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Boceprevir & Telaprevir SVR Rates Reported at FDA Hearing
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Reported by Jules Levin
Boceprevir study demographics - SPRINT-2 treatment-naives: mean age: 48-52; mean BMI 27-31; GT1a 62-63% in non-blacks, 73-79% in blacks; GT1b: 33-36% non-blacks, 17-25% blacks; HCV RNA >400,000 IU/mL 92-93% non-blacks, 94-100% blacks; Metavir F3/F4 non-blacks: 7% PR48, 8% RGT, 12% BOC/PR48; blacks: 2% PR48, 15% RGT, 11% BOC/PR48. RESPOND-2 Treatment Failures - mean age 53; black 11-15%; mean BMI 28-29; GT1a: 58-60%, GT1b 38-43%
HCV RNA >800,000 IU/mL 81% PR48, 91% RGT, 88% BOC/PR48; Metavir F3/F4 19-20%; non-responders 35%, relapser 65%.
Telaprevir study Demographics in ADVANCE naives: 7-11% Black/African-Americans; median age 49; (19-69); median BMI 26 kg/m2 (17-47); GT 1a: 58%, GT 1b: 41%. HCV RNA >800,000 IU/mL 77%; stage of fibrosis: bridging cirrhosis 14-16%; cirrhosis: 6-7%. ILLUMINATE Study: Black/African-Americans: 10-14%; median age: 51 (19-70); median BMI: 27-28 kg/m2; HCV RNA >800,000 IU/mL 77-82%; GT1a: 71-73%, GT1b: 27-28%; stage of fibrosis: bridging cirrhosis: 12-16%; cirrhosis: 8-11%. REALIZE treatment-experienced: 3-8% Black/African-American; median age: 50-51; HCV RNA >800,000 IU/mL 86-89%; GT1a 52-57%, GT1b 43-48%; stage of fibrosis: bridging fibrosis: 22-23%; cirrhosis: 23-27%; prior response: relapsers: 52-55%, null responders: 27-28%, partial responders: 18-20%.
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