ADVERSE EFFECT PROFILE OF TENOFOVIR DISOPROXIL FUMARATE IN HIV POSITIVE PATIENTS - A PROSPECTIVE STUDY
Journal Title: Journal of Evolution of Medical and Dental Sciences - Year 2016, Vol 5, Issue 31
Abstract
BACKGROUND Acquired Immunodeficiency Syndrome, a disease of the human immune system caused by the Human Immunodeficiency Virus (HIV) is a major health problem in many parts of the world. The prognosis was dramatically altered with the introduction of antiretroviral drugs in 1987 and Highly Active Antiretroviral Therapy (HAART) in 1996. Despite the absence of a cure, the natural history of the disease was radically changed since then. This study aimed at documenting and analysing the adverse effect profile of Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy (ART) in HIV positive patients attending Antiretroviral Therapy Centre, Government Medical College, Thrissur. METHODOLOGY HIV positive patients on Tenofovir Disoproxil Fumarate-based antiretroviral treatment attending Antiretroviral Therapy Centre, Government Medical College, Thrissur, were enrolled in the prospective cohort study conducted over 18 months from Jan 2013- June 2014. The patients were followed up for 12 months pattern of adverse drug reactions. RESULTS A total of 178 Adverse Drug Reactions (ADRs) were identified, out of which 86 (48.31%) were in male and 92 (51.68%) were in female patients. Out of 178 suspected ADRs, 172 (96.6%) ADRs were reported from outpatient departments. Six patients (3.3%) required hospital admission. The most commonly identified adverse drug reactions were nausea and vomiting in 54 (30.3%) patients, headache and fatigue in 30 (16.85%), heartburn and diarrhoea in 17 (9.5%) cases, lab abnormalities like dyslipidaemia in 12 (6.74%), hyperphosphatemia in 10 (5.6%), hypocalcemia in 5 (2.85%) patients. Out of 178 ADRs, 4 (2.2%) were of acute renal failure seen. One among the four died even after discontinuation of the drug, 2 were changed to non-Tenofovir based regimen who improved later within 2 months. CONCLUSION In this study of Tenofovir based regimen, the side effects which necessitated regimen change were very few. Majority of the side effects were GI related. The incidence of renal adverse effects were low and were seen in only 4 (2.2%) patients, out of which one patient died following acute renal failure which could probably be due to Tenofovir. Though renal toxicity of Tenofovir is rare, it can be fatal. So during the course of the treatment, patients should be monitored for nephrotoxicity by laboratory monitoring
Authors and Affiliations
Andis Joseph, Sanalkumar , Bharathan , Andrews , Ajithkumar
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