Efficacy and safety of Sofosbuvir/Daclatasvir (SOF/DCA) in treatment of naive patients with genotype-1b chronic hepatitis C / 中华全科医师杂志

ABSTRACT

A total of 291 patients with genotype-1b chronic hepatitis C (CHC) admitted in Hangzhou Xixi Hospital and Jiande Second People′s Hospital between August 2018 to June 2019. All patients received sofosbuvir/daclatasvir (SOF/DCA) therapy for 12 weeks, and were followed up for 24 weeks after treatment. Data were missed in 2 cases, among remaining 289 cases, there were 238 cases without cirrhosis (non-cirrhosis group), 48 cases with compensated cirrhosis (compensated cirrhosis group) and 5 cases with decompensated cirrhosis (decompensated cirrhosis group). The biochemical indexes, blood routine test results, aspartate aminotransferase-to-platelet ratio index (APRI) , fibrosis-4 (FIB-4) and related adverse event were collected. In non-cirrhotic group, 15 cases and 41 cases were lost follow-up after 12 weeks and 24 weeks of treatment, respectively. The sustained virologic response rate on week 12 (SVR12) and SVR24 in non-cirrhotic group were 82.2% (194/236) and 81.7% (193/236) respectively; whole SVR12 and SVR24 rates in compensated cirrhosis group (48/48) and decompensated cirrhosis group (5/5) were all 100% (χ 2=0.96, χ 2=0.44, P>0.05). The blood ALT [ 14 (6, 23) and 14 (5, 72) U/L], AST[22 (14, 24) and 23 (15, 52) U/L], hemoglobin [46 (42, 48) and 46 (34, 51) g/L], globulin [ (32.6±4.0)和(31.6±3.8) g/L], PLT[ (145.0±49.7) and (142.0±47.4) ×10 9/L], APRI [0.4 (0.2, 0.4) , 0.4 (0.3, 1.5) ] of 289 cases on week 12 and 24 after treatment were significantly improved; compared with baseline values [44(8, 175) U/L, 44(23, 154)U/L, 45 (41, 49) g/L, (33.0±4.0) g/L, (150.0±53.7) ×10 9/L, 0.7(0.3, 6.3)] (Week 12 Z=-14.21, Z=-13.97, Z=-14.72, t=2.00, t=5.22, Z=-13.52; (Week 24 Z=-13.12, Z=-13.04, Z=-4.63, t=7.18, t=7.25, Z=-9.48, all P<0.05). Compared with baseline values [ (16.1±5.4) μmol/L, (5.7±1.5) ×10 9/L, 3.4(1.2, 15.2)], the total bilirubin (15.4±5.8)μmol/L, WBC (6.2±1.8)×10 9/L, FIB-4[3.2 (1.5, 13.7) ] levels were also improved ( t=2.34, t=-5.51, Z=-3.40, all P<0.05). Univariate logistic analysis did not find factors influencing the SVR24 of Sofosbuvir/Daclatasvir therapy. The most common adverse events were fatigue (14.8%,36/248), headache (9.3%,23/248), skin rash and pruritus (4.8%, 12/248), diarrhea (5.6%, 14/248), all of which were alleviated after treatment. In conclusion, SOF/DCA is the optimized selection for na?ve patients with genotype-1b CHC with high SVR12 and SVR24 rate and good safety.