Current pattern of adverse drug reactions to anti-retroviral therapy in an antiretroviral therapy centre attached to a government medical college of Maharashtra, India: a retrospective study

Praveenkumar T. Patil, Mayur P. Pawar, Nimish R. Halasawadekar, Mayur P. Shinde, Arvind V. Kumbhar, Mamta S. Rathod


Background: Antiretroviral drug therapy (ART) has brought a ray of hope to people living with HIV/AIDS. Adverse drug reactions (ADRs) can often cause significant morbidity among individuals on ART, occasionally leading to mortality. The present study was conducted to assess the nature, causality, severity of ADRs to ART, and to identify risk factors for ADRs in HIV-positive patients receiving ART in India.

Methods: A total of 109 patients reported with ADRs to ART during July 2015-December 2015 were randomly included in a retrospective observational study conducted at an ART center attached to a government medical college of Maharashtra. Causality and severity assessment of ADRs was done by using Naranjo’s ADR Causality scale and Modified Hartwig and Siegel scale respectively. The data was computed using MS Excel and descriptive results were expressed as counts and percentages. The study was approved by Institutional Ethics Committee.

Results: Among 109 patients, females (60.55%) had higher prevalence of ADRs than males (39.45%). A total of 132 ADRs were reported. Anemia (76.52%) was the commonest ADR reported followed by skin rash (11.36%) and raised renal function tests (6.06%). Zidovudine + Lamivudine + Nevirapine (ZLN) were the commonest ART regimen causing anemia as ADR.

Conclusions: Reporting of ADRs is a very inefficient system in detecting drug-related conditions, leading to underestimation of the burden due to ADRs in India. A well-structured, efficient pharmacovigilance systems, which assesses and monitor safety profile and impact of antiretroviral medicines is very much needed at present in India.


Antiretroviral therapy, ADRs, HIV/AIDS, Pharmacovigilance

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