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Head-to-Head Trial Demonstrates Viramune(R)'s Similar Efficacy and Superior Effect on Lipid Profile Compared to atazanavir/ritonavir

Cape Town, South Africa (ots/PRNewswire)

- For Medical Media Outside the US Only
Results from the ARTEN* trial presented at the 5th International
AIDS Society (IAS) conference in Cape Town, South Africa demonstrated
non-inferiority regarding efficacy between Viramune(R) (nevirapine)
and ritonavir boosted atazanavir (atazanavir/r) both combined with
tenofovir and emtricitabine (Truvada(R)). This head-to-head study
also showed Viramune(R)'s more favourable effect on the lipid profile
and now clearly confirms the combination's place as an important
first line therapy for patients with HIV.
To view the Multimedia News Release, please click:
http://www.prnewswire.com/mnr/boehringeringelheim/39137/
"ARTEN puts to rest the concerns over a potential lack of
efficacy of Viramune(R) in combination with Truvada(R)," lead
investigator of the ARTEN study, Professor Vicente Soriano, Assistant
Director of the Department of Infectious Diseases, Hospital Carlos
III, Madrid said. "The results confirm that the combination of
Viramune(R) and Truvada(R) is a highly efficacious combination that
offers significant benefit even more so to patients with
cardiovascular risk."
ARTEN is the first large-scale prospective study to compare two
frequently prescribed lipid friendly, antiretrovirals(ARVs):
atazanavir and Viramune(R).(1,2) Compared to values at baseline,
Viramune(R) increased absolute HDL-c (the so called good cholesterol)
to more than two-fold the value achieved with atazanavir/r (9.7 mg/dL
vs 3.9 mg/dL (P<0.0001). Also the total cholesterol over HDL-c ratio
was significantly in favour of Viramune(R) (P<0.0001).(3)
The study also sought to establish whether the combination itself
was an effective treatment option for patients with a high viral
load. Results have successfully answered these questions by showing
that the combination of Viramune(R) with Truvada(R) achieved
undetectable viral load as early as in two consecutive office visits
prior to week 48 (e.g. week 24,36 and 48) in 67% of patients versus
65% (atazanavir/r + Truvada(R)).(1)
"ARTEN provides evidence that Viramune(R) is and continues to be
a potent choice in ARV therapy today regardless of viral load. This
is particularly important in late-presenting patients whose infection
has already progressed. We see a considerable number of those in
clinical practice." said Professor Soriano.
At the end of 2007, approximately 33 million individuals were
living with HIV.(4) With successful antiretroviral therapy, the
number of deaths per year has been declining(5) and patients infected
with HIV are now living longer. However, recent reports suggest that
cardiovascular disease has become an important cause of morbidity and
mortality in this population.(6) Many are  now also suffering
increased rates of coronary heart disease (CHD).(7)
Dr Manfred Haehl, Senior Vice-President Medicine at Boehringer
Ingelheim said "Given the current concerns regarding CHD in those
with HIV, patients are now increasingly looking for treatment
strategies that have the most lipid friendly profile in order to
safeguard their wider health and to prevent the onset of
cardiovascular and metabolic diseases. ARTEN now clearly provides
additional reassurance for physicians to treat with more confidence
patients with a Viramune(R) and Truvada(R) combination."
*Atazanavir/Ritonavir on a background of Tenofovir and
Emtricitabine (Truvada(R) a trademark of Gilead Science...) versus
Nevirapine
About ARTEN
ARTEN is an international, open label, randomized,
non-inferiority (12% margin) study comparing ATZ/r 300mg/100mg QD vs.
NVP 200mg BID or 400mg QD, each combined with fixed-dose TDF
300mg/FTC 200mg QD. Treatment-naive men and women with CD4 counts
<400 and <250 cells/mm3, respectively, were eligible. Primary
end-point was treatment response (TR), defined as plasma HIV-RNA <50
copies/mL at two consecutive visits (i.e. weeks 24 and 36) and
without subsequent rebound or change of ARVs prior to wk-48.
569 patients were randomised and treated. Baseline demographics
