Ask Dr. Jeff
Question: I haven't heard much lately about the drug known as 1592, where is it in the approval process?
Answer: The drug formerly know as 1592, developed by GlaxoWellcome, which is now named abacavir, was made available for expanded access in March, 1998.
GlaxoWellcome has submitted an application for fast track approval to the FDA on June 25, 1998. The proposed trade name is Ziagen. It is expected that the drug will be approved in the first quarter of 1999. The drug is administered as one tablet, twice a day with no food restrictions. It is a nucleoside reverse transcriptase inhibitor. The most significant side effect associated with abacavir is that 3-5% of people develop a significant flu-like syndrome, associated with fevers, aches and pains, and possibly a rash. When the drug was stopped and restarted, some people became very ill, and there were a couple of deaths associated with restarting the drug. So it is very important to tell your health care provider if you develop any flu-like symptoms the first few weeks taking this drug, because if you stop it and restart you can develop some very serious problems. See STEP's 12th World AIDS Conference summary in this issue of the Perspective for further information about abacavir.
Answer: This questions raises two excellent issues, the use of hydroxyurea (HU) in salvage regimens and recycling of drugs. A study presented in Geneva reported the use of a "mega-salvage" regimen, combing drugs that people had already received, ddI/
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Perspective.