Latebreaker Presentation Shows AIDS Drug VIRAMUNE (nevirapine) Effective in Long-Term HIV Suppression in Patients with AIDS/High Viral Load

Ingelheim, Germany (PROTEXT) - Study results show the AIDS drug VIRAMUNE(R) (nevirapine, NVP) added to a combination therapy of zidovudine (ZDV) + lamivudine (3TC) suppressed HIV for up to one year in patients with advanced HIV disease and high baseline viral loads. The study also demonstrates that similar success in viral suppression to undetectable levels was seen in the groups of patients with high baseline viral load and in those with lower baseline viral load measurements. These new findings were presented as a "latebreaker" today at the 7th European Conference on Clinical Aspects and Treatment of HIV Infection in Lisbon. "Results of this trial provide important clinical information about the use of nevirapine in the treatment of advanced HIV infection," explained Dr. Richard Pollard of the University of Texas Medical Branch at Galveston, Texas, USA. "The mean baseline CD4+ count of patients in the nevirapine arm was only 86 cells/mm3. Mean baseline viral load of these patients was 145,821 copies per/mL." Eighty-six (86) % of patients taking VIRAMUNE+ZDV+3TC achieved suppression of HIV levels below 400 copies/mL at sometime during the study. At one year, 68% were still below the 400 copies/mL level. At 12 months, viral suppression to below the limit of detection in the VIRAMUNE arm was similar in both those patients who began the study with high viral loads and those who began the study with low viral loads. Specifically, 42% of patients with a low baseline viral load of <100,000 copies/mL and 55% of those with a high baseline viral load of >100,000 copies/mL were undetectable (<50 copies/mL) after one year of treatment. The trial, known as BI 1090, was a large, international, clinical endpoint study, which evaluated the treatment effect of VIRAMUNE when used in combination with 3TC and ZDV. This analysis evaluates the changes in viral load and CD4+ cell counts of those patients who had never previously been treated with antiretroviral therapy and received ZDV + 3TC plus either VIRAMUNE or placebo. "We're pleased that this trial provided results that are relevant today. It's important to note that this trial was designed in 1995 and was based on the standard of care in the treatment of AIDS patients at that time," explained Dr. Pollard. "With significant advances in the HIV/AIDS treatment arena since the trial's inception, the original clinical endpoint design, which included a placebo control arm, is no longer considered practical. " The first 154 antiretroviral-naive patients (74 VIRAMUNE and 80 placebo) on only ZDV + 3TC as background drugs were identified among the 2,256 patients enrolled. Plasma specimens were measured using an ultrasensitive assay (<50 copies/mL). Intent-to-treat analyses (missing data, dropout or treatment switch=failure), examined the percentage of patients below the limit of detection at six and 12 months, as well as the percentage of patients who had undetectable HIV at any time point (nadir). Additional analyses used assays that detected <400 copies/mL and measured the change from baseline in CD4+ cell count. Results Table HIV RNA (% below limit of CD4+ change from baseline detection (BLD) <50 copies/mL) NVP/ZDV/3TC ZDV/3TC NVP/ZDV/3TC ZDV/3TC (N=74) (N=80) (n=74) (N=80) Baseline (Mean) 146,821 151,322 86 cells/mm3 82cells/mm3 copies/mL copies/mL BLD at any timepoint 72% 15% 6 months 62% 5% +100 +51 12 months 49% 0% +109 +56 VIRAMUNE VIRAMUNE was the first member of the NNRTI class of anti- HIV/AIDS drugs to be approved. 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, such as viral load or changes in CD4+ count. When used in chronic therapy, VIRAMUNE should always be administered with at least one additional antiretroviral agent. VIRAMUNE is generally well-tolerated. The most commonly reported adverse events associated with VIRAMUNE in the long-term combination treatment 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 conducted 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. Boehringer Ingelheim corporation, 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. The group of companies has substantial research and development, production, and distribution facilities around the globe. In 1998 the Boehringer Ingelheim corporation spent DEM 1.6 billion on R&D, equivalent to 18% of total sales. For more information on Boehringer Ingelheim please see also the company's Internet webpage: http://www.boehringer- ingelheim.com. ots Original Text Service: Boehringer Ingelheim GmbH Internet: http://www.newsaktuell.de Contact: Judith von Gordon, Corporate Public Relations Division of Boehringer Ingelheim GmbH, +49-6132-773582, or fax, +49-6132-776601; or Maureen Byrne or Denise Connolly, both of GCI Healthcare, (USA) 212-886-3312, or (USA) 212-886-3117, or fax, 212-886-3291, for Boehringer Ingelheim Web site: http://www.boehringer- ingelheim.com Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT