Investigational boosted protease inhibitor, TMC114, works better with FUZEONDecember 20, 2005
Exciting interim data presented at the annual ICAAC* conference show that adding FUZEON (enfuvirtide) to the investigational boosted protease inhibitor (PI), TMC114/r, more than doubles the proportion of patients reaching undetectable levels of the virus.
This latest study provides further evidence that FUZEON now makes undetectable viral loads more achievable for patients failing on their current therapies, when used in combination with the latest HIV drugs. The 'FUZEON effect' has also been seen in other FUZEON/boosted PI combination trials, including with lopinavir/r and tipranivir/r. This effective strategy for treatment-experienced patients of combining a boosted PI with FUZEON has been recommended by the DHHS guidelines and it is anticipated to revolutionise the management of triple class experienced patients facing HIV resistance.
Interscience Conference on Antimicrobial Agents and Chemotherapy
-end-Notes to Editors:
Details of FUZEON Arm of Power 2 Study
Investigators reported interim results of a 24-week phase IIB study of TMC114/ritonavir, POWER 2, in triple-class experienced patients. Almost two thirds (64%) of patients who received FUZEON for the first time with TMC114 (600 mg)/ritonavir (100 mg) twice-daily achieved undetectable levels of HIV at 24 weeks (less than 50 copies/mL), compared to less than a third (30%) of patients who received TMC114/ritonavir without FUZEON.
DHHS guidelines - clear recommendations for FUZEON use with boosted PIs
The importance of FUZEON in the management of HIV has been recognised by the US Department of Health and Human Services (DHHS). Their newly updated HIV/AIDS treatment guidelines support the use of FUZEON with an active boosted PI for the management of treatment experienced patients. The guidelines state that adding a drug with activity against drug-resistant virus (e.g. a boosted PI such as TMC114/r) and a drug with a new mechanism of action (e.g. an HIV entry inhibitor such as FUZEON) can provide significant antiretroviral activity.
These data come at a pivotal time as Tibotec has launched this month an international expanded access programme for TMC114/r. This will enable patients that are rapidly running out of new treatment options early access to this investigational agent, which has been seen to be highly promising when used in combination with FUZEON. The updated DHHS guidelines (October 6, 2005) are available online: http://aidsinfo.nih.gov/guidelines/.
TMC114 is an investigational product
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 triple class-experienced patients. RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients who received FUZEON plus boosted tipranavir showed a 90% drop in viral load compared with patients not receiving FUZEON POWER Phase II TMC114 dosing trials
- Over 24 weeks in the combined interim analysis of investigational TMC114 trials, almost double the proportion of patients who received FUZEON plus boosted TMC114 achieved a viral load below 50 copies/ml compared with patients not receiving FUZEON
- A remarkable 67% of the patients receiving FUZEON plus boosted TMC114 reached an undetectable viral load
- In POWER 1 63% of the patients receiving FUZEON plus boosted TMC114 reached undetectable compared with 56% not receiving FUZEON
- In POWER 2 64% of the patients receiving FUZEON plus boosted TMC114 reached undetectable compared with 30% not receiving FUZEON TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who received FUZEON plus boosted lopinavir achieved an undetectable viral load (<50 copies>
The boosting of PIs is a therapeutic strategy wherein a small dose of ritonavir is given concurrently with another PI to pharmacologically enhance exposure to the latter PI through the inhibition of the enzyme cytochrome P450. Ritonavir boosting results in increased drug levels of the concomitantly administered PI that is expected to increase efficacy, decrease pill burden, add improve the flexibility to the dosing schedule, and remove fasting restrictions. To indicate a PI has been boosted with ritonavir, the sign "/r is included after the PI's name.
All trademarks used or mentioned in this release are legally protected.
For more information, please contact:
Sébastien Desprez Ketchum Office: +44 207 611 3514 E-Mail: firstname.lastname@example.org
Libby Day F. Hoffmann-La Roche Ltd Mobile: +41 79 597 2054 Email: email@example.com
Related Adding Fuzeon Articles from Brightsurf:Adding a meter between meals boosts vegetarian appeal -- study
Researchers have identified the optimal dish positions to help ''nudge'' diners into picking more planet-friendly meals in cafeterias.
How adding green tea extract to prepared foods may reduce the risk for norovirus
Infusing prepared foods with an edible coating that contains green tea extract may lower consumers' chances of catching the highly contagious norovirus by eating contaminated food, new research suggests.
Adding an extra entrance to an ants' nest reduces their foraging efficiency
Adding an extra entrance to an ants' nest reduces their foraging efficiency: more ants go foraging, but they are less able to find and distinguish between food sources of varying value.
Adding a blend of spices to a meal may help lower inflammation
Penn State researchers found that adding six grams of spices to a meal high in fat and carbohydrates resulted in lower inflammation markers hours later.
New hope for ACL injuries: Adding eccentric exercises could improve physical therapy outcomes
People with anterior cruciate ligament injuries can lose up to 40% of the muscle strength in the affected leg--with muscle atrophy remaining a big problem even after ACL reconstruction and physical therapy.
Adding smoking cessation to lung cancer screening can reduce mortality by 14%
Including smoking cessation with existing lung cancer screening efforts would reduce lung cancer mortality by 14% and increase life-years gained by 81% compared with screening alone, according to a study from Rafael Meza from the University of Michigan and colleagues and published in the Journal of Thoracic Oncology, a publication of the International Association for the Study of Lung Cancer.
Adding sewage sludge on soils does not promote antibiotic resistance, Swedish study shows
Adding sewage sludge on soils does not promote antibiotic resistance, a study from University of Gothenburg shows.
Adding weight loss counseling to group visits improves diabetes outcomes
For people with difficult-to-control diabetes, adding intensive weight management counseling to group medical visits provided extra health benefits beyond improved blood-sugar control, according to a study led by researchers at the Duke Diet & Fitness Center and the Department of Veterans Affairs.
Adding radiation after immunotherapy improves PFS for some pts with metastatic NSCLC
Adding precisely aimed, escalated doses of radiation after patients no longer respond to immunotherapy reinvigorates the immune system in some patients with metastatic non-small-cell lung cancer (NSCLC), increasing progression-free survival (PFS).
Does adding therapy before, after surgery for urinary incontinence help?
Adding behavioral and physical therapy before and after surgery for women with stress and urgency urinary incontinence resulted in a small improvement in symptoms compared to women who just had surgery but that difference in symptoms may not be clinically important.
Read More: Adding Fuzeon News and Adding Fuzeon Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.