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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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Bulevirtide 2 mg With or Without Peginterferonα-2a for Chronic HDV Infection: Study Design

In July 2020, BLV was given conditional marketing authorization by the European Medicines Agency for use in adults with chronic HDV and compensated liver disease.17 The approved BLV dose is 2 mg once daily by subcutaneous injection monotherapy or given concomitantly with a nucleoside/nucleotide analog for treatment of underlying HBV infection. Optimal treatment duration has not yet been determined.

The French Early Access Program provides real-world data of patients with chronic HDV infection on BLV.18

In this analysis, the addition of peginterferon-α-2a to BLV was evaluated and compared to BLV monotherapy. At Month 12 and/or 18, providers could consider continuing therapy or dropping an agent (eg, continue BLV monotherapy after initial combination therapy with peginterferon). Outcomes were assessed at 24 months.

Patients included in this analysis had more advanced disease such as compensated cirrhosis, stage III fibrosis or less advanced fibrosis but significant necroinflammations implied by an ALT elevation of ≥2 times the upper limit of normal that persisted for 6 months or more.

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BLV 2 mg With or Without Peginterferon-α2a for Chronic HDV Infection: On-Treatment Primary Combined Endpoint

This graph displays results of the on-treatment primary combined endpoint (ie, undetectable HDV RNA or ≥2 log10 IU/mL decrease from baseline and ALT normalization) of 3 comparator arms: (1) BLV monotherapy, (2) BLV plus peginterferon, and (3) BLV plus peginterferon, then BLV alone at 12, 18, and 24 months.18

At 24 months, 52% of patients receiving BLV monotherapy achieved a combined response; comparator regimens of BLV with peginterferon resulted in similar rates.

When assessing on-treatment virologic response (ie, undetectable HDV RNA or ≥2 log10 IU/mL decrease from baseline), similar findings resulted. Of patients receiving BLV monotherapy, 68% of patients achieved virologic response at Month 24. BLV monotherapy did not perform differently than when combined with peginterferon.

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French ANRS Cohort: Real-World Efficacy and Safety of BLV With or Without Interferon up to 48 Weeks in Chronic HDV

In another real-world analysis of data from the French ANRS cohort, efficacy and safety data are available up to Week 48 of BLV with or without interferon in patients with chronic HDV infection. Patients received BLV for an average of approximately 18 months. More than one half of the patients had cirrhosis, with a mean FibroScan score of 14.5 kPa. Approximately 80% of patients were receiving a nucleoside/nucleotide at enrollment. More patients had an HIV coinfection in the BLV monotherapy group than the BLV plus interferon group (16.4% vs 9.3%, respectively).19

Among the 55 patients with efficacy data available at Week 48, higher rates of virologic response (ie, >2 log decline in HDV RNA and/or undetectable HDV RNA) were observed in patients receiving BLV plus interferon compared with BLV monotherapy (84% vs 39%, respectively), but ALT normalization occurred more frequently in patients receiving BLV monotherapy. Similar rates of combined responses resulted among groups.

In total, 128 patients were included in their safety analysis: 60 patients receiving BLV plus interferon and 68 patients receiving BLV monotherapy. Grade 3/4 adverse events occurred in 34 patients (60%) receiving BLV plus interferon vs 19 patients (34%) receiving BLV monotherapy.

Discontinuation of treatment occurred in 8 patients in the BLV plus interferon group; interferon was stopped in 6 patients, BLV was stopped and restarted in 1 patient, and both BLV and interferon were discontinued in 1 patient. In the BLV monotherapy group, 2 patients stopped BLV and restarted therapy.

Similar rates of bile acid increases were seen in patients receiving BLV plus interferon as compared with BLV monotherapy (7% vs 13%, respectively).

The optimal treatment duration of BLV and when patients may benefit from combination therapy with interferon remain unclear.

Additional studies evaluating the use of BLV in combination with peginterferon-α, as well as with tenofovir, are pending (NCT03852719, NCT03852433, NCT02888106).

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