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Boehringer Ingelheim

New Three-Year Data Confirms Aptivus(R) (tipranavir) as Effective and Durable Treatment Option for Treatment-Experienced Patients

Madrid, Spain (ots/PRNewswire)

- For Non-U.S. Media
New data from the combined RESIST studies (RESIST-1 and RESIST-2)
show  that Aptivus(R) (tipranavir), used with Norvir (ritonavir),
provides a  superior and durable treatment response for up to three
years in treatment- experienced HIV patients versus a comparator
group of protease inhibitors.(1)  The research was presented at the
11th European AIDS Conference (EACS) in  Madrid, Spain.
At 156 weeks, APTIVUS combined with ritonavir (APTIVUS/r),
continues to outperform a group of ritonavir-boosted comparator
protease inhibitors that includes low dose ritonavir boosted
lopinavir, amprenavir, saquinavir and indinavir. When compared to
these protease inhibitors, through three years of therapy, treatment
response rates(2) were almost three times higher in the APTIVUS/r arm
compared to the comparator arm (20.9% vs. 7.5%).
Moreover, patients taking APTIVUS/r combined with first-time use
of enfuvirtide achieved four-fold greater treatment response rates
than patients with comparator protease inhibitors (37.9% vs. 8.2%).
In this group, the proportion of patients who achieved a viral load
of less than 50 copies/mL at week 156 was more than twice as high
with APTIVUS/r as with comparator protease inhibitors (21.8% vs.
9.3%).
"The new data show that for patients who achieve successful HIV
suppression with tipranavir, the results are usually maintained over
the long term. In a patient population for which treatment options
are limited, this is an important achievement," said lead author
Charles Hicks, M.D., associate professor of medicine at Duke
University, USA.
The adverse event profile for APTIVUS/r was comparable with what
has been reported in previous analysis. The patient exposure years
(PEY)-adjusted adverse event profile was similar between APTIVUS and
the comparator protease inhibitors group.
About RESIST
The RESIST trials are randomised, controlled, open-label, Phase
III trials designed to study APTIVUS combined with ritonavir versus a
group of ritonavir-boosted comparator protease inhibitors. The RESIST
clinical trial programme is one of the largest study programs
undertaken with an investigational antiretroviral agent in patients
previously treated with three classes of antiretrovirals, with Phase
II and III data from more than 1,400 patients taking the 500 mg/200
mg dose of APTIVUS/r.
About APTIVUS
APTIVUS is a non-peptidic protease inhibitor which works by
inhibiting the viral protease, an enzyme needed to complete the HIV
replication process. It is approved for combination antiretroviral
treatment of HIV-1 infected adults that are highly pre-treated with
virus resistant to multiple protease inhibitors.
Based on available clinical and in vitro data, APTIVUS is active
against most strains of HIV-1 that are resistant to commercially
available protease inhibitors.
Currently, phase II and III studies in paediatric and other
populations are fully enrolled and ongoing.
The most commonly reported side effects of at least moderate
intensity in patients enrolled in the RESIST studies taking APTIVUS
are gastrointestinal, including diarrhoea, nausea, vomiting and
abdominal pain. Fever, fatigue, headache, bronchitis, depression and
rash also occurred. Elevated transaminase, cholesterol and
triglycerides were more frequent in the APTIVUS/r arm than in the
ritonavir boosted comparator group but only in a minority of cases
treatment discontinuation was necessary.
APTIVUS boosted with low-dose ritonavir has been associated with
reports of hepatic adverse events, which have included some
fatalities. These have generally occurred in patients with advanced
HIV disease taking multiple concomitant medications. Extra vigilance
is warranted in patients with chronic hepatitis B or hepatitis C
co-infection, as these patients have an increased risk of liver
toxicity. The most common moderate to severe laboratory abnormalities
were elevated liver enzymes and elevated lipid levels. Most
laboratory abnormalities were asymptomatic and most patients were
successfully treated without discontinuation.
APTIVUS-containing HAART regimens have been associated with
reports of both fatal and non-fatal intracranial hemorrhage (ICH) in
some highly treatment-experienced patients. Caution should be used
when prescribing APTIVUS/r in patients who may be at risk of
increased bleeding or who are receiving medications known to increase
the risk of bleeding.
APTIVUS does not cure HIV infection/AIDS or prevent the
transmission of HIV to others. Patients may continue to develop
opportunistic infections and other complications associated with HIV
disease.
Apart from the EU, APTIVUS received U.S. marketing authorization
by the FDA and was launched there in June 2005. On 4 October 2007,
the FDA granted traditional approval for APTIVUS. Additional
marketing authorizations from different countries have been received
or are expected.
About Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. Apart from Aptivus(R) (tipranavir),
Viramune(R) (nevirapine) 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 on the market. The company is involved in basic
research in that area and is committed to improving HIV therapy by
providing physicians and patients with innovative antiretroviral
treatment options.
Boehringer Ingelheim is actively conducting clinical trial
programs to further evaluate APTIVUS and VIRAMUNE for the treatment
of HIV-1 infection. The APTIVUS clinical trial program is comprised
of ongoing and planned studies in more than 1,400
treatment-experienced patients:
    -- In addition to the RESIST study, Boehringer Ingelheim is also
       conducting the SPRING trial to examine the benefits of APTIVUS/r in an
       ethnically and racially diverse highly treatment-experienced patient
       population.
    -- Enrollment also began for the POTENT study in August 2007. POTENT
       will compare the efficacy and safety of APTIVUS/r versus darunavir/r,
       both as part of combination antiretroviral therapy, for treatment-
       experienced patients.
    -- The VIRAMUNE clinical trial program includes the ArTEN trial, which
       aims to compare the efficacy and safety of VIRAMUNE dosed once or
       twice daily versus atazanavir boosted with ritonavir in HIV-positive
       antiretroviral-naive patients.
For more information on the Boehringer Ingelheim HIV Franchise,
please see www.boehringer-ingelheim.com/hiv.
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.
References:
(1) Hicks et al. Tipranavir/r (TPV/r) maintains long term
virological suppression - Three year follow-up of RESIST; 11th annual
European AIDS Conference (EACS); 24-27 October 2007, Madrid, Spain.
Abstract number P4.3/70.
(2) Treatment response rates are defined as a confirmed 1 log10 or
greater decrease in viral load from baseline.
Web site: http://www.boehringer-ingelheim.com/hiv

Contact:

Judith von Gordon, CD Communications, + 49-6132-773582, or fax,
+49-6132-776601, for Boehringer Ingelheim GmbH

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