1. Hepatitis C The Silent Epidemic
CAPT Stephen “Miles” Rudd, MD, FAAFP
Chief Medical Officer/Deputy Director, Portland Area IHS
Chairman, IHS National Pharmacy & Therapeutics Committee
October 2015 Northwest Portland Area Indian Health Board- Quarterly Board Meeting
Pendleton, OR

2. Hepatitis: A disease characterized by inflammation of the liver.
Causes of hepatitis
Toxins
Certain drugs
Some diseases
Heavy alcohol use
Bacterial and viral infection
Hepatitis A, B, C

3. Viral Hepatitis (Alphabet Soup)
Foodborne spread (contaminated food or water, fecal-oral route)
Acute illness (never chronic)
Usually improves without treatment
Vaccine preventable
Hepatitis B
Spread through blood or body fluids
Can be acute or chronic
Hepatitis C
Spread through blood most commonly
No vaccine available

4. Hepatitis C:
Contagious liver disease caused by the Hepatitis C virus (HCV)
Spread:
Mostly by blood (needles, syringes, blood transfusion before 1992, unregulated piercing/tattooing)
Low risk for spread through sharing personal care items (razors, toothbrushes)
Low risk through sex
Risk increased for those with multiple sex partners, other STDs, HIV

5. Hepatitis C: Acute Hepatitis C Chronic Hepatitis C
Short-term illness occurring in the first 6 months after exposure
Often has no symptoms (70-80%)
15-25% of people infected with HCV will clear the infection.
Chronic Hepatitis C
Long-term to life-long illness
Complications:
Chronic liver disease (60-70%)
Cirrhosis (5-20%)
Liver cancer (2-6% /yr of those with HCV-related cirrhosis)

6. Hepatitis C Statistics:
US population
29, 718 cases reported in 2013
~ million persons in US have chronic Hepatitis C virus infection
15,106 deaths due to HCV in 2007 VA
175,000 cases in 2014
IHS
25,815 patients have a positive screening test for HCV (NDW, Dec. 2014)

7. Hepatitis C in OR:

8. Hepatitis C in WA:

9. Hepatitis C Forecast:
Forecasted Annual Incident Cases of Decompensated Cirrhosis (DCC), Hepatocellular Carcinoma (HCC), Liver Transplants, and Deaths Associated with Persons with Chronic Hepatitis C Infection and No Liver Cirrhosis in the United States in 2005
Rein, DB, Wittenborn, JS, Weinbaum, CM Sabin, M, Smith, BD, Lesesne, SB. Forecasting the Mortality and Morbidity Associated with Prevalent Cases of Pre-Cirrhotic Chronic Hepatitis C Infections in the United States. Journal of Digestive Liver Diseases 2010.

10. Hepatitis C by Ethnicity:
Source: National Notifiable Diseases Surveillance System (NNDSS)

11. Hepatitis C in OR:

12. Who is at risk for Hepatitis C:
People at increased risk:
Injection drug users, current * or past (even one time)
Recipient of blood, blood products, or organs before 1992
Long-term hemodialyis patients
People who received tattoos or body peircing with non-sterile instruments
People with known exposures (healthcare workers with needlesticks)
HIV-infected persons
Children born to mothers with HCV (6%)
Less common risk
Sexual contacts of persons infected with HCV
Those sharing personal care items that may have come into contact with blood from an infected person.
IVDU:
18-30 years old- ~1/3 HCV infected
Older and former IVDU % infected
Blood transfusions: current risk is 1 chance in 2 million units transfused

13. Hepatitis C: Symptoms Acute Hepatitis C Fever Joint pain Fatigue
Jaundice (yellow color in the skin or eyes)
Loss of appetite
Nausea
Vomiting
Abdominal pain
Dark urine
Clay-colored bowel movements

14. Hepatitis C Screening:
Blood test can be used to screen for antibodies against HCV.
Screening recommended for:
High risk persons
Persons born between 1945 through 1965 (Baby Boomers)
5x more likely to be infected
3 out of 4 people with HCV infection are in this age group
A positive antibody test (ever been infected) should be followed by a test for viral genes (still infected)
Anti-HCV can be detected 4-10 weeks after infection.
Detected in >97% by 6 months.
HCV RNA can be detected by PCR in 2-3 weeks.

