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. 2024 Aug 1;119(8):1483-1495.
doi: 10.14309/ajg.0000000000002700. Epub 2024 Feb 5.

Diagnostic Ability of Simple Noninvasive Blood Tests to Predict Increased Liver Stiffness in People Living With HIV and Steatotic Liver Disease

Richard K Sterling  1 , Eduardo Vilar-Gomez  2 , Laura A Wilson  3 , Rohit Loomba  2 , Samer Gawrieh  2 , Jennifer Price  2 , Susanna Naggie  4 , Jordan E Lake  4 , Sonya Heath  4 , James Tonascia  3 , Mark Sulkowski  3 , Naga Chalasani  2 ; HIV-NASH CRN
Affiliations

Diagnostic Ability of Simple Noninvasive Blood Tests to Predict Increased Liver Stiffness in People Living With HIV and Steatotic Liver Disease

Richard K Sterling et al. Am J Gastroenterol. .

Abstract

Introduction: Steatotic liver disease is common in people with HIV (PWH). Identifying those with advanced fibrosis (AF, bridging fibrosis or cirrhosis), F3-4, is important. We aimed to examine the performance of FIB-4 and nonalcoholic fatty liver disease (NAFLD) fibrosis score (NFS) in PWH to identify those with AF assessed by liver stiffness measurement (LSM).

Methods: We prospectively collected data on adults participating in 2 National Institute of Health-sponsored HIV NAFLD networks. All had HIV on antiretroviral therapy (ART) ≥6 months with HIV RNA <200 copies/mL. Those with viral hepatitis, other liver disease, excessive alcohol use, or hepatic decompensation were excluded. Vibration-controlled transient elastrography for LSM was performed, and AF defined as ≥11 kPa was compared with FIB-4 and NFS at predefined thresholds (<1.3 and >2.67 for FIB-4 and <-1.455 and >0.675 for NFS).

Results: A total of 1,065 participants were analyzed: mean age 51.6 years, 74% male, 28% White, 46% Black, 22% Hispanic, with 34% overweight (body mass index 25-29 kg/m 2 ) and 43% obese (body mass index ≥30 kg/m 2 ). Features of the metabolic syndrome were common: hyperlipidemia 35%, type 2 diabetes 17%, and hypertension 48%. The median CD4 + T-cell count was 666 cells/mm 3 , 74% had undetectable HIV RNA, and duration of HIV-1 was 17 years with most taking a nucleoside reverse transcriptase inhibitor (92%) and an integrase inhibitor (83%). The mean LSM was 6.3 kPa, and 6.3% had AF. The area under the receiver characteristic curve for FIB-4 and NFS to identify AF were 0.70 and 0.75, respectively. While both had high negative predictive values (97%-98%), the sensitivity at low thresholds and specificity at high thresholds were 64% and 97% for FIB-4 and 80% and 96% for NFS, respectively. Neither FIB-4 nor NFS at either threshold had good positive predictive value to detect AF.

Discussion: FIB-4 and NFS have excellent specificity and negative predictive value for detecting AF, and thus can be used as screening tools in PWH to exclude those with AF who do not need further testing (LSM) or referral to hepatologist.

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Conflict of interest statement

Conflict of interest

Richard K. Sterling declares none for this paper. For full disclosure, he has research support form Gilead, AbbVie, Abbott, Roche, and Zydus and has served on a DSMB for Pfizer, AskBio.

Eduardo Vilar-Gomez: nothing to declare.

Laura Wilson: none

Rohit Loomba serves as a consultant to Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol-Myer Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen Inc., Madrigal, Metacrine, Inc., NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89 bio, Terns Pharmaceuticals and Viking Therapeutics. RL has stock options in 89bio and Sagimet Biosciences. In addition his institutions received research grants from Arrowhead Pharmaceuticals, Astrazeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galectin Therapeutics, Galmed Pharmaceuticals, Gilead, Hanmi, Intercept, Inventiva, Ionis, Janssen, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, Novo Nordisk, Pfizer, Sonic Incytes and Terns Pharmaceuticals. Co-founder of LipoNexus Inc.

Samer Gawrieh: none

Jennifer Price: none

Susanna Naggie: none

Jordan E Lake serves as a consultant to CytoDyn and Theratechnologies, and receives research support from Gilead Sciences and Zydus Pharmaceuticals.

Sonya Heath: none

James Tonascia: none

Mark Sulkowski: none

Naga Chalasani declares none for this paper. For full disclosure, he has had paid consulting agreements with Madrigal, GSK, Galectin, Zydus, Altimune, Foresite, Merck and Pfizer. He has research grants from DSM and Exact Sciences. He has equity ownership in Avant Sante Therapeutics, a contract research organization.

Figures

Figure 1
Figure 1
Diagnostic ability of Fib-4 and NFS to discriminate participants with advanced fibrosis by LSM ≥ 11 kPa.
Figure 2
Figure 2
Diagnostic ability of Fib-4 and NFS to discriminate participants with clinically significant fibrosis by LSM ≥ 8 kPa.
Figure 3
Figure 3
Diagnostic ability of Fib-4 and NFS to discriminate participants with advanced fibrosis by LSM ≥11 kPa in participants with CPA ≥263.
See this image and copyright information in PMC

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