Assessment of adverse drug reactions to antiretroviral agents among HIV patients

Objective: The objective of the study was to determine the causality, predictability, preventability and severity of Adverse Drug Reactions (ADRs) among Human Immunodeficiency Virus (HIV) positive patients who are on Highly Active Antiretroviral Therapy (HAART). Method: All spontaneous ADRs to Anti Retroviral Agents were collected over a period of three years (July 2012–June 2015) from two Anti Retroviral Therapy (ART) centers in Mysore city, Karnataka. Predictability was assessed based on previous history on exposure to the drug or literature incidence of ADRs, preventability was assessed by using modified Schumock and Thornton scale, causality was assessed by WHO probability scale and severity was assessed by using modified Hartwig and Siegel Scale. Results: A total of 1120 ADRs were documented in the study period. Majority (94.5%) of reactions were predictable. However, 72.5% of reactions were preventable (29.5% definitely preventable, 43% probably preventable). Among all the reactions, only 34.8% was assessed to be mild and 6.4% of reactions were severe. On causality assessment 74.5% of ADRs were found to be probable in nature. Conclusion: Majority of the ADRs in HIV patients are predictable and many of these reactions may also be preventable. Even though, we may not be able to prevent all predictable ADRs, the goal should be to increase awareness on ADRs and encourage early detection and intervention by conducting similar studies in understanding the ADRs and to minimize patient discomfort which results in medication non-adherence.