GS-0938 / Gilead - LARVOL DELTA

Bemnifosbuvir is a potent HCV NS5B inhibitor with a favorable antiviral profile and high resistance barrier (EASL-ILC 2024) - P2 | "The antiviral activity of BEM was profiled against a panel of sofosbuvir (SOF) non-structural protein 5B (NS5B) resistance-associated variants (RAVs) selected in vitro or identified in HCV patients... Resistance selection in GT1b replicons identified C223H as the primary substitution that confers resistance to AT-511, which is the same mutant identified in GT-2a (JFH-1) replicons cultured in the presence of PSI-352938 or PSI-353661, two HCV nucleotide analogs that also generate the same active tri-phosphate AT-9010, in previous studies (Lam, JVI, 2011)... BEM is at least 10-fold more potent than SOF across all genotypes tested and is not resistant to SOF RAVs (S282T, L159F/S282T). C223H was found to be the primary BEM RAV in GT- 1b and multiple substitutions at other NS5B regions were required to confer meaningful resistance, suggesting a very high barrier to resistance for BEM. BEM is currently being evaluated in combination with ruzasvir (RZR), a highly potent..."

Hepatitis C • Hepatology • Inflammation

Pharmasset to present at canaccord genuity growth conference (PRNewswire) - Pharmasset, will present at Canaccord Genuity Growth Conference to be held Aug 10 - 11, 2011 at Intercontinental Hotel, Boston, Massachusetts

Anticipated conference call • Hepatitis C Virus

The effect of hepatic impairment on the safety, pharmacokinetics and antiviral activity of PSI-938 in hepatitis C infected subjects treated for seven days (EASL 2012) - Presentation time: 21.04.2012, 09:00-18:00; P=NA, N=8; HCV-infected subjects with moderate hepatic impairment (Child-Pugh B) treated with PSI-938 for 7 days had higher drug exposure than subjects without hepatic impairment treated in a previous study, although with substantial variability; There were no SAEs. Two subjects experienced one mild AE each that were possibly related to PSI-938 (anemia and leukopenia)

Pharmacokinetic data • Hepatitis C Virus

PSI-938 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection (PRNewswire) - FDA granted fast track designation for Pharmasset's PSI-938 for treatment of HCV infection; Pharmasset plans to initiate QUANTUM, an interferon-free combination trial with PSI-938 & PSI-7977 in Q3 '11

Anticipated trial initiation date • Fast track designation • Hepatitis C Virus

Gilead announces data for genotype 1 null responder hepatitis C patients enrolled in ELECTRON study (Gilead) - P2, N=120; ELECTRON; The majority of hepatitis C genotype 1 pts with a prior “null” response to an IFN-containing regimen experienced viral relapse within four weeks of completing 12 weeks of treatment with GS-7977 + RBV; 10 pts were randomized to this arm, among these eight pts, six have experienced viral relapse; Two pts have not relapsed; however, they have only reached the two week post-treatment time point; The first data evaluating GS-7977 + RBV for 12 weeks in genotype 1 naïve pts will come from an arm of the QUANTUM study with 25 pts at the end of Q1 2012, followed by data from the ELECTRON study involving 25 pts in Q2 & early in Q3, data on GS-7977 & RBV treatment for 24 weeks from an arm of the QUANTUM study will become available

Anticipated P2 data • P2 interim results • Hepatitis C Virus