Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes

Zidovudine/Lamivudine (AZT/3TC) are commonly used in HAART regimen as the backbone NRTI for first-line therapy in developing countries. A generic combination tablet of AZT/3TC is currently used in all government hospitals in Malaysia. Studies comparing safety and efficacy of generic AZT/3TC are very...

Full description

Bibliographic Details
Main Author:	Mohamad Tamyes, Nor Mazni
Format:	Thesis
Language:	English
Published:	2016
Subjects:	Virology Bacteria
Online Access:	http://ir.uitm.edu.my/id/eprint/26118/ http://ir.uitm.edu.my/id/eprint/26118/1/TM_NOR%20MAZNI%20MOHAMAD%20TAMYES%20PH%2016_5.pdf

id	uitm-26118
recordtype	eprints
spelling	uitm-261182019-10-14T00:30:13Z http://ir.uitm.edu.my/id/eprint/26118/ Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes Mohamad Tamyes, Nor Mazni Virology Bacteria Zidovudine/Lamivudine (AZT/3TC) are commonly used in HAART regimen as the backbone NRTI for first-line therapy in developing countries. A generic combination tablet of AZT/3TC is currently used in all government hospitals in Malaysia. Studies comparing safety and efficacy of generic AZT/3TC are very limited. Thus, a retrospective observational cohort study was conducted to evaluate virological and immunological response, and anaemia incidence among patients treated with AZT/3TC. A total of 109 samples were recruited, with 65 samples initiated innovator and 44 generic. Virological and immunological response in both cohort were similar. Although viral load suppression to undetectable level (< 50 copies/ml) in generic group was slightly earlier as compared to innovator (median: seven months vs. eight months), this was not statistically significant (p = 0.550). Similarly, mean difference in terms of increment of CD4 cell count post 12 months therapy and median duration to achieve CD4 count >350 cells/μl were not statistically significant (p = 0.505 and p = 0.190). Incidence of Zidovudine-induced anaemia were found in 10.8% (n = 7) in innovator and 15.9% (n = 7) in generic cohort, with median time to develop anaemia was two and three months respectively (p = 0.169). In conclusion, our findings demonstrated similar clinical outcomes in patients treated with either innovator or generic formulation of AZT/3TC in terms of virological and immunological response. The risk of developing Zidovudine–induced anaemia was also similar in both groups. Therefore, it is justifiable to use generic AZT/3TC as the backbone NRTI in HAART regimen. 2016 Thesis NonPeerReviewed text en http://ir.uitm.edu.my/id/eprint/26118/1/TM_NOR%20MAZNI%20MOHAMAD%20TAMYES%20PH%2016_5.pdf Mohamad Tamyes, Nor Mazni (2016) Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes. Masters thesis, Universiti Teknologi MARA.
repository_type	Digital Repository
institution_category	Local University
institution	Universiti Teknologi MARA
building	UiTM Institutional Repository
collection	Online Access
language	English
topic	Virology Bacteria
spellingShingle	Virology Bacteria Mohamad Tamyes, Nor Mazni Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes
description	Zidovudine/Lamivudine (AZT/3TC) are commonly used in HAART regimen as the backbone NRTI for first-line therapy in developing countries. A generic combination tablet of AZT/3TC is currently used in all government hospitals in Malaysia. Studies comparing safety and efficacy of generic AZT/3TC are very limited. Thus, a retrospective observational cohort study was conducted to evaluate virological and immunological response, and anaemia incidence among patients treated with AZT/3TC. A total of 109 samples were recruited, with 65 samples initiated innovator and 44 generic. Virological and immunological response in both cohort were similar. Although viral load suppression to undetectable level (< 50 copies/ml) in generic group was slightly earlier as compared to innovator (median: seven months vs. eight months), this was not statistically significant (p = 0.550). Similarly, mean difference in terms of increment of CD4 cell count post 12 months therapy and median duration to achieve CD4 count >350 cells/μl were not statistically significant (p = 0.505 and p = 0.190). Incidence of Zidovudine-induced anaemia were found in 10.8% (n = 7) in innovator and 15.9% (n = 7) in generic cohort, with median time to develop anaemia was two and three months respectively (p = 0.169). In conclusion, our findings demonstrated similar clinical outcomes in patients treated with either innovator or generic formulation of AZT/3TC in terms of virological and immunological response. The risk of developing Zidovudine–induced anaemia was also similar in both groups. Therefore, it is justifiable to use generic AZT/3TC as the backbone NRTI in HAART regimen.
format	Thesis
author	Mohamad Tamyes, Nor Mazni
author_facet	Mohamad Tamyes, Nor Mazni
author_sort	Mohamad Tamyes, Nor Mazni
title	Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes
title_short	Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes
title_full	Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes
title_fullStr	Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes
title_full_unstemmed	Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes
title_sort	evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic zidovudine/lamivudine / nor mazni mohamad tamyes
publishDate	2016
url	http://ir.uitm.edu.my/id/eprint/26118/ http://ir.uitm.edu.my/id/eprint/26118/1/TM_NOR%20MAZNI%20MOHAMAD%20TAMYES%20PH%2016_5.pdf
first_indexed	2023-09-18T23:16:13Z
last_indexed	2023-09-18T23:16:13Z
_version_	1777419129351831552

Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes

Similar Items