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Treating Hepatitis C in Addiction Medicine and Primary Care through a Telehealth model: A Curriculum

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The American Association for the Study of Liver Disease created a simplified cascade for the treatment of non-cirrhotic, treatment naïve, adults with hepatitis C. Given the expanded guidelines, a novel curriculum was implemented to train nonspecialist providers. With the need for immediate access to hepatitis C treatment, in part due to the increase in IV drug use creating a new cohort of those infected, this project assessed the efficacy of a curriculum designed to train nonspecialist providers to treat hepatitis C following CDC and AASLD simplified guidelines. The educational curriculum and survey setting was an addiction medicine telehealth-based practice operating in several states including New Jersey, Michigan, Texas, Ohio, California, Alaska, and Florida. The providers included physician assistants and nurse practitioners who ranged from newly graduated to over twenty years’ experience. The survey had 23 questions assessing points on treating hepatitis C, past experiences, comfort level and feelings about the curriculum and support. The 37 survey participants were 85% who identified as female and 15% who identified as male, 67% of which identified as White with the overall age distribution being varied (majority between 34-45). 46% of participants stated they felt uncomfortable or very uncomfortable about treating hepatitis C before completing the curriculum and 69% of the respondents had never treated hepatitis C. After completing the training 76% remarked that they felt either comfortable or very comfortable treating hepatitis C. With the colliding epidemics, it is imperative to have trained providers who can treat hepatitis C. Since there are only 20,000 specialists, the addition of nonspecialist providers removes barriers to access and timely care. The follow-up survey assessed a compelling change in comfort level after doing the training, which supports the integration of the American Association for the Study of Liver Disease simplified guidelines in various types of practices. Curriculums designed to treat hepatis C and utilize telehealth systems will help decrease barriers and reduce the public health risk of spreading new infections.
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Treating Hepatitis C in Addiction Medicine
and Primary Care through a Telehealth
model; a Curriculum
By Michelle Melchiorre, DMSc, MPH, MS, AAHIVS, PA-C,
and Zachary I Merhavy, MSc
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Citation
Melchiorre M, Merhavy Z. Treating Hepatitis C in medicine and primary care through a telehealth model; a curriculum. HPHR.
2022;50. 
Treating Hepatitis C in Addiction Medicine and Primary Care
through a Telehealth model; a Curriculum
Abstract
Background
The American Association for the Study of Liver Disease created a simplied cascade for the treatment of non-cirrhotic,
treatment naïve, adults with hepatitis C. Given the expanded guidelines, a novel curriculum was implemented to train
nonspecialist providers. With the need for immediate access to hepatitis C treatment, in part due to the increase in IV drug use
creating a new cohort of those infected, this project assessed the ecacy of a curriculum designed to train nonspecialist
providers to treat hepatitis C following CDC and AASLD simplied guidelines.
Methods
The educational curriculum and survey setting was an addiction medicine telehealth-based practice operating in several states
including New Jersey, Michigan, Texas, Ohio, California, Alaska, and Florida. The providers included physician assistants and
nurse practitioners who ranged from newly graduated to over twenty years’ experience. The survey had 23 questions assessing
(https://hphr.org)
points on treating hepatitis C, past experiences, comfort level and feelings about the curriculum and support.
Results
The 37 survey participants were 85% who identied as female and 15% who identied as male, 67% of which identied as White
with the overall age distribution being varied (majority between 34-45). 46% of participants stated they felt uncomfortable or very
uncomfortable about treating hepatitis C before completing the curriculum and 69% of the respondents had never treated
hepatitis C. After completing the training 76% remarked that they felt either comfortable or very comfortable treating hepatitis C.
Conclusion
With the colliding epidemics, it is imperative to have trained providers who can treat hepatitis C. Since there are only 20,000
specialists, the addition of nonspecialist providers removes barriers to access and timely care. The follow-up survey assessed a
compelling change in comfort level after doing the training, which supports the integration of the American Association for the
Study of Liver Disease simplied guidelines in various types of practices. Curriculums designed to treat hepatis C and utilize
telehealth systems will help decrease barriers and reduce the public health risk of spreading new infections.
