Comparing methods for plasma HDV RNA quantification in bulevirtide-treated and untreated patients with HDV

Area of Science:

• Hepatology
• Virology
• Clinical Diagnostics

Background:

• Accurate quantification of Hepatitis Delta Virus (HDV) RNA is essential for managing chronic hepatitis delta (CHD).
• Significant variability exists between different HDV RNA quantification assays.
• Bulevirtide (BLV) is a therapeutic agent used in CHD treatment.

Purpose of the Study:

• To compare the performance of three distinct assays for quantifying HDV RNA levels.
• To evaluate the impact of assay variability on HDV RNA quantification in untreated and BLV-treated CHD patients.

Main Methods:

• A retrospective study analyzed 431 plasma samples from 130 CHD patients (69 untreated, 61 BLV-treated).
• Three assays were used: Robogene 2.0, EurobioPlex, and AltoStar HDV RNA quantification kits.
• HDV RNA levels and undetectability rates were compared across the assays.

Main Results:

• EurobioPlex and AltoStar assays reported significantly higher HDV RNA levels compared to Robogene 2.0 (1 log and 0.5 log higher, respectively).
• Viremia was detected more frequently with EurobioPlex (69%) and AltoStar (52%) than Robogene 2.0.
• While virological response rates were similar, HDV RNA undetectability rates significantly differed between assays at various time points.

Conclusions:

• HDV RNA quantification results are substantially influenced by the assay method used.
• Assay-dependent differences in HDV RNA undetectability rates were observed during BLV treatment.
• These findings highlight the clinical relevance of assay selection for CHD patient management and treatment discontinuation decisions.