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New Guidelines on Metabolic Complications of HIV and Antiretroviral Treatment
On November 1 a panel of 12 leading experts on metabolic
complications of HIV and antiretroviral treatment published
guidelines for managing these complications, and a review
of what is already known(1).
The panel looked at glucose intolerance and diabetes, lipid abnormalities such as high triglycerides, body fat distribution changes, lactic acidemia, and bone problems (both osteonecrosis and osteopenia). Guidelines were accepted by consensus of the full panel -- which was funded by the International AIDS Society--USA (not to be confused with the International AIDS Society, a different organization). In the absence of urgently needed studies to get better treatment information, "the panel recommends routine assessment and monitoring of glucose and lipid levels and assessment and monitoring of lactic acidemia and bone abnormalities if clinical signs or symptoms are detected. With the exception of body fat distribution abnormalities, specific treatments for these complications are also recommended." Changes in antiretroviral therapy are also suggested, to avoid drugs believed to contribute to the patient's problems. A copy of the guidelines is available online at: http://www.iasusa.org/pub/metcomp.html References 1. Schambelan M, Benson C, Carr A, and others. Management of metabolic complications associated with antiretroviral therapy for HIV-1 infection: Recommendations of an International AIDS Society-USA panel. JAIDS (Journal of Acquired Immune Deficiency Syndromes ). November 2002; volume 31, pages 257-275, http://www.iasusa.org/pub/metcomp.html Nevirapine Patient Assistance Program: Model for Better Administration? Comment by John S. James The new Boehringer Ingelheim patient assistance program for nevirapine for U.S. residents may be an improvement over other programs, in that it streamlines the paperwork and administration. A patient applies once for a year -- by sending a one-page application plus proof of income. A new foundation set up by Boehringer Ingelheim promises a response in two days. Then the patient picks up the drug four times per year at the doctor's office. At the end of the year the patient can apply again for the next year -- and will be sent a reminder to do so. It seems that the doctor doesn't have to do burdensome paperwork for this program -- only write the prescription, and hold the medicine package for the patient four times per year. This should prevent a major problem for medical staffs, and open the program to more people in public clinics. However, the income eligibility level for nevirapine is calculated differently than for the company's non-HIV drugs, for reasons that are not clear. What should be done instead is to have uniform income levels but allow patients to deduct out-of-pocket medical expenses in meeting the income requirement. A bigger problem may be in the interpretation of, "Be ineligible for prescription assistance through Medicaid." If a patient is eligible for Medicaid prescription coverage but that coverage does not include nevirapine, does he or she just have to do without AIDS treatment? No one eligible for Medicaid could pay for this drug out of pocket, and public programs are increasingly running out of money. We believe the important advance here is that this program could work efficiently. Many other patient-assistance programs seem designed to get the drug only to those who have enough of a support network around them to possibly make an issue in the media if they don't get treated, while limiting expenses by denying treatment to others. The very paperwork used to restrict those programs makes them expensive to run. But this new program could control costs by delivering drug efficiently to patients who have no other way to get it, at little cost to the company. For more information or to apply, visit: http://us.boehringer-ingelheim.com/about/ philanthropy/Patient_Assistance_Program.html Heart-Disease Risk and C-Reactive Protein By John S. James In an important study reported this month, in which almost 28,000 healthy U.S. women were followed for eight years, the level of C-reactive protein, a marker of inflammation, was a better predictor than LDL cholesterol of first heart attack or related disease(1). And there was almost no correlation between the two markers (both blood tests) -- meaning that these tests are finding different at-risk populations, and using both together would be a better predictor than using either alone. Smaller studies have already reported that high C-reactive protein was associated with heart attacks, strokes, and artery disease; the new study confirmed those findings with better data. C-reactive protein is easy to measure, but this test is not yet generally used in clinical practice. Also, it has not been proven that interventions to reduce the inflammation will lower the risk of disease, although this appears likely. The authors conducted an earlier study(2) and recommend a larger trial of statins for this purpose. These studies did not involve HIV. However, standard guidelines for lowering heart risk are often used in HIV treatment. And inflammation might be a greater problem in persons with HIV disease than in the general population. The HIV community should follow this developing research (as well as other experimental tests for measuring heart risk, such as homocysteine levels). Some HIV-specific research would be easy to do -- for example, testing whether certain populations have a higher level of C- reactive protein would require only one blood sample and laboratory test from each member of a cohort. Perhaps AIDS medicine could be a leader in bringing the new information into clinical practice. References 1. Ridker PM, Rifai N, Rose L, Buring JE, and Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. New England Journal of Medicine. November 14, 2002; volume 347, number 20, pages 1557-1565. 2. Ridker PM, Rifai N, Clearfield M, and others. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. New England Journal of Medicine. June 28, 2001; volume 344, pages 1959-1965. Vaccine Against Three Kinds of HIV Begins Human Tests The new Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases is starting the first human trial of its vaccine candidate, developed to target HIV clades (subtypes) A, B, and C. Together these subtypes are responsible for about 90% of the world's AIDS epidemic (clade B causes almost all of the infections in the U.S.). Also, it might be more difficult for HIV to develop mutations to escape control by a multiclade vaccine, since it targets the virus in different ways. Fifty healthy HIV-negative volunteers between 18 and 40 are needed for the first trial, which will be conducted at the National Institutes of Health in Bethesda, Maryland. This placebo-controlled trial will check for safety and also for immune responses to HIV. Later trials will run in several U.S. sites, as well as in Haiti and South Africa. For more information about the trial, including ways to volunteer, call 1-866-833-LIFE (5433), email vrcforlife@mail.nih.gov, or visit: http://www.niaid.nih.gov/vrc or http://www.clinicaltrials.gov Prevention: New Approach Will Test Tenofovir for Persons at High Risk By John S. James In a new approach to HIV prevention, the Bill & Melinda Gates Foundation will fund a multi-national trial of the antiretroviral drug tenofovir, taken orally once daily by HIV negative persons at high risk, to see if it can prevent HIV infection. The study, by Family Health International, will take three years, and will focus on sexually active adults in countries with high HIV incidence. If it works, this method could be particularly important for women who cannot negotiate condom use or other ways of protecting themselves. Dr. Helene Gayle of the Bill & Melinda Gates Foundation noted that experience in using antiretrovirals to protect healthcare workers exposed to HIV, and infants exposed during childbirth, offered hope that it might be possible to prevent sexual transmission as well. Comment This study is important because it could open a new front in HIV prevention -- and provide a woman-controlled protection method before microbicides or vaccines are available. Animal studies have suggested that the drug may prevent infection. And tenofovir, approved for over a year in the U.S. for use in HIV treatment, has fewer side effects than other antiretrovirals, so it may be acceptable to persons at high risk but not already infected. AIDS Treatment News Published twice monthly Subscription and Editorial Office: 1233 Locust St., 5th floor Philadelphia, PA 19107 800/TREAT-1-2 toll-free email: aidsnews@critpath.org useful links: http://www.aidsnews.org/ Editor and Publisher: John S. James Associate Editor: Tadd T. Tobias Statement of Purpose: AIDS Treatment News reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations that work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. AIDS Treatment News is published 24 times per year, on the first and third Friday of every month, and print copies are sent by first class mail. Email is available (see below). Back issues are available at http://www.aidsnews.org/ To subscribe, you can call 800-TREAT-1-2 or 415-255-0588: |
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