Identifying people living with HCV

In the United States alone, 2.3 million adults are infected with the hepatitis C virus²

HCV is largely asymptomatic

Most people with chronic HCV infection have nonspecific symptoms such as chronic fatigue and depression³

~40^%

may not know they're infected⁴

75%-85%

of patients will
develop chronic infection

10%-20%

will develop cirrhosis
over a period of 20-30 years

Prevalence trends: baby boomers and new cases of HCV

~1/2 of individuals with
HCV are baby boomers⁵
(born between 1945 and 1965)

New HCV infections are rapidly increasing among^6,7:

New HCV infections are rapidly increasing among patients from ages 20 to 39, Caucasian females and males, those living in rural areas and injection drug users.

Who should be tested for HCV?

AASLD & IDSA Guideline recommendations for hepatitis C testing⁸:

RECOMMENDATIONS
One-time, routine, opt-out HCV testing is recommended for all individuals aged 18 years and older.
One-time HCV testing should be performed for all persons less than 18 years old with behaviors, exposures, or conditions or circumstances associated with an increased risk of HCV infection (see below).
Periodic repeat HCV testing should be offered to all persons with behaviors, exposures, or conditions or circumstances associated with an increased risk of HCV exposure (see below).
Annual HCV testing is recommended for all persons who inject drugs and for HIV-infected men who have unprotected sex with men.

Risk behaviors⁸:

Injection drug use (current or ever, including those who injected only once)

Intranasal illicit drug use

Men who have sex with men

Risk exposures⁸:

Persons on long-term hemodialysis (ever)

Healthcare, emergency medical, and public safety workers after needlestick, sharps, or mucosal exposure to HCV-infected blood

Persons with percutaneous/parenteral exposures in an unregulated setting

Persons with percutaneous/parenteral exposures in an unregulated setting

Healthcare, emergency medical, and public safety workers after needlestick, sharps, or mucosal exposure to HCV-infected blood

Children born to HCV-infected women

Prior recipients of a transfusion or organ transplant, including persons who:

- Were notified that they received blood from a donor who later tested positive for HCV

- Received clotting factor concentrates produced before 1987

- Received a transfusion of blood or blood components, or underwent an organ transplant before July 1992

Persons who were ever incarcerated

Risk conditions and circumstances⁸:

HIV infection

Unexplained chronic liver disease including elevated alanine aminotransferase (ALT) levels

Sexually active persons about to start pre-exposure prophylaxis (PrEP) for HIV

Solid organ donors (living and deceased) and solid organ transplant recipients

Refer to AASLD/IDSA guidelines for further details.

CDC recommendations for HCV testing⁹

Recommended testing sequence for identifying current HCV infection

^*For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended. For persons who are immunocompromised, testing for HCV RNA can be considered.

^†To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be considered. Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.

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INDICATION¹

MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older 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 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.

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

MAVYRET [package insert]. North Chicago, IL; AbbVie lnc.; 2020.
Rosenberg ES, Rosenthal EM, Hall EW, et al. Prevalence of hepatitis C virus infection in US States and the District of Columbia, 2013 to 2016. JAMA Netw Open. 2018;1(8):e186371. doi:10.1001/jamanetworkopen.2018.6371
Hepatitis C questions and answers for health professionals. Centers for Disease Control and Prevention. Updated July 2, 2019. Accessed November 26, 2019. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm
Ryerson AB, Schillie S, Barker LK, Wester C. Vital signs: newly reported acute and chronic hepatitis C cases - United States, 2009-2018. MMWR. 2020;69(14):399-404
USA HCV RNA-positive patient age data. MappingHepC website. AbbVie Inc. Accessed February 6, 2020.
Viral Hepatitis Surveillance–United States 2017. Centers for Disease Control and Prevention website. https://www.cdc.gov/hepatitis/statistics/2017
surveillance/pdfs/2017HepSurveillanceRpt.pdf. Published 2017. Updated November 14, 2019. Accessed March 11, 2020.
Zibbell JE, Iqbal K, Patel RC, et al. Increases in hepatitis C virus infection related to injection drug use among persons aged ≤30 years — Kentucky, Tennessee, Virginia, and West Virginia, 2006–2012. MMWR. 2015;64(17):453-458.
American Association for the Study of Liver Diseases and the Infectious Disease Society of America. HCV guidelines: recommendations for testing, managing, and treating hepatitis C. HCV guidelines. Updated November 6, 2019. Accessed July 30, 2020. https://www.hcvguidelines.org
Centers for Disease Control and Prevention. Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR. 2013;62(18):362-365.

GLOSSARY OF TERMS
AASLD = American Association for the Study of Liver Diseases
APRI = (AST) to platelet ratio index
AUC = area under the curve
BMI = body mass index
CC = compensated cirrhotic
Cure = sustained virologic response (SVR12); HCV RNA <LLOQ at 12 weeks after the end of treatment
DAA = direct-acting antiviral
DCV = daclatasvir
DOD = Department of Defense
F-score = Fibrosis score, F-score restrictions refer to minimum METAVIR fibrosis scores from biopsy (or equivalent quantitative results from approved non-invasive diagnostics such as FibroScan® or FibroTest™) that are required for Medicaid eligibility for HCV treatment. FO = no fibrosis, F1 = portal fibrosis without septa (mild), F2 = portal fibrosis with few septa (moderate), F3 = numerous septa without cirrhosis, F4 = cirrhosis.
FIB-4 = Fibrosis-4
GT = genotype
HBV = hepatitis B virus
HCV = hepatitis C virus
HIV = human immunodeficiency virus
IDSA = Infectious Diseases Society of America
INR = international normalized ratio
ITT = intent-to-treat
KG = kilogram
LLOQ = lower limit of quantification
MAT = medication-assisted treatment
mITT = modified intent-to-treat
NC = non-cirrhotic
NS3/4A = nonstructural proteins 3 and 4A
NS5A = nonstructural protein 5A
PI = protease inhibitor
PP = per-protocol
PPI = proton pump inhibitor
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
PS = primary subset
PWID = people who inject drugs
RBV = ribavirin
Relapse = HCV RNA ≥LLOQ after end-of-treatment response among those who completed treatment
RNA = ribonucleic acid
SOF = sofosbuvir
SVR = sustained virologic response
SVR12 = sustained virologic response 12 weeks after the end of treatment
TN = treatment-naïve
VA = Veterans Affairs

FibroTest^™ is a trademark of BioPredictive.
S.A.S. FibroScan^® is a registered trademark of Echosens^™ North America.

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

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

US-MAVY-190705

Identifying people living with HCV

In the United States alone, 2.3 million adults are infected with the hepatitis C virus2

HCV is largely asymptomatic

AASLD & IDSA Guideline recommendations for hepatitis C testing8:

RECOMMENDATIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

In the United States alone, 2.3 million adults are infected with the hepatitis C virus²

AASLD & IDSA Guideline recommendations for hepatitis C testing⁸:

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