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Purpose: Adherence to antiretroviral therapy (ART) is one of the strongest predictors of disease progression in HIV/AIDS patients. This study compared adherence rates of two once-daily dosing regimens with different number of pills per daily dosing in patients with HIV/AIDS. Secondary objectives are to measure viral load suppression and CD4 count achieved with these two regimens.
Methods: Adult HIV-infected or AIDS patients with a documented clinic visit during the study period who filled medications through the state AIDS Drug Assistance Program were eligible for study inclusion. The regimens compared were efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF) in combined one pill, once-daily dose and emtricitabine/tenofovir/atazanavir/ritonavir (FTC/TDF/ATV/r) in three pills, once-daily dose. Twenty-four consecutive months of HAART were evaluated. Data collected includes: computerized pharmacy refill records, patient self-reported missed doses at each medical visit, demographics, number of concomitant medications, and ART information including treatment naïve or experienced. Viral load and CD4 count values throughout the study period were also collected.
Results: Study sample consisted of 198 patients with 99 patients in each treatment group. Sixty-five percent of patients in EFV/FTC/TDF group had >90% adherence according to pharmacy refill records. Fifty-seven percent of patients in FTC/TDF/ATV/r group had >90% adherence according to pharmacy refill records. Forty-eight patients with a detectable viral load at the beginning of the study were undetectable at the end of the study. Average increase in CD4 cells was 104.
Conclusions: HIV/AIDS patients were more adherent to one pill once a day versus three pills once a day. Virus was controlled on both ART regimens and immune response was appropriate. Pill burden and frequency continue to be important factors in designing ART regimens for individual patients.