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30. What are the key issues with the current guidelines focused on by the Treatment Algorithm?

The issues that we looked at in putting this guideline together were that PCR was critically important. Not only in identifying active disease, but also the rebound, when resistance occurs. You can’t diagnose resistance if you’re using a hybridization assay. Some of the labs in the community still use the hybridization assay. Now how do you know that? It comes back in picograms/ml rather than in copies/ml, and is much less sensitive. The ALT, we’ve talked about that. Some of the guidelines from Dr. Lok and Dr. McMahon say, “don’t treat people unless the ALT is more than 2 times the upper limit of normal”, we feel that’s too conservative. And also, what’s a normal ALT? In our laboratories, normal ALTs are often 40, 45 and sometimes even 60. And that’s because we have become an obese country, as you know. 23% of Americans are obese. How do labs get normal values? They survey people that walk through the door, and then they develop a bell-shaped curve and do two standard cutoffs and say everything below that is normal. But the people who walk through the door to get routine blood tests, some have undiagnosed hepatitis B, or undiagnosed hepatitis C, a lot drink, and a lot of them are obese. And so the normal ALT is higher than it really ought to be, we appreciate that. And biopsy is always challenging, but we thought we needed to individualize and use selectively when needed to clarify the diagnosis.