1. Managing Hepatitis C in Vermont
Module 4:
Linkage to Care and Treatment Basics

2. Welcome to the HCV Linkage to Care and Treatment Basics Module
Please take this brief pre-module quiz
Click here for brief pre-module quiz
or use this web address:

3. This module works a lot better in “presentation” mode
Above, go to “Slide Show” then hit “From Beginning” and click-through

4. Outline
Who is a good treatment candidate and when should treatment be deferred?
Linking care to VT HCV Treatment providers, and what information they need
Navigating the landscape of medication coverage
Basics of treatment:
Common medications and how they work
How long to expect treatment to last
Using HCV Guidelines as a guide
What patients for side-effects and lab testing while on treatment
Testing for cure
What to tell patients who have been cured, and those who have not been cured, and how to monitor each

5. Outline
Who is a good treatment candidate and when should treatment be deferred?
Linking care to VT HCV Treatment providers, and what information they need
Navigating the landscape of medication coverage
Basics of treatment:
Common medications and how they work
How long to expect treatment to last
Using HCV Guidelines as a guide
What patients for side-effects and lab testing while on treatment
Testing for cure
What to tell patients who have been cured, and those who have not been cured, and how to monitor each

6. Who is a good treatment candidate and when should treatment be deferred?
Cure of HCV is a very good thing!
>70% risk reduction in liver cancer, and >90% risk reduction in liver-related mortality
Increased physical, emotional, and social health
The current standard of care is to treat ALL chronically HCV infected patients except:
Those with a short life expectancy
Patients who are unable to adhere to the treatment regimen
Patients who are pregnant or breast feeding. There are insufficient safety data for HCV in these groups and HCV treatment should be delayed.
From

7. Who is a good treatment candidate and when should treatment be deferred?
What about in Persons Who Inject Drugs (PWID)?
HCV prevalence in PWID approaches 70%
Injecting drugs causes 70% of new HCV infections
There is no effective HCV vaccine
Treatment of PWID is important both for the patient as well as HCV transmission prevention
Treatment as prevention!
HCV treatment for PWID works best in a multidisciplinary fashion including social work, opioid replacement therapy, needle-exchange programs, and committed medical providers

8. Cost of NOT achieving HCV cure
Cost of managing:
Compensated cirrhosis
Decompensated cirrhosis
Hepatocellular carcinoma
Liver transplant (~$600,000)
Razavi et al. Chronic HCV disease burden and cost in the United States. Hepatology 2013.

9. ‘Bring your friends’ approach may optimize treatment and prevention outcomes in PWID
Treat all members of an individual’s injection network
Optimize treatment outcomes
(Peer support)
Reduce risk of reinfection (reduce reservoir of HCV in a network)
Courtesy of Shruti Mehta, Johns Hopkins

10. Who is a good treatment candidate and when should treatment be deferred?
What about in Persons Who Inject Drugs (PWID)?
PWID who do not share needles, and always use clean syringes, are good candidates for HCV treatment
Patients who are actively injecting drugs and sharing needles with others may be poor HCV treatment candidates given high risk of re-infection, though could become good candidates if:
They and their cohort of co-users are all treated simultaneously
They are linked to needle exchanges and stop sharing needles
They can achieve abstinence

11. Outline
Who is a good treatment candidate and when should treatment be deferred?
Linking care to VT HCV Treatment providers, and what information they need
Navigating the landscape of medication coverage
Basics of treatment:
Common medications and how they work
How long to expect treatment to last
Using HCV Guidelines as a guide
What patients for side-effects and lab testing while on treatment
Testing for cure
What to tell patients who have been cured, and those who have not been cured, and how to monitor each

12. Linking care to VT HCV Treatment providers, and what information they need
Currently, many VT healthplans require the involvement of a subspecialty HCV provider, either from Infectious Diseases or Gastroenterology
As HCV treatment becomes easier and increasingly less expensive, likely in the future subspecialist involvement will not be universally required
Primary Care Professionals should obtain basic information and labs so that the subspecialist can get the patient on HCV treatment right away

14. What information HCV specialists need (within last 6 months)
Labs
Other Info
HCV viral load and genotype
ALT, AST, bilirubin, alkaline phosphatase, albumin
Creatinine
Complete blood count
Prothrombin time (PTT)
HIV serology
Hepatitis B surface antibody, surface antigen, and core antibody
Hepatitis A total antibody
Cirrhosis or not? (see Module 3)
HCV treatment naïve or experienced?
Ensure not pregnant if a woman of child-bearing age
Medication list
Health plan

15. Where are HCV Treatment Specialists in Vermont?

16. Central Vermont Medical Center University of Vermont Medical Center
Dartmouth-Hitchcock Medical Center
Rutland Regional Medical Center

17. Outline
Who is a good treatment candidate and when should treatment be deferred?
Linking care to VT HCV Treatment providers, and what information they need
Navigating the landscape of medication coverage
Basics of treatment:
Common medications and how they work
How long to expect treatment to last
Using HCV Guidelines as a guide
What patients for side-effects and lab testing while on treatment
Testing for cure
What to tell patients who have been cured, and those who have not been cured, and how to monitor each

18. Navigating the landscape of HCV medication coverage
Although HCV drug costs have come down significantly, HCV drugs remain expensive
When the new HCV drugs came out, most health plans had “fibrosis restrictions,” limiting drug coverage to patients with more advanced fibrosis
For instance in 2016 in Vermont, Medicaid required patients have F2 fibrosis or higher to qualify for HCV treatment
However, the landscape is quickly changing…

19. Who is eligible for treatment? An Improving Landscape

20. 2014 No Medicaid fibrosis restrictions F1 restriction F2 restriction
F4 restricton

21. Are there HCV patients in your panel newly eligible for treatment?
2018
No Medicaid fibrosis restrictions
F1 restriction
F2 restriction
F3 restriction
F4 restricton
Are there HCV patients in your panel newly eligible for treatment?

