EFFECTIVENESS OF 8 OR 12 WEEK LDV/SOF IN TREATMENT-NAÏVE PATIENTS WITH NON-CIRRHOTIC, GENOTYPE 1 HEPATITIS C: REAL-WORLD EXPERIENCE FROM THE TRIO NETWORK

To determine SVR12 rates for 8 or 12 weeks of LDV/SOF for GT1, non-cirrhotic, treatment-naïve patients and to assess compliance with guidelines and patient adherence to treatment. Data was obtained through Trio Health’s Innervation Platform and directly from specialty pharmacies for 895 treatment-naïve patients with non-cirrhotic GT1 Hepatitis C who initiated 8 or 12 week LDV/SOF between Oct 2014 and Mar 2015. 62% (553/895) of patients were treated in community practices with the remainder from academic centers. Intended treatments were: 29% (263/895 patients) 8 week LDV/SOF, and 71% (632/895) 12 week LDV/SOF±RBV (2% (21/895) of patients were treated with 12 weeks of LDV-SOF+RBV). 8 week therapy was initiated for 36% (254/710) of patients with baseline HCV RNA <6MM IU and 4% (8/178) of patients with >6MM IU HCV RNA. 12 week therapy was selected for 456 patients with HCV RNA < 6MM IU indicating physician preference for longer therapy and was independent of baseline demographics including Metavir fibrosis stage >2. SVR12 rates by regimen were: 95% (251/263) for 8 weeks of LDV-SOF and 96% (604/632) for 12 weeks of LDV-SOF±RBV. Of the 58 patients that did not achieve SVR, 7 discontinued treatment, 22 were lost to follow-up, 2 died, and 9 completed therapy and were virological failures. Among the patients’ baseline characteristics, there were no significant predictors of response. In real world the 8 week regimen (SVR 95%) were comparable to the 12 week regimen of LDV-SOF (96%). Response rates were similar regardless of degree of fibrosis and baseline viral load. 456 patients (51%) with a viral load < 6MM received 12 weeks of therapy rather than 8 weeks. Overall discontinuation rate was <1% (7/895).