Sections

Hepatitis B

Medication

Medication Summary

The goals of pharmacotherapy in patients with hepatitis B disease are to reduce the risk of progression of disease, prevent transmission to others, and decrease complications.

Currently, pegylated interferon alfa (PEG-IFN-a), entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are the first-line agents in the treatment of hepatitis B disease. These are the main treatment drugs approved globally for this disease, although ongoing development and clinical trials are investigating new types of medications, such as encapsidation inhibitors, entry inhibitors, TLR7 agonists, and therapeutic vaccines.

The Centers for Disease Control and Prevention (CDC) recommends adults at risk for hepatitis B be immunized with hepatitis B vaccine. Hepatitis B vaccine is part of the standard immunization schedule for children.

Class Summary

Interferons are naturally produced proteins with antiviral, antitumor, and immunomodulatory actions.

Peginterferon alfa 2a (Pegasys)

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Peginterferon alfa-2a binds to cell surface receptors in a cascade of protein interactions, resulting in gene transcription. These stimulated genes inhibit viral replication in infected cells, cell proliferation, and immunomodulation. Peginterferon alfa-2a is indicated for adults with hepatitis B e antigen (HBeAg)–positive and HBeAg-negative chronic hepatitis B disease with compensated liver disease and evidence of viral replication and liver inflammation.

Peginterferon alfa-2a is also FDA approved for the treatment of chronic hepatitis C, alone or in combination with ribavirin, in patients not previously treated with interferon alfa, and with compensated liver disease.

Interferon alfa-2b (Intron A)

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Interferon alfa-2b (Intron A)

Interferon alfa-2b is a protein product manufactured by recombinant DNA technology. Its mechanism of antitumor activity is not clearly understood; however, direct antiproliferative effects against malignant cells and modulation of host immune response may play important roles.

The immunomodulatory effects of interferon alfa-2b include enhancement of cytolytic T-cell activity, stimulation of natural killer cell activity, amplification of human leukocyte antigen (HLA) class I protein on infected cells, and suppression of tumor cell proliferation. The direct antiviral activity of interferon alfa-2b activates viral ribonucleases and inhibits viral entry into cells and viral replication. A direct antifibrotic effect has been postulated.

Before initiation of therapy with interferon alfa-2b, perform tests to quantitate peripheral blood hemoglobin, platelets, granulocytes, hairy cells, and bone marrow hairy cells. Monitor the patient periodically (eg, monthly) during treatment to determine his/her response to therapy. If the patient's condition does not respond within 4 months, discontinue treatment.

If a response occurs, continue treatment until no further improvement is observed. Whether continued treatment is beneficial after that time remains unknown.

Class Summary

Antiviral agents interfere with viral replication and weaken or abolish viral activity.

Tenofovir AF (Vemlidy)

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Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor (NRTI) and a phosphonamidate prodrug of tenofovir. TAF, as a lipophilic cell-permeant compound, enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3, and it is converted to tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain-termination.

Compared with tenofovir disoproxil fumarate (TDF), TAF is a more targeted form of tenofovir that has demonstrated high antiviral efficacy at a dose that is 10 times lower than TDF, as well as an improved renal and bone safety profile.

It is indicated for the treatment of chronic HBV infection in adults and adolescents aged 12 years and older with compensated liver disease.

Tenofovir disoproxil fumarate (Viread)

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Tenofovir is a nucleotide analogue (adenosine monophosphate) reverse transcriptase and hepatitis B virus (HBV) polymerase inhibitor.

Tenofovir may be used as first-line therapy for treatment-naïve patients. It is preferred as additional therapy in patients with lamivudine, telbivudine, or entecavir resistance. This agent has more potent antiviral activity than adefovir and can be used as a substitute in patients who do not have an adequate response to adefovir.

Entecavir (Baraclude)

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Entecavir is a guanosine nucleoside analogue with activity against hepatitis B virus (HBV) polymerase. This agent competes with the natural substrate deoxyguanosine triphosphate (dGTP) to inhibit HBV polymerase activity (ie, reverse transcriptase). Entecavir is less effective for lamivudine-refractory HBV infection. This drug is indicated for treatment of chronic HBV infection and is available as a tablet and as an oral solution (0.05 mg/mL; 0.5 mg = 10 mL).

