"Undetectable viral load should be the ultimate treatment goal for all triple-class experienced patients. FUZEON combined with the latest drugs now makes this much more achievable," explained Dr Mike Youle the Royal Free Hospital, London. "We are seeing a consistent FUZEON effect with these new drugs and I believe these data must change the way we manage triple class experienced patients facing HIV resistance and failing to reach undetectable viral load."
Studies presented this week show that when FUZEON was given in combination with the novel HIV medication, tipranavir, an impressive 70% of FUZEON naïve patients achieved a ten-fold reduction in their viral load and furthermore they also had double the increase in immune cell count1, compared to patients receiving tipranavir/r without FUZEON.
This adds to the growing body of evidence for the powerful "FUZEON effect" which has been seen across the RESIST 1 & 2, POWER 1 & 2 and TORO 1 & 2 studies, where adding FUZEON was seen to almost double the number of patients reaching undetectable, when combined with one of the latest boosted PIs such as lopinavir/r, tipranavir/r or TMC 114/r.
Doctors underestimate significant "FUZEON effect"
Surprisingly, of the 560 doctors surveyed onsite this week at the IAS conference, three quarters (75%) underestimated the "FUZEON effect" seen in both RESIST2 and POWER3 studies.
Latest data adds to growing Body of Evidence – Latest Boosted Protease Inhibitors (lopinavir/r, tipranavir/r and TMC 114/r) all work best in combination with FUZEON
RESIST Phase III tipranavir trials
Over 24 weeks, almost double the proportion of patients who received FUZEON plus tipranavir/r showed a 90% drop in viral load compared with patients not receiving FUZEON
POWER Phase II TMC114 dosing trials
Over 24 weeks in the combined TMC114 trials, almost double the proportion of patients who received FUZEON plus TMC114/r achieved a viral load below 50 copies/ml compared with patients not receiving FUZEON
A remarkable 67% of the patients receiving FUZEON plus TMC114/r reached an undetectable viral load
TORO Phase III FUZEON trials
Over 24 weeks, double the proportion of patients who received FUZEON plus lopinavir/r achieved an undetectable viral load (<50 copies/ml) compared with patients not receiving FUZEON
Collectively the data from all six studies, in over 2,500 patients, establish a new paradigm in the management of triple class-experienced patients.
Why FUZEON is effective in face of HIV resistance
FUZEON is still the first and only anti-retroviral drug to work outside the human immune cell (CD4), blocking the HIV virus from entering. All other currently available HIV drugs fight the HIV virus once it has entered the cell. FUZEON's unique mode of action means that FUZEON has no cross-resistance with currently available drugs and that it is an effective treatment, in combination with other anti–HIV drugs, for patients facing resistance.
New combination improves quality of life
Spike, a 48 year old person living with HIV from London, whose blood levels of HIV reached undetectable within six months of taking FUZEON and boosted tipranavir and has remained undetectable ever since, explains "This new combination of treatments has really improved my quality of life. Getting back to undetectable and seeing my CD4 count increase from 20 to 268 has changed my outlook on life. I believe I can plan for the future, which I didn't even consider doing before starting this regimen. I have much more energy now than I had before, which is exhilarating since I have been held back for so long." Spike has been living with HIV since it was detected in his body in 1986 and works as a freelance designer and night-club promoter.
The use of FUZEON is continuing to grow, despite initial reluctance from patients and physicians to using an injection, and more patients are now successfully starting and remaining on treatment. Roche continues to roll out educational initiatives to support patients and physicians with the administration and use of FUZEON.
Notes to Editors:
Efficacy and Durability
The 96 week FUZEON data confirm that FUZEON based regimens continue to provide a significant, durable response to pre-treated HIV patients over two years of treatment. The safety profile was confirmed with no changes in the adverse event profile between one and two years of therapy. Consistent and continuous improvements in immune strength were seen in FUZEON patients over 96 weeks. FUZEON patients remained twice as likely to show undetectable HIV as those patients who did not receive FUZEON. In addition, more than half of patients who received FUZEON completed two years of treatment.
Safety of FUZEON
FUZEON is administered as a twice-daily subcutaneous injection. Local injection site reactions were the most frequent adverse events associated with the use of FUZEON. In the TORO studies, 98 percent of patients had at least one local injection site reaction over the course of 48 weeks. In this treatment-experienced patient population, 4 percent of patients at 48 weeks discontinued treatment with FUZEON as a result of injection site reactions.
An increased rate of some bacterial infections, primarily pneumonia, was seen in patients treated with FUZEON. It is unclear if this increased incidence is related to FUZEON use. The addition of FUZEON to background antiretroviral therapy generally did not increase the frequency or the severity of the majority of adverse reactions. The majority of adverse reactions were of mild or moderate intensity. Hypersensitivity reactions have occasionally been associated with FUZEON therapy and in rare cases have recurred on re-challenge.
Resistance to HIV drugs
It is estimated that in a single untreated person the virus can mutate to form around a billion new and potentially different versions of HIV every day. The prevalence of drug resistant HIV among already treated patients is extremely high. It was recently reported in one study that up to 50 percent of patients in North America are infected with a strain of the virus that has developed resistance to one or more anti-HIV drug.
Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS, committed since 1986 to groundbreaking research and development of innovative new drugs and diagnostic technology. Saquinavir was the first Protease Inhibitor (PI) and was introduced by Roche in 1995 in the US.
Invirase® (saquinavir) was the first protease inhibitor (PI) and was introduced by Roche in 1995. Invirase® 500, the new 500mg formulation of Invirase®, received U.S. Food and Drug Administration (FDA) marketing approval in December 2004 and was approved by the European Authorities in May 2005.
Viracept (nelfinavir), a widely used protease inhibitor (PI), was launched as a 250mg tablet in Europe in 1998. Viracept is supplied by Roche outside the USA, Canada, Japan and Korea.
FUZEON received approval from the US Food and Drug Administration (FDA) in March 2003, and from the European Commission and Switzerland in May 2003 and Canada in July 2003.
The viral load measurements in the clinical trials for FUZEON were performed using the AMPLICOR HIV-1 MONITOR TEST, version 1.5. This test from Roche Diagnostics is considered to be a highly sensitive measurement of the amount of HIV circulating in a patient's blood ("viral load"). With a limited number of treatment regimens available, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens and assess the potential onset of drug resistance.
Roche is a committed to increasing access to its medicines globally through the development of sustainable policies and initiatives which have a long-term impact, particularly on the lives of the people in the Least Developed Countries. Roche is a founding member of the Accelerating Access Initiative. For further information on Roche policies and activities, visit www.roche-hiv.com or www.roche.com/home/sustain/sus_med.htm
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.
References:
1.Grinsztejn B et al. IAS 2005 Abstract WePe 16.7B07
2.Cooper D et al. CROI 2005 Abstract 560
3.Katlama C et al. CROI 2005 Abstract 164LB
For more information, please contact:
Alexander Watson
Ketchum
Mobile: 44-771-267-5990
E-Mail: Alexander.watson@ketchum.com
Janet Sanburg
F. Hoffmann-La Roche Ltd
Mobile: 41-79-255-9414
Email: Janet.sanburg@roche.com