SEA-Hepat.-5 SEA-EPI-141 Distribution: General Prevention of Hepatitis B in India An Overview World Health Organization Regional Office for South-East Asia New Delhi August 2002 (C) World Health Organization (2002) This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced or translated, in part or in whole, but not for sale or for use in conjunction with commercial purposes. The views expressed in documents by named authors are solely the responsibility of those authors. CONTENTS Page 1. HEPATITIS B IN INDIA: BURDEN OF DISEASE ANALYSIS................................1 1.1 Introduction.............................................................................................1 1.2. Background .............................................................................................1 1.3 Hepatitis B Immunization ........................................................................3 1.4 Hepatitis B in India..................................................................................4 1.5 Conclusions and Implications...................................................................9 2. INCLUSION OF HEPATITIS B VACCINE IN NATIONAL IMMUNIZATION PROGRAMME IN INDIA: A REVIEW OF ECONOMIC ANALYSES .................10 2.1 Introduction...........................................................................................10 2.2 Economic Analyses in Health Care.........................................................11 2.3 Relevant Economic Analysis of Hepatitis B Vaccines in other Parts of the World ........................................................................18 2.4 Economic Analyses of Hepatitis B Vaccines in India ...............................19 2.5 Cost-benefit Analysis..............................................................................27 2.6 Summary of Findings of Cost-effectiveness Studies in India ....................27 2.7 Possible Limitations of Cost-effectiveness Studies in India ......................29 2.8 Conclusions ...........................................................................................32 3. ACTION PLAN FOR INTRODUCTION OF HEPATITIS B VACCINE INTO IMMUNIZATION SERVICES IN INDIA ..................................32 3.1 Introduction...........................................................................................32 3.2 Goals and Objectives of Hepatitis B Immunization ................................34 3.3 Strategies for Hepatitis B Immunization .................................................35 3.4 Approach to Vaccine Introduction: Phased Introduction........................36 3.5 Vaccine Logistics....................................................................................38 3.6 Cold Chain Logistics ..............................................................................39 3.7 Administrative Aspects...........................................................................40 3.8 Training .................................................................................................40 Page iii 3.9. Information, Education, Communication (IEC) .......................................41 3.10 Programme Evaluation...........................................................................42 Annexes 1. Studies of HBsAg Prevalence in India..............................................................51 2. Estimate HBsAg Prevalence by State, India......................................................53 3. Studies on Hepatitis B E Antigen (HBeAg) Prevalence Among Pregnant Women, India......................................................................54 4. Estimates (Provisional) of Hepatitis Disease Burden in a Single Year Birth Cohort, India....................................................................55 5. Summary of Available Studies on Cost Effectiveness of Hepatitis B Vaccination in the Indian Population ...........................................57 6. Summary of Main Baseline Findings of Various Studies ..................................66 7. Vaccine Logistics for Implementation of Monovalent Hepatitis B Vaccine (2001-2002)......................................................................................67 8. Estimated Expenses for IEC (Information, Education and Communication Activities), Training and Evaluation of Introduction of Hepatitis B Vaccine ...........................................................68 9. Time Table for Activities Related to Introduction of Hepatitis B Vaccine ........................................................................................69 Page iv ACKNOWLEDGEMENT We acknowledge with appreciation the valuable inputs provided by Dr. Craig Shapiro, Temporary Advisor to the Regional Director, World Health Organization, South-East Asia Region, Dr. Charu Prakash, Short-Term Consultant, World Health Organization, South-East Asia Region, Dr. Rakesh Aggarwal, Additional Professor, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow and Dr. Sudhansh Malhotra, Assistant Commissioner Child Health, Deptt. Of Family Welfare, Ministry of Health and Family Welfare, Govt. of India, in producing this comprehensive document. Page vi 1. HEPATITIS B IN INDIA: BURDEN OF DISEASE ANALYSIS 1.1 Introduction Hepatitis B is a major public health problem worldwide. Approximately 30% of the world’s population, or about 2 billion persons, have serological evidence of either current or past infection with hepatitis B virus. Of these, an estimated 350 million have chronic (lasting more than six months, and often for lifetime) HBV infection and at least one million chronically infected persons die each year of chronic liver disease, including cirrhosis and liver cancer. The hepatitis B vaccine is highly safe and effective, and prevents HBV infection and its serious consequences. The World Health Organization (WHO) recommends that hepatitis B vaccine should be given routinely to children in all countries. The purpose of this document is to review data regarding the disease burden due to hepatitis B in India, as a basis for a decision to introduce hepatitis B vaccine into the national immunization programme. 1.2. Background (1) General features of Hepatitis B virus HBV, the cause of hepatitis B infection, is a DNA virus. The outer surface membrane of HBV contains hepatitis B surface antigen (HBsAg). Detection of HBsAg in the serum of an individual indicates that the person is currently infected with the virus. Detection in the serum of hepatitis B e antigen (HBeAg), a soluble protein in the inner core of the virus, correlates with the presence of virus in large amounts and is associated with greater infectivity. Page 1 Prevention of Hepatitis B in India: An Overview Another agent, called hepatitis D virus (HDV), is an incomplete virus that requires the presence of HBV infection for replication. HDV cannot multiply in the absence of hepatitis B virus. Persons with acute or chronic HBV infection are at risk of infection with HDV. HDV infection in a person with chronic HBV infection significantly increases the risk and rapidity of serious outcomes of HBV infection, including cirrhosis and liver failure. (2) Clinical features of hepatitis B Infection with HBV can cause both short-term (acute) disease and long-term (chronic) disease. Acute hepatitis B occurs approximately 45-160 days after exposure to the virus. Symptoms associated with acute HBV infection typically include abdominal pain, nausea, fatigue, and jaundice (yellowing of the skin and eyes), but can range from none to occasionally fulminant hepatitis and death within days or weeks of onset of symptoms. Young children with acute HBV infection generally do not have symptoms. In comparison, adults with acute HBV infection are more likely to develop symptoms; however, even among them, a large majority (75%) of HBV infections go entirely unnoticed. Acute HBV infection can lead to one of several outcomes. Most patients with acute infection recover from the infection in a few weeks to a few months and become immune. A small minority (nearly 1% of those with symptomatic acute hepatitis) persons with acute HBV infection develop a serious illness, known as fulminant hepatitis, which is fatal in a large majority within days or weeks of onset of symptoms. Some persons with acute HBV infection develop a chronic infection. The risk of development of chronic HBV infection depends on the age at which HBV infection acquired. If the infection is acquired soon after birth, the risk of it becoming chronic is around 90%. This rate rapidly come down with increase in age at the time of infection, and by the age of six years, reaches the adult level of around 5%. Most of the serious outcomes due to HBV infection occur in persons who develop chronic HBV infection. Persons with chronic HBV infection may be asymptomatic for decades after infection; however, these persons are at high risk of eventually developing liver cirrhosis and/or primary liver cancer. The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for persons who become chronically infected during childhood and approximately 15% for persons who become chronically infected at an older age. Page 2 Prevention of Hepatitis B in India: An Overview (3) Transmission of Hepatitis B virus HBV is found in blood and blood-derived body fluids of infected persons. Transmission results by either percutaneous or mucosal exposure to blood or other infectious body fluids.