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Foundational Overview of HDV

CE / CME

Hepatitis Delta in Focus: A Foundational Overview of HDV

Pharmacists: 0.75 contact hour (0.075 CEUs)

Nurses: 0.75 Nursing contact hour

Physicians: Maximum of 0.75 AMA PRA Category 1 Credit™

Released: December 09, 2022

Expiration: December 08, 2023

CME/CE Information

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HDV Treatment: Peginterferon-α

Our standard of care, as outlined in current guidelines, is -α, which is used off-label for HDV treatment.1 At the time of this writing, a newer agent, bulevirtide (BLV), is available in some areas of Europe; US approval is being evaluated, and other therapeutics are on the verge of approval. HDV treatment recommendations are expected to change drastically based on these new options.

Let us begin by talking about peginterferon-α and its role in HDV treatment. First, on-treatment virologic response is not common. Only a small portion (~20% to 50%) will have a virologic suppression, and of these individuals, only approximately 25% will remain HDV RNA negative 6 months after treatment cessation.5

Late relapses observed well beyond 24 weeks can be seen in up to 50% of responders. Because of this, all patients with HDV need long-term monitoring even if they have responded to peginterferon-α.

HBsAg loss is recognized in approximately 10% of peginterferon-α recipients. That does not sound encouraging, but it is significantly higher than treated with oral antiviral therapy alone.13

Neither HBV antiviral therapy (eg, nucleoside/nucleotide) nor ribavirin has shown any efficacy in treating HDV, so when we use these to suppress HBV in indicated persons, we should not expect them to treat the HDV.5

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10-Year Follow-up of Peginterferon-α for Chronic HDV Treatment: Viral Response and Clinical Outcomes

In this study by Kim and colleagues,14 patients with chronic HDV were treated with an extended duration of peginterferon and followed for 10 years. The study included a small number of patients (N = 13). The average treatment duration was 75 months, with a study extension past 5 years in 5 cases. Typically, peginterferon is not used for this long, except in patients who may be responding well and have the desire to continue therapy, as done in this study

Clinical outcomes were compared among responders, those who achieved virologic response (ie, negative serum HDV RNA) and nonresponders.

Looking more granularly at data from the 10-year follow-up, a significant decrease in ALT and AST was observed in the responders, but not in the nonresponders (both P = .016).

Use of peginterferon-α resulted in sustained virologic suppression in some individuals after 2 years of treatment, even after the drug was stopped. Of the 13 patients, 54% of individuals had an undetectable serum HDV RNA. Four patients had HBsAg clearance and developed anti-HBs suggesting a durable response, but this was not sustained for one of the patients.

In the responder group (n = 7), and only 1 death occurred that was not related to liver disease. In the nonresponder group, 2 patients (33%) had a liver-related outcome (eg, transplant, cholangiocarcinoma or hepatocellular carcinoma) and all but 1 patient died.

Based on study findings, prolonged peginterferon-α regimens may be considered but may be less reasonable given the increased risk for potential adverse events associated with long-term use of peg-α. Before considering this strategy, healthcare professionals should account for the current or impending availability of new and emerging treatments.

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