Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy.

Mukta N Chowta,Priyanka Kamath,K Ashok Shenoy,Sanjay Hadigal,John T Ramapuram

doi:10.1155/2018/8095609

Abstract

Background and Objectives The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. Methods This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. Results 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the ‘probable' category (60.1%), and the rest were “possible”. ADRs to zidovudine and nevirapine superseded all others. Interpretation and Conclusion Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.

Highlights

HIV-AIDS, first recognized in the United States in the summer of 1981, was considered an incurable and terminal infection, till the development and availability of effective antiretroviral drugs
The study was conducted at a tertiary care teaching hospital in South India; the study population consisted of HIV-positive subjects of either gender who were on antiretroviral drugs (ART)
It was conducted after approval from the institutional ethics committee was obtained. It was an observational longitudinal study, with a follow-up at 6 months, and the sample size was calculated to be 171 HIV-positive patients who were on ART

Summary

Introduction

HIV-AIDS, first recognized in the United States in the summer of 1981, was considered an incurable and terminal infection, till the development and availability of effective antiretroviral drugs. The Consolidated Guidelines on the use of Antiretroviral Drugs for Treating and Preventing HIV Infection, Recommendations for a Public Health Approach, were published by the World Health Organization (WHO) in 2016 These guidelines outline a detailed schema for diagnosis, treatment of HIV, and the related opportunistic infections, what to expect during the first six months of treatment, monitoring response to treatment, dealing with antiretroviral drug toxicities and substitutions, managing comorbidities, HIV prevention including pre- and postexposure prophylaxis, switch of antiretroviral regimen, and the general care of the HIVpositive individual. These guidelines encompass details on how to provide the various services in different age groups and vulnerable groups including adolescents [2]. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported

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