The treatment options for hepatitis D virus (HDV) infection are limited. Currently, no pharmacologic therapies are available for acute infection, while patients with chronic infection may be considered for antiviral treatment, including peginterferon alfa. Antiviral therapies specific for HDV infection are available in some countries, but not in the US as yet. Liver transplant is often required in patients with end-stage liver disease or acute liver failure.[12]Centers for Disease Control and Prevention. Hepatitis D questions and answers for health professionals. Jul 2024 [internet publication].
https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm
The goal of treatment should be to prevent disease progression and lead to biochemical and virologic resolution. In hepatitis B virus (HBV) and hepatitis C virus (HCV) infection, control of virus replication and virus eradication, respectively, leads to improvement in liver function tests (LFTs) and a decrease in clinical endpoints such as cirrhosis, hepatocellular carcinoma, and death.[2]Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99.
https://www.doi.org/10.1002/hep.29800
http://www.ncbi.nlm.nih.gov/pubmed/29405329?tool=bestpractice.com
[54]Belli LS, Berenguer M, Cortesi PA, et al. Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: a European study. J Hepatol. 2016 Sep;65(3):524-31.
http://www.ncbi.nlm.nih.gov/pubmed/27212241?tool=bestpractice.com
In HDV infection, sustained suppression of viral replication and seroconversion of HBV surface antigen (HBsAg) - loss of HBsAg and appearance of antibody to hepatitis B surface antigen (anti-HBs) - would be ideal but is rarely achievable with currently available therapy.
Given the limited efficacy of current treatment and issues with standardization of virologic assays, it is advisable to refer all patients with confirmed HDV infection to a specialized center for management.
This topic does not cover the management of special patient groups (e.g., pregnant women, children) as there are very limited data available on these patients.
Acute HDV infection
Manage patients with acute HDV infection with supportive care, according to their symptoms (e.g., encouraging the patient to remain hydrated and maintaining nutrition).
Note that >95% of immunocompetent adults with simultaneous HDV/HBV coinfection will spontaneously clear the virus. However, evolution to chronic infection may occur in >90% of patients with superinfection (HDV infection in a person with chronic HBV infection).[34]Farci P, Niro GA. Clinical features of hepatitis D. Semin Liver Dis. 2012 Aug;32(3):228-36.
https://www.doi.org/10.1055/s-0032-1323628
http://www.ncbi.nlm.nih.gov/pubmed/22932971?tool=bestpractice.com
Monitor patients for any change in clinical status that indicates progression to a disease state that requires treatment.[2]Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99.
https://www.doi.org/10.1002/hep.29800
http://www.ncbi.nlm.nih.gov/pubmed/29405329?tool=bestpractice.com
Evaluate patients with fulminant hepatitis for liver transplantation due to the high risk of mortality in this group of patients without transplant.[12]Centers for Disease Control and Prevention. Hepatitis D questions and answers for health professionals. Jul 2024 [internet publication].
https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm
See Acute liver failure.
Transplantation in eligible patients is associated with an excellent outcome.[55]Martini S, Tandoi F, Romagnoli R, et al. Liver transplantation in hepatitis B/hepatitis D (delta) virus coinfected recipients. Transplantation. 2022 Oct 1;106(10):1935-9.
http://www.ncbi.nlm.nih.gov/pubmed/35404869?tool=bestpractice.com
Chronic HDV infection
Peginterferon alfa
Offer peginterferon alfa-2a in all eligible patients with chronic HDV infection with detectable HDV RNA (with or without associated compensated cirrhosis).[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
The preferred duration of treatment is 48 weeks.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
[56]National Institute for Health and Care Excellence. Hepatitis B (chronic): diagnosis and management. October 2017 [internet publication].
https://www.nice.org.uk/guidance/cg165
Note that the National Institute for Health and Care Excellence (NICE) in the UK recommends giving peginterferon alfa-2a to patients with chronic HDV infection only if there is evidence of significant fibrosis (METAVIR stage ≥F2 or Ishak stage ≥3) (see Criteria).[56]National Institute for Health and Care Excellence. Hepatitis B (chronic): diagnosis and management. October 2017 [internet publication].
