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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

Patients’ preferences. Patients’ opinion was significantly in favor of the fixed dose combination (FDC) compared to the use of single drug pills (T0).Note: Statistics refers to differences observed during the FDC use (from 1 month versus 6 months after the switch).
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f6-ppa-4-115: Patients’ preferences. Patients’ opinion was significantly in favor of the fixed dose combination (FDC) compared to the use of single drug pills (T0).Note: Statistics refers to differences observed during the FDC use (from 1 month versus 6 months after the switch).

Mentions: The comparative evaluation of the HAART regimen based on the use of single drug pills or on the FDC favored the last one in terms of patients’ preferences concerning tolerability, convenience and simplicity. The preference was evident 1 month after the switch, but steadily increased over time (Figure 6) for all the considered characteristics of HAART. Of note, patients previously treated with lamivudine (thus receiving a regimen based on 3 pills) reported a higher preference rate for the FDC than those treated with emtricitabine (2 pills regimen because of the FDC emtricitabine/tenofovir). This difference was constant over time and expressed for all the characteristics, but was not statistically significant. However, the study was not powered to detect such a difference.


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)

Patients’ preferences. Patients’ opinion was significantly in favor of the fixed dose combination (FDC) compared to the use of single drug pills (T0).Note: Statistics refers to differences observed during the FDC use (from 1 month versus 6 months after the switch).
© Copyright Policy
Related In: Results  -  Collection

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

f6-ppa-4-115: Patients’ preferences. Patients’ opinion was significantly in favor of the fixed dose combination (FDC) compared to the use of single drug pills (T0).Note: Statistics refers to differences observed during the FDC use (from 1 month versus 6 months after the switch).
Mentions: The comparative evaluation of the HAART regimen based on the use of single drug pills or on the FDC favored the last one in terms of patients’ preferences concerning tolerability, convenience and simplicity. The preference was evident 1 month after the switch, but steadily increased over time (Figure 6) for all the considered characteristics of HAART. Of note, patients previously treated with lamivudine (thus receiving a regimen based on 3 pills) reported a higher preference rate for the FDC than those treated with emtricitabine (2 pills regimen because of the FDC emtricitabine/tenofovir). This difference was constant over time and expressed for all the characteristics, but was not statistically significant. However, the study was not powered to detect such a difference.

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