Sequencing of the Hepatitis D Virus RNA WHO International Standard

Pyne, Michael T.; Mallory, Melanie A.; Xie, Hongyao; Mei, Yanhua; Salais, Robert; Hillyard, David R.

doi:10.1016/j.jcv.2017.03.009

Cited by 13 publications

(10 citation statements)

References 26 publications

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“…In this study, a quarter of CHD patients showed spontaneous declines in serum HDV-RNA levels during a mean follow-up of 5.6 years when samples were tested by a sensitive method using the first international HDV-RNA standard of the WHO. 17 The HDV-RNA decline was associated with HBsAg and HBV-DNA decreases. However, patients with a <2 log 10 HDV-RNA decline also showed HBV-DNA and HBsAg decreases.…”

Section: Discussionmentioning

confidence: 95%

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One‐quarter of chronic hepatitis D patients reach HDV‐RNA decline or undetectability during the natural course of the disease

Palom

Sopena

Riveiro‐Barciela

et al. 2021

Aliment Pharmacol Ther

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Background: Spontaneous HDV-RNA fluctuations, assessed by nonstandardised inhouse assays, have been reported during the course of chronic hepatitis delta (CHD).Aims: To evaluate changes in serum HDV-RNA concentrations in untreated CHD patients and correlate these changes with other HBV markers.Methods: A total of 323 consecutive serum samples from 56 CHD patients (detectable HDV-RNA) followed for >3 years were retested for HDV-RNA levels by a sensitive technique using the first WHO international HDV-RNA standard. Quantitative HBsAg, HBV-DNA, and HBV-RNA were also determined.Results: Most participants were male, middle-aged, white European, and HBeAgnegative (82%). Almost half had liver cirrhosis and 64% were receiving nucleos(t)ide analogues. At inclusion, median-HDV-RNA was 5.3 (4.2-6.5) log 10 IU/mL, HBsAg 4.0 (3.5-4.3) log 10 IU/mL, and HBV-DNA 1.6 (1.0-2.6) log 10 IU/mL; ALT values were normal in 13 (23%). During a mean follow-up of 5.6 (3-16) years, 14 (25%) showed ≥2log 10 HDV-RNA decline, including 11 (20%) who spontaneously achieved undetectable HDV-RNA. Four patients (7%) lost HBsAg, with undetectable HDV-RNA. The remaining 42 (75%) had persistently detectable HDV-RNA. During follow-up, patients with a ≥2log 10 HDV-RNA decline showed a greater HBsAg drop (−0.7 ± 1.1 vs −0.09 ± 0.9 log IU/mL; P = 0.039) than those with a <2 log 10 HDV-RNA decline. Overall, ALT and HBV-DNA levels decreased over time. There were no differences in clinical outcomes between groups.Conclusions: One-quarter of untreated CHD patients showed a ≥2log 10 decline in HDV-RNA and 20% reached HDV-RNA undetectability during a mean follow-up of | 463 PALOM et AL. How to cite this article: Palom A, Sopena S, Riveiro-Barciela M, et al. One-quarter of chronic hepatitis D patients reach HDV-RNA decline or undetectability during the natural course of the disease.

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Section: Discussionmentioning

confidence: 95%

“…In this study, a quarter of CHD patients showed spontaneous declines in serum HDV‐RNA levels during a mean follow‐up of 5.6 years when samples were tested by a sensitive method using the first international HDV‐RNA standard of the WHO 17 …”

Section: Discussionmentioning

confidence: 96%

One‐quarter of chronic hepatitis D patients reach HDV‐RNA decline or undetectability during the natural course of the disease

Palom

Sopena

Riveiro‐Barciela

et al. 2021

Aliment Pharmacol Ther

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“…HBV-DNA was quantified by real-time PCR with a detection limit of 10 IU/ml (COBAS 6800, Roche Diagnostics, Mannheim, Germany). HDV-RNA was quantified with an in-house 1-step quantitative RT-PCR using the HDV-RNA international standard of the World Health Organization (1st World Health Organization International Standard for Hepatitis D Virus RNA for Nucleic Acid Amplification Technique-based Assays; PEI code number: 7657/12), 9 with a detection limit of 100 IU/ml and a quantification limit of 600 IU/ml. Liver fibrosis stage was assessed by transient elastography: the cut-offs were >7.5 kPa for advanced fibrosis and >13.5 kPa for liver cirrhosis.…”

Section: Methodsmentioning

confidence: 99%

Implementation of anti-HDV reflex testing among HBsAg-positive individuals increases testing for hepatitis D

Rando-Segura¹,

Vico²,

Pacín³

et al. 2022

JHEP Reports

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“…Again, the J o u r n a l P r e -p r o o f sensitivity and specificity of the applied RT-PCR method to determine HDV serum levels were limited in these trials. A WHO HDV standard was introduced in 116,117 and more sensitive pan-genotypic RNA assays were developed only in 2016, 118 so direct comparison of these early responses with those of the recent trials should be taken with caution.…”

Section: Viral Countermeasures To Hdv Induced Ifn Responsesmentioning

confidence: 99%

New insights into HDV persistence: The role of interferon response and implications for upcoming novel therapies

Zhang

Urban

2021

Journal of Hepatology

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Sequencing of the Hepatitis D Virus RNA WHO International Standard

Cited by 13 publications

References 26 publications

One‐quarter of chronic hepatitis D patients reach HDV‐RNA decline or undetectability during the natural course of the disease

One‐quarter of chronic hepatitis D patients reach HDV‐RNA decline or undetectability during the natural course of the disease

Implementation of anti-HDV reflex testing among HBsAg-positive individuals increases testing for hepatitis D

New insights into HDV persistence: The role of interferon response and implications for upcoming novel therapies

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