New drugs shift thinking on AIDS management

The role of HIV case managers is changing

It’s the best of times and the worst of times for individuals infected with HIV. The new protease inhibitor drugs and so-called "triple cocktails" hold great promise for infected individuals to lead longer, healthier lives. However, the drugs are only effective in about 30% of patients, require complicated medication regimens difficult for patients to comply with, and present many financial problems for patients who once believed their condition was terminal, say HIV/AIDS experts.

"We have patients who are once again asymptomatic. I had a patient come to me and say, ‘I sold my house, maxed out my credit cards, and took out a viatical settlement. I guess I’ll have to go out and buy a new house, because apparently I’m going to live,’" says Cade Fields-Gardner, MS, RN/CD, director of services for the Cutting Edge in Cary, IL, who provides nutritional counseling for HIV/AIDS patients.

And the AIDS death rate is dropping. "We have been treating and tracking AIDS patients since 1981," says Stephen Boswell, MD, medical director of the Fenway Community Health Center in Boston. "If you look at our data, three years ago we averaged seven AIDS deaths a month. If you look at our data for the past 12 months, we have between zero and one death each month."

As the death rate continues to drop, case managers must shift their thinking from crisis management to wellness and prevention strategies, says Fields-Gardner. "We have to focus more on wellness maintenance. We have patients doing so well we need to integrate more wellness management strategies into the care plan, such as exercise programs, improved nutrition, and adequate water intake."

"The key is to shift the view of the patient into an optimal health mindset," says Robin Foust, director of product and market development for Health Management Corporation (HMC), a disease management company in Richmond, VA. "The nurses who provide case management for our HIV program counsel patients on a wide range of lifestyle behaviors, including exercise, stress reduction, smoking cessation, and diet. As patients live longer and remain healthier, healthy lifestyle and financial planning become more important."

The compliance factor

Case managers also need to shift the way they view the so-called 80/20 rule, Fields-Gardner says. "We used to spend 80% of all total medical costs in the last two years of life. With the new HIV treatment regimens, we may need to shift the balance to 80% of costs in the early stages of infection and 20% for hospice and other end-of-life care."

Case managers also can help patients work more effectively with their physicians, Foust says. "Patients only have about seven minutes to spend with each patient. That’s not enough time to adequately discuss a complicated medication regimen or address all the concerns of the patient. Case managers can help patients organize their questions and concerns prior to office visits. They can also help educate patients about the importance of medication compliance."

The bottom line is that compliance preserves the immune system, Boswell says. "With the protease inhibitors, we’re having excellent success keeping levels of virus down to undetectable levels and keep CD-4 counts high. This is important because the one thing that we can’t do yet is reconstitute someone’s damaged immune system."

Eleven drugs have been approved for treatment of HIV infection. They can be used in 155 different combinations of so-called "triple cocktails," Boswell says. The drug cocktails include two antiviral drugs, such as AZT, with one potent protease inhibitor, such as indinavir. (For more information about new treatment guidelines, see story, p. 156.)

Failure to comply with complicated medication regimens is perhaps the leading reason the triple cocktail fails in many HIV/AIDS patients, Boswell says. "It’s one thing to give a patient who is sick three separate drugs, often a total of 36 pills a day, to make them feel better. But earlier intervention means that we are often giving individuals who feel well three separate drugs, or 36 pills, in order to keep them well, when the pills make them feel sick," he says. "Case managers can play a role in helping patients understand the importance of early intervention and helping patients adhere to treatment regimens."

The new protease inhibitors also are expensive. "The protease inhibitors range from $5,400 to $7,500 a year. When they are combined with a reverse transcriptase, such as AZT, the cost soars to about $12,000 annually. And that’s just for drugs; it doesn’t include the costs of office visits or lab tests," says John Roberts, MSN, RNCS, ANP, assistant clinical director of the AIDS program at the Community Medical Alliance in Boston. (For information on drug assistance programs, see chart, p. 155.)

Although the new triple cocktails come with a high price tag, the cost of HIV care is surprisingly low compared to other types of specialized care for the chronically ill, Fields-Gardner says. "I recently met with a health economist who explained to me that the current price tag for HIV was $10,000 per year of life saved. By comparison, the current acceptable cost for leukemia is $50,000 per year of life saved."

Along with the new drugs comes an increased need to monitor their effectiveness in reducing the amount of virus in the blood, Boswell says. "The best test we now have is the viral load test, which measures the amount of virus in the bloodstream. While CD-4 counts measure how well the immune system is doing, earlier intervention dictates regular use of the viral load test to measure the effectiveness of drug therapy."

Unfortunately, the viral load test is expensive. "The test needs to be repeated four to six times a year for each patient," Boswell observes. "At Fenway we care for more than 800 people who are HIV-infected, and we spend $400,000 annually on this test alone."

Perhaps due to the expense associated with viral load testing, less than 50% of all HIV-infected individuals are having this test performed, he says. "It’s important from a case management standpoint that we talk to practitioners about the use of these tests and make sure that they are used to monitor the effectiveness of drug regimens."

To further complicate these already complicated three-drug regimens, failure to comply with the prescribed dosing schedules often leads to earlier drug resistance, Roberts says. "It’s important that patients take medications as prescribed, on time, all the time, or there is a risk of quickly developing drug resistance."

Case managers should work with patients and physicians to make drug regimens as uncomplicated as possible, Roberts says. "The new mantra is: Hit hard. Hit early. This is fine if you’re dealing with the virus in a test tube, but when you are working with the virus in people, other variables must be considered." He suggests case managers consider these issues:

• Which combinations of drugs can be taken at the same time, rather than several hours apart?

• How do the patient’s work schedule, normal meal times, and normal sleep patterns fit with the proposed drug regimen?

• What social supports does the patient have to help support the medication regimen?

• What are the potential side effects of each drug — or of the drug combination — and how can they be minimized?

• Does the patient have a refrigerator to store medications properly?

• Does the patient have any existing drug dependencies or drug habits that make the proposed regimen a poor choice? (For details on drug interactions, see chart, at left.)