More Good News: 100% cEVR GT1 and 100% SVR12 GT2/3 (PSI-7977)

[Juttutin]

I mentioned the GT2/3 trial arm results elsewhere, but I was going through the slides again more closely, and looking at the GT1 arm also, and found the great-so-far results in that trial also.

The GT1 arm 100% results are on slide 12/13 (oddly they don't do the math for you to add the two cohorts together eliminating patients who dropped out before completing treatment) - 43+47 = 91 of 91 patients cEVR (ie: UND at end of 12 weeks tx - tx to continue for a further 12 weeks for 90 of 91 patients - one poor person gets a further 24 weeks)

The GT2/GT3 arm 100% results are on slide 23, and shows 24 of 24 patients achieved SVR12 (ie: UND 12 weeks after stopping tx - in this case tx lasted 12 weeks also)

[tashka]

This is so encouraging! Gives us a lot of hope.

[BeatTheBeast]

Thanks very much for this great information!  INF-free treatment for GT1 may indeed become a reality sooner than most people have heretofore thought.  Certainly the "life cycle" (beginning of dosing through tabulation of data 6 months after end of dosing) is short  when the treatment period is 14 days!

BTB

[BelB64]

If you go to the Pharmasset website  www.pharmasset.com you can hear an audio  presentation about all the above inhibitors that was given at the EASL conference. It's fascinating as well as very exciting. The results of the combination trial without interferon will be available later this year, and with the success of 7997 and 938 I think we might be looking at the end of interferon sooner than anyone realized.

[Juttutin]

You are such an idiot!  '43+47 = 91' ??

(Just for accuracy - It was actually 48+43=91)

[Juttutin]

Susie, that's awesome!

[SusieS2010]

Here's the one I love. It is results in previous geno 1 NULL-responders:

QUADRUPLE THERAPY WITH BMS-790052, BMS-650032 AND PEG-IFN/RBV FOR 24 WEEKS RESULTS IN 100% SVR12 IN HCV GENOTYPE 1 NULL RESPONDERS
A. Lok1*, D. Gardiner2, E. Lawitz3, C. Martorell4, G. Everson5, R. Ghalib6, R. Reindollar7, V. Rustgi8, F. McPhee9, M. Wind-Rotolo10, A. Persson10, K. Zhu2, D. Dimitrova2, T. Eley2, T. Guo9, D. Grasela2, C. Pasquinelli2
1Medicine, University of Michigan, Ann Arbor, MI, 2Bristol-Myers Squibb Research and Development, Hopewell, NJ, 3Alamo Medical Research, San Antonio, TX, 4The Research Institute, Springfield, MA, 5University of Colorado-Denver, Aurora, CO, 6The Liver Institute at Methodist Dallas, Dallas, TX, 7Carolinas Center for Liver Disease Research Dept, Statesville, NC, 8Metropolitan Research, Fairfax, VA, 9Bristol-Myers Squibb Research and Development, Wallingford, CT, 10Bristol-Myers Squibb Research and Development, Princeton, NJ, USA. ****@****



Background: Only ~30% of null responders to pegIFN/RBV achieve SVR when retreated with pegIFN/RBV plus telaprevir, thus, this population maintains a high unmet medical need. BMS-790052 is a potent HCV NS5A replication complex inhibitor while BMS-650032 is a potent HCV NS3 protease inhibitor. AI447011 is a randomized, open label, Phase 2a study exploring the antiviral activity and safety of BMS-790052 (60 mg QD) and BMS-650032 (600 mg BID) alone (Group A) or with pegIFN/RBV (Group B) for 24 weeks in a sentinel cohort of HCV GT 1 null responders. The primary objective was to determine the proportion of subjects achieving undetectable HCV RNA (< 10 IU/mL) 12 weeks post-treatment (SVR12).
Methods: Twenty-one subjects (11 Group A, 10 Group B), 19 of whom had unfavorable IL28B genotypes (rs12979860 CT/TT) were treated in the sentinel cohort. Null response was defined as an HCV RNA decrease 3x ULN all had total bilirubin < 2x ULN. Six subjects (all receiving pegIFN/RBV) experienced Grade 3/4 neutropenia. No SAEs or discontinuations due to AEs occurred.
Conclusions: Two antivirals alone can lead to SVR in some difficult-to-treat subjects. Inclusion of pegIFN/RBV with the 2 direct-acting antivirals suppresses the emergence of resistance variants resulting in a 100% rate of SVR12. Enrollment of additional cohorts of patients is ongoing to validate these results.

[susan400]

The real test will be how these results look in non-responders, null responders, relapsers, partial responders, etc.  Alot of these drugs do fantastic in the naive patients, but the typically these results aren't quite that high on a non-responder patient.  Now, if it's still this high in a non-responder patient, I'd be the first one to say, 'give me that drug'!

Susan400

[EyesofBlue55]

This sounds like a real promising thing in the near future.I have been watching this for a little while. cindy