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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

Nancy Reau
Nancy Reau, MD
CME/CE Information

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BLV Monotherapy in HDV: Efficacy

Here is a pooled analysis of 2 phase II (MYR 203 and MYR 204) and 1 phase III (MYR 301) randomized, open-label trials that demonstrates the efficacy and safety of BLV monotherapy in patients with HDV.16

BLV monotherapy, given as 2 different doses (2 mg or 10 mg), was compared with either peginterferon-α monotherapy or placebo (the control arm).

The primary outcome was a combined response that included both ALT normalization and HDV viral suppression (ie, undetectable HDV RNA or a decrease in ≥2 log10 IU/mL from baseline) at Week 24. ALT normalization and HDV viral suppression were also assessed separately.

As shown in the bar graph, more patients who received BLV (2 mg or 10 mg) achieved virologic response, ALT normalization, and a combined response compared with the other 2 study arms. Patients receiving BLV 10 mg were more likely to achieve virologic response than those receiving BLV 2 mg, but the higher dose did not result in higher rates of ALT normalization or combined response.

Although only approximately one third of patients achieved combined response for both BLV 2 mg and 10 mg, no patients in the peginterferon-α or placebo arm met these criteria at Week 24.

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BVL Monotherapy in HDV: Combined Response in Patients Receiving Low Dose

When we look more closely at the patients who received BLV 2 mg, there was little difference in efficacy based on age, sex, race, or baseline ALT.16

There was a slight suggestion that efficacy was better in those who had a lower HDV DNA and for those who did not have cirrhosis. Theoretically, this may be because of less “distance to drop” in terms of viral load, and it also could imply that a higher BLV dose in those with underlying cirrhosis is needed; however, that is still left to be determined.

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