Direct acting antiviral agent for Chinese patients with chronic hepatitis C genotype 1b infection——a real world experience

Objective To evaluate the effectiveness and safety of direct-acting antiviral agents (DAA) treatment in Chinese chronic hepatitis C (CHC) patients with genotype (GT) 1b HCV infection in a real world setting. Methods The consecutive GT1b CHC Chinese patients treated with sofosbuvir (SOF) plus daclatasvir (DCV) (n=62) or SOF plus ledipasvir (LDV) (n=171) were enrolled from July 2014 to December 2016 at 302 Military Hospital of China. The treatment duration for all the patients was 12 weeks. All the clinical parameters were measured at baseline and then 4-weekly till 12 weeks after the end-of-treatment (EOT). Baseline clinical characteristics, treatment efficacy, safety and tolerance were compared. Serum HCV RNA concentration was detected by means of COBAS TaqMan assay with a lower detection limit of 15 IU/mL, and liver stiffness was measured using FibroScan®. Sustained virologic response (SVR) was defined as HCV RNA under the lower limit of quantification 12 weeks after EOT (SVR12). Students′ t-test, pearson χ2 test, Spearman rank correlation analysis and Fisher exact test were used for comparison between groups when appropriate. Results Among 233 patients, 173 cases had baseline HCV RNA level ≥6.0 lg IU/mL and 97 cases hade liver stiffness measurement (LSM)≥17.5 kPa. The baseline liver inflamation, liver fibrosis, and HCV RNA load of patients in the two groups were not significantly different (all P>0.05). The HCV RNA of all the 233 patients was undetectable at the end of 12-week treatment, while 2 patients relapsed after 12 weeks of EOT with the overall SVR12 of 99.1%. HCV RNA decline was significantly faster in patients with lower LSM than those with higher LSM (ρ=0.233, P=0.001), and SVR12 was higher in those with lower LSM. In terms of other clinical characteristics of SOF+ DCV and SOF+ LVD groups, alanine transaminase declined from (68.0±60.1) and (70.1±56.1) U/L to (21.1±10.9) U/L and (15.3±9.5) U/L, respectively, total bilirubin declined from (21.3±17.3) and (18.2±14.0) μmol/L to (13.2±6.7) and (10.2±4.6) μmol/L, respectively, AFP declined from 19.6 (10.6, 62.3) and 15.0 (12.0, 25.0) μg/L to 6.5(4.5, 18.7) and 7.8(5.3, 15.4) μg/L, respectively, LSM declined from 17.6 (8.9, 25.4) and 15.7 (7.8, 23.9) kPa to 13.9(6.5, 21.4) and 9.1(5.6, 19.9) kPa, respectively, serum album elevated form (37.5±5.8) and (38.7±5.5) g/L to (41.3±4.7) and (42.8±5.1) g/L, respectively, platelet elevated from (120.9±78.2) ×109/L and (136.6±65.8)×109/L to (139.5±71.8)×109/L and (149.7±71.4)×109/L, respectively. Reports of adverse events were low in both groups. Conclusions Both SOF+ DCV and SOF/LDV therapy are highly effective with >98% of SVR12 and reduce LSM value significantly with good safety for CHC GT1b Chinese patients. Key words: Hepatitis C, chronic; Treatment; Direct-acting antiviral agents