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PIN2 REAL-WORLD EFFECTIVENESS OF HEPATITIS C VIRUS (HCV) TREATMENT WITH DIRECT-ACTING ANTIVIRALS (DAA) IN POPULATIONS WITH FATTY LIVER/NON-ALCOHOLIC STEATOHEPATITIS (FL/NASH), DECOMPENSATED CIRRHOSIS (DCC), HEPATOCELLULAR CARCINOMA (HCC), AND/OR POST LIVER TRANSPLANT (PTX)

      Objectives

      DAA therapies are highly effective for treatment of HCV, however their efficacy in patients with existing advanced liver disease (ALD) has not been well described, especially in real-world populations. This study assessed utilization patterns and outcomes with DAAs in patients with HCV and ALD (FL/NASH, DCC, HCC, and/or PTX).

      Methods

      Data were collected using Trio Health’s disease management program and are specific to patients with physician-reported ALD at therapy initiation occurring between October 2015 to February 2019 and with ≥9 months follow-up.

      Results

      Of 667 patients with ALD, 9% had NASH, 22% FL, 31% DCC, 31% HCC, and 21% were PTX. Overall, 70% were male, 35% age >65, 50% (299/602) FIB4 >3.25, 20% (122/617) eGFR < 60 ml/min, 25% diabetes, 55% hypertension, 17% (110/653) >6M HCV viral load, and 74% (491/666) treatment-naïve. Majority (91%, 538/667) were treated with ledipasvir-sofosbuvir (51%), sofosbuvir-velpatasvir (18%), glecaprevir-pibrentasvir (12%), elbasvir-grazoprevir (6%), or sofosbuvir-velpatasvir-voxilaprevir (5%). In intent to treat (ITT) ALD patients, sustained virologic response [SVR] was 84% (CI 81%-86%); per protocol (PP) SVR was 95% (CI 93%-96%) with 5% virologic failure. Differences in ITT vs PP SVRs were due to loss of follow-up (37 patients, 6%), death (22, 3%), and treatment discontinuation (20, 3%). Within this ALD study population, ITT SVR [95% CI] was lowest in patients with DCC (74% [68%-80%]) due to a higher rate of patient death relative to the overall study population (9% v. 3%, respectively). PP SVRs were similar between overlapping ALD subgroups and ranged from 92% to 97%.

      Conclusions

      Virologic failures with DAAs in patients with ALD were limited and consistent with reported outcomes in real-world studies of patients with less severe disease. The reduced cure rate in this intent to treat ALD population was predominantly due to patients lost to follow up.