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Prevention of Perinatal HBV and HCV Transmission John W. Ward, M.D. Director, Division of Viral Hepatitis Centers for Disease Control and Prevention Division of Viral Hepatitis National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Natural History of HBV Infection Varies depending on age of infection Among infected children acute (symptomatic) hepatitis B rare; likelihood of developing chronic infection high: Age at infection <1 year 1-5 years >5 years Acute HBV <1% 5-15% 20-50% Chronic HBV 90% 25-50% 6-10% Morbidity and mortality associated with chronic infection > 90% of deaths from cirrhosis and hepatocellular carcinoma Current Recommendations to Eliminate HBV Transmission among Vaccinated Pediatric Cohorts United States Universal Birth dose of Hepatitis B vaccine- 70% coverage Timely completion hepatitis B vaccine series -93% coverage Maternal HBsAg testing - >90% Infants of HBsAg+ mothers HepB vaccine /HBIG < 12 hours of birth Post-vaccination serology* (HBsAg and anti-HBs) ~1 % of infants become HBsAg+ CDC, MMWR 2012, 2013 4 Hepatitis B Vaccine Policy and Rates of Acute Hepatitis B, U.S.,1980-2011 Cases/100,000 population 14 Universal maternal HBsAg testing 1988 12 Ages 0-18 years, 1999 10 8 6 4 2 0 Infants of HBsAg-positive women, 1984 High-risk groups,* 1982 Adults <60 years with Diabetes Birth dose, 2006 All US infants, 1991 Year *Health care providers, MSM, IDU, hemodialysis patients, household & sexual partners of persons with chronic HBV, persons in certain institutional settings, e.g, inmates of long-term correctional facilities. Source: National Notifiable Disease Surveillance System (NNDSS) 5 HepB Vaccination Has Decreased HBV incidence Protecting Newborns Remains a Challenge HCV incidence 7 6 7000 6000 5000 4000 3000 2000 1000 0 HepB vaccination, infants, at risk adults a 5 Catch-up, older children 4 3 Birth dose 2 Diabetics 1 0 1992 1997 2002 2007 2010 2012 2013 2014 ~1000 HBsAg+ newborns/yr. Improve birth dose coverage Infant case management Consider anti-viral prophylaxis Outcomes of Infants Born to HBsAg+ Women – United States 2008-2013 120% 95% 89% 100% 96% 80% 60% 40% 20% 1% 0% Total Foreign born HepB <12 hrs.95% HBIG <12 hrs. HBsAg+ infants 17, 951 mother –infant pairs; 11,,335 with data for HBIG/HepB status; 100 HBsAg+ infants S Schillie, Pediatrics 2015 Interventions to Improve Prevention of Perinatal HBV Transmission Case management of HBV exposed infants - Maternal HBV testing- USPSTF recommendation - Hepatitis B Perinatal Prevention Coordinators- manage ~50% of exposed infants - Addition of pregnancy status to HBV test requisitions - Medicaid support for case management (discussed with CMS) Birth dose - CDC recommendation – for vaccination before hospital discharge - Standing orders - Evaluation criteria for licensing of birth facilities Results of Perinatal Prophylaxis to Prevent Vertical Transmission of HBV 3353 HBV exposed infants received HBIG, HepB vaccine < 12 hrs of birth 99% of infants protected from HBV infection 25 infants (0.75%) became HBV infected; 0.75/100 births 24/25 born to HBeAg+ mothers; (RR 79.92) All transmissions at maternal HBV DNA > 5 × 107 IU/mL Kubo A et al. Ann Intern Med. 2014 Jun 17;160(12):828-35 9 Cost-Effectiveness : HBeAg or HBV DNA Testing vs. Current Recommendation Variable Decrease in perinatal transmission with antiviral treatment ICER ($/QALY saved) Range 20% - 80% reduction Sequential HBeAg test Sequential HBV DNA load test Cost saving – 4,708 Cost saving – 11,167 L, Fan, Obstet Gynecol. 2014 May 10 UPDATING ACIP RECOMMENDATIONS FOR HEPATITIS B VACCINATION Advisory Committee for Immunization Practices ACIP October 2016 Updates to ACIP Statement o Hepatitis B vaccine birth dose administered within 24 hours of birth for medically stable infants weighing ≥2,000 grams and born to HBsAgnegative mothers o Testing HBsAg-positive pregnant women for hepatitis B virus (HBV) DNA to guide the use of maternal antiviral therapy during pregnancy for prevention of perinatal HBV transmission o Refer to AASLD recommendation for the use of antiviral therapy among mothers with HBV DNA >200,000 IU/mL for preventing perinatal transmission o Post-vaccination serologic testing for infants whose mother’s HBsAg status remains unknown indefinitely o Recommend hepatitis B vaccination for persons with HCV and for those with chronic liver disease 12 Modes of HCV Transmission • Unsafe health care – Most common risk globally • Injection drug use- population with highest HCV prevalence • Other modes – Perinatal – Sexual transmission; rare; HIV infected MSM at highest risk – Also reported - (e,g inhaled drugs , unregulated tattooing, household) MSM: Men who have sex with men. Scheinmann, Drug and Alcohol Dependence 