The Wall Street Journal - Thursday, 19 June 1997
Laurie McGinley

The long-awaited clinical guidelines -- the first ones from the government on how to use the protease inhibitors that have revolutionized AIDS treatment over the past two years -- are likely to result in more people being treated with more drugs at an earlier stage of infection, AIDS doctors and activists say.

The guidelines were drafted by a 32-member panel made up of some of the nation's most prominent AIDS researchers, physicians and activists. The committee, co-headed by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and John Bartlett of Johns Hopkins University's School of Medicine, was convened by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation. The recommendations were announced yesterday in the Federal Register and will be finalized after a 30-day public-comment period.

The panel strongly recommended that all individuals with AIDS symptoms , regardless of the level of virus in their blood, receive combination antiretroviral therapy -- preferably one protease inhibitor and two other drugs called nucleoside analogs. It urged doctors to avoid treating patients with a single drug, except in the cases of pregnant women who are given AZT to cut the transmission of the virus to the fetuses. Treatment with two drugs, the group said, was "less than optimal."

On the important question of when to start treatment for patients who show no symptoms, the group gave several guideposts but didn't provide a hard-and-fast rule, saying that the decision depended heavily on doctors' judgments and patients' preferences. Once treatment is begun, however, it should constitute a fullscale assault aimed at driving HIV below detectable limits, with all three drugs begun at the same time, the panel said. If a particular combination doesn't work, two or three drugs should be changed.

AIDS groups applauded the guidelines, but expressed concern that people without generous private insurance may have trouble getting treatments because of the expense involved. The three-drug therapy can easily cost $12,000 a year.

"I don't know where the resources are going to come from to give people the standard of care outlined in this document," said Richard Jefferys, access project director for AIDS Treatment Data Network. Of special concern, he said, are federally funded state programs -- many already low on funds -- that offer AIDS drug assistance for the uninsured and underinsured.

AIDS activists have been pressing for additional federal funding for the state programs, and were angry when the administration declined recently to seek more money for this year as part of the disaster-relief bill. But in a statement yesterday, Donna Shalala, the secretary of health and human services, said that she recognizes that "these new medical guidelines raise important public policy issues, and we're working rapidly to address them."

The administration is considering amending its 1998 budget request to Congress to seek additional funding for AIDS drugs, said officials who didn't want to be identified. It also is exploring ways to make people with HIV eligible for Medicaid, which pays for drugs, at an earlier point in their illness.

As for private health plans, many cover at least some of the new HIV therapies, but some have limits on the number of prescriptions that can be filled each month. Clinton administration officials hope that the guidelines -- by essentially establishing a government-backed standard of care -- will prod insurers to remove obstacles to treatment.

Dr. Fauci, at a news conference where the new guidelines were unveiled, said the recommendations are needed because rapid changes in the treatment of HIV -- and the availability of 11 antiretrovirals and an array of possible combinations -- have left some physicians confused about how to administer the complicated new therapies. Doctors, he said are grappling with such difficult questions as, "When do you start [drug therapy]? What do you start with? How do you know if you're being successful?"

970619
WJ970604

Copyright © 1997 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.

Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1997. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .