Study of Adverse Drug Reactions Associated with Antiretroviral Agent At Government General Hospital & GMC, Anantapur

Objectives: To study the adverse drug reactions (ADRs) associated with antiretroviral agents (ARVs) in HIV positive patients.

Methods: The present study was a prospective observational study conducted at Government General Hospital, Anantapur from JUNE 2014 – JUNE 2015 (for one year period).  Qualified Pharmacologist monitored all the in – patients receiving ARVs during the study period for suspected adverse reactions.   WHO causality assessment scale, Modified Hartwig & Seigel scale and Modified Schumock & Thornton scales were applied to assess the causality, severity and preventability  of the reported ADRs respectively.  All cases and assessments were further reviewed by senior Pharmacologist & Head of the Department of STI.

Results: During the study period,  94 ADRs were observed in 71 patients.  As per WHO scale, 80 ADRs were probable and 14 were possible.  Based on the severity assessment, 10 ADRs were mild, 80 ADRs were moderate and 4 ADRs were severe in nature.  Among the reported  ADRs, 70  were definitely preventable and 24 were probably preventable.  Antiretroviral drugs responsible for ADRs were Zidovudine (46), Stavudine (21), Nevirapine (10), Effavirenz (10), Lamivudine (5), Tenofovir (1), and Retonvir (1),.  Among the reported ADRs, major ADRs were Anemia (25), Skin rashes (10), Hepatitis (10), Vomiting (10), Lactic acidosis (9), IRIS (5).