Monitoring adverse drug reactions in patients on TDF+3TC+EFV in a tertiary care hospital in Eastern India: a prospective observational study

Abstract

Background: Recently, the National Aids Control Organisation (NACO) in India advocated and recommended the use of tenofovir, lamivudine and efavirenz as a fixed-dose combination in initiating ART in all future treatment-naïve patients. The present study was thus undertaken to assess the nature and extent of safety concerns with this regime.Methods: A prospective observational study was carried out in the outpatient setting of nodal ART centre of Eastern India. A total of 242 patients on various ART regimens were studied for suspected ADRs over one year. Adverse event history, medication history and other relevant details were captured. Causality and severity of each reported ADR were duly assessed.Results: Out of 242 PLHIV put on this regimen, 75 patients did not encounter any adverse reactions during the entire study period. Out of remaining 167 patients who presented with a total of 451 ADRs, maximum ADRs were attributed to various psychiatric disorders which included insomnia, dizziness, drowsiness etc, which were followed by gastrointestinal disorders including anorexia, flatulence, nausea, vomiting etc. Dermatological complications included rashes, itching, SJS, pigmentation of nails, skin hyper pigmentation respectively.Conclusions: The study enables to obtain information on the pattern of adverse drug reactions associated with treatment naïve PLHIV put on first line antiretroviral regimen comprising of once daily dosing of tenofovir, lamivudine, efavirenz. Need of intensive monitoring for ADRs in ARTs followed with proper patient counselling regarding its nature can lead to better compliance to the therapy.

A Study on Adverse Drug Reactions in Patients on Antiretroviral Therapy in a Tertiary Care Hospital at Jaipur, Rajasthan

“…Generalized weakness, bodyache and muscle cramps/pain were common amongst various musculoskeletal complaints. A previous study done by Nikhil era et al 6 showed 10.2% of musculoskeletal complications on the same regimen.…”

“…Our study revealed that nervous system related complaints accounted for the maximum number of reported ADRs (47%), followed by GI disorder (23.9%), dermatological disorders (12.8%), and musculoskeletal disorders (7.6%). Study done by Nikhil Era et al 6 on monitoring adverse drug reactions in patients on TDF+3TC+EFV also observed that maximum ADRs were related to neuro psychiatric disorders (43.24%), gastrointestinal disorders (21.95%)and dermatological complications (9.97%). Aboubacar Alassane Oumar et al 9 in their study "Adverse Drug Reactions to Antiretroviral Therapy (ART): Prospective Study in HIV Infected Adults in Sikasso (Mali)" in 2017 also observed neurological ADRs in 40.4%, gastro intestinal in 35.8%, cutaneous in 18.3% and hematological disorder in 5.5% patients on various ART regimens in their study with a total of 61.2% ADRs in the 178 patients enrolled.…”