Comparison of hepatitis drugs zeros in on null responders/ Merck,Vertex

[Guest guest]

Comparison of hepatitis drugs zeros in on null responders/ Merck,Vertex

I am a bit late bringing this to you, I posted a link to the original article from In Vivo when it was published back in November. However, I did not follow up the article reiterating the point of interest until today. You may have already read the piece but I wanted to make sure it wasn't missed. A few weeks ago I mentioned Nature.com as a great source for hepatitis c information. While making my rounds at Nature I was reminded of the importance of the "In Vivo" article .Vertex (Telaprevir) and Merck (Boceprevir) .Excerpt From Nature; Comparison of hepatitis drugs zeros in on null responders"But when comparing the two companies' compounds, the devil is in the details. An 'apples and oranges' problem was highlighted on the pharmaceutical blog In Vivo..In its RESPOND-2 study, Merck defines a null responding patient — someone who is faring the worst under the current standard of care — as a patient whose viral load decreased less than 1 log after four weeks of standard treatment. That's a considerably different criteria from the US

Food and Drug Administration, which defines null responders as 'less than a 2 log10 reduction in HCV RNA at week 12'..Vertex used the FDA's definition of null responder in its study, REALIZE. Since both companies are trying to show that their protease inhibitor works better for patients for whom current options have failed, there is a remote chance that Merck's numbers might paint an artificially rosier picture."The original article from In Vito ; Notes from AASLD: Apples and Oranges and Null Responders

http://Hepatitis Cnewdrugs.blogspot.com/2011/02/comparison-of-hepatitis-drugs-zeros-in.html