NOW
APPROVED

8-WEEK TREATMENT DURATION FOR MORE PATIENTS¹

Including GT 1–6 TN, CC

8 WEEKS:
THE SHORTEST ROUTE TO CURE

ONLY MAVYRET OFFERS A PANGENOTYPIC 8‑WEEK DURATION FOR TN HCV PATIENTS

Liver or kidney transplant recipients are not eligible for an 8-week regimen.
Cure = sustained virologic response (SVR12); HCV RNA <LLOQ at 12 weeks after the end of treatment.

EFFICACY >

SAFETY >

ACCESS >

ELIGIBILITY

Based on a Nationwide Physician Chart Audit, (n=3,646).

98% OF TREATMENT-NAÏVE PATIENTS MAY BE ELIGIBLE FOR 8 WEEKS OF TREATMENT²

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 and rifampin.

METHODOLOGY

OVERALL EFFICACY: TN

PROVEN 8-WEEK EFFICACY IN TREATMENT-NAÏVE PATIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS^1,3

98%

Cure Rate (SVR12)

In 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)

TN STUDY DESIGN SUMMARIES

Endurance 1^1,4	Randomized, open-label, Phase 3 study in GT 1 TN or PRS‑experienced NC subjects with or without HIV‑1 coinfection (N=703). Subjects received MAVYRET for 8 or 12 weeks. Primary endpoints: SVR12 in the 12‑week ITT‑PS population (ITT population excluding patients with HIV coinfection and patients with SOF experience); SVR12 in 8‑week vs 12‑week arm in the ITT‑PS and per‑protocol ITT‑PS populations (“per‑protocol” excludes patients with premature discontinuation or virologic failure prior to Week 8 and missing data in the SVR12 window).
Endurance 3^1,4	Partially randomized, open-label, active-controlled, Phase 3 study in GT 3 TN, NC subjects (N=505). Subjects received MAVYRET for 8 or 12 weeks vs SOF + DCV for 12 weeks. Primary endpoints: demonstrate noninferiority in the percentage of subjects achieving SVR12 with 12 weeks of MAVYRET to 12 weeks of SOF + DCV and demonstrate noninferiority of 8 weeks vs 12 weeks of MAVYRET.
Endurance 5,6^1,5	Single-arm, open-label, Phase 3b study in GT 5–6, TN or PRS‑experienced, NC or CC subjects (N=84). Subjects received MAVYRET for 8 or 12 weeks. Primary endpoint: SVR12.
EXPEDITION 2^1,6	Non-randomized, open-label, Phase 3 study in GT 1–6/HIV‑1 coinfected, TN or PRS‑experienced, NC or CC and antiretroviral therapy (ART) naïve or on a stable ART regimen subjects (N=153). Subjects received MAVYRET for 8 and 12 weeks. Treatment-experienced GT 3‑infected patients were excluded. Primary endpoint: SVR12.
EXPEDITION 5⁷	Non-randomized, open-label, Phase 3b study in GT 1–6 TN or PRS‑experienced, NC or CC subjects with chronic kidney disease stage 3b, 4, or 5 (N=101). Treatment‑experienced GT 3‑infected patients were excluded. Subjects received MAVYRET for 8, 12, or 16 weeks. Primary endpoint: SVR12.
EXPEDITION 8^1,8	Single-arm, open-label, Phase 3b study in GT 1–6 TN, CC subjects (N=343) who received MAVYRET for 8 weeks. Primary endpoint: SVR12 vs historical (historical rate based on 99% ITT and 100% per‑protocol [PP] SVR12 rate of 12 weeks of MAVYRET in GT 1–6 TN/CC patients) and noninferiority margin (6%; the lower 95% CI bound of the SVR12 ITT rate must be >93%) in PP and ITT populations. PP excludes patients from the ITT population with virologic breakthrough or discontinuation prior to Week 8, and those missing data in the SVR12 window.
Surveyor 1^9,10	Open-label, 2-part, Phase 2 study in GT 1, 4–6 TN or PRS‑experienced, NC or CC subjects (N=174). Part 2: Subjects received MAVYRET for 8 or 12 weeks. Primary endpoint: SVR12.
Surveyor 2^1,11-13	Randomized, open-label, 4‑part, Phase 2 study in GT 2–6 TN or PRS‑experienced NC or CC subjects (N=691). In Part 2 & 4 subjects received MAVYRET for 8 or 12 weeks. Primary endpoints: SVR12 and noninferiority of SVR12 for GT 2 (Part 4) to historical control with 12 weeks of SOF + RBV.

