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next drug regimen?
Jul 6, 2003

Dear Dr Cohen:

I am asking for guidance as to which drug combination I should go to next. I tested HIV+ in 1991, and since Oct 2002, I have been on a structured drug holiday. My counts in Oct. were: Viral Load > 400 and T-cell count averaging around 400- 500. My latest counts as of April were viral load 12,000 and T-cell - 400. However, 3 weeks ago I developed shingles, partly due to job stress and probably to the drug holiday. My question is where do I go from here? Past drugs have been, AZT 1991 -- bad reaction, stopped after 6 months and switched to Videx -- on that for 4 years until 1995, switched to Viracept and Epivir, until 1997 -- added invirase and zerit, changed invirase to fortovase in 1999? and have been on the combination of Viracept, fortovase, zerit and epivir until Oct, 2002. I also have had to take lipitor to control cholestrol and triglicerides, with a history of heart disease in my family. My resistance profile is the following: AZT, Ziagen -- resistance likely, Epivir -- 45.7, and Videx, hivid, and zerit, reisitance unlikely, but with neuropathy. (the # after drug names following is Fold change in IC 50) - Viread - 1.3, Viramune - 1.4, Rescriptor - 1.5, sustiva - 1.1 (but with heart problems I don't think it would be good to go on), Crixivan - 5.6, Norvir - 23.4, viracept -67.2, fortovase - 26.4, agenerase - 2.5 and Kaletra - resistance unlikely. My HIV type is HIV-1, subtype, Clade B. Hopefully this is understandable and you can use this information to advise, where I should go from here.

Thank you - your work with this web site has been outstanding and I appreciate your work with all of us in this situation.

Thank you again, Gary in NYC

Response from Dr. Cohen

Hey Gary -

By now perhaps you've picked a new combination? This resistance pattern you present is a common one and one that is difficult with a few issues that we must balance, including interpreting resistance testing, handling drug side effect issues in further narrowing options, and finding active meds despite a lot of resistance.

What we can say to guide us now is based on a few years of study. First -- about the most impressive data we have to guide us here comes from studies we've had a new class of drugs to add to a potent protease inhibitor -- such as when Sustiva (or Viramune) was added to a "boosted" PI. For example -- Abbott did a study called 957 a few years ago that had people who had NEVER taken a nonnucleoside (NNRTI)in the past -- (I assume that is the case for you as well?) and added this nonnuke to Kaletra -- their boosted PI. In those who took a somewhat higher dose of Kaletra -- 4 caps twice a day instead of the standard 3 caps twice daily -- the results were quite impressive. The combination was Sustiva, Kaletra, and whichever nucleosides were predicted to be best. In your circumstance -- most would pick viread and epivir and possibly ziagen. Most (though not all) in this study did reestablish control of HIV -- and the one factor that predicted this best was how much HIV was resistant to the Kaletra -- which in your case I gather we cannot be certain about. But this lesson -- of adding a new class (the nonnuke) to a boosted PI -- or perhaps even two boosted PIs -- can reestablish control in a good number of people. This lesson was seen again in the recent studies of the drug T-20 -- where we learned that adding this one new drug to those starting a new combo were twice as likely to reestablish suppression, even if they had only a few (or even just one) other medication to add to it. And there are studies also exploring how we can do better after PI resistance with newer PIs such as tipranavir -- a new PI now in wide scale phase III testing in many sites.

So what to do? Well, one question is when to restart. And here there is active debate -- and sometimes when there's debate there's research. And one study -- enrolling in NYC and around the world -- is comparing those who -- by random assignment -- restart a combo now with a CD4 count above 350 -- vs. waiting until a lower count such as 250 -- and restarting then. You might read more about this on their SMART trial web site. This is among the more important issues since it may be months before you need to go back on meds -- but the recent shingles might lead us towards wanting to do something now... maybe?

So hopefully these thoughts are of some help to you - perhaps by now you've got a new combo and can let us know what happened next...



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