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Boehringer Ingelheim

Tipranavir Achieves Virologic and Immunologic Improvements in HIV-Positive Children at 48-Weeks of Therapy

Toronto (ots/PRNewswire)

New data on tipranavir oral solution from a Phase II dose finding
study in 115 HIV-1 infected children aged 2 to 18 years were
announced today at the 16th International AIDS Conference (IAC) in
Toronto, Canada. Results from this 48-week analysis show that
patients achieved virologic and immunologic improvements when taking
tipranavir oral solution combined with ritonavir (tipranavir/r), as
part of combination antiretroviral therapy. This study of tipranavir
oral solution is the first to evaluate an antiretroviral drug in
highly pre-treated HIV-1 infected paediatric patients.
Tipranavir oral solution is an investigational formulation of
APTIVUS(R) (tipranavir). Boehringer Ingelheim plans to submit an
application to the European Medicines Agency (EMEA) for tipranavir
for an indication in treatment-experienced HIV-1 infected paediatric
patients in 2007. APTIVUS(R) received marketing authorisation from
the European Commission for combination antiretroviral treatment of
HIV-1 infection in highly pre-treated adult patients with virus
resistant to multiple protease inhibitors in October 2005.
"A significant need exists for paediatric formulations of
antiretroviral drugs, especially for treatment-experienced children
who have limited options for constructing an active and durable
treatment regimen," said Pedro Cahn, M.D., director, Fundacion
Huesped, Buenos Aires, Argentina. "We now have evidence that
tipranavir oral solution, in combination with other antiretroviral
medications, may be useful for this paediatric patient population."
This study shows that HIV-positive children receiving tipranavir/r
as part of combination antiretroviral therapy achieved virologic
(decrease in viral load to <400 copies/mL or <50 copies/mL) and
immunologic (increase in CD4+ cell count) improvements at 48 weeks of
therapy. Patients received one of two doses of tipranavir/r (290/115
mg/m(2) or 375/150 mg/m(2)) twice daily. Among patients receiving the
290/115 mg/m(2) dose of tipranavir/r, 39.7% achieved viral loads <400
copies/mL and 34.5% achieved undetectable viral loads <50 copies/mL.
With regard to patients taking the 375/150 mg/m(2) dose of
tipranavir/r, 45.6% achieved viral loads <400 copies/mL and 35.1%
achieved undetectable viral loads <50 copies/mL. Treatment with
tipranavir/r was associated with a mean CD4+ cell increase of 157
cells/mm(3) and 96 cells/mm(3) in the 290/115 mg/m(2) and 375/150
mg/m(2) dose groups, respectively.
This study is an international, multi-center, open-label,
randomised trial of two doses of tipranavir/r in 115 HIV-positive
children. All but three of the children randomised into the trial
were treatment-experienced and infected with HIV strains showing high
levels of resistance to other antiretroviral drugs. Children were
stratified by age (2 to <6 years, 6 to <12 years, and 12 to 18
years). Fifty-eight children received a 290/115 mg/m(2) dose of
tipranavir/r twice daily and fifty-seven children received a 375/150
mg/m(2) dose of tipranavir/r twice daily. Doses of tipranavir/r for
children were based on body surface area (BSA) equivalency to the
adult 500 mg/200 mg twice daily dose approved in the EU. The 375/150
mg/m(2) dose was selected based on the mean 12-year-old male BSA to
allow for higher metabolism in young children.
The 2- to <6-year age group had the least prior antiretroviral
experience. The 12- to 18-year age group represented a highly
treatment-experienced patient population closely resembling the
patient population enrolled in the RESIST Phase III clinical trials,
with a median of 17 PI mutations.
Tipranavir/r was well tolerated in this study. The most commonly
reported adverse events in children taking tipranavir/r were
gastrointestinal-related and include vomiting, diarrhoea and nausea.
The most frequent laboratory abnormalities were asymptomatic elevated
liver and creatine phosphokinase enzymes (GGT/CPK).
APTIVUS(R) Clinical Trial Program
Boehringer Ingelheim is actively conducting a clinical trial
program to further evaluate APTIVUS(R) for the treatment of HIV-1
infection. The APTIVUS(R) clinical trial program is comprised of
ongoing and planned studies in more than 1,000 treatment-experienced
patients, including paediatric, racially and gender diverse, or
hepatitis co-infected patients.
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. 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(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 has not yet been established.
Currently, phase 2 and 3 studies in paediatric and other 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
authorisation by the FDA and was launched there in June 2005.
Additional marketing authorisations from different countries have
been received or are expected.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. Apart from APTIVUS(R), 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
www.boehringer-ingelheim.com/hiv.
Reference:
Salazar et al. Efficacy and safety results of 48 weeks of
treatment with APTIVUS oral solution co-administered with low dose
ritonavir (APTIVUS/r) in children and teenagers (Phase I/IIa study);
16th International AIDS Conference; August 13 - 18, 2006, Toronto,
Canada. Abstract #WEAB0301
Web site: http://www.boehringer-ingelheim.com/hiv

Contact:

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

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