BETA January 1998.
Two national studies conducted by DuPont Merck shed light on patient adherence. New and potent combination drug therapies can dramatically suppress replication of HIV. With profound viral suppression, the development of resistance becomes less likely. Without resistance, the benefits of new therapies may be extended over a greater period of time. Unfortunately, many factors can compromise the effectiveness of these drugs.
Poor adherence by patients is one critical factor that can reduce the potency of therapy and lead to viral resistance. Research on adherence to date suggests the dilemma is widespread and has serious implications. Further compounding the problem is a lack of reliable methods to predict which patients are likely to comply with which treatment regimens.
To shed light on this alarming trend, 2 research surveys that examine adherence issue within the HIV community have recently been completed. The first study focuses specifically on patients. The data was obtained through telephone interviews with more than 665 patients. These participants were HIV positive; taking a minimum of 2 antiretrovirals; did not have a professional relationship with a pharmaceutical company, or advertising or marketing research firm; were not employed as a healthcare professional; and were over the age of 18.
The second study targeted 100 HIV-treating physicians. All physician participants are board-certified or board- eligible in their area of specialty (FP, IM, and ID); treat a minimum of 50 HIV patients; are in active practice and have treated HIV patients for a minimum of 2 years; have no professional affiliation with a pharmaceutical company; and are between the ages of 25 and 65.
The studies were sponsored by The DuPont Merck Pharmaceutical Company.
Nearly all HIV patients who were surveyed indicate that they have been well educated about the importance of adherence. Specifically, the majority say their healthcare provider explained both the consequences of not taking their antiretrovirals according to schedule as well as the meaning of viral resistance. In addition, many have received educational materials about the importance of adherence. Moreover, most patients say they understand the consequences of non-adherence, as well as agree that adherence is important and will prolong their life.
Despite this high level of awareness and understanding, one-fourth (26%) disclose personal non-adherence in the prior day and almost half (43%) admit to non-adherent behavior in the prior week. Furthermore, slightly over half (54%) profess to know of other people who are non-adherent because of complicated antiretroviral dosing regimens.
Respondents are more likely to miss a dose of all their medications or take an entire dose at the wrong time than they are to miss a specific antiretroviral pill, take a pill at the wrong time or not follow the food requirements of their regimen.
Missing a dose of all antiretroviral medications is often due to sleeping through a late night or early morning dose, simple forgetfulness or not having the medication on hand when the dose is due. Respondents tend to take an entire dose late because they don't have their medication with them at dosing time, are forgetful, or are too busy to take the dose at the scheduled time.
The factors of antiretroviral medications and regimens which contribute most to non-adherence are: side effects, 3 or more doses per day, requirement that medication must be taken on an empty stomach and large pills. The most often mentioned suggestions (unaided) to enhance adherence include a pill box with an alarm and fewer pills per dose.
One-fifth of all patients feel some specific antiretroviral agents cause more non-adherence problems than others. However, factors such as number of pills per dose, number of doses per day and whether the medication is taken with or without food suggest that patients are less likely to follow the manufacturer recommended dosages.
On average, the HIV patients in this study have been taking antiretroviral medications for 3 years and 3 months. Patients are generally satisfied with their current therapy regimen. Nearly half (42%) say they are "very satisfied" with their current regimen (answer of 7 on a 7-point scale).
Reasons for satisfaction with regimens include:
Reasons for dissatisfaction with current therapy regimens include:
Respondents are more likely to miss a dose of all their medications or take an entire dose at the wrong time rather than miss a specific antiretroviral pill, take a pill at the wrong time or not follow the food requirements of their regimen. Approximately one-fifth of respondents claim to have taken a "drug holiday" or neglected to refill an antiretroviral prescription.
The majority of patients indicate their healthcare provider educated them about the consequences of non-adherence. Most discussed viral resistance and received educational materials.
Nearly all respondents (94%) indicate their healthcare provider has explained the consequences of not taking their antiretrovirals according to their instructions.
Side effects, number of doses per day, number of pills per dose and having to take medication with or without food are the factors perceived to have the greatest impact on a patient's ability to adhere to their antiretroviral treatment regimen. When asked which one product feature most contributes to non-adherence, more than half of HIV treaters cite number of doses per day, whereas just over one-fourth cite side effects.
