Factors Affecting Adherence to Antiretroviral Therapy

Abstract
In both clinical trials and clinical practice, nonadherence to medications is widespread among patients with chronic
diseases. The shift to combination therapies for treating human immunodeficiency virus (HIV)-infected individuals has
increased adherence challenges for both patients and health-care providers. Estimates of average rates of nonadherence to
antiretroviral therapy range from 50% to 70%. Adherence rates of <80% are associated with detectable viremia in a
majority of patients. The principal factors associated with nonadherence appear to be patient-related, including substance
and alcohol abuse. However, other factors may also contribute, such as inconvenient dosing frequency, dietary
restrictions, pill burden, and side effects; patient-health-care provider relationships; and the system of care. We discuss the
major reasons reported by HIV-infected individuals for not taking their medications. Improving adherence probably
requires clarifying the treatment regimen and tailoring it to patient lifestyles.
Measurement of Adherence
The shift to the use of highly active antiretroviral therapy (HAART) for treating human immunodeficiency virus (HIV)
disease has led to increasingly complex drug regimens. These present significant challenges to both patients and healthcare providers with respect to adherence. Without adequate adherence, antiretroviral agents are not maintained at
sufficient concentrations to suppress HIV replication in infected cells and to lower the plasma viral load. In addition to
being associated with poor short-term virological response, poor adherence to antiviral medication accelerates
development of drug-resistant HIV. Therefore, identifying and overcoming the factors that reduce adherence to
combination antiretroviral agents is of utmost importance for prolonged viral load suppression.
There are a number of key issues in the study of adherence to antiretroviral therapy, including accurate measurement of
adherence, assessment of the impact of adherence on viral load and clinical outcome, determination of the factors that
affect adherence, and the development of interventions. Addressing these issues may provide valuable information about
which patients are most at risk for nonadherence and about how adherence might be improved. The critical factors that
influence adherence fall into 4 main groups: (1) patient factors, such as drug use, alcohol use, age, sex, or ethnicity; (2)
medication regimen, such as dosing complexity, number of pills, or food requirements; (3) the patient-health-care provider
relationship; and (4) the system of care.
Adherence to therapy is difficult to measure accurately. Four basic techniques have been developed for quantifying
adherence, all of which have limitations. First and most common are patient self-reports. These have the advantages of
low cost and flexibility of design (questionnaires suit individual language abilities). The data are easily collected and can
help to determine the reasons why patients are nonadherent. They assume, however, that patients can accurately recall
their behavior and are providing honest answers. A major limitation of self-reports is that they reflect only short-term or
average adherence and may often overestimate it. Nevertheless, some studies show significant relationships between data
from self-reports and viral load [1, 2]. Other studies that compare data from self-reports to pill counts or electronic
measurements found differences, suggesting that self-reports provide inflated estimates of adherence behavior [3, 4].
Second are patients' reports of missing pills, which are almost always reliable [5], so self-reports can be helpful for
understanding the dynamics surrounding missed medication. Pill counts have been widely used. The return of excess pills
provides tangible evidence of nonadherence. However, pill counts require patients to return the medication packaging to
the clinician. Even in clinical trial situations, patients tend to forget the packages or inadvertently discard them. There
have also been reports that patients other than those with HIV, aware that pill counts are being conducted, engage in pill
dumping to appear adherent. As a result, pill counts typically overestimate adherence.
Third, assays of drug levels have been used in clinical trials to measure the last dose taken; however, these assays are
often impractical because of their expense and lack of general availability. In addition, serum concentrations of nucleoside
analogues may not reflect intracellular concentration of the active triphosphates. Furthermore, these assays typically
measure only recent doses and thus provide limited data. Adherence may be overestimated if patients are more
conscientious about taking their medication before a clinic visit.
Fourth, electronic monitoring systems, such as the Medication Event Monitoring System (MEMS), are inserted into
medication bottle caps; they contain a computer chip that records the date and time of opening and closing of the bottle.
Interpretation of these data assumes that a single dose is taken each time the bottle is opened, and may lead to inaccuracies
if multiple doses are removed at once. Despite the limitations of these measurement techniques, adherence data are

providing valuable insight into the association between drug taking and viral load, as well as approaches that may be
useful for improving adherence.
Adherence to HIV Therapy
Large-scale studies of the impact of adherence on viral load and clinical outcome in HIV therapy are underway within the
AIDS Clinical Trials Group (ACTG) and at clinical sites in the United States and abroad. However, findings have not yet
been reported. A small study by Paterson et al. [6] examined patient adherence to protease inhibitor therapy by use of
MEMS. The investigators found that poor adherence correlated with clinical and virological failure at 3 months of followup (table 1). These results suggest that a high degree of adherence is necessary for maintenance of drug efficacy. Further
similar studies are needed to corroborate these data and to establish whether adherence requirements vary for different
drugs.

