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Hepatitis C The Silent Epidemic

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Presentation on theme: "Hepatitis C The Silent Epidemic"— Presentation transcript:

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?


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