Imminent Arrival of Latest HIV Drug Darunavir, When Combined With FUZEON, Will Give Treatment-Experienced Patients a Better Chance to Achieve Undetectable Viral Load

Basel, Switzerland (ots/PRNewswire) - Today's positive opinion by
the European Committee for Medicinal Products for Human Use (CHMP) of
Tibotec's boosted protease inhibitor darunavir is good news for HIV
treatment-experienced patients facing drug resistance. Studies have
shown that darunavir, when used in combination with the fusion
inhibitor FUZEON, can substantially increase the chances of reaching
undetectable viral load - the new treatment goal in HIV.

Until recently, it was reluctantly considered acceptable for
treatment-experienced patients to continue to have a detectable viral
load (more than 50 copies of viral RNA per ml of blood) so long as
their immune system was preserved. Unfortunately the consequences of
remaining detectable while on therapy are that patients are likely to
develop drug resistance, with a consequent loss of future
antiretroviral treatment options and ultimately leading to a
decrease in immune function and an increase in clinical disease
progression.

However guidelines issued by major health associations such as the
US Department of Health and Human Services (DHHS), the International
AIDS Society (IAS-USA Panel), the French Ministry of Health and
Solidarity and the British HIV Association have recommended that
achieving maximum viral suppression should now be the treatment goal
in treatment experienced patients. This far more ambitious goal for
people living with drug-resistant HIV has been made possible through
the emergence of new HIV medications such as FUZEON. The use of
FUZEON with an active agent such as a boosted protease inhibitor is
acknowledged in the guidelines as one of the best way to achieve
undetectable viral load. Today's positive opinion by the CHMP means
that patients will soon have access to a new potent anti-viral
combination.

Notes to Editors:

Approved by the FDA in March 2003, FUZEON is the first and only
fusion inhibitor for the treatment of HIV and works in a way that is
different from other types of anti-HIV drugs. Darunavir, also known
as TMC-114 and the trade name Prezista(TM), is a product of Tibotec
Pharmaceuticals Ltd., a division of Janssen-Cilag. Darunavir is a
member of the PI class and is reported to be active against virus
that has developed resistance to other PIs.

Rückfragehinweis:
For more information, please contact: Vicki Norgan, Ketchum, Office:
+44-207-611-3566, Mobile: +44-7834-766146, E-Mail:
[email protected]; Janet Kettels, F. Hoffmann-La Roche Ltd,
Office: +1-973-235-4093, Mobile: +1-862-596-9084, Email:
[email protected]

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