Biotech Values

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ABT’s all-oral phase-3 trial in HCV:

That is just one (for patients with compensated cirrhosis) of several studies. For patients with absence of cirrhosis, here is the study (from investigator) - ritonavir dosage is 100mg QD:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ ABT 267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin
(RBV) in Treatment Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)

? Treatment naïve adults between 18 – 70 y/o with a BMI = 18 to < 38 kg/m2

? Liver biopsy within 24 months of screening showing absence of cirrhosis or a FibroTest score of = 0.72 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) = 2
Approximately 600 HCV genotype 1-infected, treatment-naive adults will be randomized to Arms A and B in a 3:1 ratio in the Double-blind (DB) Treatment Period. Randomization will
be stratified by HCV subtype (1a versus non-la) and interleukin 28B (IL28B) genotype (CC versus non-CC). This study will consist of three periods: the DB Treatment Period, an Openlabel
(OL) Treatment Period for previous placebo subjects, and a Post-Treatment (PT) Period for all subjects who received active drugs.

Arm A: ABT-450/r/ABT-267 150 mg /100 mg /25 mg once daily (QD) + ABT-333 250 mg twice daily (BID) with weight-based RBV BID for 12 weeks;

Arm B: Placebo for ABT-450/r/ABT-267 150 mg /100 mg /25 mg QD + Placebo for ABT-333 250 mg BID with weight-based Placebo for RBV BID for 12 weeks followed by ABT-450/r/ABT-267 150 mg /100 mg /25 mg QD + ABT-333 250 mg BID with weight-based RBV BID for 12 weeks