NEW

8-WEEK TN, CC DATA

8-WEEK TREATMENT DURATION IS NOW APPROVED FOR EVEN MORE PATIENTS¹

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)

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 & SVR12 by GT

SAFETY PROFILE

DEMONSTRATED SAFETY PROFILE IN NC AND CC PATIENTS¹

0.1%

OVERALL DISCONTINUATION
RATE DUE TO ADVERSE REACTIONS¹

DERIVED FROM 9 REGISTRATIONAL
PHASE 2 AND 3 CLINICAL TRIALS

Most adverse reactions were mild in severity

The most common adverse reactions >10% prevalence were headache (13%) and fatigue (11%)

One subject experienced a serious adverse reaction

The type and severity of adverse reactions in subjects with compensated cirrhosis were similar to those seen in subjects without cirrhosis¹

ACCESS LANDSCAPE

MAVYRET HAS BROAD FORMULARY COVERAGE¹⁴

MAVYRET has preferred formulary status on the majority of national commercial health plans

MAVYRET has preferred formulary status on the majority of state Medicaid plans

MAVYRET has preferred formulary status on the majority of Medicare Part D Plans

COST

LEARN ABOUT MAVYRET’S OUT-OF-POCKET COST^16-18

With MAVYRET your patients may pay:

As little as $5 per month with commercial insurance
Most patients with commercial insurance pay as little as $5 per month with their MAVYRET co-pay card.*

$8 or less per month with Medicaid
Patients on Medicaid can have out‑of‑pocket costs of $8 or less, depending on state plan.

With Medicare Part D
Monthly out-of-pocket costs for MAVYRET may vary depending on patient’s other medication costs. Most Medicare patients have Standard Part D prescription coverage, which has different costs depending on deductibles and coverage gaps.

Call 1-877-MAVYRET (877-628-9738) to get the out-of-pocket costs for specific patients.

Important Details About Understanding Patient’s Individual Costs: The chart above provides cost information based on what a person with the type of coverage listed may pay for a 4-week supply of MAVYRET. A patient's type of health or prescription insurance plan will determine exactly how much a patient will pay.

*TERMS AND CONDITIONS

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

REFERENCES:

