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Replies to #66937 on Biotech Values
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iwfal

10/03/08 10:44 PM

#66939 RE: iwfal #66937

New HCV drugs as monotherapy to compare to ifn as monotherapy:

Telapravir - in G1 patients naive to treatment every patient had more that log 2 reduction at day 14. But oddly the viral load was increasing from day 8 to day 14. So not clear that it is easily comparible since the viral kinetics appear to be different.

http://www.hivandhepatitis.com/2005icr/aasld/docs/111405_d.html

Ribavarin - as monotherapy it doesn't seem to do much. See:

http://www.ncbi.nlm.nih.gov/pubmed/7486483?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=2&log$=relatedarticles&logdbfrom=pubmed

Finally note that it is going to be hard for people to experiment with drug cocktails when nothing is approved but ifn and ribavarin. So I wouldn't expect a lot of drug cocktail experimentation until several years after there are at least two potent different MOA drugs approved and on the market.

PS - An interesting question is whether 3x per day pills are preferable to self injection 1x per week. The answer isn't obvious to me.

Comments welcome!
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DewDiligence

10/04/08 11:48 PM

#66982 RE: iwfal #66937

Re: Non-ifn regimens for HCV

>are there any drugs seeking approval via a clinical program without IFN? Your answer at the time was no. Obviously there are the earliest possible signs that that is changing - but so far I've only seen one trial aimed at a no IFN treatment<

Roche will likely start a trial of ITMN191 + R7128 within the next six months. They may also test ITMN191 + R1626.

>As standalone agents how well do some of the candidates for a drug cocktail work?<

R7128 showed a mean 2.7-log reduction in viral load (with zero cases of viral breakthrough) after 14 days of monotherapy in patients with prior ifn failures.

p.s. IDX184 may be the best candidate of all for a non-ifn cocktail insofar as it appears to be synergistic (rather than merely additive) with ribavirin.