�Boehringer Ingelheim presented new 100 week data at the International AIDS Conference demonstrating Aptivus� (tipranavir) long-term efficacy and safety in treatment-experienced children. Results from this two-year study show that Aptivus� enabled the children to achieve free burning virologic and immunologic responses and was a well-tolerated antiretroviral therapy.
These results build on the positive 48 week information presented in 2006 at the International AIDS Conference in Toronto and submitted to the FDA for the recent approval of the Aptivus� paediatric oral solution and paediatric reading in the United States: Data which is also currently organism reviewed by the EMEA for a paediatric and oral solution licences in Europe.
This biennial follow-up data evaluated tipranavir co-administered with low dosage ritonavir (Aptivus/r) in 78 treatment-experienced children. Those complementary the original 48 week trial were given the choice of continuing their therapy with Aptivus� for an propagation of the trial. The continuing analysis confirms the results of the 48 week information and demonstrates the lastingness of Aptivus�. Over half of jr. children in the trial achieved free burning virologic reply and the oral solution continued to be well tolerated over the 100 weeks.
Dr. Manfred Haehl, Corporate Senior Vice President Medicine at Boehringer Ingelheim said, "We ar pleased that tipranavir showed such a positive efficaciousness and base hit profile in treatment-experienced children who hold fewer treatment options than adults and need more than therapy choices, including therapies that cause been especially formulated to meet their needs."
The number of children diagnosed with HIV/AIDS is growing. There are just about 2.1 million children living with HIV worldwide and recent statistics bear witness that some other 29,000 will be infected with the disease this year alone.1 Once a child is infected with HIV, they face a higher chance of development AIDS unless they crapper successfully be treated with antiretroviral therapy. Just as with adults, children canful become resistant to certain therapies which underscores the need for an addition in intervention options active against drug-resistant HIV.
The data, collected in over 26 sites in Europe, the United States and Latin America, shows that HIV-1 positive children and adolescents receiving tipranavir boosted by ritonavir as part of their combination antiretroviral therapy can reach sustained virologic and immunological responses at 100 weeks of therapy: after C weeks of treatment, 56% of children between 2 and 6 years achieved a viral load of less than 400 copies per ml, and 48% of this age chemical group saw their viral rafts drop to undetectable levels (less than 50 copies per ml).
For the 6 to 12 years old group, 30% achieved an undetectable viral load (less than 50 copies per ml), and for the 12 to 18 eld old grouping, still over 20% achieved an undetectable viral load. The lower rate of undetectable viral loads in older children is due to them being more treatment-experienced and harbouring HIV which has become more drug-resistant than in younger children.
"There are many children and adolescents with HIV who run out to maintain viral inhibition of the disease, which speaks to the pressing need for a new generation of therapies intentional specifically for this group," noted lead author of the analysis and Associate Professor of Paediatrics, Dr. Juan Salazar, MD, MPH, Connecticut Children's Medical Centre, Hartford, CT, USA. "For these treatment-experienced children world Health Organization have had limited options for maintaining an active and long-wearing treatment regimen, we now have evidence that tipranavir is effective and tolerable."
Up to 50% of HIV-infected children and adolescents flush it to maintain suppression of HIV echo beyond two years of initial discussion, according to some studies,2,3 and up to 90% of children who fail antiviral therapy carry drug-resistant strains of HIV. These statistics make it critical that new options ar made available which are able to suppress HIV in the treatment-experienced pediatric group.
The to the highest degree common incline effect was gastrointestinal effects such as vomiting and diarrhoea, piece over 6% of patients experienced Grade 3 liver enzyme rises (ALT). None of the patients experient Grade 4 ALT elevations, indicating an acceptable hepatoxicity profile.
About Aptivus� Aptivus� is a non-peptidic protease inhibitor which workings by inhibiting the viral protease, an enzyme required to complete the HIV replication treat. Based on available clinical and in vitro data, Aptivus� is active against to the highest degree strains of HIV-1 that are immune to commercially available proteolytic enzyme inhibitors. It is approved for combination antiretroviral intervention of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple peptidase inhibitors.
