| Outcome Measures: |
Main Objective: A change in hepatic immune cells- including CD3+, CD4+, CD8+, T-bet+, CD56, CD68, CD163 and myeloperoxidase<br>positive cells identified on liver biopsy tissue using immunohistochemistry- following 48 weeks MVC ;Secondary Objective: 1. Improvement in biochemical (fasting glucose, lipids and HOMA index) metabolic parameters at EOT as compared to<br>baseline.<br>2. Modification of circulating inflammatory cytokines, adipokines and markers of macrophage activation (high sensitive<br>IL6, sTNFR1 /2, sCD14, sCD163, hsCRP, Leptin, Total and High molecular weight adiponectin) at EOT as compared to<br>baseline.<br>3. Number of subjects with a reduction in the NAS score by =2 points without worsening of fibrosis at EOT as<br>compared to baseline.<br>4. Number of subjects with a reduction in the degree of liver steatosis, inflammation and/or ballooning at EOT as<br>compared to baseline<br>5. Number of subjects with a reduction of at least one stage of liver fibrosis in patients with fibrosis at EOT as<br>compared to baseline<br>6. Number of subjects with a reduction of Fibroscan?? values and biochemical markers of fibrosis (APRI, Fib-4, NAFLD<br>Fibrosis Score[5]) from at EOT as compared to baseline<br>;Primary end point(s): A change in hepatic immune cells- including CD3+, CD4+, CD8+, T-bet+, CD56, CD68, CD163 and myeloperoxidase<br>positive cells identified on liver biopsy tissue using immunohistochemistry- following 48 weeks MVC therapy.;Timepoint(s) of evaluation of this end point: Compare values at baseline (within 12 months before enrollment) with values after 48 weeks treatmentSecondary end point(s): 1. Improvement in biochemical (fasting glucose, lipids and HOMA index) metabolic parameters at EOT as compared to<br>baseline.<br>2. Modification of circulating inflammatory cytokines, adipokines and markers of macrophage activation (high sensitive<br>IL6, sTNFR1 /2, sCD14, sCD163, hsCRP, Leptin, Total and High molecular weight adiponectin) at EOT as compared to<br>baseline.<br>3. Number of subjects with a reduction in the NAS score by =2 points without worsening of fibrosis at EOT as<br>compared to baseline.<br>4. Number of subjects with a reduction in the degree of liver steatosis, inflammation and/or ballooning at EOT as<br>compared to baseline<br>5. Number of subjects with a reduction of at least one stage of liver fibrosis in patients with fibrosis at EOT as<br>compared to baseline<br>6. Number of subjects with a reduction of Fibroscan?? values and biochemical markers of fibrosis (APRI, Fib-4, NAFLD<br>Fibrosis Score[5]) from at EOT as compared to baseline<br>7. Number of subjects with normalization of Fibroscan values at the EOT<br>8. Number of subjects with a reduction in liver transaminases (ALT and AST) levels during the course and the EOT<br>9. Additional stool and urine samples will be collected at baseline and EOT and stored in Imperial College<br>Gastroenterology and Hepatology Biobank for analysis of the impact of the intestinal microbiome and associated<br>metabolic biomarkers on the progression of NAFLD/NASH in HIV;Timepoint(s) of evaluation of this end point: Compare values at baseline with values after 48 weeks treatment
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