A Prospective Study of Adverse Drug Reactions to Antiretroviral Therapy in a Tertiary Care Hospital at Allahabad, Uttar Pradesh

Abstract

Introduction: Human Immunodeficiency Virus has a significant disease burden globally. India has a large proportion of the global HIV infected patients. The state of Uttar Pradesh had 7500 new cases in 2015. Antiretroviral therapy is the cornerstone of treatment of HIV. These drugs are highly toxic and lead to diverse adverse drug reactions. The present prospective study was done to study the occurrence of adverse drug reactions and analyse the associated factors. Material and Methods: The present study was conducted at Antiretroviral Therapy Centre, Swarup Rani Nehru Hospital at Allahabad, Uttar Pradesh. Patients were enrolled for two months and followed up monthly over a period of six months. A pretested interview schedule was administered to the study subjects. Information regarding socio-demographic profile, drug regimen and occurrence of adverse drug reactions was collected. Causality assessment was done by Naranjo's criteria. Bivariate and multivariate logistic regression was done to analyse the association of selected variables with the occurrence of adverse reactions. Results: This study enrolled 163 participants and 152 participants completed the study. During the study period, 94 participants reported occurrence of at least one ADR. A total of 334 ADRs were reported among them. TLE regimen constituted 66.4% of adverse reactions. Central nervous system was most commonly involved (34.4%). By Naranjo's scale, majority of ADRs (61.6%) were categorised as "possible". Multi-variate analysis showed statistically significant association of occurrence of ADR with higher clinical staging of the patient. Conclusion: Tenofovir based regimen was most commonly associated with ADRs. Rigorous monitoring is essential to prevent future events and improve safety.

Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)

“…Ceftriaxone has been implicated for the highest number of deaths in the Iranian database also [39]. A study on ADRs due to antimicrobial agents reports TLE-based regimens accounting for 66.9% of the total ADRs but do not mention any fatal reaction [40]. We must keep in mind that antiretroviral therapy is relatively safe, and, 5-40.8% of death in patients with human immunodeficiency virus (HIV) occur within the first six months of initiating treatment and could be due to advanced clinical stage of the disease, low baseline CD4 count predisposing to infections, and poor treatment adherence [41].…”