AIDSWEEKLY Plus; November 25, 2002
Staff Medical Writers

The findings of the Perspectives on Adherence and Simplicity for HIV-positive Patients on Antiretroviral Therapy (PASPORT) survey were presented in Chicago October 26, 2002, at the 40th Annual Meeting of the Infectious Diseases Society of America (IDSA).

Of the 10 attributes evaluated in the survey, total pills per day had a mean attribute importance score of 14%, followed by dosing frequency (13%), adverse events (12%), diet restrictions (11%), pill size (10%); number of refills (9%) number of insurance copays (9%), number of prescriptions (8%) number of medication bottles (8%) and the requirement of bedtime dosing (6%).

"In the past, studies have looked primarily at one or two factors related to adherence and measured their impact as single entities," said Valerie Stone, MD, MPH, lead investigator, associate chief, general medicine unit, department of medicine, Massachusetts General Hospital; and associate professor of medicine, Harvard Medical School, Boston. "In the PASPORT survey, we used an adaptive conjoint methodology, sometimes called 'trade off' analysis, which reflects the reality of making HIV treatment decisions as patients consider various trade-offs to tailor a regimen that fits their lifestyles and preferences."

Based on survey results, the preferred characteristics of a regimen would include two small pills dosed at the same time each day with no food requirements or restrictions, an "acceptable" adverse event profile, and one prescription refilled monthly with one copay.

"The PASPORT Survey supports research documenting that multiple factors impact a patient's ability to follow a treatment plan exactly as prescribed," said Stone. "Adherence is a complex problem, and overreliance on any single factor may, in fact, impede adherence for some patients, as our survey suggests. Multiple treatment characteristics and the interactions among them should be taken into consideration in tailoring a treatment regimen that may enhance adherence for the individual patient.

"Despite a lack of data, it is a common assumption that QD dosing will improve adherence. Although QD dosing was deemed the most desirable dosing schedule by the individuals surveyed, actual QD regimens currently available were perceived as no more likely to improve adherence than a BID regimen consisting of one pill per dose when multiple attributes of HAART regimens were considered simultaneously. This seems to be in large part again, because patients seem to prefer low pill count over QD dosing as the most important attribute," said Stone. Further, the survey found that QD regimens requiring more than 2 pills per day were less favorably rated than a BID regimen requiring a total of 2 pills per day.

The main findings related to dosing simplicity derived from the survey were:

• Total number of pills per day. Patients rated fewer pills higher.

• Dosing frequency. Taking medication less often was rated higher by patients. Taking all drugs once a day at the same time was rated the highest.

• Adverse events. Although the differences in adverse events (AEs) among the regimens studied was not large, AEs ranked third in importance relative to other treatment characteristics considered in the survey. "This reinforces the importance of discussing potential side effects with patients, and taking steps to prevent them or manage them aggressively should they occur," Stone said.

• Dietary restrictions. The requirement that pills be taken on an empty stomach was viewed as a greater barrier to adherence than other dietary restrictions, according to survey responses. Having no food restrictions or requirements was rated the highest.

• Number of prescriptions/copayments. Patients rated fewer number of prescriptions/copays higher, with one prescription filled monthly with one copay being rated the highest.

In addition to assessing the relative impact on anticipated adherence of dosing characteristics, the survey participants also evaluated seven triple-HAART regimens frequently prescribed for patients with HIV, including three regimens comprising QD medications. The regimens were evaluated individually, and also in head-to-head paired comparisons in which each of the seven regimens was compared with every other regimen, for a total of 21 comparisons. Information about the specific attributes of each regimen, and pictures and symbols were used to indicate features such as food requirements, pill size, number of pills and adverse event profiles.

Neither the brand nor the generic names of the medications were mentioned and identifying markers were obscured. The data collected in the survey are not necessarily representative of all HIV-positive individuals. The survey population included 299 HIV-positive patients ranging in age from 17 to 72 (median 43), 76% of whom were males. African Americans made up approximately 45% of participants, Caucasians 38%, Hispanics 15% and Asian and other ethnic groups made up the remainder. The survey was conducted in six U.S. cities with a high proportion of citizens infected with HIV (Seattle, San Francisco, Miami, New York City, Atlanta, and Washington, DC).

All individuals who participated in the survey were treatment-experienced with the majority having been on HAART regimens for 4 years or more. Of 295 patients who responded to a question on their current level of adherence, 26% reported no doses missed in the past 3 months. Another 32% said they had missed one or two doses; 24% said three to five, 8% said six to eight, and 10% said nine or more.

This article was prepared by AIDS Weekly editors from staff and other reports.

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