Biotech Values

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http://www.natap.org/2010/EASL/EASL_36.htm


Summary: SVR-12 results are available for 39 patients in groups A through D. A total of 14 of these individuals (36%) were HCV RNA negative at week 12 of untreated follow-up. Three of nine placebo recipients (33%) have also achieved an SVR-12. One patient in group G has completed 12 weeks of untreated follow-up and has achieved an SVR-12. Among patients who received 13 days of RG7128/RG7227, 23 have SVR-12 results available, of whom 10 (44%) were HCV RNA-negative at week 12 of un-treated follow-up.

There was no evidence of treatment-emergent resistance in any of the 55 patients who received 13 days of interferon-free DAA combination therapy.

Treatment
INFORM-1 was a randomized, double-blind, placebo-controlled trial of the combination of an orally administered nucleoside polymerase inhibitor (RG7128; Roche/Pharmasset) plus an orally administered protease inhibitor (RG7227; Roche/InterMune). Treatment-naive (Cohorts A-D, and G), -experienced non-null (Cohort E), or null responder (Cohort F) patients were randomised to escalating doses of RG7128 (500 or 1000 mg bid) and RG7227 (100 mg or 200 mg tid, or 600 mg or 900 mg bid) for 7 or 13 days, after which, patients were switched to the SOC (peginterferon alfa-2a (40KD) plus ribavirin) (Figure 1).