Tuesday, 10th of April 2012 |
‘[C]linical outcomes appeared similar among patients on generic or proprietary formulations. These findings support continued use of generic anti-retroviral drug formulations in resource-constrained settings.’
International Journal of Epidemiologyije.oxfordjournals.org
Effectiveness of generic and proprietary first-line anti-retroviral regimens in a primary health care setting in Lusaka, Zambia: a cohort study
Elizabeth M Stringer1,2, Priscilla Mulenga1, Michael S Saag4, Patrick Musonda1,5,
Frank B Williams1,4, Stewart E Reid1,2 and Benjamin H Chi1,2
+ Author Affiliations
Accepted January 31, 2012.
Abstract below; full text at http://ije.oxfordjournals.org/content/41/2/448.full
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 (AHR): 0.93, 95% confidence interval (CI): 0.77–1.12]. Similar findings were noted when drug formulation was treated as a time-varying exposure (AHR: 1.15, 95% CI: 0.89–1.48) when analysis was limited to those with a predominant exposure to one formulation or the other (AHR: 0.59, 95% CI: 0.24–1.49). Results were consistent across all approaches when programme failure was considered as an outcome. No longitudinal differences were detected between formulations for CD4 response, weight change and haemoglobin concentration. Generic ZDV formulations were associated with slight decreases in single-drug substitution.
Conclusions In this large programmatic cohort of adults starting ZDV-based first-line therapy, clinical outcomes appeared similar among patients on generic or proprietary formulations. These findings support continued use of generic anti-retroviral drug formulations in resource-constrained settings.
Are three drugs for malaria better than two?
Friday, 24th of April 2020 |
Public health Interventions and epidemic intensity during the 1918 influenza pandemic
Thursday, 16th of April 2020 |
Chloroquine and hydroxychloroquine as available weapons to fight COVID-19
Tuesday, 17th of March 2020 |
Using models to shape measles control and elimination strategies in low- and middle-income countries: A review of recent applications
Monday, 17th of February 2020 |
Immunization Agenda 2030
Tuesday, 11th of February 2020 |
41031099 |
www.measlesinitiative.org www.technet21.org www.polioeradication.org www.globalhealthlearning.org www.who.int/bulletin allianceformalariaprevention.com www.malariaworld.org http://www.panafrican-med-journal.com/ |