up, or subject withdrawal.
* Data for MAVYRET 12-week treatment is displayed to reflect the original randomized study design. The treatment difference (95% confidence interval) was -1.2% (-5.6, 3.1) between the randomized arms of MAVYRET 12 weeks and DCV + SOF 12 weeks.
SURVEYOR-2 Part 3 was an open-label trial randomizing PRS treatment-experienced subjects with genotype 3 infection without cirrhosis to 12- or 16-weeks of treatment. In addition, the trial eva luated the efficacy of MAVYRET in genotype 3 infected subjects with compensated cirrhosis in two dedicated treatment arms using 12-week (treatment-naïve only) and 16-week (PRS treatment-experienced only) durations. Among PRS treatment-experienced subjects treated with MAVYRET for 16 weeks, 49% (34/69) had failed a previous regimen containing sofosbuvir.
Table 15. SURVEYOR-2 Part 3: Efficacy in Treatment-Naïve or PRS Treatment-Experienced, HCV Genotype 3-Infected Adults Without Cirrhosis or With Compensated Cirrhosis
Treatment-Naïve
With Compensated
Cirrhosis PRS Treatment-Experienced
Without Cirrhosis or With
Compensated Cirrhosis
MAVYRET
12 Weeks
(N=40) MAVYRET
16 Weeks
(N=69)
SVR12 98% (39/40) 96% (66/69)
Outcome for Subjects Without SVR12
On-treatment VF 0/40 1% (1/69)
Relapse 0/39 3% (2/68)
Other* 3% (1/40) 0/69
SVR12 by Cirrhosis Status
Without Cirrhosis NA 95% (21/22)
With Compensated Cirrhosis 98% (39/40) 96% (45/47)
VF=virologic failure
* Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
14.5 Treatment-Naïve and PRS Treatment-Experienced Adults With CKD Stage 4 and 5 and Chronic HCV Infection Without Cirrhosis or With Compensated Cirrhosis
EXPEDITION-4 was an open-label, single-arm, multicenter trial to eva luate safety and efficacy in subjects with severe renal impairment (CKD Stages 4 and 5) with compensated liver disease (with and without Child-Pugh A cirrhosis). There were 104 subjects enrolled, 82% were on hemodialysis, and 53%, 15%, 11%, 19%, 1% and 1% were infected with HCV genotypes 1, 2, 3, 4, 5 and 6; respectively. Overall, 19% of subjects had compensated cirrhosis and 81% of subjects were non-cirrhotic; 58% and 42% of subjects were treatment-naïve and PRS treatment-experienced, respectively. The overall SVR12 rate was 98% and no subjects experienced virologic failure. The presence of renal impairment did not affect efficacy; no dose-adjustments were required during the trial.
14.6 Adults Who are NS5A Inhibitor or NS3/4A-Protease Inhibitor (PI)-Experienced, Without Cirrhosis or With Compensated Cirrhosis
MAGELLAN-1 was a randomized, multipart, open-label trial in 141 genotype 1- or 4-infected subjects who failed a previous regimen containing an NS5A inhibitor and/or NS3/4A PI. Part 1 (n=50) was a randomized trial exploring 12 weeks of glecaprevir 200 mg and pibrentasvir 80 mg, glecaprevir 300 mg and pibrentasvir 120 mg, with and without ribavirin (only data from glecaprevir 300 mg plus pibrentasvir 120 mg without ribavirin are included in these analyses). Part 2 (n=91) randomized genotype 1- or 4-infected subjects without cirrhosis or with compensated cirrhosis to 12- or 16-weeks of treatment with MAVYRET.
Of the 42 genot |
