Hepatitis web study Hepatitis web study Daclatasvir + Asunaprevir + Peg/RBV in Genotype 1 and 4 HALLMARK-QUAD Study Phase 3 Treatment-Experienced Jensen.

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Presentation transcript:

Hepatitis web study Hepatitis web study Daclatasvir + Asunaprevir + Peg/RBV in Genotype 1 and 4 HALLMARK-QUAD Study Phase 3 Treatment-Experienced Jensen D, et. al. J Hepatol. 2015;63:30-7.

Hepatitis web study Source: Jensen D, et. al. J Hepatol. 2015;63:30-7. Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Study Features

Hepatitis web study Source: Jensen D, et. al. J Hepatol. 2015;63:30-7. Treatment-Experienced GT 4 N = 44 Treatment-Experienced GT 1a or 1b N = 354 SVR12 Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Design Daclatasvir + Asunaprevir + Peginterferon + Ribavirin Drug Dosing Daclatasvir: 60 mg once daily Asunaprevir: 100 mg twice daily Peginterferon alfa-2a: 180 mcg once weekly Ribavirin, weight-based dosing, twice daily: 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg Week 02412

Hepatitis web study Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Patient Characteristics Source: Jensen D, et. al. J Hepatol. 2015;63:30-7. CharacteristicGenotype 1 (n=354) Genotype 4 (n=44) Male, n (%) 240 (68%)33 (75%) Median age, years (range) 54 (19-76)52 (20-71) Race White Black Asian 271 (77%) 33 (9%) 47 (13%) 33 (75%) 4 (9%) 1 (2%) HCV genotype 1a 1b 176 (50%) 178 (50%) N/A HCV RNA ≥800,000 IU/ml 307 (87%)29 (66%) Cirrhosis 73 (21%)20 (46%) IL28B non-CC genotype 321 (91%)41 (93%) Prior treatment failure Partial response Null response 120 (34%) 234 (66%) 10 (23%) 34 (77%)

Hepatitis web study Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Results HALLMARK-QUAD: SVR 12 by Genotype a Source: Jensen D, et. al. J Hepatol. 2015;63:30-7. a Modified intention-to-treat analysis; GT = genotype 329/354153/176176/17843/44

Hepatitis web study Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Results HALLMARK-QUAD: SVR12, by Cirrhosis Status Source: Jensen D, et. al. J Hepatol. 2015;63: /7319/2024/24263/281

Hepatitis web study Source: Jensen D, et. al. J Hepatol. 2015;63:30-7. Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Adverse Events Event All patients (n=398) Serious Adverse Events (AEs)22 (6%) AEs leading to discontinuation18 (5%) Adverse Events in ≥20% of patients Fatigue Headache Pruritus Asthenia Influenza-like illness Insomnia Rash 165 (41%) 124 (31%) 104 (26%) 96 (24%) 89 (22%) 82 (21%) Grade 3 or 4 Lab Abnormalities Hemoglobin < 9 g/dL Neutrophils < 0.75 x 10 9 /L Platelets < 50 x 10 9 /L 25 (6%) 89 (22%) 15 (4%)

Hepatitis web study Source: Jensen D, et. al. J Hepatol. 2015;63:30-7. Daclatasvir + Asunaprevir + P/R for HCV GT 1,4 HALLMARK-QUAD Trial: Conclusions Conclusions: “Daclatasvir plus asunaprevir and peginterferon/ribavirin demonstrated high rates of SVR12 in genotype 1- or 4-infected prior null or partial responders. The combination was well tolerated and no additional safety and tolerability concerns were observed compared with peginterferon/ribavirin regimens.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.