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Author Topic: Good article on drugs in testing and when they will be available  (Read 7568 times)

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Offline charly8

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  • Posts: 113
Comparison of 7-day monotherapy of Sovaldi vs. MK-3682 and ACH 3422 indicate a rate of viral clearance of Sovaldi > MK-3682 > ACH 3422.

Gilead will be reporting Phase 3 data on GS-5816 with Sovaldi in 3Q15 and could have this pan-genotypic combo on the market by the end of 2016.

Merck initiated a Phase 2 study with their triple combo in GT3 patients and could field a best-in-class pan-genotypic regimen in 2018, some two years behind Gilead's next generation.

Achillion’s nuke ACH 3422 suffers from poor bioavailability, has a tenuous IP position, and a slow pace of development.

JNJ’s nucleotide AL-335 acquired from Alios is in Phase 1 and, with access now to ACH 3102, JNJ could have a pan-genotypic therapy approved in the 2019 to 2020 time frame.

1a, VL  1.05 Mil, ALT 47
Fibrosure F3 December 2014
Fibroscan F0-F1 March 2015
1995 INT & RYB -non-responder
2007 PEGIN & RYB 72 weeks tx - partial responder relapsed
1/23/15 Started Harvoni 12 weeks, EOT 4/17
2 week blood work -  <15 Und. (ALT 25)
4 week blood work - <15 Und. (ALT 29)
2/20/15 added RYB (4 weeks into 12 of tx)
8 week blood work - <15 Und. (ALT 23)
(EOT) 12 week blood work - <15 Und.
4wk POST tx VL - Und. (ALT16, AST 17)

Offline dragonslayer

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  • Posts: 873
Re: Good article on drugs in testing and when they will be available
« Reply #1 on: May 22, 2015, 03:22:47 pm »
I wonder if the Gilead combo will  get Breakthrough status from the FDA for even earlier approval.

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
likely infected early '70s


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