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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (July 3, 1997)
8 ▼ ju ly 3 . 1 9 9 7 ▼ ju s t o u t Let Me Earn Your Business national news When buying or selling real estate, I represent yo u r interests! E xperienced, In n o va tive, Up-to-Date Treatm ent h o w -to Panel stumbles over triple-drug mandate and funding issues in drafting federal HIV treatment guidelines Steve Buchert, Realtor Office: 228-9801 • Mobile: 970-3801 VM: 228-0750, ext. 142 e-inail: buchert@teleport.com 25 NW 23rd Place, Portland, OR 97210 by Bob Roehr D 5 s .tr Food The Way Mother Nature Intended Organic Produce Natural Groceries Delicious Deli From Scratch Cruelty-Free Personal Care Vitamins, Homéopathies, & Herbs Environmentally Safe Cleaning Products ) Food Front 9 n ° p®o Qrrih p C o o p e rative G ro ce ry ° o ¡L 2 3 7 5 N W Thurman Si. Portland 222-5Ó58 ’/ / feel. ) Oregon HotSpring Spas 7 / k one frie n d s recom m end. WOWr.-; / ieaorrlnn 643-3002 /lend 333-0903 t Salem J itr lla n d 23 3 - 333 raft “Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents” were un veiled by the federal government during a June 19 news conference at the National Institutes of Health. The proposed guidelines do not break new ground for clinicians and patients well-versed in state-of-the-art AIDS therapies, but they do seek to spread those standards across the country. The guidelines may also influence health in surance companies, managed care organizations and Medicaid. “Our focus was to give the clinician and the patient information to move through relatively complex therapeutic decisions and make appro priate decisions at each point,” explains Dr. Eric Goosby, director of the Office of HI V/AIDS Policy at the Department of Health and Human Services. The guidelines will be updated periodically as new information breaks for at least three years. Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases and co-chair of the panel that drafted the guidelines, offered a brief lecture on AIDS pathogenesis: “The CD4 count tells you where you are in the disease, while the [viral load] tells you where you are going.” The guidelines use these two markers as in dicators of when to ini tiate and change thera pies. They differ from ear lier federal standards by including the new tech nology of viral-load test ing and the use of pro tease inhibitors in com bination with earlier therapies. Fauci adds, “The meat of these guidelines is to treat aggressively— to get the virus down to as low as possible for as long as possible— but mm [also] build into the Dr. Anthony Fauci guidelines the flexibility” that would allow individuals to defer treatment. According to the guidelines, a person who exhibits symptoms associated with AIDS should be treated regardless of CD4 count or viral load. Asymptomatic cases with a CD4 count of 500 or less and a viral load greater than 10,000 (bDNA) copies should be offered treatment and decide based upon “prognosis for disease-free survival and willingness of the patient to accept therapy.” Opinion is more di vided over whether or not to initiate therapy in those with a CD4 count greater than 500 and a viral load of less than 10,000 (bDNA) copies. Treatment with one drug is not recommended, while treatment with two drugs “is considered less than optimal.” The guidelines recommend starting treatment with three drugs (including a protease inhibitor) and changing at least two drugs when there are indications that treatment is failing. The draft was unclear as to what defines drug failure, but Dr. John Bartlett, a professor and clinician at the Johns Hopkins University School of Medicine and a panel co-chair, defines drug failure as having detectable levels of virus four to six months after beginning triple therapy. He suggests that if a patient decides to discon / 363 - 4 000 P/7? tinue a drug because of toxicity or difficulty in complying with the regimen, it is probably better to discontinue all drugs rather than take partial therapy that will encourage resistance. Martin Delaney, executive director of Project Inform and a member of the panel, takes some exception to “ordaining a therapy of a protease plus two nucleosides.” He believes it is “largely an artifact of the studies that have been done rather than hard conclusions from science.” “If those are the only studies that you do, then that is what your data is going to say works,” he says. Fauci concedes there are gray zones “where we don’t know the balance between toxicides and clinical benefits over the long range.” The issue had proven to be the major source of dispute within the panel, delaying the recommen dations for several months. Mark Harrington, policy director of the Treat ment Action Group, sat on the drafting panel. “The activists had to all threaten to pull out of the process at one point because there was a raid on the integrity of the guidelines by many of the scientists,” he says. “They basically wanted every body with a detectable viral load, regardless of T- count, to go on therapy.” He adds, "We said that was wrong. We are much more aware of how difficult it is to do these regimens if you are not motivated. And how a lot of people who have a relatively low risk of immediate progression probably should wait until there is a drug you can take once a day.” Money was often an unspoken factor lurking in the background. Sev eral weeks ago Steve Morin, legislative aide to Rep. Nancy Pelosi (D- Calif.), suggested that the C linton adm inistra tion—then in the middle of budget negotiations with congressional Re publicans—delayed release of the guidelines be cause of the financial implications. Delaney called it “a stalling tactic” by people at the Office of Management and Budget who really wanted to kill the plan entirely. Daniel Zingale, executive director of the AIDS Action Council, meanwhile, said in order for the guidelines to be meaningful there needs to be an increased federal commitment to getting AIDS drug therapies into the hands of all those living with HIV and AIDS. He has called for the expansion of Medicaid eligibility and increased funding for AIDS-spe cific programs. According to Winnie Stachelberg, legislative director of the Human Rights Campaign, the Clinton administration did not request any spe cific increases in the AIDS Drug Assistance Pro gram for fiscal 1998, and no HI V/AIDS programs were on the “protected list” in the budget agree ment. “These guidelines point to the need to rectify that,” she says. The release of the guidelines opens a 30-day period to receive public comments, after which revisions may be made and a final version issued.