PE-078 : Real-World Sustained Virologic Response Rates (SVR12) with Interferon (IFN)-Free Direct Acting Antiviral (DAA) Therapy in East Asia- Results from REAL-C (Real-World Effectiveness from the Asia Liver Consortium for Chronic Hepatitis C)

Aims: Since their recent introduction in Asia, IFN-free DAAs have revolutionized treatment of chronic hepatitis C across all HCV genotypes. However, experience from large and diverse routine clinical practice is still limited. The aim of this study was to report real-world outcomes from a large multinational co hort of East Asian HCV patients treated with IFN-free DAAs. Methods: Data were obtained using a required case report form from the REAL-C registry of patients who were initiated on IFN-free DAA therapy in routine practice and represented 10 study centers inclusive of 30 clinical sites in Hong Kong, Japan, Korea, and Taiwan. Cirrhosis was determined by liver biopsy, noninvasive tests (elastography/fibroscan, fibrotest), or the presence of clinical, radiologic, endoscopic, laboratory evidence of cirrhosis and/or portal hypertension. Results: A total of 3702 patients have been registered. Table 1 displays the patient characteristics. The average age was 63.6±12.8; 17.7% had diabetes, 8.7% had chronic renal impairment, 26% had cirrhosis (5.1% decompensated cirrhosis), and 5.4% had HCC at baseline or prior to DAA treatment initiation. The majority of patients were HCV GT1 (68.7%), followed by HCV GT2 (30.4%). Ten different DAA regimens were used, with the majority receiving LDV/SOF (43.7%), followed by SOF+RBV (27.8%). One-third were treatment experienced (24.8% with prior PEG-IFN+RBV, 4.5% with prior DAA). SVR12 overall rate was 96.6%. Significant decreases noted in all major liver enzymes at week 12 and 24 post treatment. No increase in creatinine noted across treatments; 3.2% stopped treatment and 13.4% had an adverse event with fatigue (5.6% in patients treated with RBV vs. 6.4% in those treated without RBV, P=0.61) and anemia (5.6%) the most reported. Table 2 displays SVR12 rates by cirrhosis and prior treatment status for the most commonly used DAA treatments for GT1 and GT2 patients. SVR12 rates were excellent ranging from 97.1% (95%CI: 94.1-98.8%) to 99.7% (95%CI: 99.0-99.9%) for GT1 patients treated with LDV/SOF who did not have cirrhosis regardless of prior treatment history and who were treatment-naive with cirrhosis but lower in the cirrhotic treatment-experienced group (92.2%; 95%CI: 86.7-95.9%) (P<0.0001). Sub-analysis results for GT1b were similar, with SVR12 99.7% for non-cirrhotic treatment-naive, 99.5% for non-cirrhotic treatment-experienced, 97.4% for cirrhotic treatment-naive, and 93.0% for cirrhotic treatment-experienced, (P<0.0001). For GT2 patients, SVR12 was excellent for all groups (96.8-98.0%) except for cirrhotic treatment-experienced patients (n=66) who experienced an SVR12 of 87.9% (95%CI: 77.5-94.6%) (P=0.002). Conclusions: HCV cure rates were high overall in the REALC cohort-LDV/SOF GT1 98%; SOF+RBV GT2 96% except for cirrhotic, treatment-experienced patients especially in GT2, suggesting alternative therapy is needed.