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23.06.2006 – 23:22

Roche Pharmaceuticals

World's First Approval of New HIV Drug TMC114 Provides Potent New Treatment Option With FUZEON Making Goal of 'Undetectable' More Achievable for Patients Living With Drug Resistant HIV

Basel, Switzerland (ots/PRNewswire)

The US approval of TMC114
(darunavir), a new boosted protease inhibitor (PI), provides the
opportunity to build a potent new treatment combination with the
fusion inhibitor FUZEON (enfuvirtide) that can successfully combat
the HIV virus in treatment resistant patients.
Data have shown that up to two-thirds of patients with extensive
prior exposure to anti-HIV drugs achieved undetectable levels of
virus (less than 50 copies of viral RNA per ml of blood) when
darunavir was used with FUZEON - a result that has never been seen
before in this patient population.
"The benefits of adding one new drug, such as darunavir/r, to a
failing regimen could be short-lived and result in what is called
'virtual monotherapy.' It is vitally important that patients who have
developed resistance to a significant number of the available
antiretroviral medications start at least two fully active drugs to
maximize their chances for treatment response and survival," said
Nelson Vergel, an HIV treatment advocate who founded and has been living with the disease for more
than 20 years. "This principle has been further substantiated by the
excellent clinical results with the combination of FUZEON and
The goal of reaching an undetectable viral load has been clearly
considered possible for previously untreated or minimally pre-treated
HIV patients. For the first time in late 2005, the U.S. Department of
Health and Human Services (DHHS) guidelines established that maximal
suppression of HIV was the goal for treatment-experienced patients
and recommended using FUZEON with an active boosted PI, such as
darunavir, as a strategy to achieve this goal.1,2 Until then,
achieving an undetectable viral load in these patients had not been
considered a realistic target.
"I have treated people living with HIV for many years who, for the
first time, achieved undetectable viral levels with the combination
of TMC114 and FUZEON. This is likely to be driven by the unique
mechanism of action of FUZEON and the activity of TMC114 against
PI-resistant virus", commented Dr Anton Pozniak, the Chelsea and
Westminster Hospital, London.
"We welcome Tibotec's launch of TMC114 and realize just how
important an opportunity this is for patients facing HIV resistance
who are in need of new options. With the compelling data and approval
of TMC114 physicians can now aggressively pursue undetectable viral
load and give their patients the best possible care," commented Jenny
Edge-Dallas, Roche's newly appointed head of HIV.
1. Up until recently, failure to achieve an undetectable viral
load in treatment-experienced patients has been reluctantly
considered acceptable if immune function can be preserved. However,
there are real risks associated with such a treatment strategy where
patients' viral load remains detectable in their blood. Such patients
face an increased likelihood of accumulating drug resistant mutations
leading to a loss of future antiretroviral treatment options and a
potential for a decrease in their quality of life associated with
decreased CD4 cell counts and disease progression.
2. As recently as 2003, DHHS guidelines addressed the treatment of
patients with extensive prior exposure to antiretrovirals by
commenting that "viral suppression is often difficult or impossible
to achieve," and emphasizing the preservation of immune function and
prevention of disease progression as the primary goals of therapy in
these patients.
Notes to Editors:
For further information on FUZEON and Roche in HIV, please visit
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. A product of Tibotec
Pharmaceuticals Ltd., darunavir, also known as TMC-114 and the trade
name Prezista(TM), is a member of the PI class and is reported to be
active against virus that has developed resistance to other PIs.
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 that can increase efficacy, decrease pill
burden, add 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


For more information, please contact: Alexander Watson, Ketchum,
Office: +44-207-611-3663, E-Mail:, Janet
Sanburg, F. Hoffmann-La Roche Ltd, Mobile: +41-792-559-414, Email:

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