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

Airoldi M, Zaccarelli M, Bisi L, Bini T, Antinori A, Mussini C, Bai F, Orofino G, Sighinolfi L, Gori A, Suter F, Maggiolo F - Patient Prefer Adherence (2010)

Bottom Line: One month post switch to FDR the adherence rate increased significantly to 96.1% from a baseline value of 93.8% (P < 0.01).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).

View Article: PubMed Central - PubMed

Affiliation: Division of Infectious Diseases, Ospedali Riuniti, Bergamo;

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.

No MeSH data available.


Related in: MedlinePlus

Influence of quality of life on adherence. Box-plot analysis reporting median, interquartile range, and outliers.Abbreviation: QoL, quality of life.
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f5-ppa-4-115: Influence of quality of life on adherence. Box-plot analysis reporting median, interquartile range, and outliers.Abbreviation: QoL, quality of life.

Mentions: QoL levels significantly influenced adherence rates (P < 0.0001) (Figure 5). Patients in the lowest percentiles of QoL took 92.9% of doses (95% CI 83.4 to 100.0) in the last month; the doses taken in the same period of time with respect to the dosing schedule were 82.6% (95% CI 66.0 to 99.1); those taken in the last week were 94.8% (95% CI 87.9 to 99.7); and those taken in the last week with respect to the dosing timing were 85.2% (95% CI 72.8 to 97.5); the equivalent figures in patients in the highest percentiles were 98.5 (95% CI 98.3 to 99.1); 97.3% (95% CI 92.9 to 96.4); 98.6% (95% CI 98.1 to 99.1); and 97.7% (95% CI 96.2 to 99.2), respectively.


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

Airoldi M, Zaccarelli M, Bisi L, Bini T, Antinori A, Mussini C, Bai F, Orofino G, Sighinolfi L, Gori A, Suter F, Maggiolo F - Patient Prefer Adherence (2010)

Influence of quality of life on adherence. Box-plot analysis reporting median, interquartile range, and outliers.Abbreviation: QoL, quality of life.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2875721&req=5

f5-ppa-4-115: Influence of quality of life on adherence. Box-plot analysis reporting median, interquartile range, and outliers.Abbreviation: QoL, quality of life.
Mentions: QoL levels significantly influenced adherence rates (P < 0.0001) (Figure 5). Patients in the lowest percentiles of QoL took 92.9% of doses (95% CI 83.4 to 100.0) in the last month; the doses taken in the same period of time with respect to the dosing schedule were 82.6% (95% CI 66.0 to 99.1); those taken in the last week were 94.8% (95% CI 87.9 to 99.7); and those taken in the last week with respect to the dosing timing were 85.2% (95% CI 72.8 to 97.5); the equivalent figures in patients in the highest percentiles were 98.5 (95% CI 98.3 to 99.1); 97.3% (95% CI 92.9 to 96.4); 98.6% (95% CI 98.1 to 99.1); and 97.7% (95% CI 96.2 to 99.2), respectively.

Bottom Line: One month post switch to FDR the adherence rate increased significantly to 96.1% from a baseline value of 93.8% (P < 0.01).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).

View Article: PubMed Central - PubMed

Affiliation: Division of Infectious Diseases, Ospedali Riuniti, Bergamo;

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.

No MeSH data available.


Related in: MedlinePlus