RESIST I and II two large-scale clinical studies on Aptivus� involving more than 1,400 patients formed the foundation for granting traditional approval by the FDA and replete marketing sanction by the EMEA. The RESIST clinical trial program is one of the largest study programs undertaken with an investigational antiretroviral agent in patients previously treated with multiple combinations of antiretroviral drug regimens.
Aptivus� can be combined with new agents with novel mechanisms of action (e.g. integrase inhibitors and CCR-5 antagonists) without dose adjustment to build efficacious and perdurable treatment regimens. Such a benefit has been clearly demonstrated by favourable results with the concomitant use of APTIVUS in combination with modern drug classes.4,5
The most normally reported side effects of at least moderate intensiveness in patients enrolled in the RESIST studies pickings Aptivus� are gastrointestinal, including diarrhoea, sickness, vomiting and abdominal painfulness. Fever, weariness, headache, bronchitis, depression and rash besides occurred. Elevated transaminase, cholesterol and triglycerides were more frequent in the Aptivus�/r arm than in the ritonavir boosted comparator radical 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 experience included some fatalities. These have broadly occurred in patients with advanced HIV disease pickings multiple co-occurrence medications. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased peril of liver toxicity. The most common moderate to severe testing ground abnormalities were elevated liver enzymes and elevated lipide levels. Most laboratory abnormalities were symptomless and to the highest degree patients were successfully treated without discontinuation.
Aptivus�-containing HAART regimens have been associated with reports of both black and nonfatal intracranial haemorrhage (ICH) in some highly treatment-experienced patients. Caution should be used when prescribing Aptivus�/r in patients world Health Organization may be at risk of exposure of increased bleeding or who ar receiving medications known to increase the risk of bleeding.
Aptivus� does not cure HIV infection/AIDS or forestall the transmittal of HIV to others. Patients crataegus oxycantha continue to develop timeserving infections and other complications associated with HIV disease.
Aptivus� received U.S. marketing sanction by the U.S. Food and Drug Administration (FDA) and was launched in the Unites States in June 2005. On October 4th, 2007, the FDA granted traditional approval for Aptivus�, and in April 2008 the EMEA granted full marketing authorisation for Aptivus� in Europe. Additional marketing authorizations from different countries give been standard or ar expected.
Aptivus� OS (oral solution) received U.S. marketing say-so for use in treatment experienced children and adolescents by the U.S. Food Drug Administration (FDA) on 24 June 2008.
About Boehringer Ingelheim HIV Clinical Trials Boehringer Ingelheim is actively conducting clinical trial programs to further evaluate Aptivus� and the non-nucleoside-reverse transcriptase inhibitor (NNRTI) Viramune� for the discourse of HIV-1 infection.
The Viramune� clinical test program includes the ArTEN trial, which aims to compare the efficacy and safety of Viramune dosed once or twice day-after-day versus atazanavir boosted with ritonavir in HIV-positive antiretroviral-na�ve patients. The ArTEN trial will enrol 561 HIV-positive patients wHO have yet to be treated with antiretrovirals.
About Boehringer Ingelheim Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Aptivus� (tipranavir), Viramune� (viramune) is a product of original research done at Boehringer Ingelheim. Viramune� was the first member of the non-nucleoside reverse rNA polymerase inhibitor (NNRTI) class of anti-HIV drugs on the market. The company is involved in basic research in that area and is committed to up HIV therapy by providing physicians and patients with innovative antiretroviral treatment options.
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be mindful that in that respect may be national differences between countries regarding specific medical info, including licensed uses. Please take accounting of this when referring to the information provided in this document. This press release is non intended for distribution inside the U.S.A.
References:1) AIDS Epidemic Update, December 2007, UNAIDS/WHO.
2) van Rossum AM, Geelen SP, Hartwig NG, Wolfs TF, Weemaes CM, Scherpbier HJ, et al. Results of 2 years of treatment with
