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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

Immunolgic response (panel A) and virologic response (panel B). CD4 cell counts are expressed as means, while virologic outcome indicates the proportion of subjects below a determined threshold.
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f7-ppa-4-115: Immunolgic response (panel A) and virologic response (panel B). CD4 cell counts are expressed as means, while virologic outcome indicates the proportion of subjects below a determined threshold.

Mentions: Although the mean baseline CD4 count was fairly elevated in our patients, a steady increase of CD4 cells was observed over time (Figure 7, panel A). At any time point the intra-patients analysis yielded a statistically significant result (P < 0.001). After 6 months the mean CD4 increase was 49 cells/μL.


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)

Immunolgic response (panel A) and virologic response (panel B). CD4 cell counts are expressed as means, while virologic outcome indicates the proportion of subjects below a determined threshold.
© Copyright Policy
Related In: Results  -  Collection

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

f7-ppa-4-115: Immunolgic response (panel A) and virologic response (panel B). CD4 cell counts are expressed as means, while virologic outcome indicates the proportion of subjects below a determined threshold.
Mentions: Although the mean baseline CD4 count was fairly elevated in our patients, a steady increase of CD4 cells was observed over time (Figure 7, panel A). At any time point the intra-patients analysis yielded a statistically significant result (P < 0.001). After 6 months the mean CD4 increase was 49 cells/μL.

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