PMID- 20517472 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20110714 LR - 20240317 IS - 1177-889X (Electronic) IS - 1177-889X (Linking) VI - 4 DP - 2010 May 13 TI - One-pill once-a-day HAART: a simplification strategy that improves adherence and quality of life of HIV-infected subjects. PG - 115-25 AB - 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. FAU - Airoldi, Monica AU - Airoldi M AD - Division of Infectious Diseases, Ospedali Riuniti, Bergamo; FAU - Zaccarelli, Mauro AU - Zaccarelli M FAU - Bisi, Luca AU - Bisi L FAU - Bini, Teresa AU - Bini T FAU - Antinori, Andrea AU - Antinori A FAU - Mussini, Cristina AU - Mussini C FAU - Bai, Francesca AU - Bai F FAU - Orofino, Giancarlo AU - Orofino G FAU - Sighinolfi, Laura AU - Sighinolfi L FAU - Gori, Andrea AU - Gori A FAU - Suter, Fredy AU - Suter F FAU - Maggiolo, Franco AU - Maggiolo F LA - eng PT - Journal Article DEP - 20100513 PL - New Zealand TA - Patient Prefer Adherence JT - Patient preference and adherence JID - 101475748 PMC - PMC2875721 OTO - NOTNLM OT - EFV/FTC/TDF OT - QoL OT - adherence OT - once-daily antiretroviral regimen OT - patient preferences OT - single-pill regimen EDAT- 2010/06/03 06:00 MHDA- 2010/06/03 06:01 PMCR- 2010/05/13 CRDT- 2010/06/03 06:00 PHST- 2010/05/03 00:00 [received] PHST- 2010/06/03 06:00 [entrez] PHST- 2010/06/03 06:00 [pubmed] PHST- 2010/06/03 06:01 [medline] PHST- 2010/05/13 00:00 [pmc-release] AID - ppa-4-115 [pii] AID - 10.2147/ppa.s10330 [doi] PST - epublish SO - Patient Prefer Adherence. 2010 May 13;4:115-25. doi: 10.2147/ppa.s10330.