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Can the Interferon package be used in conjunction with the IL-2 without causing problems or invalidating the trial?
Dear Dr. Rodrigues,
I'm co-infected, have been HIV+ for 17 years that I know of and HCV+ for at least 12. Seven or eight years ago my HCV was treated with Interferon Alpha for a time, I don't remember how long, and the enzyme levels returned to normal levels. Since that time I started taking ARV's for the HIV with great success. My HIV viral load is now and has been or years <50. Fourteen months ago a month after my third session of IL-2 my CD-4 count was 3101. Three weeks ago it was down to 1089; I'm supposed to have more of the IL-2 when it gets to below 1000, and at this rate that will probably be in a couple of months. I've got a couple of questions. The only ARV's that I've taken in all this time are D4T and 3TC, and they are obviously still working well. Also obviously, the IL-2 is doing wonders.
Just for reference, before I started the IL-2 - as a part of the Esprit rial - my CD-4 count had been stable in the 800 range for about four of the five years that I had been taking the ARV's. I have also been told that my liver enzymes are rising again and it's been predicted that I'll have to go on the Interferon/Ribavirin routine soon - I'll have to confess that I don't know what the HCV viral load is right now. My questions are thus: Can the Interferon package be used in conjunction with the IL-2 without causing problems or invalidating the trial? Also, I read somewhere on the internet recently, though I can't remember where, that Ribavirin has been shown to reduce the levels of 3TC in the blood, and that increasing the dosage of the 3TC to bring the levels back to normal wipes out the effect of the Ribavirin. Since the Interferon worked successfully by itself last time, would it be appropriate to use it that way again? The HIV ARVs' have been working so well that I'd hate to do anything that would bring on resistance. Is this a catch 22, or is there a practical way out?
All this is being done at the VA here in Atlanta. I don't know about the H EPC people having not really met them yet, but the consulting doctors in the ID clinic are from the CDC. I would still appreciate your comments, though, as second opinions are always valued.
Thanks for your time.
  Dr Rodrigues Writes-  
In coinfection interferon monotherapy has a dismal rate of HCV clearance. This does not mean, that you did not have a benefit of the treatment, as you had ALT decrease, and probably some effect in the liver histology. The problem is that we do not know for how long, and what is the progression of your disease in the liver.
Most likely, you wont be able to start in any interferon based therapy, while you are in the HIV trial. This therapy can interfere with the responses, and the parameters being studied.You need to consult this with your doctor. Of major importance to decide what to do, will be to assess exactly the status of your disease.
RBV is under evaluation at this moment to determine what effect has in the intracellular levels of AZT, d4t and 3tc. The exact data will be reported this year. I can tell you however, that no study in coinfection has shown any problem of resistance, or lack of effect of these drugs during HCV therapy with RBV. This is not important clinically,and you should not be concerned about it.
The final issue, would be to decide the therapy to use and for how long. The best data in HCV non responders is with the use of Pegasys and RBV. Plenty of data will be available later this year, in coinfection with the same combination. We are s not sure if the best efficacy will be obtained with 48 weeks of treatment. We suspect that coinfected patients will have lesser % of viral clearance and non responders, and maybe naive cases, may need longer duration of treatment as 18 months.
Good luck.
  Dr. Rodriguez      
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