15. Why screen for HCV? Counseling on prevention of spread.
Vaccination against Hepatitis A & B.
Counseling on avoidance of alcohol.
Counseling on avoidance of certain prescription pills, supplements, or over-the-counter medications that can damage the liver.
Monitoring for chronic hepatitis and cirrhosis (and complications).
Identifying patients that would benefit from treatment.

16. Hepatitis C Treatment:
Two important definitions:
Sustained Virologic Response (SVR)- a marker for HCV cure
HCV is undetectable in the blood for 24 weeks after therapy.
HCV Genotype- differing strains of HCV (6)
Genotype 1 is most common (subtypes a & b)
Genotype 2 and 3 respond better to treatment
Antiviral medications for the treatment of Hepatitis C infection have been available since the 1990s.
Recently, there has been a rapid increase in newer medications.

17. Hepatitis C Treatment: 1990s
Interferon and ribavirin
Required weeks of treatment
Involved weekly injections (interferon) and twice daily pills (ribavirin).
Significant side effects
Flu-like symptoms (80%)- fever, headach, body aches
Depression and irritability (40%)
Other- low blood counts and thyroid inflammation.
10-14% cannot tolerate therapy
SVR- genotype 1 (45-60%), genotype 2 & 3 (75-80%)
Cost: ~$12,000 (24 week)- $24,000 (48 week)

18. Hepatitis C Treatment: 2015
Several newer options
Ledipasvir/sofosbuvir (Harvoni®)
Daclatasvir (Daklinza®)
Simeprevir (Olysio®)
Sofosbuvir (Sovaldi®)
Ombitasvir/paritapevir/ritonavir plus dasabuvir (Viekira Pak®)
Typically 12 weeks of treatment
Once daily dosing.
Well tolerated (few side effects)
SVR- greater than 90% (some approach 100%)
Cost: ~$38,00-$91,000

19. Who should be treated?
Cure of HCV results in improved survival, reduced morbidity, and higher quality of life.
Safety and efficacy of newer regimens create a benefit for all patients with chronic HCV infection, except for those with a limited life expectancy due to non-related diseases (< 12 months)
To treat the ~29,000 identified IHS patients with Harvoni® for 12 weeks would cost ~ $1.1 billion.
With limited resources, the recommendation is to prioritize treatment to those at highest risk
Advanced fibrosis
Transplant recipients
Severe extrahepatic manifestations
High-risk for fibrosis progression (HIV coinfection, diabetes, coexisting liver disease)

20. Risk Stratification
The degree of liver fibrosis (scarring) is used as a measure for the severity of the liver disease
The gold standard for determining fibrosis is a liver biopsy
Not the most practical test due to limited availability, costs, and risk.
Calculation based on blood tests can be used to approximate fibrosis (APRI, FIB-4)
Hepatitis C Risk Stratification Panel
Export iCare panel into Excel tool
Automatically calculates APRI and FIB-4

21. Paying for Treatment
CMS and some third party insurers will pay for antiviral therapy for HCV infection.
Why?
Liver transplant cost ~$300,000 + $25,000/yr for antirejection drugs
Cirrhosis cost ~$25,000 per admission
Various eligibility criteria can still limit access
Patient Assistance Programs
Drug company sponsored programs that provide free medication
Most meet low-income eligibility
Non-formulary status has been critical

22. Mandating Treatment
VA announced in Feb that they would provide treatment to all HCV patients.
Set aside $700 million for drug cost
Completed depleted fund by June.
The budget shortfall required the VA to pull back and prioritize treatment
IHS policy for federal IHS facilities is in early draft form.

23. Supports for Treatment
Previously, many patients with HCV received treatment under the care of hepatologist or infectious disease specialist.
The safety of newer treatments and the growing number of patients is shifting care more and more to primary care.
Extension for Community Healthcare Outcomes (ECHO)
UNM developed model for teleconsultation
Multiple options
Univ. of WA
IHS- 1st Wed.,12:00-1:00 pm MDT

24. Recommendations
Screen for Hepatitis C Infection (High-risk, Baby Boomers).
Use a confirmatory test for all positives.
Educate all HCV + patients on liver protection (alcohol/drugs), prevention of spread, and vaccinate against Hepatitis A & B.
Create a HCV panel and risk-stratify patients.
Use a multi-pronged approach to providing treatment (CMS, third-party, patient assistance programs).
Utilize ECHO supports.

25. Questions?