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BROWSE SLIDES

Design

* Randomisation was stratified on genotype (1a or 1b) in both cohorts, IL28B in cohort 1 and treatment history (naïve or non-responder) in cohort 2

• SOF : 400 mg (2 x 200 mg) qd in cohort 1, 400 mg qd in cohort 2
• SMV : 150 mg qd
• RBV weight based (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if = 75 kg

Objective

• Exploratory study
• SVR₁₂ (HCV RNA < 25 IU/ml), with 95% CI
• ITT analysis
• No sample size calculation
• Analyses within each cohort and on pooled cohort data

Baseline characteristics

Female : 36%, median age : 57 years ; white : 81%, black : 19% ; median BMI : 28.0 kg/m 2
NS3 Q80K polymorphism mutation present in 45% of genotype 1a

SVR₁₂ (HCV RNA < 25 IU/ml) in Cohort 1
Prior non responders, Metavir F0-F2

SVR₁₂ (HCV RNA < 25 IU/ml) in Cohort 2
Treatment naïve and non responders, Metavir F3-F4

• SVR₁₂ similar in patients with IL28B CC and non-CC genotypes, irrespective of whether they received RBV, in treatment-naïve or previous non-responders, with 12 or 24 weeks of SMF + SOF, also high in F4 patients
• Relapse in patients with HCV RNA < 25 IU /ml at end of completed treatment : 6 (all genotype 1a)

SSR : SOF + SMV + RBV ; NR : null responder

Adverse events , N (%)

Summary

• High Rates of SVR₁₂ with SOF + SMV, even in difficult to treat groups, including patients with compensated cirrhosis and prior non response to therapy
• Rapid virologic response did not predict SVR₁₂
• Addition of RBV did not improve SVR₁₂ rates
• Extending treatment to 24 weeks did not improve SVR₁₂ rates, except possibly in patients with prior relapse and advanced fibrosis
• Patients with baseline G80K mutation had high SVR₁₂ rates, including those with compensated cirrhosis, with no impact of RBV
• Regimen well tolerated: fatigue, headache, and nausea were the most common side effects
• Overall, SOF + SMV shows high efficacy and tolerability in patients with chronic HCV genotype 1 infection, either naïve or non-responders to previous IFN-based therapy