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21.11.2005 – 10:04

Boehringer Ingelheim

APTIVUS(R) Sustains Convincing Anti-HIV Effect Through 48 Weeks

Dublin, Ireland, November 21 (ots/PRNewswire)

- Additional Data Provide Further Guidance on Maximizing Treatment
Response with APTIVUS(R)
New data presented at the 10th European AIDS Conference (EACS) in
Dublin demonstrate that through 48 weeks, APTIVUS(R) (tipranavir)
provides a convincing and durable benefit, achieving and maintaining
a superior treatment response in patients with resistant HIV.(1) The
European Commission granted marketing authorization for APTIVUS(R) in
the European Union on 25 October 2005 for the combination
antiretroviral treatment of HIV-1 in highly pre-treated adult
patients with virus resistant to multiple protease inhibitors (PIs),
when co-administered with a common boosting agent ritonavir
(APTIVUS(R)).
"Patients with resistance to current therapies have become one of
the most challenging populations to treat in recent years," said
Professor Pedro Cahn of Buenos Aires University Medical School in
Argentina. "The lasting efficacy seen with tipranvir arms physicians
with a convincing new treatment for patients whose virus has
developed reduced susceptibility to other drugs."
A combined analysis of the RESIST-1 and RESIST-2 clinical trials
demonstrate that APTIVUS(R) continues to outperform a group of
ritonavir-boosted comparator protease inhibitors (PIs) that included
lopinavir/r (Kaletra(R)), amprenavir/r (Agenerase(R)), saquinavir/r
(Invirase(R)) and indinavir/r (Crixivan(R)), through 48 weeks.(2)
When compared to these PIs:
- More than double the percentage of patients in the APTIVUS(R) arm
      responded to treatment
    - More than double the percentage of patients taking APTIVUS(R) were able
      to reduce the amount of HIV present in their blood (viral load) to
      undetectable levels
    - Treatment with APTIVUS(R) more than doubled the amount of patients'
      immune (CD4+) cells.
Underlining the 48 week trial results, a 24-week sub-analysis of
the RESIST studies also presented at EACS shows that for those
patients who responded to APTIVUS(R) therapy, the majority were able
to reduce the amount of HIV in their blood to undetectable levels.
These patients also experienced an improvement in their immune
system, having significantly increased their amount of immune cells
with APTIVUS(R) therapy.(3)
Additional sub-analyses of the RESIST studies presented at EACS
provide further guidance for HIV-specialists on maximizing treatment
response with APTIVUS(R).
Early Initiation of APTIVUS(R) Leads to Better Treatment Outcomes
Two separate 24-week sub-analyses within the RESIST patient
population provide evidence that patients who initiate APTIVUS(R)
treatment earlier have better overall treatment outcomes. These
analyses found that:
- Patients who started treatment with APTIVUS(R) or CPI/r with less PI
      experience achieved better treatment outcomes.(4) However, APTIVUS(R)
      consistently achieved a superior treatment outcome -- measured in viral
      load decreases and immune cell increases -- over the comparator PI/r,
      regardless of the number of PIs patients had taken previously.
    - APTIVUS(R) achieved a consistently superior treatment response and a
      larger decrease in viral load than comparator PIs, regardless of
      patients' viral load and immune cell count when initiating therapy.
      However, the efficacy of APTIVUS(R) was greater in patients with a
      Lower viral load and a higher immune cell count.(5)
Addition of Active Anti-HIV Medications Improves APTIVUS(R)
Treatment Response and Superiority Over Comparator PI
An additional two 24-week RESIST sub-analyses within the RESIST
patient population demonstrate that APTIVUS(R) more effectively
reduces the amount of virus in a patient's system and suppresses the
virus for a longer period of time with the addition of other active
anti-HIV agents. These analyses found that:
- A greater percentage of patients taking APTIVUS(R) were able to reduce
      their viral load to undetectable levels compared to those taking a
      comparator PI/r, -- regardless of the number of active drugs taken in
      combination with APTIVUS(R) or the comparator PI/r. The magnitude of
      difference in treatment response between APTIVUS(R) and comparator PI/r
      group increased, however, as more active agents were added to the two
      treatment arms.(6)
    - Patients taking APTIVUS(R) in combination with a further active
      anti-HIV drug of/from the non-nucleoside reverse transcriptase
      inhibitor class (NNRTI) achieved larger viral load decreases and immune
      cell increases than patients who received APTIVUS(R) without an
      NNRTI.(7)
APTIVUS(R)
APTIVUS(R) is a new non-peptidic protease inhibitor which works by
inhibiting the viral protease, an enzyme needed to complete the HIV
replication process.
Based on available clinical and in vitro data, APTIVUS(R) is
active against most strains of HIV-1 that are resistant to
commercially available protease inhibitors. The safety and efficacy
of APTIVUS(R) in paediatric patients or in adult patients who have
not previously taken anti-HIV medications have not yet been
established. Currently, phase 2 and 3 studies in these populations
are fully enrolled and ongoing.
In studies to date, APTIVUS(R) has been well tolerated by most
patients and has a safety profile similar to other PIs. The most
commonly reported side effects of at least moderate intensity in
patients enrolled in the RESIST studies taking APTIVUS(R) are
gastrointestinal, including diarrhoea, nausea, vomiting and abdominal
pain. Fever, fatigue, headache, bronchitis, depression and rash also
occurred.
APTIVUS(R) boosted with low-dose ritonavir has been associated
with reports of hepatic adverse events, which have included 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 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(R) 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(R) has received US marketing
authorization by the FDA and was launched there in June 2005.
Additional marketing authorizations from different countries have
been received or are expected.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. 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 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.
For more information on Boehringer Ingelheim, please see
http://www.boehringer-ingelheim.com/hiv.
    Notes:
    In a 48-week meta-analysis of the RESIST-1 and RESIST-2 trials:
    - 33.6% of patients who received APTIVUS(R) achieved a treatment response
      vs. 15.3% in the comparator PI/r arm.
    - A greater proportion of patients achieved a viral load below the level
      of detection in the APTIVUS(R) arm than in the comparator PI/r arm.
      30.4% in the APTIVUS(R) arm and 13.8% in the comparator PI/r arm
      achieved a viral load of less than 400 copies/mL.
    - Patients taking APTIVUS(R) also experienced greater increases in CD4+
      count than those taking a comparator PI/r, with mean CD4+ increases of
      +44.8 cells/mm3 and +21.1 cells/mm3, respectively.
    References:
    1. Cahn P. and Hicks C. 48 Week Meta-Analyses Demonstrate Superiority of
       Protease Inhibitor (PI) Tipranavir + Ritonavir (TPV/r) Over an
       Optimized PI (CPI/r) Regimen in Antiretroviral (ARV) Experienced
       Patients. 10th European AIDS Conference, Dublin, Ireland. Abstract
       #PS 3/8.
    2. Kaletra, Agenerase, Invirase and Crixivan are registered trademarks of
       Abbott Laboratories, GlaxoSmithKline, Hoffmann-La Roche Inc. and
       Bristol-Myers Squibb Company, respectively.
    3. Cassetti et al. Most TPV/r Treatment Responders Achieve Large Viral
       Load Reductions, Viral Loads Below Detection, and Substantial CD4+
       Cell Restoration. 10th European AIDS Conference, Dublin, Ireland.
       Abstract # PE2.7/1.
    4. Rockstroh et al. 24-Week Analysis of the Efficacy of Tipranavir
       Boosted With Ritonavir (TPV/r) in HIV Patients Stratified by Previous
       Protease Inhibitor (PI) Use. 10th European AIDS Conference, Dublin,
       Ireland. Abstract # PE7.9/11.
    5. Farthing C. Superior Efficacy of Tipranavir Boosted With Ritonavir
       (TPV/r) vs Comparator Boosted Protease Inhibitors (CPI/r) in Patients
       Stratified by Viral Load (VL) and CD4+ Cell Count. 10th European AIDS
       Conference, Dublin, Ireland. Abstract # PE7.3/22.
    6. Moreno et al. Impact of Including Genotypically Sensitive
       Antiretrovirals in a Tipranavir Boosted With Ritonavir (TPV/r) Regimen
       on Viral Load Response. 10th European AIDS Conference, Dublin,
       Ireland. Abstract # PE3.3/4.
    7. Kohlbrenner at al. Tipranavir Boosted With Ritonavir (TPV/r) Combined
       with an NNRTI Shows Superior Antiviral Activity Than TPV/r Without an
       NNRTI. 10th European AIDS Conference, Dublin, Ireland. Abstract #
       PE7.7/2.
Web site: http://www.boehringer-ingelheim.com/hiv

Contact:

Judith von Gordon, CD Communications, of Boehringer Ingelheim GmbH,
+49-6132-773582, Fax: +49-6132-776601

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