A study on the safety and tolerability of antiretroviral drugs prescribed in ART center of a rural-based tertiary care hospital

Abstract

Background: Human immunodeficiency virus (HIV) is a serious health problem worldwide. The mainstay treatment of HIV infected individuals is antiretroviral therapy (ART). Although ART is effective, it has its drawbacks as it is causes various adverse drug reactions (ADRs) which negatively affects patient compliance resulting in treatment failure. Various studies have been conducted in western population to study the adverse effects of ART, but such study in Eastern India is scanty. This study was conducted to fill the void and to help optimize treatment in this area. Aim and Objectives: The aim of the study was to find the incidence and type of ADRs among patients on antiretroviral drugs and to evaluate the severity assessment of the ADRs caused by them. Materials and Methods: Pre-structured case record form was used to collect information regarding demography, disease, treatment, etc., of 188 patients who came to the ART center after taking consent. ADRs were noted on the basis of patient complaints and changes diagnosed by the physician (if any) during routine visit. Descriptive statistical analysis was performed and inference drawn. Results: Most of the subjects followed Tenofovir-Lamivudine-Efavirenz regimen of whom 89% experienced at least one ADR, central nervous system (CNS) being the most affected. Followed by Zidovudine-Lamivudine-Nevirapine regimen of whom 96% presented with at least one ADR where gastrointestinal (GI) side effects were maximum. Common CNS side-effects were dizziness followed by insomnia. Common GI side effects was anorexia followed by nausea and vomiting. Most of them were mild in severity assessment scale. Conclusions: The study shows the ART regimens used by HIV patients and assess the ADRs caused by them. It helped to obtain information regarding demographic factors and disease pattern in this region. Further and more elaborate studies are needed to have proper insight and practical gains in this regard.