Wednesday, July 22, 2009

Current Hep C Regimens -- Either Current Drug Will Do -- Except, Of Course, If You're Black. . . .

Even though Schering funded the IDEAL study (reported tonight in The NEJM), it turns out that neither the Schering-Plough currently approved drug, nor the Roche Holding AG one differ much -- in treating Hep C. Sadly, neither drug does a very good job in treating people of color -- for reasons (as yet) unknown.

The IDEAL results must be at least a mild disappointment to Kenilworth, as they also appear to suggest that using less of either drug still causes a significant decrease in viral loads.

Finally, this study says nothing about the so-called next-generation of Hep C candidates -- those still awaiting FDA filings and apporvals. The lead in that next gen race clearly belongs to Vertex's teleprevir. It is theirs to lose. Perhaps teleprevir will show improved efficiacy in people of color -- where the current regimens are doing a particularly poor job. In fact, I'll try to go track down some information on that, for a future post -- it would be a very-welcome development.

I suppose I am, personally, very frustrated about the racial disparity in treatment success -- as it has been widely known, and widely-reported, in The Wall Street Journal, even, going back to at least 1991. African Americans -- although only about 13 percent of the United States population -- are disproportionately hard-hit by this disease.

And yet -- here we sit -- almost two full decades later, with very little in the way of any actual data, or even operating assumptions -- as to what might work for them, as a group -- or even, why this sad state of affairs continues to exist.

Perhaps this would change, if there were a greater financial incentive (i.e., health care coverage for all) -- given that a disproportionate number of people of color tend to be under-, or un-insured -- and given that Hep C disproportionately presents, hand in hand, with poverty, more generally.

Unfortunate, in the extreme. From the NEJM synopsis, then:

. . . .Consistent with previous observations14,15,16,17,18,19,20 a sustained virologic response was less frequent among blacks. . . .


[Click to read some of the prior findings, depicted above.]

. . . .14. Muir AJ, Bornstein JD, Killenberg PG. Peginterferon alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-Hispanic whites. N Engl J Med 2004;350:2265-2271.

15. Myers RP, Patel K, Pianko S, Poynard T, McHutchison JG. The rate of fibrosis progression is an independent predictor of the response to antiviral therapy in chronic hepatitis C. J Viral Hepat 2003;10:16-22.

16. Soresi M, Tripi S, Franco V, et al. Impact of liver steatosis on the antiviral response in the hepatitis C virus-associated chronic hepatitis. Liver Int 2006;26:1119-1125.

17. Reddy KR, Govindarajan S, Marcellin P, et al. Hepatic steatosis in chronic hepatitis C: baseline host and viral characteristics and influence on response to therapy with peginterferon alpha-2a plus ribavirin. J Viral Hepat 2008;15:129-136.

18. Bronowicki JP, Ouzan D, Asselah T, et al. Effect of ribavirin in genotype 1 patients with hepatitis C responding to pegylated interferon alfa-2a plus ribavirin. Gastroenterology 2006;131:1040-1048.

19. Moucari R, Ripault MP, Oul├Ęs V, et al. High predictive value of early viral kinetics in retreatment with peginterferon and ribavirin of chronic hepatitis C patients non-responders to standard combination therapy. J Hepatol 2007;46:596-604.

20. Yu ML, Dai CY, Huang JF, et al. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology 2008;47:1884-1893. . . .

Yep -- at least six prior studies observed the same thing (per the numbered footnotes, above). Yet here we sit.


Anonymous said...

Unfortunately, it appears that there is a genetic predisposition to interferon insensitivity in some people, and this profile is more common in African Americans. Telaprevir and Boceprevir will improve SVR in African Americans, maybe even double the SVR, but the SVR rate in tehse patients will still be lower than in non-AA patients as interferon response still clearly plays a role, even with protease inhibitors.

I will again disagree with your contention that it is Vertex's game to lose. Given your predisposition to dis all things Schering, your position must be taken with a grain of salt. The same goes for the analysts who have been in bed with Vertex from the get go.

Condor said...

Fair enough -- as to your interferon comments.

As to teleprevir v. boceprevir, this is plainly a matter upon which reasonable people may -- and do -- disagree. For my part, I do not concur that all analysts are drinking Vertex Kool-Aid, any more than I believe all analysts drink Schering's.

I do regularly report "the other side" -- the side Schering-Plough leaves out -- because that is the central purpose of this blog: to blunt, or counter, at least one pharma company's spin -- the one (IMHO) most likely to never let the facts get in the way of a chance at profits.

Thanks, as always, for the keen insights -- whether I agree with you or not, I do welcome the feedback, and hope you'll stop back.