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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 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.
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f3-ppa-4-115: 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.

Mentions: When actively asked, a relevant proportion of patients reported several symptoms that could be related to the taking of antiretroviral agents (Figure 2). Most patients (56.1%) reported the presence of fatigue, while symptoms indicated by between 40% and 50% of patients included: muscles aches, sleep abnormalities, changes in body shape, diarrhea, problems with having sex, sadness or depression, nervousness or anxiety. Over time, the proportion of patients not reporting any symptoms significantly (P < 0.0001) improved, changing from 9.9% (at baseline) to 30.7%, 6 months after the switch to the FDC. The number of symptoms each patient reported significantly (P = 0.018) decreased, too. On the contrary, among patients reporting a given symptom, the perception of discomfort and the grading of it was rather stable over time. The presence and number of reported symptoms was strictly correlated (P < 0.0001) with the perception of health status by each patient (Figure 3) and how patients perceived their health status was a significant determinant of how subjects judged their limitations to everyday social and work activities; how much time in the past 4 weeks they experienced positive (eg, feeling full of life, feeling happy) or negative (feeling nervous, feeling worn-out) situations; and how true or false were statements investigating the current attitude and future concerns about their health status (P < 0.0001). Univariate analysis indicated that several other variables could influence perception of health status. The mean perception was lower in heterosexuals (75.9%) and in intravenous drug users (72.9%) and higher in men having sex with men (81.9%) or in patients with other risk factors for HIV infection (92.6%) (P = 0.003) and it was also correlated with the length of HAART (P = 0.031). However, when entered in a multivariate model, only the reported symptoms retained a strong statistical significance (P < 0.0001).


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 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.
© Copyright Policy
Related In: Results  -  Collection

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

f3-ppa-4-115: 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.
Mentions: When actively asked, a relevant proportion of patients reported several symptoms that could be related to the taking of antiretroviral agents (Figure 2). Most patients (56.1%) reported the presence of fatigue, while symptoms indicated by between 40% and 50% of patients included: muscles aches, sleep abnormalities, changes in body shape, diarrhea, problems with having sex, sadness or depression, nervousness or anxiety. Over time, the proportion of patients not reporting any symptoms significantly (P < 0.0001) improved, changing from 9.9% (at baseline) to 30.7%, 6 months after the switch to the FDC. The number of symptoms each patient reported significantly (P = 0.018) decreased, too. On the contrary, among patients reporting a given symptom, the perception of discomfort and the grading of it was rather stable over time. The presence and number of reported symptoms was strictly correlated (P < 0.0001) with the perception of health status by each patient (Figure 3) and how patients perceived their health status was a significant determinant of how subjects judged their limitations to everyday social and work activities; how much time in the past 4 weeks they experienced positive (eg, feeling full of life, feeling happy) or negative (feeling nervous, feeling worn-out) situations; and how true or false were statements investigating the current attitude and future concerns about their health status (P < 0.0001). Univariate analysis indicated that several other variables could influence perception of health status. The mean perception was lower in heterosexuals (75.9%) and in intravenous drug users (72.9%) and higher in men having sex with men (81.9%) or in patients with other risk factors for HIV infection (92.6%) (P = 0.003) and it was also correlated with the length of HAART (P = 0.031). However, when entered in a multivariate model, only the reported symptoms retained a strong statistical significance (P < 0.0001).

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