Treatment outcome with DAAs in a multinational cohort of 11,099 hepatitis C (CHC) patients with genotypes 1, 2, 3, 4 and 6: A REAL-C study

Abstract

Objectives: The Western Pacific is a large region but few studies have examined the real-world outcomes of DAAs in a multinational study with diverse HCV genotypes (GT). This REAL-C study (real-world evidence from the Asia Pacific Rim Liver Consortium for HCV) will characterize CHC patients treated with DAAs in routine practice. Methods: We analyzed 11,099 CHC patients from 51 REAL-C clinical sites from Mainland China, Hong Kong, Taiwan, Korea, Japan, and Singapore. The primary outcome was SVR12. Results: The cohort had mean age of 64.0, 44.8% male, 24.2% Chinese (10.0% Mainland China, 1.2% HK, 13.0% Taiwan), 7.5% Korean, 68.1% Japanese, 32.6% with cirrhosis, 9.1% HCC, and 27.0% treatment-experienced (TE: 23.2% interferon, 3.8% DAA). The largest group was GT1 (7837 [70.6%]: 642 1a, 7195 1b), then GT2 (2945 [26.5%]: 1761 2a, 1184 2b), GT3 (211: 70 3a, 126 3b, 11 others), GT6 (91), GT4 (5), and mixed (10). DAA use was also diverse: 3349 (30.2%) SOF/LDF ± RBV, 2437 (22.0%) SOF + RBV, 2251 (20.3%) DCV + ASV, 1270 (11.4%) 2D/3D ± RBV, 633 (5.7%) GLE/PIB, 623 (5.6%) SOF/VEL ± RBV, and others. Overall SVR12 was 96.2% (10,674/11099). By cirrhosis and prior treatment, SVR12 was > 96% for all groups, except GT1 cirrhosis/TE (93.4%, 759/813), GT2 cirrhosis/TE (89.0%, 146/164 [144 with SOF + RBV]), GT3 cirrhosis/TE (88.9%, 8/9), and GT6 no cirrhosis/TE (93.3%, 14/15). There was no treatment-related SAE. Conclusion: In this diverse cohort of Asian patients with genotypes 1, 2, 3, 4 and 6, the overall cure rate was 96.2%, despite large numbers of cirrhosis, HCC, prior treatment failure, and older DAA use.