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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
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.
Contacts:
Judith von Gordon                      Maureen Byrne/Denise
Connolly
   Corporate Public Relations Division    GCI Healthcare
   Boehringer Ingelheim GmbH              114 Fifth Avenue
   55216 Ingelheim/Germany                New York, NY 10011
   Phone: + 49 - 6132 - 773582            On site: 9-14 July
   Fax: + 49 - 6132 - 776601              +27 082 370 0768
                                         +27 082 370 0457
                                         Phone: +1 (212)
886-3312/3117
                                         Fax: +1 (212) 886-3291
* 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
combination
      with two nucleosides in advanced, treatment- naive HIV infected
      patients with high viral loads: A BI 1090 substudy. (abstract
No.
      WeOrB607)
ots Original Text Service: Boehringer Ingelheim GmbH
Internet: http://recherche.newsaktuell.de

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

Web site: http://www.boehringer-ingelheim.com

Original content of: Boehringer Ingelheim, transmitted by news aktuell

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