Introduction
The opioid epidemic in the United States has created a new health crisis inthe20–30-year-old demographic,increasing new
hepatitis C infections. Once viewed as a baby-boomer disease, the CDC now recommends screening everyone 18-75 at least
once regardless of risk factors for hepatitis C. In the United States today, approximately 2.4 million people have been diagnosed
with hepatitis C, and up to 50%more peopledo not even know they have this diagnosis. The United States Preventative Services
Task Force (USPSTF) states that hepatitis C is the most common blood-borne infection in the United States and supports the
increase in new hepatitis C infections and the link to IV drug use. The USPSTF recommends screening everyone from 18-79 at
least once to help to identify new infections. There are currently 20,000 specialists practicing (GI, Hepatology) in the United
States today that have traditionally treated hepatitis C. To put this decit in perspective, Dr. Arora, who helped create Project
Echo at the University of New Mexico, is one of 75 GI specialists practicing in New Mexico. That translates to roughly 1 specialist
for every 27,939 people, according to data from the American College of Medicine. With over 2.4 million people affected, it is
necessary to look outside of traditional means to tackle this epidemic. Hepatitis C is a public health concern. While it is a blood-
borne disease, it is easily transmitted by sharing needles, spoons, straws, and even toothbrushes. Treating and curing hepatitis C
helps the community at large. One less infection means one less person can transmit the disease. The World Health
Organization (WHO) states that 77 million people worldwide have hepatitis. The WHO has a goal to eradicate hepatitis by 2030
and implemented an aggressive campaign to make this goal feasible. The WHO has endorsed a simplied cascade of treatment
that will involve nonspecialist providers The United States has only three states on track to align with the WHO goals: South
Carolina, Connecticut, and Washington State. Overall, the US is more aligned towards 2037. The Department of Health and
Human Services has created a program called Viral Hepatitis National Strategic Plan A Roadmap to Elimination to create urgency
to align more with WHO goals.
Thispaper looks atnonspecialist providers that undertook the curriculum to learn to treat hepatitis C.
 The COVID pandemic has birthed the telehealth model of medicine out of necessity. New support from The Center for
Medicare and Medicaid Services (CMS) in reimbursement for telemedicine has opened the world of medicine to new
possibilities. This has created opportunities to reach out to the community affected by opioid abuse through telehealth to treat
addiction. This removes barriers to care, such as stigma and access.
 The purpose of this project was to develop hepatitis C treatment curriculum for use via telemedicine through addiction
medicine practices and primary care. The rules of treatment have been simplied and benet from nonspecialist providers as a
treatment option. The American Association for the Study of Liver Disease (AASLD) updated their guidelines for treatment of
hepatitis C to include a simplied cascade available to those patients who have never been treated for hepatitis C or have
advanced disease. In other words, for treatment naïve, non-cirrhotic, without coinfection with HIV or hepatitis B patients. The
goal is to support the goals of the World Health Organization’s (WHO) edict to eradicate hepatitis by 2030.
 In the past ve years, studies and governing bodies have changed the focus of hepatitis C treatment from baby boomers to
people who inject drugs (PWIDs). An epidemic of opioid abuse in the United States has changed the demographic dynamic of
who the typical hepatitis C patient is. Drug use is now driving the transmission of hepatitis C. In fact, it is the number one cause
of new infections, driven primarily by injection drug users. While PWIDs are the major force in new cases, many patients have not
had access to care and stigma is still present. In the past, specialists werereluctantto treat PWIDs due to risk factors of
reinfection and treatment noncompliance. Insurance companies had placed restrictions for treatment on patients proving that
they had not used drugs for six months. The SIMPLIFY study followed PWIDs with the direct-acting antiviral protocols and
showed that drug abuse did not affect outcomes adversely; PWIDs had similar outcome success to non-drug users. In fact,
PWIDs had similar outcome success to non-drug users.
