Data Published in AIDS Show Viramune(R) (nevirapine) Achieves Durable Benefit in Switch Patients

Ingelheim, Germany (ots/PRNewswire) -

Long-term data from the Nevirapine/Efavirenz/Abacavir (NEFA) study
demonstrate that patients who switched from a protease
inhibitor-based regimen to a non-nucleoside reverse transcriptase
inhibitor-based regimen containing Viramune(R) (nevirapine) or
efavirenz achieved comparable efficacy and safety to their previous
regimen and were more likely to maintain virologic suppression after
three years of follow-up than patients who switched to an
abacavir-containing regimen. These data were published in the 30
January issue of AIDS.

"Patients may want to consider simpler regimens that can suppress
the virus long term but are more tolerable and have fewer side
effects than some protease inhibitor-based therapies. The findings of
the NEFA study reveal that HIV-positive patients seeking effective
alternatives can benefit from a switch to a treatment regimen
containing a non-nucleoside reverse transcriptase inhibitor such as
VIRAMUNE," said Esteban Martinez, M.D., Ph.D., professor of medicine,
University of Barcelona.

The NEFA study has been the largest prospective protease inhibitor
switch study conducted to date. The NEFA study was a multicentre,
randomized, open-label clinical trial initially designed for one-year
follow up of 460 HIV-positive adults who had previously been treated
with at least one protease inhibitor plus two nucleoside reverse
transcriptase inhibitors. The follow up was extended to three years
following recommendations from the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMEA).
Patients participating in the study were required to have maintained
the amount of HIV in their blood (viral load) to less than 200
copies/mL for at least six months on their protease inhibitor-based
regimen containing indinavir (n=278), nelfinavir (n=135), ritonavir
(n=15), saquinavir (n=13), or indinavir or saquinavir in combination
with low-dose ritonavir (n=19) prior to study entry. Patients were
then randomized to replace their protease inhibitor with VIRAMUNE
twice daily (n=155), efavirenz once daily (n=156) or abacavir twice
daily (n=149).

An intent-to-treat (ITT) analysis of patients originally
randomized to switch from their protease inhibitor to VIRAMUNE,
efavirenz or abacavir showed that 93.5 percent of patients who
switched to VIRAMUNE, 92.9 percent of patients who switched to
efavirenz and 80.5 percent of patients who switched to abacavir
achieved virologic success after three years. This analysis was
conducted to control for the effects of study discontinuation and
switching from study medication.

In this study, the incidence of adverse events leading to
discontinuation was significantly lower in the abacavir (9 percent)
and VIRAMUNE (19 percent) groups than the efavirenz (25 percent)
group. The majority of adverse events that led to discontinuation in
the abacavir and VIRAMUNE arms occurred in the first weeks of the
study. The most common adverse events experienced were
neuropsychiatric events in the efavirenz arm and rash in the VIRAMUNE
arm. While in the VIRAMUNE group adverse events occurred within the
first year, neuropsychiatric adverse events that led to late
discontinuation in the efavirenz group occurred steadily through
three years of follow-up.

About VIRAMUNE

VIRAMUNE(R) (nevirapine) 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
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(R) CD4+ guidelines the risk of hepatic
events can be dramatically reduced. 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 6 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.

Boehringer Ingelheim

Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. Apart from VIRAMUNE(R), 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 involved in basic research and is
committed to improving HIV therapy by providing physicians and
patients with innovative antiretrovirals.

For more information on Boehringer Ingelheim, please see
http://www.boehringer-ingelheim.com/hiv.

Reference:

Martinez E. et al. Three-year Follow-Up of Protease
Inhibitor-based Regimen Simplification in HIV-infected Patients. AIDS
2007 21(3):367-369

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

ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Judith von Gordon, CD Communications, Boehringer Ingelheim GmbH,
+49-61-32-77-3582, Fax: +49-61-32-77-6601