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Updated International AIDS Society Guidelines Recommend New Goal of Undetectable Viral Load for Treatment-Experienced Patients

Basel, Switzerland (ots/PRNewswire)

- FUZEON Combined With New Protease Inhibitors Provides Best Hope
for  Patients who Have Been Battling Resistant Virus
During the world's largest HIV/AIDS congress in Toronto (XVI
International AIDS Conference) new guidelines from the influential
International AIDS Society (IAS-US panel) have been published
supporting  important changes for the management of
treatment-experienced patients. The  guidelines published in JAMA[1]
provide clear guidance that physicians should  set a treatment goal
of reaching undetectable levels of the virus (<50  copies/mL) for all
HIV patients, including treatment-experienced patients.  Furthermore,
in the opinion of the panel the best way to achieve this goal,  in
this difficult-to- treat clinical patient population, is to combine
FUZEON  with new HIV agents such as darunavir/r or tipranavir/r[1].
Recent clinical trials have convinced the authors of the
guidelines that undetectable viral load should be the goal for all
treatment-experienced patients. These trials, including POWER and
RESIST, confirm the efficacy of the new drugs darunavir and
tipranavir and emphasise that FUZEON should be the cornerstone to
achieve undetectable levels of virus for treatment-experienced
patients.
"Maintaining undetectable viral load is the best way to achieve
long-term treatment success in HIV," said Dr Julio Montaner,
President elect of the International AIDS Society. "Today using
FUZEON with darunavir or tipranavir, we have the right drugs to help
us achieve this goal for treatment-experienced patients. The new IAS
guidelines clearly support this approach."
"This concept of the significance of getting to under 50 is not
complicated. If viral load is over 50, resistance can develop leading
to a deterioration in immune function and eventually resulting in
disease progression," said community advocate, Jules Levin from
NATAP. "Now that the IAS guidelines have been updated, doctors must
aim for an undetectable viral load if they have the drugs available -
none of us should be complacent."
Detectable viral load can lead to drug resistance, and recent
research shows that 66% of HIV patients in the US and 43% in Europe
have a detectable viral load[2]. Furthermore, a recent study of
untreated patients in Europe found that 10% of patients harboured HIV
that carried at least one drug-resistant mutation[3] limiting their
future treatment options. In order  to combat these growing rates of
resistance, patients need the full potency  of at least two active
drugs such as a boosted protease inhibitor (darunavir) and a drug
with a new mechanism of action (such as FUZEON) added to a background
of an optimised antiretroviral regimen. This strategy is not only
recommended by the IAS-US panel guidelines published this week but
also by the US Department of Health and Human Services (DHHS)
guidelines[4], as well  as the recently updated guidelines issued by
the French Ministry of Health  and Solidarity[5].
The significant antiviral effect achieved by adding FUZEON to
other new HIV drugs, known as the 'FUZEON effect', has been
consistently demonstrated across a number of studies[6].
As physicians and patients eagerly await news on the latest
developments in drugs from new classes of HIV medicines such as the
integrase inhibitors and CCR5 inhibitors, it is expected that FUZEON
can be combined with these new investigational drugs to help ensure
that treatment-experienced patients stay one step ahead of the
rapidly mutating HIV virus.
References:
1. Hammer SM, Saag MS, Schechter M et al. Treatment for adult HIV
infection: 2006 recommendations of the International AIDS Society -
USA panel. JAMA, 2006;296:827-843
2. Synovate Global HIV Monitor, Q1 2006
3. Wensing AM, van de Vijver DA, Angarano G et al. Prevalence of
drug-resistant HIV-1 variations in untreated individuals in Europe:
implications for clinical management. Journal of Infectious Diseases
2005, 192:958-966.
4. The Panel on Clinical Practices for Treatment of HIV Infection
convened by the Department of Health and Human Services (DHHS).
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected
Adults and Adolescents. May 4, 2006 http://AIDSinfo.nih.gov (accessed
August 10 2006).
5. Recommandations du groupe d'experts sous la direction du
Professeur Patrick Yeni réalisé avec le soutien du Ministère de la
Santé et des Solidarités. Prise en charge médicale des personnes
infectées par le VIH. 2006: 46
6. Youle M, Staszewski S, Clotet B et al. Concomitant use of an
active boosted protease inhibitor with enfuvirtide in
treatment-experienced, HIV-infected individuals: recent data and
consensus recommendations. HIV Clinical Trials 2006: 7: 86-96.
Notes to Editors:
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines for
cancer and transplantation and a market leader in virology. In 2005
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on
the Internet (www.roche.com).
For further information on FUZEON and Roche in HIV, please visit
http://www.roche-hiv.com/Newsandfeatures/fuzeon.cfm
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
protected.

Contact:

Contact: Janet Kettels, Roche, +41-79-597-82-85 (mobile). Alexander
Watson, Ketchum, +44-7712-675-990 (mobile)

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