bsp;0/46 0/2 0/10 0/27 0/30
Relapse 1%
(2/195) 0/45 0/2 0/10 0/26 0/29
Other* 1%
(2/197) 7% (3/46) 0/2 0/10 0/27 0/30
GT=genotype; VF= virologic failure
* Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
14.3 Treatment-Naïve or PRS Treatment-Experienced Adults With HCV Genotype 1, 2, 4, 5, or 6 Infection With Compensated Cirrhosis
The efficacy of MAVYRET in subjects who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir (PRS) with genotype 1, 2, 4, 5 or 6 chronic hepatitis C virus infection with compensated cirrhosis (Child-Pugh A) was studied in the single-arm, open-label EXPEDITION-1 trial, which included 146 subjects treated with MAVYRET for 12 weeks.
Table 13. EXPEDITION-1: Efficacy in Treatment-Naïve and PRS Treatment-Experienced Adults With HCV Genotype 1, 2, 4, 5 or 6 Infection With Compensated Cirrhosis
MAVYRET 12 Weeks
(N=146)
Total
(all GTs)
(N=146) GT1
(N=90) GT2
(N=31) GT4
(N=16) GT5
(N=2) GT6
(N=7)
SVR12 99%
(145/146) 99%
(89/90) 100%
(31/31) 100%
(16/16) 100%
(2/2) 100%
(7/7)
Outcome for Subjects Without SVR12
On-treatment VF 0/146 0/90 0/31 0/16 0/2 0/7
Relapse <1% (1/144) 1% (1/88) 0/31 0/16 0/2 0/7
GT = genotype; VF = virologic failure
14.4 Treatment-Naïve or PRS Treatment-Experienced Adults With HCV Genotype 3 Infection Without Cirrhosis or With Compensated Cirrhosis
The efficacy of MAVYRET in subjects without cirrhosis or with compensated cirrhosis who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir (PRS) with genotype 3 chronic HCV infection was studied in ENDURANCE-3 and in SURVEYOR-2 Part 3.
ENDURANCE-3 was a partially-randomized, open-label, active-controlled trial in treatment-naïve subjects. Subjects were randomized (2:1) to either MAVYRET for 12 weeks or to the combination of sofosbuvir and daclatasvir for 12 weeks; subsequently the trial included a third non-randomized arm with MAVYRET for 8 weeks. The SVR12 data are summarized in Table 14. Due to numerically similar efficacy MAVYRET is recommended for 8 weeks for treatment-naïve genotype 3 subjects without cirrhosis, rather than 12 weeks [see Dosage and Administration (2.2)].
Table 14. ENDURANCE-3: Efficacy in Treatment-Naïve, HCV Genotype 3-Infected Subjects Without Cirrhosis
MAVYRET1
8 Weeks
(N=157) MAVYRET
12 Weeks*
(N=233) DCV+SOF
12 Weeks
(N=115)
SVR12 94.9% (149/157) 95.3% (222/233)* 96.5% (111/115)
Outcome for Subjects Without SVR12
On-treatment VF 1% (1/157) <1% (1/233) 0/115
Relapse 3% (5/150) 1% (3/222) 1% (1/114)
Other2 1% (2/157) 3% (7/233) 3% (3/115)
VF=virologic failure
1 MAVYRET 8 weeks was a non-randomized treatment arm.
2 Includes subjects who discontinued due to adverse event, lost to follow- |
