Table 1.: Summary of major Trials leading to the FDA approval of Sofosbuvir; NEUTRINO, FISSION, POSITRON, FUSION, VALENCE Trials [25-28].

Study Patients Treatment Regimen Overall SVR
NEUTRINO GT1, 4, 5 or 6 treatment naive SOF + Peg-IFNα+ RBV (12 weeks) (n=327) 90% (295/327)
FISSION GT2&3 treatment naive SOF + RBV (12 weeks) (n=256) 67% (171/256)
Peg-IFNα + RBV (24 weeks) (n=243) 67% (162/243)
POSITRON GT2&3 Peg-IFNα intolerant SOF + RBV (12 weeks) (n=207) 78% (161/207)
FUSION GT2&3 previously treated SOF + RBV (12 weeks) (n=103) 50% (51/103)
SOF + RBV
(16 weeks) (n=98)
71% (70/98)
VALENCE GT2&3 treatment naive and previously treated Genotype 2 SOF + RBV (12 weeks) (n=73) 93% (68/73)
Genotype 3 SOF + RBV (24 weeks) (n=250) 84% (210/250)