Updated International AIDS Society guidelines recommend new goal of undetectable viral load

FUZEON combined with new protease inhibitors provides best hope for patients who have been battling resistant virus

Basel, Switzerland – August 14, 2006 – 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.

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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 PrezistaTM, 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.

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