Table 1
Poor medication adherence correlates with virologic failure: a study of 45 HIV-infected patients.
Although very little published information is available on medication adherence of HIV-infected patients, new data from a
number of studies were presented at numerous conferences, including the 12th World AIDS Conference in Geneva and the
38th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego. Because the
study of adherence is in its infancy, study designs and end points vary widely, making study comparisons difficult. Selfreported adherence, as defined in research studies, has been reported to range from 0% to 100% [6-13]. Although the
results of some of these studies appear to conflict, important information is emerging about the extent of and factors
associated with adherence. The earliest reports of nonadherence suggested that slightly >10% of patients missed 1 dose
of medication each day [1, 14]. Rates of nonadherence may be as high as 50% when averaged over time and with an
arbitrary cutoff point of <80% of medication taken [8]. This figure is supported by observations from 2 larger studies: an
international multicenter study of 235 HIV-infected patients and a United States study of 244 HIV-infected Medicaidinsured patients. The reported rates of patients who take <80% of doses in these studies were 46% and 40%, respectively
[9, 10]. It is interesting to note that these results are consistent with estimates of adherence in other chronic diseases and
support the view that nonadherence is a common behavior that should be expected, even with a serious disease such as
HIV infection.
In order to implement measures to improve adherence, it is first essential to identify the principal factors that contribute to
the inability of patients to take their medication. Those factors identified to date are summarized in table 2.

Table 2
Factors reported to negatively affect adherence in HIV-infected patients.
A published study of adherence by Eldred et al. [10] required 244 patients who were receiving antiretroviral therapy
and Pneumocystis cariniipneumonia (PCP) prophylaxis to report the medications they were taking, their pattern of use,
and their knowledge and attitudes about HIV therapies [10]. Most of the patients in the study were receiving monotherapy.
Eldred et al. found that 60% of patients reported >80% adherence to treatment regimens in the previous 7 days. When
PCP prophylaxis was analyzed by assaying urinary sulfamethoxazole levels, a correlation of 80% was found between
self-report and levels of sulfamethoxazole in the urine. This leads to the conclusion that at least 40% of patients were
getting <80% of their antiviral medication. Good adherence was associated with dosing twice a day or less, the likelihood
that patients take medication when away from home, and self-efficacy (i.e., patients' belief in their ability to take their
medication). The major factor associated with nonadherence was active illicit drug use. In particular, patients who had
used crack cocaine were significantly less adherent. These findings, although not directly applicable to combination
therapy, may shed light on adherence issues for patients who are receiving HAART.
Preliminary data from a number of studies of adherence to antiretroviral agents have been presented in abstract form
[4, 6, 12, 15, 19-22]. Specific findings vary from study to study, due at least in part to the different samples and measures
used. In general, it appears that the most important factors that affect adherence are patient-related. The most common
reasons given by patients for nonadherence are summarized intable 3; the principal reasons are that they forgot or were
busy. Data from a large cohort of HIV-infected patients (1322 persons living with HIV/AIDS) who were receiving

antiviral combination therapies demonstrated that characteristics that predict non-adherence included youth, governmentsubsidized health insurance, extreme anxiety or pain, and no perceived change in health status as a result of drug therapy
[15]. These data suggest that vulnerable subgroups of HIV-infected patients need to be identified and targeted [15].

