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BROWSE SLIDES

Design

Objective

• SVR₂₄ with two-sided 95% CI, descriptive analysis

Baseline characteristics and dosing of medication

SOF : 400 mg qd ; RBV weight based ( bid dosing ) : 1000 mg/ day if < 75 kg or 1200 mg/ day if = 75 kg ;
PEG-IFNα-2a : 180 m g SC once weekly

HCV RNA < 15 IU/ml

All patients had HCV RNA < 15 IU/ml at W4 on treatment

Resistance testing (sequencing)

• 4 relapse (2 genotype 2 and 2 genotype 3) in the SOF 12W group
  • 1 patient with S282T mutation (genotype 2b)
  • No NS5B substitutions in the other 3 patients
• 15 relapse in genotype 1 patients
  • No NS5B substitutions

Adverse events

• Most common : headache, fatigue, insomnia, nausea, rash, anemia
• IFN-free groups : less severe reductions in hemoglobin, no neutropenia, no thrombopenia
• SOF monotherapy : mean decrease of 0.54g/dl of hemoglobin

Summary

• By W4 of treatment, all 95 patients in the study had an undetectable level of HCV RNA
• All 50 previously untreated patients with HCV genotype 2 or 3 infection who received 8 or 12 weeks of treatment with SOF + RBV, with or without PEG-IFN- alfa 2a, had a sustained virologic response at 24 weeks after treatment
• SOF alone 12W was associated with 40% of relapse, suggesting a role for RBV in genotype 2 or 3 to maintain antiviral response
• In genotype 1, SVR was much higher in patients naïve to treatment
• There was no discontinuation of SOF or RBV in any group
• Sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection