Tuesday, March 08, 2016 1:24:10 PM
(FWIW) I saw 100% SVR rates for G-4 12 weeks too, and other studies G1-6 data.
I've been looking thru EASL abstracts. So far it's just titles.
Every year there are some interesting things, game changer things.
There are going to quite a few presentations of the Abbvie 1st gen program.
A fair number will be on the 2nd gen program. My interest/confusion of the SVR rates for G-3 was the way they were quantifying the SVR Rates. I think in trials if data is lost or there is stoppage, it's regarded as a failure. In the case of the 97% SVR rate, they (I think) are saying, yeah, a discontinuation, but a cure.....a SVR, never the less.
We will see how deep the data is, and of interest is what the higher dose optimized rates bring. IF they can bring in good cure rates I think they will will be quite competitive; amoung the highest cure rates, and using 2 compounds, not 3, such as we may see in GILD, JNJ or MRK. (SOV and VEL is 95% range)
By the way.... I belive they will present data comparing directly; ABT530/493 to the Sovaldi/Daclatasvir duo. It looks as though both Gilead and BMY have a lot of data on that combo in numerous groups. IF the 2nd gen is as good as it looks, it could be tops in dual therapy for G-3. I believe G-1 is coming in very good in 12 and 8 weeks as well.
Abstract THU-482: ENDURANCE-3: A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY TO COMPARE EFFICACY AND SAFETY OF ABT-493/ABT-530 TO SOFOSBUVIR CO-ADMINISTERED WITH DACLATASVIR IN ADULTS WITH HCV GENOTYPE 3 INFECTION
Bottom line..... it appears to me that the ABBV/ENTA 2nd gen could be the most efficacious doublet out (if and when it is approved). IF a 3rd component, a nuke or a cyclophilin inhibitor were added it could be the highest efficacy and most effective RX for treating RAVs. I kinda wonder if a 3rd agent might be added at some point. I'm seeing a LOT of interest in treating past treatment failures.
Enanta will also present data on it's cyclophilin inhibitor.
When one starts looking thru all the presentations and concentration on RAVs, I think we may start seeing that the subject of resistance and RAVs will start becoming more prevalent.
Think perhaps how some infections no longer respond to a spectrum of antibiotics. This same thing may be happening in HCV. Exposure to for instance a NS5a or PI may be a bigger deal, or longer term issue than was thought. IF so..... the ENTA asset should generate some interest.
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(example)
Abstract THU-217: RETREATMENT OF HCV DAA FAILURES: HCV INFECTION MAY BE INCURABLE
Abstract THU-241: VIROLOGICAL FAILURES TO NEW DIRECT ACTING ANTIVIRALS IN A REAL LIFE SETTING MAY REQUIRE UNCONVENTIONAL REGIMENS FOR RE-TREATMENT
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Also spoiler..... there looks like there will be some presentations on the JNJ and MRK triple therapies with nukes. I think I also saw a JNJ new nuke in early early stage.
Meanwhile, GILD and MRK are in court this week over rights to nukes. Gilead saying they have the rights from purchasing Pharmasset, MRK alleging they had rights due to a prior short term partnership with Pharmasset. It's hard to imagine Gilead would spend 11+billion and not have it covered, but they are in court right now getting a ruling.
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