A comparison of treatment response in two cohorts of once daily HAART and twice daily HAART in a sample population in Gaborone, Botswana
Thesis (MFamMed) -- Stellenbosch University, 2012.
ENGLISH ABSTRACT: Background Sub-Saharan Africa has been hard hit by the HIV/AIDS epidemic with an estimated 22.9 million adults infected in 2010. The advent of antiretroviral therapy (ART) has seen significant reduction in mortality from AIDS related illnesses. With the reduction of mortality and the indisputable positive results seen from the use of Anti-retroviral Treatment (ART), the demand both from people living with HIV and health care providers to phase in less toxic ARVs while maintaining simplified fixed-dose combinations has increased considerably. Botswana like most low-resource countries has adapted the WHO recommendation of daily ART as opposed to the previous twice daily HAART. No evidence from resource limited settings has been found that clearly indicates the superiority of regimens based on AZT, d4T or TDF. Aim The primary aim was to compare treatment response between two cohorts. The secondary aim was to compare any association of regimen to age or gender. Objectives To comparatively determine treatment response at 3 months based on immunological response (shown by an increase in CD4 above pre-therapy levels) and viral load response. Methods The study is a retrospective comparative cohort study. Three ART sites were selected from a total of 6 sites. A sample size of 263 was required to achieve a 90% effect power. An equal number of patient records were reviewed per site and each arm had an equal number of reviewed records. A total of 286 patient record files which fit the inclusion criteria were retrospectively analysed and data entered in Excel before being analysed using Statistica Version 10. A p <0.05 represents statistical significance whilst a 95% confidence interval was used for estimation of unknown variables. Results n=263. The overall sample was predominantly male (75.19%). An overwhelming majority (95.88%) of patients in both arms had undetectable viral loads (VL<400). A significant association was found between the regimen and viral load (p=0.0315-Pearson Chi Test). The difference in CD4 between the two arms was not statistically significant (p=0.655890-ANOVA). A positive association was found between the regimen and gender (p=0.03190-Pearson Chi Test). This was possibly owing to the high numbers of males and no statistical adjustment to gender made. No association was found in the difference in CD4 cell counts for regimen and gender (p=0.612191-Anova). Conclusion Treatment response at 3 months post initiation between once daily and twice daily HAART in Gaborone Botswana by use of virologic and immunologic response has been shown to be comparable. The use of one regimen over the other as first line as recommended by WHO and the subsequent adoption of the current first line regimen by the Botswana Ministry of Health may be justified. This study has therefore reinforced the applicability of previous findings in other settings of this recommendation. As part of the targeted audience and indeed as a partner in the care and management of HIV, the responsibility to ensure applicability of the recommendations set out for resource limited areas has been achieved through this study. However, bigger randomized trials in resource limited settings are needed to justify and accredit these findings as well as add to the evidence obtained in developed countries.