Antiretroviral therapy (ART) has been proved to be efficacious in reducing morbidity and mortality related to Human Immunodeficiency Virus (HIV) infection. However it is also associated with long and short term adverse drug reactions (ADRs) which lead to non-adherence to ART and is one of major causes of hospitalization and higher cost of treatment. The present study focuses on ART induced ADRs by spontaneous reporting system under Pharmacovigilance Program of India. Suspected adverse drug reaction reporting forms provided by PvPI were used to collect the data from ART centre of Madras Medical College & Rajiv Gandhi Govt. General Hospital, Chennai. A total of 94 spontaneous ADR reports were collected from December 2015 to December 2019. Among 94 reports, 116 ADRs were analysed and found that majority of the reactions were blood & lymphatic system disorders (anaemia n=53). Among all the reports, the majority were in females (n=59) and maximum number of ADRs were in the age group of 31-59 yrs (n=80). The most implicated fixed dose combination of ART was found to be Zidovudine+Lamivudine+Nevirapine (n=66) and on causality assessment 72 were found to be “Probable “category. Our study concludes that the majority of the ADRs were “anaemia” due to ZLN regimen. The success of ART depends on the patient adherence and one of the most common reasons for poor compliance is occurrence of ADRs. Early detection and prevention of ADRs is the key function of treating physician to optimize adherence and to maintain safety and efficacy of antiretroviral therapy.
Impact Factor
2022: 6.012
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