FUZEON with investigational HIV drug results in remarkable number of patients achieving undetectable

Results unveiled at ICAAC show that over 90 percent of treatment-experienced patients achieve treatment goal of undetectable viral load

Basel, October 5, 2006 -- Exciting new clinical data demonstrate that 90 to 95 percent of treatment-experienced HIV patients who initiate therapy with FUZEON® (enfuvirtide) and the investigational integrase inhibitor MK-0518 can achieve undetectable levels of HIV (less than 400 copies per mL of blood)1. Such response rates have never been achieved in clinical trials of HIV patients living with drug-resistant virus. This significant antiviral effect achieved by adding FUZEON to other new drugs, known as the "FUZEON effect", has been consistently demonstrated across a number of studies.2 These data were presented at the 46th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

"These remarkable results show us that by partnering FUZEON and a novel integrase inhibitor, treatment-experienced patients can have a similar chance to achieve the ultimate goal of treatment, undetectable viral load, as treatment-naïve patients," said Dr Anton Pozniak, the Chelsea and Westminster Hospital, London. "Today, we already see that using FUZEON with darunavir or tipranavir, we have the right drugs to help us achieve the treatment goal of undetectable viral load in the majority of treatment-experienced patients. But more importantly we look set to achieve this goal of undetectable in more patients in the future with the availability of FUZEON and exciting novel agents such as MK-0518."

About the results presented at ICAAC

Investigators reported results of a 24-week, Phase II, Merck-sponsored study of MK-0518 in treatment-experienced patients with resistance to protease inhibitors, nucleoside analogues and non-nucleoside analogues. Patients received one of three doses of MK-0518 (200 mg, 400 mg or 600 mg) twice-daily in combination with an optimised background regimen of anti-HIV drugs. In the subset of patients who received FUZEON for the first time in their drug regimen, 90 to 95 percent of 32 subjects achieved undetectable HIV, compared to 60 to 70 percent of 82 subjects who received MK-0518 without FUZEON. FUZEON usage was associated with dramatically increased response rates in the study by approximately 50 percent.

Compliment new treatment guidelines

These findings are consistent with the recently updated HIV treatment guidelines, which emphasise undetectability as the goal of therapy in treatment-experienced patients, as well as the need to initiate multiple active anti-HIV agents simultaneously in order to achieve this goal.3-5 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.

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Notes for editors: 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.

MK-0518 is a novel investigational integrase inhibitor being developed by Merck & Co., Inc.

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.

Tipranavir, know by the trade name AptivusTM is also a member of the PI class of medications and is marketed by Boehringer Ingelheim.

References: 1. Grinsztejn, B, Nguyen, B-Y.; Katlama, C et al. Potent Antiretroviral Effect of MK-0518, a Novel HIV-1 Integrase Inhibitor, in Patients with Triple-class Resistant Virus: 24 Week Data. Data presented at ICAAC 2006 (H-1670B). 2. 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. 3. 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). 4. 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. 5. Hammer S, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society – USA panel. JAMA, 2006;296:827-843 .

Contact:

Janet Kettels, Roche +41 79 597 82 85 (mobile)


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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