Wednesday, October 5, 2016

FDA Warning -- Current Hep C Regimens: Hep B May Re-Emerge, While On Meds, Industry Wide...

I'll post this mostly just to keep a complete record. It is immaterial to Merck.

And it will matter very little to the overall horse-races (in claiming that coveted lead, now held by Gilead) underway between Merck, Gilead and Abbvie, primarily -- since the FDA's latest black box warning applies to all of them (and six others, besides). Here's a bit -- it has been widely reported, overnight:

. . . .The Food and Drug Administration is warning about the risk of reactivation of hepatitis B among patients who have had that disease and who are taking some prominent and expensive newer medicines for hepatitis C.

The federal agency said it is requiring a so-called black-box warning in the labels for at least nine brand-name direct-acting antiviral drugs, including Sovaldi and Harvoni from Gilead Sciences Inc., Viekira Pak from AbbVie Inc. and Zepatier from Merck & Co. . . .

I suppose the fascinating object lesson, of this development (for me) -- is one of evolutionary biology. It seems that suppressing the Hep C virus to an undetectable level in humans, leads in some cases to a rise in a perhaps mutated version of the other, Hep B virus. Or maybe it simply allows Hep B to compete effectively for biological resources inside the host once more. But it is plainly proof of the complexity of human viral biology. Onward, with an expectant twinkle in my eyes -- as so, so much (grin-worthy) looms ahead -- in the coming weeks!


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