# Comparative cost-effectiveness of HCC prevention in metabolic dysfunction associated fatty liver disease

> **NIH NIH P01** · BAYLOR COLLEGE OF MEDICINE · 2022 · $201,942

## Abstract

Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer deaths among Americans. Metabolic
(dysfunction) associated fatty liver disease (MAFLD) is now the leading cause of chronic liver disease and will
become the leading risk factor for HCC. Most HCC patients present with advanced stage and have low survival.
Therefore, HCC prevention is required to reduce the burden of MAFLD HCC. There are several gaps around
prevention of MAFLD HCC. Practice guidelines recommend ultrasound-based HCC surveillance because it can
reduce HCC-related morbidity and mortality among individuals with cirrhosis by detecting cancer at a treatable
stage. However, this clinical evidence and corresponding guidelines are based on outdated data from studies of
patients with hepatitis C or B and cannot be extrapolated to individuals with MAFLD because of a lower risk of
HCC and a higher competing cardiovascular mortality. HCC chemoprevention with metformin and statins hold
substantial promise. However, limited evidence exists on the long-term harms and benefits of HCC surveillance
or chemoprevention in individuals with MAFLD. Ideally, large randomized controlled trials (RCTs) should address
these data gaps. However, these trials are difficult to conduct due to feasibility and ethical concerns.
The goal of Project 3 is to reduce HCC related mortality and burden by evaluating comparative cost-effectiveness
of prevention strategies in individuals with MAFLD. Combining information from several published sources with
new original data from a prospective multi-site cohort of ~4000 patients with MAFLD cirrhosis (Project 1 of the
Program Project), and an emulated RCT in a large, geographically diverse retrospective cohort of >580,000
patients with MAFLD (Project 2 of the Program Project), we will develop decision-analytic models that will
weigh the risks (costs) and benefits of HCC surveillance and/or chemoprevention in MAFLD individuals.
In Aim 1, using innovative decision-analytic approach, we will simulate the natural history of MAFLD and
incorporate key data from literature and two unique two cohorts leveraged for this Program Project. We will use
this model to simulate a virtual trial comparing long-term benefits, harms, and costs of no HCC surveillance, fixed
surveillance, and tailored surveillance (frequency, start/stop times based on risk factors) with ultrasound and
also new imaging and serum biomarkers. In Specific Aim 2, we will extend the model to determine when and
for which subgroups of MAFLD patients the benefits of chemoprevention outweigh the harms, and when to start
and stop chemoprevention. To ensure that our results are useful for patients with MAFLD and their clinicians,
we will develop an interactive decision support tool, HCC Simulator, that will provide a personalized long-term
outcomes, with and without HCC surveillance and/or chemoprevention (Specific Aim 3). The HCC Simulator
will also serve as a platform to other users for conducting virtual tr...

## Key facts

- **NIH application ID:** 10410752
- **Project number:** 1P01CA263025-01A1
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Jagpreet Chhatwal
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $201,942
- **Award type:** 1
- **Project period:** 2022-07-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10410752

## Citation

> US National Institutes of Health, RePORTER application 10410752, Comparative cost-effectiveness of HCC prevention in metabolic dysfunction associated fatty liver disease (1P01CA263025-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10410752. Licensed CC0.

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