TABLE 1

SVR12 in pooled analysis of phase 2 and 3 registrational studies with glecaprevir/pibrentasvir in the modified-ITT populationa

HCV GTSVR12 rate (%) by patient population, prior treatment experience, and treatment durationb
No cirrhosisCompensated cirrhosis
TN (8 wk)TE-PRS (8 wk)TN (12 wk)TE-PRS (12 wk)TE-PRS (16 wk)TN (12 wk)TE-PRS (12 wk)TE-PRS (16 wk)
1100 (245/245)99 (138/139)100 (241/241)100 (159/159)100 (69/69)97 (29/30)
2100 (172/172)91 (21/23)99 (167/167)100 (65/65)100 (26/26)100 (9/9)
395 (177/183)96 (258/261)90 (44/49)96 (21/22)100 (64/64)94 (48/51)
4100 (37/37)100 (7/7)100 (71/71)100 (40/40)100 (12/12)100 (8/8)
5100 (2/2)100 (22/22)100 (6/6)100 (2/2)
6100 (8/8)100 (2/2)100 (27/27)100 (4/4)100 (6/6)100 (1/1)
  • a Patients not achieving SVR12 for nonvirologic reasons such as premature study drugs discontinuation, missing SVR12 data, or reinfection were excluded in the modified-intent-to-treat analysis.

  • b Values in parentheses are the number of patients who achieved SVR12/total number of patients in the group. TE-PRS, treatment-experienced to peg-IFN plus RBV with or without sofosbuvir; TN, treatment-naive; —, patients with this HCV genotype were excluded from treatment for that duration, per enrollment criteria.