Coverage of 2006 International
Conference on AIDS

August 14–18, 2006, Toronto, Canada

 

Expanded Access Program Announced for MK-0518, the First Integrase Inhibitor

Martin Delaney, Founding Director, Project Inform
August 16, 2006

The pharmaceutical company Merck announced on Thursday morning that it will launch a large international expanded access program for its integrase inhibitor MK-0518. The drug will be made available to people who have failed on existing therapies and need a new drug to overcome resistance to other options. MK-0518 can be combined with most other available drugs so it should be fairly easy for doctors to incorporate it into existing treatment regimens.

In studies that have given the drug to people with high levels of resistance to other drugs, MK-0518 produced some of the best results yet seen in such people. When combined with other new drugs, such as the protease inhibitor Prezista or the entry inhibitor Fuzeon, it should be possible for most people to achieve undetectable levels of virus, regardless of previous drug resistance.

Although the announcement about the program says only that the drug will be made available sometime over the next two months, this wording does not reflect the actual plans for the US. In the US, where the drug was developed and will be produced, the expanded access program will begin no later than the first few days of September, and possibly as early as the last week of August. In other words, access in the US is imminent. Access might take a little longer outside the US where the expanded access protocol has not yet been approved by all the necessary regulatory authorities.

However, scientists and regulators worldwide recognize the potential offered by the new drug and all are working to provide the earliest possible access for people failing current therapy. Many people who recently gained access to the new protease inhibitor Prezista from Tibotec Therapeutics, have been withholding their use of the drug until they could combine it with MK-0518. Thus, there are many people ready to move quickly as soon as Merck gives the signal that the program is ready.

In the US, the expanded access program will be managed via email or over the phone. Merck will announce the details of the email process as soon as the program is ready to begin. Project Inform will post the details the moment they become available.