Pharmacist-Led Hepatitis C Management

Kendall A. Spicer, Pharm.D., PGY-1 Pharmacy Resident

Katherine L. Canup, Pharm.D., Clinical Operations Manager – Union Hospital Specialty Pharmacy
Marcia J. Hunt-Curran, Pharm.D., BCPS, Systems Manager – Clinical Pharmacy Services
 Conflicts of Interest

• The speaker and preceptors have no conflict of interest to

disclose regarding the material being presented

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 Learning Objectives

• Describe how a pharmacist-led hepatitis C virus management

program can improve patient outcomes

• Outline the scope of a pharmacist per a collaborative practice

agreement in terms of what labs can be drawn and which
medications can be adjusted

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 Background: Hepatitis C Virus

• The hepatitis C virus (HCV) is spread via blood-to-blood contact

• Infection may be asymptomatic or involve severe hepatic
disease
• Most commonly spread in the setting of intravenous drug use
• No HCV vaccine, but can be cured/cleared
• Has 6 primary genotypes

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 Background: Acute HCV

• Acute HCV infection: symptom onset 2-26 weeks

– Fatigue
– Change in appetite, nausea/vomiting
– Fever
– Darkened urine or clay-colored stool
– Jaundice
– Possible findings: elevated ALT on labs, focal tenderness to liver

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 Background: Chronic HCV

• Chronic HCV infection: if left untreated

– Cirrhosis/liver failure
– Hepatocarcinoma
– Impact to other organ systems
• Painful, blistering skin disorders
• Diabetes
• Acute or chronic kidney damage

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 Indiana Department of Health

2020 Statistics:
Acute HCV Infection
• Indiana = 264 reported cases (3.9 per 100k)
• Vigo County = 5 reported cases (4.7 per 100k)
• Surrounding counties = 0 reported cases
Chronic HCV Infection
• Indiana = 4,924 reported cases (72.6 per 100k)

7
Indiana Department of Health. Epidemiology Resource Center – Hepatitis C, Acute & Chronic (2020). IDoH ODA Stats Explorer.
https://gis.in.gov/apps/isdh/meta/stats_layers.htm. Accessed 3/10/2022.
 Indiana Department of Health
2020 County Data – Chronic HCV
160 400
144 371.4
140 350

120 300

Rate per 100,000

Reported Cases

100 250

80 200
135.7 60
60 150

40 100
67.3
14 52.9 14 38.9
20 50
6
0 0
Vigo Clay Parke Sullivan Vermillion
Cases . 2 Incidence

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Indiana Department of Health. Epidemiology Resource Center – Hepatitis C, Acute & Chronic (2020). IDoH ODA Stats Explorer.
https://gis.in.gov/apps/isdh/meta/stats_layers.htm. Accessed 3/10/2022.
 Evolution of Treatment Options
First treatment: Interferon-alpha (1991)
• Use associated with significant illness (e.g.,
neurologic and hematologic complications)

First direct-acting antiviral (DAA):

Boceprevir (2011)
• Used in combination with interferon and
ribavirin

First non-interferon regimen:

Ledipasvir/Sofosbuvir (2014)
• One-tablet regimen

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Geddawy A, Ibrahim YF, Elbahie NM, Ibrahim MA. Direct Acting Anti-hepatitis C Virus Drugs: Clinical Pharmacology and
Future Direction. Journal of Translational Internal Medicine. 2017;5(1):8–17. PMID: 28680834
 Barriers to Treatment & Cure

Unable to obtain Unable to obtain Unable to obtain

diagnosis treatment cure
Unaware of
Fear & stigma Non-adherence
disease
Affordability & Affordability & Persistent
access access exposure
Missed by Requiring Delayed
provider specialist initiation

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McGowan CE, Fried MW. Barriers to Hepatitis C Treatment. Liver International. 2012;32:151-156. PMID: 22212587
 Union Hospital Specialty Pharmacy
• Located within Union Hospital
• Established in February of 2021
– Oncology and rheumatology medication focus
• Added more service lines in March of 2021
– Included neurology, pulmonology, and gastroenterology management
• Retail space recently opened in December of 2021
• Employs 3 pharmacists & 3 pharmacy liaisons, adding 4th liaison
• Specialize in improving access and adherence measures related
to specialty medications
• ACHC accredited, seeking URAC accreditation

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 Pharmacist Impact
Increase medication access
• Acquisition of specialty medications
• Utilization of patient assistance and grant programs

