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 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.