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POWERFUL 8-WEEK EFFICACY
IN TN, NC AND CC PATIENTS1,10

CC = compensated cirrhotic, NC = non-cirrhotic, TN = treatment-naïve

Overall treatment-naïve efficacy

Proven 8-week efficacy in treatment-naïve patients without cirrhosis or with compensated cirrhosis1,2

98%

CURE RATE  (SVR12)

Based on an integrated pooled analysis of GT 1–6 TN, NC and CC patients across 8 clinical trials that included United States study locations (n=1218/1248, ITT)

SVR Range: 95%-99% (ITT)

0.1% on-treatment virologic failure (n=1/1248)


0.6% relapse (n=7/1226)

Safety Considerations

In patients with compensated cirrhosis (Child-Pugh A) or evidence of advanced liver disease such as portal hypertension, 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.

Cure = sustained virologic response (SVR12); HCV RNA <LL0Q at 12 weeks after the end of treatment.

Relapse = HCV RNA ≥LLOQ after end-of-treatment response among subjects who completed treatment.

ITT = intent-to-treat.

Treatment-naïve study design summaries
8-WEEK REAL-WORLD EVIDENCE

Results from 2 TRIO Health Network studies13,14

99%

CURE RATE
in Per Protocol Population

In GT 1–4 and 6, TN, NC (n=537/540) and TN, CC (n=70/71) patients treated for 8 weeks. ITT population: 96% cure rate (SVR12) across GT 1–4 and 6 TN, NC (N=537/560) and TN, CC (n=70/73) patients treated for 8 weeks.

PP = The per protocol population excludes patient from the ITT population with non-virologic failure.

Reasons for discontinuation were medical care unrelated to treatment, patient choice, MD choice, insurance denial/positive drug or alcohol screening, and side effects. Data are insufficient to determine whether side effects are related or unrelated to treatment.

Real-world data are observational in nature, may be prospectively or retrospectively collected, and are not based on controlled clinical studies. Results from these cohorts may differ from those observed in clinical practice and are not presented in the MAVYRET Prescribing Information.

Bar graph depicting 99% cure rate 8-Week real-world evidence Bar graph depicting 99% cure rate 8-Week real-world evidence Bar graph depicting 99% cure rate 8-Week real-world evidence
Methodology13,14
Overall treatment-naïve efficacy by genotype

High cure rates in 8 weeks across all genotypes1,2

Based on an integrated pooled analysis of GT 1–6 TN, NC and CC patients across 8 clinical trials
that included United States study locations (n=1218/1248, ITT)

SVR12 by GENOTYPE (mITT)

100% (n=573/573) GT 1 100% (n=226/226) GT 2 97% (n=267/274) GT 3 100% (n=63/63) GT 4 95% (n=19/20) GT 5 100% (n=70/70) GT 6

The efficacy of MAVYRET in subjects with GT 3b infection was evaluated in 2 trials conducted in China, Singapore, and South Korea. Across both trials, subjects with GT 3b infection had a numerically lower SVR12 rate. GT 3b is uncommon in the US (<1% of HCV GT 3 infections).

mITT = modified intent-to-treat excluding non-virologic failure

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OVERALL TREATMENT-NAÏVE EFFICACY BY SUBPOPULATION

High cure rates in 8 weeks across multiple subpopulations1,2

Person Icon
OVERALL TREATMENT-NAÏVE EFFICACY BY SUBPOPULATION

High cure rates in 8 weeks across multiple subpopulations1,2

PWID1,15
MAT1,15
CC1,7
PEDS1,16
Renal/PPI/HIV1,2
Other traits2

What could an 8-week cure mean for
you and your patients?

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with 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 12 years and older or weighing at least 45 kg 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.

 

IMPORTANT SAFETY INFORMATION1

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 post-treatment 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

US-MAVY-190705

References and glossary

IMPORTANT SAFETY INFORMATION1

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

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older...

IMPORTANT SAFETY INFORMATION1

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

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older...

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with 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 12 years and older or weighing at least 45 kg 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.

 

IMPORTANT SAFETY INFORMATION1

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 post-treatment 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

US-MAVY-190705