The ONLY 8-WEEK Pangenotypic Cure for Your TN, NC and CC Patients With HCV^1,a

Cure = SVR12 (HCV RNA <LLOQ 12 weeks after the end of treatment).

^aLiver or kidney transplant recipients are not eligible for an 8-week regimen.

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). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.¹

Demonstrated Efficacy Across the Patients You Treat Today^a

AI-generated imagery. Not real patients.

Real-World Effectiveness in the Largest MAVYRET Meta-Analysis¹⁰

99%

Cure Rate¹⁰

(n=3657, mITT SVR12)
In GT 1-4, TN, NC patients

Of 12,531 patients treated with MAVYRET across 18 studies, 3,657 were clearly characterized as TN, NC and treated for 8 weeks according to label.¹⁰

SVR12 (HCV RNA <LLOQ 12 weeks after the end of treatment).¹

METHODOLOGY¹⁰

Real-world studies reporting SVR12 in adults with chronic HCV infection treated with MAVYRET were identified in journal publications from January 1, 2017, to February 25, 2019, and congress presentations through April 14, 2019. Data from a total of 12,531 patients across 18 studies (7 from Europe, 6 from Japan, 3 from the United States, and 2 multicountry) were included in this random-effects meta-analysis. Nine of the studies included SVR12 data from 3657 patients (mITT population) who were clearly characterized as TN, NC, and who had received on-label treatment with MAVYRET for 8 weeks. The mITT population included the ITT population (ie, patients treated with MAVYRET who had SVR12 data available, discontinued early, or were lost to follow-up) and excluded those with nonvirologic failure.

LIMITATIONS¹⁰

These real-world studies are retrospective, are observational in nature, and are not in the MAVYRET Prescribing Information. Results of these cohorts may differ from those observed in clinical practice, and the included studies may have differed in regard to their study design and patient characteristics. The level of detail reported across the individual studies was inconsistent, particularly with mITT reporting of SVR12 rates. Insufficient data were available to analyze SVR12 rates in patients with HCV GT 5 or GT 6 infection. The reporting of safety information in this analysis varied widely by study design and data availability. Please refer to MAVYRET’s full Prescribing Information for clinical study safety.

INDICATION¹

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and posttreatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

CONTRAINDICATIONS

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.
MAVYRET is contraindicated with atazanavir or rifampin.

WARNINGS AND PRECAUTIONS

Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease

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.

Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Certain Drugs

Carbamazepine, efavirenz, and St. John’s Wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.

ADVERSE REACTIONS

Most common adverse reactions observed with MAVYRET:

>10% of subjects: headache and fatigue

MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir.

US-MAVY-250347

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection

INDICATION¹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

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.
MAVYRET is contraindicated with atazanavir or rifampin.

WARNINGS AND PRECAUTIONS

Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease

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.

Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Certain Drugs

Carbamazepine, efavirenz, and St. John’s Wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.

ADVERSE REACTIONS

Most common adverse reactions observed with MAVYRET:

>10% of subjects: headache and fatigue

MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir.

US-MAVY-250347

The ONLY 8-WEEK Pangenotypic Cure for Your TN, NC and CC Patients With HCV1,a

Demonstrated Efficacy Across the Patients You Treat Todaya

Real-World Effectiveness in the Largest MAVYRET Meta-Analysis10

INDICATION1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

INDICATION1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The ONLY 8-WEEK Pangenotypic Cure for Your TN, NC and CC Patients With HCV^1,a

Demonstrated Efficacy Across the Patients You Treat Today^a

Real-World Effectiveness in the Largest MAVYRET Meta-Analysis¹⁰

INDICATION¹

INDICATION¹