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Fuzeon Helped Patients in Merck Integrase Study
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Roche released this press announcement. The data from Merck was reported at ICAAC in a study of treatment-experienced patients who received MK-0518. The data was in a relatively small number of patients, about 100 patients across 4 dose groups who received MK-0518, but in a highly experienced patient group 60-70% receiving MK-0518 plus optimized background therapy (OBR) achieved <400 c/ml. And 90-100% of patients who included Fuzeon in the OBR achieved <400 c/ml, 40 patients included Fuzeon in their OBR.
New Data Show Unprecedented Undetectable Rates of over 90 Percent in HIV Patients Receiving Fuzeon and Investigational Integrase Inhibitor MK-0518
NUTLEY, N.J. & MORRISVILLE, N.C.--(BUSINESS WIRE)--Oct 5, 2006 - New data presented at the 46th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco indicate that nearly all treatment-experienced HIV patients who initiated therapy with FUZEON(R) (enfuvirtide) and the investigational integrase inhibitor MK-0518 in a clinical trial achieved undetectable levels of HIV (less than 400 copies per mL of blood). Such response rates have never been attained in clinical trials of HIV patients living with drug-resistant virus. FUZEON, co-developed by Roche and Trimeris (Nasdaq: TRMS), is the first and only fusion inhibitor available for the treatment of HIV. MK-0518 is a novel investigational integrase inhibitor being developed by Merck & Co., Inc.
Investigators reported results of a 24-week, Phase IIB, Merck-sponsored study of MK-0518 in patients with resistance to protease inhibitors, nucleoside analogues and non-nucleoside analogues. Patients received one of three doses of MK-0518 (200 mg, 400 mg or 600 mg) twice-daily in combination with an optimized regimen of anti-HIV drugs. In the subset of patients who received FUZEON for the first time in their drug regimen along with MK-0518, approximately 90 to 95 percent achieved undetectable HIV, compared to approximately 60 to 70 percent who received MK-0518 without FUZEON. Overall, FUZEON increased response rates in the study by approximately one-half.
These findings are consistent with the recent HIV treatment guidelines, which emphasize undetectability as the goal of therapy in treatment-experienced patients, as well as the need to initiate multiple active anti-HIV agents simultaneously in order to achieve this goal.
"These exciting data with FUZEON and MK-0518 show that when agents from two classes of anti-HIV drugs are used together, we can expect to achieve very high response rates which have only previously been observed in the most successful trials with treatment-naive patients," said Richard Haubrich, Professor of Medicine, Division of Infectious Diseases, University of California at San Diego. "With the availability of FUZEON and novel agents such as MK-0518 available in expanded access programs, treatment-experienced patients now have an excellent opportunity to achieve undetectable HIV."
According to a Merck press release on the study, the most commonly reported study therapy-related side effects (occurring in at least five percent of patients in at least one treatment group) were diarrhea, nausea, fatigue, headache and itching. Four patients discontinued treatment due to adverse experiences.
Facts About FUZEON
Administered via one 90 mg injection twice-daily, 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.
FUZEON is indicated for use in combination with other antiretroviral agents for the treatment of HIV in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
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).
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