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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

Variation of quality of life over time.Note: Dots represent mean reported values and bars 95% confidence intervals.Abbreviation: QoL, quality of life.
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f4-ppa-4-115: Variation of quality of life over time.Note: Dots represent mean reported values and bars 95% confidence intervals.Abbreviation: QoL, quality of life.

Mentions: The various components of the QoL evaluation, although not always to a significant extent, invariably improved over time after the therapeutic switch. Limitations to everyday social and work activities declined from a baseline value of 17.3% (95% CI 14.3 to 20.3) to 16.5% (95% CI 13.7 to 19.3) after 6 months; the presence of positive feelings such as being full of life or happy increased from 67.8% of the time (95% CI 64.3 to 71.4) at baseline to 70.2% (95% CI 70.0 to 73.4) after 6 months, while time with negative feelings (nervous or worn-out) was reduced from 40.3% (95% CI 37.0 to 43.6) to 31.5% (95% CI 28.2 to 34.8) (P < 0.0001). Patients worried less about their current health status and were less concerned about the risk of it deteriorating in the future. On a scale with the most negative judgment equal to 100 and the best possible equal to 0, their evaluation was 34.4 (95% CI 31.3 to 37.5) at baseline and 31.5 after 6 months (95% CI 28.3 to 34.6). As a consequence the overall evaluation of QoL significantly (P = 0.042) increased over time from a baseline value of 68.8 (95% CI from 67.7 to 70.0) to a value of 72.7 (95% CI 71.5 to 73.8) after 6 months (Figure 4). QoL was strictly related to the perception of health status and to the presence of symptoms (P < 0.0001), too.


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)

Variation of quality of life over time.Note: Dots represent mean reported values and bars 95% confidence intervals.Abbreviation: QoL, quality of life.
© Copyright Policy
Related In: Results  -  Collection

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

f4-ppa-4-115: Variation of quality of life over time.Note: Dots represent mean reported values and bars 95% confidence intervals.Abbreviation: QoL, quality of life.
Mentions: The various components of the QoL evaluation, although not always to a significant extent, invariably improved over time after the therapeutic switch. Limitations to everyday social and work activities declined from a baseline value of 17.3% (95% CI 14.3 to 20.3) to 16.5% (95% CI 13.7 to 19.3) after 6 months; the presence of positive feelings such as being full of life or happy increased from 67.8% of the time (95% CI 64.3 to 71.4) at baseline to 70.2% (95% CI 70.0 to 73.4) after 6 months, while time with negative feelings (nervous or worn-out) was reduced from 40.3% (95% CI 37.0 to 43.6) to 31.5% (95% CI 28.2 to 34.8) (P < 0.0001). Patients worried less about their current health status and were less concerned about the risk of it deteriorating in the future. On a scale with the most negative judgment equal to 100 and the best possible equal to 0, their evaluation was 34.4 (95% CI 31.3 to 37.5) at baseline and 31.5 after 6 months (95% CI 28.3 to 34.6). As a consequence the overall evaluation of QoL significantly (P = 0.042) increased over time from a baseline value of 68.8 (95% CI from 67.7 to 70.0) to a value of 72.7 (95% CI 71.5 to 73.8) after 6 months (Figure 4). QoL was strictly related to the perception of health status and to the presence of symptoms (P < 0.0001), too.

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