"FUZEON is a revolutionary therapy and for the majority of patients the significant improvements in health far outweigh the burden of the injection. It is alarming that many of these patients offered FUZEON are not accepting the offer due to the fear of injection and are missing out on the modern era of HIV therapy," comments Professor Joep Lange, President of the International AIDS Society.
Comprehensive FUZEON benefits seen by 3 months and maintained at 2 years
Dramatic FUZEON virological benefits can be seen as early as 1 week. Within just 3 months, FUZEON patients are twice as likely to achieve undetectable levels of HIV compared to those who are not taking FUZEON. Furthermore, data show these benefits are maintained at 2 years. FUZEON patients also reported approximately half the incidence of diarrhoea, a common and often debilitating side effect associated with HIV therapy.
"We urge physicians and nurses to work closely with their patients during the first 3 months of FUZEON therapy, by which time dramatic benefits should be seen and self injection should have become routine," comments Dr Mike Youle, Royal Free Hospital, London.
The pivotal role of physicians and nurses
"It is essential that, as physicians, we present FUZEON to all triple class experienced patients, balancing the remarkable improvements in viral load, CD4 count and quality of life, with the need for self-injection. Our challenge is to identify ways in which we can improve the offer of FUZEON to help patients understand how FUZEON could improve their quality of life and in all likelihood live longer as a result of sustained viral suppression," concludes Dr Youle.
Nurses have a pivotal role in helping patients to understand the offer of FUZEON and incorporate injections into their daily lives. Dominick Varsalone, a nurse from the North Jersey Community Research Initiative, New Jersey, comments: "The true success of our empowerment programme can be gauged by the fact that, of the 64 patients prescribed FUZEON in our clinic since drug launch, 91% are still on FUZEON. My FUZEON patients are greatly motivated by the improvements in their health, sometimes just a week after beginning therapy. FUZEON experienced patients are also providing invaluable support and practical advice for new patients beginning FUZEON therapy."
Roche's continued commitment to patients
Roche has activities under way in all countries where FUZEON is available to help educate and support patients with their therapy. These include nurse-to-patient and patient-to-patient support initiatives to help coach patients through the first 3 critical months of therapy to provide their best chance for sustained success with FUZEON.
A closer look at the 96 week data
A closer look at the 96 week data confirm that FUZEON based regimens continue to provide a significant, durable response to pre-treated HIV patients over 2 years of treatment. The safety profile was confirmed with no changes in the adverse event profile between 1 and 2 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 2 years of treatment.
HIV resistance – "ticking time bomb" in the west
"There is a disturbing misconception that 'access for all' is just a challenge for the developing world. Access to optimal combination therapy remains an urgent issue in the west where alarming levels of resistance to HIV therapies is a ticking time bomb. While people continue to die from AIDS in the western world – with more than 15,000 patients dying in the US in 2003 alone – there is an urgent need to use all drugs currently available to provide the most effective combination treatment for patients," commented Professor Lange.
Notes to Editors:
Efficacy and Durability
The 48 week FUZEON data released earlier, demonstrated consistent and durable results for FUZEON where the overall response rate at week 48 was higher among patients on the FUZEON containing arm compared to the arm without FUZEON. Also the benefit of regimens containing FUZEON lasted three times longer than those without and patients exposed to fewer prior antiretrovirals had a longer time to virological failure compared with more extensively pre-treated patients.
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/r (saquinavir 1000/ritonavir 100mg) has shown high efficacy, an excellent safety and tolerability profile and saquinavir/r is recommended in the new antiretroviral WHO guidelines. Invirase is used in double boosting, a new treatment trend which combines two PIs with a minidose ritonavir. Viracept (nelfinavir) has proven efficacy and safety in the treatment of HIV infection and is widely used as an early treatment. It has a unique cross-resistance profile, which is clinically proven to allow the future use of other drugs in its class. Roche Viracept 625mg will provide reduced pill count and improved GI tolerability and received approval in Europe in May 2004. Viracept is supplied by Roche outside the USA and Canada.
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.
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