Alle Storys
Folgen
Keine Story von Boehringer Ingelheim mehr verpassen.

Boehringer Ingelheim

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

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

Original-Content von: Boehringer Ingelheim, übermittelt durch news aktuell

Weitere Storys: Boehringer Ingelheim
Weitere Storys: Boehringer Ingelheim