Replies to post #116135 on Biotech Values

[ThomasS]

VRUS: Great early news which flies in the face of the doubters.
There WILL BE an all-oral combo treatment at some juncture. Interferon may go the way of the incandescent light bulb, which is now difficult to find in Asia.

[ThomasS]

VRUS: Small sample, yet astounding, imo.

ONCE DAILY DUAL-NUCLEOTIDE COMBINATION OF PSI-938 AND PSI-7977 PROVIDES 94% HCV RNA < LOD AT DAY 14: FIRST PURINE/PYRIMIDINE CLINICAL COMBINATION DATA (THE NUCLEAR STUDY)

E. Lawitz1*, M. Rodriguez-Torres2, J. Denning3, M. Cornpropst3, D. Clemons3, L. Mcnair3, M.M. Berrey3, W. Symonds3
1Alamo Medical Resarch, San Antonio, TX, 2Fundacion de Investigacion De Diego, San Juan, PR, 3Pharmasset, Inc., Princeton, NJ, USA. *[e-mail]

Background: PSI-938 (purine) and PSI-7977 (pyrimidine) are nucleotide analogs in development for the treatment of HCV infection. Complementary resistance profiles, high barriers to resistance, broad genotype coverage, and independent phosphorylation pathways characterize this potentially ideal DAA combination.
Methods: Treatment-naïve, non-cirrhotic patients with HCV GT1 received: 1) PSI-938 for 14 days; 2) PSI-938 days 1-7 and PSI-938+PSI-7977 days 8-14; 3) PSI-7977 days 1-7 and PSI-938+PSI-7977 days 8-14; or 4) PSI-938+PSI-7977 for 14 days. 10 patients per cohort (2 placebo) received PSI-938 300mg QD and/or PSI-7977 400mg QD. Safety, pharmacokinetics, HCV RNA, and viral resistance were assessed.
Results: 30 patients were enrolled in cohorts 1-3 with baseline HCV RNA values of 7.0, 6.2 and 6.3 log10 IU/mL, respectively. Monotherapy (14 days) and 7+7 day combinations were generally safe and well tolerated with no SAEs and no discontinuations. Steady-state pharmacokinetics from monotherapy (day 7) and the combination (day 14) confirmed the absence of clinically-relevant PK interactions between PSI-7977 and PSI-938. Monotherapy PSI-938, monotherapy PSI-7977, or combination PSI-938+PSI-7977 provided profound and consistent reductions in HCV RNA with HCV RNA < LOD (15 IU/mL) as early as day 3 of the monotherapy phase.