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Post Info TOPIC: Janssen 2a trial


Guru

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RE: Janssen 2a trial
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Hey,

Good-un Tig!

A "new" NS5B (AL-355)??!! Very interesting indeed! (sof, move over??)

We see others, working on new 5A's (like RAV and RUZ), but I can't recall any other big pharma's working on a "new" 5B!

Also of interest to me were the locations they are recruiting for this Oda/Simi/AL-355 trial - "only in Canada you say"!, hee hee, like when does THAT ever happen! Of all the limited country locations worldwide for this trial (from Belgium/France/Poland/Sweden etc.) who are NOT recruiting yet, there are "some locations" in 3 Canadian provinces who ARE recruiting, and apparently, recruitment has happened only in Canada so far! Weirder things happened, but not much I figure! 

Wonders never cease. smile C.



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 63 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



Guru

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This is always interesting news as more and more developments in this cure happen. It seems everyone wants a piece of the pie now since there is a small fortune still to be made until generics become readily available.

They need to tackle B ... They need to do it now and they need to find something for a fatty liver. These both will be the biggest reasons for the requirement for transplants.

SF

 



__________________

65 yo, GT1A, , Cirrhosis, F-Scan F4 33.5, TX Naive Harvoni 12 wks

SOT 2/9/16 / ALT 187 AST 114 VL 2.3M.    POSTS

EOT 5/2/16  ALT 35/ AST/25  platlets 126 C/B VL UND

EOT +12 7/26/16  ALT 25 /AST 22/ ALP 83  platlets 129 C/B VL UND

EOT + 24 10/18/16 ALT 27/ AST 20/ ALP 71 platlets 153 C UND

 * SVR *

Tig


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Janssen launches mid-stage study of six-to-eight week HCV regimen

Johnson & Johnson's (NYSE:JNJ) Janssen Research & Development, LLC initiates an open-label Phase 2b study assessing the combination of simeprevir, odalasvir and JNJ-4178 (AL-335) in treatment-naive and treatment-experienced patients with chronic hepatitis C virus infection genotypes 1,2,4,5 and 6 without cirrhosis.

Subjects will receive the triple combination for either six or eight weeks. The primary endpoint is the percentage of patients who achieve clinical cure (SVR12) at the end of treatment. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is August 2017. The estimated study completion date is October 2017.

An ongoing Phase 2b study is evaluating the triple combo regimen in HCV patients with or without compensated cirrhosis.

Simeprevir (Olysio) is an NS3/4 protease inhibitor. Odalasvir is an NS5A inhibitor. JNJ-4178 (AL-335) is a novel uridine nucleotide analog polymerase inhibitor.

Seeking Alpha - Janssen.      ClinicalTrials.Gov Info



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Tig

61 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 1-4 years!

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