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Design

Objective

• SVR₁₂ (HCV RNA < LLOQ) by ITT

Baseline characteristics (genotype 3)

Baseline characteristics (genotype 2)

SRV₁₂, (HCV RNA < 25 IU/mL), by ITT- Genotype 3

* At baseline: no NS3 RAS, A30K NS5A RAS ; A t relapse: NS3 RASs (Y56H + Q168R) and NS5A RASs (A30K + Y93H)

SRV₁₂, (HCV RNA < 25 IU/mL), by ITT- Genotype 2

* Lost to follow-up after treatment W2
At baseline: N3 RAV in 1 patient, NS5A RAVs in 39 (31M in 36/39) ; no virologic failure

Adverse events and laboratory abnormalities (genotype 3)

* Abdominal pain and sensation of heat

Adverse events and laboratory abnormalities (genotype 2)

* Atrial fibrillation (not related)

Summary

• High SVR₁₂ rates were achieved in HCV genotype 3-infected patients without cirrhosis after 12 weeks of once daily GLE + PIB
  • All but one patient achieved SVR₁₂ with GLE 300 mg + PIB 120 mg
• SVR₁₂ of 100% in genotype 2 with the different regimens tested (1/75 patients lost to follow-up, no failure in the 74 others)
  • All patients with baseline NS3 or NS5A RAVs achieved SVR₁₂
• Adverse events were mostly mild in severity
  • 1 discontinuation for adverse event
• Selected doses for future studies: GLE 300 mg qd + PIB 120 mg qd