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HIGH CURE RATES ACHIEVED WITH THE ONLY 8-WEEK PANGENOTYPIC TREATMENT1

 

 

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

Overall treatment-naïve efficacy

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

98%

CURE RATE  (SVR12)

Integrated pooled analysis of GT 1–6 non-cirrhotic and compensated cirrhotic patients (n=1218/1248, ITT, across 8 clinical trials)

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.

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

Treatment-naïve study design summaries
Overall treatment-naïve efficacy by genotype

High cure rates in 8 weeks across all genotypes with MAVYRET1,2

 

SVR12 by GENOTYPE (mITT)
mITT = modified intent-to-treat excluding non-virologic failure

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
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Overall treatment-naïve efficacy by subgroup

High cure rates in 8 weeks across multiple subgroups1,2

 

POOLED ANALYSIS: SVR12 BY SUBGROUP (mITT)

Safety Consideration: The most common adverse reactions (≥5% prevalence) in HCV-infected adults with severe renal impairment were pruritus (17%), fatigue (12%), nausea (9%), asthenia (7%), and headache (6%).

Safety Consideration: MAVYRET is contraindicated with atazanavir and not recommended with darunavir, lopinavir, ritonavir, or efavirenz.

Safety Consideration: No buprenorphine/naloxone or methadone dosage adjustment is required when used concomitantly with MAVYRET. There is insufficient information to make a recommendation regarding the concomitant use of naltrexone with MAVYRET.

Additional Consideration: AASLD-IDSA guidelines recommend abstinence from alcohol and, when appropriate, interventions to facilitate cessation of alcohol consumption should be advised for all persons with HCV infection.

*Alcohol use was self-reported at the time of screening. Patients were categorized as drinker, ex-drinker or non-drinker. Recent (within 6 months prior to study drug administration) history of alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator were excluded.

Treatment-Naïve Compensated Cirrhotic Data

8-week duration is indicated for TN, CC patients1

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CURE RATE  (SVR12)

In GT 1–6 treatment-naïve, compensated cirrhotic patients

0% on-treatment virologic failure (n=0/343)


0.3% relapse (n=1/336)

PP = Per-protocol analysis which excludes patients from the intent-to-treat (ITT) population with virologic breakthrough or discontinuation prior to week 8, and those missing data in the SVR12 window.

Safety Considerations
  • 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.
  • 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.
Study Design and SVR by Genotype

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