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U.S. FDA Approves New Anti-HIV Drug Aptivus(R) for Use in Combination Therapy

Ridgefield, Connecticut (ots/PRNewswire)

- The Following Press Release Was Issued By Our U.S. Affiliate
Boehringer Ingelheim Pharmaceuticals, Inc. in The United States on
June 23, 2005
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that
the U.S. Food and Drug Administration (FDA) has granted accelerated
approval of Aptivus(R) (tipranavir) capsules. Accelerated approval is
a regulatory process that expedites the approval of therapies for
serious or life-threatening illnesses that provide meaningful benefit
to patients over existing treatments. This approval is based on
24-week data from ongoing studies. Longer term data will be needed
before FDA can consider traditional approval for APTIVUS. There are
no study results demonstrating the effect of APTIVUS on clinical
progression of HIV-1.
The approved dose of APTIVUS is 500 mg taken with 200 mg of
ritonavir (APTIVUS/r), twice daily. APTIVUS must be co-administered
with ritonavir to boost the therapeutic levels of APTIVUS; otherwise,
levels of APTIVUS will be insufficient to inhibit HIV replication.
APTIVUS/r must be taken in combination with other anti-HIV
medications. APTIVUS 250 mg soft gel capsules will begin to be
available in pharmacies nationwide within two weeks of FDA approval.
APTIVUS is a non-peptidic protease inhibitor that works by
inhibiting protease, an enzyme needed to complete the HIV replication
process. APTIVUS is able to enter infected immune cells and inhibit
HIV replication for many strains of HIV that are resistant to other
commercially available protease inhibitors (PI).
Drug resistance is one of the major challenges that patients and
physicians face in the treatment of HIV. Resistance develops when the
virus mutates and is no longer suppressed by drugs that were once
effective.
"The prevalence of drug resistant HIV underscores the need for new
treatments," said Dr. Daniel Kuritzkes, Associate Professor of
Medicine, Harvard Medical School, Director of AIDS Research, Brigham
and Women's Hospital. "APTIVUS offers an important new treatment
option to highly treatment-experienced patients or those with
multiple protease inhibitor resistant virus."
APTIVUS (tipranavir), co-administered with 200 mg of ritonavir, is
indicated for combination antiretroviral treatment of HIV-1 infected
adult patients with evidence of viral replication, who are highly
treatment-experienced or have HIV-1 strains resistant to multiple
protease inhibitors. This indication is based on analyses of plasma
HIV-1 RNA levels in two controlled studies of APTIVUS of 24 weeks
duration. Both studies were conducted in clinically advanced, 3-class
antiretroviral treatment-experienced adults with evidence of HIV-1
replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy
with APTIVUS/ritonavir:
    --  The use of other active agents with APTIVUS/ritonavir is associated
        with a greater likelihood of treatment response.
    --  Genotypic or phenotypic testing and/or treatment history should
        guide the use of APTIVUS/ritonavir.  The number of baseline primary
        protease inhibitor mutations affects the virologic response to
        APTIVUS/ritonavir.
    --  Liver function testing should be performed at initiation of therapy
        with APTIVUS/ritonavir and monitored frequently throughout the
        duration of treatment.
    --  Use caution when prescribing APTIVUS/ritonavir to patients with
        elevated transaminases, hepatitis B or C co-infection or other
        underlying hepatic impairment.
    --  The extensive drug-drug interaction potential of APTIVUS/ritonavir
        when co-administered with multiple classes of drugs must be
        considered prior to and during APTIVUS/ritonavir use.
    --  The risk-benefit of APTIVUS/ritonavir has not been established in
        treatment-naïve adult patients or pediatric patients.
Pivotal Data
Patients enrolled in the RESIST studies were failing their current
PI-based regimen, had received at least two previous PI-based
regimens, had received prior treatment from at least three classes of
antiretroviral agents and had documented PI resistance. These trials
examined the treatment response at 24 weeks of APTIVUS/r versus a
comparator group in which patients received one of several marketed
ritonavir-boosted PIs. Investigators selected a comparator PI that
offered patients the best opportunity for treatment response based on
resistance testing. The comparator PIs were lopinavir, indinavir,
saquinavir and amprenavir. In addition, patients in both arms
received an optimized background regimen of other antiretroviral
drugs. Patients in these trials were highly treatment-experienced and
the majority were at least possibly resistant to the comparator PI
chosen. The median baseline viral load and CD4+ count were 4.82 log10
copies/mL and 155 cells/mm3, respectively.
The results of the RESIST studies showed that a statistically
significant greater percentage of HIV-positive patients taking
APTIVUS/r achieved a treatment response versus the comparator group
(40% vs. 18%). Treatment response was defined as a confirmed 1 log10
or greater decrease in viral load from baseline.
In addition, a significantly greater proportion of patients
receiving regimens that contain boosted APTIVUS were able to reduce
the amount of HIV in their blood to undetectable levels than in the
boosted comparator group. At 24 weeks, 34% of patients in the
APTIVUS/r group and 16% of patients in the boosted comparator group
achieved a viral load of less than 400 copies/mL, and 23% vs. 9%
achieved less than 50 copies/mL.
Patients treated with APTIVUS/r also experienced greater increases
in their immune cells than those treated with a ritonavir-boosted
comparator PI. The median change from baseline in CD4+ cell count at
week 24 was +34 cells/mm3 in patients receiving APTIVUS/r (n=582)
versus +4 cells/mm3 in the comparator group of ritonavir-boosted PIs
(n=577).
"The approval of APTIVUS marks an important milestone in
Boehringer Ingelheim's long-standing commitment to the HIV
community," said Burkhard Blank, M.D., Senior Vice President, Medical
and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals,
Inc. "Our HIV research and development program is dedicated to
bringing innovative HIV therapies to patients and their healthcare
providers."
Safety Information
APTIVUS co-administered with 200 mg ritonavir has been associated
with reports of clinical hepatitis and hepatic decompensation
including some fatalities. Extra vigilance is warranted in patients
with chronic hepatitis B or hepatitis C co-infection, as these
patients have an increased risk of hepatotoxicity. All patients
should be followed closely with clinical and laboratory monitoring.
Liver function tests should be performed prior to initiating therapy
with APTIVUS/r and frequently throughout the duration of treatment.
Patients who develop symptoms of liver problems, such as fatigue,
loss of appetite, yellowing of the eyes or skin, or liver tenderness,
should stop taking APTIVUS/r treatment. Patients with moderate to
severe hepatic insufficiency should not take APTIVUS/r.
APTIVUS/r has an effect on the way some medications are eliminated
by the body, and if these medications are combined with APTIVUS/r, an
elevation of their level may occur, which can lead to serious and/or
life-threatening side effects. This concern is due to the extensive
drug-drug interaction potential of APTIVUS/r. Some medications from
the following drug classes must not be taken with APTIVUS/r:
antiarrhythmics, antihistamines, ergot derivatives, GI motility
agents, neuroleptics and sedatives/hypnotics.
Other medications taken with APTIVUS/r may require a dose
adjustment or additional monitoring, including those in the following
classes: reverse transcriptase inhibitors, protease inhibitors,
antifungals, antimycobacterials, calcium channel blockers,
antidepressants, HMG-CoA reductase inhibitors, hypoglycemics,
immunosuppressants, narcotic analgesics, estrogens, PDE5 inhibitors,
anticoagulants, antibiotics, and drugs to treat alcohol dependence.
Patients should discuss the potential for drug interactions with
their healthcare provider.
APTIVUS, a sulfa-containing drug, should be used with caution in
patients with a known sulfa allergy. Mild to moderate rashes
including urticarial rash, maculopapular rash, and possible
photosensitivity have been reported in subjects receiving APTIVUS/r.
In Phase 2 and 3 trials rash was observed in 14% of females and in
8-10% of males receiving APTIVUS/r. Additionally, in one drug
interaction trial in healthy female volunteers who were administered
a single dose of ethinyl estradiol followed by APTIVUS/r, 33% of
subjects developed a rash. Rash accompanied by joint pain or
stiffness, throat tightness, or generalized itching has been reported
in both men and women receiving APTIVUS/r. Women taking
estrogen-containing medications with APTIVUS/r have an increased risk
of developing a rash.
Like other protease inhibitors, APTIVUS/r may be associated with
the development or worsening of diabetes, elevations in cholesterol
and triglycerides, abnormal distribution of body fat, immune-related
inflammatory response to infections and increased bleeding in
hemophiliacs.
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. There are no adequate and well-controlled studies in
pregnant women for the treatment of HIV-1 infection. APTIVUS should
be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. The long-term effects of APTIVUS are
unknown at this time.
The most commonly (greater than or equal to 2%) reported side
effects of at least moderate intensity in patients enrolled in the
RESIST studies taking APTIVUS/r are gastrointestinal, including
diarrhea (10.9%), nausea (6.7%), vomiting (3.4%), and abdominal pain
(2.8%). Fever (4.6%), fatigue (4%), headache (3.1%), bronchitis
(2.9%), depression (2%), and rash (2%) also occurred. The most common
(greater than or equal to 2%) moderate to severe laboratory
abnormalities in patients enrolled in the RESIST studies taking
APTIVUS/r are elevated triglycerides (45.1%), elevated liver enzymes
(17.5%), elevated cholesterol (14.6%), decreased white blood cell
count (3.6%), and elevated amylase (2.9%).
Ongoing Clinical Trials
Boehringer Ingelheim is committed to further understanding the
clinical utility of APTIVUS for the treatment of HIV. Ongoing studies
will continue to evaluate the safety and efficacy of APTIVUS. The
safety and efficacy of APTIVUS in pediatric patients or in
treatment-naïve adults have not been established. Phase 2 and 3
studies in these populations are fully enrolled and ongoing. In
addition, Boehringer Ingelheim will continue to study APTIVUS in
women and hepatitis co-infected patients, and conduct further
pharmacokinetic interaction studies of the drug.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. VIRAMUNE(R) (nevirapine), a product
of original research done at Boehringer Ingelheim, was the first
member of the non-nucleoside reverse transcriptase inhibitor (NNRTI)
class of anti-HIV drugs. Boehringer Ingelheim is involved in basic
research and is committed to the development of tipranavir and
improving HIV therapy by providing physicians and patients with
innovative antiretrovirals.
For more information on Boehringer Ingelheim, please visit
http://www.boehringer-ingelheim.com .
Web Site: http://www.boehringer-ingelheim.com

Contact:

Outside the U.S.: Judith von Gordon of Boehringer Ingelheim GmbH,
External Communications, +49-61-32-77-3582, +49-61-32-77-6601 (Fax),
press@boehringer-ingelheim.com, Within the U.S.: Ann Davin of
Boehringer Ingelheim Pharmaceuticals, Inc., Public Relations Manager,
+1-203-791-6318, +1-203-791-6442 (Fax),
adavin@rdg.boehringer-ingelheim.com

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