Lamivudine (Epivir, Epivir-HBV)

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Lamivudine is a thymidine analogue that blocks viral replication by competitive inhibition of viral reverse transcriptase. There is evidence that an indirect immunomodulatory effect can be observed.

Relative to other oral treatments, lamivudine is lower in cost. Other agents, however, except for adefovir, are superior to lamivudine in suppression of viral replication. Another disadvantage to this therapy includes its high rate of drug resistance. The role of lamivudine in hepatitis B treatment is diminishing as alternate therapies become available.

Adefovir dipivoxil (Hepsera)

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Adefovir is used to treat chronic hepatitis B disease. This agent is a prodrug that is converted to the diphosphate salt. The active drug is classified as an antiviral nucleotide reverse transcriptase inhibitor. It inhibits hepatitis B virus (HBV) DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate (dATP) and by causing DNA chain termination after its incorporation into viral DNA.

Class Summary

Stimulates active immunity by developing antibodies to hepatitis B surface antigen (HBsAg).

Hepatitis B vaccine (Engerix B, Heplisav-B, Recombivax HB, PreHevbrio)

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Hepatitis B vaccines are recommended by the CDC for at-risk adults who seek protection from HBV infection. Newborns should receive the vaccine within 24 hours of birth to HBsAg–negative mothers and within 12 hours for HBsAg–positive mothers.

Childhood catch-up and adolescent immunization schedules are also defined if a child did not receive the vaccine at birth. The vaccines are available as a 3-dose regimen over 6 months (Engerix B, Recombivax HB) for adults or children. Also, options for adults are a 2-dose regimen over 1 month (Heplisav-B [adjuvanted]) and a 3-dose regimen at 0, 1, and 6 months (PreHevbrio [3-antigens]).

Hepatitis A/B vaccine (Twinrix)

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Confers antibodies to HAV and HBV. It is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus in adults aged 18 years or older.

Questions

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Media Gallery

Hepatitis B. Under higher-power magnification, ground-glass cells may be visible in chronic hepatitis B virus (HBV) infection. Ground-glass cells are present in 50% to 75% of livers with chronic HBV infection. Immunohistochemical staining is positive for hepatitis B surface antigen (HBsAg.)
Hepatitis B. Liver biopsy with hematoxylin stain showing stage 4 fibrosis (ie, cirrhosis) in a patient with hepatitis B.
Hepatitis B. Hepatitis B virus (HBV) is a hepadnavirus, highly resistant to extremes of temperature and humidity, that invades the hepatocytes. The viral genome is a partially double-stranded, circular DNA linked to a DNA polymerase that is surrounded by an icosahedral nucleocapsid and then by a lipid envelope. Embedded within these layers are numerous antigens that are important in disease identification and progression. Within the nucleocapsid are the hepatitis B core antigen (HBcAg) and precore hepatitis B e antigen (HBeAg), and on the envelope is the hepatitis B surface antigen (HBsAg). Transmission electron micrograph (TEM) from Graham Colm and Wikipedia, licensed under the Creative Commons Attribution 3.0 Unported license.
Hepatitis B. Serologic course of hepatitis B virus (HBV) infection. The flat bars show the duration of seropositivity in self-limited acute HBV infection. The pointed bars show that HBV DNA and e antigen (HBeAg) can become undetectable during chronic infection. Only immunoglobulin G (IgG) antibodies to the HBV core antigen (anti-HBc) are predictably detectable after resolution of acute hepatitis or during chronic infection. Antibody to hepatitis B surface antigen (anti-HBs) is generally detectable after resolution of acute HBV infection but may disappear with time. It is only rarely found in patients with chronic infection and does not indicate that immunologic recovery will occur or that the patient has a better prognosis. ALT = alanine transaminase. (Adapted from Liaw YF, Chu CM. Hepatitis B virus infection. Lancet. 2009;373(9663):582-92.)
Hepatitis B. Radiologic studies may be useful in all stages of hepatitis B infection. Ultrasonography, computed tomography (CT) scanning, or magnetic resonance imaging (MRI) may exclude biliary obstruction in acute infection. In chronic disease, ultrasonograms may show nonspecific increased echogenicity of the liver parenchyma. In patients with long-standing disease, CT imaging may be used to detect cirrhosis or hepatocellular carcinoma (as shown).
Hepatitis B. Long-standing cirrhosis leads to progressive replacement of liver parenchyma with fibrotic tissue. Over time, the liver contracts and develops a lobulated contour. These changes are readily apparent on cross-sectional imaging. This contrast-enhanced computed tomography (CT) scan demonstrates extensive cirrhosis, as well as malignant hepatocellular lesions (arrow).
Hepatitis B. Liver biopsy with hematoxylin stain showing stage 4 fibrosis (ie, cirrhosis) in a patient with hepatitis B.

