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International HIV/AIDS Community Gains Access To Updated USA Treatment Guidelines
New Recommendations for First-Line Treatment
Ingelheim, Germany (ots-PRNewswire) - The Journal of the American Medical Association (JAMA) today published HIV/AIDS treatment guidelines updated by the International AIDS Society's (IAS) USA Panel on antiretroviral therapy use in adult HIV-1 infection. The updated guidelines reflect the increasingly important role of VIRAMUNE(R) (nevirapine) and other non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the treatment of HIV/AIDS.
The guidelines identify three strongly recommended treatment regimens for use as first-line therapy. Among these options is the new recommendation to begin therapy with an NNRTI plus two nucleoside analogues. Authors cite two advantages of an NNRTI-based regimen: low pill burden and sparing the use of a protease inhibitor (PI). Other options strongly recommended by the panel for first-line treatment are two nucleoside analogues with either one or two protease inhibitors.
"VIRAMUNE is an important agent for first-line treatment of HIV. It is potent, requires only two pills daily, and can be taken with or without food," said Professor Joep Lange of the National AIDS Therapy Evaluation Centre (NATEC), University of Amsterdam. "Physicians have been using VIRAMUNE as a first-line treatment for several years. Recognition by the IAS expert panel will encourage continued use of VIRAMUNE in this utility."
The guidelines included new data on VIRAMUNE based on results of the Atlantic Study, which demonstrated that a Viramune-based regimen was as effective in reducing the amount of the AIDS virus in a patient's blood as a regimen based with the protease inhibitor indinavir. According to the guidelines, "virologic and CD4+ cell count results of a study comparing Viramune+ddI+d4T with indinavir+ddI+d4T were similar at 24 weeks."
It is suggested that choice of a regimen be individualized based on several criteria including the strength of supporting data and on regimen potency, tolerability, adverse effect profile and convenience. The guidelines also outline the differences between antiretroviral drug combinations.
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points. At present, there are no results from controlled clinical trials evaluating the effect of VIRAMUNE in combination with other antiretroviral agents on the clinical progression of HIV-1 infection, such as the incidence of opportunistic infections or survival. VIRAMUNE should always be administered in combination with other antiretroviral agents.
VIRAMUNE is generally well-tolerated. In clinical trials the most commonly reported adverse events associated with VIRAMUNE use are rash, fever, nausea, headache and abnormal liver function tests. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with VIRAMUNE.
VIRAMUNE is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc., a member of the Boehringer Ingelheim group of companies. VIRAMUNE is marketed world-wide by Boehringer Ingelheim and in the United States by Roxane Laboratories, also a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group of companies, with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical corporations in the world. It reported revenues exceeding DEM 8.7 billion in 1998.
The corporation has more than 140 affiliated companies and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self-medication -- as well as animal health.
Substantial research and development, production, and distribution facilities are located around the globe. In 1998 Boehringer Ingelheim spent DEM 1.6 billion on R&D, equivalent to 18% of total sales.
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* Antiretroviral drugs mentioned in this release: d4T (Zerit(R),
stavudine) and ddI (Videx(R), didanosine), Bristol-Myers Squibb;
indinavir (Crixivan(R)), Merck & Co.
-- The guidelines can be found on the web at
-- Additional information on VIRAMUNE can be found on the web at
-- Additional information on the Atlantic Study can be found on
the web at
ots Original Text Service: Boehringer Ingelheim GmbH Internet: http://www.newsaktuell.de
Contact: Judith von Gordon, Corporate Public Relations Division of Boehringer Ingelheim GmbH, Tel. +49-6132-773582, or fax, +49-6132-776601; or Maureen Byrne, Tel. (USA) 212-886-3312, or Denise Connolly, Tel. (USA) 212-886-3117, both of GCI Healthcare, fax, (USA) 212-886-3291, for Boehringer Ingelheim GmbH
Web site: http://www.boehringer-ingelheim.comOriginal-Content von: Boehringer Ingelheim GmbH, übermittelt durch news aktuell