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High Efficacy of GS-7977 in Combination with Low or Full dose Ribavirin for 24 weeks in Difficult to Treat HCV Infected Genotype 1 Patients
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Reported by Jules Levin
AASLD 2012 Nov 9-13 Boston
1,2Osinusi A, 3Heytens L, 1Lee YJ, 4Bon D, 1Shivakumar B,
1Nelson A, 1 Meissner EG, 1,2Kohli A, 1Barrett L, 1Proschan M, 2Fishbein D, 2Silk R, 1Kwan R, 4Herrmann E, 1Sneller M, 5Teferi G, 6Talwani R, 7Kleiner D, 8Symonds B, 8Subramanian M, 1Polis M, 3Masur H, 8McHutchison J, 1Fauci AS, 1Kottilil S.
1NIAID, NIH, Bethesda, MD, 2 CMRP, SAIC-Frederick, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, 3CCMD, Clinical Centre, NIH, Bethesda, MD, 4IBBM, Johann Wolfgang Goethe University Frankfurt, 5Unity Health Care Inc, 6University of Maryland Medical Center, Baltimore, MD, 7NCI, NIH, Bethesda, MD, 8Gilead Sciences, Foster City, CA
Summary
In 60 treatment-naive, HCV genotype 1 subjects, GS-7977 with ribavirin for 6 months resulted in:
- Full dose RBV: SVR4 OF 77% (ITT), 82% (mITT)
- Low dose RBV: SVR4 of 56% (ITT), 64% (mITT)
There were no safety signals or drug-related discontinuations in this study
CONCLUSIONS
In this inner city population of HCV genotype 1 subjects, an interferon-free regimen of GS-7977 with ribavirin was well tolerated and effective in achieving sustained virologic response
Ongoing analysis is focused on identifying
- Biologic correlates of HCV clearance
- Mechanisms of relapse
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