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Featured Story April 23, 2008 More Effective HIV/AIDS Therapies Lead to a New Set of Management ChallengesReprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively. By Angela Maas, Managing Editor, (amaas@aispub.com) Similar to how cancer has become a chronic disease, people diagnosed with HIV/AIDS are living longer, healthier lives. Newer therapies are holding the virus in check for longer and easing the symptoms. But while many of the comorbid conditions that would traditionally have affected these patients are no longer as common as they used to be, they have been supplanted by different illnesses that require just as much management. The U.S. Centers for Disease Control and Prevention (CDC) says that in 2005, the latest figures available for this, more than 1 million people in the United States were living with cases of HIV infection, regardless of whether they have progressed to AIDS, the final stage of HIV infection. Almost 40,000 per year are diagnosed with HIV/AIDS, and more than 500,000 between 1981 and 2006 have died of it. From 2002 to 2005, the number of annual AIDS diagnoses — about 37,000 — and deaths — about 16,000 — remained stable, says the CDC. In 2006, the number of cases remained stable, but the deaths decreased to approximately 14,000. The CDC says it is too early to know whether that trend will continue. Nevertheless, experts agree that better treatments are prolonging patients' lives. The FDA has approved 30 drugs, including three since last August, for the treatment of HIV. Of those three, two — Pfizer Inc.'s Selzentry (maraviroc) and Merck & Co.'s Isentress (raltegravir) — are the first therapies in their respective classes. All three therapies are indicated for use in patients who have developed resistance to other therapies. Managing HIV/AIDS patients is very similar to the approach with other conditions and disease states treated with specialty pharmaceuticals, says Lynn Nishida, director of clinical pharmacy services for The Regence Group. There is not a cure, so suppressing the disease and preventing it from progressing is the goal. Managing the disease's complications, as well as the side effects from the drugs, is crucial. Moreover, "the drugs are expensive, and so is the investment needed to make sure that patients are taking them appropriately," she says. Compliance with their therapies is absolutely critical for patients, but the issue is complicated by extensive treatment regimens. Many HIV/AIDS patients are on a protocol where there is a cycle of drugs, says Ed Pezalla, M.D., national medical director for Aetna Pharmacy Management. "Having more [treatment] choices is helpful in getting patients in cycles they tolerate," he says. However, "figuring out which drug they are resistant to" can be a challenge, Nishida says, because "these drugs are usually used in a combination and rarely as stand-alone therapies." There are, however, "standard combinations…and practice guidelines for rearranging drugs within a combination if they are not working." Treatment regimens of numerous drugs can also be challenging because "it is not uncommon for patients to be on 20 products a day," says Nishida. Patients may be taking "multiple medications and multiple pills multiple times a day." While many of the newer products need to be taken only once or twice daily, as opposed to four or so daily doses of older therapies, "this is still a challenge because of the amount of tablets that patients need to take at those times," she says. Noncompliance Leads to Drug Resistance Although side effects, most commonly nausea and vomiting, have certainly been lessened in newer therapies, they still plague patients. This means that so-called "drug holidays," or when patients stop taking their medication, continue to be an issue with HIV/AIDS management. "Compliance is the biggest driver" of patients developing resistance to a drug, says Richard Tinsley, a partner with consulting firm Putnam Associates. "When drugs are taken less often, patients develop a resistance faster." Additional compliance problems can arise from psychological vectors as much as anything else, says Glen Pietrandoni, program manager for HIV/AIDS and hepatitis with Walgreen Co. "Patients are still sensitive to taking their pills in public and carrying them around," he says. Measuring compliance and adherence is also difficult with HIV/AIDS patients, says Nishida, since it's hard to know whether a patient stopped taking a medication because he or she was unhappy with the side effects or the pill burden or because his or her therapy changed. "You don't see a lot of adherence studies because of this," she says. In the United States, "HIV/AIDS has been a chronic disease for many," says Pezalla. "That's not to say that some people don't die from complications" of it, he adds. Many of the patients who were being treated for HIV/AIDS when the disease was first identified in the 1980s had Kaposi's sarcoma, "rampant infections of the gastrointestinal tract and infections of the lungs," says Pezalla. "They died at a pretty alarming rate" from many autoimmune infections. "We're now seeing fewer of those in patients," he says. However, as these patients are living longer, they are suffering from some different afflictions than HIV/AIDS patients traditionally have. While many patients used to suffer from wasting syndrome, and some still do, a recent study from physicians at the TriService AIDS Clinical Consortium in San Diego found that obesity is now more of a problem among people with HIV/AIDS. Both conditions may lead to problems with high cholesterol, diabetes and heart disease, which can be exacerbated by some of the HIV/AIDS drugs. Treating these other conditions means patients' drug regimens are even more complex. "One challenge that is pretty new is there is a whole generation of older patients" who have conditions generally relegated to that demographic, such as diabetes and heart disease, says Paul Bogorad, Ph.D., senior manager for Putnam Associates. The CDC says more than a quarter of people with HIV/AIDS are more than 50 years old. Many of them suffer heart attacks and strokes, says Pezalla. "Some of these [HIV/AIDS] drugs have a lower impact on cholesterol," notes Tinsley. "Who would have thought 10 years ago that we'd be worrying about cardiac disease risk?" Another issue is that "it is unclear at some level — even when the virus is under control — what the virus does to the body to enhance the ability to develop other conditions, both mental and physical," says Tinsley. "It is also unclear what the long-term consequences of the drugs are." According to Pezalla, end-stage renal disease (ESRD) in the HIV/AIDS population is seen "at a much higher rate than in the general public — up to 30% higher," as patients' kidneys deteriorate over time. "The management of kidney disease can become an issue," he explains. This might mean that patients will need to cut back on some of the drugs they are taking. "It is not uncommon for some of the medications to cause liver toxicity," says Nishida. Physicians may need to take patients off therapies or reduce doses of some drugs. There is "a host of drug-drug interactions," she says, so "it may be hard to decide if [adverse reactions] are the result of a drug or the disease itself." Patients may also be on cholesterol or blood pressure medications, which may be contraindicated as well. "Physicians may need to be more aggressive in preventing ESRD and kidney disease," which may mean the patient will be treated "more aggressively with kidney-protective drugs," says Pezalla. So a patient may be on six or seven kidney medications and three to five HIV/AIDS drugs. These medications may be taken at different times, some with meals and some on an empty stomach, all of which translates into a complicated regimen, he says. For this reason, he maintains, "case management is definitely helpful." Having a specialty pharmacy manage these patients can be extremely beneficial and cost-effective, asserts Pietrandoni. Patients are often switching therapies, and new drugs are continuously coming onto the marketplace. Patient overdosing and underdosing may also occur, as may drug interactions with both other HIV/AIDS medications and drugs for comorbid conditions. |
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