 New support from The Center for Medicare and Medicaid Services (CMS) in reimbursement for telemedicine has opened the
world of medicine to new possibilities. This is new territory since it has been in the past ve years that studies and governing
bodies have changed the focus of hepatitis C from baby boomers to people who inject drugs (PWIDs). A study of 13 Federally
Qualied Community Health Centers (FQHC) in the District of Columbia used non-specialist providers to train and then treat
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hepatitis C. The outcomes were comparable to the specialists. The focus of the ASCEND phase four pilot study was to look at
using direct acting antivirals in an outpatient, community health center format. The providers were given three hours of training,
access to Project Echo, the 2015 AASLD guidelines, and the FDA indications where they studied only 1a genotype. The study also
included co-infection with HIV and cirrhotic patients. The work done by this principal investigator was able to build on that
foundation with the addition of the AASLD simplied cascade and the University of Washington hepatitis C training.
 This project created and implemented the new simplied treatment guidelines that support nonspecialist providers treating
non-cirrhotic, treatment-naïve hepatitis C patients. The curriculum draws from the CDC-sponsored University of Washington
Hepatitis C modules, Project Echo, a remote-based, provider-led learning environment created by the University of New Mexico in
response to New Mexico having the highest rate of liver disease in the United States and a decit of specialists to treat them.
The educational curriculum created a model of care that can be taught easily to other interested providers.
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Methods
The advanced practice providers were given an anonymous survey created through Qualtrics, a statistical survey tool. The survey
had 23 questions designed to assess the comfort level, experience, opinions, and demographics of the providers who
participated in thehepatitis C training. Inclusion criteria were physician assistants, nurse practitioners, and primary care
physicians currently working at Workit Health with or without experience in treating hepatitis C. Exclusion criteria were those
providers not treatinghepatitis C voluntarily, or those for whom the opportunity had not presented itself during the study. The
survey was sent out through employer-based email and placed in the Workit Health Slack channels appropriate to the providers.
The providers were given three weeks to complete the survey.The educational curriculum and survey setting was Workit Health,
an addiction medicine virtual telehealth-based practice. The providers were advanced practice providers, which included
physician assistants and nurse practitioners with experience ranging from just out of school to over twenty years in practice.
Workit Health had clinics in several states.The survey had 23 questions assessing points on treating hepatitis C, experience,
comfort level and feelings about the curriculum and support.
Results
The results recorded 37 individual responses from the survey results.The sample survey had 37 completed responses with
clinic participants from New Jersey, Michigan, Texas, Ohio, California, Alaska, Florida, and Oregon. Participant demographics
included 85% who identied as female and 15% who identied as male. At the same time, the survey included non-binary and
preferred not to disclose; these options were not utilized by those who completed the survey (Figure 1).The providers identied
67% as White, 10% as Black or African American, 16% as Asian-American, and 5% as Native Hawaiian or Pacic Islander (Figure
2). Overall, the age distribution varied as well. The majority fell in the age group between 34-45 years of age (Figure 3). Before the
training program,69% of the responding providers had not treatedhepatitis C. A complete protocol presented the opportunity to
see if nonspecialist providers would be comfortable treatinghepatitis C after the training. One of the survey questions asked the
providers to describe their comfort level in treatinghepatitis C before the curriculum. Only 13% identied as feeling very
comfortable treatinghepatitis C before the training.Of the survey respondents,20% identied as very uncomfortable and 26% as
uncomfortable (Figure 4).After completing the training, 47% identied as strongly agreeing to have an increased comfort level in
treatinghepatitis C, 30% somewhat agreed, and only 3% disagreed with feeling more comfortable. The survey questions showed
a consistent theme of support helping to make the segue from training to treatment possible. Part of the curriculum included 1:1
coaching, question and answer sessions, and prerecorded trainings. The survey responses showed that providers found these
tools helpful. Overall, nonspecialist providers who responded to this survey felt that curriculum and support were helpful in
making a decision to treat hepatitis C.
