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Investigational Boosted Protease Inhibitor, TMC114, Works Better in Combination With FUZEON(R)

Basel, Switzerland (ots/PRNewswire)

- Power of "FUZEON effect" Provides Much Needed Hope for HIV
Patients  Facing Treatment Failure
Exciting interim data presented at the annual ICAAC(i) 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.
(i) Interscience Conference on Antimicrobial Agents and
Chemotherapy
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/ml) compared with patients not receiving FUZEON
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.

Contact:

For more information, please contact: Sébastien Desprez, Ketchum,
Office: +44-207-611-3514, E-Mail: sebastien.desprez@ketchum.com;
Libby Day, F. Hoffmann-La Roche Ltd, Mobile: +41-79-597-2054, Email:
elisabeth.day@roche.com

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