Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias

The human immunodeficiency virus (HIV) inflicts one of the most severely debilitating illnesses known as Acquired Immune-Deficiency Syndrome (AIDS). The current practice of management of AIDS involves antiretroviral therapy (ART). The use of ART must be judiciously evaluated to prevent treatment...

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Main Author:	Alias, Aliza
Format:	Thesis
Language:	English
Published:	2020
Subjects:	Examination Diagnosis Including radiography
Online Access:	https://ir.uitm.edu.my/id/eprint/60791/1/60791.pdf
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spelling	my-uitm-ir.607912022-06-01T06:21:46Z Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias 2020-08 Alias, Aliza Examination. Diagnosis. Including radiography The human immunodeficiency virus (HIV) inflicts one of the most severely debilitating illnesses known as Acquired Immune-Deficiency Syndrome (AIDS). The current practice of management of AIDS involves antiretroviral therapy (ART). The use of ART must be judiciously evaluated to prevent treatment failure. This research focused on the evaluation of treatment effectiveness and safety of ART regimens tenofovir/emtricitabine/efavirenz; tenofovir/emtricitabine/nevirapine; zidovudine/ lamivudine/efavirenz and zidovudine/lamivudine/nevirapine. Effectiveness was measured through immunological and virological responses, while disproportionality analysis consisting of proportional reporting ratio (PRR) and reporting odd ratio (ROR) was used to determine potential safety signals from reported adverse events. A retrospective non-interventional study was conducted. The result showed no significant difference in all recommended first line ART regimens in immunological and virological response (P=0.99 and P=0.06) respectively. Ineffectiveness or poor treatment outcome was highly associated with non-adherence, low baseline CD4, coinfected tuberculosis, younger age, unhealthy diet and alcohol intake, use of supplements and improper storage of the medicine (P<0.001). Moreover, safety signals related to nausea, vomiting, anaemia, skin discolouration, renal impairment, dry skin, lipid abnormalities, hepatotoxicity, central nervous system effects and rashes were detected. The safety signals that were detected could potentially unveil hitherto unknown aspects of adverse reactions especially the least reported adverse reaction. As a conclusion, firstly since there is no statistically significant difference in treatment effectiveness of the four ART regimens, the selection under health care environment with limited resource may be based on other non-therapeutic considerations. Secondly, understanding safety signals related to adverse drug reactions early and explicitly could serve as an important guide to the healthcare team in providing better services to protect HIV/AIDS patients. As recommendations, on novel potential safety signals detected in this study, confirmation through reinvestigation of data from randomized trials or experimental study together with specific and case control or cohort analysis is proposed. Also, since concomitant intake of supplements could potentiate the risk of poor treatment outcome, a quantitative prospective study is suggested to find out if any specific types of supplement and diet could affect the treatment outcome. 2020-08 Thesis https://ir.uitm.edu.my/id/eprint/60791/ https://ir.uitm.edu.my/id/eprint/60791/1/60791.pdf text en public phd doctoral Universiti Teknologi MARA Faculty of Pharmacy Abdul Majeed, Abu Bakar (Professor Dato' Dr.)
institution	Universiti Teknologi MARA
collection	UiTM Institutional Repository
language	English
advisor	Abdul Majeed, Abu Bakar (Professor Dato' Dr.)
topic	Examination Diagnosis Including radiography
spellingShingle	Examination Diagnosis Including radiography Alias, Aliza Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias
description	The human immunodeficiency virus (HIV) inflicts one of the most severely debilitating illnesses known as Acquired Immune-Deficiency Syndrome (AIDS). The current practice of management of AIDS involves antiretroviral therapy (ART). The use of ART must be judiciously evaluated to prevent treatment failure. This research focused on the evaluation of treatment effectiveness and safety of ART regimens tenofovir/emtricitabine/efavirenz; tenofovir/emtricitabine/nevirapine; zidovudine/ lamivudine/efavirenz and zidovudine/lamivudine/nevirapine. Effectiveness was measured through immunological and virological responses, while disproportionality analysis consisting of proportional reporting ratio (PRR) and reporting odd ratio (ROR) was used to determine potential safety signals from reported adverse events. A retrospective non-interventional study was conducted. The result showed no significant difference in all recommended first line ART regimens in immunological and virological response (P=0.99 and P=0.06) respectively. Ineffectiveness or poor treatment outcome was highly associated with non-adherence, low baseline CD4, coinfected tuberculosis, younger age, unhealthy diet and alcohol intake, use of supplements and improper storage of the medicine (P<0.001). Moreover, safety signals related to nausea, vomiting, anaemia, skin discolouration, renal impairment, dry skin, lipid abnormalities, hepatotoxicity, central nervous system effects and rashes were detected. The safety signals that were detected could potentially unveil hitherto unknown aspects of adverse reactions especially the least reported adverse reaction. As a conclusion, firstly since there is no statistically significant difference in treatment effectiveness of the four ART regimens, the selection under health care environment with limited resource may be based on other non-therapeutic considerations. Secondly, understanding safety signals related to adverse drug reactions early and explicitly could serve as an important guide to the healthcare team in providing better services to protect HIV/AIDS patients. As recommendations, on novel potential safety signals detected in this study, confirmation through reinvestigation of data from randomized trials or experimental study together with specific and case control or cohort analysis is proposed. Also, since concomitant intake of supplements could potentiate the risk of poor treatment outcome, a quantitative prospective study is suggested to find out if any specific types of supplement and diet could affect the treatment outcome.
format	Thesis
qualification_name	Doctor of Philosophy (PhD.)
qualification_level	Doctorate
author	Alias, Aliza
author_facet	Alias, Aliza
author_sort	Alias, Aliza
title	Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias
title_short	Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias
title_full	Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias
title_fullStr	Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias
title_full_unstemmed	Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias
title_sort	evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (art) / aliza alias
granting_institution	Universiti Teknologi MARA
granting_department	Faculty of Pharmacy
publishDate	2020
url	https://ir.uitm.edu.my/id/eprint/60791/1/60791.pdf
_version_	1783735172568449024

Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias

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