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.

Question: I have failed several regimens that include a protease inhibitor, can I benefit from recycling a drug like ddI and adding hydroxyurea?

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/d4t/3TC/nelfinavir/saquinavir/nevirapine. The regimen was surprisingly tolerated by 9/12 people, and 9/9 people had viral loads of <400 at 12 weeks. It remains to be seen how long the virus stays suppressed, but these are encouraging data. For a discussion and update on drug resistance tests, see STEP's 12th World AIDS Conference review in this issue of the Perspective. Also, in the Conference review is a brief summary of the HU studies reported in Geneva. Many clinicians are using genotype and/or phenotype testing, along with a complete review of all past drug exposure, to design regimens for people who have failed several combinations. HU definitely enhances the efficacy of ddI and is well tolerated, so it is being used in many "salvage" regimens. The next STEP Perspective will have a more in depth review of HU.

Ask Dr. Jeff your question! Mail in your question or e-mail us at step@lifelongaidsalliance.org. We will answer all questions and print those that space allows.

Dr. Jeff Schouten is a former general surgeon, who has been living with HIV for over 10 years. He has been co-chair of STEP's Scientific Review Committee for several years and contributes regularly to the STEP Perspective. He has also recently earned a law degree from the University of Washington, so HIV-related legal questions, as well as medical, will be accepted.

Back to STEP Perspective Fall 1998 contents page.