Washington — Antiretroviral (ARV) therapy is proven to stop replication of the HIV virus and prevent the most devastating effects of HIV infection, including progression to full-blown AIDS and death. Despite that knowledge, many patients neglect their drug regimen and allow the disease to progress again.
A doctor at the Perelman School of Medicine is working with both international and U.S. patients to find ways to keep them on their medication. "We are not talking aberrant, abnormal behavior," said Dr. Robert Gross, an associate professor of infectious diseases and epidemiology at Perelman, located at the University of Pennsylvania in Philadelphia. "Non-adherence to medication is absolutely universal. It is virtually impossible to take every single dose of your medicine as prescribed."
For some diseases, pain offers a reminder to take medicine. But when you are not having urgent symptoms -- as is the case with high blood pressure, high cholesterol and early HIV infection -- missing a dose is easy. Life gets in the way. Your child is ill; your spirits are low; the roof is leaking.
Gross isn't judgmental about why someone falls off their medication routine. He just wants to find ways to minimize the failure or prevent it. The need for solutions is especially urgent with those on ARV therapy. These medications have transformed what was a terminal disease into a manageable chronic condition, and successful treatment is effective at preventing spread to others.
Efforts of the United States and other international donors to increase the availability of ARV therapy to the developing world has been a "huge, huge success" for public health. But staying on the therapy, Gross said, is "critical with HIV." An on-again, off-again pattern of ARV use can allow the virus to mutate into another form, an HIV strain that is resistant to the ARVs.
If the patient then engages in unsafe sex or other means of transmission, a more dangerous virus may be let loose, Gross said. "Now someone else walks in [to the clinic] with HIV that's not treatable with the standard drugs."
MANAGED PROBLEM SOLVING
In late January JAMA Internal Medicine published results from a study that Gross conducted with U.S. HIV patients that showed they had greater success following their medication regimen with the help of a counselor. The counselor helped patients identify personal circumstances that disrupt their medication schedule. Then, in a collaborative way, the counselor works with the patient to devise behavior to avoid or overcome the circumstance. Gross calls this strategy Managed Problem Solving (MAPS).
Linking the medication schedule to other established habits in life is one strategy, Gross said. Put the pills next to your toothbrush. Set a cell phone alarm as a reminder. Tape a note to the mirror.
Some patients may resist taking the medication because they develop uncomfortable or embarrassing side effects. Gross said patients should ask how to avoid the side effects, but stay on the medication.
Gross' study of the MAPS method involved 180 patients receiving care at several Philadelphia HIV clinics. Half received MAPS training; half received basic care including a discussion with a pharmacist about their medications.
The MAPS group was almost twice as likely as the other group to follow the proper drug routine. The research also found that higher adherence also correlated to improvement in a key marker of patient survival.
"They had lower amounts of virus in the blood than the control group," Gross said. "That's really good evidence that the intervention works."
With funding from the U.S. National Institutes of Health (NIH), Gross is running a trial on another method for improving drug adherence among HIV patients. He calls it partner-based support, defining a partner as any person who has a large presence in the patient's life -- spouse, parent, child, friend or sibling.
"We trained partners how to be encouraging about adherence but not scolding, how to be helpful without nagging," Gross said.
Gross and his team now are analyzing the data resulting from the partner-based treatment strategy, with conclusions expected in the near future. The study included patients in Botswana, Zimbabwe, South Africa, Uganda, Zambia, Brazil, Peru and Haiti.
The MAPS training program is available for free download at http://www.med.upenn.edu/cceb/maps-form.shtml.
The U.S. has directly supported life-saving antiretroviral treatment for nearly 5.1 million men, women and children worldwide through the President's Emergency Plan for AIDS Relief (PEPFAR). The agency reported in December that an estimated 8 million people in low- and middle-income countries are currently receiving ARV treatment; nearly 6.8 million receive support through PEPFAR bilateral programs or the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria.
The Global Fund began in 2002 as a vehicle to distribute funding for ARV therapy and other treatment and prevention efforts worldwide. The U.S. remains its single largest donor, having donated almost $7.3 billion, with a pending pledge to donate almost $2 billion more.