One-pill once-a-day HAART: a simplification strategy that improves adherence and quality of life of HIV-infected subjects

Abstract

Objective: The aim of the ADONE (ADherence to ONE pill) study was to verify the effect of a reduced number of pills on adherence and quality of life (QoL) in HIV-infected patients on highly active antiretroviral therapy (HAART).

Design: Prospective, multicenter, study.

Methods: Patients chronically treated with emtricitabine (FTC) + tenofovir (TDF) + efavirenz (EFV) or lamivudine (3TC) +TDF +EFV and with a HIV-RNA < 50 copies/mL were switched to the single-pill fixed-dose regimen (FDR) of FTC +TDF +EFV. Data were collected with SF-36 using visual analog scales. Results of the final (6 months) primary as-treated analysis are reported.

Results: 212 patients (77.4% males) of mean age 45.8 years were enrolled; 202 completed the study. One month post switch to FDR the adherence rate increased significantly to 96.1% from a baseline value of 93.8% (P < 0.01). The increase was steadily maintained throughout the study (96.2% at 6 months). QoL improved over time from 68.8% to 72.7% (P = 0.042) as well, and was significantly associated with the perception of health status, presence of adverse events (AEs) and number of reported AEs (P < 0.0001). QoL significantly influenced adherence (P < 0.0001). During FDR use the mean CD4 count increased from 556 to 605 cells/muL (P < 0.0001). At the end of follow-up 98% of patients maintained HIV-RNA level < 50 copies/mL and 100% <400 copies/mL. Four patients stopped therapy because they were lost to follow-up and 6 because of AEs (insomnia/nervousness 4, allergy 1, difficulties swallowing pills 1).

Conclusion: By substituting a one-pill once-a-day HAART, we observed an improvement of both adherence and QoL while maintaining high virologic and immunologic efficacy. HAART simplicity is an added value that favors adherence and may improve long-term success.

Keywords: EFV/FTC/TDF; QoL; adherence; once-daily antiretroviral regimen; patient preferences; single-pill regimen.

Figure 1

Self-reported adherence rates at different time points (T expressed in months) according to the specific recall periods and eventual dosing timing. Notes: The Y axis represents the indication on the VAS scale and can be regarded as a percentage. Data are expressed as means and 95% confidence intervals.

Figure 2

Baseline proportion of patients indicating the presence of specific symptoms possibly related to HAART. All symptoms were actively investigated by means of a structured questionnaire and patients were asked to grade the discomfort each symptom caused (VAS scale).

Figure 3

Influence of the presence and number of symptoms possibly related to HAART on the perception of health status at baseline. Box-plot analysis reporting median, interquartile range, 95% CI and outliers. Abbreviation: AEs, adverse events.

Figure 4

Variation of quality of life over time. Note: Dots represent mean reported values and bars 95% confidence intervals. Abbreviation: QoL, quality of life.

Figure 5

Influence of quality of life on adherence. Box-plot analysis reporting median, interquartile range, and outliers. Abbreviation: QoL, quality of life.

Figure 6

Patients’ preferences. Patients’ opinion was significantly in favor of the fixed dose combination (FDC) compared to the use of single drug pills (T0). Note: Statistics refers to differences observed during the FDC use (from 1 month versus 6 months after the switch).

Figure 7

Immunolgic response (panel A) and virologic response (panel B). CD4 cell counts are expressed as means, while virologic outcome indicates the proportion of subjects below a determined threshold.