Table 3
Frequent causes for medication nonadherence by HIV- infected patients who are receiving highly active antiretroviral
therapy.
Reduction of the administration frequency of current drug regimens may be limited by the relatively short half-lives of the
nonnucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors. Although it has been assumed that
reducing dosing frequency or pill burden will increase adherence, it is important to note that this may not be the case. In
the above-mentioned trial of 179 patients and in another smaller trial of 45 patients, there was no association between
dose frequency or pill burden and nonadherence [6, 10]. There are indications from a number of other studies that meal
restrictions and other factors, and not simply pill burden, are predictors of nonad-herence [2, 4, 10, 13, 19]. It is worth
noting that the pharmaceutical industry is investing considerable effort to develop new compounds or regimens with
longer half-lives in order to reduce pill count and dosing frequency and is also trying to find other ways to simplify drug
regimens. The simplification of existing regimens may prove worthwhile as therapies continue to fail in nonadherent
patients and even more medications are added to regimens.
A good patient-health-care provider relationship may be an important motivating factor for taking and adhering to
complex combination drug therapies [20]. A qualitative study of homosexual youths showed that primary-care providers
exhibited judgmental behavior, stereotyping, homophobia, and failure to address cultural issues when administering care
[17]. Such experiences are likely to lead some people with HIV infection to avoid the health care system. On the other
hand, factors that have been identified as strengthening patient-health-care provider relationships include perceptions of
health-care provider competence, communication quality and clarity, compassion, willingness to include patients in
treatment decisions, adequacy of referrals, and convenience of visiting the doctor [21]. Conversely, frustration for healthcare providers is associated with lack of patient adherence to treatment, miscommunication, missed appointments,
complexity of treatment regimens, and medication side effects [21, 23]. In light of these problems, it is heartening to find
that initiatives are underway to encourage health-care providers to work with patients as partners in care and to involve
representatives from the entire HIV community [24].
Other important adherence issues have arisen, particularly with regard to economically disadvantaged patients with
multiple social problems. Many clinicians feel that lifestyle factors, such as homelessness, substance abuse, lack of
education, and mental illness, are predictors of nonadherence and therefore are withholding HAART from these patients.
A review of these studies indicates that some, but not all, have found an association between nonadherence and youth,
female sex, less edu-cation, or a current or past history of substance abuse [25]. Therefore, health-care providers should be
cautious in making assumptions about patients' likelihood to encounter problems. It is of interest that results of trials show
that health-care providers are not very good at predicting which patients will be adherent to medication [6, 22, 26]. For
example, a comparison of health-care providers' opinions and self-reports from 193 HIV-infected patients revealed that the
health-care providers overestimated the influence of social factors on adherence [22]. In this study, social factors made no
significant difference. Results of another study of 45 patients indicated that health-care providers predicted adherence of
patients poorly: 33% of nonadherent patients were identified by health-care providers as adherent, and 36% of patients
with better than 95% adherence (measured by MEMS Caps) were identified as being poorly adherent [3]. In addition, the
results of a recent study of 31 HIV-infected youths found that homelessness, current living situation, years of education,

