Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis

Sanyal, Arun J.; Ratziu, Vlad; Loomba, Rohit; Anstee, Quentin M.; Kowdley, Kris V.; Rinella, Mary E.; Sheikh, Muhammad Y.; Trotter, James F.; Knapple, Whitfield L.; Lawitz, Eric; Abdelmalek, Manal F.; Newsome, Philip N.; Boursier, Jérôme; Dufour, Jean–François; Berrey, M. Michelle; Shiff, Steven J.; Sawhney, Sangeeta; Capozza, Thomas; Leyva, Rina; Harrison, Stephen A.; Younossi, Zobair M.

doi:10.1016/j.jhep.2023.07.014

Cited by 38 publications

(11 citation statements)

References 41 publications

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“…About 22 % of patients with MASH achieved improvement in ≥1 stage fibrosis without worsening of MASH compared to 9 % in the placebo group. Furthermore, 6 % of patients who received OCA exhibited MASH resolution compared to 3 % of the placebo group [46] . The compound is no longer being investigated for the treatment of MASH.…”

Section: Novel Therapies For Masld and Mashmentioning

confidence: 94%

Emerging therapies for MASLD and their impact on plasma lipids

Nguyen,

Asgharpour,

Dixon

et al. 2024

American Journal of Preventive Cardiology

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Section: Novel Therapies For Masld and Mashmentioning

confidence: 94%

Emerging therapies for MASLD and their impact on plasma lipids

Nguyen,

Asgharpour,

Dixon

et al. 2024

American Journal of Preventive Cardiology

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“…1d). Recently, the phase III REGENERATE clinical trial proved safety and antifibrotic efficacy of OCA 25 mg in non-cirrhotic patients with NASH-associated liver fibrosis [58]. However, FXR-agonist therapy is currently under development, and the precise mechanisms behind the antifibrotic efficacy of OCA are yet not fully known.…”

Section: Bile Acid Modulationmentioning

confidence: 99%

Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis

Juanola,

Francés,

Caparrós

2024

Visc Med

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Background: The global burden of liver disease and cirrhosis has been progressively increasing in the last decade. The interplay between gut microbiota and immune system and the bidirectional relationship with the liver, known as the gut-liver axis, has arisen as a fundamental aspect of liver disease. Summary: Alterations of the gut microbiome have been described and include both dysbiotic microbial signatures and intestinal bacterial overgrowth. The integrity of the intestinal epithelial barrier is essential for preventing the access of harmful substances and bacterial products into the host. Bacterial translocation due to altered host-microbiota interactions triggers local immune cell activation and facilitates a chronic inflammatory state that can ultimately lead to immune exhaustion, characteristic of cirrhosis. In cirrhosis, breakdown of the gut vascular barrier allows access of bacterial products to portal blood circulation and facilitates their influx into the liver, further contributing to disease progression. Key Messages: A better understanding of the contributing factors to pathological bacterial translocation and the impact of dysbiosis in liver disease will lead to achieve innovative therapeutic strategies in cirrhosis.

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“… 147 Similarly, in a phase III, randomized, double-blind, placebo-controlled trial known as REGENERATE ( ClinicalTrials.gov , NCT02548351), notable improvements in significantly improved fibrosis and key components of MASH disease activity were observed among patients with MASH. 148 However, two recent trials, REVERSE ( ClinicalTrials.gov , NCT03439254) and OCALIVA evaluating the efficacy of OCA failed to reach expected MASH endpoints in terms of statistical significance for histological improvement. Several nonsteroidal FXR agonists (tropifexor, nidufexor, and turofexorate) are also in the trial pipeline for MASH treatment.…”

Section: Non-steroid Hormone Receptorsmentioning

confidence: 99%

Targeting nuclear receptors for NASH/MASH: From bench to bedside

Sinha

2024

Liver Research

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Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis

Cited by 38 publications

References 41 publications

Emerging therapies for MASLD and their impact on plasma lipids

Emerging therapies for MASLD and their impact on plasma lipids

Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis

Targeting nuclear receptors for NASH/MASH: From bench to bedside

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