우리나라간염관리대책평가및개선방안연구 과제배경및경과보고 우리나라간염관리대책평가및개선방안연구사업단 실무총괄신동현
1. 바이러스간염종류및치료의발전 2. 연구과제배경및경과보고
Characteristics HAV Genome RNA Family Incubation (days) Transmission Picornaviridae 15-45 Fecal to oral Prevention Vaccine Dr. Feinstone and colleagues (1970s) Chronicity No Treatment Symptomatic
HBV Genome DNA Family Incubation (days) Transmission Hepadnaviridae 30-180 Blood Dr. Blumberg and colleagues (1960s) Prevention Chronicity Vaccine Yes Treatment Antivirals
Cohort 1: born before HBV vaccine (1983) Cohort 2: born after HBV vaccine (1983) cohort 1 cohort 2 50 40 30 20 10 0 40.2 16.4 HBsAg positive mother 2.3 0.4 HBsAg negative mother http://www.genscript.com/recombinant-vaccine.html; Jeong et al, Epidemiol Infect 2010
Ganem et al, NEJM 2003; Dienstage New Engl J Med 2008
Liaw et al, N Engl J Med 2004
HBV HBV Host Cell cccdna Nucleus Host DNA Treatment Goal: Life-long viral suppression 1 Soriano et al., J Antimicrob Chemother 2008; Cho JY et al, Gut 2014
HCV Genome RNA Family Incubation (days) Transmission Flaviviridae 15-150 Blood Dr. Choo and colleagues (1989s) Prevention Chronicity None Yes Treatment Antivirals Choo et al, Science 1989;244:359
HCV HCV HBV HBV HIV HIV Viral RNA Host Cell Host Cell cccdna Host Cell Proviral DNA Nucleus Host DNA Nucleus Host DNA Nucleus Host DNA Treatment Goal: Viral eradication 1 Treatment Goal: Life-long viral suppression 1 Treatment Goal: Life-long viral suppression 1 Majority of patients who achieve an sustained virological response do not experience viral recurrence 2 1. Soriano V, et al. J Antimicrob Chemother. 2008; 2. Swain MG, et al. Gastroenterology. 2010
100 PegIFN DAAs 2011 2013 90+ 80 60 40 Standard IFN 1991 RBV 1998 34 42 2001 39 55 70+ 20 16 6 0 IFN 6 mos IFN 12 mos IFN/RBV 6 mos IFN/RBV 12 mos PegIFN 12 mos PegIFN/ R BV 12 mos PegIFN/ RBV/ DAA DAAs Adapted from the US FDA, Antiviral Drugs Advisory Committee Meeting, 2011
Will it be eradicated as a smallpox? The last case of wild smallpox occurred in Somalia in 1977 Smallpox HCV Only human can transmit Yes Yes Highly effective vaccine present Easily recognized Lifelong immunity develop Yes Yes Yes No But, highly effective medication are present No But, simple screening methods are present No, But, recurrence after eradication of the virus is rare
HDV HEV Genome RNA RNA Family Deltavirus Hepaviriade Incubation (days) 30-180 15-60 Transmission Blood Oral Prevention HBV Vaccine Vaccine Chronicity Yes Rare Treatment Antivirals Symptomatic
1. 바이러스간염종류및치료의발전 2. 연구과제배경및경과보고
Global burden of disease 2010; www.healthmetricsandevaluation.org/gbd
Global Burden of Disease and WHO/UNAIDS estimates
