Clinicians explore ways to ensure compliance
Clinicians explore ways to ensure compliance
More counseling needed
With combination therapy requiring more than a dozen pills taken daily — and possibly for a lifetime — the prescription for fighting HIV today is so demanding that compliance has emerged as one of the biggest issues in HIV care. And while research is lacking in HIV therapy compliance, clinicians are exploring everything from directly observed therapy for the homeless to delaying treatment until patients are trained and prepared to take their pills.
Whatever strategies and incentives prove most helpful, experts agree that more time must be devoted to patients before they initiate therapy.
"There isn’t a list of tips right now because it’s so complicated," says Marcy Fraser, RN, assistant to the chief of health and prevention services at the San Francisco Department of Health’s Office of AIDS. "We acknowledge that it takes a lot more time and it takes a team of people — not just physicians, but nurses and people in community and home visitors and treatment advocates."
At the Johns Hopkins University AIDS outpatient clinic in Baltimore, clinicians may take more than one or two sessions to educate patients about protease inhibitors and discuss the drugs’ demands before prescribing them, particularly if the patients are known to have a history of noncompliance or missing appointments.
"We might spend a few extra sessions trying to educate the patient before prescribing them something because they might not be ready to start them," says Lois Eldred, PA-C, MPH, who treats patients at the clinic and has recently completed a study on compliance in AIDS patients.
Patient compliance is an old medical problem, but with HIV it has been the focus of growing concern, particularly with the approval of protease inhibitors. The remarkable results of this new class of drugs come at a steep price in the form of a difficult regimen. Moreover, patients are warned that suboptimal dosing or missed doses can reduce efficacy and increase the likelihood that resistance will develop and their arsenal against the virus will be spent.
From her recent study of patient compliance, which followed patients before protease inhibi tors were available, Eldred does not doubt that compliance will become a serious problem. In one of the few studies of compliance in HIV treatment, Eldred followed more than 200 patients attending the AIDS outpatient clinic. She gathered information from medical records, pharmacies, and patient interviews to document factors that hinder compliance. In a subset of patients she also used urine assays to track adherence.1
What she found was that compliance is a significant problem, even for the 70% of patients who were taking monotherapy. Out of 74 patients on zidovudine (AZT), 28 — or 38% — reported missing more than nine capsules in the past week.
"Self-reporting notoriously underestimates compliance, so assuming it’s probably greater than that and you need something like 80% to 90% adherence for protease inhibitors to be effective, you know you have a big problem," she says.
Physicians are poor at predicting adherence’
Researchers at Johns Hopkins and other universities are trying to test interventions that may improve compliance, such as pill caps that monitor each time a bottle is opened. For now, however, clinicians have few incentives known to get HIV patients to take their pills. Moreover, they have little insight into predicting who the noncompliant patients will be.
"Physicians are notoriously poor at predicting patient adherence," Eldred tells AIDS Alert. "Even frequency and severity of symptoms have little to do with adherence, and in general, disease type [i.e., alcoholism, mental illness, injection drug use] doesn’t predict adherence well either."
Because so many factors can influence whether a patient adheres to HIV therapy regimens, clinicians should consider tailoring medications to fit a patient’s lifestyle, she says.
"Although tailoring sounds vague, it can be extremely helpful. You need to look at each individual and the issues they are dealing with in their lives," she explains.
Helping patients organize their lives around taking medications, providing medication calendars and treatment kits to jog memories and track pill taking, and periodically contacting patients to monitor compliance can help ease the burden of adherence, Eldred adds.
A recent round-table discussion in San Francisco on treating patients with multiple diagnoses, such as substance abuse and mental illness, raised the importance of possibly needing to treat other problems in a patient’s life before HIV, particularly if those problems get in the way of compliance.
"If we can address their primary diagnosis and stabilize them, they can feel better on protease inhibitors in many cases," Fraser says.
In San Francisco, where an estimated 10% of homeless people are infected with HIV, public health officials have been debating the pros and cons of offering the newest HIV treatment regimens when poor compliance can have such negative consequences. With tuberculosis, lack of compliance contributed to the rise of multidrug-resistant strains, and ultimately, to a large infusion of funding to pay for directly observed therapy (DOT). Some homeless shelters have considered offering DOT for AIDS patients, but the prospect of providing daily observed AIDS therapy indefinitely is daunting.
Taking cues from TB
Sarah Bur, MD, Maryland’s state TB controller, has discussed ways that AIDS programs can learn about compliance from TB programs. Bur says DOT, which is offered with twice-weekly therapy, is not feasible with the current HIV drug regimens.
"The issues related to adherence and drug resistance are very similar to the two groups," she says. "However, the frequency with which AIDS patients have to take medication makes it an entirely different battle than with TB."
For AIDS patients taking three-drug combinations — a "cocktail" that has become standard for many patients with high viral load — the number of pills ingested daily can reach more than 20, often taken twice or three times a day. Moreover, some must be taken on an empty stomach, others on a full stomach.
Using peers instead of health care workers for DOT is one possible approach. Another possibility is using beepers to remind patients to take their medications.
At a time when dollars are being stretched just to pay for antiretroviral therapy, spending resources on getting noncompliant patients to take their medications strikes many AIDS activists as a misplaced priority. But studies of drug adherence for other diseases show that compliance cannot be predicted by race, education, socioeconomic status, or even the degree to which one is sick. And as Eldred found, the same holds true with HIV.
"I am very concerned about physicians or clinicians jumping to conclusions about who will or will not be adherent, particularly in relation to class," she says.
Even for injection drug users, who have been shown in some studies to be less compliant for TB medications, predictions about adherence may not be accurate. "Somebody who has been an injection drug user previously and was unable to keep appointments may be in remission from drug use and be completely willing to try, so you really need to give patients the benefit of the doubt," she says.
Fraser agrees. "It’s not as simple as some would like. A lot of people who treat homeless people have been surprised [by their compliance]."
Although the new combinations of anti-HIV drugs are difficult to adhere to, they have had such a strong and immediate impact on patients’ health that the benefits may act as an incentive for compliance, says Charles Carpenter, MD, an AIDS researcher and associate professor of medicine at Brown University.
"I’ve had a number of patients who — probably, in retrospect, for very good reasons — were never compliant with nucleoside monotherapy, and yet have been extremely compliant with triple-drug therapy because they can see and measure the benefit," he says. "They follow their viral load, it drops, they are impressed, and they stick to that medication."
Reference
1. Eldred L, Wu A, Chaisson R, et al. Medication adherence to long-term therapy in HIV disease. Presented at the XI International Conference on AIDS. Vancouver, British Columbia; July 1996. Abstract # Mo.B.1165.
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