Viral breakthrough isn't all that unusual. If you're talking about HCV, the treatment is only about 50% effective to eliminate the virus to the point of a SVR. All those who are on the bad side of the 50% either 1) didn't respond at all, 2) responded but slowly and removed from treatment or 3) were UND at some point but the virus came back. UND just means that the viral level is below the detection limit of the test - it doesn't mean that the virus is gone.
Would following protocol be as specific as full dose compliance, i.e. no dose reductions, or do they have some leeway here. The first question my consulting hep doctor asked was what dose of riba was I taking, any riba reductions and any missed shots. Obviously, he was heavily factoring in compliance before he suggested how long to treat and what my chances of SVR were.
"Intent to treat" analysis is one in which you include everyone who started treatment, but stopped, disappeared etc.
"Per protocol" analysis includes only such patients which followed the protocol all the way through...
Oh, I know I am already disturbed by the way my doc read my 10 week PCR as UND. Now I don't know... I think some writers write in a confused way possibly because they themselves don't understand what they are writing.
I think it's just bad writing perpetuated by a system that doesn't penalize it. One day they should do a study on how good (or bad) doctors interpret studies. I think the results would be disturbing.
The "Berg" figures get tossed around a lot, but seemingly not that relevant for those of us who actually follow protocol. Also, the fact that Berg used fixed dose riba (800 mg) seems to get lost when we compare out own treatment response which in almost all cases is weight-based riba for geno 1's. Again, careful reading and analysis of the studies seems to be very key. Thanks for putting at least this aspect into perspective.
-- Jim