Figure 1. Gender Identication of Providers
Figure 2. Race Distribution of Providers
(https://hphr.org)
Figure 3. Age Distribution of Providers
Figure 4. Provider comfort level with the idea of treating Hepatitis C before completing the Hepatitis C treatment training
program
Figure 5. Provider level of Comfort Treating Hepatitis C after completing Curriculum
Limitations
 This study was powered by the IRB to look at provider comfort level in treating hepatitis C before and after the training
(https://hphr.org)
curriculum. The interpretation is based on a limited cohort of providers trying out a novel program and the study does not have a
comprehensive, calculated analysis. This work was primarily created to see if it was viable in real world application and
enhancements will be implemented in future studies.
Conclusion
With 2.4 million Americans infected with hepatitis C and an increase in the opioid crisis, which is a major risk factor for viral
transmission, and with the colliding epidemics, it is imperative to have trained providers who can treat hepatitis C. Since there are
only 20,000 hepatitis-identied specialists in the United States, this creates barriers to access and timely care. This fact changes
with the advent of the CDC and AASLD simplied treatment cascade for treatment naïve, non-cirrhotic patients to be
implemented by primary care, addiction medicine and other non-specialist provider. The addition of a complete educational
curriculum designed to treat hepatitis C was developed based on these guidelines and the CME courses from the University of
Washington and AASLD guidelines. Programs like this can help to chip away at the 2.4 million people infected with hepatitis C.
The follow-up survey assessed the comfort level and experience before and after the training. There was a compelling change in
comfort level after doing the training, which supports the integration of the AASLD simplied guidelines in various types of
practices.
Disclosure Statement
The authors have no relevant nancial disclosures or conicts of interest.
Acknowledgements
The authors would like the thank the Yale School of Public Health, Yale Institute for Global Health, and University of Mississippi
School of Applied Sciences for making this collaboration possible.
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About the Authors
Michelle Melchiorre, DMSc, MPH, MS, AAHIVS, PA-C,
Dr Melchiorre is an eternal student who is committed to the underserved while working with like-minded community to make
innovative, yet attainable changes for a compassionate tomorrow.
Zachary I Merhavy, MSc
MS2 at Ross University Medical School with research, writing, editing, and publishing experience in medical education, sexual
health, anesthesiology, microbiology, and more. Founding member of the Varkey-Merhavy Research Consortium producing over
25+ publications in the past 2 years, spanning various elds.
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Article
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) initiated the hepatitis C guidance project (hereafter HCV guidance) in 2013. The AASLD‐IDSA HCV guidance website (www.HCVGuidelines.org) disseminates up‐to‐date, peer‐reviewed, unbiased, evidence‐based recommendations to aid clinicians making decisions regarding the testing, management, and treatment of hepatitis C virus (HCV) infection. Utilizing a web‐based system enables timely and nimble distribution of the HCV guidance, which is periodically updated in near real time as necessitated by emerging research data, recommendations from public health agencies, the availability of new therapeutic agents, or other significant developments affecting the rapidly evolving hepatitis C arena.
Article
Injection drug use is the most common transmission route for hepatitis C. High rates of infection are observed among individuals on opioid agonist therapy. Although people who inject drugs carry the highest burden, few have initiated treatment. We present a comprehensive review of the evidence on the efficacy of HCV medications, drug–drug interactions, and barriers to and models of care. Studies have demonstrated comparable efficacy for individuals who are on opioid agonist therapy compared with those who are not. We propose that a strategy of treatment and cure-as-prevention is imperative in this population to curb the hepatitis C epidemic.
Article
Background: Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in high rates of disease cure; however, not enough specialists currently are available to provide care. Objective: To determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy. Design: Nonrandomized, open-label clinical trial initiated in 2015. (ClinicalTrials.gov: NCT02339038). Setting: 13 urban, federally qualified health centers (FQHCs) in the District of Columbia. Patients: A referred sample of 600 patients, of whom 96% were black, 69% were male, 82% were treatment naive, and 20% had cirrhosis. Seventy-two percent of the patients had HCV genotype 1a infection. The baseline characteristics of patients seen by each provider type were similar. Intervention: Patients were assigned in a nonrandomized but specified manner to receive treatment from 1 of 5 NPs, 5 PCPs, or 6 specialists. All providers underwent an identical 3-hour training session based on guidelines. Patients received treatment with ledipasvir-sofosbuvir, which was provided on site, according to U.S. Food and Drug Administration labeling requirements. Measurements: Sustained virologic response (SVR). Results: 516 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Response rates were consistent across the 3 provider types: NPs, 89.3% (CI, 83.3% to 93.8%); PCPs, 86.9% (CI, 80.6% to 91.7%); and specialists, 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR. Limitation: Nonrandomized patient distribution; possible referral bias. Conclusion: In a real-world cohort of patients at urban FQHCs, HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists. Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection. Primary funding source: National Institutes of Health and Gilead Sciences.
