Mark S. Sulkowski, MD, Sarah Kattakuzhy, MD, and Brittany G. Yerkes, PA-C, prepared useful practice aids pertaining to hepatitis C and substance use disorder for this CME/MOC/CE/CPE activity titled "Addressing the Evolving Opioid and HCV Epidemics Through Community Engagement and Education." For the full presentation, monograph, complete CME/MOC/CE/CPE information, and to apply for credit, please visit us at http://bit.ly/2z9EyRv. CME/MOC/CE/CPE credit will be available until November 29, 2019.
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Addressing the Evolving Opioid and HCV Epidemics Through Community Engagement and Education
1. This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Pharmaceutical Company Patient
Assistance and Cost-Sharing Assistance
Programs: HCV1
PRACTICE AID
Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through Community Engagement and
Education,âat www.peerview.com/QYB40.
a
Effective July 1, 2015, patients who are insured and who do not meet their payerâs coverage criteria will no longer be eligible for support via Gileadâs patient assistance program. This includes clients whose insurer has limited access based on: fibrosis score;
step-therapy; or clinical criteria (eg, drug and alcohol testing). b
Effective May 18, 2016, patients who are insured and who do not meet their payerâs coverage criteria will no longer be eligible for support via Merckâs patient assistance program. This includes
clients whose insurer has limited access based on: fibrosis score; step-therapy; or clinical criteria (eg, drug and alcohol testing).
Company Contact Information Drugs Covered Eligibility
AbbVie
855-687-7503
www.viekirahcp.com
Mavyret and Viekira XR
500% FPL or <$100,000
annual household income
Bristol-Myers
Squibb
800-736-0003
www.bmspaf.org
Daklinza 300% FPL
Gilead Sciencesa 855-769-7284
www.mysupportpath.com
Epclusa, Harvoni, Sovaldi,
and Vosevi
500% FPL or <$100,00
annual household income
Merck and Co.b 866-251-6013
www.merckhelps.com
Zepatier 500% FPL
What is a Patient Assistance Program?
A patient assistance program is a program run through pharmaceutical companies to provide free or low-cost
medications to people with low-incomes who do not qualify for any other insurance or assistance programs, such as
Medicaid, Medicare, or AIDS Drug Assistance Programs. Each individual company has different eligibility criteria for
application and enrollment in their patient assistance program.
Pharmaceutical Company Patient Assistance Programs
2. Pharmaceutical Company Patient
Assistance and Cost-Sharing Assistance
Programs: HCV1
PRACTICE AID
Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through Community Engagement and
Education,âat www.peerview.com/QYB40.
FPL: federal poverty level.
1. https://www.nastad.org/sites/default/files/Uploads/2018/hepatitis-and-paps-caps-resource-document-61318.pdf. Accessed November 19, 2018.
What is a Cost-Sharing Assistance Program?
A cost-sharing assistance program is a program run through pharmaceutical companies to offer cost-sharing assistance (including
deductibles, copayments, and coinsurance) to people with private health insurance to obtain viral hepatitis drugs at the pharmacy.
Company Contact Information Drugs Covered Assistance Renewal
AbbVie
844-277-6233 or
844-865-8725
www.viekira.com
www.mavyret.com
Mavyret and
Viekira XR
Individuals cannot have federally-funded
prescription coverage. Individuals pay the
first $5 and then receive up to a maximum
of 25% of the catalog price for
their medication prescription.
Card expires 12 months
after initial use. Reapply
if additional prescriptions
are needed.
Bristol-Myers
Squibb
844-442-6663
www.patientsupportconnect.com
Daklinza
The program provides participants with a
copayment card that covers costs up to $5,000
per 28-day supply of 30 mg or 60 mg Daklinza
or up to $10,000 per 28-day supply of 90 mg
Daklinza for people who have private insurance.
Card expires at the end
of each calendar year.
Automatic renewal for
patients with an active
Daklinza prescription.
Gilead
Sciences
855-769-7284
www.epclusa.com
www.harvoni.com
www.sovaldi.com
www.vosevi.com
Epclusa,
Harvoni,
Sovaldi,
and Vosevi
The copayment coupon program covers
up to a maximum of 25% of the catalog price
of a 12-week regimen of a Gilead HCV
medication (Epclusa, Harvoni, Sovaldi,
and Vosevi) after the payment of first $5 per
prescription fill. Offer is valid for 6 months
from the time of first redemption.
Reapply if another
regimen is later
needed.
Merck and
Co.
866-251-6013
www.zepatier.com
Zepatier
Participants pay the first $5 and then
receive savings of up to 25% of the catalog
price of Zepatier per prescription on up to
four prescriptions of 28 tablets each.
