ADVERSE EFFECT PROFILE OF ANTIRETROVIRAL DRUGS IN THE INITIAL THREE MONTHS OF THERAPY

Abstract

Abhigyan Kumar1, Prashant Kumar Verma2

HIV disease is becoming increasingly prevalent. With ART being available in government ART centres and also drugs prices getting cheaper, most HIV patients receive ART. Success of ART treatment depends on patient compliance and major factor interfering with compliance is drugs toxicities. Adverse effects often trivial earlier are the major cause of patient drop out. Hence, we studied ART toxicity in first 3 months of therapy. MATERIALS AND METHODS Ninety-three successive patients started on ART in our institutional ART centre were enrolled for this study. Base line parameters including clinical status, CD4 count and baseline investigation were done as per NACO guidelines. (1,4). They were followed for three months for clinical and lab evidence of toxicity. Laboratory monitoring was done as per NACO recommendations. The impact of toxicity on treatment interruptions were documented and analysed. RESULTS Following common early toxicity was observed in this study: anorexia and vomiting occurred in 44% (N 24 + 17 pts) fatigue and anaemia in 26% (24 pts) pruritus and rash in 10% (9 pts). 6% patient had psychiatric manifestation and 7% (6 pts) had ALT elevation however hepatotoxicity was not found to be a major problem despite many patients being on ART and ATT simultaneously. None of the patients with gastro-intestinal symptoms, psychiatric manifestation and ALT elevation needed change in ART due to toxicities. 5 of 9 (56%) patients who had skin reactions and 10 of 24 (42%) patients who had developed anaemia had to change their initial ART regimen. Stavudine for zidovudine in patients associated with anaemia and Nevirapine to Efavirenz in patients with skin reactions. Minimal number of patients stopped their treatment for 1-2 weeks for rash, vomiting etc., underscoring the importance of this minor symptoms in patient compliance. Age, gender, baseline CD4 count and concurrent ATT were not predictors of toxicity in our study, zidovudine was found to be significantly associated with occurrence of anaemia and Nevirapine with skin toxicity. CONCLUSION In this study of 93 HIV positive patients newly started on ART, the early toxicities observed were anorexia and vomiting, fatigue and anaemia, pruritus and skin rash, psychiatric manifestations and ALT elevations.

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