Eastern Europe urged to prepare for HIV resistance
John Bowis, OBE, Member of the European Parliament applauds the Ministry of Health in Poland for taking a pro-active lead in the fight against HIV and drug resistance: "The growing problem of HIV resistance is a serious issue which all members of the EU have a responsibility to manage. We must commit to share knowledge, particularly those countries more experienced in tackling the HIV epidemic, in an effort to provide a consistent standard of care and avert a potential healthcare crisis. We need to ensure that all European countries are benefiting from new treatments and are allocating vital resources where they will be of most value."
The increasing prevalence of HIV drug resistance means that many patients can no longer benefit from the first three classes of HIV drugs. Unlike existing anti-HIV drugs, which act inside the cell once it has been infected, FUZEON works on the outside actively blocking the fusion of the virus with cells of the human immune system (CD4 cells). Because of this very different mechanism of action, FUZEON is active against HIV strains that have become resistant to current therapies. FUZEON reduces HIV levels and increases CD4 cell counts even in patients with resistance to the three conventional classes of HIV drugs.
Improving survival in pre-treated patients carrying drug-resistant HIV
Reduction in HIV levels and improvements in CD4 cell counts have been shown to result in improved survival and reduced AIDS-related infections. Pre-treated patients taking FUZEON as part of their regimen were twice as likely to achieve a reduction in HIV to undetectable levels as those who did not. Patients taking FUZEON also received twice the increase in CD4 cell count versus those who did not take the drug. Based upon the reduction in HIV and increase in CD4 cell count provided by FUZEON it is projected that FUZEON plus an optimised background regimen will increase patient survival from 4.6 years to 6.2 years (an additional 1.6 years), compared with an optimised background regimen alone.
New data on value of FUZEON
A new evaluation presented today by health economists and doctors shows that FUZEON is found to be cost-effective in pre-treated HIV positive patients studied in the phase III trials program. FUZEON, however, was more cost-effective by as much as £8,000 a year when used earlier in patients in whom at least 2 other antiretroviral drugs are still active versus when used later. In an environment of scarce resources, cost-effectiveness is a valued and recognised way of evaluating the benefits provided by a medicine. A cost-effectiveness ratio of £30,000 per Quality Adjusted Life Year (QALY) is widely considered to be good value for money. FUZEON when used as part of an optimized regimen is a cost-effective treatment for HIV patients with an additional cost per QALY gained of approximately £23,200 when compared to conventional optimized background therapy alone.
"The data revealed today highlights not only the value of FUZEON to healthcare professionals and health systems but the crucial importance that FUZEON has for pre-treated patients," Dr Mike Youle, Director of HIV Research, Royal Free Hospital commented. "We're talking about patients not only living longer but having increased quality of life through reduced side effects, allowing patients to get on with their every day lives. We need to help patients return to work and to their families and friends."
Notes to Editors
FUZEON has received marketing authorisation in the European Union, USA, Switzerland, Canada and Australia. FUZEON has not currently received marketing authorisation in Poland.
Poland had a cumulative total of 7,307 reported HIV/AIDS cases at the end of 2001, although some experts suggest the actual number of cases could be much higher – from 15,000 to 20,0001 . A multi-sectoral National Programme for HIV Prevention and Care for People Living with HIV/AIDS (1999-2003) has the two main goals of limiting the spread of HIV infection in Poland, and improving the quality of, and access to, care. The Programme is being implemented under the main responsibility of the Ministry of Health, in collaboration with other ministries and government entities as well as with civil society institutions. It is estimated that a large proportion of the 350,000 Western Europeans living with HIV/AIDS will or have already developed viral resistance to currently available HIV drugs. In addition, as many as 1 in 10 newly diagnosed HIV/AIDS cases in Western Europe have been found to exhibit drug resistance.2
References
1 UNAIDS, http://www.unaids.org/EN/Geographical+Area/by+country/poland.asp
2
Wensing AMJ, van de Vijveer DAMC, Asjo B, et al. Analysis from more than 1600 newly diagnosed patients with HIV from 17 European countries shows that 10% of the patients carry primary drug resistance: the CATCH study. 2nd IAS conference on pathogenesis and treatment, 13-16 July 2003, Paris. Abstract LB1.
Study Design
TORO 1 (T-20 vs. Optimised Regimen Only) and TORO 2 are randomised, open-label trials that enrolled approximately 1,000 patients at 112 centres internationally. Patients in the trials were treatment-experienced and/or had documented resistance to each of the three classes of currently available antiretrovirals. In addition, each patient was required to have a HIV level of greater than 5,000 copies/mL.
At entry, genotypic and phenotypic resistance testing was used to aid in the selection of an antiretroviral regimen, consisting of three to five drugs, including if appropriate, up to two newly approved or investigational drugs. After selection of the regimen, patients were randomised 2:1 to receive either the regimen in combination with FUZEON or the regimen alone. Patients randomized to FUZEON receive FUZEON administered as one 90 mg subcutaneous self-injection twice-daily.
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.
FUZEON indication in the European Union
The indication for FUZEON in the European Union is for "use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate."
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 incidence of drug resistant HIV among already treated patients is increasing at a disturbing rate. 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 drugs.
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 first introduced by Roche in 1995 in the US.
As a consequence of Roche's continuous research and development, the combination of boosted saquinavir with ritonavir (1000/100 mg twice daily) has shown encouraging results in the MaxCmin 1 trial with high efficacy and an excellent safety and tolerability profile. Saquinavir/r was approved in the EU in August 2002. Viracept® (nelfinavir), a leading PI is supplied by Roche outside the US and Canada. In first-line HIV therapy, Viracept delivers consistent long-term efficacy and safety. When used first line, Viracept also allows the subsequent use of both NNRTIs and other PIs for most patients due to its unique resistance pattern. 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. T-1249 is being co-developed by Roche and Trimeris.
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 partner of the Accelerating Access Initiative to increase access to HIV care in sub-Saharan Africa and the world's Least Developed Countries. For more information on Roche policy and pricing of HIV protease inhibitors for these regions and research in HIV, visit www.roche-hiv.com.
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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About Trimeris
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the discovery, development and commercialization of novel therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON, recently approved in the U.S. and the European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. Trimeris' second fusion inhibitor product candidate, T-1249, has received fast track status from the FDA and is in Phase I/II clinical testing. Trimeris is developing FUZEON and T-1249 in collaboration with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the company's website at www.trimeris.com.
Trimeris Safe Harbor Statement
This document and any attachments may contain forward-looking information about the Company's financial results and business prospects that involve substantial risks and uncertainties. These statements can be identified by the fact that they use words such as "expect," "project," "anticipate," "intend," "plan," "believe" and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially are the following: there is uncertainty regarding the success of research and development activities, regulatory authorisations and product commercialisations; the results of our previous clinical trials are not necessarily indicative of future clinical trials; and, our drug candidates are based upon novel technology, are difficult and expensive to manufacture and may cause unexpected side effects. For a detailed description of these factors, see Trimeris' Form 10-K filed with the Securities and Exchange Commission on March 27, 2003 and its periodic reports filed with the SEC.
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