART) and to assess their impact on treatment compliance in patients with HIV/AIDS.
  
  
  METHODS
  Two hundred and thirty-five (235) AIDS patients who received ART were monitored for ADRs over a period of 6 months. The incidence and nature of ADRs occurring with different ART regimens were recorded. We also assessed the severity, causality as well as the impact of ADRs on the patients' compliance.
  
  
  RESULTS
  Of 235 patients receiving ART, 90.6% patients experienced ADRs. A total of 618 ADRs involving various systems were observed. A majority were related to gastrointestinal (42.39%) and central nervous (25.57%) system. 23.1% ADRs were severe in intensity. Severe ADRs occurred in 41 out of 235 (17.4%) patients necessitating drug withdrawal. A majority of the patients (87.8%) who complained of severe ADRs received combination of stavudine, lamivudine and nevirapine. Causality assessment revealed 6.63% ADRs were probable and 93.3% ADRs were possible. Non-compliance due to ADRs was observed in 28.9% patients.
  
  
  CONCLUSIONS
  Myriad ADRs are associated with ART which leads to poor patient compliance. With the increasing access to ART in India, it is prudent that antiretroviral drugs are used judicially with regular monitoring of ADRs.
authors.affiliation: Department of Pharmacology, Maulana Azad Medical College and associated Lok Nayak Hospital, Delhi, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Nagpal
authors.forename: Vandana
authors.initials: V
authors.lastname: Tayal
authors.forename: Suresh
authors.initials: S
authors.lastname: Kumar
authors.forename: Usha
authors.initials: U
authors.lastname: Gupta
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D002493:Central Nervous System Diseases / Q000139:chemically induced*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D007194:India; D019259:Lamivudine / Q000009:adverse effects; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects; D012720:Severity of Illness Index; D018119:Stavudine / Q000009:adverse effects; D062606:Tertiary Care Centers
chemical_list: D019380:Anti-HIV Agents; D019259:Lamivudine; D019829:Nevirapine; D018119:Stavudine