Treatment Candidacy for Pharmacologic Therapies for NASH

Rowe, Ian A.; Wong, Vincent Wai-Sun; Loomba, Rohit

doi:10.1016/j.cgh.2021.03.005

Cited by 41Liver Disease Diagnosis and TreatmentLiver Diseases and ImmunityLiver physiology and pathology

Treatment Candidacy for Pharmacologic Therapies for NASH

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Rowe, Ian A., Wong, Vincent Wai-Sun, Loomba, Rohit·2022·Clinical Gastroenterology and Hepatology

DOI 10.1016/j.cgh.2021.03.005PMC PMC8908435

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Abstract

Nonalcoholic steatohepatitis (NASH) has emerged as one of the important causes of cirrhosis and hepatocellular carcinoma, and over 50 therapeutic agents are in various phases of clinical development. Recently, obeticholic acid has achieved the interim histological endpoint of fibrosis improvement with no worsening of NASH in the phase 3 REGENERATE study, and now patients are being followed for long-term clinical outcomes. Several drugs are in Phase 3 trials with a goal to achieve conditional registration under the subpart H pathway by the United States Food and Drug Administration (FDA). It is thus timely to consider the current situation and the way ahead in the management of NASH. In this article, we review the natural history of nonalcoholic fatty liver disease, upcoming treatments for NASH and various assessments. Based on the current knowledge, we discuss what should be the target treatment population and whether noninvasive tests are ready to guide NASH treatments both for patient selection and evaluation of treatment response.

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No drugs are approved for MASH, making it a major unmet medical need.
“Despite the scale and urgency of the disease, there are currently no approved drugs for MASH, making it a major unmet need (3, 12).”
From Found in translation—Fibrosis in metabolic dysfunction–associated steatohepatitis (MASH) (2023) · cites this paper as [12]

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Authors: Rowe, I. A., Wong, V. W.-S., & Loomba, R.
Affiliations: University of Leeds (GB)
Chinese University of Hong Kong (HK)
University of California San Diego (US)
Corresponding author: Loomba, Rohit
ORCID: Rowe, Ian A.
Wong, Vincent Wai-Sun
Loomba, Rohit
Venue: Clinical Gastroenterology and Hepatology
Publisher: Elsevier BV
Published: 2022-06
Volume: 20
Issue: 6
Pages: 1209-1217
ISSN: 1542-3565 (ISSN-L)
DOI: 10.1016/j.cgh.2021.03.005
PMC: PMC8908435
OpenAlex: W3135797835
Cited by: 41
References: 67
Citations by year: 2026: 3 · 2025: 3 · 2024: 8 · 2023: 14 · 2022: 8 · 2021: 5
FWCI: 1.34
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Clinical Gastroenterology and Hepatology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: U.S. Department of Defense (W81XWH-18-2-0026)
NHLBI (P01HL147835)
National Institute of Environmental Health Sciences (P42ES010337)
AstraZeneca
Allergan
NCATS (UL1TR001442)
National Institute of Diabetes and Digestive and Kidney Diseases (P30DK120515, R01DK124318, R01DK121378, U01DK061734, R01DK106419)
Boehringer Ingelheim
Gilead Sciences
Bristol-Myers Squibb
Merck
Arrowhead Pharmaceuticals
AbbVie
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, non-alcoholic fatty liver disease, liver fibrosis, hepatocellular carcinoma, liver cirrhosis, non-invasive tests, treatment response assessment, patient selection
MeSH terms: Pharmaceutical Preparations, Humans, Liver Cirrhosis, United States, Non-alcoholic Fatty Liver Disease

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