Adverse effects of medications and trade-offs between length of life and quality of life in human immunodeficiency virus infection.

In the mid-1990s, the availability of enhanced “combination therapy” antiviral regimens revolutionized treatment of patients with the human immunodeficiency virus (HIV) (1,2). Although efficacious in controlling viral expression in many patients, combination therapy does not cure the infection. Furthermore, in contrast with advanced infection, there is little published evidence that early initiation of combination therapy influences the course of HIV disease (3). In response, several recent articles have called for delays in initiation of therapy and an “individualized” approach to treatment (3–5). We sought to determine which aspects of therapy physicians should discuss with patients, given the limitations of combination therapy. An important consideration, for example, may be a patient’s beliefs about adverse drug effects. A patient who believes that combination therapy poses a substantial threat to his or her quality of life might prefer to initiate treatment at a lower CD4 count, or to take an alternative, less effective, regimen. We examined the beliefs and preferences of patients with HIV disease about trade-offs between length of life and an aspect of quality of life that many persons value highly—physical appearance. We were concerned specifically about the lipodystrophy syndrome, a relatively common problem that is thought to be an adverse effect of combination antiretroviral therapy (6,7). Lipodystrophy syndrome can include loss of body fat in the face and extremities, deposition of fat in the central abdomen and the back of the neck, and, in women, enlargement of the breasts (7). Although not the only potential adverse effect of combination therapy regimens, the syndrome can be grossly disfiguring and is easily explained to patients. This makes it a potentially useful model to study HIV-infected patients’ willingness to trade length of life to avoid risks to quality of life from adverse drug effects. METHODS

[1]  Mark Harrington,et al.  Hit HIV-1 hard, but only when necessary , 2000, The Lancet.

[2]  M A Fischl,et al.  A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. , 1997, The New England journal of medicine.

[3]  Leslie Lenert iMPACT3: online tools for development of web sites for the study of Patients' preferences and utilities , 2000, AMIA.

[4]  D. Cooper,et al.  Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor-associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: acohort study , 1999, The Lancet.

[5]  L. Lenert,et al.  The Effect of Search Procedures on Utility Elicitations , 1998, Medical decision making : an international journal of the Society for Medical Decision Making.

[6]  Leslie A. Lenert,et al.  The reliability and internal consistency of an Internet-capable computer program for measuring utilities , 2004, Quality of Life Research.

[7]  O. Rouvière,et al.  A syndrome of peripheral fat wasting (lipodystrophy) in patients receiving long-term nucleoside analogue therapy. , 1999, AIDS.

[8]  T. Merigan,et al.  Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group. , 1996, The New England journal of medicine.

[9]  D. Cooper,et al.  Lipodystrophy Associated with an HIV-Protease Inhibitor , 1998 .

[10]  David A. Cooper,et al.  A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors , 1998, AIDS.

[11]  J A Fleishman,et al.  Variations in the care of HIV-infected adults in the United States: results from the HIV Cost and Services Utilization Study. , 1999, JAMA.

[12]  C. Grunfeld,et al.  Fat distribution and metabolic changes in patients with HIV infection. , 1999, AIDS.

[13]  S. Walmsley,et al.  Psychosocial impact of the lipodystrophy syndrome in HIV infection. , 2000, The AIDS reader.

[14]  S. Asch,et al.  National estimates of HIV-related symptom prevalence from the HIV Cost and Services Utilization Study. , 2000, Medical care.

[15]  J. J. Henning,et al.  Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, January 28, 2000 , 1998, HIV clinical trials.

[16]  K Henry,et al.  The Case for More Cautious, Patient-Focused Antiretroviral Therapy , 2000, Annals of Internal Medicine.

[17]  L A Lenert,et al.  Effects on Preferences of Violations of Procedural Invariance , 1999, Medical decision making : an international journal of the Society for Medical Decision Making.