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HIV Adherence Survey in Italy: dosing, adverse events, body shape changes
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Is "Once-Daily" Regimen a Key Strategy for Improving Adherence to Antiretroviral Regimens?
[Letters to the Editor]
JAIDS Journal of Acquired Immune Deficiency Syndromes: Volume 42(2) June 2006 pp 259-260
Murri, Rita*; Marcotullio, Simone ; Lupoli, Piergiorgio ; von Schloesser, Filippo
*Department of Infectious Diseases, Catholic University of Rome, Italy; Nadir Onlus Foundation, Rome, Italy; and Edge Consulting, Milan, Italy
To the Editors:
In recent years, a major improvement in the convenience of antiretroviral regimens was observed with a significant impact on the daily routine life of people living with HIV/AIDS (PLWHA).
The reduction in number of doses is one of the most crucial improvements recently achieved.1 Simplification is thought to be a major strategy to improve or sustain adherence of people taking antiretroviral medications.2,3
However, studies of HIV-infected people demonstrated a clear efficacy of the reduction of doses in terms of improving drug adherence. Moreover, preferences of PLWHA focus on various components of the regimen convenience, especially tolerability of drugs and visible adverse events.
From July to September 2005, we conducted a survey on PLWHA investigating preferences regarding antiretroviral drugs. A questionnaire was posted on a frequently accessed Web site of one of large Italian not-for-profit nongovernmental organizations (NGOs) operating in the field of HIV/AIDS, whose mission is specific on the impact of HIV therapy on PLWHA (Nadir Onlus Foundation Web site, accessible at http://www.nadironlus.org ; the site receives more than 40,000 hits per month). The same questionnaire was administered face-to-face by trained interviewers to PLWHA attending 6 Italian clinical centers.
The respondents were asked the following:
(1) type of highly active antiretroviral therapy (HAART);
(2) number of previous antiretroviral schemes;
(3) number of daily doses;
(4) preferred type of antiretroviral formulations;
(5) self-reported missed doses of antiretrovirals;
(6) problems related to therapy;
(7) modalities on seeking information on antiretroviral drugs; and (8) sharing or influencing the choice of therapy with the physician.
To investigate the preferences on the type of formulation of antiretrovirals, the subjects were asked whether they would prefer to have a simplification of therapy; if the answer was yes, the subjects were asked whether they would prefer fewer pills or fewer doses daily (no other answers were allowed). Nonadherent people were defined as those who admitted to having missed at least 1 dose in the previous week.
Four hundred sixteen people completed the questionnaire (229 via the Web and 187 during a face-to-face interview). Of these, 341 (82%) were taking HAART. Mean age was 32 years (SD, 8.5); 28% were women and 32% were HCV/HIV coinfected. Less than 2% were missing answers.
We observed some differences in people who participated in the survey via the Web versus people filling in the questionnaire during a face-to-face interview. People participating via the Web were more often men (77% vs 66%; P = 0.002), were more frequently taking at least a second regimen (78% vs 60%; P < 0.0001), were taking a once-daily regimen (22% vs 13%; P = 0.006), and were more often seeking information on therapy (88% vs 67%; P < 0.0001).
More than 35% of respondents taking HAART reported taking zidovudine plus lamivudine; more than 30%, tenofovir; 22%, efavirenz; 18%, nevirapine; 19%, lopinavir/ritonavir; and 10%, atazanavir. Thirty percent were taking their first HAART regimen; 23%, the second regimen; 17%, the third; and 30% were taking their fourth or more. Eighteen percent of the study population were taking a once-daily regimen; 70%, a twice-daily; 11%, a thrice-daily; and 1%, a more-than-thrice-daily scheme. More than 90% would agree to simplify therapy: 51.6% would like a reduction of the daily pill number, and 39.4% a reduction in number of daily doses (9% of respondents did not answer).
Twenty-five respondents (7.3%) were self-reported to be nonadherent. No differences on the rate of nonadherent respondents were found between respondents taking a once-daily regimen and those taking a twice-daily scheme. However, among respondents taking a twice-daily regimen, 13 (72.2%) of 18 who were self-reported to be nonadherent would prefer a reduction of number of doses compared with 87 (43.9%) of 198 adherent respondents (odds ratio [OR], 3.31; 95% confidence interval [CI], 1.14-9.67; P = 0.02). The risk of nonadherence was higher for people taking the third or more regimen when compared with people taking the first or second antiretroviral scheme (OR, 5.09; 95% CI, 1.86-13.91; P = 0.001); the risk was also higher for those reporting body changes (OR, 2.16; 95% CI, 0.99-4.88; P = 0.055) and for those preferring a reduction of doses than for those preferring less daily pills (OR, 2.4; 95% CI, 0.996-6.02; P = 0.045).
One hundred fifty-four respondents (37%) reported to have some degree of problem with therapy. Of these, 42% identified the adverse events as the main problem related to therapy; 32%, the body changes; 24%, too much pills; and only 2%, too many doses.
Seventy-eight percent of respondents seek information on antiretroviral drugs (73% from a physician, 65% from the Web, 36% from NGOs fighting HIV/AIDS, and 30% from media).
Eighty percent of respondents reported to have agreed with their physician regarding the choice of antiretroviral therapy. However, only 45% of respondents declared to have "influenced" this choice. At multivariable analysis, respondents who influenced the choice of therapy were more likely to have completed the questionnaire via the Web (hazards ratio [HR], 1.65; 95% CI, 1.03-2.63; P = 0.03), to seek information on antiretroviral drugs (HR, 2.54; 95% CI, 1.36-4.74; P = 0.003), and take a once-daily regimen (HR, 1.57; 95% CI, 1.05-2.35; P = 0.03).
From the present survey, the main concerns of PLWHA taking HAART are related to tolerability of drugs and to body changes. The reduction of number of doses seems to be a major issue only for a small proportion of respondents. However, a significant rate of respondents taking twice-daily regimens and preferring a reduction of daily doses were those who self-reported as nonadherent. In these patients, the simplification of therapy may represent a crucial strategy to achieve the best results in terms of adherence improvement.
Simpler regimens may increase satisfaction with therapy. However, advantages in terms of adherence to drugs are probably influenced by a combination of several attributes of the regimen complexity, mainly including tolerability, visible adverse events, and number of pills.
People seeking information on antiretroviral therapy and those with a more active role in the patient-physician relationship have the highest probability to have more convenient regimens.
Although the population filling in a questionnaire via the Web is different in some characteristics than people filling in a face-to-face survey, we think that, in the future, the use of the Internet for such a purpose has a lot of potential.
Rita Murri*
Simone Marcotullio
Piergiorgio Lupoli
Filippo von Schloesser
*Department of Infectious Diseases Catholic
University of Rome, Italy
Nadir Onlus Foundation
Rome, Italy and Edge Consulting
Milan, Italy
REFERENCES
1. Rosenbach KA, Allison R, Nadler JP. Daily dosing of highly active antiretroviral therapy. Clin Infect Dis. 2002;34:686-692.
2. Frank I. Once-daily HAART: towards a new treatment paradigm. J Acquir Immune Defic Syndr. 2002;31:S10-S15.
3. Benson CA, van der Horst C, LaMarca A, et al. A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV. AIDS. 2004;18:2269-2276.
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