A retrospective study to determine adverse effects of anti-retroviral agents in tertiary care hospital in Central India

The introduction of Highly Active Anti-retroviral Therapy (HAART) has led to significant reduction in AIDS related morbidity & mortality. The majority of drugs available today are costly & have serious adverse effects, undesirable drug interactions & have to be taken lifelong. Though Anti-retroviral Therapy (ART) has increased lifespan of HIV positive patients, adverse drug reactions (ADRs) of this therapy still remains a major concern.

To collect demographic details & to assess incidence & causality of ADRs in HIV positive patients receiving ART.

A retrospective observational study was carried out for a period of 18 months (1^st January 2014 to 30^th June 2015) at Government Medical College & Hospital, Nagpur. The ADRs reported by physician were collected, analysed & causality assessment was done.

Out of 85 patients evaluated, 58 (68.3%) were females. ADRs reported were rash (40.6%), anemia (26.0%), nausea (16.7%), dizziness (6.3%), vomiting (5.2%), gastritis (3.2%), Steven Johnson Syndrome (1.0%) & diarrhoea (1.0%). Out of 96 ADRs reported, 39 (40.6%) were related to skin. Use of Zidovudine + Lamivudine + Nevirapine regimen reported majority of ADRs. Sixty one (67%) regimens were dechallenged, 29 (31.9%) regimens were continued while only 1 (1.1%) regimen was rechallenged. Seventy six (79.2%) ADRs were probable & 1 (1.0%) was definite as assessed by Naranjo's Causality Assessment Scale.

Rash was commonly reported ADR from ART. The findings from study suggests that there is need for intensive monitoring of ADRs in ART centre of Government Medical College & Hospital (GMCH), Nagpur.