TARGET AREA BASELINE 2015 2020 TARGETS 2030 TARGETS Hepatitis B virus vaccination: childhood vaccine coverage 82% in infants 90% 90% Prevention of hepatitis B virus mother-to-child transmission: 38% 50% 90% Blood safety 39 countries do not routinely test all blood donations for transfusion-transmissible infections 95% of donations screened in a quality assured manner 100% of donations are screened in a quality assured manner Safe injections: percentage of injections administered with safety-engineered devices in and out of health facilities Harm reduction: number of sterile needles and syringes provided per person who injects drugs per year Viral hepatitis B and C diagnosis Viral hepatitis B and C treatment 5% 50% 90% 20 200 300 <5% of chronic hepatitis infections diagnosed <1% receiving treatment 30% 90% 5 million people will be receiving hepatitis B virus treatment 3 million people have received hepatitis C virus treatment 80% of eligible persons with chronic hepatitis B virus infection treated 80% of eligible persons with chronic hepatitis C virus infection treated
( 가 ) 2015 년사망원인순위및사망률 - 통계청발표자료 - ( 나 ) 2015 년사망원인순위및사망률 - 간질환 / 간암통합시 - 악성신생물 ( 암 ) 150.8 악성신생물 ( 암 ) 128.6 심장질환 55.6 심장질환 55.6 뇌혈관질환 48.0 뇌혈관질환 48.0 폐렴 28.9 간질환 + 간암 35.6 자살 26.5 폐렴 28.9 당뇨병 20.7 자살 26.5 만성하기도질환 14.8 당뇨병 20.7 간질환 13.4 만성하기도질환 14.8 0 50 100 150 200 0 50 100 150
Cirrhosis HCC Prevention by HBV vaccination Primary prevention Prevention of HCV transmission Alcohol, smoking, metabolic syndrome Secondary prevention Antiviral therapy for HBV, HCV Management of chronic hepatitis
2016. 5. 9 우리나라간염관리대책개선방안연구입찰공고 과제 번호 사업명 사업기간 사업예산 ( 부가가치세포함 ) 담당부서 / 담당자 2 우리나라간염관리대책개선방안연구 6 개월 50,000 감염병관리과 / 송정숙
정책연구용역사업제안요청서 정책연구과제명 연구방식 우리나라간염관리대책평가및개선방안연구 1. [V] 위탁형용역 2. [ ] 공동연구형용역 3. [ ] 자문형용역 연구기간계약일 ~ 2016.11.30. ( 6 개월 ) 계약방법 1. [V] 일반경쟁 2. [ ] 수의계약 우리나라는 A, B 형간염에대한관리대책은마련되어있으나그외바이러스간염에대한대책부재 연구의목적및필요성 WHO 에서는바이러스간염을전세계공중보건문제로인식, 각국에바이러스간염관리를촉구하고 있으며, 15 년바이러스간염에대한 5 개년전략을수립하고 30 년까지바이러스간염퇴치달성목표 이에, 국내에서도 WHO 의바이러스간염관리정책에맞추어바이러스간염관리에대한국가적대책을 수립하고바이러스간염전파예방및확산방지를위한전략수립필요 ( 수행체계 ) 수행기관에서연구를진행하고발주부서에서이와관련하여필요한행정사항지원, 정도 관리및중간점검, 최종평가등수행 ( 연구내용및방법 ) 문헌고찰을통해대책을평가를수행하고해외사례조사등을통해간염관리대책 연구내용 을수립하며, 국가정책에반영하기위한효과적인추진방안모색 - 우리부처및관련부처의바이러스간염관리정책에대한평가 - WHO 의바이러스간염관리정책및외국의대책조사 연구결과활용방안 - 바이러스간염퇴치수준목표달성을위한중장기적개선대책수립 종료시제출연구결과물 종료후연구결과활용계획 최종결과보고서 1. [ ] 법령제 개정 2. [ ] 제도개선 3. [ ] 정책반영 4. [V] 정책참조
2016.5.9 대한간학회공문수신후의료정책위원회에서준비하여상기 공모과제에지원하기로함 2016.5.13 공모과제지원사전준비회의 ( 서울팔래스강남, 참석자 : 최문석, 김윤준, 김도영, 김지훈, 김형준, 신동현, 조은주 ) 에서상기과제에공모하기로하고, 의료정책위원을중심으로연구진을구성하여제안서작성하여질병관리본부에제안서를제출 2016. 6.3 질병관리본부연구과제계획대면평가 2016. 6.13 정책연구용역사업협상적격자통보 2016. 6.29 정책연구용역사업과제계약
우리나라간염관리대책평가및 개선방안연구사업단책임연구원 최문석대한간학회정책이사성균관의대삼성서울병원교수 실무총괄 신동현 ( 성균관의대 ) 연구자문전병율前질병관리본부장차의과대학예방의학교실교수 총괄운영위원회김윤준 ( 서울의대 ) 김도영 ( 연세의대 ) 김지훈 ( 고려의대 ) 신동현 ( 성균관의대 ) 조은주 ( 서울의대 ) 고재성 소아소화기학 서울의대소아청소년과교수
정책연구용역사업과제를세분과로나누어진행함 실무 1 분과 B 형 /D 형간염 실무 2 분과 C 형간염 실무 3 분과 A 형 /E 형간염 김윤준 ( 서울의대 ) 정우진 ( 계명의대 ) 안지현 ( 울산의대 ) 조은주 ( 서울의대 ) 김성은 ( 한림의대 ) 석기태 ( 한림의대 ) 정승원 ( 순천향의대 ) 김도영 ( 연세의대 ) 김형준 ( 중앙의대 ) 김정한 ( 건국의대 ) 박수영 ( 경북의대 ) 김범경 ( 연세의대 ) 안성복 ( 연세의대 ) 장은선 ( 서울의대 ) 김지훈 ( 고려의대 ) 이현웅 ( 중앙의대 ) 신동현 ( 성균관의대 ) 윤아일린 ( 인제의대 )
2016.7.20 정책연구용역사업착수보고회 ( 서울역회의실 KTX II) 2016.9.6 정책연구용역사업중간보고회 ( 삼경 C&M 회의실 ) 2016.11.7 정책연구용역과제자문위원회 2016.11.23 정책연구용역과제토론회