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FUSION Study : SOF + RBV (12 vs 16 weeks) for HCV genotypes 2 and 3

This study compares the efficacy of a 12-week and 16-week treatment regimen of sofosbuvir (SOF) and ribavirin (RBV) for patients with HCV genotypes 2 and 3 who had no response to prior IFN-based therapy. Results show high SVR rates in genotype 2 patients without cirrhosis, but sub-optimal response rates in genotype 3 patients. Virologic resistance was not detected in non-responders. Rate of treatment discontinuation due to adverse events was low.

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FUSION Study : SOF + RBV (12 vs 16 weeks) for HCV genotypes 2 and 3

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  1. FUSION Study: SOF + RBV (12 vs 16 weeks)for HCV genotypes 2 and 3 • Design Randomisation 1 : 1* Blinded, active-control W12 W16 W24 W28 HCV genotype 2 or 3 No response to prior treatment with IFN-based regimen HCV RNA ≥ 10,000 IU/ml Compensated cirrhosis allowed N = 103 SVR12 SVR12 N = 98 * Randomisation was stratified on cirrhosis (presence vs absence) and genotype (2 vs 3) • SOF : 400 mg qd • RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg • Objectives • SVR ≥ 20% compared with historical control of 25%, 97% power • Difference of SVR > 20% between the 2 groups, 82% power Jacobson IM. NEJM 2013;368:1867-77 FUSION

  2. FUSION Study: SOF + RBV (12 vs 16 weeks)for HCV genotypes 2 and 3 Baseline characteristics and patient disposition * Excludedfromefficacyanalysis Jacobson IM. NEJM 2013;368:1867-77 FUSION

  3. FUSION Study: SOF + RBV (12 vs 16 weeks)for HCV genotypes 2 and 3 HCV RNA < 25 IU/ml SOF + RBV 12 weeks SVR12 by genotype and cirrhosis SOF + RBV 16 weeks W4 W12 W4 W12 • No cirrhosis • Cirrhosis No cirrhosis Cirrhosis During treatment Post treatment (SVR) Genotype 2 • Genotype 3 Jacobson IM. NEJM 2013;368:1867-77 FUSION

  4. FUSION Study: SOF + RBV (12 vs 16 weeks)for HCV genotypes 2 and 3 • Virologic breakthrough during treatment : none • Relapse in patients with HCV RNA < 25 IU/ml at end of completed treatment • 46/99 (46%) in 12W group vs 26/95 (27%) in 16W group • Multivariate analysis of factors associated with SVR12 • Resistance testing (sequencing) • 73 relapses : • No SOF-associated mutation (S282T) • 11 NS5B substitutions in > 2 subjects (no change in susceptibility to SOF) Jacobson IM. NEJM 2013;368:1867-77 FUSION

  5. FUSION Study: SOF + RBV (12 vs 16 weeks)for HCV genotypes 2 and 3 • Adverse events, N (%) Jacobson IM. NEJM 2013;368:1867-77 FUSION

  6. Summary In this phase III study, 12 or 16 weeks of treatment with SOF and RBV resulted in a SVR12 in 50 to 73% of patients with prior treatment failure In genotype 2, high response rates (SVR12 > 96%) were observed in patients with no cirrhosis ; those with cirrhosis had lower SVR12(60 to 78%) In genotype 3 infection, response rates were sub-optimal, whether patients had or not cirrhosis No virologic resistance was detected in patients who did not have a sustained virologic response The rate of premature discontinuation of treatment with SOF and RBV due to adverse events was low (1%) In conclusion, 12 weeks of treatment with SOF and RBV can be an effective option for patients with HCV genotype 2 infection who failed prior IFN-based therapy, in the absence of cirrhosis FUSION Study: SOF + RBV (12 vs 16 weeks)for HCV genotypes 2 and 3 Jacobson IM. NEJM 2013;368:1867-77 FUSION

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