Treatment Guidelines for HIV-Associated Wasting

Introduction

During the early years of the AIDS epidemic, HIV-associated wasting was a highly visible sign of the disease's devastating effects. The gaunt appearance of some patients was quite stigmatizing, making it more difficult for them to deal with their disease and its consequences.

Since highly active antiretroviral therapy (HAART) was not available at this time, clinicians and patients were frustrated by the lack of therapeutic options.

Today, HIV disease has come almost full circle, and is now considered by many to be a manageable chronic condition. HAART has provided dramatic reductions in hospitalization and mortality rates. It has also increased the quality of life for many individuals living with this disease. Unfortunately, new advances in therapies have also brought a host of complications, many of which affect body habitus. Fat redistribution syndromes have created a new stigma associated with these emerging side effects of therapy.

Throughout all of these advances in HIV care and treatment, HIV-associated wasting still exists, often masked by many of the morphologic changes brought about by HAART. Today, patients with HIV disease may not be aware they are experiencing wasting, and their clinicians may not recognize the problem. Since HIV-associated wasting has a significant impact on mortality and quality of life, early diagnosis and treatment are imperative.

The diagnosis of wasting is best achieved by using bioelectrical impedance analysis (BIA) to measure changes in body cell mass (BCM). This necessary evaluation, combined with the proper clinical assessments (history and physical, psychosocial evaluation, laboratory tests, dietary evaluation), allows for the confirmation of a wasting diagnosis. General patient management consists of concurrent interventions to control viral load, correct any immediate causes of wasting, address psychosocial issues, improve nutritional intake, and treat anorexia.

Specific treatments for HIV-associated wasting are always individualized according to the patient's needs. Male patients who are hypogonadal often benefit from testosterone replacement therapy. Recombinant human growth hormone is indicated in patients with normal testosterone levels, female patients, and in male patients for whom testosterone therapy does not give the desired results. Other therapeutic interventions may also be used, such as anabolic steroids, progressive resistance exercise, nutritional supplements, and cytokine modulation. Once therapy is effective, expected clinical outcomes include the replacement of lost body cell mass and weight; improved physical capabilities, quality of life, and physical appearance; decreased frequency of opportunistic infections, hospitalizations, and related complications; and improved survival.

Nearly 20 years into the AIDS epidemic, clinicians and payers continue to struggle with the clinical management of what has become, for many, a chronic, manageable disease state. With the continuous refinement of highly active antiretroviral therapy (HAART) regimens, the frequent utilization of inpatient hospital services has decreased dramatically. Today, the patient with HIV infection may be effectively managed in the outpatient and office settings.

As the paradigm of patient care has shifted, emerging issues have surfaced. One of these is the frequently overlooked complication known as HIV-associated wasting. Although the incidence has decreased since the early years of the epidemic, HIV-associated wasting still occurs. Often, it is masked by complications associated with HAART, specifically the fat redistribution syndromes (lipodystrophy). Since HIV-associated wasting is a serious, debilitating, and sometimes life-threatening condition, clinicians must be vigilant to its presence, identify it early, and treat it appropriately.

The clinical definition of HIV-associated wasting and its appropriate treatment are not well understood, creating confusion for clinicians and payers alike. Various therapies have different efficacies and variable costs. Without fully understanding the condition and its appropriate interventions, both parties may find it difficult to justify the appropriate use of such treatments. Clearly, education on the clinical and reimbursement issues associated with HIV-associated wasting is needed in order for patients to receive and benefit from the most effective therapies.

With this in mind, a Consensus Development Panel met in New York City, NY, July 26, 2000, to discuss the issues associated with HIV-associated wasting from a clinical and reimbursement standpoint. Specifically, the Panel met to achieve the following objectives:

› Review the incidence of HIV-associated wasting in the HAART era;
› Define HIV-associated wasting in patients receiving HAART;
› Identify the most accurate methods for diagnosis;
› Review assessment approaches for initial and ongoing management;
› Analyze currently approved therapies from clinical and cost-effective standpoints; and
› Develop treatment recommendations.

The following guidelines have been specifically designed to benefit reimbursement professionals who are faced with decisions regarding coverage for therapies to treat HIV-associated wasting. The Panel hopes these guidelines will assist them when making the important decisions that affect patient care.