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*C S Manju, Muhammed Shajeel P, Dr. Aquil Kalanad and B. Athira


Human immune deficiency virus infection is one of the most serious challenges in health care. Highly Active Anti Retroviral Therapy (HAART) is the name given to the aggressive treatment regimen. Anti retro viral therapy exhibit greater level of efficacy with satisfactory degree of toxicity. Adverse reactions to therapy lead to decrease in patient compliance and adherence. The present work was a prospective observational study used to evaluate the adverse drug reactions associated with the use of antiretroviral drugs used in a tertiary care hospital. The total incidence rate for Adverse Drug Reactions (ADRs) was observed to be 40.50% in clinical settings of this study. Tuberculosis was the most common Opportunistic Infection followed by Candidiasis and skin infections. Incidence of ADRs was significantly higher in Females. Gastrointestinal system involvement was the commonest ADR encountered. Zidovudine + Lamivudine +Nevirapine were responsible for majority of ADRs. Causality assessment between the ADR and suspected drug therapy were assessed using the Naranjo probability scale. The severity of reaction was determined according to modified Hartwig and Siegel scale and preventability by modified Schumock and Thornton scale. Majority of the ADRs were probable, mild and preventable. The risk factors to ADRs observed in this study are CD4 less than 200 cells/μL, female gender, tuberculosis, candidiasis and polypharmacy. In spite of high ADRs, HAART is the only answer to HIV/AIDS; thus, management requires a highly precise balance between benefits of durable HIV suppression and the risks of drug toxicity to achieve the therapeutic goals.

Keywords: Adverse drug reactions, HAART therapy, opportunistic infections, poly pharmacy, causality, severity, preventability.

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