NOW APPROVED:
MAVYRET IS THE
FIRST AND ONLY
FDA-APPROVED DAA FOR
BOTH ACUTE AND CHRONIC HCV1
THE ONLY 8-WEEK PANGENOTYPIC CURE1*In treatment-naïve, non-cirrhotic and compensated cirrhotic HCV patients
Advance Elimination, One Patient at a Time
*Liver or kidney transplant recipients are not eligible for an 8-week regimen.
Cure = SVR12 (HCV RNA <LLOQ 12 weeks after the end of treatment).
THE ONLY FDA-APPROVED DAA FOR BOTH ACUTE AND CHRONIC HCV1
Acute HCV1,2
ITT
96%
Cure Rate (n=275/286)
0% on-treatment virologic failure (n=0/286)
0% relapse (n=0/286)
mITT
100%
Cure Rate (n=275/275)
Single-arm, open-label study of GT 1-4, TN, NC and CC adult participants with acute HCV treated for 8 weeks.
Chronic HCV1,3
ITT
98%
Cure Rate(n=1218/1248)
0.1% on-treatment virologic failure (n=1/1248)
0.6% relapse (n=7/1226)3
mITT
99%
Cure Rate(n=1218/1226)
Integrated, pooled analysis of GT 1-6, TN, NC and CC adult participants with chronic HCV treated for 8 weeks from 8 clinical trials.3
MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation.1
Curing HCV Can Start at the First Detectable Viral Load
Cure = SVR12 (HCV RNA <LLOQ 12 weeks after the end of treatment).
mITT population excludes participants who did not achieve SVR12 for reasons other than virologic failure.
Relapse = HCV RNA ≥LLOQ after end-of-treatment response among participants who completed treatment.
MAVYRET IS THE ONLY FDA-APPROVED DAA WITH A DEMONSTRATED SAFETY PROFILE FOR BOTH ACUTE AND CHRONIC HCV1
Discontinuation rates due to adverse reactions
0%
in Acute HCV(n=0/286)
Derived from a single-arm, open-label study of GT 1-4, TN, NC and CC adult participants with acute HCV for 8 weeks.
Adverse Reactions: Acute HCV
- Most common: fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%)
- No serious adverse reactions were observed
0.1%
in Chronic HCV(n=~2300)
Derived from 9 registrational phase 2 and 3 clinical trials of adult participants with chronic HCV treated for 8, 12, or 16 weeks.
Adverse Reactions: Chronic HCV
- Most common (>10%): headache (13%) and fatigue (11%)
- Most adverse reactions were mild in severity
- One participant experienced a serious adverse reaction
The overall safety profile in participants with acute HCV was similar to that observed in participants with chronic HCV.