EVALUATION OF THE ADVERSE REACTIONS OF ANTIRETROVIRAL DRUG REGIMENS IN A TERTIARY CARE HOSPITAL IN KOLKATA: A PROSPECTIVE OBSERVATIONAL STUDY

Abstract

Avishek Banerjea1, Saugata Ghosh2, Sourav Chakraborty3, Amit Kumar Ghosh4

BACKGROUND
The introduction of Highly Active Antiretroviral Therapy (HAART) has led to a significant decrease in AIDS-related mortality and morbidity. However, adverse reactions to these drugs, being inevitable, have led to major obstacles in its success, especially in developing nations like India. Moreover, the latest changes made by W.H.O. in the treatment guidelines of ART naive patients would expectedly lead to changes in the Adverse Drug Reaction (ADR) patterns as well. Hence, this study aimed at evaluating the ADRs of currently prescribed ART regimens in a tertiary care hospital in Kolkata (WB).
METHODOLOGY
168 ART naive patients enrolled initially were studied prospectively over a period of 1 year; each patient being followed up individually for 6 months. All patients were asked to visit the ART centre once a month or whenever they developed any symptom. They were screened clinically and investigated suitably by the physician according to the latest NACO guidelines.
RESULTS
Majority were males (56%) with an M:F ratio of 1:0.774; 93.3% patients belonging to the 15-49 yrs. age group. TDF+3TC+EFV (56%) was the commonest 1st line regimen prescribed. 76.6% patients experienced ADRs. Total 184 ADRs were noted, of which, GIT contributed the most (27.17%). Majority (66.67%) of neurological ADRs was contributed by neuropsychiatric manifestations. Rash (10.3%) was the commonest cutaneous ADR. Anaemia (13.6%) was the commonest haematological ADR with a statistically significant female preponderance. Most ADRs were grade 1 (63.04%). Majority ADRs were “possible” (65.76%) while 34.24% were “probable” by Naranjo scale. Maximal ADRs (48.37%) were noted from patients under AZT+3TC+NVP regime. IRIS was observed as a paradoxical reaction to ART in 10% cases.
CONCLUSION
It should not be forgotten that ADRs are the inevitable consequence of pharmacotherapy. Hence, proper implementation of current protocols designed for screening of patients especially during the initial months of therapy may help in earlier detection of ADRs and thus help in preventing serious/life threatening consequences.

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