Adverse event monitoring of antiretroviral drugs- A pharmacovigilance perspective

Rakshit Sehgal, M. C. Gupta, P. S. Ghalaut


Objective: To monitor and evaluate adverse drug reactions (ADRs) to antiretroviral drugs in patients of HIV/AIDS by active and spontaneous/solicited ADR monitoring.

Methods: A prospective observational study to monitor ADRs was carried out over 12 months in 187 patients of HIV/AIDS taking antiretroviral treatment. The ADRs reported were evaluated for incidence, frequency, causality, severity, seriousness and preventability. Causality assessment was done using the WHO-UMC and Naranjo scale, seriousness was considered as per the ADR reporting form, severity and preventability assessment were done as per the Hartwig severity scale and the modified Schumock and Thornton criteria respectively.

Results: 103 patients (55.1%) reported at least one ADR and 108 ADR reports were collected. Mostly the ADRs came from the tenofovir + lamivudine + efavirenz regimen with efavirenz related to most number of ADRs (52.5%). Maximum ADRs belonged to the system organ class of neurological disorders (64.81%) followed by gastrointestinal (19.44%) and skin and appendages disorders (7.40%). Causality assessment by WHO-UMC scale revealed most of the reactions as possible (99.2%) while Naranjo scale assessed most of them as probable (69.8%). Most of the reactions (96.1%) were mild in nature and no serious reactions were reported. Preventability assessment determined most reactions (94.6%) as not preventable.

Conclusion: Antiretroviral drugs have a huge potential for causing ADRs specially neurological and gastrointestinal. Active pharmacovigilance is vital in recognizing such reactions to ensure timely management and optimal therapeutic outcomes.


Antiretrovirals, Adverse Drug Reactions, Pharmacovigilance

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