This Web site was developed as a service provided by Roche Laboratories Inc. ("Roche") and Trimeris, Inc. ("Trimeris"). This Web site provides certain information available about HIV and related health content. Like any printed material, it may become out of date over time. It is important that consumers rely on the advice of a healthcare professional for detailed information about medical conditions and treatment. This information is not intended to be a substitute for the advice of a healthcare professional, or a recommendation for any particular treatment plan.

Legal Statement and Terms of Use

EFFECTIVE AS OF December 23, 2008

PLEASE READ AND REVIEW CAREFULLY THE FOLLOWING TERMS OF USE BEFORE USING THIS WEB SITE. This Web site was developed as a service provided by Hoffmann-La Roche Inc. ("Roche"). By using this Web site, you agree to these Terms of Use. If you do not agree, please exit and disregard the information contained herein.

This Web site is intended for US audiences only.

Modification of Terms

Roche reserves the right to change these terms from time to time, as it deems to be necessary. You may view the current applicable version of these Terms of Use at any time through a link at the bottom of each page within this Web site.

Medical Information

The information on consumer focused Web sites is intended only for the purpose of helping consumers better understand certain health conditions and treatment options. The information is not intended to be a substitute for the advice of a healthcare professional, or a recommendation for any particular treatment plan. IT IS IMPORTANT THAT CONSUMERS CONSULT WITH A HEALTHCARE PROFESSIONAL FOR DETAILED INFORMATION ABOUT MEDICAL CONDITIONS AND TREATMENT.

Disclaimers

Roche has made and will continue to make efforts to include accurate and up-to-date information on this Web site. However, Roche makes no warranties or representations, express or implied, as to the accuracy or completeness of the information contained or referenced herein. This Web site is provided "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. ROCHE DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED ON THIS WEB SITE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT THIS WEB SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you.

All users agree that all access and use of this Web site and the content thereof is at their own risk. Neither Roche nor any other party involved in creating, producing or delivering this Web site shall be liable in any manner whatsoever for any direct, incidental, consequential, indirect or punitive damages arising out of your access, use or inability to use this Web site, or any errors or omissions in its content.

Links to Other Web Sites

This Web site contains links to other web sites maintained by third parties over whom Roche has no control. Such links are provided merely as a convenience to users of this Web site. Roche assumes no responsibility for the content of such web sites and makes no representations as to the accuracy or completeness of any information contained on such sites. Roche assumes no liability for any damages or injuries of any kind arising from such content or information.

Intellectual Property

All images and information contained on this Web site are copyrighted and otherwise proprietary. Unless otherwise expressly noted, nothing on this Web site may be copied or used except as provided in these Terms of Use or with the prior written consent of Roche.

Roche grants you permission to print individual pages from this Web site, unless otherwise expressly noted, for your own personal, non-commercial use in learning about services or products offered by Roche or for your non-commercial use in connection with healthcare or education. No other permission is granted to you to print, copy, reproduce, distribute, license, transfer, sale, transmit, upload, download, store, display in public, alter, modify or create derivative works of these materials. This grant of permission is not a transfer of title.

Unless otherwise indicated, all logos, designs, and marks on this Web site are trademarks or service marks owned or used under license by Roche. All product names printed in capitals or otherwise appropriately marked on this Web site are trademarks of Hoffmann-La Roche Inc., or companies within the Roche Group.

Representations by You

You are solely responsible for any material you submit to this Web site. You agree not to submit or transmit any material that is unlawful, threatening, libelous, defamatory, obscene, profane, or might in any other way violate any law, regulation, or rule. You further agree not to upload, email, post or transmit to, or distribute or otherwise publish through this Web site any material which disrupts the normal operation of the site, including posting or otherwise transmitting material that is not related to the subject at issue or otherwise restricts or inhibits any other user from using the site.

Should you submit any information to us, including feedback, questions, comments, suggestions, or the like regarding the content of this Web site, such information shall be deemed to be non-confidential, and Roche shall have no obligation of any kind with respect to such information. Roche shall be free to reproduce, use, disclose, and distribute such information to others without limitation. Roche shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever, including but no limited to developing, manufacturing, and marketing products incorporating such information.

Registration

To obtain full access to this Web site, you may be required to complete a registration. You are responsible for maintaining the confidentiality of your account and password and for restricting access to your computer. You accept responsibility for all activities that occur under your account or password and such use shall be deemed to be use by you. You will ensure that all use of your account fully complies with these Terms of Use. Transfer of the account by you to any other person or entity is prohibited.

Privacy

Please refer to Roche's Internet Privacy Policy for information on how Roche protects personal information about you.

Termination of Access

Roche reserves the right to suspend or terminate your access to all or part of this Web site, at any time, without notice to you, if it believes, in its sole judgment, that you have breached or may breach any term or condition of this agreement, or for its convenience.

Choice of Law and Jurisdiction

These Terms of Use are governed by the internal substantive laws of the State of New Jersey, without resort to its conflict of laws principles. If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use. You expressly agree that exclusive jurisdiction for any dispute with Roche, or in any way relating to your use of this Web site, resides in the courts of the State of New Jersey.

Indication

FUZEON (enfuvirtide) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

This indication is based on results from two controlled studies of 48-weeks’ duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral-naive patients.

Important Safety Information

Pneumonia

An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. However, because of this finding, patients with HIV infection should be monitored for signs and symptoms of pneumonia, especially if they have underlying conditions that may predispose them to pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.

Hypersensitivity Reactions

FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components. Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have occurred in < 1% of patients and have included combinations of rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune-mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome. Patients developing signs and symptoms suggestive of a systemic hypersensitivity reaction should discontinue FUZEON treatment and should seek medical evaluation immediately. Therapy with FUZEON should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction. Risk factors that may predict the occurrence or severity of hypersensitivity to FUZEON have not been identified.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including FUZEON.

Administration with Biojector 2000

Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with use of the Biojector 2000 needle-free device for administration of FUZEON.
Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.

Other Adverse Events

Excluding ISRs, the events most frequently reported in patients receiving FUZEON plus a background regimen were diarrhea (38 per 100 patient-years, or 32%), nausea (27 per 100 patient-years, or 23%) and fatigue (24 per 100 patient-years, or 20%). These events were seen at a lower incidence than in patients receiving a background regimen without FUZEON: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years) and fatigue (38 per 100 patient-years).

Most Common Adverse Events

Injection Site Reactions (ISRs)

ISRs were the most frequently reported adverse event (98%). Few patients (4%) discontinued treatment because of ISRs. Signs/symptoms may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, ecchymosis and infection. Eleven percent of patients had local reactions that required analgesics or limited usual activities.

FUZEON is not a cure for HIV infection or AIDS. FUZEON does not prevent the transmission of HIV.

For more information on FUZEON, please see package insert, go to www.FUZEON.com or call 1.877.4.FUZEON (1.877.438.9366).