Article
The authors describe an innovative academic health center (AHC)-led program of health care delivery and clinical education for the management of complex, common, and chronic diseases in underserved areas, using hepatitis C virus (HCV) as a model. The program, based at the University of New Mexico School of Medicine, represents a paradigm shift in thinking and funding for the threefold mission of AHCs, moving from traditional fee-for-service models to public health funding of knowledge networks. This program, Project Extension for Community Health care Outcomes (ECHO), involves a partnership of academic medicine, public health offices, corrections departments, and rural community clinics dedicated to providing best practices and protocol-driven health care in rural areas. Telemedicine and Internet connections enable specialists in the program to comanage patients with complex diseases, using case-based knowledge networks and learning loops. Project ECHO partners (nurse practitioners, primary care physicians, physician assistants, and pharmacists) present HCV-positive patients during weekly two-hour telemedicine clinics using a standardized, case-based format that includes discussion of history, physical examination, test results, treatment complications, and psychiatric, medical, and substance abuse issues. In these case-based learning clinics, partners rapidly gain deep domain expertise in HCV as they collaborate with university specialists in hepatology, infectious disease, psychiatry, and substance abuse in comanaging their patients. Systematic monitoring of treatment outcomes is an integral aspect of the project. The authors believe this methodology will be generalizable to other complex and chronic conditions in a wide variety of underserved areas to improve disease outcomes, and it offers an opportunity for AHCs to enhance and expand their traditional mission of teaching, patient care, and research.
Core Concepts -HCV Epidemiology in the United States -Screening and Diagnosis of Hepatitis C Infection -Hepatitis C Online. www.hepatitisc.uw
  • M D Spach
Spach, MD D. Core Concepts -HCV Epidemiology in the United States -Screening and Diagnosis of Hepatitis C Infection -Hepatitis C Online. www.hepatitisc.uw.edu. Accessed August 20, 2022. https://www.hepatitisc.uw.edu/go/screeningdiagnosis/epidemiology-us/core-concept/all#citations
VIRAL HEPATITIS National Strategic Plan a Roadmap to Elimination
  • S U S Charuchandra
Charuchandra S. U.S. Is Not on Track to Hit the WHO's Hep C Elimination Targets. Hep. Published September 9, 2020. Accessed August 21, 2022. https://www.hepmag.com/article/us-track-hit-hep-c-elimination-targets . VIRAL HEPATITIS National Strategic Plan a Roadmap to Elimination.; 2020. Accessed August 20, 2022. https://www.hhs.gov/sites/default/ les/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf (https://www.hhs.gov/sites/default/ les/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf)
  • C Lynch
Lynch C. Acrobat Accessibility Report. www.medicaid.gov. Published April 20, 2020. Accessed August 20, 2022. https://www.medicaid.gov/sites/default/ les/Federal-Policy-Guidance/Downloads/cib040220.pdf
Sofosbuvir and velpatasvir for hepatitis c virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. The Lancet Gastroenterology &amp
  • J Grebely
  • O Dalgard
  • B Conway
Grebely J., Dalgard O., Conway B., et al. Sofosbuvir and velpatasvir for hepatitis c virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. The Lancet Gastroenterology & Hepatology 2018;3(3):153-161. doi:10.1016/S2468-1253(17)30404-1 2021. https://pubmed.ncbi.nlm.nih.gov/28785771/ (https://pubmed.ncbi.nlm.nih.gov/28785771/)