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Clinical studies have demonstrated that sFASL levels correlate with histological features of liver injury, particularly ballooning degeneration, lobular inflammation, and fibrosis

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We are codifying that for single source drugs that are not biosimilars with all negative or zero ASP data for a given quarter, the payment limit will be, until at least one NDC for the drug has positive manufacturer ASP data for a quarter, the lesser of 106 percent of the volume-weighted average of the most recently available positive manufacturer ASP data for at least one NDC from a previous quarter and 106 percent of the WAC, and we will use 106 percent of the lowest WAC per billing unit if there is more than one WAC per billing unit

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Results: Patients with the heterozygous LOXL1 G153D mutation exhibited reduced reversibility after 78 weeks of antiviral treatment (26.3% and 52.4% reversal rates in heterozygous mutated and non-mutated patients, respectively, p=0.025)

Pallone and Freedman 2021)