Magazin
2005-10-26
Basel, Switzerland (ots/PRNewswire) - Following today's Europeanapproval of Boehringer Ingelheim's boosted protease inhibitortipranavir (APTIVUS(R)), European patients now have the chance tobenefit from the potent combination of the fusion inhibitor FUZEON(enfuvirtide) and boosted tipranavir in addition to their currenttreatment regimen.
The clinical trials RESIST I and II showed that almost double theproportion of patients who received FUZEON plus tipranavir/r showed a90 percent drop in viral load compared with patients not receivingFUZEON. This FUZEON effect was shown in other clinical trialscombining FUZEON with other boosted protease inhibitors, includinglopinavir/r and TMC 114/r.
The use of FUZEON with tipranavir for the management oftreatment-experienced patients was supported by recently updatedtreatment guidelines by the Department of Health and Human Servicesin the US, where tipranavir has been available to patients since June2005. For the first time, the guidelines also recommended thetreatment goal of achieving suppression of the virus to levels thatmake it undetectable in the blood for these patients.
Notes to Editors:
Growing Body of Evidence, RESIST 1&2 / POWER 1&2 / TORO 1&2 -Collectively the data from all six studies, in over 2,500 patients,establish a new paradigm in the management of tripleclass-experienced patients.
RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients whoreceived FUZEON plus boosted tipranavir showed a 90% drop in viralload compared with patients not receiving FUZEON
POWER Phase II TMC114 dosing trials
- Over 24 weeks in the combined TMC114 trials, almost double theproportion of patients who received FUZEON plus boosted TMC114achieved a viral load below 50 copies/ml compared with patients notreceiving FUZEON
- A remarkable 67% of the patients receiving FUZEON plusboosted TMC114 reached an undetectable viral load
TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who receivedFUZEON plus boosted lopinavir achieved an undetectable viral load(<50 copies/ml) compared with patients not receiving FUZEON
Recommendations - The updated DHHS guidelines (October 6,2005) are available online: http://aidsinfo.nih.gov/guidelines/.
The Panel on Clinical Practices for Treatment of HIV Infection ofthe US Department of Health and Human Services (DHHS) focuses on theoverall management of treatment-experienced patients. It alsoprovides guidance on changing an antiretroviral therapy regimen forvirologic failure, for which the latest recommendations include:
- Using the treatment history and past and current resistance testresults to identify active agents (preferably at least two fullyactive agents) to design the new regimen. A fully active agent is onelikely to demonstrate antiretroviral activity on the basis of boththe treatment history and susceptibility on drug-resistance testing.
- Adding a drug with activity against drug-resistant virus (e.g. apotent ritonavir-boosted PI) and a drug with new mechanism of action(e.g. HIV entry inhibitor) to an optimised background antiretroviralregimen can provide significant antiretroviral activity.
The boosting of PIs is a therapeutic strategy wherein a small doseof ritonavir is given concurrently with another PI topharmacologically enhance exposure to the latter PI through theinhibition of the enzyme cytochrome p450. Ritonavir boosting resultsin increased drug levels that can increase efficacy, decrease pillburden, add flexibility to the dosing schedule, and remove fastingrestrictions. To indicate a PI has been boosted with ritonavir, thesign "/r is included after the PI's name.
All trademarks used or mentioned in this release are legallyprotected.
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:For more information, please contact: Laura Bertossi, Ketchum, Office: +44-207-611-3597 E-Mail: laura.bertossi@ketchum.com Janet Sanburg, F. Hoffmann-La Roche Ltd, Mobile: +41-79-255-9414 Email: janet.sanburg@roche.com
Tipranavir's EU Approval Provides a New Active Drug to be Combined with FUZEON(R) for HIV Patients Facing Resistance
The clinical trials RESIST I and II showed that almost double theproportion of patients who received FUZEON plus tipranavir/r showed a90 percent drop in viral load compared with patients not receivingFUZEON. This FUZEON effect was shown in other clinical trialscombining FUZEON with other boosted protease inhibitors, includinglopinavir/r and TMC 114/r.
The use of FUZEON with tipranavir for the management oftreatment-experienced patients was supported by recently updatedtreatment guidelines by the Department of Health and Human Servicesin the US, where tipranavir has been available to patients since June2005. For the first time, the guidelines also recommended thetreatment goal of achieving suppression of the virus to levels thatmake it undetectable in the blood for these patients.
Notes to Editors:
Growing Body of Evidence, RESIST 1&2 / POWER 1&2 / TORO 1&2 -Collectively the data from all six studies, in over 2,500 patients,establish a new paradigm in the management of tripleclass-experienced patients.
RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients whoreceived FUZEON plus boosted tipranavir showed a 90% drop in viralload compared with patients not receiving FUZEON
POWER Phase II TMC114 dosing trials
- Over 24 weeks in the combined TMC114 trials, almost double theproportion of patients who received FUZEON plus boosted TMC114achieved a viral load below 50 copies/ml compared with patients notreceiving FUZEON
- A remarkable 67% of the patients receiving FUZEON plusboosted TMC114 reached an undetectable viral load
TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who receivedFUZEON plus boosted lopinavir achieved an undetectable viral load(<50 copies/ml) compared with patients not receiving FUZEON
Recommendations - The updated DHHS guidelines (October 6,2005) are available online: http://aidsinfo.nih.gov/guidelines/.
The Panel on Clinical Practices for Treatment of HIV Infection ofthe US Department of Health and Human Services (DHHS) focuses on theoverall management of treatment-experienced patients. It alsoprovides guidance on changing an antiretroviral therapy regimen forvirologic failure, for which the latest recommendations include:
- Using the treatment history and past and current resistance testresults to identify active agents (preferably at least two fullyactive agents) to design the new regimen. A fully active agent is onelikely to demonstrate antiretroviral activity on the basis of boththe treatment history and susceptibility on drug-resistance testing.
- Adding a drug with activity against drug-resistant virus (e.g. apotent ritonavir-boosted PI) and a drug with new mechanism of action(e.g. HIV entry inhibitor) to an optimised background antiretroviralregimen can provide significant antiretroviral activity.
The boosting of PIs is a therapeutic strategy wherein a small doseof ritonavir is given concurrently with another PI topharmacologically enhance exposure to the latter PI through theinhibition of the enzyme cytochrome p450. Ritonavir boosting resultsin increased drug levels that can increase efficacy, decrease pillburden, add flexibility to the dosing schedule, and remove fastingrestrictions. To indicate a PI has been boosted with ritonavir, thesign "/r is included after the PI's name.
All trademarks used or mentioned in this release are legallyprotected.
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:For more information, please contact: Laura Bertossi, Ketchum, Office: +44-207-611-3597 E-Mail: laura.bertossi@ketchum.com Janet Sanburg, F. Hoffmann-La Roche Ltd, Mobile: +41-79-255-9414 Email: janet.sanburg@roche.com
Roche Pharmaceuticals