Provide high-quality, comprehensive education

• Help dispel fears and stigmas surrounding medication
• Provide medication counseling

Be accessible
• Increased access to follow-up and adherence measures
• Additional point of patient support

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Mohammad RA, Bullock MN, Chan J, et al. Provision of Clinical Pharmacist Services for Individuals with Chronic
Hepatitis C Viral Infection: Joint Opinion of the GI/Liver/Nutrition and Infectious Diseases Practice and Research
Networks of the American College of Clinical Pharmacy. Pharmacotherapy. 2014;34(12):1341-54. PMID: 25359244
 Project Design

• Purpose – Establish a referral-based, pharmacist-led

HCV management program at Union Hospital Specialty
Pharmacy (UHSP) to enhance patient access and quality
of disease management

• Methods – Manage patients via collaborative practice

agreement (CPA) and collect data relating to adherence
and rates of positive patient outcomes
– Targeted clinics and providers include infectious disease,
gastrointestinal disease, and internal medicine

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 Initiating Patient Care

Diagnosis Referral Contact Consult

• Screening, labs, • Patient meets • The clinical • Establish care
and diagnosis of criteria for pharmacist and educate the
HCV completed referral to the assesses the patient on HCV
by provider or clinical case and treatment
specialist pharmacist for schedules the
management consultation

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 Planning & Initiation of Drug Regimen

Contact other
Assess prescribers to Address
genotype and Order any address barriers to
other relevant labs potential cost and
comorbidities drug-drug adherence
interactions

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 Plans for Follow-Up
• Perform first check-in appointment within 30 days (goal
within 1-2 weeks from initiation)
• Address adherence and other concerns every 4 weeks
• After completion, obtain test of cure: repeat viral load
– Sustained virologic response at 12 weeks post-treatment (SVR12)

• Once SVR12 is interpreted, the patient is discharged back to

referring physician
• If lost to follow-up at any time, the patient may be discharged
– Non-compliant with medications/appointments
– Unable to contact

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 Research in Progress
• Currently, our CPA is under legal review, but will then be
available present to physicians
• Goals:
– Zero missed-dose days
– ≥95% of patients reach SVR12 follow-up
– Clinical cure rate of ≥90% in treatment-naïve patients
• Secondary goal: track patient cost savings

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 Obstacles

• Electronic health record migration in November 2021

• Delayed opening of UHSP retail space
• Requires location build within EHR, still in process
• Recent staffing turnover and further expansion
• Our current service lines at UHSP were more successful
than anticipated, resulting in substantial patient load
• Awaiting legal approval of CPA to begin enrolling patients

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 Summary
• Hepatitis C, if not treated timely and appropriately, may lead
to development of additional comorbidities, worsened
outcomes, and eventually death
• A CPA is currently being established to allow physicians the
opportunity to refer HCV patients to our specialty pharmacy
for focused disease management
• Health system-based specialty pharmacy resources can
increase access to the necessary medications, aid in education
and adherence, and improve patient outcomes
• Metrics will be collected to track the impact of this added
service and identify areas of improvement

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 References
• Indiana Department of Health. Epidemiology Resource Center – Hepatitis C, Acute &
Chronic (2020). IDoH ODA Stats Explorer.
https://gis.in.gov/apps/isdh/meta/stats_layers.htm. Accessed 3/10/2022.
• Geddawy A, Ibrahim YF, Elbahie NM, Ibrahim MA. Direct Acting Anti-hepatitis C Virus
Drugs: Clinical Pharmacology and Future Direction. Journal of Translational Internal
Medicine. 2017;5(1):8–17. PMID: 28680834
• McGowan CE, Fried MW. Barriers to Hepatitis C Treatment. Liver International.
2012;32:151-156. PMID: 22212587
• Mohammad RA, Bullock MN, Chan J, et al. Provision of Clinical Pharmacist Services for
Individuals with Chronic Hepatitis C Viral Infection: Joint Opinion of the
GI/Liver/Nutrition and Infectious Diseases Practice and Research Networks of the
American College of Clinical Pharmacy. Pharmacotherapy. 2014;34(12):1341-54. PMID:
25359244

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 Pharmacist-Led Hepatitis C Management
Kendall A. Spicer, Pharm.D., PGY-1 Pharmacy Resident
Katherine L. Canup, Pharm.D., Clinical Operations Manager – Union Hospital Specialty Pharmacy
Marcia J. Hunt-Curran, Pharm.D., BCPS, Systems Manager – Clinical Pharmacy Services