New coupon must be
obtained for every
four prescriptions.
Pharmaceutical Company Cost-Sharing Assistance Programs
3. Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through
Community Engagement and Educationâat www.peerview.com/QYB40.
Resources for People Living
With HCV1
PRACTICE AID
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Chronic Disease Fund
The Chronic Disease Fundâs (www.mygooddays.org) copayment and medication assistance
program provides financial assistance to eligible individuals.
HealthWell Foundation
The HealthWell Foundationâs (www.healthwellfoundation.org) copayment assistance program
provides up to $15,000 in financial assistance to eligible individuals for HCV treatment.
Eligible patients include those who are insured and have an annual household income of up
to 500% of the federal poverty level.
Needy Meds
Needy Meds (www.needymeds.org) offers resources that are helpful to uninsured and
underinsured patients, including an MRI/CAT scan discount program and medical bill mediation.
Patient Access Network Foundation
The Patient Access Network Foundation (www.panfoundation.org) offers help and hope to
people with chronic or life-threatening illnesses, including HIV and hepatitis, for whom cost
limits access to medical treatments.
Patient Advocate Foundation Copay Relief Program
The Patient Advocate Foundation Copay Relief Program (www.copays.org) provides direct
financial support to insured patients, including Medicare Part D beneficiaries, who financially
and medically need assistance paying prescription medication copayments, coinsurance,
and deductibles relative to their diagnosis.
RxOutreach
RxOutreach is (www.rxoutreach.org) a mail-order pharmacy for people with little to no health
insurance coverage.
Wells Specialty Pharmacy
Wells Specialty Pharmacy (www.wellsspecialtypharmacy.com) is a mail-order pharmacy that
provides specialty medications for HCV at affordable prices. They also offer a PAP and CAP
and can connect patients to manufacturer discount programs.
Foundations Providing Access to Care Assistance for People Living With Viral Hepatitis
4. Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through
Community Engagement and Educationâat www.peerview.com/QYB40.
Resources for People Living
With HCV1
PRACTICE AID
CAP: cost-assistance sharing program; CAT: computerized axial tomography; PAP: patient assistance program.
1. https://www.nastad.org/sites/default/files/Uploads/2018/hepatitis-and-paps-caps-resource-document-61318.pdf. Accessed November 19, 2018.
Clinical Trials
A service of the US National Institutes of Health, ClinicalTrials.gov is a registry and results
database of publicly and privately supported clinical studies of human participants
conducted around the world.
Fair Pricing Coalition
As part of their advocacy work, the Fair Pricing Coalition (www.fairpricingcoalition.org)
negotiates with companies to ensure that PAPs are adequately generous and easy to
apply for.
Health Insurance Marketplace
The official site of the Health Insurance Marketplace, Healthcare.gov, allows individuals
and families to sign up for insurance coverage through the Affordable Care Act.
Help-4-Hep
Help-4-Hep (www.help4hep.org) is a nonprofit, toll-free helpline for those with concerns
about HCV. Help-4-Hep can also help individuals access lower-cost testing for HCV.
Patient Advocate Foundation
The Patient Advocate Foundation (www.hepatitisc.pafcareline.org) hosts a âHepatitis C
CareLineâ devoted to all aspects of access to care, insurance denials, etc for patients and
providers. The hotline may be reached by calling 800-532-5274.
Treatment Action Group
Treatment Action Group (www.treatmentactiongroup.org) collaborates with activists,
community members, scientists, governments, and drug companies to make safer, more
effective, and less toxic treatment for viral hepatitis available.
HealthHCV
HealthHCV (healthhcv.org) designs and implements medical and consumer education and
training programs to improve the ability of organizations, professionals, and individuals to
address the needs of people living with viral hepatitis. HealthHCV's advocacy initiatives
focus on increasing the number of individuals aware of their HCV infection; improving
access to therapy for people living with chronic HCV infection; and building surveillance
and research capacity nationwide. HealthHCV is an initiative of HealthHIV, a national
healthcare nonprofit based in Washington, DC.
Additional Resources
5. Identification of HCV-Infected Persons
PRACTICE AID
Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through Community Engagement and
Education,âat www.peerview.com/QYB40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
a
Mentioned in guidelines but described as of uncertain need.
