Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The degree of hepatic steatosis and fibrosis
研究概览
简要总结
Acquired immunodeficiency syndrome (AIDS) remains a severe global infectious disease, with over 38 million people living with HIV and around 35 million cumulative deaths worldwide by 2023; approximately 1.24 million HIV-positive individuals and 100,000 new infections are reported annually in China. Widespread use of HAART has prolonged HIV patients' survival and reduced AIDS-related mortality, yet non-AIDS comorbidities dominated by chronic liver disorders, particularly metabolic dysfunction-associated fatty liver disease (MAFLD), have become a major challenge in long-term HIV management. Triggered by elevated blood lipids from lifestyle, antiretroviral agents and inherited metabolic factors, MAFLD initiates with hepatic steatosis and may progress to NASH, liver fibrosis, cirrhosis and even hepatocellular carcinoma (HCC) without timely intervention. HIV-positive patients develop more severe MAFLD progression than HIV-negative counterparts; existing biopsy data shows 91% of ART-treated HIV patients have NAFLD, among whom 65% suffer from NASH complicated with liver fibrosis.
Fatty liver prevalence keeps rising with younger onset age in China, which highlights the necessity of early screening. Liver biopsy, the historical diagnostic gold standard for liver injury grading, is restricted by invasiveness, bleeding risks and poor reproducibility. Transient elastography (TE), a novel non-invasive ultrasonic technique, quantifies hepatic steatosis via the ultrasound attenuation parameter (UAP) and liver fibrosis via liver stiffness measurement (LSM), and has been validated and guideline-endorsed for multiple chronic liver diseases globally. Published foreign data report 35%, 42% and 22% prevalence of NAFLD, NASH and fibrosis in PLWH, while domestic evidence on HIV-associated MAFLD is limited, especially liver-related discrepancies among varied ART regimens. With the implementation of China's new medical insurance policy, numerous patients are shifting from non-INI regimens to once-daily single-tablet INSTI STR regimens, whose hepatic and lipid impacts remain unclear. This study targets early detection of HIV patients with concomitant fatty liver to optimize management strategies and improve clinical outcomes.
Our preliminary cohort at Peking Union Medical College Hospital included 188 virologically suppressed HIV patients on ART, 56.9% (107/188) of whom developed fatty liver (mild:27.1%, moderate:19.7%, severe:10.1%). Liver fibrosis (LSM≥7.3 kPa) was found in 12.8% (24/188) subjects, with 1.1% having advanced cirrhosis, and no significant inter-group difference in fatty liver incidence was noted between INSTI and NNRTI recipients. These findings lay a foundation for early diagnosis and follow-up intervention of metabolic liver disease among HIV-infected populations.
详细描述
Acquired immunodeficiency syndrome (AIDS) is a severe infectious disease. As of 2023, over 38 million people globally are living with HIV/AIDS, and approximately 35 million deaths have been attributed to the disease. China faces a notable AIDS epidemic, with roughly 1.24 million registered people living with HIV/AIDS and around 100,000 new infections annually.
Widespread application of Highly Active Antiretroviral Therapy (HAART) has markedly improved clinical outcomes for HIV-infected individuals and reduced AIDS-related mortality. Nevertheless, non-AIDS comorbidities including chronic liver disease have become core concerns in long-term clinical management of people living with HIV. Among these conditions, Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) has emerged as a critical clinical challenge for HIV patient care. MAFLD arises from excessive hepatic fat accumulation; HIV infection, combined with lifestyle changes, antiretroviral medications, and inherited metabolic predispositions, elevates serum low-density lipoprotein, total cholesterol and triglyceride levels, ultimately triggering intrahepatic lipid deposition and MAFLD development.
MAFLD typically initiates with simple hepatic steatosis. Without timely clinical intervention, it can progress to nonalcoholic steatohepatitis (NASH) and subsequent liver fibrosis. In fibrotic cases, NASH may further advance to liver cirrhosis, or even hepatocellular carcinoma (HCC) in the absence of established cirrhosis. In HIV-negative populations, 25%-30% of patients with NAFLD progress to NASH. By contrast, HIV-positive individuals tend to develop NAFLD and experience disease progression at higher clinical severity. Relevant histopathological data remain limited, yet liver biopsy findings from ART-treated HIV patients confirm NAFLD in 91% of participants, 65% of whom have NASH with prevalent hepatic fibrosis.
Nationwide epidemiological data show a rising incidence of fatty liver disease alongside younger age at onset in China, highlighting the urgent need for early screening. Percutaneous liver biopsy has long remained the clinical gold standard to grade hepatic inflammation, fibrosis and steatosis via histopathology. However, this invasive procedure carries bleeding risk, procedural complications and poor repeatability, limiting patient acceptance and clinical application. Advances in non-invasive diagnostic modalities and hepatic imaging have overcome such drawbacks. Transient Elastography (TE), an emerging ultrasound-based technique, enables quantitative assessment of hepatic fibrosis and fatty liver.
##(接第二段) For fatty liver assessment, ultrasound signals decay substantially when propagating through lipid-laden hepatocytes; this property enables quantitative grading of hepatic steatosis via the Ultrasound Attenuation Parameter (UAP). Meanwhile, Liver Stiffness Measurement (LSM) quantifies liver fibrosis based on the positive correlation between propagation velocity of low-frequency shear waves and hepatic tissue rigidity. TE is now widely adopted in global clinical practice and well validated across chronic hepatitis B, chronic hepatitis C and fatty liver cohorts, with robust correlation between TE-derived LSM/UAP values and histopathological findings, and formal endorsement in multiple international clinical guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly treated or treated AIDS patients;
- •Regular follow-up visits to the hospital, medication compliance is good;
- •Patients or their family members were willing to participate in the study by understanding the study plan and providing written informed consent.
排除标准
- •Unable to complete the position requirements of ultrasonic examination (lying flat) due to mobility difficulties;
- •Patients have poor compliance and cannot follow up regularly or take medicine on time;
- •Patients or family members cannot understand the conditions and objectives of the study;
- •Other conditions considered unsuitable for inclusion by the investigator.
结局指标
主要结局
The degree of hepatic steatosis and fibrosis
时间窗: 12 months
The ultrasound attenuation parameter(UAP) and liver stiffness in HIV/AIDS patients treated with either of INSTI and NNRTI for at least 12 months.
次要结局
未报告次要终点
研究者
Wei LYU
Chief Physician
Peking Union Medical College Hospital
