Data Show VIRAMUNE(R) (nevirapine) Combination Durably Suppresses HIV in Patients with Advanced HIV/AIDS
Durban, South Africa (ots-PRNewswire) - Study results demonstrating the significant potency of VIRAMUNE(R) (nevirapine, NVP) were presented today at the 13th International AIDS Conference in Durban, South Africa. Findings show VIRAMUNE-based treatment combinations suppressed HIV in the blood for up to one year in patients with advanced HIV disease and high baseline levels of HIV.
Prof. Robin Wood presented an analysis today that evaluated 171 previously untreated patients with very high median baseline levels of HIV -- 142,883 copies/mL of plasma -- and low median baseline CD4+ cell counts of 97 CD4+ cells/mm3. Patients were randomized to receive ZDV* and 3TC* plus either VIRAMUNE or placebo (77 VIRAMUNE and 94 placebo) as a part of a large, international study (BI 1090) conducted in North America, Western Europe, South Africa and Argentina(1).
"Results presented today demonstrate that VIRAMUNE suppresses HIV in patients with advanced HIV infection and very high viral loads," explained Prof. Wood of the Somerset Hospital, University of Cape Town, South Africa. "This is important because the VIRAMUNE+ZDV+3TC combination can be taken in a simple treatment regimen."
Since this trial was conducted, the triple combination of VIRAMUNE+ ZDV+3TC has become available in a simple, twice-daily regimen (VIRAMUNE+Combivir**) that requires a total of only four tablets per day. There are no food or fluid restrictions associated with this combination.
Sixty percent (60%) and 44% of patients taking the triple drug combination (VIRAMUNE+ ZDV+3TC) achieved suppression of HIV below the limit of detection at six months and one year. This result was achieved using an assay that can detect virus in the blood as low as 50 copies/mL, and using a strict 'intent- to-treat analysis,' which accounts for all patients, including those who stopped treatment before the end of the evaluation period (therapy is considered to have failed in those who stopped prior to evaluation). At six months and one year, an 'as-treated analysis' found the percentage of patients taking the triple drug combination with undetectable levels of HIV (below 50 copies/mL) was 71% and 65%. This analysis includes patients who did not stop therapy due to toxicity or loss to follow-up. Additionally, a mean 98 CD4+ cell increase was seen in these patients at six months; a 137 CD4+ cell increase was seen at one year.
"We're pleased that this trial provided results that are relevant today. This study was designed in 1995 and was based on the standard of treating AIDS patients at that time," explained Prof. Wood. "With significant advances in HIV/AIDS treatment since the trial's inception, the dual-therapy comparator arm in this study is no longer considered standard of care. However, this study demonstrates that the VIRAMUNE triple therapy regimen is a viable treatment option for patients today, regardless of patients' viral load."
Safety data indicated that both treatment arms were safe and generally well tolerated with similar adverse events in both treatment arms.
VIRAMUNE, the first member of the non-nucleoside reverse transcriptase inhibitor (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.
VIRAMUNE is generally well-tolerated. The most clinically important adverse events associated with VIRAMUNE are rash and increases in liver function tests. 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 additional anti-HIV drug, an investigational protease inhibitor, tipranavir.
For more information on Boehringer Ingelheim or VIRAMUNE, please see http://www.boehringer-ingelheim.com.
Judith von Gordon Maureen Byrne/Denise
Corporate Public Relations Division GCI Healthcare
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* ZDV (zidovudine, AZT, Retrovir(R)) and 3TC (Epivir(R), lamivudine) and ** Combivir(TM) (ZDV+3TC) are registered trademarks of Glaxo Wellcome Inc.
Wednesday, 12 July, 2000, Poster Session, 16:30
(1) Wood R. et al. Sustained efficacy of nevirapine (NVP) in
with two nucleosides in advanced, treatment- naive HIV infected
patients with high viral loads: A BI 1090 substudy. (abstract
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Contact: Judith von Gordon, Corporate Public Relations Division of Boehringer Ingelheim GmbH, +49-6132-773582, or fax, +49-6132-776601; or On site - 9-14 July - Maureen Byrne, +27-082-370-0768 or 212-886-3312, or Denise Connolly, +27-082-370-0457 or 212-886-3117, or Fax, 212-886-3291, both of GCI Healthcare, for Boehringer Ingelheim GmbH
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