clinical depression, and substance abuse did not predict adherence to combination therapy [26]. These data do not support
the routine withholding of HAART from specific social groups, since adherence cannot reliably be predicted on the basis
of patient characteristics [27].
Special issues with adherence exist for HIV-infected children and adolescents. Infants and young children are dependent
on adults for administration of their medications, which means that their adherence is only as good as that which their
caregivers are able to achieve. Unfortunately, liquid formulations are often not particularly palatable, and food
requirements for some anti-retroviral agents make therapies difficult to administer to infants who require frequent formula
feeding. These factors can affect the willingness of the caregiver to administer the medication and the willingness of the
child to take it. Another barrier to adherence for children and adolescents with HIV may be their families' desire for
secrecy about the condition. For example, parents may be unwilling to fill prescriptions at local pharmacies and/or may
send their child to school without their medication to hide the fact that the child is HIV-infected. Adolescents find
adherence particularly challenging as they enter a stage of life when they are particularly self-conscious and do not want
to be different from their peers. A detailed assessment of the barriers to adherence should be implemented for all minors
who require antiretroviral therapy. Case managers and counselors may often be able to work with families to resolve
specific issues.
The Way Ahead
A variety of methods for improving adherence have been suggested, and descriptions from clinicians, pilot studies, and 1
trial [28] provide encouraging positive results. A study by Workman et al. [18] describes a practice that implemented a
number of patient management interventions aimed at improving adherence. These included extended consultation time to
explain and to reinforce medication instructions, tailoring the choice of drug regimen to patient lifestyle, frequent followup when initiating or changing drug regimens, rapid viral load feedback, and the use of reminder calls and alarms [18].
Adherence rates of 80%-100% (with 73% reporting 100% adherence) were reported by 99% of 77 HIV-infected patients
[18]. The authors concluded that the interventions significantly enhanced adherence, compared with mean adherence rates
reported in the literature [6, 8-10]. The effectiveness of an alarm set to alert patients when their drugs should be taken was
tested in another study of 49 HIV-infected patients [29]. After 3 months, the frequency of 100% pill adherence was 89%;
80% adherence was observed in 99% of patients. The patients also exhibited good adherence to timing and diet
requirements. All the patients were enthusiastic about the alarm device; however, concerns were raised as to its durability,
since malfunctions occurred in the devices issued to half of the patients. Managed social support and perceived healthcare provider support for promoting adherence have also been investigated. In 2 separate studies, patient support systems
were found to enhance adherence and were particularly helpful with regard to enabling patients to better follow advice
and instructions [30, 31].
As the previous review demonstrates, the major factors associated with nonadherence are related to patient behavior, and a
variety of strategies by health care professionals are beginning to yield improved adherence. Some of the interventions
that have been studied are listed in table 4. Of particular importance is the tailoring of medication to the patient's lifestyle
[18, 25, 28]. This can be illustrated by consideration of dosing requirements and the need for special instructions that take
into account the life patterns of patients. For some patients, certain dosing intervals might be easier to adhere to; for
others, lack of ready access to refrigeration or water may prove problematic. Moreover, if a patient's treatment fails, the
patient should be approached to review adherence before the regimen is changed. This should help ensure that patients
begin a new regimen with optimal adherence.

Table 4
Strategies for enhancing adherence to antiretroviral therapy.
Future clinical trials that study safety and efficacy of anti-retroviral agents with respect to virologic and immunologic
endpoints may be considered deficient if they do not include at least 1 acceptable measure of adherence to therapy.
Indeed, simultaneous measurement of adherence by 2 different methods may be the best approach. In addition, there is a
need for studies that directly assess strategies that are designed to increase adherence.
Finally, important lessons can be drawn from studies of adherence among patients with other chronic diseases, where
there is a larger body of published literature. Both the factors related to adherence and many of the interventions to
improve adherence to other medications may largely overlap with those important to antiretrovirals [27]. For example, a
recent review of hypertension stated the following: Once-daily dosing should be coupled with selection of a drug with
long duration of action to overcome problems of missed doses. Widespread adoption of simple compliance enhancement
methods could lead to decreased morbidity and mortality [32]. Incomplete compliance with any long-term medication is
a multifactorial problem, but it is a problem that can and must be addressed.
Summary
It is important to recognize that some degree of nonadherence is common and should be expected in all patients who are
receiving antiretroviral therapy. The first step toward addressing the problem of medication nonadherence is to accurately
identify patients whose risk of nonadherence is sufficient to undermine clinical outcomes. However, a number of studies
have demonstrated that health-care providers cannot accurately identify those patients likely to be nonadherent. Studies of
large samples suggest that substance abuse is associated with nonadherence. Therefore, health-care providers may want to
be careful to ask patients with histories of substance abuse about adherence. It does not follow, however, that all patients
who abuse substances will be nonadherent. Similarly, homelessness, lack of education, and mental illness are not
necessarily predictors of nonadherence, but might warrant extra attention and support. Furthermore, the absence of
alcohol and drug abuse does not predict good adherence. Steps to maximize adherence, therefore, should be reviewed with
all patients. Although self-reports tend to overestimate adherence, they are inexpensive and fairly accurate for providing
an indication of problems. In particular, reports of nonadherence are reliable and call for action. Such reports also help to
determine why HIV-infected patients are nonadherent. Of the available methods, self-reports are the most practical for
routine use in the clinic. Once nonadherent patients are identified, health-care providers may want to implement a variety
of interventions to enhance adherence. Strategies for intervention are likely to be based on tailoring the drug regimen to
the lifestyle of the patient and assessing adherence as part of a follow-up program.

Previous SectionNext Section

Footnotes

Financial support for this research was provided by National Institutes of Health grants to the Center for AIDS
Prevention Studies (MH42459) and the Center for AIDS Research (MH59037).

2000 by the Infectious Diseases Society of America

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