[procaare] Treatment-experienced Patients Achieving Undetectable Viral Load

["ProCAARE" <procaare@healthnet.org>]

FUZEON with investigational HIV drug results in remarkable number of 
patients achieving undetectable
Public Release: 5-Oct-2006
*****************

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.

###

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)

Contact: Alexander Watson
alexander.watson@ketchum.com
44-771-267-5990
Ketchum

Source: EurekaAlert
http://www.eurekalert.org/pub_releases/2006-10/k-fwi100506.php