and HIV-related characteristics were similar between groups. Mean
HIV-RNA was 5.1 log10 copies/mL (64% >100,000 copies/mL); mean CD4
count was 183 cells/mm3.
About Viramune(R)
Viramune(R) is a product of original research done at Boehringer
Ingelheim. Viramune(R) was the first member of the non-nucleoside
reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs.
Viramune(R) is indicated for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection. This
indication is based on one principal clinical trial that demonstrated
prolonged suppression of HIV-RNA and several smaller supportive
studies. Studies have also shown that patients switching to
Viramune(R) from a PI-based regimen demonstrate an improved lipid
profile while maintaining viral suppression. The most clinically
important adverse events associated with Viramune(R) are rash and
hepatic events, which have included fatal cases. Any patient can
experience hepatic events; however, female gender and higher CD4+
cell counts at initiation of therapy place patients at greater risk.
Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk.
Viramune(R) should not be initiated in adult females with CD4+ cell
counts greater than 250 cells/mm3 or in adult males with CD4+ cell
counts greater than 400 cells/mm3 unless the benefit outweighs the
risk. The greatest risk of severe rash and hepatic events occurs in
the first six weeks of therapy. It is essential that patients be
monitored for these reactions at all times, and intensively during
the first few months of therapy. Viramune(R) should be discontinued
and not restarted following severe hepatic, skin or hypersensitivity
reactions.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 138 affiliates in 47 countries and 41,300
employees. Since it was founded in 1885, the independent,
family-owned company has been committed to researching, developing,
manufacturing and marketing novel products of high therapeutic value
for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion
euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.
For more information please visit
http://www.boehringer-ingelheim.com and http://www.viramune.com
References
1 Martinez, E., et al., Substitution of nevirapine, efavirenz, or
abacavir for protease inhibitors in patients with human
immunodeficiency virus infection. N Engl J Med, 2003. 349(11): p.
1036-46.
2 Friis-Moller, N., et al., Cardiovascular disease risk factors
in HIV patients - association with antiretroviral therapy. Results
from the DAD study. Aids, 2003. 17(8): p. 1179-93.
3 Soriano, V et al., Prospective comparison of Nevirapine and
Atazanavir/ritonavir both combined with Tenofovir DF/Emtricitabine in
treatment-naive HIV-1 infected patients: ARTEN Study week 48 results
5th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS
2009), July 19 -22, 2009, Poster LBPEB07
4 UNAIDS 2008 Report, http://www.unaids.org/en/KnowledgeCentre/HI
VData/GlobalReport/2008/2008_Global_report.asp , Accessed 05 June
2009
5 Worldwide HIV & AIDS Statistics Commentary
http://www.avert.org/worlstatinfo.htm, Accessed 05 June 2009
6 Lohse N, Hansen AB, Pedersen G, Kronborg G, Gerstoft J,
S0rensen HT, Vaeth M, Obel N. Survival of persons with and without
HIV infection in Denmark, 1995-2005. Ann Intern Med. 2007;146:87-95.
7 DAD Study Group, Friis-M0ller N, Reiss P, et al., Class of
antiretroviral drugs and the risk of myocardial infarction, N Engl J
Med, 2007;356(17):1723-35.
(Due to the length of the URL in reference 4, it may be necessary
to  copy and paste the hyperlink into your Internet browser's URL
address  field. Remove the space if one exists.)
Media Contact:
    Boehringer Ingelheim GmbH
    Corporate Division Communications
    Dr Heike Specht
    Binger Strasse 173
    55216 Ingelheim am Rhein
    Germany
    T: +49-6132-7793319
    E:  press@boehringer-ingelheim.com
    Nick James
    T: +44-7776-258-990
    E:  n.james@cca-uk.com

Contact:

Media Contact: Boehringer Ingelheim GmbH, Corporate Division
Communications, Dr Heike Specht, Binger Strasse 173, 55216 Ingelheim
am Rhein, Germany, T: +49-6132-7793319, E:
press@boehringer-ingelheim.com; Nick James, T: +44-7776-258-990, E:
n.james@cca-uk.com

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