Selecting the Right HCV Treatment

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)