Distributed January 18, 2000
For Immediate Release
News Service Contact: Scott Turner



International panel announces new treatment guidelines for HIV
A 17-member international panel of AIDS/HIV experts has reviewed existing treatment guidelines for people infected with HIV and announced new guidelines. The new guidelines focus on individualized therapy, a greater choice of treatment regimens, and enhanced patient adherence to the prescribed treatment regimen. The new guidelines appear in the January 19, 2000, issue of The Journal of the American Medical Association.

PROVIDENCE, R.I. — An international group of AIDS specialists today (Jan. 19, 2000) released updated guidelines for treating HIV disease in adults. The new guidelines take into account the availability of new anti-retroviral drugs and expanded therapy choices.

Reported in the January 19, 2000, issue of The Journal of the American Medical Association, the recommendations represent the consensus of a 17-member physician panel of the International AIDS Society-USA. That panel was first convened in 1995 to develop treatment guidelines for health care providers that would set a standard of care for HIV. Since then, the panel has reviewed the recommendations annually; a revised version was last issued in July 1998.

The most important changes in the new recommendations are:

  • The decision to initiate therapy must be individualized for each patient. The widespread use of potent anti-retroviral therapies in recent years has had a significant impact on quality of life and survival of people infected with HIV. However, with these important advances has also come recognition of difficulties with current regimens, including the emergence of long-term side effects of the drugs. These issues suggest that deferral of therapy may sometimes be advantageous.

  • Choices for initial regimens have expanded. At least three new drugs became available in the past year. Recommended combinations include (1) a protease inhibitor and two nucleoside reverse transcriptase inhibitors (nRTIs); (2) a nonnucleoside and two nRTIs; and (3) two protease inhibitors (where one is used to enhance the pharmacologic properties of the other) and two nRTIs.

  • Assessing and supporting patient adherence to the prescribed anti-viral regimen are critical to successful therapy. Drugs and regimens with more convenient administration requirements (e.g., twice daily dosing) are now available to help in this area.

“In the mid-90s, emerging clinical and basic science data supported a theoretical case for HIV eradication within two to three years through early and aggressive anti-retroviral drug therapy that would completely suppress viral replication,” said Paul Volberding, M.D., chair of the IAS-USA board and a University of California-San Francisco professor of medicine. “Now we know that eradication with drug therapy alone is not a realistic goal at this time. Our new recommendations take this into consideration along with long-term survival.” Volberding is senior author of the JAMA paper and also serves as director of the UCSF Positive Health Program at San Francisco General Hospital Medical Center.

“Since our last recommendations in 1998 were announced, three effective new drugs have become available and new ways of combining drugs are in common use, greatly increasing the opportunity for positive treatment outcomes in our patients,” said Charles C. J. Carpenter, M.D., chair of the panel, first author of the JAMA paper and professor of medicine at the Brown University School of Medicine. “Now with more convenient drug administration schedules and carefully individualized treatment plans, most patients with HIV infection can live fully active and productive lives.”

The new guidelines are limited to therapies approved by the U.S. Food and Drug Administration and available in 1999, according to Volberding. Other highlights of the treatment recommendations include:

When to initiate anti-retroviral therapy

Physicians and patients must weigh the risks and benefits of starting therapy and make individual informed decisions. When to initiate therapy and what regimen to choose are crucial decisions, otherwise future options may be severely compromised. Ultimate long-term success may be a function of the aggregate effectiveness of sequential therapies, the panel noted.

Therapy is generally recommended for patients with a confirmed plasma HIV RNA level (viral load) above 30,000 copies per milliliter, irrespective of CD4 cell count, and for patients with CD4 cell counts below 350, irrespective of HIV RNA level.

Initial therapy

Recommendations for specific combination of drugs cannot be made. Choice of a regimen should be individualized based on its potency, tolerability and adverse effects.

Dual protease inhibitor combinations are increasingly being used because they offer pharmacologic and adherence benefits and improved efficacy. Data has shown ritonavir can be used effectively with saquinavir, indinavir, and amprenavir. Also, much more data support the initial use of non-nucleoside RTIs in place of protease inhibitors. These combinations, regardless of the specific class of drug used, can offer potential for increased potency, reduced pill burden, dose frequency and cost, and no mealtime restrictions.

Monitoring therapy

Both CD4 cell and HIV RNA levels are important for evaluating treatment response. The HIV RNA levels should decrease rapidly after therapy is initiated. Failure to achieve a target level of less than 50 copies per milliliter after about 16 to 24 weeks should raise concern about poor adherence, inadequate drug absorption or drug resistance. Increases in CD4 cell counts reflect reconstitution of the immune system.

Changing therapy /regimen

A decision to change therapy must be balanced by consideration of the likelihood that another regimen will achieve control of viral replication or be better tolerated. The panel also pointed out, however, that there is little direct experience with comparative retroviral drug potency, even within drug classes. Changes in a successful regimen should be approached cautiously.

Stopping therapy

Based on clinical and immunologic benefit in patients with advanced disease and few or no remaining anti-retroviral options, it is reasonable to continue treatment as long as possible.

IAS-USA is a national not-for-profit organization based in San Francisco that provides information and education for physicians involved in HIV/AIDS care. IAS-USA is not affiliated with the worldwide IAS, based in Sweden.

The panel for the newly released guidelines, in addition to Volberding and Carpenter, included David A. Cooper, M.D., D.Sc., University of New South Wales; Margaret A. Fischl, M.D., University of Miami; Jose M. Gatell, M.D., Ph.D., University of Barcelona; Brian G. Gazzard, M.A., M.D., Chelsea and Westminster Hospital, London; Scott Hammer, M.D., Columbia University; Martin S. Hirsch, M.D., Harvard Medical School; Donna M. Jacobsen, B.S., IAS-USA; and David A. Katzenstein, M.D., Stanford University; Julio S. G. Montaner, M.D., St. Paul’s Hospital, Vancouver; Douglas D. Richman, M.D., University of California-San Diego; Michael S. Saag, M.D., University of Alabama-Birmingham; Mauro Schechter, M.D., Ph.D., Universidado Federal do Rio de Janeiro; Robert T. Schooley, M.D., University of Colorado; Melanie A. Thompson, M.D., AIDS Research Consortium of Atlanta; Stefano Vella, M.D., Instituto Superiore de Sanita, Rome; and Patrick G. Yeni, M.D., Hopital Bichat-Claude Bernard X. Bichat Medical School, Paris.

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Contacts

Brown: Scott Turner (401) 863-1862 (scott_turner@brown.edu)
UCSF: Corinna Kaarlela (415) 476-3804 (ckaarlela@pubadff.ucsf.edu)
IAS-USA: Donna Jacobsen (415) 561-6720 (djacobsen@IASUSA.org)