Effectiveness of generic and proprietary first-line anti-retroviral regimens in a primary health care setting in Lusaka, Zambia: a cohort study


Authors

Stringer JS, Mwango AJ, Giganti MJ, Mulenga L, Levy JW, Stringer EM, Mulenga P, Saag MS, Musonda P, Williams FB, Reid SE, Chi BH


Journal

Int J Epidemiol. 2012 Apr;41(2):448-59. PubMed PMID: 22493326; PubMed Central PMCID: PMC3324461


Abstract

BACKGROUND:

Although generic anti-retroviral drugs are in common use throughout the developing world, studies comparing their clinical effectiveness with that of proprietary formulations are lacking.

METHODS:

We analysed observational data from a large cohort of adults on anti-retroviral therapy (ART) to assess potential differences between generic and proprietary zidovudine (ZDV) formulations in post-90-day mortality, ‘programme failure’ (a composite of death, follow-up losses and withdrawals) and other clinical outcomes. We accounted for drug exposure in three ways: an ‘initial dispensation’ approach that categorized patients according to the first prescription; ‘time-varying’ approach that attributed an outcome to the formulation taken at the time of event; and ‘predominant exposure’ approach that considered only those with >75% exposure to either brand or generic ZDV. Proprietary formulations were used as the reference group in all adjusted Cox proportional hazard regressions.

RESULTS:

Among 14 736 patients eligible for analysis, 7277 (49%) initiated a generic formulation of ZDV and 7459 (51%) initiated a proprietary formulation. When categorized according to initial dispensation, no difference in post-90-day mortality was observed between the two groups [adjusted hazard ratio

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