2/20/2018 Hepatitis C Virus Screening & Treatment: What does an - PDF document

2/20/2018 Hepatitis C Virus Screening & Treatment: What does an Ob/Gyn need to know? Ricardo A. Franco, MD Assistant Professor of Infectious Diseases University of Alabama at Birmingham Disclosures I disclosed that I have received funds for research support from Merck, Janssen and Gilead and consulting fees from Gilead Outline • Epidemiological trends concerning women’s health • Hepatitis C and Perinatal Care • Hepatitis C Care and Treatment in 2018 1

2/20/2018 Estimated prevalence of anti-HCV and HCV RNA in persons aged ≥6 y - NHANES Blood supply screening Disease incidence decreases Steady liver dz death rates Limited treatment options Denniston MM, Jiles RB, Drobeniuc J, et al. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160(5):293-300. Number of Individuals in the United States With Hepatitis C Antibody and Viremia Edlin BR, Eckhardt BJ, Shu MA, et al. Toward a more accurate estimate of the prevalence of hepatitis C in the United States. Hepatology . 2015 Nov;62(5):1353-63 Reported Number of Acute Hepatitis C Cases, United States, 2000-2014 3,500 3,000 30 000 incident infections in 2014 2,500 Number of cases 2,000 1,500 1,000 500 0 Year Source: CDC, National Notifiable Diseases Surveillance System (NNDSS) 2

2/20/2018 Emerging HCV Epidemic Among Young Nonurban Persons Who Inject Drugs in the US, 2006 – 2012 Source: CDC, National Notifiable Diseases Surveillance System (NNDSS) Clin Infect Dis. 2014;59:1411-9 Trends in acute HCV incidence among young persons by Urbanicity, 2006 – 2012 Among young persons who inject drugs, about half are women in reproductive age Clin Infect Dis. 2014;59:1411-9 Vertical Transmission of Hepatitis C Virus: Systematic Review and Meta-analysis Clinical Infectious Diseases , Volume 59, Issue 6, 15 September 2014, Pages 765 773 3

2/20/2018 HCV detection rate (females aged 15 – 44 years) and testing rate (children aged = 2 years) — US and KY 2011-14 Source: Quest Diagnostics reporting to CDC 151% 213% 14% 22% MMWR Morb Mortal Wkly Rep 2016;65:705 – 710 Proportion of infants born to hepatitis C virus (HCV)- infected women — US and KY, 2011 – 2014 Source: Birth Certificate data 124% 68% MMWR Morb Mortal Wkly Rep 2016;65:705 – 710 Prevalence of HCV Infection in Pregnancy • This has been difficult to determine – Estimated in 1-8% worldwide; 1-2.5% in the US (as high as 4% in high risk populations) – Routine screening is not performed in this population (but rather is risk based) • Many HCV infections go undetected (under-recognition of risk behaviors) – Concerns about stigmatization or legal consequences of risk behaviors – Even when HCV infection is detected, most at-risk children are not screened subsequently and do not receive appropriate medical care MMWR Morb Mortal Wkly Rep. 2016 Jul 22;65(28):705-10 Clin Infect Dis. 2016; 62: 980-5 4

2/20/2018 CDC Analysis of the National Notifiable Diseases Surveillance System and the Quest Diagnostics Health Trends Estimated Number of HCV-Infected Women Who Gave Birth and of HCV-Infected Infants – 2011 to 14 Number of reported cases of HCV infection among women aged 15 – 44 years and 45 – 64 • 3.9 million live births occurred/year years in the United States, 2006 – 2014 • 0.73% of pregnant women tested for HCV infection were found to have the infection • 29 000 women (0.73%) with HCV infection gave birth during that period • 1700 infants (5.8% vertical transmission rate) were born with HCV infection/year Ann Intern Med. 2017;166(11):775-782 Women in Whom Prenatal Screening for HCV is Recommended • Women who ever injected illegal drugs (even once) • Users of intranasal illicit drugs • Women ever on long-term hemodialysis • Women with percutaneous/parenteral exposures in unregulated setting (eg, tattoos received outside of licensed parlors or medical procedures done in settings without strict infection control policies) • Recipients of transfusions or organ transplants before July 1992 and recipients of clotting factor concentrates produced before 1987 • Recipients of blood products from donor who later tested positive for HCV • Women with history of incarceration • Women seeking evaluation or care for sexually transmitted infection, including HIV • Women with unexplained chronic liver disease (including persistently elevated ALT) American College of Obstetricians and Gynecologists. Viral hepatitis in pregnancy. Practice bulletin no. 86. Obstet Gynecol 2007;110:941-55. Screening Tests for HCV ELISA Screening Tests HCV RNA Assays • Serologic assays to detect circulating HCV antibodies • When to test? • Sensitivity (97%-100%) – If anti-HCV Ab test result is positive • Positive predictive value – If antiviral treatment is being – 95% with risk factors + elevated ALT considered – 50% without risk factors + normal ALT – If unexplained liver disease and anti- • False-positive results HCV Ab test result is negative and – More likely in patients with low risk of HCV person is immunocompromised infection – If acute HCV infection is suspected • False-negative results – More likely in severely immunocompromised patients 1. AASLD and IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report-view. Accessed April 18, 2017. 2. Smith BD et al. MMWR Recomm Rep . 2012;61:1-32. 3. Moyer VA et al. Ann Intern Med . 2013;159:349-357. 4. World Health Organization, April 2014. www.who.int. 5

2/20/2018 Effects of HCV in Pregnancy Gervais A, Bacq Y, Bernuau J, et al. J Hepatol 2000;32:293-9 Intrahepatic Cholestasis of Pregnancy higher risk of ICP in HCV+ pregnant women increased risk of later HCV diagnosis in ICP patients Wijarnpreecha K, Thongprayoon C, Sanguankeo A, Upala S, Ungprasert P, Cheungpasitporn W. Hepatitis C infection and intrahepatic cholestasis of pregnancy: a systematic review and meta-analysis. Clin Res Hepatol Gastroenterol 2017;41:39-45. Pregnancy complications associated with HCV • Washington state birth cohort, 2003-2005 Outcome OR 95% CI Low birthweight 2.17 1.24 - 3.80 Small for gestational age 1.46 1.00 - 2.13 Need assisted ventilation 2.37 1.46 - 3.85 Require NICU admission 2.91 1.86 - 4.55 – HCV-positive mothers with excess weight gain also had a greater risk of gestational diabetes (OR, 2.51; 95% CI, 1.04, 6.03) – Compared with the drug-using cohort, NICU admission and the need for assisted ventilation remained associated with HCV Pergam SA, et al. Pregnancy complications associated with hepatitis C: data from a 2003-2005 Washington state birth cohort. Am J Obstet Gynecol 2008;199:38.e1-9 6