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Adverse drug events due to Antiretroviral Therapy in a Northern Indian Tertiary Care Institution

Shamiya Sadiq, Sapna Gupta, Vijay Khajuria, Vishal R Tandon, Annil Mahajan, Mrityunjay Gupta.




Abstract

Background: The introduction of highly active antiretroviral therapy (HAART) has led to significant reduction in acquired immune deficiency syndrome (AIDS) related to morbidity and mortality. However, adverse drug reactions (ADRs) to antiretroviral treatment (ART) are major obstacles.

Aims and Objective: To examine the adverse effects of antiretroviral therapy in a tertiary care hospital.

Materials and Methods: Ninety patients receiving antiretroviral therapy were studied prospectively over a period of 6 months and were evaluated for ADRs.

Result: Of the 90 patients, 80 (89%) developed ADRs. A total of 111 ADR events were seen in 80 patients. The number of adverse drug events was seen higher in females (64%) than males (36%). The maximum frequency of ADRs was seen with Zidovudine + Lamivudine + Nevirapine (70.27%) combination followed by Stavudine + Lamivudine + Nevirapine (21.62%) and Stavudine + Lamivudine + Efavirenz (8.10%). Anemia and gastritis (12% each) were most common ADRs followed by vomiting (11.7%) and rash (10.8%). Most of the adverse drug events (ADE) were of type A (83.78%). The severity of most of the ADR events was mild (70.27%), followed by moderate (27.02%) and severe (1.78%).

Conclusion: ADRs are common with HAART. Maximum number of ADRs occurred in females and Zidovudine + Lamivudine + Nevirapine (70.27%) combination was the main culprit. To minimize the potential risks of ADR due to ART, the clinicians need to detect them earlier and prevent them whenever possible and choose drugs with safer adverse drug profile.

Key words: ADRs; Adverse drug events; Anti-retroviral therapy; HAART; HIV






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