A study to assess adverse drug reactions to anti retro viral therapy
Keywords:
Adverse drug reactions ; Antiretroviral therapy; Human Immunodeficiency Virus.Abstract
Introduction: AIDS is a chronic and potentially fatal disease of the immune system caused by the HAART, a combination of at least three drugs for HIV-1 infection has led to substantial reductions in morbidity and mortality. Adverse effects have been reported with all ARV drugs and are among the most common cause for switching or discontinuing therapy as well as medication non adherence. Hence evaluation of ADRs may help clinicians to optimize the drug regimens.
Material and methodology: A prospective study was conducted in HIV positive patients attending ART centre at Government Dharmapuri Medical college, Dharmapuri. Totally 150 patients were included in the first 6 months after initiation of the study and followed up over a period of next 6 months. At follow up visit’s patients underwent detailed clinical evaluation with special emphasis on any new symptoms. Causality assessment of ADRs was done by Naranjo algorithm and Severity assessment of ADRs by Hartwig and Seigel’s severity scale.
Results: In our study out of the 150 patients 56 (37.3%) had experienced ADRs. Majority of ADRs occurred in patients aged 14-50 years (85.7%). Majority of adverse drug reactions occurred in first 2 weeks of antiretroviral therapy. Most of ADRs were related to Hematological (32.1%), Gastrointestinal system (26.8%) and CNS (21.4%). Most of the ADRs were with Zidovudine + Lamivudine + Nevirapine regimen (73.2%). Naranjo causality assessment showed 60% were possible, 32.5% were probable and 7.5% definitive ADRs. Of the total adverse drug reactions 48.2% were mild and 51.8% were moderately severe in intensity.
Conclusions: ADRs among the patients with ART regimen is a critical public health issue for Anti- retroviral treatment adherence. Therefore, continuous monitoring is required to prevent severe ADRs and to improve patient compliance.
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