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
Recent ENTA News
- Enanta Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 04/30/2024 11:10:00 AM
- Enanta Pharmaceuticals Announces the Appointment of Matthew P. Kowalsky as Chief Legal Officer • Business Wire • 04/30/2024 11:00:00 AM
- Enanta Pharmaceuticals to Host Conference Call on May 6 at 4:30 p.m. ET to Discuss its Financial Results for its Fiscal Second Quarter Ended March 31, 2024 • Business Wire • 04/29/2024 11:00:00 AM
- Enanta Pharmaceuticals Announces Data Presentation at ESCMID Global 2024 • Business Wire • 04/17/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:27:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:23:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:19:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:15:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:12:41 PM
- Enanta Pharmaceuticals to Participate at Leerink Partners Global Biopharma Conference • Business Wire • 03/06/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 11:31:52 PM
- Form SCHEDULE 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/27/2024 06:11:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:23:37 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:21:41 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:18:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:15:48 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:12:54 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:09:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:00:28 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 07:26:49 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/08/2024 09:24:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/07/2024 09:05:12 PM
- Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2023 with Webcast and Conference Call Today at 4:30 p.m. ET • Business Wire • 02/07/2024 09:01:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM