Sunday, November 13, 2016 10:52:43 AM
http://www.aasld.org/sites/default/files/LBA%20Full%20Abstracts%20Final%20%28Trimmed%29_1.pdf
1126A
AASLD ABSTRACTS
HEPATOLOGY, December, 2016
LB-12
A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/
Voxilaprevir for 8 Weeks Compared to Sofosbuvir/
Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6
HCV-Infected Patients: The POLARIS-2 Study
=======================
(I have cut out some parts-view page to see full details~W)
This Phase 3 study (NCT02607800)
compared treatment with SOF/VEL/VOX fixed dose combi-
nation (FDC) for 8 weeks to SOF/VEL FDC for 12 weeks in
patients with genotype 1-6 HCV infection with and without
compensated cirrhosis who have not previously received treat-
ment with an HCV direct-acting antiviral agent (DAA).
Now compare to the Abbvie 8 week results;
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126481635
What appears to be a comparable test group
Genotype 1... ABBV G/P 8 wk 99% (348/351)
.......................GILD S/V/V 8 wk 96% (482/501)
Genotype 3...
...........ABBV G/P 8 wk 95% tx naivenon & noncirrhotic
...........GILD S/V/V 8 wk 100% (92/92) w/ % cirr
Genotype 2, 4, 5, & 6.. ABBV G/P 8 wk 97% (196/203)
........GILD S/V/V 8 wk G-2 97 (61/63)
.............................G-4 94 (59/63
.............................G-5 94 (17/18)
.............................G-6 100 (30/30)
GILD group G-2, 4, 5 & 6 is 174 patients compared to ABBV 203
The data shows very comparable 8 week results.
There is one difference however;
per the gilead late breaker
the group was DAA naive
On the other hand it appears that some exposure to sovaldi was allowed into Abbvie trials.
(from the endurance trial; HCV treatment-naïve or treatment experienced (IFN or pegIFN with or without RBV; SOF plus RBV with or without pegIFN).")
So there were some % of cirrhotics in Gilead trials; non in the abbvie
Obviously, not a 100% apples to apples comparison
Even so..... we will be able to detect some of the weaknesses when we compare therapies in shorter threshold treatment durations.
Both therapies look quite strong at 8 weeks and both will look very good at 12 weeks
This indicates to me that the Abbvie program looks very good compared even to Gileads triple; the top gun reserved for salvage.
I know it isn't a perfect comparison, but it is possible to look at comparable groups in 8 weeks. Thoughts? Any mistakes?
I'm busy and haven't looked at all the other trials or compared, but this looked noteworthy.
Worth mention.... some of the presentations at AASLD will provide final SVR data, so until that is known that final comparison isn't possible
~W
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