Daclatasvir + Peg/RBV in Treatment-Naïve Genotype 4 COMMAND-4 Study

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Daclatasvir + Peg/RBV in Treatment-Naïve Genotype 4 COMMAND-4 Study Phase 3 Treatment-Naïve Daclatasvir + Peg/RBV in Treatment-Naïve Genotype 4 COMMAND-4 Study Hézode C, et. al. Antivir Ther. 2015;21:195-205.

Daclatasvir + Peginterferon/RBV for HCV GT 4 COMMAND-4 Trial: Study Features Daclatasvir + PR Trial: Features Design: Phase 3 randomized, placebo-controlled trial of daclatasvir (DCV) with peginterferon alfa-2a and ribavirin in treatment-naïve patients with chronic HCV genotype 4 Setting: United States and Europe Entry Criteria - Chronic HCV Genotype 4 - Treatment-naïve - HCV RNA >10,000 IU/ml - Compensated cirrhosis allowed Treatment Arm - Daclatasvir with peginterferon alfa-2a and ribavirin (weight-based dosing) x 24 weeks with response-guided treatment: if extended rapid virologic response (eRVR), then treatment stopped, if no eRVR, then followed by 24-week PR tail. End-Points: Primary=SVR12 Source: Hézode C, et. al. Antivir Ther. 2015;21:195-205.

Daclatasvir + Peginterferon/RBV for HCV GT 4 COMMAND-4 Trial: Design 24 48 Week Treatment Arm (n=82) Daclatasvir 60 mg once daily PEG + RBV If no eRVR continue PEG + RBV Placebo Arm (n=42) Placebo PEG + RBV eRVR = HCV RNA < 25 IU/mL at weeks 4 and 12 PEG = peginterferon; RBV = ribavirin Source: Hézode C, et. al. Antivir Ther. 2015;21:195-205.

Daclatasvir + Peginterferon/RBV for HCV GT 4 COMMAND-4 Trial: Patient Characteristics DCV + Peg/RBV (n=82) Placebo + Peg/RBV (n=42) Male 61 (74%) 29 (69%) Median age, years 49 (20-71) 50 (32-61) Race White Black Other 60 (73%) 18 (22%) 4 (5%) 36 (86%) 5 (12%) 1 (2%) HCV genotype 4 unspecified 4a, 4c, or 4d 26 (32%) 46 (56%) 16 (38%) 24 (57%) HCV RNA ≥800,000 IU/ml 39 (48%) Cirrhosis 9 (11%) 4 (9.5%) IL28B non-CC genotype 33 (79%) Source: Hézode C, et. al. Antivir Ther. 2015;21:195-205.

Daclatasvir + Peginterferon/RBV for HCV GT 4 COMMAND-4 Trial: Results COMMAND-4: SVR12 by Analysis 60/82 16/42 67/82 18/42 Modified ITT, intent-to-treat: patients with missing data at post-treatment week 12 were considered treatment failures. Source: Hézode C, et. al. Antivir Ther. 2015;21:195-205.

COMMAND-4: SVR12 by eRVR in Patients Receiving DCV Daclatasvir + Peginterferon/RBV for HCV GT 4 COMMAND-4: Results in Daclatasvir Arm COMMAND-4: SVR12 by eRVR in Patients Receiving DCV 56/62 4/17 In DCV group, most (79%) patients achieved an eRVR and were eligible for shortened (24 week) duration Source: Hézode C, et. al. Antivir Ther. 2015;21:195-205.

Daclatasvir + Peginterferon/RBV for HCV GT 4 COMMAND-4: Conclusions Conclusions: “In treatment-naive patients with HCV GT4 infection, daclatasvir plus peginterferon/ribavirin achieved higher SVR12 rates than peginterferon/ribavirin alone. These data support daclatasvir-based regimens for treatment of HCV GT4 infection, including all-oral combinations with other direct-acting antivirals.” Source: Hézode C, et. al. Antivir Ther. 2015;21:195-205.

This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.