HIV/AIDS & e-pill
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Pill Box Organizers – Handy Tool For HIV-Afflicted
The FDA has recently approved Gilead's Complera, the second complete HIV treatment in a single, once-daily pill.
Complera is a combination of Truvada (which combines the nucleoside reverse transcriptase inhibitors Emtriva and Viread) and the non-nucleoside reverse transcriptase inhibitor Edurant.
Truvada has been around since 2004 and is a popular component of so-called "AIDS drug cocktails" or combination HIV therapy. Edurant, also known as rilpivirine, was approved last May.
The first single-tablet regimen for HIV, Gilead's Atripla, was approved by the FDA in 2006. Yet another single-pill treatment from Gilead, the four-drug Quad, is in advanced clinical trials.
Complera is approved as a first-line treatment for adults with HIV infection who have not yet begun treatment with any other HIV medications.
It's not for everyone, as different doctors may prefer to prescribe different HIV drug combinations for different patients. However, the once-daily formulation makes it much easier for people to take their medication exactly as prescribed. That's extremely important for people with HIV, as the AIDS virus can quickly become resistant to HIV drugs when doses are missed.
Like all HIV drugs, Complera can have serious side effects. These include lactic acidosis and severe liver damage -- side effects linked to most drugs in the class of nucleoside reverse transcriptase inhibitors when given as part of combination therapy.
Find out more about how you can improve HIV/AIDS care in your community. How can you become a better (more compliant) patient? Never forget to take your medications again with an e-pill Medication Reminder!
Inexpensive pill box organizers are touted as an easy and cost-effective tool to help patients take their medications as directed to.
This comes from a new study of low-income urban residents living with HIV infection by authors from the Berkeley School of Public Health and the University of California, San Francisco. The research is published in the Oct. 1 issue of Clinical Infectious Diseases, now available online.
Clinicians and pharmacists can meaningfully improve treatment outcomes with simple and inexpensive strategies, such as pill box organizers, to help people organize how they take medication,” said senior author David Bangsberg, MD, MPH, of UCSF.
Incomplete adherence to HIV therapy is the most common cause of incomplete viral suppression, drug resistance, disease progression, and death among people living with HIV/AIDS.
The subjects of this study, who were recruited from homeless shelters, free food programs, and single-room occupancy hotels, are thought to be at elevated risk for poor adherence partly because of the high rates of substance abuse, untreated mental illness, and unstable housing.
Patients in this difficult-to-treat population were given inexpensive pill box organizers to use with their antiretroviral medications. Study organizers made a total of 3,170 unannounced visits every three to six weeks to the subjects’ places of residence and compared the number of pills remaining in the patients’ possession with the number that would be expected to remain if the patients were perfectly compliant with the treatment regimen.
Pill box organizers were associated with a 4 percent improvement in adherence, 0.12 log reduction in HIV viral load, and an estimated 11 percent reduction in the risk of progression to clinical AIDS. At only $5 per pill box, this intervention was highly cost-effective.
“While this population has often been regarded as having difficulty with adherence,” the authors write, “adherence problems are by no means limited to patients with low socioeconomic status.”
Lead author Maya Petersen, PhD, from the Berkeley School of Public Health, adds, “Incomplete adherence is a major problem that prevents people from realizing the full benefits of a wide range of treatments for chronic diseases, such as hypertension and diabetes mellitus. Thus, the findings of this study have the potential to inform a wide range of diseases, not just HIV.
“It would be interesting to explore whether changes in packaging or delivery of antiretrovirals and other drugs could be used to reproduce the benefits of pill box organizer use. One model to consider is oral contraceptive therapy, which is routinely dispensed using labeled blister packs, a kind of pre-packaged version of a pill box. Antiretroviral regimens are generally more complicated, but a modification of this general model at either a pharmacy or manufacturer level might be possible, with wide-ranging patient benefits.”
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Adherence Strategies: HIV pill reminder device shows some adherence improvement
Researchers studying a population of HIV patients found that a pill reminder improved adherence for those who were memory impaired. 1
One reason patients don’t take medications is because they simply forget it, and its more of an issue in the population we studied because some started with mild cognitive impairment, says Adriana Andrade, MD, MPH, an assistant professor at Johns Hopkins University Division of Infectious Diseases in Baltimore, MD.
So a device that prompts your memory and tells you what to take and when to take it might over come some normal memory impairment that comes with this disease, Andrade says. I think these findings raise a very important point, maybe not just for HIV-infected population, but for the elderly population as well.
Investigators used a Disease Management Assistance System (DMAS) device developed by Adherence Technologies Corp. of Dulles, VA. The device was battery-powered with a digital signal processor to produce a timed, programmed voice message. It also records data about when medication was taken after the person using it presses a response button.
The study measured antiretroviral drug adherence using electronic drug-exposure monitoring (eDEM) caps.
At 24 weeks in the study, the HIV patients with mild memory impairment who used the DMAS device had a significantly higher adherence rate than did memory-impaired subjects who did not use the device, with 79 percent adherence versus 56 percent adherence among the control group.
Although the HIV patients without memory impairment also tended to have greater adherence in the DMAS device group, when compared to a control group, these differences were not significant, Andrade says.
Subjects with mild memory impairment were not HIV patients with dementia, but were those who were able to go about their daily routine and take medications on their own, Andrade explains.
The only way to find out if they had memory impairment was to do psychological testing like I did, Andrade says. So what we found was that among the patients who got the device, the memory-impaired subjects were the ones who benefited the most from the device.
The adherence percentages didn’t raise for any group to the high levels of adherence that researchers say is necessary to obtain optimal suppression of the virus, Andrade notes.
The point is that there might be a subset of HIV-infected patients with mild memory impairment where this high cutoff might be unachievable, Andrade suggests. Or in order to be achieved we will have to use much more frequent monitoring and come up with ways to help these patients take their medication and improve their compliance.
The DMAS device was small and rectangular with a play button and yes key and advice button.
Patients had the option to carry it in a pocket or camera case or fanny pack, Andrade says.
When the device beeps and the light on the play button blinks, the patient could press the play button to acknowledge the beep and to hear the recorded message that would tell the patient to take this particular medication in this dosage, Andrade says.
Then when the patient took the medication, he or she could press the yes button, which would record the time and date of their taking the medication. The patient also had the option of pressing the advice button to hear additional instructions, such as, Take one tablet on an empty stomach, Andrade explains.
To assuage privacy concerns, the process was set up so that the verbal message did not come on unless the patient pressed play. This way the patient could take the device to a private area before hearing the reminder, Andrade says.
Interestingly, the company that made the device has abandoned that design and has created a cell phone reminder tool instead, which is being sold as a service for pharmacies, Andrade says.
Patients enrolled in the study were on a variety of antiretroviral regimens for a total of no more than three different regimens, Andrade says.
We looked at very experienced in terms of exposure and at antiretroviral-nave patients, Andrade says. We wanted a representative sample for the study.
The main lesson from the study is that adherence interventions need to be individualized since not every approach helps each person the same way, Andrade says.
Also, as patients infected with HIV age, the prevalence of mild forms of cognitive impairment might be increasing, Andrade says.
For this population, the message is that caregivers must be aware of the negative impact that even a mild cognitive impairment can have on HIV therapy, Andrade says. So providers should be aware of that and explore other adherence aids that can help this patient population with antiretroviral medication.
Andrade AS, et al. A Programmable Prompting Device Improves Adherence to Highly Active Antiretroviral Therapy in HIV-Infected Subjects With Memory Impairment. Clin Infect Dis. 2005;41(15):875-882.SOURCE-AIDS Alert Adherence Technologies Corp.