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25.07.2007 – 03:03

Boehringer Ingelheim

Data Presented at International AIDS Society (IAS) Conference Shows Long-Term Viramune(R) (nevirapine) Efficacy and Increase in Good Cholesterol

Sydney, Australia (ots/PRNewswire)

New data from two new studies of Viramune(R) (nevirapine) were
presented at the 4th International AIDS Society (IAS) in Sydney,
Australia. Results from an extended three-year follow-up analysis of
the 2NN study demonstrated that HIV-positive patients taking VIRAMUNE
(nevirapine) achieved a comparable virologic and immunologic response
to patients taking efavirenz. The second study, NILE, examined the
mechanism by which VIRAMUNE increases the level of high-density
lipoprotein cholesterol (HDLc, also called "good cholesterol" because
of its cardioprotective character) and confirmed again that VIRAMUNE
increases HDL-cholesterol through 24 weeks.
"These studies show how to further maximise the benefits of
treatment with VIRAMUNE. The findings of the NILE study are
particularly encouraging as it was thought that some therapies for
HIV may increase cardiovascular risk. What NILE has shown is that
VIRAMUNE may increase good cholesterol in a manner which might be
expected to reduce cardiovascular risk, and therefore, the study may
help us identify promising novel targets for increasing good
cholesterol," Peter Reiss, Professor of Medicine, Academic Medical
Centre, Amsterdam, Netherlands.
NILE (Nevirapine Intensive Lipid Evaluation)
The NILE study examined the way that VIRAMUNE increases
HDL-cholesterol in 13 HIV positive patients with viral loads of <50
copies/mL. Patients who had been on treatment containing zidovudine,
lamivudine and abacavir for six months added VIRAMUNE to their
regimes and were evaluated at six and twenty four weeks for enzymes
that alter HDLc levels. The results showed that VIRAMUNE increased
HDLc by 19% through an increase of apolipoprotein A1 by 14% The
findings may help identify new promising novel targets for increasing
good cholesterol.
The 2NN study was an open-label, comparison trial of first-line
antiretroviral therapy that randomized 1,216 patients in 17
countries. Inclusion criteria was a plasma HIV-1 viral load greater
than 5,000 RNA copies/mL without CD4 restriction. The median baseline
CD4 count was 190 cells/mm3, and median viral load was 4.7 log10,
with no significant differences among treatment arms.
"The 2NN analysis provides long-term evidence that patients taking
an NNRTI-containing regimen can achieve a good treatment response
with either VIRAMUNE or efavirenz for at least three years," said
Joep Lange, M.D., Professor of Internal Medicine, Academic Medical
Centre, University of Amsterdam, Netherlands. "As treatment
strategies continue to grow more complex, these findings demonstrate
that VIRAMUNE and efavirenz can offer simple, effective and durable
options for long-term treatment success."
A retrospective intent-to-treat (ITT) analysis of the study
examined 567 patients randomly assigned to receive VIRAMUNE 400 mg
once daily (n=120), VIRAMUNE 200 mg twice daily (n=224) or efavirenz
600 mg once daily (n=223), and a nucleoside background containing
stavudine and lamivudine, from 49 to 144 weeks of therapy. The
primary endpoint was the percentage of treatment failures between
week 49 and 144, defined as the occurrence of CDC-B/C events(i),
virologic failure, or a change in allocated NNRTI. Secondary
endpoints included the percentage of patients with virologic failure,
change in CD4 cell count, incidence of CDC-B/C events, and incidence
of laboratory grade 3/4 adverse events.
Among patients included in the ITT analysis, the following was
observed from week 49 to 144:
There were no statistically significant differences with regard to
the primary endpoint, treatment failure.
    -- Treatment response was comparable across all three study arms: 55% for
       VIRAMUNE once daily, 64% for VIRAMUNE twice daily, and 65% for
       efavirenz. Comparisons for all secondary analyses yielded no
       significant differences.
    -- The rates of virologic failure were similar for all three study arms:
       4.9% for efavirenz, 5.8% for VIRAMUNE BID and 8.3% for VIRAMUNE QD.
    The authors concluded:
    -- Change of medication was the most frequent reason for treatment
    -- There was a low incidence of virologic failure during the 2nd and 3rd
    -- There was a continued increase in CD4+ T-cell counts;
VIRAMUNE is a product of original research done at Boehringer
Ingelheim. VIRAMUNE was the first member of the non-nucleoside
reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs.
VIRAMUNE 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
from a PI-based regimen demonstrate an improved lipid profile while
maintaining viral suppression. The most clinically important adverse
events associated with VIRAMUNE 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. By application of the
VIRAMUNE CD4+ guidelines the risk of hepatic events can be
dramatically reduced. VIRAMUNE 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 should be discontinued and not restarted following severe
hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. Apart from Viramune(R) (nevirapine),
Aptivus(R) (tipranavir) is a new non-peptidic protease inhibitor,
approved for combination antiretroviral treatment of HIV-1 infected
adults that are highly pre-treated with virus resistant to multiple
protease inhibitors. The company is committed to improving HIV
therapy by providing physicians and patients with innovative
Boehringer Ingelheim is actively conducting clinical trial
programs to further evaluate VIRAMUNE and APTIVUS for the treatment
of HIV-1 infection. Boehringer Ingelheim recently announced the
initiation of the ArTEN trial, which will compare the efficacy and
safety of VIRAMUNE dosed once-or twice-daily versus atazanavir
boosted with ritonavir in HIV-positive antiretroviral-naive patients.
The APTIVUS clinical trial program is comprised of ongoing and
planned studies in more than 1,400 treatment-experienced patients,
including the SPRING study, which is examining the benefits of
APTIVUS in an ethnically and racially diverse highly
treatment-experienced patient population and the POTENT study, which
will compare the efficacy and safety of APTIVUS versus darunavir.
For more information on Boehringer Ingelheim, please see
Please be advised
This release is from the Corporate Headquarters of Boehringer
Ingelheim and is intended for all international markets. This being
the case, please be aware that there may be some differences between
countries regarding specific medical information including licensed
uses. Please take account of this when referring to the material.
Wit, F. et al. Three-year extended follow-up of the 2NN study: a
randomised comparative trial of first-line antiretroviral therapy
with regimens containing either nevirapine, efavirenz or both drugs
combined, together with stavudine and lamivudine. 4th International
AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment;
Sydney, Australia. Abstract #WEPEB032
Sankatsing, R. et al. Nevirapine increases High Density
Lipoprotein-cholesterol by stimulation of apolipoprotein AI
synthesis. 4th International AIDS Society (IAS) conference on HIV
Pathogenesis and Treatment; Sydney, Australia. Abstract #WEPEB120LB
    (i) The U.S. Centers for Disease Control and Prevention (CDC) disease
        staging system assesses the severity of HIV disease by CD4 cell
        counts and by the presence of specific HIV-related conditions.
        Category B events are symptomatic conditions of HIV infection in
        adolescents or adults. Category C events are AIDS-indicator
        conditions, such as recurrent bacterial pneumonia, coccidioidomycosis
        and histoplasmosis. (Source: AIDS Education and Training Centers
        (AETC) National Resource Center)
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Judith von Gordon, CD Communications, Boehringer Ingelheim
+49-61-32-77-3582, or fax: +49-61-32-77-6601

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