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Author

Nikolaos T Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP(Edin) Professor and Chief, Division of Gastroenterology and Hepatology, Professor of Physiology, Pharmacology, and Neuroscience, Medical Director of Liver Transplantation, Rutgers New Jersey Medical School

Nikolaos T Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP(Edin) is a member of the following medical societies: American Association for the Study of Liver Diseases, American College of Gastroenterology, American College of Physicians, American Gastroenterological Association, American Liver Foundation, American Medical Association, American Society for Gastrointestinal Endoscopy, American Society of Transplantation, International Liver Transplantation Society, Transplantation Society

Disclosure: Received research grant from: GRIFOLS. BAYER, DURECT, INTERCEPT, BEIGENE, BMS.

Coauthor(s)

Ranya Selim, MD Gastroenterologist/Transplant Hepatologist

Ranya Selim, MD is a member of the following medical societies: American College of Gastroenterology

Disclosure: Nothing to disclose.

Specialty Editor Board

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

Chief Editor

BS Anand, MD Professor, Department of Internal Medicine, Division of Gastroenterology, Baylor College of Medicine

BS Anand, MD is a member of the following medical societies: American Association for the Study of Liver Diseases, American College of Gastroenterology, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy

Disclosure: Nothing to disclose.

Acknowledgements

George Y Wu, MD, PhD Professor, Department of Medicine, Director, Hepatology Section, Herman Lopata Chair in Hepatitis Research, University of Connecticut School of Medicine

George Y Wu, MD, PhD is a member of the following medical societies: American Association for the Study of Liver Diseases, American Gastroenterological Association, American Medical Association, American Society for Clinical Investigation, and Association of American Physicians

Disclosure: Springer Consulting fee Consulting; Gilead Consulting fee Review panel membership; Gilead Honoraria Speaking and teaching; Bristol-Myers Squibb Honoraria Speaking and teaching; Springer Royalty Review panel membership

Hepatitis B Medication

Medication Summary

Interferons

Class Summary

Peginterferon alfa 2a (Pegasys)

Peginterferon alfa 2a (Pegasys)

Interferon alfa-2b (Intron A)

Interferon alfa-2b (Intron A)

Antihepadnaviral, Reverse Transcriptase inhibitors

Class Summary

Tenofovir AF (Vemlidy)

Tenofovir AF (Vemlidy)

Tenofovir disoproxil fumarate (Viread)

Tenofovir disoproxil fumarate (Viread)

Entecavir (Baraclude)

Entecavir (Baraclude)

Lamivudine (Epivir, Epivir-HBV)

Lamivudine (Epivir, Epivir-HBV)

Adefovir dipivoxil (Hepsera)

Adefovir dipivoxil (Hepsera)

Vaccines, Inactivated, Viral

Class Summary

Hepatitis B vaccine (Engerix B, Heplisav-B, Recombivax HB, PreHevbrio)

Hepatitis B vaccine (Engerix B, Heplisav-B, Recombivax HB, PreHevbrio)

Hepatitis A/B vaccine (Twinrix)

Hepatitis A/B vaccine (Twinrix)

Hepatitis B Medication

Medication Summary

Interferons

Class Summary

Peginterferon alfa 2a (Pegasys)

Interferon alfa-2b (Intron A)

Antihepadnaviral, Reverse Transcriptase inhibitors

Class Summary

Tenofovir AF (Vemlidy)

Tenofovir disoproxil fumarate (Viread)

Entecavir (Baraclude)

Lamivudine (Epivir, Epivir-HBV)

Adefovir dipivoxil (Hepsera)

Vaccines, Inactivated, Viral

Class Summary

Hepatitis B vaccine (Engerix B, Heplisav-B, Recombivax HB, PreHevbrio)

Hepatitis A/B vaccine (Twinrix)

References

Tables

Contributor Information and Disclosures

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