The Only FDA-Approved DAA With a Demonstrated Safety Profile for Both Acute and Chronic HCV1
AI-generated imagery. Not real patients.
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).1
A Demonstrated Safety Profile
Discontinuation Rates Due to Adverse Reactions1
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 treated for 8 weeks.
Adverse Reactions: Acute HCV1
- The most commonly reported adverse reactions were 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 HCV1
- The most commonly reported adverse reactions (≥5%) were 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.1
In the Acute HCV Trial, ALT Levels Improved or Stayed the Same for Most Participants1,2,a
All participants with baseline ALT >3x ULN improved from baseline by the final treatment visit. At baseline, 49% of participants had ALT elevations >3x ULN.1
No participant experienced exacerbation of HCV-associated hepatitis.1,2
No participant experienced hepatic decompensation or hepatic failure during the study.1
aBased on a total of 282 participants from the ITT population (n=286) with available laboratory results.1,2
Safety Considerations1
Postmarketing cases of hepatic decompensation/failure, some fatal, have been reported in patients treated with HCV NS3/4A protease inhibitor–containing regimens, including MAVYRET. The median time to onset for MAVYRET was 27 days. The majority had moderate or severe hepatic impairment prior to initiating therapy, including some with compensated cirrhosis at baseline but with a prior decompensation event. Rare cases were reported in patients without cirrhosis or with compensated cirrhosis; many of these patients had evidence of portal hypertension. In patients with compensated cirrhosis or evidence of advanced liver disease, perform hepatic laboratory testing as clinically indicated; and monitor for signs and symptoms of hepatic decompensation such as the presence of jaundice, ascites, hepatic encephalopathy, and variceal hemorrhage. Discontinue MAVYRET in patients who develop evidence of hepatic decompensation/failure.