Almost all physicians (89%) feel selected lifestyle factors contribute to making some patients more non-adherent than others. Nearly two-thirds cite IV drug use with other considerations, such as indigence and lack of education, all being mentioned by less than one-fifth of respondents.
On average, most physicians believe their patients only somewhat understand the implications of non-adherence (4.9 on a 7- point scale). The majority (82%) report giving educational materials to their patients about adherence, with high volume treaters significantly more likely to provide these than medium or low volume treaters. Two-thirds of respondents provide information about adherence at times other than when a new drug is initiated or the treatment regimen is altered in some way. Most (79%) report talking to patients about non-adherence leading to resistance.
Over half of the respondents suggest that other healthcare professionals assume the active role in patient education, with nurses (69%) and case workers (29%) mentioned most often as alternative teachers.
Three-fourths of respondents express the need for additional patient education materials about the effects of non-adherence, however almost two-thirds do not feel the need for additional professional materials on the same subject.
When asked what one thing could be done to improve patient adherence, HIV treaters suggest antiretrovirals with once-a-day dosing (28%) and drugs with fewer side effects (15%). Another one-fifth of respondents mention that less dosing (unspecified) and fewer pills per dose would enhance patient adherence.
Nearly all of the HIV treaters represented in this study (93%) consider non-adherence with antiretroviral treatment regimens a problem with their patients. Of these 93 physicians, most feel the non-adherence problem is either somewhat or very serious.
The HIV treaters estimate that over half (54%) of their patients miss doses or were otherwise non-adherent with their antiretroviral medication in the past month. The respondents also estimate that, on average, 6% of the antiretroviral prescriptions they write are not ever filled by the patient. It appears that as HIV patient loads increase, so does the estimation that patients are non-adherent with their antiretroviral therapy.
Physicians perceive that side effects, number of doses per day, number of pills per dose and whether the medication must be taken with or without food have the greatest impact on a patient's ability to adhere to their antiretroviral treatment regimen. Conversely, the respondents indicate that the ability to take medication privately and efficacy are least likely to affect patient adherence. When asked which one antiretroviral product feature most contributes to non-adherence, 50% cite number of doses per day while 28% cite side effects.
In addition, when the treaters were asked what one thing could be done to improve patient adherence with antiretroviral therapy regimens, 28% cite once-a-day dosing and 15% say less side effects. Other product improvements which could enhance patient adherence include less dosing (unspecified) (21%) and fewer pills per dose (20%).
Most physicians (89%) feel that there are certain patient characteristics and/or lifestyle factors that make some patients more likely to be non-adherent than others. Increased patient volume appears to strengthen this feeling, perhaps because those doctors who see many patients experience varied types of patient characteristics and lifestyle factors.
Of the 89 physicians who perceive that certain patient characteristic or lifestyle factors exacerbate non-adherence, nearly two-thirds (61%) cite IV drug use as a complicating characteristic/factor. Other patient characteristics and/or lifestyle factors which make some patients more likely to be non-adherent than others include:
The majority of physicians (82%) report giving educational materials such as brochures or pamphlets about the consequences of non-adherence to patients. Treaters with 250 or more HIV patients are significantly more likely than their counterparts to provide educational materials (93% vs. 79% medium volume treaters and 70% low volume treaters). However, most respondents (75%) express the need for additional patient educational materials about the consequences of non-adherence.
Of the 82 respondents who give educational materials about the importance of adherence to their patients with HIV, 60 (73%) provide these materials on other occasions than when the antiretroviral therapy regimen is prescribed. These occasions include:
Other than physician-supplied information, treaters indicate their patients use support groups (40%) to learn about the importance of adhering to their antiretroviral therapy regimen. Patients also turn to medical journal articles (21%), the Internet (19%), and friends/peers with HIV (16%) to learn about adherence.
The studies were sponsored by DuPont Merck located in Wilmington, Delaware. For more information, call 312-240-2875.
This information is designed to support, not replace, the relationship that exists between you and your doctor.