Power of �FUZEON effect� provides much needed hope for HIV patients facing treatment failure

Basel, 20 December 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

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

o   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. 

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S�bastien Desprez                              

Ketchum                                                

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Libby Day

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Email: elisabeth.day@roche.com