Clinical trial NCT05330923: Effect of NNRTI or INSTI on Nonalcoholic Steatosis in HIV/AIDS Patients
Official title: Effect of NNRTI or INSTI on Nonalcoholic Steatosis in HIV/AIDS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Fibrosis
HIV/AIDS
Keywords: integrase inhibitors
non-nucleoside reverse transcriptase inhibitors
transient elastography
iLivTouch
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Wuxi Hisky Medical Technology Co Ltd
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Newly treated or treated AIDS patients

Brief summary: Identifying patients at risk of NAFLD(Nonalcoholic fatty liver disease), especially severe disease with NASH(nonalcoholic steatohepatitis) and fibrosis, is critical. Prevalence of NAFLD in PLWH(People Living With HIV) evaluated by different imaging techniques including US (ultrasonography), elastography, CT(computed tomography ), and magnetic resonance varies from 13% to 58.6% in all published studies. In previous studies, the effect of ART(Anti-Retroviral Therapy) on NAFLD was limited. A cross-sectional analysis found that INSTI（Integrase strand transfer inhibitor） was associated with a higher prevalence of steatosis in AIDS (acquired immunodeficiency syndrome) patients. However, it is not clear whether there is a difference in the degree of nonalcoholic steatosis between AIDS patients receiving NNRTI(non-nucleoside reverse transcriptase inhibitors).

Therefore, the investigators plan to conduct a prospective study to assess whether there is any difference in the degree of nonalcoholic steatosis and fibrosis between Chinese HIV(human immunodeficiency virus)/AIDS patients after initial treatment with NNRTI or INSTI, or switching from NNRTI to INSTI.

Detailed description: Chronic liver disease is now a leading cause of non-AIDS-related death, representing 13% of all deaths in this patient population. While coinfection with viral hepatitis is the primary cause of liver disease, hepatic steatosis is emerging as a major contributor. NAFLD is defined by liver steatosis, the accumulation of triglycerides in the hepatocytes, in the absence of a secondary cause such as excessive alcohol consumption. The condition encompasses a spectrum of diseases from nonalcoholic fatty liver to NASH, fibrosis and cirrhosis. Recent studies report a wide range of prevalence of NAFLD between 15% and 60% among HIV patients. In non-HIV patients NAFLD is principally the hepatic manifestation of the metabolic syndrome, occurring in the context of insulin resistance, central obesity and dyslipidaemia, with disease progression involving a number of complex interacting factors such as genetic susceptibility, oxidative stress and dysbiosis. There is a growing body evidence for weight gain following initiating integrase inhibitor therapy, particularly with dolutegravir and bictegravir. However, the consequences of weight gain have not been evaluated.

Identifying patients at risk of NAFLD, especially severe disease with NASH and fibrosis, is critical. Prevalence of NAFLD in PLWH evaluated by different imaging techniques varies from 13% to 58.6% in all published studies. In previous studies, the effect of ARTon NAFLD was limited. A cross-sectional analysis found that INSTI was associated with a higher prevalence of steatosis in AIDS patients. However, it is not clear whether there is a difference in the degree of nonalcoholic steatosis between AIDS patients receiving NNRTI.

Transient elastography is a non-invasive technique to measure UAP(ultrasound attenuation parameter)and liver stiffness simultaneously. The former reflects the degree of hepatic steatosis. The typical features of fatty liver on abdominal ultrasonography include bright liver echotexture, deep attenuation of ultrasound signal and vascular blunting. The latter two features are because of the faster attenuation of ultrasound wave amplitude in a steatotic liver. UAP takes advantage of this physical property and estimates the ultrasound attenuation at the central frequency of transient elastography, while assuming a homogeneous fat distribution and an adequate penetration.

Therefore, the investigators plan to conduct a prospective study to assess whether there is any difference in the degree of nonalcoholic steatosis and fibrosis between Chinese HIV/AIDS patients after initial treatment with NNRTI or INSTI, or switching from NNRTI to INSTI.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The degree of hepatic steatosis and fibrosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of Infectious Diseases, PekingUMCH
name: WEI Lyu
role: PRINCIPAL_INVESTIGATOR
References: