Hepatitis C. David Byers, MD, FACP Senior Medical Director for Infectious Diseases and Wound Healing Services Southern Ohio Medical Center

Transcription

1 Hepatitis C David Byers, MD, FACP Senior Medical Director for Infectious Diseases and Wound Healing Services Southern Ohio Medical Center

2 DISCLOSURE The speaker and members of the planning committee do not have a conflict of interest in this topic. There is no commercial support for this program.

3 Objectives In 45 minutes we ll try to cover. Epidemiology Natural history Evaluation and Treatment Current barriers

4 Hepatitis C

5 Magnitude of the Problem 3-4 million persons in United States infected Approximately 35,000 new cases yearly Acute infections on the rise since 2010 <10% chronically infected patients are treated Leading cause of Chronic liver disease Cirrhosis Liver cancer Liver transplantation

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7 A Global Disease Hepatitis C - Chapter Yellow Book Travelers' Health CDC

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9 Hepatitis C

10 Number of cases 3,500 3,000 2,500 2,000 1,500 1, Year Source: CDC, National Notifiable Diseases Surveillance System (NNDSS)

11 Reported cases/100,000 population yrs yrs yrs yrs yrs > 60 yrs Year Source: CDC, National Notifiable Diseases Surveillance System (NNDSS)

12 Risk Factors for HCV Injection drug use (60%) Blood transfusion before 1992 Multiple sex partners Iatrogenic (hemodialysis, re-use of vials, etc) Intranasal cocaine Piercing, tattooing, scarification Unknown (10%)

13 HCV Prevalence (%) HCV Prevalence of Anti-HCV Among Street Injection Drug Users San Francisco Bay Area, < Injection Drug Use Duration (Years) Source: Tseng FC, et al. Hepatology. 2007;46:

14 Indications for HCV screening? HIV IVDU History of chronic HD, transfusion, blood product or organ transplant prior to 1992 Unexplained persistent elevation in ALT and.

15 Hepatitis C: Screening guidelines CDC 2012: Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During Recommendations and Reports, August 17, 2012 one-time testing without prior ascertainment of HCV risk for persons born during , a population with a disproportionately high prevalence of HCV infection and related disease.

16 HCV Prevalence(%) NHANES Survey: United States, and Prevalence of HCV Antibody, by Year of Birth Year of Birth Armstrong GL, et al. Ann Intern Med. 2006;144:

17 How Do We Test for HCV?

18 What Happens To Those Who Get Hepatitis C?

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21 Factors Associated with Spontaneous Clearance IL28 (C/C) more common in those of European descent The presence of specific HLA-DRB1 and DQB1 alleles High titers of neutralizing antibodies against HCV structural proteins Host neutralizing responses that target viral entry after HCV binding The persistence of an HCV-specific CD4 T-cell response White patients with relatively low peak levels of HCV viremia during acute infection Female sex Infection during childhood Symptomatic acute infection

22 Predictors Related to Rate of Progression of Fibrosis Older age at infection Male sex Alcohol HIV infection Post-transplant Quasispecies complexity Presence of comorbid liver diseases

23 Hepatitis C Evaluation Key elements of the patient s history When and how diagnosed Risk factors Work-up to date Prior treatment status Comorbidities Family history of liver disease Current medications

24 Initial Medical Work-up HCV Viral Load Genotype CBC CMP PT/INR ANA Iron Studies A1-AT* Wilson s* HIV Hepatitis B sag Hep B sab Hep A total Ab Drug Screen Pregnancy Test RUQUS Fibrosis Staging

25 Hepatitis C Genotype Genetically distinct variants of the virus Affects treatment options

26 Fibrosis Staging Fibrosis is one of the end results of HCV infection Important baseline information which can affect treatment Duration/drug Insurance coverage Patients with advanced fibrosis need ongoing screening for complications (HCC, varices)

27 Fibrosis Staging: How? Biopsy remains the gold standard Patients aren t enthusiastic about it Sampling error possible It is invasive Some insurers require Fibroscan Reproducible, relatively sensitive and specific Now available at SOMC! Fibrosure Can over-estimate disease APRI/FIB-4 Cheap, available but lower sensitivity/specificity Afdhal, et al. Clin Gastroenterol Hepatol

28 Counseling for those with Hep C Avoid additional liver injury Hepatitis A and B vaccination Prevent transmission to others Survives on surfaces - 16 hours to 4 days and in liquid 2 days to 20 weeks depending on temperature Avoid sharing items with potential blood contamination - Razors - Nail clippers - Toothbrushes Clean Up Any Blood Spill with Appropriate Method - Use dilution of 1 part bleach to 10 parts water - Wear gloves during clean up of blood spill

29 Can Hepatitis C be spread through sexual contact? Yes, but the risk of transmission from sexual contact is believed to be low. The risk increases for those who have multiple sex partners, have a sexually transmitted disease, engage in rough sex, or are infected with HIV. More research is needed to better understand how and when Hepatitis C can be spread through sexual contact. Source: CDC and Prevention. Hepatitis C FAQ for the Public

30 Heterosexual Transmission of Hepatitis C among Monogamous Serodiscordant Couples 895 monogamous heterosexual spouses of HCV-infected individuals Couples prospectively followed for 10 years Follow-up of 7,760 person years of observation Couples denied: anal sex, sex during menses, or condom use 3 transmissions occurred - Incidence 0.37/1000 person-years - Phylogenetic analysis did not support sexual transmission Conclusion: Our data indicate that the risk of sexual transmission of HCV within heterosexual monogamous couples is extremely low or even null. No general recommendations for condom use seem required for individuals in monogamous partnerships with HCVinfected partners. Source: Vandelli C, et al. Am J Gastroenterol. 2004;99:855-9.

31 2010 CDC STD Guidelines Recommendations for Preventing Hepatitis C Transmission HCV-positive persons with one long-term, steady sex partner do not need to change their sexual practices. They should discuss the low but present risk for transmission with their partner and discuss the need for counseling and testing. Source: Workowski KA, et al. MMWR Recomm Rep. 2010;59(RR-12):1-110.

32 Hepatitis C among HIV-Infected MSM Identified Risk Factors for HCV Infection Unprotected anal intercourse Concurrent anogenital infections Sex while high on methamphetamine Rough (traumatic sexual practices) Group sex Source: Garg S, et al. Clin Infect Dis Feb 5. [Epub ahead of print].

33 Mother-to-Child Transmission of Hepatitis C Risk of Transmission Annual births with HCV-infected mothers: estimated at 40,000 Risk of Transmission from mother-to-child: 3-10% Factors Identified that Increase Risk of Transmission - High HCV RNA at delivery - Maternal HIV coinfection - Female gender of baby - Prolonged rupture of membranes Factors NOT Identified to Increase Risk of Transmission - Cesarean delivery - Breastfeeding Source: Cottrell EB, et al. Ann Intern Med. 2013;158:

34 Hepatitis C Treatment

35 Hepatitis C Treatment: Where We Were

36 Where We Are

37 Applied lessons learned treating disease such as HIV to target specific steps in viral replication

38 Hepatitis C Treatment Guidelines recommend treatment for all Treatment often* specific for: Genotype degree of fibrosis Changes frequently due to new drug development Guidelines are updated in real time (web based) due to rapid changes

39 Genotype 1 a/b

40 Genotype 2

41 Genotype 3

42 Do The Meds Work? Harvoni for GT1 Afdhal, et al. NEJM ION-1

43 Do The Meds Work? Epclusa for GT 1,2,4,5,6 (ASTRAL) Field, et al. NEJM ASTRAL

44 Do the Meds Work? Epclusa for GT3 (ASTRAL-3) Foster, et al. NEJM ASTRAL-3

45 Side effects? These meds are incredibly well tolerated Most common side effect is no side effects As a class, are associated with headache, fatigue, insomnia not dramatically different from placebo Drug-drug interactions remain a challenge PPI s for all but Zepatier and Sovalidi/Daklinza

46 So What Happens After Treatment Goal is no detectable virus 12 weeks after treatment (SVR12)- this is considered cure Benefits of SVR Lower risk of HCC Lower risk of cirrhosis Lower risk of decompensation for those w/ cirrhosis Lower risk of all cause mortality Pearlman & Traub. CID, 2011.

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48 So Everyone is Cured Now, Right? Unfortunately no Graphic: hepatitisc.uw.edu

49 Barriers to HCV Treatment Essentially all insurance companies require proof of six months of drug abstinence Medicare and most private insurance companies are covering Medicaid programs have declined coverage for all except those with significant fibrosis (F3-4) Patient assistance programs from the drug companies haven t helped many

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51 Graphic: RIPR.org(2014)

52 Summary Hepatitis C is a blood-borne infection that disproportionately affects our area Treatment has been revolutionized by newer medications The medications are highly effective and low side-effect This life saving medication is still out of reach for many due to insurance restrictions

53 Questions/Comments??