Non-invasive evaluation of response to obeticholic acid in patients with NASH: results from the REGENERATE study
Open accessAbstract
Background & aims Non-alcoholic steatohepatitis (NASH) is a chronic, progressive fibrotic liver disease that can lead to cirrhosis. While liver biopsy is considered the reference standard for the histologic diagnosis of NASH and staging of fibrosis, its use in clinical practice is limited. Non-invasive tests (NITs) are increasingly being used to identify and stage liver fibrosis in patients with NASH, and several can assess liver-related outcomes. We report changes in various NITs in patients treated with obeticholic acid (OCA) or placebo in the phase III REGENERATE study.Methods Patients with NASH and fibrosis stage F2 or F3 (n = 931) were randomized (1:1:1) to receive placebo, OCA 10 mg, or OCA 25 mg once daily. Various NITs based on clinical chemistry and/or imaging were evaluated at baseline and throughout the study.Results Rapid, sustained reductions from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase levels, as well as in Fibrosis-4 (FIB-4), FibroTest, FibroMeter, and FibroScan-AST scores were observed in OCA-treated vs. placebo-treated patients. Reduction in liver stiffness by vibration-controlled transient elastography was observed in the OCA 25 mg group vs. the placebo group at Month 18. NIT changes were associated with shifts in histologic fibrosis stage. The greatest improvements were observed in patients with ≥1-stage fibrosis improvement; however, improvements in ALT, AST, FIB-4, and FibroTest were also observed in OCA-treated patients whose histologic fibrosis remained stable.Conclusions Based on the REGENERATE Month 18 interim analysis, rapid and sustained improvements in various NITs were observed with OCA treatment. Dynamic changes in selected NITs separated histologic responders from non-responders. These results suggest that NITs may be useful in assessing histologic response to OCA therapy. CLINICALTRIALS.Gov number NCT02548351 LAY SUMMARY: Non-alcoholic steatohepatitis (NASH) is a chronic, progressive liver disease that can lead to cirrhosis. To diagnose and assess liver fibrosis (scarring) in patients with NASH, non-invasive tests (NITs) are increasingly being used rather than liver biopsy, which is invasive, expensive, and can be risky. In the REGENERATE study, which is evaluating the effects of obeticholic acid vs. placebo in patients with NASH, various NITs were also evaluated. This analysis shows that improvements in levels of certain blood components, as well as favorable results of ultrasound imaging and proprietary tests of liver function, were associated with improvements in liver fibrosis after treatment with obeticholic acid, suggesting that NITs may be useful alternatives to liver biopsy in assessing NASH patients' response to therapy.
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In the REGENERATE trial, VCTE or ELF correlated better with changes in fibrosis stage regardless of the treatment arm.
“Some improvements in NITs were related to the treatment arm but not per se to histological response, whereas others, e.g. VCTE or ELF, correlated better with changes in fi brosis stage regardless of the treatment arm, suggesting that they re fl ect histological changes regardless of a drug ' s mode of action.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [267]
The Imaging-based markers of liver stiffness section reports that VCTE improved with fibrosis improvement in all three treatment arms and worsened with fibrosis progression. The Proprietary serum fibrosis markers section reports that ELF rose with fibrosis worsening in all arms, but improved with fibrosis improvement only in the obeticholic-acid arms. The paper therefore supports an association with histologic change, but not an unqualified claim that both tests correlated better with fibrosis-stage changes regardless of treatment arm; it does not establish the claimed comparative ‘better’ correlation. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn the REGENERATE trial, some improvements in NITs were related to the treatment arm but not per se to histological response.
“Some improvements in NITs were related to the treatment arm but not per se to histological response, whereas others, e.g. VCTE or ELF, correlated better with changes in fi brosis stage regardless of the treatment arm, suggesting that they re fl ect histological changes regardless of a drug ' s mode of action.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [267]
The Aminotransferases section (page unavailable) reports ALT reductions with OCA even in patients whose fibrosis was stable or worsened, supporting a treatment-arm effect that did not require measured histologic improvement. The Discussion (page unavailable) says NIT changes generally tracked fibrosis-stage changes across treatment groups, but also says that ELF improvement among patients with improved fibrosis occurred only in the OCA arms. Thus the claim overstates both the separation from histologic response and the assertion that VCTE or ELF reflected fibrosis changes regardless of treatment arm. (LLM, conf=0.83)
Experimental — accuracy not yet measuredThe REGENERATE trial of obeticholic acid analysed NIT responses between histological responders and nonresponders.
“The most extensive analysis in that regard is from the REGENERATE trial of obeticholic acid, 267 which analysed NIT responses between histological responders and nonresponders.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [267]
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- Authors
- Rinella, M. E., Dufour, J.-F., Anstee, Q. M., Goodman, Z., Younossi, Z., Harrison, S. A., Loomba, R., Sanyal, A. J., Bonacci, M., Trylesinski, A., Natha, M., Shringarpure, R., Granston, T., Venugopal, A., & Ratziu, V.
- Affiliations
- Northwestern University (US)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Inova Health System (US)
- Pinnacle Clinical Research (US)
- University of California San Diego (US)
- Virginia Commonwealth University (US)
- Intercept Pharmaceuticals (United States) (US)
- Inserm (FR)
- Corresponding author
- Ratziu, Vlad
- ORCID
- Venue
- Journal of Hepatology
- Publisher
- Elsevier BV
- Published
- 2022-03
- Volume
- 76
- Issue
- 3
- Pages
- 536-548
- ISSN
- 0168-8278 (ISSN-L)
- OpenAlex
- W3208671080
- Cited by
- 164
- References
- 45
- Citations by year
- 2026: 20 · 2025: 35 · 2024: 46 · 2023: 43 · 2022: 20
- FWCI
- 19.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Hepatology (acceptedVersion)
- PubMed (publishedVersion)
- Bern Open Repository and Information System (University of Bern) (submittedVersion, cc-by-nc-nd)
- Open Access CRIS of the University of Bern
- Funders
- Intercept Pharmaceuticals
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- nonalcoholic steatohepatitis, obeticholic acid, liver fibrosis, non-invasive tests, treatment response, vibration-controlled transient elastography, FIB-4, FibroTest, FibroMeter, liver stiffness, alanine aminotransferase, histological response, fibrosis regression, liver cirrhosis
- MeSH terms
- Adult, Aged, Chenodeoxycholic Acid, Double-Blind Method, Female, Humans, Liver, Liver Cirrhosis, Liver Function Tests, Male, Middle Aged, Placebos, Logistic Models, Non-alcoholic Fatty Liver Disease
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