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...
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my-uitm-ir.261182019-10-14T00:30:13Z Evaluation of virological and immunological response, and incidence of zidovudine-induced anaemia among innovator and generic Zidovudine/Lamivudine / Nor Mazni Mohamad Tamyes 2016 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 https://ir.uitm.edu.my/id/eprint/26118/ https://ir.uitm.edu.my/id/eprint/26118/1/TM_NOR%20MAZNI%20MOHAMAD%20TAMYES%20PH%2016_5.pdf text en public masters Universiti Teknologi MARA Faculty of Pharmacy |
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Universiti Teknologi MARA |
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Virology Bacteria |
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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 |
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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 |
qualification_level |
Master's degree |
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 |
granting_institution |
Universiti Teknologi MARA |
granting_department |
Faculty of Pharmacy |
publishDate |
2016 |
url |
https://ir.uitm.edu.my/id/eprint/26118/1/TM_NOR%20MAZNI%20MOHAMAD%20TAMYES%20PH%2016_5.pdf |
_version_ |
1783733884367667200 |