2006-08-14

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 findingstudy in 115 HIV-1 infected children aged 2 to 18 years wereannounced today at the 16th International AIDS Conference (IAC) inToronto, Canada. Results from this 48-week analysis show thatpatients achieved virologic and immunologic improvements when takingtipranavir oral solution combined with ritonavir (tipranavir/r), aspart of combination antiretroviral therapy. This study of tipranaviroral solution is the first to evaluate an antiretroviral drug inhighly pre-treated HIV-1 infected paediatric patients.

Tipranavir oral solution is an investigational formulation ofAPTIVUS(R) (tipranavir). Boehringer Ingelheim plans to submit anapplication to the European Medicines Agency (EMEA) for tipranavirfor an indication in treatment-experienced HIV-1 infected paediatricpatients in 2007. APTIVUS(R) received marketing authorisation fromthe European Commission for combination antiretroviral treatment ofHIV-1 infection in highly pre-treated adult patients with virusresistant to multiple protease inhibitors in October 2005.

"A significant need exists for paediatric formulations ofantiretroviral drugs, especially for treatment-experienced childrenwho have limited options for constructing an active and durabletreatment regimen," said Pedro Cahn, M.D., director, FundacionHuesped, Buenos Aires, Argentina. "We now have evidence thattipranavir oral solution, in combination with other antiretroviralmedications, may be useful for this paediatric patient population."

This study shows that HIV-positive children receiving tipranavir/ras part of combination antiretroviral therapy achieved virologic(decrease in viral load to <400 copies/mL or <50 copies/mL) andimmunologic (increase in CD4+ cell count) improvements at 48 weeks oftherapy. Patients received one of two doses of tipranavir/r (290/115mg/m(2) or 375/150 mg/m(2)) twice daily. Among patients receiving the290/115 mg/m(2) dose of tipranavir/r, 39.7% achieved viral loads <400copies/mL and 34.5% achieved undetectable viral loads <50 copies/mL.With regard to patients taking the 375/150 mg/m(2) dose oftipranavir/r, 45.6% achieved viral loads <400 copies/mL and 35.1%achieved undetectable viral loads <50 copies/mL. Treatment withtipranavir/r was associated with a mean CD4+ cell increase of 157cells/mm(3) and 96 cells/mm(3) in the 290/115 mg/m(2) and 375/150mg/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-positivechildren. All but three of the children randomised into the trialwere treatment-experienced and infected with HIV strains showing highlevels of resistance to other antiretroviral drugs. Children werestratified by age (2 to <6 years, 6 to <12 years, and 12 to 18years). Fifty-eight children received a 290/115 mg/m(2) dose oftipranavir/r twice daily and fifty-seven children received a 375/150mg/m(2) dose of tipranavir/r twice daily. Doses of tipranavir/r forchildren were based on body surface area (BSA) equivalency to theadult 500 mg/200 mg twice daily dose approved in the EU. The 375/150mg/m(2) dose was selected based on the mean 12-year-old male BSA toallow for higher metabolism in young children.

The 2- to <6-year age group had the least prior antiretroviralexperience. The 12- to 18-year age group represented a highlytreatment-experienced patient population closely resembling thepatient 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 commonlyreported adverse events in children taking tipranavir/r weregastrointestinal-related and include vomiting, diarrhoea and nausea.The most frequent laboratory abnormalities were asymptomatic elevatedliver and creatine phosphokinase enzymes (GGT/CPK).

APTIVUS(R) Clinical Trial Program

Boehringer Ingelheim is actively conducting a clinical trialprogram to further evaluate APTIVUS(R) for the treatment of HIV-1infection. The APTIVUS(R) clinical trial program is comprised ofongoing and planned studies in more than 1,000 treatment-experiencedpatients, including paediatric, racially and gender diverse, orhepatitis co-infected patients.

APTIVUS(R)

APTIVUS(R) is a new non-peptidic protease inhibitor which works byinhibiting the viral protease, an enzyme needed to complete the HIVreplication process. It is approved for combination antiretroviraltreatment of HIV-1 infected adults that are highly pre-treated withvirus resistant to multiple protease inhibitors.

Based on available clinical and in vitro data, APTIVUS(R) isactive against most strains of HIV-1 that are resistant tocommercially available protease inhibitors. The safety and efficacyof APTIVUS(R) in paediatric patients has not yet been established.Currently, phase 2 and 3 studies in paediatric and other populationsare fully enrolled and ongoing.

In studies to date, APTIVUS(R) has been well tolerated by mostpatients and has a safety profile similar to other PIs. The mostcommonly reported side effects of at least moderate intensity inpatients enrolled in the RESIST studies taking APTIVUS(R) aregastrointestinal, including diarrhoea, nausea, vomiting and abdominalpain. Fever, fatigue, headache, bronchitis, depression and rash alsooccurred.

APTIVUS(R) boosted with low-dose ritonavir has been associatedwith reports of hepatic adverse events, which have included somefatalities. Extra vigilance is warranted in patients with chronichepatitis B or hepatitis C co-infection, as these patients have anincreased risk of liver toxicity. The most common moderate to severelaboratory abnormalities were elevated liver enzymes and elevatedlipid levels. Most laboratory abnormalities were asymptomatic andmost patients were successfully treated without discontinuation.

APTIVUS(R) does not cure HIV infection/AIDS or prevent thetransmission of HIV to others. Patients may continue to developopportunistic infections and other complications associated with HIVdisease.

Apart from the EU, APTIVUS(R) has received US marketingauthorisation by the FDA and was launched there in June 2005.Additional marketing authorisations from different countries havebeen received or are expected.

Boehringer Ingelheim

Boehringer Ingelheim is committed to the research and developmentof novel antiretroviral agents. Apart from APTIVUS(R), VIRAMUNE(R)(nevirapine) is a product of original research done at BoehringerIngelheim. VIRAMUNE(R) was the first member of the non-nucleosidereverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs onthe market. The company is involved in basic research in that areaand is committed to improving HIV therapy by providing physicians andpatients with innovative antiretroviral treatment options.

For more information on Boehringer Ingelheim, please seewww.boehringer-ingelheim.com/hiv.

Reference:

Salazar et al. Efficacy and safety results of 48 weeks oftreatment with APTIVUS oral solution co-administered with low doseritonavir (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

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

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

Boehringer Ingelheim

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

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