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BROWSE SLIDES

Design

* Child-Pugh A, B or C, MELD score 8-40, hepatocarcinoma allowed
** = 3 months post-transplant, no rejection, any immunosuppressive regimen

RBV : 600 mg/day (bid dosing), adjusted to 1000 mg/day, based on hemoglobin and creatinine clearance

Objective

• SVR₁₂ (HCV RNA < 25 IU/ml) in genotype 1

Baseline characteristics

Advanced cirrhosis cohort

• Child Pugh A = 12 (MELD score 10-15 : 5/12)
• B = 32 (2/3 with ascites and/or encephalopathy , MELD score 10-20 : 25/32)
• C = 16 (all with ascites and encephalopathy ; MELD score = 16 : 13/16)

SVR₁₂ (HCV RNA < 25 IU/ml)

Baseline resistance polymorphisms

• NS5A variants (-28, -30, -31, or -93 polymorphisms) detected in 22 of 112 patients
  • 82% (18/22) achieved SVR₁₂
    • 10/14 in cirrhosis cohort ; 8/8 in post-transplant cohort
  • 90% (81/90) without NS5A polymorphisms achieved SVR₁₂
    • 39/45 in cirrhosis cohort ; 42/45 in post-transplant cohort
• No NS5B-S282 variants detected at baseline or failure

NS5A resistance-associated variants in patients with virologic failure

* Assessed by population-based sequencing

Adverse events, n (%)

* 4 events (anemia, non-cardiac chest pain, arthralgia, headache) considered related to study medication

Summary

• SVR₁₂ achieved by 94% of liver transplant recipients with HCV recurrence
  • Favorable drug-drug interaction profile that did not require dose modification of pre-transplant or immunosuppressant medications
  • No events of graft rejection
• SVR₁₂ in 92% of patients with Child-Pugh class A cirrhosis, 94% in class B, 56% in class C
• High SVR₁₂ rates in GT-3 patients: 83% of advanced cirrhosis, 91 % of post- transplant
• SVR₁₂ rate of only 76% in genotype 1 advanced cirrhosis