Pharmalyst wishes to thank anonymous for his/her insightful comments regarding the previous post on this topic. Anonymous highlights some interesting issues around the testing for Maraviroc:
"Speaking of tests each patient will be required to have a trofile assay from Monogram to see if they can safely take miraviroc. The cost of this test not including clinic visits will be about 1000.00 and has a 3 week turn around time. In trials about half of those who needed miraviroc were unable to take it safely due to having the x4 which shows up in advanced HIV patients. It is unclear how Pfizer intends to market this product given its close ties to Monogram and the cost of testing...who will pay for the test? will it be bundled as one product? Since the trofile test is not FDA approved or regulated it seems it should be a seperate test much like other testing that happens regularly for HIV patients. It is also unclear how often you must have the trofile test and it only works when a patient stops reponding to therapy. There is also an issue surrounding what will happen if during therapy they develop the x4 which is contraindicated for the start of therapy. "
Pharmalyst is also a bit confused regarding an apparent catch-22 situation with the product. Given that the safety issues etc haven't been fully studied, the product is only being recommended for those who have failed other treatment options etc. Yet the CCR5 pathway is used more often during the early stages and during the early stages patients have other treatment options....so unless the safety picture with this drug is clearer, it may not be used earlier and using it later may render the product less effective...no?
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