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MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial)
Univ Calif San Diego Hlth, CA USA.
Univ Calif San Diego, CA 92103 USA.
Family Hlth Ctr, CA USA.
Univ Calif San Diego Hlth, CA USA.
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2019 (English)In: Hepatology, ISSN 0270-9139, E-ISSN 1527-3350, Vol. 70, no 5, p. 1531-1545Article in journal (Refereed) Published
Abstract [en]

Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor, has been shown to reduce hepatic fat content in patients with primary nonalcoholic fatty liver disease (NAFLD); however, its effect in patients with human immunodeficiency virus (HIV)-associated NAFLD is unknown. The aramchol for HIV-associated NAFLD and lipodystrophy (ARRIVE) trial was a double-blind, randomized, investigator-initiated, placebo-controlled trial to test the efficacy of 12 weeks of treatment with aramchol versus placebo in HIV-associated NAFLD. Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) amp;gt;= 5%, were randomized to receive either aramchol 600 mg daily (n = 25) or placebo (n = 25) for 12 weeks. The primary endpoint was a change in hepatic fat as measured by MRI-PDFF in colocalized regions of interest. Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI. The mean (+/- standard deviation) of age and body mass index were 48.2 +/- 10.3 years and 30.7 +/- 4.6 kg/m(2), respectively. There was no difference in the reduction in mean MRI-PDFF between the aramchol group at -1.3% (baseline MRI-PDFF 15.6% versus end-of-treatment MRI-PDFF 14.4%, P = 0.24) and the placebo group at -1.4% (baseline MRI-PDFF 13.3% versus end-of-treatment MRI-PDFF 11.9%, P = 0.26). There was no difference in the relative decline in mean MRI-PDFF between the aramchol and placebo groups (6.8% versus 1.1%, P = 0.68). There were no differences in MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA. Compared to baseline, end-of-treatment aminotransferases were lower in the aramchol group but not in the placebo arm. There were no significant adverse events. Conclusion: Aramchol, over a 12-week period, did not reduce hepatic fat or change body fat and muscle composition by using MRI-based assessment in patients with HIV-associated NAFLD (clinicaltrials.gov ID:NCT02684591).

Place, publisher, year, edition, pages
WILEY , 2019. Vol. 70, no 5, p. 1531-1545
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:liu:diva-162060DOI: 10.1002/hep.30674ISI: 000493023400005PubMedID: 31013363OAI: oai:DiVA.org:liu-162060DiVA, id: diva2:1371358
Note

Funding Agencies|the John A. Hartford Foundation; GALMED; American Association for the Study of Liver Diseases Foundation Clinical and Translational Research Award; Atlantic Philanthropies, Inc.

Available from: 2019-11-19 Created: 2019-11-19 Last updated: 2019-11-19

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Dahlqvist Leinhard, Olof
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Division of Radiological SciencesFaculty of Medicine and Health SciencesDepartment of Radiation Physics
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