Risk Factor USPSTF1
CDC2
AASLD-IDSA3
Adults born during 1945-1965
Current or past injection drug use
Receipt of blood transfusion before 1992
Receipt of clotting factor concentrates produced before 1987
Organ transplant before July 1992
Long-term hemodialysis
Children born to HCV-positive women
Incarceration
Intranasal drug use a
Other noninjecting illegal drug use a
Receipt of an unregulated tattoo a
Other percutaneous exposures
Healthcare, emergency medical, and public safety workers after needle sticks,
sharps, or mucosal exposures to HCV-positive blood
HIV-infected
Persistently abnormal alanine aminotransferase (ALT)
Unexplained chronic liver disease and chronic hepatitis
Solid organ donors (deceased and living)
Sexually active persons about to start pre-exposure prophylaxis (PreP) for HIV
Persons with a history of multiple sex partners or sexually transmitted diseases a
Long-term steady sex partners of HCV-positive persons a
Recipients of transplanted tissue (eg, corneal, musculoskeletal, skin, ova, sperm) a
Hepatitis C Screening Recommendations Issued by the USPSTF, CDC, and AASLD-IDSA
6. Identification of HCV-Infected Persons
PRACTICE AID
Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through Community Engagement and
Education,âat www.peerview.com/QYB40.
Recommendations for Screening and Treatment of HCV Infection in PWID
RECOMMENDED RATING
Annual HCV testing is recommended for PWID with no prior testing or past negative testing and subsequent injection drug use.
Depending on the level of risk, more frequent testing may be indicated.
IIa, C
Substance use disorder treatment programs and needle/syringe exchange programs should offer routine, opt-out HCV-antibody
testing with reflexive or immediate confirmatory HCV-RNA testing and linkage to care for those who are infected.
IIa, C
PWID should be counseled about measures to reduce the risk of HCV transmission to others. I, C
PWID should be offered linkage to harm reduction services when available, including needle/syringe service programs and
substance use disorder treatment programs.
I, B
Active or recent drug use or a concern for reinfection is not a contraindication to HCV treatment. IIa, B
Recommendation for Testing for Reinfection in PWID
RECOMMENDED RATING
At least annual HCV-RNA testing is recommended for PWID with recent injection drug use after they have spontaneously cleared
HCV infection or have been successfully treated.
IIa, C
Key Populations: Identification and Management of HCV in People Who Inject Drugs (PWID)3
7. Identification of HCV-Infected Persons
PRACTICE AID
Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through Community Engagement and
Education,âat www.peerview.com/QYB40.
a
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. b
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.
AASLD-IDSA: American Association for the Study of Liver Disease and the Infectious Disease Society of America; CDC: Centers for Disease Control and Prevention; USPSTF: United States Preventive Services Task Force.
1. Moyer VA. Ann Intern Med. 2013;159:349-357. 2. Smith BD et al. MMWR Recomm Rep. 2012;61:1-32. 3. https://www.hcvguidelines.org/. Accessed November 19, 2018. 4. CDC. MMWR Morb Mortal Wkly Rep. 2013;62:362-365.
HCV
antibody
STOPa
Nonreactive
No HCV antibody
detected
HCV
RNANot detected
No current HCV
infection
Additional testing as
appropriateb
Detected
Link to care
Current HCV
infection
Reactive
Recommended Testing Sequence for Identifying Current HCV Infection4
8. Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through
Community Engagement and Educationâat www.peerview.com/QYB40.
Recommendations for the Initial
Treatment of HCV Infection1,a
PRACTICE AID
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Genotype 1a Without Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Elbasvir/grazoprevir for patients without
baseline NS5A RASs for elbasvirb 12 weeks I, A
Glecaprevir/pibrentasvirc
8 weeks I, A
Ledipasvir/sofosbuvir 12 weeks I, A
Ledipasvir/sofosbuvir for patients who are
non-black, HIV-uninfected, and whose
HCV RNA level is <6 million IU/mL
8 weeks I, B
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 1a With Compensated Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Elbasvir/grazoprevir for patients without
baseline NS5A RASs for elbasvirb 12 weeks I, A
Glecaprevir/pibrentasvirc
12 weeks I, A
Ledipasvir/sofosbuvir 12 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 1b Without Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Elbasvir/grazoprevir 12 weeks I, A
Glecaprevir/pibrentasvirc
8 weeks I, A
Ledipasvir/sofosbuvir 12 weeks I, A
Ledipasvir/sofosbuvir for patients who are
non-black, HIV-uninfected, and whose
HCV RNA level is <6 million IU/mL
8 weeks I, B
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 1b With Compensated Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Elbasvir/grazoprevir 12 weeks I, A
Glecaprevir/pibrentasvirc
12 weeks I, A
Ledipasvir/sofosbuvir 12 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 2 Without Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Glecaprevir/pibrentasvirc
8 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 2 With Compensated Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Sofosbuvir/velpatasvir 12 weeks I, A
Glecaprevir/pibrentasvirc
12 weeks I, B
Genotype 3 Without Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Glecaprevir/pibrentasvirc
8 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 3 With Compensated Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Glecaprevir/pibrentasvirc
12 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, A
Genotype 1
Genotype 2 Genotype 3
9. Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through
Community Engagement and Educationâat www.peerview.com/QYB40.
