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Updated HIV/AIDS Treatment Guidelines Support Use of Fuzeon Plus an Active Boosted Protease Inhibitor To Achieve New Treatment Goal

DHHS Panel Revises Approach for Treatment Experienced Patients

NUTLEY, NJ -- October 13, 2005 -- Newly updated HIV/AIDS treatment guidelines issued by the Department of Health and Human Services (DHHS) support the use of FuzeonŽ (enfuvirtide) with an active boosted protease inhibitor (PI) in patients with three class virologic failure, as this treatment approach results in better and more prolonged virologic suppression.

"Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents,"1 provide clinicians and other healthcare providers direction for using antiretroviral drugs to treat HIV-infected adults and adolescents. Fuzeon, the first and only fusion inhibitor available for the treatment of HIV, was co-developed by Roche and Trimeris.

Recently commenting on these guidelines, in an Expert Viewpoint opinion piece, Dr. William Powderly stated that: "In three class experienced patients, the use of the fusion inhibitor enfuvirtide with an active boosted PI with demonstrated activity against PI-resistant virus should be the foundation of the new regimen."2

Prior versions of the DHHS treatment guidelines have emphasized preservation of immune function and delay of clinical progression as the treatment goals for patients with extensive prior treatment and drug resistance. Now, with the emergence of new active boosted PIs to pair with Fuzeon, the current guidelines for these patients suggest, "in patients with active antiretroviral agents available (e.g. an active ritonavir-boosted PI and enfuvirtide), the goal of therapy is suppression of viremia." The evidence cited includes several recent clinical trials of new boosted PIs in treatment-experienced patients, which demonstrated a better and more prolonged virologic response in those utilizing Fuzeon with these new boosted PIs.

The guidelines also cite new data from a study evaluating Fuzeon use with a needle-free injection device, Biojector 2000 (B2000). Roche and Trimeris have filed a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA), asking the FDA to consider including information about the needle-free injection device in the Fuzeon labeling. The FDA decision on this filing is expected by the end of the year. The B2000 device is manufactured by Bioject Medical Technologies, Inc.

Facts About Fuzeon
Fuzeon is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, Fuzeon works outside the CD4 cell, blocking HIV from entering the cell. For this reason, Fuzeon is effective in treatment- experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to Fuzeon. Fuzeon was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.

Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with Fuzeon. ISRs occurred in 98% of patients studied and 4% discontinued Fuzeon due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.

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. Patients with HIV infection should be carefully monitored for signs and symptoms of 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: Systemic hypersensitivity reactions have been associated with Fuzeon therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: 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.

Other Adverse Events: The events most frequently reported in patients receiving Fuzeon plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a Fuzeon-based regimen compared to those receiving an optimized background regimen without Fuzeon when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving Fuzeon-based regimens vs. 73 per 100 patient-years in patients who did not receive Fuzeon), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).

REFERENCES:
1. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Developed by the Panel on Clinical Practices for the treatment of HIV Infection Convened by the Department of Health and Human Services. October 6, 2005. http://AIDSinfo.nih.gov

2. Strategies for Using New Antiretroviral Agents in Patients With Prior Treatment Experience. Clinical Care Options. William G. Powderly, MD. September 2005. http://www.clinicaloptions.com/hiv/news/


SOURCE: Roche and Trimeris

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