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Lesson 4 of4
In Progress

Selecting the Right HCV Treatment

Riszel March 9, 2022

Factors to Consider

1.HCV treatment history (naïve or experienced)

2.Cirrhosis (none, compensated, decompensated)

3.HCV genotype

4.Medication reconciliation (including herbal/dietary supplements) & potential drug interactions

5.Access to food

6.Adherence (one vs. three tablets; duration – 8 vs. 12 weeks)

7.Past medical history (e.g., transplant, human immunodeficiency virus)


Glecaprevir/Pibrentasvir Data

  • ENDURANCE-1
  • Phase 3 randomized trial of HCV genotype-1 patients without cirrhosis on glecaprevir-pibrentasvir for 8 (n=351) or 12 (n=352) weeks

  • 8 week treatment duration was non-inferior to 12 weeks
  • One patient experienced on-treatment virologic failure
  • Similar safety profile across both treatment duration with headaches and fatigue being most common
  • No patients discontinued treatment due to side effects
  • No documented relapse in either study arm

Ledipasvir/Sofosbuvir Data

  • ION-1
    • Phase 3 randomized trial of HCV genotype-1 patients + cirrhosis on ledipasvir/sofosbuvir OR ledipasvir/sofosbuvir + ribavirin x 12 weeks, ledipasvir-sofosbuvir OR ledipasvir-sofosbuvir + ribavirin x 24 weeks

    • No difference in SVR12 rate between those with cirrhosis (97%) vs. without cirrhosis (98%)
    • Most common side effects were fatigue, headache, insomnia, nausea

 

  • ION-3
    • Phase 3 randomized trial of HCV genotype-1 patients without cirrhosis on ledipasvir/sofosbuvir OR ledipasvir/sofosbuvir + ribavirin x 8 weeks, ledipasvir-sofosbuvir x 12 weeks

    • SVR12 rates of 93-95% across all study arms
    • Higher relapse rates with 8 week tx noticed in those who had baseline HCV RNA level <6 million IU/mL
    • Most common side effects were fatigue, headache, and nausea

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HCV PACU Presentation (1)