Recommendations for the Initial
Treatment of HCV Infection1,a
PRACTICE AID
a
Initial treatment of HCV infection includes patients with chronic hepatitis C who have not been previously treated with interferon, peginterferon, ribavirin, or any HCV direct-acting antiviral
(DAA) agent, whether experimental, investigational, or US Food and Drug Administration (FDA) approved. b
Includes genotype 1a resistance-associated substitutions at amino acid positions 28,
30, 31, or 93 known to confer antiviral resistance. c
This is a three-tablet coformulation. Please refer to the prescribing information.
NS5A: nonstructural protein 5A; RASs: resistance-associated substitutions.
1. https://www.hcvguidelines.org/treatment-naive. Accessed November 19, 2018.
Genotype 5 or 6 With and Without Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Glecaprevir/pibrentasvirc 8 weeks
(no cirrhosis)
I, A
Glecaprevir/pibrentasvirc
12 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, B
Ledipasvir/sofosbuvir 12 weeks IIa, B
Genotype 4 Without Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Glecaprevir/pibrentasvirc
8 weeks I, A
Sofosbuvir/velpatasvir 12 weeks I, A
Elbasvir/grazoprevir 12 weeks IIa, B
Ledipasvir/sofosbuvir 12 weeks IIa, B
Genotype 4 With Compensated Cirrhosis:
Recommended Daily Fixed-Dose Regimens
Recommended Duration Rating
Sofosbuvir/velpatasvir 12 weeks I, A
Glecaprevir/pibrentasvirc
12 weeks I, A
Elbasvir/grazoprevir 12 weeks IIa, B
Ledipasvir/sofosbuvir 12 weeks IIa, B
Genotype 4
Genotype 5 Genotype 6
10. Chart of Evidence-Based
Screening Tools for Adults
and Adolescents1
PRACTICE AID
Access the activity,âAddressing the Evolving Opioid and HCV Epidemics Through
Community Engagement and Educationâat www.peerview.com/QYB40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
The table below includes examples of trusted screening tools
that are easy to use and available at no charge.
Screening Tool
Substance Type Patient Age How Tool Is Administered
Alcohol Drugs Adults Adolescents
Self-
Administered
Clinician-
Administered
Prescreen
NIDA Drug Use
Screening Tool:
Quick Screen2
X X X a
X
CRAFFT (Part A)3
X X X X X
Alcohol Use
Disorders
Identification
Test-C (AUDIT-C)4
X X X X
Opioid Risk Tool5
X X X
Brief Screener for
Alcohol, Tobacco,
and Other Drugs
(BSTAD)6
X X X X X
Screening to Brief
Intervention
(S2BI)7
X X X X X
Full Screen
NIDA Drug Use
Screening Tool2
X X X X
Alcohol Use
Disorders
Identification Test
(AUDIT)8
X X X
CAGE-AID9
X X X X
CAGE10
X X X
CRAFFT3
X X X X X
a
a
See APA Adapted NM ASSIST tools at https://www.drugabuse.gov/nidamed-medical-health-professionals/tool-resources-your-practice/screening-assessment-drug-testing-resources/
american-psychiatric-association-adapted-nida.
APA: American Psychiatric Association; NIDA: National Institute on Drug Abuse; NM ASSIST: NIDA-Modified Alcohol, Smoking, and Substance Involvement Screening Test.
1. https://www.drugabuse.gov/nidamed-medical-health-professionals/tool-resources-your-practice/screening-assessment-drug-testing-resources/chart-evidence-based-screening-tools-
adults. Accessed November 19, 2018. 2. https://www.drugabuse.gov/nmassist/. Accessed November 19, 2018. 3. http://ceasar.childrenshospital.org/crafft/. Accessed November 19, 2018.
4. http://www.integration.samhsa.gov/images/res/tool_auditc.pdf. Accessed November 19, 2018. 5. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/files/OpioidRiskTool.pdf.
Accessed November 19, 2018. 6. https://www.drugabuse.gov/ast/bstad/#/. Accessed November 19, 2018. 7. https://www.drugabuse.gov/ast/s2bi/#/. Accessed November 19, 2018.
8. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/files/AUDIT.pdf. Accessed November 19, 2018. 9. http://www.integration.samhsa.gov/images/res/CAGEAID.pdf.
Accessed November 19, 2018. 10. https://www.uspreventiveservicestaskforce.org/Home/GetFileByID/838. Accessed November 19, 2018.