Background: Acquired immunodeficiency syndrome (AIDS) is a disease of the human immune system caused by the human immunodeficiency virus (HIV). Objective of this study was to evaluate the adverse drug reaction profile of anti-retroviral drugs in HIV patients in terms of causality, severity and preventability.
Methods: Patients newly started on ART were followed prospectively for a period of initial six months and were interviewed in person during their routine follow-up or visit following development of any ADRs. ADRs were screened clinically and investigated accordingly for causality, severity and preventability.
Results: Out of 59 cases, zidovudine+lamivudine+nevirapine (ZLN) was the most commonly used ART regimen. A total 122 ADRs involving various systems were observed in these patients; majority being related to gastrointestinal system (54.10%). Most of these ADRs were observed in the ZLN regimen followed by the stavudine+lamivudine+nevirapine (SLN) regimen. On causality assessment in ZLN regimen, 74.58% of ADRs were possible, while 25.42% were probable. Severity assessment showed that most of the ADR were mild whereas on preventability assessment it was observed that most of the ADRs were not-preventable.
Conclusions: Antiretroviral drugs are not solely responsible for the ADRs due to these medications; various co-morbid and predisposing conditions share the responsibility. An efficient pharmacovigilance is imperative by means of improving ADR reporting and monitoring, in order to improve compliance and acceptability of ART.
ADRs, AIDS, Antiretroviral therapy, Causality, Pharmacovigilance, Preventability, Severity