Boehringer Ingelheim GmbH

Simple VIRAMUNE(R) (nevirapine) Treatment Combination Shows Comparable Efficacy to Protease Inhibitor Combination

Glasgow, Scotland (ots-PRNewswire) - A simple anti-HIV treatment regimen of VIRAMUNE(R) (nevirapine) plus Combivir(TM) (3TC/ZDV)* showed comparable efficacy in reducing HIV below the limit of detection when compared to a regimen of the protease inhibitor nelfinavir* plus Combivir. These preliminary 36-week findings from the Combine Study were presented today at a satellite symposium of the 5th Congress on Drug Therapy in HIV Infection in Glasgow, Scotland. A protease inhibitor-based regimen has often been described as the "standard of care" for HIV/AIDS but can require patients to take numerous tablets. VIRAMUNE is a non-nucleoside reverse transcriptase inhibitor (NNRTI), which requires only two tablets per day -- the lowest daily intake of any NNRTI. "After 36 weeks of treatment(1), a greater percentage of patients taking VIRAMUNE plus Combivir had undetectable levels of HIV (less than 20 copies/mL) in their blood than those taking Combivir plus nelfinavir," said Daniel Podzamczer, MD, lead investigator, of the Hospital Princeps d'Espanya in Barcelona, Spain. "This is important because the VIRAMUNE-based regimen is much simpler for patients, requiring only two tablets (one VIRAMUNE/one Combivir) in the morning and two (one VIRAMUNE/one Combivir) in the evening." The nelfinavir plus Combivir regimen requires six tablets in the morning and six in the evening. COMBINE is a randomized, open, multicenter trial of 142 patients in 12 hospitals in Spain (9) and Argentina (3). The study compares the efficacy and safety of VIRAMUNE plus Combivir to nelfinavir plus Combivir in patients who have not previously been treated with antiretroviral therapy. A final analysis of the data is planned at 48 weeks. In an intent-to-treat (ITT) analysis at 36 weeks, 70.8% of patients in the VIRAMUNE arm and 55.7% in the nelfinavir arm were below the limit of detection (<200 copies/mL); 66.7% and 38.6%, respectively, were below 20 copies/mL. In an on-treatment (OT) analysis, 83.7 % in the VIRAMUNE arm versus 78% in the nelfinavir arm had undetectable levels of HIV (<200 copies/mL) and 79.6% and 56.1% were below 20 copies/mL. About 30% of patients had baseline HIV-1 RNA >100,000 copies/mL. A 36-week ITT analysis of this subgroup of patients showed that 71.4% of patients taking the VIRAMUNE-based combination vs. 53.8% taking the nelfinavir-based combination had undetectable levels of HIV (<200 copies/mL) and 61.9% and 15.4%, respectively, achieved undetectable levels below 20 copies/mL. In an OT analysis of these patients, 72.2% of patients taking the VIRAMUNE-based combination vs. 80% taking the nelfinavir-based combination had undetectable levels of HIV (<200 copies/mL); 61.1% and 26.7% achieved undetectable levels below 20 copies/mL. Baseline characteristics of patients in the VIRAMUNE-based treatment group and the nelfinavir-based treatment group were similar. Median CD4+ count in each group was 361 and 351, and HIV-RNA was 59,698 copies/mL and 65,806 copies/mL, respectively. The regimens were generally well tolerated by patients, although some serious adverse events were reported in this study. A total of 7 patients discontinued zidovudine and switched to d4T (stavudine) due to anemia or neutropenia (an abnormal drop in white blood cells). Additionally, 10 out of 72 patients stopped taking the VIRAMUNE-based combination due to adverse events, which were hepatitis (5), rash (4) and gastrointestinal symptoms (1), and 12 out of 70 patients stopped taking the nelfinavir-based combination because of adverse events, including gastrointestinal symptoms (10), hepatitis (1) and rash (1). VIRAMUNE, the first member of the NNRTI class of anti-HIV drugs to be approved, 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. VIRAMUNE should always be administered in combination with other antiretroviral agents. The most clinically important adverse events associated with VIRAMUNE are rash (16%) and hepatic events. Other commonly reported events include fever, nausea and headache. Cases of hypersensitivity reactions have been observed. 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. Boehringer Ingelheim recently acquired world-wide marketing rights to an investigational protease inhibitor, tipranavir. For more information on Boehringer Ingelheim or VIRAMUNE, please see Contacts: Judith von Gordon Corporate Public Relations Division Boehringer Ingelheim GmbH 55216 Ingelheim/Germany Phone: +49-61-327-73-582 Fax: +49-61-327-76-601 Mobile: +49-72-610-61-74 Maureen Byrne/Peter George GCI Healthcare 114 Fifth Avenue New York, NY 10011 Phone: +1-212-886-3312/3491 Fax: +1-212-886-3291 * antiretroviral drugs mentioned in this release: Combivir(TM) (3TC 150 mg/ZDV 300 mg), Glaxo Wellcome Inc.; nelfinavir (Viracept(R)), Agouron Pharmaceuticals Inc. final analysis of the data will take place at 48 weeks of the study. ots Originaltext: Boehringer Ingelheim GmbH Internet: Contact: Judith von Gordon, Corporate Public Relations Division, Boehringer Ingelheim GmbH, +49-61-327-73-582, or fax, +49-61-327-76-601, or mobile, +49-72-610-61-74; or Maureen Byrne, 212-886-3312, or Peter George, 212-886-3491, both of GCI Healthcare, 212-886-3291, for Boehringer Ingelheim GmbH Web site: Original-Content von: Boehringer Ingelheim GmbH, übermittelt durch news aktuell

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