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An assessment of adverse reactions to antiretroviral therapy in a South Indian government hospital

Shrinivas R Raikar, Shivaraj B Patil, Venkata Rao Y, Raghuveer B.


Background: Adverse drug reactions (ADRs) can lead to non-adherence to antiretroviral therapy (ART) and are also the major causes of hospitalization and higher cost of treatment.

Aims and Objectives: The aims of this study were to analyze the pattern of ADRs, causality, and severity among HIV-infected patients.

Materials and Methods: It was a retrospective analysis conducted over 1 year from January 2017 to December 2017. ADRs due to antiretroviral drugs (ARVs) were collected from the Government District Hospital, Nalgonda, as part of pharmacovigilance program and analyzed. The WHO-UMC scale was used for assessing the causality and Hartwig–Siegel scale for severity of reactions.

Results: A total of 113 ADRs due to ART were received. In that 68 were female patients. 83% ADRs were of mild grade of severity. Most of the ADRs were related to gastrointestinal system. Causality assessment of ADRs was probable in 62(54.9%) patients and possible in 51 (45.1%) patients.

Conclusion: Maximum number of ADRs was of mild nature suggesting that the ART is well tolerated among the patients. Further studies need to be conducted to fully understand the determinants of ADRs due to ART in a statistically significant manner.

Key words: Adverse Drug Reactions; Antiretroviral Therapy; Human Immunodeficiency Virus; Pharmacovigilance

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