Leading AIDS experts at Johns Hopkins and other institutions around the world have issued new guidelines to promote entry into and retention in HIV care, as well as adherence to HIV treatment, drawn from the results of 325 studies conducted with tens of thousands of people infected with HIV, the virus that causes AIDS.
The guidelines are believed to be the first ever to focus exclusively on how best to get those newly diagnosed with HIV into treatment plans and to help them adhere to lifelong drug and check-up regimens.
Some 50,000 Americans each year are diagnosed with the potentially deadly, but now-treatable infection, and more than a million Americans already are known to be HIV positive.
However, experts worry that barely two-thirds of Americans with HIV disease, some 69 percent, have ever used potent antiretroviral drug therapy, or ART, to keep viral levels in the blood low. Still fewer, they say, 59 percent, continue their drug therapy, and less than a third, or 28 percent, have achieved near total viral suppression to keep the disease in check by carefully complying with treatment regimens and getting regular tests for viral load.
"Clearly, there is lots of room for improvement in how we, as care providers, can get new patients into treatment and help them adhere to the often strict drug regimens needed to suppress the viral disease and prevent drug resistance," says guidelines co-author and infectious disease specialist Larry W. Chang, M.D., M.P.H.
The need is urgent, he says, because other research has shown that patients who miss follow-up medical visits within the first year after they begin outpatient drug treatment for HIV infection tend to be out of compliance with regimens, and, over the long term, die at twice the rate of those who keep their appointments.
Chang, an assistant professor at the Johns Hopkins University School of Medicine, was one of 31 experts worldwide, including three faculty members at Johns Hopkins, who drafted the guidelines on behalf of the International Association of Physician in AIDS Care, or IAPAC.
The guidelines were published online this week in the Annals of Internal Medicine and the publication was timed to coincide with the 19th annual Conference on Retroviruses and Opportunistic Infections in Seattle.
"We know that clinical care and antiretroviral therapy are very effective when we can convince our patients to follow their treatment plans and take their medications as prescribed, and much less effective when they don't," says internationally renowned AIDS researcher and infectious disease specialist John Bartlett, M.D., another guidelines co-author.
Bartlett, a professor and former chief and director of infectious diseases at Johns Hopkins, points out that adherence to ART is a key indicator of how well infected people will suppress the virus. Sufficient suppression is needed to reduce the risk of developing drug resistance, slow disease progression, prevent progression to death from AIDS, and lessen the likelihood of transmitting the virus to others.
The 37 recommendations that make up the guidelines were pulled together by an international team co-chaired by Jean B. Nachega, M.D., Ph.D., M.P.H., senior author of the guidelines and an associate scientist at the Johns Hopkins University Bloomberg School of Public Health, as well as a professor of medicine and director of the Center for Infectious disease at Stellenbosch University, Cape Town, South Africa.
"These novel guidelines are timely and overdue, especially now that successful treatment is as part of HIV prevention efforts," says Nachega. "We anticipate that they will be welcomed by both HIV care providers and patients, and that the guidelines will contribute to save lives and decrease the likelihood of transmission of the AIDS virus from mother to child or to sexual partners."
Key among the guidelines was the need for systematic monitoring and tracking of people newly diagnosed with HIV and those already under care to make sure they are actively involved in treatment decisions and properly following their treatment regimens.
Possible strategies to help newly diagnosed people include using patient "navigators," or personal guides, to help them sort through the various hospital and community services available, and to offer assistance with filling out paperwork for drug discounts or government aid.
Chang says that once people have kept their first clinic appointment, another system needs to be in place to follow up with them, keep them "engaged" (or personally involved in their care) and make sure they never "lose touch" with their care team. He says this could be as simple as periodic follow-up calls from a nurse or case manager to direct questions from physicians during clinic visits asking about adherence to medication.
More elaborate tracking systems, Chang adds, could include automated devices or systems that alert the pharmacist or physician to missed drug refills or to lapses longer than six months in booking regular physician check-ups. What is key, he emphasizes, is that physicians track their patients' visits and compliance with drug therapy and work more closely with pharmacies to keep track.
The expert panel notably calls for stopping practices that have proven ineffective or not feasible in routine clinical practice, including testing of hair and blood for drug levels, and counting pills to monitor compliance with drug prescriptions. People can always find ways to dispose of their pills, Chang says, to game the system, especially if they are worried about or bothered by drug side effects.
The experts say streamlining therapies wherever possible to include only drugs that need to be taken once daily, as opposed to two or three times a day, would help simplify drug-taking for people and improve ART adherence.
Patient counseling was found effective in keeping patients engaged in their care and ART compliant, but such counseling is best delivered one-on-one instead of in a group setting. This was especially the case in teaching patients how to use a pill box to sort multiple medications, and in offering helpful hints, such as taking medications all at once and at the same time of day, if possible.
Other recommendations were specific to people and groups disproportionately affected by HIV, including pregnant women, children, homeless people and prisoners. Methadone or buprenorphine therapy, for example, was recommended jointly with HIV treatment for those dealing with drug addiction to painkillers, especially heroin.
Worldwide, an estimated 10 million of the 34 million people infected worldwide with HIV receive drug treatment for their infection.
Chang says the group plans to launch an accredited, online medical education program to promote the new guidelines to other physicians and health care providers. The international team also has plans for further research into the value of patient navigators, peer support networks and other tactics to foster rapid entry into care for newly infected people or those who have never entered treatment.
Funding support for the guidelines, which took over a year to complete, was provided by the National Institutes of Health's Office of AIDS Research.
For additional information, go to:
http://www.hopkinsmedicine.org/doctors/results/directory/profile/0021498/larry-chang
http://www.hopkinsmedicine.org/Press_releases/2005/03_30a_05.html
http://www.jhsph.edu/faculty/directory/profile/1040/Nachega/Jean_B.
http://www.annals.org
http://iapac.org/
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