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7 Management of Hepatitis B and HIV Coinfection Clinical Protocol for the WHO European Region (2011 Revision)

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7 Management of Hepatitis B and HIV Coinfection Clinical Protocol for the WHO European Region (2011 Revision) MANAGEMENT OF HEPATITIS B AND HIV COINFECTION 7 Management of hepatitis B and HIV coinfection Clinical Protocol for the WHO European Region (2011 revision) i KEYWORDS HIV INFECTIONS – COMPLICATIONS – DRUG THERAPY HEPATITIS B – COMPLICATIONS – DRUG THERAPY CLINICAL PROTOCOLS EUROPE Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe Scherfigsvej 8 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office web site (http://www.euro.who.int/pubrequest). © World Health Organization 2011 All rights reserved. The Regional Office for Europe of the World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the World Health Organization. ii MANAGEMENT OF HEPATITIS B AND HIV COINFECTION Contents Abbreviations and acronyms ........................................................................................................ v Acknowledgements ....................................................................................................................... vi I. Epidemiology and natural course of HBV infection ............................................................... 1 1. Prevalence of chronic hepatitis B ........................................................................................... 1 2. Modes of transmission and risk factors .................................................................................. 1 3. Genotypes ............................................................................................................................... 2 4. Epidemiology of HBV infection in HIV-infected patients ..................................................... 2 5. Natural course of HBV infection ............................................................................................ 2 5.1. Complications of chronic hepatitis B .............................................................................. 2 5.2. Evolutionary phases of chronic hepatitis B .................................................................... 3 5.3. Vaccination against HBV ................................................................................................ 4 6. Reciprocal impact of HIV and HBV ....................................................................................... 4 6.1. Impact of HIV infection on HBV disease progression ................................................... 4 6.2. Impact of HBV infection on HIV disease progression ................................................... 4 II. Identification of HBV/HIV ...................................................................................................... 5 1. Assessment of HBV risk and diagnosis of hepatitis B in HIV-infected patients .................... 5 1.1. Initial laboratory assessment of HBV status ................................................................... 5 1.2. Evaluation of HBV disease severity ............................................................................... 5 1.2.1. Clinical evaluation for signs and symptoms of advanced liver disease .................. 5 1.2.2. Serum alanine aminotransferase (ALT) level ......................................................... 6 1.2.3. Determination of HBeAg ........................................................................................ 6 1.2.4. HBV DNA level ...................................................................................................... 6 1.2.5. Ultrasound and other evaluations ........................................................................... 7 1.2.6. Histological evaluation ........................................................................................... 7 1.2.7. Clinical situations not requiring histological evaluation ........................................ 8 2. Evaluation of co-morbidities and co-conditions ..................................................................... 9 2.1. Psychiatric disorders ....................................................................................................... 9 2.2. Alcohol abuse .................................................................................................................. 9 2.3. Drug use .......................................................................................................................... 9 2.4. Other co-morbidities and co-conditions.......................................................................... 9 3. Assessment of HIV risk in HBV patients.............................................................................. 10 III. Clinical management of HBV/HIV patients ........................................................................11 1. Coinfected patients not requiring HIV or HBV treatment .....................................................11 2. HBV/HIV coinfected patients requiring hepatitis B treatment ..............................................11 2.1. Anti-HBV drugs for treatment of hepatitis B in HIV-coinfected patients ....................11 2.1.1. IFN and PEG-IFN ................................................................................................. 12 2.1.2. Adefovir ............................................................................................................... 13 2.1.3. Entecavir ............................................................................................................... 13 2.1.4. Lamivudine .......................................................................................................... 13 2.1.5. Emtricitabine (FTC) .............................................................................................. 14 2.1.6. Telbivudine ........................................................................................................... 14 2.1.7. Tenofovir ............................................................................................................... 14 2.2. Evaluation and treatment algorithms for chronic hepatitis B in HIV-infected patients ............................................................................................................................ 14 2.2.1. Algorithm 1 ........................................................................................................... 14 2.2.2. Algorithm 2 ........................................................................................................... 16 iii 2.2.3. HBV/HIVco-infected patients with clinical evidence of cirrhosis or decompensated cirrhosis........................................................................................ 16 2.2.4. First line ART regimens ........................................................................................ 17 2.2.5. Second line ART regimens ................................................................................... 18 2.2.6. HIV-infected patients with 3TC-resistant HBV strains ........................................ 18 3. Monitoring and evaluation of HBV/HIV-coinfected patients ............................................... 18 3.1. Hepatitis B treatment response ..................................................................................... 18 3.1.1. Monitoring of HBV DNA ..................................................................................... 19 3.1.2. Recommendations for changing or modifying HBV therapy .............................. 19 3.1.3. Monitoring of ALT ................................................................................................ 19 3.2. Monitoring and evaluation of ART in HBV/HIV-coinfected patients .......................... 19 3.3. Monitoring of adherence to treatment........................................................................... 20 3.4. Management of hepatotoxicity ..................................................................................... 20 3.4.1. Immune reconstitution in HBV/HIV-coinfected patients ..................................... 20 3.4.2. Drug-related hepatotoxicity .................................................................................. 20 3.4.3. Drug-induced
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