Comparison of adherence to treatment and effectiveness of fixed dose combination ARV drugs to multiple dose regimens in adult patients in public sector.
Jali-Lubanga, Helen Lulama.
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Background As antiretroviral medicines have become increasingly available and affordable for the treatment of HIV infected patients in South Africa, the adoption of a fixed dose combination (FDC) was implemented in 2013 as a strategy to improve adherence and to ensure that the emergence of resistant strains is delayed. Previous studies in other countries have shown that even with FDC, adherence was still below optimal levels. This study aimed to evaluate the impact of introducing the FDC regimen (emtricitabine/ efavirenz/ tenofovir) on adherence, virologic response, immunological response, retention to care and death rates compared to multiple dose regimens (MDC). Methods An institution based, adult patient retrospective record review was conducted at four facilities rendering ART services at Uthukela District, Kwa-Zulu Natal, for ART naïve patients from January 2013 to December 2013. A total of 800 records were sampled, 400 from each of Tenofovir/emtricitabine/efavirenz FDC and the MDC regimens. Proportion of days covered (PDC) and absolute adherence ( PDC≥ 95%) were used as parameters to determine adherence for each of the ART regimens, calculated from pharmacy records over a period of 84 days at 6, 12 and 24 months after initiating treatment . Comparison of viral load (VL) suppression, mean Cd4 count, retention to care and death rates as clinical outcomes ,was done for each group to determine regimen effectiveness. Results At 0-6 months, 85 patients switched from MDC to FDC, at 12 months 220 had switched, and at 24 months 252 had switched (MDC unswitched). Mean PDC at 6, 12 and 24 months for FDC was (66± 30.29; 60± 34.27 and 54± 36.98days), for the MDC-switched Group was (74±20.14; 70± 27.58 and 65± 33.59 days out of 84 days); and for MDC-unswitched was (59±36.85; 34±39.96 and 22±36.99 days), the difference between FDC and MDC-switched was significant, p value< 0.05, and significant between FDC and MDC-unswitched, p value < 0.05. Absolute adherence for FDC was (65,6%, 59.05% and 50.9%), MDC-switched (73.8%, 72.9% and 71.1%) and MDC-unswitched (64.% 36.4% and 23.3%), at 6, 12 and 24 months. Females on FDC had higher PDC and Absolute adherence than males at 12 and 24 months. VL suppression for FDC was [97%(249 out of 256 tests), 86.2%(145/167), 89.3%( 191/124)], for MDC-unswitched [ 81.8% (23/27), 82%(89/102) ,56%(153/181], p value<0.05, and for MDC-switched [85.5% (23/27); 87.3% (89/102) , 84.5% (153/181)], p value>0.05 compared to FDC, at 6, 12 and 24 months respectively. Patients on FDC, with PDC below 50%, had VL suppression rates above 90% at 6 months, but this could not be sustainable beyond 6 months. On FDC, VL suppression for females was (97%, 78.8% and 80%) versus males (89.16%, 87.18% and 83.05%), the difference was only significant at 6 months, p value <0.05 At 24 months mean Cd4 count for FDC recovered by 152% from baseline, and by 126% for MDC unswitched. Retention to care for FDC was [91.8% (368/400), 91.8% (367/400), 91% (363/4000], for MDC switched [98.8%(84/85), 94.5% (208/220) and 92.5% (233/252)], and for MDC switched [88.6%984/85), 95.5%9208/220), 81% (120/148) ] at 6, 12 and 24 months respectively, p value <0.05. At 24 months the death rate for FDC was 4.75% (19/400), that of MDC switched 1.59% (2/252), and MDC unswitched 17.57% (26/148), p value < 0.05 compared to FDC. Conclusion The FDC regimen demonstrated better PDC and absolute adherence than the MDC regimen, however the group that switched from MDC to FDC demonstrated superior PDC and absolute adherence than FDC. Absolute adherence rates for all three regimen groups were less than the optimal level of 90%. VL suppression and Cd4 recovery were significantly higher for FDC than the MDC unswitched regimen. Even though females demonstrated higher adherence than males on FDC, there was no significant difference in VL suppression between the two genders. FDC demonstrated retention to care than the MDC regimen group. The implementation of the FDC regimen improved adherence and clinical outcomes for adult patients on ART. Keywords: Adherence, Fixed Dose Combination, Viral Load suppression, Retention to Care, Death rates, Fixed Dose Combination ART