The Only FDA-Approved DAA with a Demonstrated Safety Profile for Both Acute and Chronic HCV1

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 treated 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.

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 visit1

At baseline, 49% of participants had ALT elevations >3x ULN.

aBased on a total of 282 participants from the ITT population (n=286) with available laboratory results.

Safety Considerations
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.1

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