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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE. ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION TO BE SUBMITTED IN DUPLICATE 1. NAME OF THE CANDIDATE AND DR SUMANA M H ADDRESS D/O - H HANUMANTHAPPA ‘ C ‘TYPE OLD QUARTERS, KRISHI VIGYAN KENDRA, KANKANADY, MANGALORE -575002 ADDRESS FOR DR SUMANA M H CORRESPONDANCE PG IN PHARMACOLOGY DEPT OF PHARMACOLOGY MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401. 2. NAME OF THE INSTITUTION MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401. 3. COURSE OF THE STUDY AND M.D. PHARMACOLOGY SUBJECT 4. DATE OF ADMISSION TO THE 22/06/2011 COURSE 5. TITLE OF THE TOPIC A STUDY OF ANTIRETROVIRAL DRUG INDUCED ADVERSE DRUG REACTIONS IN PATIENTS VISITING A.R.T. (Antiretroviral therapy) CENTRE AT MIMS, MANDYA. 6. Brief resume of intended work 6.1. Introduction and need for the study: The potent antiretroviral therapy has led to significant reduction in the rates of illness and prolongs the life1. Despite the positive therapeutic effects, antiretroviral therapy (ART) may cause undesirable adverse effects. Adverse drug reactions (ADRs) are the most common reasons for ART interruption among HIV infected patients and over 25% of these patients discontinue ART within the first year of treatment due to side effects2. Immune dysregulation, altered drug metabolism and polypharmacy in these patients result in the presence of some degree of ADRs in about 80% of HIV-infected patients3. Among these ADRs some are clinically presented and the others are laboratory documented4. The most prevalent ADRs following ART are dermatological reactions and gastrointestinal (GI) problems5.HIV-infected patients have a higher risk of developing cutaneous reactions than the general population6. The major individual toxicities include bone marrow suppression (zidovudine), pancreatitis (didanosine), hypersensitivity (abacavir), hepatic necrosis (nevirapine), neuropsychiatric complaints (efavirenz), and nephrolithiasis (indinavir). Hyperlipidemia has emerged as an important concern with HAART(Highly active antiretroviral therapy), due to the potential for premature atherosclerosis and coronary artery disease7. There is a lack of awareness and inadequate training about drug safety monitoring among healthcare professionals in India. ART-induced ADRs may significantly impact patients’ quality of life and drug adherence. This systematic study in district hospital Mandya concerning ADRs( Adverse drug reactions) to HAART(Highly active antiretroviral therapy) in HIV positive patients will help physicians to gain a working knowledge of these adverse effects, with the ultimate goal of improving the prescription habits and promoting the early recognition and management of adverse effects. 6.2. Review of literature: Harmful, unintended reactions to medicines that occur at doses normally used for treatment are called adverse drug reactions (ADRs) 8. Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem9. A study of Antiretroviral induced adverse drug reactions in Iranian human immunodeficiency virus positive patients conducted by Khalili H, et al. showed prevalence of ADRs based on affected organ was: gastrointestinal (GI) (63.7%), haematological (32.6%), neurological (30%), cutaneous (22%), musculoskeletal (21.3%), hepatic (20%), metabolic (18.6%),and renal (2.6%) adverse effects10. A study of Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients conducted by Rajesh R, et al. showed that anaemia and hepatotoxicity were the most commonly observed ADRs. The incidence rate of ADRs (65.9%) was highest with Zidovudine + Lamivudine + Nevirapine combination11. A study of Adverse drug reactions to antiretroviral therapy (ART):an experience of spontaneous reporting and intensive monitoring from ART centre in India conducted by Modayil RR, et al. showed Monitoring by active surveillance identified 159 (52.82%) ADRs from 400 patients. One hundred and forty-two (47.17%) reactions were spontaneously reported. Anaemia and vomiting were the most commonly observed ADRs. The ADRs were severe in 10.9% of cases. Prevalence of ADRs in intensively monitored patients was found to be 39.7%12. A study of Prospective, observational cohort study to elicit adverse effects of antiretroviral agents in a remote resource-restricted tribal population of Chhattisgarh conducted by Singh H, et al. showed peripheral neuropathy (20.83%), followed by skin rashes (15.83%) were the most commonly observed ADRs13. A study of Adverse effects of antiretroviral treatment conducted by Sharma, et al. (2008) reported ADRs in 71.1% of cases, and the most common ADR reported was cutaneous manifestation14. 6.3. Objective of the study: 1. To Assess and analyse adverse drug reactions (ADRs) according to reporting and presentation. 2. To describe causality and severity analysis of antiretroviral drug induced adverse drug reactions. 3. To describe the socio-demograhic profile of antiretroviral drug induced adverse drug reactions. 7. Materials and methods: 7.1. Source of data: HIV positive patient on antiretroviral treatment attending Out Patient Department of ART centre of District hospital, Mandya will be enrolled in the study. Study design: Prospective study. Study period: Study is conducted over 1year tentatively from Jan 2012-dec 2012 Study subject:HIV positive patients on antiretroviral treatment attending Out Patient Department of ART centre of district hospital, Mandya from 1 Jan 2012-30 June 2012 will be enrolled in the study and these patients will be followed up to next 6 months. 7.2. Method of collection of data: Study will be initiated after obtaining approval from the Institutional Ethical Committee, MIMS Mandya. HIV positive patient on antiretroviral treatment attending Out Patient Department of ART center of district hospital MIMS, Mandya will be enrolled in the study. After enrolling patients, written informed consent is taken, clinical history will be taken, general physical and systemic examination will be done and patient will be followed up to 6 months at the interval of 15days, 1 month, 2month, 3 month and 6 month for ADRs. Inclusion Criteria: - HIV positive patients with fixed dose of highly active antiretroviral therapy (HAART) ,irrespective of their age and sex. - Pregnant women - Willing to give consent Exclusion Criteria: - Intentional overdose - Patient taking antitubercular treatment and other drugs with potential for hepatic or renal toxicity or interaction with HAART(highly active antiretroviral therapy) drugs. - Patient who does not follow up. - Not willing to give consent. - Patients on second line drugs Statistical Analysis: - The collected data will be analysed by using sfi-info or SPSS software - Descriptive statistics, ‘chi-square’test, ‘t-test’ and other suitable statistical test will be applied for analysing the data applicable 7.3. Does the study require any investigations or interventions to be conducted on patients or other humans or animals? if so please describe briefly. Yes Complete blood count Liver function test Renal function test Random blood sugar Lipid profile 7.4. Has ethical clearance been obtained from your institution? Yes obtained 8. List of references. 1. Palella FJ, Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med. 1998;338:853–60 2. d’Arminio Monforte A, Lepri AC, Rezza G, et al. Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naive patients.I.CO.N.A. Study Group. Italian Cohort of Antiretroviral-Naïve Patients. AIDS 2000; 14: 499–507. 3. Manzardo C, Zaccarelli M, Aguero F, et al. Optimal timing and best antiretroviral regimen in treatment-naive HIV-infected individuals with advanced disease. J Acquir Immune Defic Syndr 2007; 46 (Suppl 1):S9–S18 4. Fellay J, Boubaker K, Ledergerber B, et al. Prevalence of adverse drug events associated with potent antiretroviral treatment: Swiss HIV Cohort study. Lancet 2001; 358(9290): 1322–1327. 5. Rudorf DC, Krikorian SA. Adverse effects associated with antiretroviral therapy and potential management strategies. J Pharm Pract 2005;18(4): 258–277. 6. Ward HA, Russo GG, Shrum J. Cutaneous manifestations of antiretroviral therapy. J Am Acad Dermatol 2002; 46: 284–293. 7. Charlesr F. Antiretroviral agents and treatment of hiv infection. In: Laurence LB, John SL, Keith Parker L, editors. Goodman Gilman's the pharmacological basis of therapeutics. 11th ed. McGraw-Hill: Medical Publishing Division; 2006. pp. 1284–308. 8. http://www.who.int/mediacentre/factsheets/fs293/en/(accessed on 28th oct,2011;17:00) 9. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/index.ht ml(accessed on 28th oct,2011;18:00) 10. Khalili H, Dashti-Khavidaki S, Mohraz M, Etghani A, Almasi F. Antiretroviral induced adverse drug reactions in Iranian human immunodeficiency virus positive patients. Pharmacoepidemiol Drug Saf. 2009 Sep;18(9):848-57. 11. Rajesh R, Vidyasagar R, Varma D M, Nandakumar K. Highly active antiretroviral therapy induced drug-drug interactions in Indian Human Immunodeficiency Virus positive patients .J. Clin. Med. Res.. 2011; 3(5): 60-67. 12. Modayil RR, Harugeri A, Parthasarathi G, Ramesh M, Prasad R, Naik V, Giriyapura V. Adverse drug reactions to antiretroviral therapy (ART): an experience of spontaneous reporting and intensive monitoring from ART centre in India. Pharmacoepidemiol Drug Saf. 2010 Mar;19(3):247-55. 13. Singh H, Dulhani N, Tiwari P, Singh P, Sinha T. A prospective, observational cohort study to elicit adverse effects of antiretroviral agents in a remote resource-restricted tribal population of Chhattisgarh. Indian J Pharmacol. 2009 Oct; 41(5): 224–226 14. Sharma A, Vora R, Modi M, Sharma A, Marfatia Y. Adverse effects of antiretroviral treatment. Indian J Dermatol Venereol Leprol. 2008;74:234–7. 9 SIGNATURE OF THE CANDIDATE The replicative immunodeficiency cycle of virus) HIV (Human presents many opportunities for the targeting of antiviral drugs against HIV. But majority of drugs available today have serious side effects, unwelcome drug interaction & have to be taken life long, because HIV cannot be eradicated completely. The virus may be lying latent in the memory of T cell, integrated into host genome, forming a source of potential reactivation any time after stopping the 10 REMARKS OF THE GUIDE drug. The 1st antiretroviral drug zidovudine was developed in 1987, over the past 20 yrs, more than 20 drugs belonging to 3 classes have been introduced & large number of other drugs are under, development to achieve better patient compliance & to select best molecule for HIV it is essential to monitor ART(antiretroviral treatment) induced adverse drug reaction. This study is particularly necessary in Mandya general hospital which is attached to Mandya institute of medical sciences, where HIV positive cases are increasing in number. 11 NAME AND DESIGNATION OF DR. H P SHIVAPRASAD , M.D PROFESSOR AND HOD 11.1 GUIDE DEPARTMENT OF PHARMACOLOGY MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401 11.2 SIGNATURE DR. K M SHIVAKUMAR , M.D PROFESSOR AND HOD DEPARTMENT OF MEDICINE 11.3 CO-GUIDE MANDYA INSTITUTE OF SCIENCES, MANDYA- 571401 11.4 SIGNATURE MEDICAL 11.5 HEAD OF THE DR. H P SHIVAPRASAD, M.D DEPARTMENT PROFESSOR AND HEAD DEPARTMENT OF PHARMACOLOGY MANDYA INSTITUTE OF SCIENCES, MANDYA- 571401. 11.6 SIGNATURE 12 12.1 REMARKS OF DEAN AND PRINCIPAL 12.2 SIGNATURE MEDICAL