Abstract

Background and Objectives: Antiretroviral therapy (ART) has been proved efficacious in reducing morbidity and mortality related to Human Immunodeficiency Virus (HIV) infection, however, also associated with long and short term drug induced toxicities. This study was conducted to monitor the adverse drug reactions (ADRs) associated with various antiretroviral drug regimens, its causality, severity and preventability assessment in patients receiving ART. Methods: Using a prospective observational study design, 280 patients were enrolled for the study. The ADR monitoring was carried out for a period of one year (December 2015 – November 2016) in patients living with HIV (PLHIV) and receiving ART from an outpatient setting of nodal ART centre of Rajendra Institute of Medical Sciences, Ranchi (Jharkhand). Results: A total of 280 patients were monitored by active surveillance. Out of them 228 patients identified of at least one or more ADRs. The most number of ADRs were observed with ZLN (Zidovudin + Lamivudin + Nevirapin) and ZLE (Zidovudin + Lamivudin + Efavirenz). The ADRs commonly found, GIT side effects (29%), CNS side effects (27%) and anaemia (25%). Tenofovir based regimens was safer than ZLN and ZLE. Conclusion: Type of antiretroviral regimen and time since initiation of ART were associated in causality of related adverse reactions. This study addressed the added morbidity among HIV patients taking ART. With the increasing incidence of ADRs associated with antiretroviral chemotherapy, it requires proper monitoring and reporting to intervene at an early stage and modify the antiretroviral drug regimen (ARV) as per.