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For those of you applying for TMC 125 Expanded Access and who have had NNRTI resistance in the past (resistance to Sustiva or Viramune), read this:
I want to make sure that people who are applying for TMC 125 expanded access are very careful when assuming that this medication will be represent an "active" agent that they can use to construct a two or three-active agent combo. No genotype test for EAP drugs is available, so we are in danger of assuming that a new drug is an active drug (this assumption may not be true when starting drugs in existing classes). An active drug is one that is shown in your resistance test (genotype or phenotype) to have a good chance to work in controlling your virus. Another danger with TMC 125 is that it is a NNRTI and we know that prior NNRTI resistance can be archived and not show up in genotype tests. Many patients like myself with extensive NNRTI resistance in the past show activity to that class in our genotype test. If the doctor does not carefully review prior medication history and asks the right questions to the patient, both the doctor and patient will assume that there is no archived prior resistance. So be very careful!
These medicines probably offer a better chance at being "true" active agents if you have never taken them before:
Fuzeon (approved)
MK-518 integrase inhibitor ( available via EAP)
Maraviroc (if you have a R5 virus as determined by the Trofile test provided for free as part of the Maraviroc EAP)
Prezista (if shown as active in genotype test)
Aptivus ( if shown as active in genotype test)
It is debatable that the "partial activity" that usually shows up in most genotype tests with Viread is such!
Also, do not join any study that will expose you to a OBT (optimized background therapy) if you can construct a regimen with 2-3 active agents on your own without having to take the risk of virtual monotherapy in a study. Companies need to stop the use of OBT's that present a virtual monotherapy risk to patients and this practice should not be allowed in patients in salvage settings.
Regards,
Nelson Vergel
powerusa dot org
Nelson Vergel
powerusa dot org
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