#66: Hepatitis C: Workup and Treatment in Primary Care

November 6, 2017 | By Sarah Phoebe Roberts

Hiding from Hep C? Dive in with experts Dr. Gina Simoncini, MD, MPH Associate Professor of Clinical Medicine at Temple University Hospital, & Dr. David Koren, PharmD, BCPS, AAHIVP,  board-certified pharmacotherapy specialist and infectious diseases clinical pharmacist at Temple University Hospital. They walk us through a simplified approach on whom to screen, how to start antiviral therapy, what to follow up on, and how to navigate insurance waters along the way.

Special thanks to Sarah Roberts and Jordana Kozupsky who wrote and produced this episode and the show notes!

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Case from Kashlak Memorial:
A 38 year old male presents to the outpatient clinic complaining of a month of worsening fatigue. Past medical history includes depression, high blood pressure, and diabetes. He currently takes an antidepressant and a blood pressure medication. Patient lives in a men’s shelter after being evicted from his house. Patient smokes marijuana and reports past experimentation with cocaine and injection drug use. His urine tox screen is positive for cannabinoids. His HIV assay is non-reactive. His hepatitis C (HCV) antibody test is reactive.

Clinical Pearls:

1. Always start by ordering an HCV antibody test with reflex viral load testing
2. Lab assessment prior to initiating treatment: CBC, CMP, coags, genotyping, NS5A resistance, HBsAg, HBsAb, anti-HBc, liver ultrasound, biomarkers for fibrosis
3. If a person has HCV and a low platelet count, they have cirrhosis until proven otherwise.
4. Use validated lab markers (FibroTest™ or Fibrosure™) to check for Fibrosis; biopsies are more invasive and have a 15% inherent sampling error. Scores will be reported as a range from F0-F4 (no cirrhosis – cirrhosis); some insurances require a certain score before covering antiviral therapy.
5. Be aware of state restrictions for covering treatment, including who can prescribe, what degree of fibrosis the patient must have to qualify, and if the patient must be sober prior to treatment.
6. You can extend length of treatment based on resistance patterns dictated in the NS5A resistance test.
7. 3 main HCV therapeutic targets and drug endings:
   1. NS5A protein:  “-asvir”
   2. NS5B RNA-dependent polymerase: “-buvir,”
   3. NS3/4A protease: “-previr’”
8. Common drug interactions: watch for statins, PPIs/high dose H2 blockers, and anti-epileptics
9. Side effects of treatment: mild fatigue, GI upset, myalgias and rhabdomyolysis if taken concurrently with statin. Usually very well tolerated.
10. Follow up visits on directing-acting antivirals (DAA):
    1. Obtain a HCV RNA, CBC, CMP at 1 month, end of treatment, and 3 month post treatment.
    2. “Cure Labs”- check a HCV viral load, CBC, CMP at 3 months post treatment to assess for sustained virologic response (SVR12)
    3. Post-SVR: dependent on harmful activities
       1. IVDU: check yearly HCV RNA.
       2. If cirrhotic, move to HCC screening
11. HCC screening: screen for > 3 years post treatment with US Q 6-12 months
12. Lifetime reinfection rate is  5-10%; cure rates are 95-97%
13. Watch out for Hepatitis B reactivation in exposed patients! e.g. Core Ab positive
14. Patient Counseling: risk reduction (clean needle exchanges if applicable), overdose prevention (Narcan), methods of transmission, lifetime reinfection risk
15. If you’re just starting to treat Hep C, establish a network of experienced providers for clinical advice, and do your research ahead of time (insurance regulations, cost of medication, charting requirements)
16. ASCEND study: PCPs and NPs were just as successful as their specialist colleagues when it came to safely and effectively treating HCV patients

Goal: Listeners will develop a standardized approach to the diagnosis, management, treatment options, and follow up care for patients with hepatitis C infection (HCV).

Learning objectives:
After listening to this episode listeners will…

1. Recognize who to screen, and how, for Hepatitis C
2. Understand pre-treatment workup, including different methods for staging fibrosis
3. Recognize main antiviral groups based on genotyping.
4. Have an organized framework for follow-up visits and laboratory monitoring
5. Learn what you’ll need to know prior to treating your first Hep C patient, including how to approach insurance carriers, required documentation, and establishing an interdisciplinary network of providers.
6. Recall important discussion points for patient counseling, including methods of transmission and recurrence/cure rates.

Disclosures: Dr Simoncini receives research support from Gilead Sciences.

Time Stamps
00:00 Intro
01:00 Guest bios
03:00 Getting to know our guests
05:35 Picks of the week
10:05 Clinical case
10:54 Diagnosing HCV
12:00 ASCEND study
13:14 Restrictions on HCV treatment
15:17 Ordering and interpreting pre-treatment tests
19:30 Prescribing medication
22:00 Genotyping and drug resistance
24:10 Patient counseling
25:49 Understanding drug classes
27:33 Drug interactions
30:06 Multidisciplinary approach to treatment
33:01 Follow-up
36:47 Reinfection/cure rates
39:35 Patient counseling revisited
41:25 Side effects of treatment
42:53 Screening
44:02 Take home points

Links from the show:

1. Gina’s book pick: And the Band Played On by Randy Shilts
2. David’s book pick: Antibiotics Simplified by Jason Gallagher and Conan MacDougall
3. David’s restaurant recommendation: Zahav Israeli restaurant in Philadelphia
4. David’s medical app recommendation: Lexicomp
5. Gina’s medical app recommendation:
   1. University of Liverpool, Hep iChart and HIV iChart websites and apps
6. HCVguidelines.org
7. ASCEND study on HCV treatment by NPs and PCPs versus specialists
8. Annals of Internal Medicine article by Dr. Pamela Belperio on curing HCV infection

Recommended reading:

1. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Int Med 2017 (Subscription required)
2. Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus: A Review of Cases Reported to the U.S. Food and Drug Administration Adverse Event Reporting System. Ann Int Med 2017 (Subscription required)
3. American Gastroenterological Association Institute Clinical Practice Update-Expert Review: Care of Patients Who Have Achieved a Sustained Virologic Response After Antiviral Therapy for Chronic Hepatitis C Infection. Gastroenterology 2017 (Free)
4. Assessment of cost of innovation versus the value of health gains associated with treatment of chronic hepatitis C in the United States: The quality-adjusted cost of care. Medicine (Baltimore) 2016 (Free)
5. Extrahepatic Manifestations of Hepatitis C: A Meta-analysis of Prevalence, Quality of Life, and Economic Burden. Gastroenterology 2016 (Free)