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Combination Oral, Ribavirin Free, Antiviral Therapy to Optimize Treatment Outcomes for Hepatitis C Treatment Naïve Patients: Interim Results from the NIAID SYNERGY Trial (6 & 12 weeks therapy)
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Reported by Jules Levin
AASLD Nov 1-4 2013 Wash DC
Anita Kohli1,2, Zayani Sims2, Miriam Marti3, Amy Nelson3, Anu Osinusi2,4, Dimitra Bon5, Eva Hermann5, Colleen Kotb1, Rachel Silk1, Gebeyehu Teferi6, William T. Symonds7, Phil S Pang7, John McHutchison7, G. Mani Subramanian7, Michael A. Polis3, Henry Masur2, Shyam Kottilil3
1Clinical Research Directorate/Clinical Monitoring Research Program, Science Applications International Corp (SAIC)-Frederick Inc, Frederick, Maryland 2Critical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland 3Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 4Department of Infectious Diseases, University of Maryland, Baltimore 5Institute of Biostatistics and Mathematical Modeling, Johann Wolfgang Goethe University, Frankfurt, Germany6 Unity Health Care Inc, Washington, DC 7Gilead Sciences, Foster City, California
from Jules: This NIH study looked at 12 and 6 weeks therapy with 3 different IFN & RBV-free regimens in a difficult-to-treat patient population. There are 165 patients in this study, mostly African-Americans (88%), 72% men, 80% were the more difficult to treat IL28B non-CC genotype, 30% had a high BMI >30 (harder to treat because they are heavier in weight), 70% infected with the harder to treat genotype 1a, and 28% had had stage 3 liver disease, more advanced liver disease, also harder to treat. Patients received 12 weeks of Sofosbuvir+Ledipasvir (Fixed Dose Combination [FDC]; n=20; Arm A), or 6 weeks of the FDC + GS9669 (a Gilead non-nuc polymerase inhibitor; n=20; Arm B), or 6 weeks of the FDC + GS9451 (a Gilead HCV protease inhibitor; n=20; Arm C). After 7 days of therapy the patients in arm C, with the protease plus the FDC had a lower viral load compared to the 2 other groups. 100% of patients in Arm A receiving the FDC alone for 12 weeks achieved SVR12; 100% who received the FDC+the protease for 6 weeks achieved SVR4; and 18/20 in Arm B who had 6 weeks of therapy with the FDA + the non-nuc achieved SVR4. "HCV viral load was suppressed below LLOQ in all patients soon after initiation of treatment. Subjects on Arm A maintained HCV viral loads below LLOQ until 12 weeks after stopping therapy (SVR 12). 18/20 subjects on Arm B and 20/20 on Arm C maintained viral loads below LLOQ until four weeks after stopping treatment (SVR 4). One patient on Arm B relapsed 2 weeks after stopping therapy and one patient who achieved SVR2 missed the subsequent SVR4 visit." Average time to normalization for ALT (A) was 13.3 ± 20.3 vs. 5.5 ± 3.7 vs. 6.6 ± 5.6 days (p=0.11) and 11.4 ± 18.0 vs. 4.9 ± 4.6 vs. 4.8 ± 4.1 days for AST (B) (p=0.26) on Arms A, B and C respectively.
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