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 AIDSdrug VIRAMUNE(R) (nevirapine, NVP) added to a combination therapyof zidovudine (ZDV) + lamivudine (3TC) suppressed HIV for up toone year in patients with advanced HIV disease and high baselineviral loads. The study also demonstrates that similar success inviral suppression to undetectable levels was seen in the groupsof patients with high baseline viral load and in those with lowerbaseline viral load measurements. These new findings werepresented as a "latebreaker" today at the 7th European Conferenceon Clinical Aspects and Treatment of HIV Infection in Lisbon. "Results of this trial provide important clinical informationabout the use of nevirapine in the treatment of advanced HIVinfection," explained Dr. Richard Pollard of the University ofTexas Medical Branch at Galveston, Texas, USA. "The mean baselineCD4+ count of patients in the nevirapine arm was only 86cells/mm3. Mean baseline viral load of these patients was 145,821copies per/mL." Eighty-six (86) % of patients taking VIRAMUNE+ZDV+3TC achievedsuppression of HIV levels below 400 copies/mL at sometime duringthe study. At one year, 68% were still below the 400 copies/mLlevel. At 12 months, viral suppression to below the limit ofdetection in the VIRAMUNE arm was similar in both those patientswho began the study with high viral loads and those who began thestudy with low viral loads. Specifically, 42% of patients with alow baseline viral load of <100,000 copies/mL and 55% of thosewith a high baseline viral load of >100,000 copies/mL wereundetectable (<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 ofVIRAMUNE when used in combination with 3TC and ZDV. This analysisevaluates the changes in viral load and CD4+ cell counts of thosepatients who had never previously been treated withantiretroviral therapy and received ZDV + 3TC plus eitherVIRAMUNE or placebo. "We're pleased that this trial provided results that arerelevant today. It's important to note that this trial wasdesigned in 1995 and was based on the standard of care in thetreatment of AIDS patients at that time," explained Dr. Pollard."With significant advances in the HIV/AIDS treatment arena sincethe trial's inception, the original clinical endpoint design,which included a placebo control arm, is no longer consideredpractical. " The first 154 antiretroviral-naive patients (74 VIRAMUNE and80 placebo) on only ZDV + 3TC as background drugs were identifiedamong the 2,256 patients enrolled. Plasma specimens were measuredusing an ultrasensitive assay (<50 copies/mL). Intent-to-treatanalyses (missing data, dropout or treatment switch=failure),examined the percentage of patients below the limit of detectionat six and 12 months, as well as the percentage of patients whohad undetectable HIV at any time point (nadir). Additionalanalyses used assays that detected <400 copies/mL and measuredthe change from baseline in CD4+ cell count. Results Table

HIV RNA (% below limit of CD4+ change frombaseline

detection (BLD) <50 copies/mL)

NVP/ZDV/3TC

ZDV/3TC

NVP/ZDV/3TCZDV/3TC

(N=74)

(N=80)

(n=74)(N=80) Baseline (Mean) 146,821

151,322 86 cells/mm382cells/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 incombination with other antiretroviral agents for the treatment ofHIV-1 infection. This indication is based on analysis of changesin surrogate end-points, such as viral load or changes in CD4+count. When used in chronic therapy, VIRAMUNE should always beadministered with at least one additional antiretroviral agent. VIRAMUNE is generally well-tolerated. The most commonlyreported adverse events associated with VIRAMUNE in the long-termcombination treatment are rash, fever, nausea, headache andabnormal liver function tests. Severe and life-threatening skinreactions and hepatotoxicity, including fatal cases of each, haveoccurred in patients treated with VIRAMUNE. VIRAMUNE is a product of original research conducted atBoehringer Ingelheim Pharmaceuticals, Inc., a member of theBoehringer Ingelheim group of companies. VIRAMUNE is marketedworld-wide by Boehringer Ingelheim and in the United States byRoxane Laboratories, also a member of the Boehringer Ingelheimgroup of companies. Boehringer Ingelheim corporation, with headquarters inIngelheim (Germany) is one of the 20 leading pharmaceuticalcorporations in the world. It reported revenues exceeding DEM 8.7billion in 1998. The corporation has more than 140 affiliated companies and itconducts business on every continent. Its product range isfocused on human pharmaceuticals -- hospital, prescription andself-medication -- as well as animal health. The group of companies has substantial research anddevelopment, production, and distribution facilities around theglobe. In 1998 the Boehringer Ingelheim corporation spent DEM 1.6billion on R&D, equivalent to 18% of total sales. For more information on Boehringer Ingelheim please see alsothe company's Internet webpage: http://www.boehringer-ingelheim.com. ots Original Text Service: Boehringer IngelheimGmbH Internet: http://www.newsaktuell.de Contact: Judith vonGordon, Corporate Public Relations Division of BoehringerIngelheim GmbH, +49-6132-773582, or fax, +49-6132-776601; orMaureen Byrne or Denise Connolly, both of GCI Healthcare, (USA)212-886-3312, or (USA) 212-886-3117, or fax, 212-886-3291, forBoehringer Ingelheim Web site: http://www.boehringer-ingelheim.com

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