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PSI-7977 400 mg with PEG/RBV Provides 93% SVR Across HCV GT 1, 2 and 3
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Reported by Jules Levin
HepDart, December 4-8, 2011 Kauai, Koloa, HI
E Lawitz1, JP Lalezari2, T Hassanein3, KV Kowdley4, FF Poordad5, AM Sheikh6, NH Afdhal7, DE Bernstein8, E DeJesus9, B Freilich10, DR Nelson11, DT Dieterich12, IM Jacobson13, D Jensen 14, GA Abrams15, JM Darling16,
M Rodriguez-Torres17, KR Reddy18, MS Sulkowski19, NH Bzowej20, MP DeMicco21, JS Strohecker22, RH Hyland23, M Mader23, R Hindes23, E Albanis23, WT Symonds23, MM Berrey23
1Alamo Medical Research, San Antonio, TX; 2Quest Clinical Research, San Francisco, CA; 3Southern California Liver Ctr, Coronado, CA; 4VMMC, Seattle, WA; 5Cedars Sinai Med Ctr, Los Angeles, CA; 6GI Specialists of Georgia, Marietta, GA; 7Beth Israel Deaconess, Boston, MA; 8North Shore University Hospital, Manhassett, NY; 9OIC, Orlando, FL;
10Kansas City Gastroenterology and Hepatology, LLCG, Kansas City, MO; 11University of Florida, Gainesville, FL; 12Mount Sinai, New York, NY; 13Cornell University, New York, NY;14University of Chicago, Chicago, IL; 15Alabama Liver and Digestive Specialists, Montgomery, AL;16University of North Carolina, Chapel Hill, NC;17Fundacion de Investigacion De Diego, San Juan, PR;
18University of Pennsylvania, Philadelphia, PA;19Johns Hopkins University, Lutherville, MD;20California Pacific Medical Center, San Francisco, CA; 21ACRI, Anaheim, CA; 22Columbia Gastroenterology, Columbia, SC; 23Pharmasset, Inc., Princeton, NJ.
from Jules: PSI-7977 is a nucleotide, a potent class of new orally administered HCV drugs, and has shown about a 4.5 log reduction in viral load in monotherapy studiesa potent class of HCV drugs. It works effectively across genotypes including 1, 2 and 3; has been studied with peg/rbv and in combination with the other nucleotide PSI-938 from the same research group. Phase 3 study plan has been announced and is supposed to start in Spring 2012. In a study presented at AASLD in November 2011 a group of 30 genotype 2/3 patients achieved 100% SVR, cure, rates. In genotype 1 in small studies 91-98% SVR rates have been reported, links to these & additional studies reported this year are below.
AASLD: PROTON: PSI-7977 & Peg/RBV in Treatment-naïve Patients with HCV GT1: Sustained Virologic Response - (11/08/11)
AASLD: PSI-7977: ELECTRON Interferon is not required for Sustained Virologic Response in Treatment-Naïve Patients with HCV GT2 or GT3 - (11/07/11)
Pharmasset Announces the Initiation of an Interferon-Free Phase 3 Program with PSI-7977 for HCV - (11/01/11)
Pharmasset Phase 3 Plan Announced: Slides Presented This Morning on Pharmasset Conference Call - (11/01/11)
Pharmasset Initiates Phase 2b ATOMIC Trial of PSI-7977 for Multiple HCV Genotypes - (03/31/11)
Gilead Sciences to Acquire Pharmasset, Inc. for $11 Billion - (11/21/11)
Gilead Acquires Pharmasset $11 Billion - (11/21/11)
EASL: PROTON Study: PSI-7977 QD with PEG/RBV: 12-week Safety, RVR, cEVR, & SVR12 in Treatment-naïve Patients with HCV GT2 or GT3 - (04/01/11)
EASL: 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) - (03/31/11)
EASL: PSI-7977 QD Plus PEG/RBV In HCV GT1: 98% Rapid Virologic Response, Complete Early Virologic Response: The PROTON Study - (03/31/11)
EASL: PSI-352938, A Novel Purine Nucleotide Analog, Exhibits Potent Antiviral Activity and No Evidence of Resistance in Patients with HCV Genotype 1 Over 7 Days - (04/06/11)
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