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Roche Pharmaceuticals

Newest HIV Drugs Should be Used With FUZEON(R)

Rio De Janeiro, Brazil (ots/PRNewswire)

- Giving Patients Facing HIV Resistance Their Best Chance to
Achieve  Undetectable Viral Loads
Data presented at IAS build a compelling case for FUZEON
(enfuvirtide, formerly known as T-20) to be combined with the newest
drugs to give patients facing resistance their best chance of
achieving undetectable viral load - the optimal treatment goal for
all people living with HIV.
"Undetectable viral load should be the ultimate treatment goal for
all triple-class experienced patients. FUZEON combined with the
latest drugs now makes this much more achievable," explained Dr Mike
Youle the Royal Free Hospital, London. "We are seeing a consistent
FUZEON effect with these new drugs and I believe these data must
change the way we manage triple class experienced patients facing HIV
resistance and failing to reach undetectable viral load."
Studies presented this week show that when FUZEON was given in
combination with the novel HIV medication, tipranavir, an impressive
70% of FUZEON naïve patients achieved a ten-fold reduction in their
viral load and furthermore they also had double the increase in
immune cell count(1),  compared to patients receiving tipranavir/r
without FUZEON.
This adds to the growing body of evidence for the powerful "FUZEON
effect" which has been seen across the RESIST 1 & 2, POWER 1 & 2 and
TORO 1 & 2 studies, where adding FUZEON was seen to almost double the
number of patients reaching undetectable, when combined with one of
the latest boosted PIs such as lopinavir/r, tipranavir/r or TMC
114/r.
Doctors underestimate significant "FUZEON effect"
Surprisingly, of the 560 doctors surveyed onsite this week at the
IAS conference, three quarters (75%) underestimated the "FUZEON
effect" seen in both RESIST(2) and POWER(3) studies.
Latest data adds to growing Body of Evidence - Latest Boosted
Protease Inhibitors (lopinavir/r, tipranavir/r and TMC 114/r) all
work best in combination with FUZEON
RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients who
received FUZEON plus tipranavir/r 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 TMC114 trials, almost double the proportion of patients who received FUZEON plus TMC114/r achieved a viral load below 50 copies/ml compared with patients not receiving FUZEON
  • A remarkable 67% of the patients receiving FUZEON plus TMC114/r reached an undetectable viral load
TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who received
FUZEON plus lopinavir/r achieved an undetectable viral load (<50
copies/ml) compared with patients not receiving FUZEON
Collectively the data from all six studies, in over 2,500
patients, establish a new paradigm in the management of triple
class-experienced patients.
Why FUZEON is effective in face of HIV resistance
FUZEON is still the first and only anti-retroviral drug to work
outside the human immune cell (CD4), blocking the HIV virus from
entering. All other currently available HIV drugs fight the HIV virus
once it has entered the cell. FUZEON's unique mode of action means
that FUZEON has no cross-resistance with currently available drugs
and that it is an effective treatment, in combination with other
anti-HIV drugs, for patients facing resistance.
New combination improves quality of life
Spike, a 48 year old person living with HIV from London, whose
blood levels of HIV reached undetectable within six months of taking
FUZEON and boosted tipranavir and has remained undetectable ever
since, explains "This new combination of treatments has really
improved my quality of life. Getting back to undetectable and seeing
my CD4 count increase from 20 to 268 has changed my outlook on life.
I believe I can plan for the future, which I didn't even consider
doing before starting this regimen. I have much more energy now than
I had before, which is exhilarating since I have been held back for
so long." Spike has been living with HIV since it was detected in his
body in 1986 and works as a freelance designer and night-club
promoter.
The use of FUZEON is continuing to grow, despite initial
reluctance from patients and physicians to using an injection, and
more patients are now successfully starting and remaining on
treatment. Roche continues to roll out educational initiatives to
support patients and physicians with the administration and use of
FUZEON.
References:
(1) Grinsztejn B et al. IAS 2005 Abstract WePe 16.7B07
(2) Cooper D et al. CROI 2005 Abstract 560
(3) Katlama C et al. CROI 2005 Abstract 164LB

Contact:

Vicki Leverett, Tel: +44-207-611-3570, email:
Vicki.Leverett@ketchum.com, Alexander Watson, Ketchum, Mobile:
+44-7712-675-990, E-Mail: Alexander.watson@ketchum.com, Janet
Sanburg, F. Hoffmann-La Roche Ltd, Mobile: +41-79-255-9414, Email:
janet.sanburg@roche.com

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