FUZEON Combined With New Investigational HIV Drug Results in Remarkably High Number of HIV Patients Achieving Undetectable Viral Load

Basel (ots/PRNewswire) -

- Results Unveiled at ICAAC Show That Over 90% of
Treatment-Experienced Patients Achieve Treatment Goal of Undetectable
Viral Load

Exciting new clinical data demonstrate that 90 to 95 percent of
treatment-experienced HIV patients who initiate therapy with
FUZEON(R) (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.

Notes to 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 Prezista(TM), 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 Aptivus(TM) 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 .

ots Originaltext: Roche Pharmaceuticals
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Contact:
Contact: Janet Kettels, Roche, +41-79-597-82-85 (mobile), Alexander
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