MAVYRET [package insert]. North Chicago, IL: AbbVie Inc; 2019.
Data on file, AbbVie Inc. ABVRRTI69094.
Zeuzem S, Foster GR, Wang S, et al. Glecaprevir–pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018;378(4):354-369.
Asselah T, Lee SS, Yao BB, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infections (ENDURANCE-5,6): an open-label, multicenter, phase 3b trial. Lancet Gastroentrol Hepatol. 2019;4(1):45-51.
Rockstroh JK, Lacombe K, Viani RM, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study. Clin Infec Dis. 2018;67(7):1010-1017.
Persico M, Flisiak R, Abunimeh M, et al. Efficacy and safety of glecaprevir/pibrentasvir in renally-impaired patients with chronic HCV genotype 1–6 infection. Poster presented at: 53rd Annual Meeting of the European Association for the Study of the Liver (EASL); April 11–15, 2018; Paris, France.
Brown RS, Hezode C, Wang S, et al. Preliminary efficacy and safety of 8-week glecaprevir/pibrentasvir in patients with HCV genotypes 1-6 infection and compensated cirrhosis: the EXPEDITION-8 study. Oral presentation at: 69th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); November 9–13, 2018; San Francisco, CA.
Kwo PY, Poordad F, Asatryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis. J Hepatol. 2017;67(2):263-271.
Gane E, Poordad F, Wang S, et al. High efficacy of ABT-493 and ABT-530 treatment in patients with HCV genotype 1 or 3 infection and compensated cirrhosis. Gastroenterology. 2016;151(4):651-659.e1.
Data on file, AbbVie Inc. ABVRRTI64729.
Kwo PY, Wyles DL, Wang S, et al. 100% SVR12 with ABT-493 + ABT-530 with or without ribavirin in treatment-naïve HCV genotype 3-infected patients with cirrhosis. Poster presented at: 51st Annual Meeting of the European Association for the Study of the Liver (EASL); April 13–17, 2016; Barcelona, Spain.
Hassanein T, Wyles D, Wang S, et al. SURVEYOR-II, Part 4: glecaprevir/pibrentasvir demonstrates high SVR rates in patients with HCV genotype 2, 4, 5, or 6 infection without cirrhosis following an 8-week treatment duration. Poster presented at: 52nd Annual Meeting of the European Association for the Study of the Liver; April 19–23, 2017; Amsterdam, the Netherlands.
Data on file, AbbVie Inc. Source: Managed Markets Insight & Technology, LLC MMIT Analytics™ as of September 2019.
Data on file, AbbVie Inc. IQVIA National Prescription Audit (NPA) week ending 1/5/2018 to week ending 8/30/2019, Weekly Sales Perspective (WSP) and Longitudinal Prescription Claims (LRx) week ending 12/29/2017 to week ending 8/23/2019. September 2019. IQVIA, all rights reserved.
Kaiser Family Foundation. Premium and cost-sharing requirements for selected services for Medicaid adults. https://www.kff.org/health-reform/state-indicator/premium-and-cost-sharing-requirements-for-selected-services-for-medicaid-expansion-adults/. Updated January 1, 2019. Accessed September 17, 2019.
Medicare.gov. Find your level of extra help (Part D). https://www.medicare.gov/your-medicare-costs/get-help-paying-costs/find-your-level-of-extra-help-part-d. Accessed September 17, 2019.
Data on file. AbbVie Inc. Standard Part D patient out-of-pocket design. 2019.

GLOSSARY OF TERMS:

CC=compensated cirrhosis
DCV=daclatasvir
GT=genotype
HCV=hepatitis C virus
ITT=intent-to-treat
LLOQ=lower limit of quantification
mITT=modified intent-to-treat
NC=non-cirrhotic
PRS-experienced=prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an NS5A inhibitor or HCV NS3/4A protease inhibitor
RBV=ribavirin
RNA=ribonucleic acid
SOF=sofosbuvir
SVR12=sustained virologic response 12 weeks after the end of treatment
TN=treatment‑naïve

INDICATION¹

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

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

INDICATION¹

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

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

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

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

8-WEEK TREATMENT DURATION FOR MORE PATIENTS1

98% OF TREATMENT-NAÏVE PATIENTS MAY BE ELIGIBLE FOR 8 WEEKS OF TREATMENT2

PROVEN 8-WEEK EFFICACY IN TREATMENT-NAÏVE PATIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS1,3

8-WEEK TN, CC DATA

8-WEEK TREATMENT DURATION IS NOW APPROVED FOR EVEN MORE PATIENTS1

DEMONSTRATED SAFETY PROFILE IN NC AND CC PATIENTS1

MAVYRET HAS BROAD FORMULARY COVERAGE14

LEARN ABOUT MAVYRET’S OUT-OF-POCKET COST16-18

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

8-WEEK TREATMENT DURATION FOR MORE PATIENTS¹

98% OF TREATMENT-NAÏVE PATIENTS MAY BE ELIGIBLE FOR 8 WEEKS OF TREATMENT²

PROVEN 8-WEEK EFFICACY IN TREATMENT-NAÏVE PATIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS^1,3

8-WEEK TREATMENT DURATION IS NOW APPROVED FOR EVEN MORE PATIENTS¹

DEMONSTRATED SAFETY PROFILE IN NC AND CC PATIENTS¹

MAVYRET HAS BROAD FORMULARY COVERAGE¹⁴

LEARN ABOUT MAVYRET’S OUT-OF-POCKET COST^16-18

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