Monitoring
Monitoring is required in patients with chronic hepatitis D virus (HDV) infection who are on treatment. The aim of monitoring in these patients is to evaluate treatment response, adverse effects, and disease progression or reactivation.
Monitor complete blood count and hepatic panel at initiation of treatment, then every 3-6 months and more frequently if clinically indicated.[1]
Monitor virologic response to treatment during and after therapy:[1]
Hepatitis B virus (HBV) DNA levels every 6 months (patients not on nucleoside/nucleotide analog therapy)
HDV RNA levels should be monitored regularly, with the frequency of testing guided by clinical circumstances (e.g., every 3-4 months during treatment, whenever there is clinical indication, at the end of treatment, and at regular intervals following cessation of treatment)
HBV surface antigen (HBsAg) status every 6 months during therapy and annually after therapy ends.
Testing should also be performed at the end of treatment, 6 months, and 12 months post treatment (or more frequently if clinically indicated) and then annually following this.[1]
Additionally for patients on nucleoside/nucleotide analog therapy:[2]
Perform renal function tests at baseline and regularly during treatment
Monitor hepatic panel every 3-4 months during the first year, and every 6 months thereafter
Monitor HBV DNA at baseline and every 3-4 months during the first year, and every 6-12 months thereafter
Check HBsAg status annually
Monitor lactic acid levels if there is a clinical concern for lactic acidosis (e.g., with use of entecavir or tenofovir in patients with decompensated cirrhosis)
Consider bone density study at baseline and during treatment if the patient has a history of fracture or risks for osteopenia (tenofovir).
Consider:[1]
Determination of liver stiffness - can be performed annually during and after antiviral treatment
Liver biopsy - may be of benefit in patients where histologic diagnosis can aid management
Monitoring for liver-related clinical events, both during and after antiviral treatment.
Also monitor patients for development of neuropsychiatric, autoimmune, ischemic, and infectious complications.
Observe patients without detectable HDV RNA, elevated liver function tests (LFTs), or advanced fibrosis with intermittent monitoring (every few months) and follow guidance for treatment of HBV infection in this group of patients.[2] See Hepatitis B.
Continue to monitor all patients at least every 6-12 months to identify a change in clinical status that indicates progression to disease state that requires treatment:[1][2]
Monitor alanine aminotransferase (ALT), HBV DNA, HBsAg, and HDV RNA levels
If ALT level becomes elevated, measure HBV DNA and HDV RNA.
Screening for hepatocellular carcinoma (HCC)
Request alpha-fetoprotein as a part of screening for HCC in conjunction with ultrasound every 6 months in patients with advanced fibrosis of cirrhosis, regardless of anti-HDV therapy.[1]
Alpha-fetoprotein is elevated in 75% of patients with HCC, but can also be normal. The sensitivity ranges from 41% to 65% and specificity ranges from 80% to 94%.[71] Alpha-fetoprotein level >400 nanograms/mL has a 95% specificity for HCC.[72]
Additionally, all HBsAg-positive patients with cirrhosis at high risk for HCC (e.g., Asian or black men ages >40 years, Asian women ages >50 years, people with a first-degree family member with a history of HCC) should be screened with an abdominal ultrasound, with or without alpha-fetoprotein, every 6 months.
In areas where ultrasound is not readily available, screen with alpha-fetoprotein every 6 months.
Use of this content is subject to our disclaimer