22. Navigating the landscape of HCV medication coverage
On January 1, 2018, Vermont Medicaid dropped all fibrosis restrictions for HCV treatment
Most but not all other health plans in VT have followed suit
There are now many chronically HCV infected patients in Vermont who have access to HCV treatment who did not previously, and should be linked to care

23. Outline
Who is a good treatment candidate and when should treatment be deferred?
Linking care to VT HCV Treatment providers, and what information they need
Navigating the landscape of medication coverage
Basics of treatment:
Common medications and how they work
How long to expect treatment to last
Using HCV Guidelines as a guide
What patients for side-effects and lab testing while on treatment
Testing for cure
What to tell patients who have been cured, and those who have not been cured, and how to monitor each

24. HCV Treatment Multiple highly-effective regimens
Selection may be guided by health plan restrictions
Treatment range: 8-12 weeks
All patient groups have a >95% virologic cure rate with 1st line agents

25. HCV Treatment Let’s look at where and how 1st line HCV drugs work…

26. HCV Viral Structure NS3/4a Protease NS5A Transcription co-factor
NS5B RNA polymerase
HCV Viral Structure

27. Harvoni Epclusa Zepatier Mavyret HCV Viral Structure NS3/4a Protease
NS5A Transcription co-factor
NS5B RNA polymerase
Grazoprevir
Glecaprevir
Ledipasvir
Velpatasvir
Elbasvir
Pibrentasvir
Sofosbuvir
Harvoni
Epclusa
Zepatier
Mavyret
HCV Viral Structure

28. HCV Treatment in Vermont in 2019 made easy
Genotype 1a
Mavyret
Epclusa
Harvoni
Zepatier
Genotype 1b
12-16
weeks
8-12
weeks
Genotype 2
Genotype 3
8-12
weeks 12
weeks
Genotype 4
Harvoni
Zepatier
Genotype 5
Genotype 6
Harvoni

29. HCV Treatment: The Bible
These HCV guidelines are the current standard of care and should always be consulted before starting HCV treatment.

30. What patients on treatment can expect regarding side-effects
The main side effects are:
Headache
Fatigue
These are usually mild and rarely limit the patient’s ability to complete treatment

31. Drug-Drug interactions with HCV Treatment
Many drugs interact with HCV medications and may need to be stopped or modified
Acid suppressive medications, such as PPIs and H2 blockers, can significantly decrease HCV med absorption
These medications are best stopped during HCV treatment. If that is not possible, talk with an HCV specialist.
Birth control also often an issue, requires careful selection of HCV medications
This website is an excellent resource to check HCV medication drug- drug interactions:

32. What patients on treatment can expect regarding lab testing
Labs should be drawn every 4 weeks while on treatment, including:
HCV RNA viral load
The HCV RNA viral load should drop precipitously. However, if it goes to 0 while on treatment that does NOT mean the patient is cured yet
Complete blood count
Creatinine, AST, ALT, Alk Phos, and total bilirubin
If 4 week viral load is undetectable and other labs look good, in non- cirrhotic and non-co-infected, HCV therapy compliant patients, it is reasonable to NOT get week 8 and 12 labs as they are unlikely to be abnormal.

33. Testing for cure
A negative HCV RNA viral load 12 weeks AFTER the end of treatment is called a sustained virologic response (SVR, or SVR12)
Patients who achieve SVR12 are very likely to be cured of their HCV infection
All patients should have SVR12 checked
In patients with cirrhosis, an HCV RNA viral load should also be checked at 24 weeks after treatment, because of late recurrences
Cirrhotic patients need SVR12 and SVR24

34. What to tell patients who have been cured
Congratulations! However….
They are not immune from HCV and can easily get it again via injection drug use, sex, or other methods of body fluid sharing (via toothbrushes, razors, nailclippers)
They will always have a positive HCV antibody (serology). Thus they will always “screen positive” on an HCV test.
The only way to know if they are re-infected with HCV is to obtain an HCV RNA viral load
In patients at high-risk for HCV re-infection (in particular persons who inject drugs), an HCV RNA viral load at least once yearly is indicated to monitor for re-infection

35. What to tell patients who have not been cured despite HCV treatment
2-5% of patients receiving HCV therapy will not be cured with the 1st round of therapy
Cure is still very likely with a 2nd round of a different type of HCV therapy
These patients need to see a Hepatologist or Infectious Diseases physician with expertise in HCV care

36. Treating HCV: Key Points
Most patients with HCV can and should be treated and cured
Treatment for HCV follows strict guidelines as outlined at
Be sure to check for drug-drug interactions before starting HCV therapy, especially acid-suppressing medications and birth control
Patients need routine lab monitoring while being treated for HCV, and a test of cure 12 weeks after therapy is complete
Patients who have been cured can be re-infected and must be counseled on how to avoid this

37. Congratulations! Click here for brief post-module quiz
Please take the post-module quiz here
Click here for brief post-module quiz
or use this web address: