Vibration‐controlled transient elastography for the detection of cirrhosis in chronic hepatitis D infection

Da, Ben L.; Surana, Pallavi; Takyar, Varun; Kleiner, David E.; Heller, Theo; Koh, Christopher

doi:10.1111/jvh.13235

Cited by 30 publications

(47 citation statements)

References 55 publications

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“…We based the diagnosis of liver cirrhosis on laboratory values (e.g. platelets below 150/nl, albumin <35 g/L, INR >1.25), transient elastography (Fibroscan®) examination with a cut‐off of ≥12.5 kPa 6 and ultrasonography of the liver. Following ultrasound features were considered as indicative for cirrhosis: the presence of collaterals or ascites, liver nodularity, right lobe atrophy, hypertrophy of the left lobe or caudate lobe, liver surface irregularities in high‐resolution ultrasound and splenomegaly.…”

Section: Methodsmentioning

confidence: 99%

Real‐life experiences with bulevirtide for the treatment of hepatitis delta—48 weeks data from a German centre

Zöllner

Hofmann

Lutz

et al. 2022

Liver International

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Hepatitis D virus (HDV), termed delta hepatitis, is a satellite virus of Hepatitis B virus (HBV). 1 Synchronous infection mostly leads to viral clearance, while metachronous infection generally causes chronic HBV/HDV coinfection, which is associated with rapid progression to severe liver disease and hepatocellular carcinoma. 1 Estimations vary between 12 million 2 and about 70 million people worldwide living with HBV/HDV. 3 The coinfection poses a relevant public health challenge in numerous countries. 3 Effective drug therapy options for chronic hepatitis B/D virus infections are still needed. Until 2020, interferon-alpha was the only available therapy and only approved for the treatment of chronic HBV infection. With serious side effects, poor tolerability and a limited efficacy of about 30%, it remains an ineffective option for the majority of patients. 4 Thus, there is a high medical need for new therapeutic options in chronic hepatitis B/D, and several new concepts have been tested in the last years. The first drug that has been granted provisional approval so far is bulevirtide (trade name Hepcludex, former denomination Myrcludex B, company name Myr GmbH, Burgwedel, DE; since December 2020 Gilead). The drug blocks the sodium/bile salt cotransporter NTCP (Na+−taurocholate cotransporting polypeptide), which is also the entry receptor for Hepatitis B and D viruses. 5 In July 2020, bulevirtide (2 mg/day s.c.) was provisionally approved in the European Union for the treatment of chronic hepatitis B/D. In Germany, it received market approval in September 2020 for all HBV/HDV coinfected patients with compensated liver disease. An early access program allowed for a therapy start with bulevirtide around 6 weeks before market approval. Here, we describe the first real-life treatment experience with bulevirtide at a German tertiary referral center.

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Section: Methodsmentioning

confidence: 99%

Real‐life experiences with bulevirtide for the treatment of hepatitis delta—48 weeks data from a German centre

Zöllner

Hofmann

Lutz

et al. 2022

Liver International

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“…In patients with a positive anti-HDV, irrespective of viral load, assessment of liver disease staging should be undertaken using locally available noninvasive, or where required, invasive (liver biopsy) tools. Noninvasive liver staging tools used in the setting of HDV include the aspartate aminotransferase (AST) to platelet ratio index (APRI) and the fibrosis-4 score (FIB4), as well as measures of liver stiffness with transient elastography [36,37]. If HDV RNA is negative, ongoing monitoring is required with view to repeat testing as clinically indicated.…”

Section: Treatmentmentioning

confidence: 99%

“…In 2020, the first antiviral agent for hepatitis D was approved under conditional authorization by the European Medical Agency for patients with compensated liver disease and positive viraemia with or without nucleos(t)ide analogueshere [36,42]. Bulevirtide (Hepcludex ® ) 2 mg subcutaneous daily stops HDV and HBV from entering the human hepatocyte allowing for recovery, protecting uninfected cells and allowing potential clearance.…”

Section: Treatmentmentioning

confidence: 99%

Hepatitis D Review: Challenges for the Resource-Poor Setting

Lee

2021

Viruses

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Hepatitis D is the smallest virus known to infect humans, the most aggressive, causing the most severe disease. It is considered a satellite or defective virus requiring the hepatitis B surface antigen (HBsAg) for its replication with approximately 10–70 million persons infected. Elimination of hepatitis D is, therefore, closely tied to hepatitis B elimination. There is a paucity of quality data in many resource-poor areas. Despite its aggressive natural history, treatment options for hepatitis D to date have been limited and, in many places, inaccessible. For decades, Pegylated interferon alpha (Peg IFN α) offered limited response rates (20%) where available. Developments in understanding viral replication pathways has meant that, for the first time in over three decades, specific therapy has been licensed for use in Europe. Bulevirtide (Hepcludex®) is an entry inhibitor approved for use in patients with confirmed viraemia and compensated disease. It can be combined with Peg IFN α and/or nucleos(t)ide analogue for hepatitis B. Early reports suggest response rates of over 50% with good tolerability profile. Additional agents showing promise include the prenylation inhibitor lonafarnib, inhibitors of viral release (nucleic acid polymers) and better tolerated Peg IFN lambda (λ). These agents remain out of reach for most resource limited areas where access to new therapies are delayed by decades. strategies to facilitate access to care for the most vulnerable should be actively sought by all stakeholders.

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“…However, the high cost, patient acceptability, sampling error, inter-observer, intra-observer variability, and the risk of complications such as bleeding and infection have limited its widespread clinical application [8] . Numerous recent studies have shown that transient elastography (TE), serum biochemical tests, and Mac-2 binding protein glycosylation isomer (M2BPGi) are promising non-invasive tools for the diagnosis of liver brosis in LT recipients and patients with chronic Hepatitis B (CHB) [9][10][11][12][13] . However, none of the above methods could thoroughly assess liver brosis, and clinicians cannot make a holistic judgment of the distribution and development of liver brosis.…”

Section: Introductionmentioning

confidence: 99%

Clinical Value of 18F-FAPI PET/CT in assessing early-stage fibrosis of graft after liver transplantation: preliminary experience

Fang

Xie

Zhao

et al. 2022

Preprint

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Aims To investigate the clinical usefulness and performance of 18F-FAPI PET/CT in assessing early-stage liver fibrosis in liver transplantation (LT) recipients. Methods A prospective study including 17 LT recipients and 12 chronic Hepatitis B (CHB) patients was conducted. All patients received liver biopsy, transient elastography (TE), and 18F-FAPI PET/CT. On 18F-FAPI PET/CT scans, the liver parenchyma's maximum standardized uptake values (SUVmax) were noted. The receiver operating characteristic (ROC) curve analysis was applied to determine the diagnostic efficacy of 18F-FAPI PET/CT in early-stage liver fibrosis (S1 ~ S2) compared with the diagnostic performance of TE. Results Of 29 patients, 15(51.7%) had fibrosis S0, 10(34.5%) had S1, and 4(13.8%) had S2 respectively. The SUVmax of patients with early-stage liver fibrosis was significantly higher than those without liver fibrosis in LT recipients and CHB patients (p = 0.004, p = 0.02). In LT recipients, a SUVmax cut-off value of 2.0 detected early-stage liver fibrosis with an AUROC of 0.92 (P = 0.006), and a Liver Stiffness measurements (LSM) score cut-off value of 8.2 kPa diagnosed early-stage liver fibrosis with an AUROC of 0.80 (P = 0.012). In CHB patients, a SUVmax cut-off value of 2.7 detected early-stage liver fibrosis with an AUROC of 0.94 (P < 0.001) and an LSM scores cut-off value of 8.4 kPa diagnosed early-stage liver fibrosis with an AUROC of 0.91 (P < 0.001). Conclusions As a non-invasive method, 18F-FAPI PET/CT could be applied to evaluate early-stage liver fibrosis in LT recipients and CHB patients properly. 18F-FAPI PET/CT provided a diagnostic accuracy higher than TE for staging of early-stage liver fibrosis with the additional advantages in whole-liver evaluation.

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Vibration‐controlled transient elastography for the detection of cirrhosis in chronic hepatitis D infection

Cited by 30 publications

References 55 publications

Real‐life experiences with bulevirtide for the treatment of hepatitis delta—48 weeks data from a German centre

Real‐life experiences with bulevirtide for the treatment of hepatitis delta—48 weeks data from a German centre

Hepatitis D Review: Challenges for the Resource-Poor Setting

Clinical Value of 18F-FAPI PET/CT in assessing early-stage fibrosis of graft after liver transplantation: preliminary experience

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