New HIV primary care guidelines broaden focus, stress adherence
New HIV primary care guidelines broaden focus, stress adherence
'A big push to get patients to remain in care.'
In the world of HIV medication therapy and care, five years can make a world of difference.
Since the Infectious Diseases Society of America (IDSA) released its primary care guidelines for management of persons with HIV in 2004, a number of pharmaceutical advances and population trend changes have occurred.
"We did quite a bit of changes more than we originally thought would be involved," says Judith Aberg, MD, an associate professor of medicine at New York University (NYU) and director of virology at Bellevue Hospital Center in New York, NY. Aberg also is the director of the AIDS clinical trials unit at the NYU School of Medicine.
Aberg is the lead author of the new guidelines, which are titled, "Primary Care Guidelines for the Management of Persons Infected with Human Immunodeficiency Virus: 2009 Update by the HIV Medicine Association of the Infectious Diseases Society of America." The guidelines were published in September in the Clinical Infectious Diseases journal.1
"There have been continual, tremendous improvements in the management of HIV because of the availability of newer drugs," Aberg says. "These are more tolerable and patients are living longer, so we're seeing more patients who are developing what we call traditional common diseases, like heart disease, malignancy, and other diseases we see as we age."
The guidelines were reformatted to add consistency to their presentation, Aberg notes.
"Every heading would start with a question, which is different from what we did in the previous version," Aberg says.
For example, the guidelines include these headings:
- What is the optimal way to diagnose HIV infection?
- What risk-screening measures and interventions are appropriate for HIV-infected patients?
- What initial evaluation and laboratory testing should be performed for HIV-infected patients?
- How is HIV disease staged?
- What is the schedule-of-care evaluation for HIV-infected patients?
- What are the special considerations for women?
- What are the special considerations for mother-to-child transmission and children?
- What are the long-term metabolic complications associated with antiretroviral therapy?
- How can patient adherence to HIV care be optimized?1
Another major difference in the 2004 and 2009 versions is that the revised guidelines emphasize the importance of adherence to care, as well as to medications, Aberg says.
"We're trying to change the focus and broaden it," Aberg says. "Someone can be adherent to medication, but we want to make sure they have all their concerns addressed and have the appropriate lab work."
Five years ago, antiretroviral drug regimens still were very complicated and had side effects and food restrictions, so it made sense to focus on the complexity of adhering to these different regimens, says Joel Gallant, MD, MPH, an associate professor of medicine and epidemiology at Johns Hopkins School of Medicine in Baltimore, MD. Gallant is one of the guidelines' co-authors.
"Now, over time the regimens have become much easier to adhere to," Gallant says. "So we're finding the challenge is different."
A major reason for patients' ART failure now is their being lost to follow-up and not adhering to their overall medical care, he notes.
"There's a big push to get patients to remain in care," Gallant says.
Part of this shift involves the demographics and histories of the people who now are not adherent to care and treatment.
Five to ten years ago there were more people who were having difficulty with medication adherence because of the drugs themselves. Once the drug regimens were simplified and became more effective, the group of people remaining non-adherent included more people with socioeconomic challenges, such as substance abuse, homelessness, mental illness, and chaotic lifestyles, Gallant explains.
"We know that virologic failure is much less likely than it used to be," Gallant says. "But we still see people who fail because they stop taking their medications for one reason or another."
At Bellevue Hospital, there's a greater emphasis put on primary care and the need for HIV patients to be in care, Aberg says.
"We've gone away from giving people five or six months of refills," she says. "We give people for the most part three-month refills, and we prefer they come in a week before their visit to get lab work done."
Therefore, when HIV patients have their clinic visit their lab results are available, and clinicians can go over their CD4 cell counts, viral load, and other test results, Aberg explains.
Another important change in the revised guidelines involves the recommendation that all HIV-infected patients should have a genotypic resistance test performed at baseline, even when ART will not be initiated immediately.1
"We used to say you should have a resistance test at baseline if you're going to start medications," Gallant says.
The change recommends resistance testing soon after someone is diagnosed with HIV, regardless of whether he or she will be given ART now or months or years in the future.
"The reason for that change is because the test will be most accurate if it's performed as soon after infection with HIV as possible, before there's an opportunity for mutations to refer back to wild type virus," Gallant explains. "An early resistance test gives you a more accurate picture of a patient's resistance profile."
The results can be saved in the patient's medical record and referred to when ART finally is initiated, he adds.
Research has shown that mutations over time can lead to HIV mutating back to wild type, but leaving the transmitted resistance virus resting in low levels in CD4 cells. So if genotypic testing is first done right before a patient begins ART, the results might suggest the patient is not resistant to standard treatment-naïve therapy, even when resistant virus exists and can quickly lead to medication failure, Gallant explains.
"You need to know up front whether an individual has any mutations that could confer resistance to any ART," Aberg says.
Five years ago, genotypic resistance testing often wasn't done until a patient had begun the first regimen and failed on it, Aberg notes.
"For quite a few years, this was a consideration for baseline testing, and now we've said 'Enough already! We've seen enough baseline transmitting of resistant virus, and we should do something about this up front,'" Aberg says. "You don't want to give someone a medication regimen that's doomed to fail."
When HIV clinicians first see a patient who has been newly diagnosed with HIV, they should confirm infection and conduct other screening tests, Aberg suggests.
"Then we wait for the viral load to come back, and we ensure there's enough virus to do a genotypic test," she says. "You need over 1,000 copies to do a genotypic resistance test."
If clinicians believe the patient should be started on antiretrovirals immediately, they'll choose the best regimen, sometimes starting with one that will cover most common mutations in the area, and then wait for the genotypic testing results to return, Aberg says.
The revised guidelines should serve as recommendations for clinicians to use as a tool for their own patient care, Aberg suggests.
"It's up to each clinician to say how these guidelines apply to their particular patient," she ads. "They have to be tailored individually."
HIV clinicians also should keep in mind that these revised IDSA guidelines are written with HIV patients' primary care needs in mind, Gallant says.
For example, the guidelines include a table of routine health care maintenance for HIV adults, and these include the following interventions:
- blood pressure check;
- digital prostate examination;
- ophthalmologic examination;
- depression screening;
- fasting glucose;
- fasting lipid profile;
- syphilis serology;
- gonorrhea and chlamydia testing;
- prostate-specific antigen;
- tuberculin screening test;
- colonoscopy;
- mammography;
- cervical pap smear;
- bone densitometry;
- abdominal ultrasonography;
- patient education.
"There is an emphasis on bone health, cardiovascular disease prevention, and a lot of other medical needs that we're recognizing as part of HIV care, but which are not on the traditional list," Gallant adds.
Reference
- Aberg JA, Kaplan JE, Libman H, et al. Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV Medicine Association of the Infectious Diseases Society of America. CID. 2009;49:651-681.
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