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Biotech / Medical : Gilead Science (GILD) Followers

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To: scaram(o)uche who wrote (257)	4/14/1997 2:20:00 AM
From: Doug Meetmer	of 961

Rick, Sorry I haven't gotten back to you. The question of using LFTs versus viral load is certainly interesting. In the HIV arena, for example, viral titers are looked at because it is a more precise marker for disease activity than CD4 cell count. The end organ in that case is CD4 cells. With hepatitis, the end organ is the liver and so I suppose an analogy can be drawn between LFTs in Hepatitis and CD4 count in HIV disease. Measuring Viral load of Hep B is certainly useful, since what we are talking about is chronic active hep B infection and there are measurable levels of Hep B DNA in the blood. The more common blood marker for chronic hep B is the presence of detectable surface antigen in the blood (which is not usually quantitated.) Using viral titers would seem to be a more exact method of showing that a drug directly affects a given virus than measuring LFTs. LFTs can also be misleading, if treatment with a drug causes transient elevation of LFTs (as has been discussed on this thread). I would not surmise that it would be necessary to have blood titers for approval of a drug. LFTs would probably suffice, since it would be apparant that Hep B would be the cause of the hepatitis and it is implied that a longterm reduction in LFTs after treatment with a drug would indicate reponsiveness of the virus to that drug. It is circumstantial but very strong evidence. You might say that if a child has Strep throat that is culture proven, and penicillin is given as treatment, you wouldn't have to reculture the throat to measure the response. You would simply look at the throat and see if the white spots and redness had gone away and you would know that the drug worked. The same would be true for a treatment for Hep B with regard to LFTs. Lets keep up the good discussion Doug

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