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

Monica Airoldi, Mauro Zaccarelli, Luca Bisi, Teresa Bini, Andrea Antinori, Cristina Mussini, Francesca Bai, Giancarlo Orofino, Laura Sighinolfi, Andrea Gori, Fredy Suter, Franco Maggiolo

Research output: Contribution to journalArticle

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/μL (P <0.0001). At the end of follow-up 98% of patients maintained HIV-RNA level <50 copies/mL and 100%

Original languageEnglish
Pages (from-to)115-125
Number of pages11
JournalPatient Preference and Adherence
Volume4
Publication statusPublished - 2010

Fingerprint

efavirenz
Highly Active Antiretroviral Therapy
quality of life
Quality of Life
HIV
Lamivudine
Tenofovir
event
RNA
health status
CD4 Lymphocyte Count
Visual Analog Scale
Health Status
Multicenter Studies
Prospective Studies
Values

Keywords

  • Adherence
  • EFV/FTC/TDF
  • Once-daily antiretroviral regimen
  • Patient preferences
  • QoL
  • Single-pill regimen

ASJC Scopus subject areas

  • Social Sciences (miscellaneous)
  • Medicine (miscellaneous)
  • Health Policy
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Cite this

One-pill once-a-day HAART : A simplification strategy that improves adherence and quality of life of HIV-infected subjects. / Airoldi, Monica; Zaccarelli, Mauro; Bisi, Luca; Bini, Teresa; Antinori, Andrea; Mussini, Cristina; Bai, Francesca; Orofino, Giancarlo; Sighinolfi, Laura; Gori, Andrea; Suter, Fredy; Maggiolo, Franco.

In: Patient Preference and Adherence, Vol. 4, 2010, p. 115-125.

Research output: Contribution to journalArticle

Airoldi, M, Zaccarelli, M, Bisi, L, Bini, T, Antinori, A, Mussini, C, Bai, F, Orofino, G, Sighinolfi, L, Gori, A, Suter, F & Maggiolo, F 2010, 'One-pill once-a-day HAART: A simplification strategy that improves adherence and quality of life of HIV-infected subjects', Patient Preference and Adherence, vol. 4, pp. 115-125.
Airoldi, Monica ; Zaccarelli, Mauro ; Bisi, Luca ; Bini, Teresa ; Antinori, Andrea ; Mussini, Cristina ; Bai, Francesca ; Orofino, Giancarlo ; Sighinolfi, Laura ; Gori, Andrea ; Suter, Fredy ; Maggiolo, Franco. / One-pill once-a-day HAART : A simplification strategy that improves adherence and quality of life of HIV-infected subjects. In: Patient Preference and Adherence. 2010 ; Vol. 4. pp. 115-125.
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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/μL (P <0.0001). At the end of follow-up 98{\%} of patients maintained HIV-RNA level <50 copies/mL and 100{\%}",
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