New Data Show Unprecedented Undetectable Rates of over 90 Percent in HIV Patients Receiving FUZEON(R) and Investigational Integrase Inhibitor MK-0518
Thursday October 5, 6:01 pm ET
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® (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 - News), 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 of 32 subjects achieved undetectable HIV, compared to approximately 60 to 70 percent of 82 subjects who received MK-0518 without FUZEON. Overall, FUZEON increased response rates in the study by approximately 50 percent.
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 enfuvirtide and MK-0518 show that when agents from two new classes of anti-HIV drugs are used together, we can expect to achieve 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. "If these data are confirmed in larger groups of patients, the availability of enfuvirtide and novel agents such as MK-0518, now available in expanded access programs, will provide treatment-experienced patients with an excellent opportunity to achieve undetectable HIV-RNA values."
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.
