MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial).

Autor: Ajmera VH; NAFLD Research Center, University of California San Diego Health, La Jolla, CA.; Division of Gastroenterology, Department of Medicine, University of California San Diego Health, La Jolla, CA., Cachay E; Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA., Ramers C; Family Health Center, San Diego, CA., Vodkin I; Division of Gastroenterology, Department of Medicine, University of California San Diego Health, La Jolla, CA., Bassirian S; NAFLD Research Center, University of California San Diego Health, La Jolla, CA., Singh S; NAFLD Research Center, University of California San Diego Health, La Jolla, CA., Mangla N; NAFLD Research Center, University of California San Diego Health, La Jolla, CA., Bettencourt R; NAFLD Research Center, University of California San Diego Health, La Jolla, CA., Aldous JL; San Ysidro Health, San Diego, CA., Park D; San Ysidro Health, San Diego, CA., Lee D; Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA., Blanchard J; Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA., Mamidipalli A; Liver Imaging Group, University of California San Diego, La Jolla, CA., Boehringer A; Liver Imaging Group, University of California San Diego, La Jolla, CA., Aslam S; Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, CA., Leinhard OD; AMRA Medical AB, Linköping, Sweden.; Department of Medical and Health Sciences, Linköping University, Linköping, Sweden., Richards L; NAFLD Research Center, University of California San Diego Health, La Jolla, CA., Sirlin C; Liver Imaging Group, University of California San Diego, La Jolla, CA., Loomba R; NAFLD Research Center, University of California San Diego Health, La Jolla, CA.; Division of Gastroenterology, Department of Medicine, University of California San Diego Health, La Jolla, CA.; Division of Epidemiology, Department of Family and Preventive Medicine, University of California San Diego, La Jolla, CA.
Jazyk: angličtina
Zdroj: Hepatology (Baltimore, Md.) [Hepatology] 2019 Nov; Vol. 70 (5), pp. 1531-1545. Date of Electronic Publication: 2019 Jun 18.
DOI: 10.1002/hep.30674
Abstrakt: 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) ≥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).
(© 2019 by the American Association for the Study of Liver Diseases.)
Databáze: MEDLINE
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