2006. Weinbaum ,MMWR 2003. Gough, BMC Public Health 2010. Mast, J Infect Dis, 2005. Marincovich B, Sex Transm Infect 2003. Yaphe S, Sex Transm Inf 2012. Bottieau, Eurosurveillance 2010. Ackerman Z, J Viral Hepat 2000. Tohme RA, CID 2012 ; CDC/hepatitis.gov; CDC MMWR 2001; Hagan, et al, Int J Drug Policy 2007; Perinatal Transmission of HCV • Transmission from HCV RNA + mothers – Mono-infected 6.5% – HIV –infected- 13.6% • Transmission risks – HCV viral load • < 6 log viral load- 3.9% • > 6 log viral load – 14.3% – Prolonged rupture of membranes( > 6 hours; OR 9.3) – Often cited but poor or no supportive data • Internal fetal monitoring • Vaginal versus cesarean delivery • No risk from breast feeding • No recommendations for maternal testing • Role of new antivirals yet to defined Cottrell E, Ann Int Med 2013; Delotte J, J Matern Fetal Neonatal Med. 2014 Risk of Chronic infection and Disease Progression in HCV Infected Children Chronic HCV infection - Perinatal exposures- 90% - Older children – 70-75% Disease progression - Cause of 110 of 12,439 pediatric liver transplants (1988-2010) - Children appear to have less progressive disease than adults ( no alcohol or other co-factors) - On liver biopsy of 76 HCV+ children - 35% no fibrosis - 50%- mild fibrosis - 4%- moderate/severe fibrosis - Severity related to age and duration of infection New HCV meds not yet licensed for children Abdel-Hady M. J Viral Hepat 2011; Robinso J, Liver Int 2012 3,500 Number of cases 3,000 2,500 2,000 1,500 1,000 500 0 Year Source: National Notifiable Diseases Surveillance System (NNDSS) Reported cases/100,000 population 1.6 1.4 Male 1.2 Female 1.0 0.8 0.6 0.4 0.2 0.0 Year Source: CDC, National Notifiable Diseases Surveillance System (NNDSS) PROPORTION OF BIRTHS TO HCVINFECTED WOMEN Proportion* of infants born to hepatitis C virus (HCV)-infected women† — United States and Kentucky, 2011–2014 2.0% 1.5% ~1600 infants born with HCV infection in 2014 1 of 67 births 1.0% 1 of 308 births 0.5% 0.0% 2011 2012 2013 YEAR OF INFANT BIRTH 2014 * Proportion calculated annually as infants born to HCV-infected women divided by totalKentucky infants born. United States † HCV infection status of mother is determined by notation on infant’s birth certificate. Birth categorization is based on mother’s place of residence. Reports of HCV among Pregnant Women, Kentucky December 2013 – July 2015 HR Sands et al. Perinatal Hepatitis C Surveillance in Kentucky, Dec 2013-July 2015 Distribution of HCV Among Young Persons and Location of Syringe Service Programs 29,382 persons 15-29 years with HCV Syringe Service Program 1 dot = 1 person HCV Cases: LabCorp and Quest commercial laboratories SSPs: North American Syringe Exchange Network Canary L, Hariri S, Campbell C, et al. “Geographic disparities in access to syringe service programs among young people with hepatitis C virus infection in the U.S.” November 2016. In Peer Review. CDC and USPSTF Updated Recommendations for HCV Testing One time screening test for persons born 1945-1965 Major risk Past or present injection drug use Other risks Received blood/organs prior to June 1992 Received blood products made prior to 1987 Ever on chronic hemodialysis Infants born to HCV infected mothers Intranasal drug use Unregulated tattoo History of incarceration Medical Persistently elevated ALT HIV MMWR Aug 2012. Moyer VA, Ann Int Med 2013. Considerations to Improve Prevention of HCV among Pregnant Women and their Children • Improve HCV risk screening or routine testing – Pregnant women, HCV exposed newborns: improve early identification of HCVinfected infants and linkage of the mother and infant to care and treatment – Women of reproductive age or in family planning- linkage to care, treatment, and cure to avoid HCV infection during pregnancy – Other newborns with illicit drug exposures (e.g. neonatal abstinence syndrome) – Frequency of testing, regional or national recommendations Considerations to Improve Prevention of HCV among Pregnant Women and their Children Surveillance • Utilize existing data – birth certificate data –Cross matching HCV and birth certificate registries ( e.g., Phil) –Mandated reporting of HCV among pregnant women, exposed infants and children (e.g, KY) – Reporting pregnancy status as part of HCV lab-based surveillance • • DVH work group formed, expert consultation planned Considerations to Improve Prevention of HCV among Pregnant Women and their Children Next Steps • Utilize existing data – birth certificate data –Cross matching HCV and birth certificate registries ( e.g., Phil) –Mandated reporting of HCV among pregnant women, exposed infants and children (e.g, KY) – Reporting pregnancy status as part of HCV lab-based surveillance • • DVH work group formed, expert consultation planned Thank You