ROCHE PRESENTS DATA ON FUZEON COMBINED WITH INTEGRASE INHIBITOR

New data presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy 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, is the first and only fusion inhibitor available for the treatment of HIV. MK-0518 is an investigational integrase inhibitor being developed by Merck.

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, 400 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 with approximately 60 to 70 percent who received MK-0518 without Fuzeon. Overall, Fuzeon increased response rates in the study by approximately 50 percent.

These findings are consistent with the current 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.