https://www.nice.org.uk/guidance/cg165
Consider personalized treatment durations based on HDV RNA and HBsAg kinetics and treatment tolerability.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
Consider stopping treatment if there is no decrease in HDV RNA following 6 or more months of treatment.[56]National Institute for Health and Care Excellence. Hepatitis B (chronic): diagnosis and management. October 2017 [internet publication].
https://www.nice.org.uk/guidance/cg165
Stop treatment after HBsAg seroconversion.[56]National Institute for Health and Care Excellence. Hepatitis B (chronic): diagnosis and management. October 2017 [internet publication].
https://www.nice.org.uk/guidance/cg165
Treatment success is defined as undetectable HDV RNA 24 weeks after completing treatment (alongside normalization of alanine aminotransferase [ALT]).[2]Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99.
https://www.doi.org/10.1002/hep.29800
http://www.ncbi.nlm.nih.gov/pubmed/29405329?tool=bestpractice.com
One review of 13 studies including 1078 patients demonstrated that the overall virological response (defined as undetectable HDV RNA after 24 weeks following the end of treatment) was 31%.[57]Brancaccio G, Gaeta GB. Treatment of chronic hepatitis due to hepatitis B and hepatitis delta virus coinfection. Int J Antimicrob Agents. 2019 Dec;54(6):697-701.
http://www.ncbi.nlm.nih.gov/pubmed/31541699?tool=bestpractice.com
However, relapses of HDV RNA occur commonly in the post-treatment phase and have been reported even 5-10 years after the end of treatment.[58]Sandmann L, Wedemeyer H. Interferon-based treatment of chronic hepatitis D. Liver Int. 2023 Aug;43 Suppl 1:69-79.
https://onlinelibrary.wiley.com/doi/10.1111/liv.15410
http://www.ncbi.nlm.nih.gov/pubmed/36002390?tool=bestpractice.com
Peginterferon alfa is contraindicated in patients with decompensated cirrhosis.
Nucleoside/nucleotide analog therapy
Give a nucleoside/nucleotide analog (e.g., entecavir, tenofovir) in all patients with compensated cirrhosis and detectable HBV DNA, regardless of HBV DNA levels.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
Also consider a nucleoside/nucleotide analog in patients with persistent HBV infection, especially if HBV DNA levels are close to or higher than 2000 IU/mL.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
[2]Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99.
https://www.doi.org/10.1002/hep.29800
http://www.ncbi.nlm.nih.gov/pubmed/29405329?tool=bestpractice.com
See Hepatitis B.
Give a nucleoside/nucleotide analog to patients with decompensated cirrhosis irrespective of the presence of detectable HBV DNA.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
Liver transplantation for decompensated cirrhosis
Evaluate patients with decompensated cirrhosis for liver transplantation.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
[2]Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99.
https://www.doi.org/10.1002/hep.29800
http://www.ncbi.nlm.nih.gov/pubmed/29405329?tool=bestpractice.com
This may include patients with end-stage liver disease as well as those with fulminant hepatitis.[12]Centers for Disease Control and Prevention. Hepatitis D questions and answers for health professionals. Jul 2024 [internet publication].
https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm
Transplantation in eligible patients is associated with an excellent outcome.[55]Martini S, Tandoi F, Romagnoli R, et al. Liver transplantation in hepatitis B/hepatitis D (delta) virus coinfected recipients. Transplantation. 2022 Oct 1;106(10):1935-9.
http://www.ncbi.nlm.nih.gov/pubmed/35404869?tool=bestpractice.com
If liver transplantation is not possible, a best-supportive-care strategy is recommended.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
See Cirrhosis.
Give patients who have undergone liver transplantation for chronic HDV infection hepatitis B immune globulin combined with a high genetic barrier nucleoside/nucleotide analog after transplantation.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
Patients with hepatocellular carcinoma
Prioritize optimal treatment for hepatocellular carcinoma (including liver transplantation) in patients with chronic HDV infection and hepatocellular carcinoma.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
Evaluate patients with hepatocellular carcinoma for antiviral treatment on an individual basis.[1]European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.
https://www.doi.org/10.1016/j.jhep.2023.05.001
http://www.ncbi.nlm.nih.gov/pubmed/37364791?tool=bestpractice.com
See Hepatocellular carcinoma.