Adverse Drug Reactions To Highly Active Antiretroviral Therapy (HAART): First Pharmacovigilance Study in HIV Positive patients using HAART

This was a Retrospective Case-Control study conducted at the Antiretroviral department, Rajiv Gandhi Institute of Medical Sciences(RIMS),Kadapa,India.The study was conducted to assess the incidence, prevalence, severity pattern, predictability, preventability of adverse drug reactions (ADRs) to HAART, and to identify the risk factors for ADRs in HIV-positive patients receiving HAART. Patients between 2010 and May 2011 newly registered HIV patients on HAART therapy of either sex were included. Demographic details, occupations details, education, CD4 cell count, weight and hemoglobin (Hb),Laboratory data, drugs used and suspected ADRs observed were collected.This is the First Retrospective Case-Control study that was designed to evaluate the incidence of ARV therapy-induced ADRs in Indian HIV-positive patients.