Nonalcoholic Fatty Liver Disease in HIV Database

Inclusion Criteria:

• Documented HIV infection

• ≥18 of age at time of initial screening

• HIV suppression with HIV RNA <200 copies/ml on stable ART for ≥ 6 months and nochange in ART class for ≥ 3 months, prior to enrollment

• Participants must meet at least one of the following inclusion criteria:

• Histologically confirmed NAFLD [defined as NAFL (>5% steatosis, with or withoutlobular or portal inflammation), borderline NASH or definitive NASH] within 6months prior to screening (per local pathology report)

• Liver stiffness measurement (LSM) ≥6 kPa from FibroScan exam performed duringscreening or within 12 months prior to screening and a diagnosis of NAFLD basedon clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI)diagnosis at any time

• LSM ≥8 kPa from FibroScan exam performed during screening or within 12 monthsprior to screening, in the absence of CAP ≥263 dB/m

• Able to provide written informed consent to part

• Willingness to be in the study for 1 or more years

• Provision of written informed consent

Exclusion Criteria:

• Positive hepatitis B surface antigen

• Evidence of recent or current hepatitis C virus (HCV) as marked by the presence ofanti-HCV antibody with detectable HCV RNA in serum within 3 years prior toenrollment. Participants with anti-HCV antibody positivity who have undetectable HCVRNA 3 years prior to enrollment (either due to spontaneous clearance or clearancewith treatment) will be eligible to participate if HCV RNA at entry remainsundetected

• Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinksdaily on average in women)

• Evidence of other causes of chronic liver disease

• History of prolonged (> 1 month) total parenteral nutrition within a 6-month periodbefore liver biopsy or before baseline FibroScan VCTE exam

• Short bowel syndrome

• History of biliopancreatic diversion

• History of bariatric surgery within 2 years of enrollment (participants expecting toundergo bariatric surgery can be enrolled prior to the procedure)

• Solid organ transplant recipients

• Other condition that is likely to interfere with study follow-up