The first-year costs to manage a single symptom of an increasingly common complication associated with HIV/AIDS therapy could range from $410 to $7,369 per patient, according to a pharmacoeconomic modeling study presented at the 40th annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Fat maldistribution and metabolic abnormalities (FMMA), often is referred to as "lipodystrophy syndrome," but currently there is no consensus among experts on whether this is a broad syndrome or multiple independent conditions.
Fat maldistribution in HIV-infected patients is a disorder characterized by the redistribution of body fat to places such as the stomach and the back of the neck, or wasting of fat from the arms, face or legs. Metabolic abnormalities include abnormally high lipid or glucose levels in the blood and insulin resistance. These metabolic disorders often are seen in combination with fat maldistribution, but they also may occur in patients with no noticeable changes in body fat.
Although the exact cause of FMMA is unknown, it has been associated with HIV/AIDS drug therapies. Approximately half of the patients taking protease inhibitors and 3 percent to 4 percent of patients taking other antiretroviral therapies will experience one or more symptoms, according to a modified Delphi panel of experts convened as part of the study presented today at ICAAC.
In general, physicians recommend diet modifications and exercise to treat the symptoms associated with FMMA. While there are clear guidelines for the treatment of metabolic abnormalities, currently there is a lack of effective therapeutic options for the treatment of fat maldistribution in HIV-infected patients. Additionally there is no standard of practice to diagnose and treat patients who present with these symptoms. The panel reported switching antiretroviral medications as a treatment method in about 17% of the patients experiencing fat maldistribution. Other therapies sometimes used to treat fat maldistribution include recombinant human growth hormone, liposuction or plastic surgery.
In the study, the costs for diagnosing FMMA were estimated to be $128.74 per patient. The total first year costs for diagnosing, treating and managing FMMA range from $410 for insulin resistance to $7,368 for abnormal fat distribution at the back of the neck (a condition sometimes called "buffalo hump"). The second year costs of treating and monitoring each patient range from $115 to $3,895 depending on the symptom being treated.
Treatment algorithms used in the pharmacoeconomic modeling study were developed based on input from the expert panel. Unit costs (reported in 1999 dollars) were obtained for health care resources used to diagnose, treat and monitor HIV patients with FMMA. These included medical procedures, medications, outpatient visits and hospitalizations. Cost estimates for health care resources were based on an extended version of the Medicare Resource Based Relative Value Scale (RBRVS) and Current Procedural Terminology (CPT) codes of the American Medical Association and reflect current treatment patterns. Medication costs were obtained from the Red Book, which lists the average wholesale prices for medications available in the U.S.
"The benefits of Highly Active Antiretroviral Therapy (HAART) have been documented in the literature. HIV patients are experiencing the benefits of therapy with HIV treatments such as protease inhibitors but are also beginning to experience signs and symptoms of FMMA. Thus as patients continue to experience these signs and symptoms, the evaluation of risk factors for the long-term complications may become an essential component of HIV drug therapy selection," said Jacqueline Carranza Rosenzweig, a medical affairs scientist with Glaxo Wellcome.
Glaxo Wellcome is a pharmaceutical industry leader in HIV research and therapies. Glaxo Wellcome manufactures and markets Ziagen® (abacavir sulfate), Combivir® (lamivudine/zidovudine), Agenerase® (amprenavir), Epivir® (lamivudine) and Retrovir® (zidovudine). The company is engaged in basic research programs designed to investigate new targets to treat HIV.
For additional information, please go to http://www.ziagen.com, http://www.combivir.com, http://www.epivir.com, http://www.agenerase.com.