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.