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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