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What am I going to do now, Nelson?
Aug 6, 2010

Hi Nelson, I hope all is well. Last year you told me about the trial with ibalizumab at ACRIA and I received the meds for about 1 year. In the beginning of thet trial the virus became undectadable but then it started to go up again and they took me out of the study. I was in the trial for about 1 year. My doctor changed my regimen to recycle meds...I'm resistant to all of them. I am now on Aptivus, Viread, Norvir and Trizivir. Do you know of any other trials in NYC? Thanks for your help.

Response from Mr. Vergel

I am so sorry that your virus developed resistance to ibalizumab (Taimed's intravenous CD4 monoclonal antibody that may be given once every two weeks).

I am working with ACRIA and two San Francisco doctors in setting up a small expanded access pilot to combine two investigational agents by early summer 2011, but we are still waiting for data. But it is not a done deal. However, one of the drugs may be ibalizumab.

GSK-ViiV are testing a second generation integrase inhibitor (GSK572) in phase II now and we are really hoping it can help people with raltegravir resistance. Some preliminary data show that it may help those with certain integrase mutations. GSK is also testing two non nucleosides in early phase 2. So, it will take at least 8 months to know where we are going with these agents.

AVEXA, an Australian company that has an interesting nucleoside, may be back in the picture after their board reconsidered not dropping their drug due to activist pressure. I am following that drug closely also.

BMS seems to have an entry inhibitor but they are a company that does not like to share information with treatment activists, so it has been a challenge to get them to tell us anything. It is unfortunate that in 2010 we still have this lack of communication going (but they are rare among companies).

Progenics also had a once a week subcutaneous entry inhibitor that looks very exciting. They are also a company that has refused to meet with treatment activists. They are small and may not understand the power that activists have in the present to help advocate for new drugs.

Koronis (http://www.koronispharma.com/KP1461forHIV.html) also has an interesting nucleoside that works very differently than the ones we have right now, but they have not tested it in people like you with a failing regimen.

Some of these companies may or may not agree to provide drug in a compassionate manner for one patient (but remember that you need at least two new active drugs to avoid functional monotherapy). But if your doctor wants to ask them, the FDA has set up a way to do so provided that the companies are willing to help. The FDA procedure is http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm163982.htm

It is getting harder and harder for companies to justify spending money on new drugs that attack new targets since they perceive the treatment experienced market to be too small to justify the investment. And many doctors are telling them that people like you and me do not exist anymore. So, it is more important than ever not to fall asleep in treatment activism.

I am focusing a lot of my energies in helping people like you who may fall through the cracks if we do not provide at least two drugs at the same time that your virus does not have resistance to.

One more thing. This is anecdotal but I have seen people in salvage's viral load go down a lot with good daily prophylaxis for herpes (acyclovir, Valtrx, or Famvir) (http://www.aidsmap.com/page/1431675/) twice a day and also with the use of an antibiotic called minoxycline ( http://www.aidsmap.com/page/1438246/), plus their HIV drug regimen. Talk to your doctor about these if you are not taking them already.

Keep in contact with me. I will keep everyone informed through this column as things progress.

Hang in there and please keep in touch with me.

Nelson



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