| Objective: To systematic review the efficacy and safety of sofosbuvir(SOF)combined with velpatasvir(VEL)for the treatment of chronic hepatitis C(CHC).Method: Pub Med,Web of Science,Medline,Embase,The Cochrane Central Register of Controlled Trials(CENTRAL),Clinical Trials.gov,China National Knowledge Infrastructure(CNKI),and Wanfang Digital Journal Full-text Database were searched for the randomized controlled trials(RCTs)in evaluating the efficacy and safety of sofosbuvir plus velpatasvir for CHC.A meta-analysis was performed by using R 3.4.3 software.Result: Six randomized controlled trials involving 2,523 CHC patients were included in this study.The results of meta-analysis showed that:(1)The regimen of SOF(400 mg/day)plus VEL(100 mg/day)for 12 weeks in GT 1-6infection patients achieved SVR12 rates of 96.7%(95%CI: 86.6%-99.3%),98.3%(95%CI: 93.6%-99.6%),89.0%(95%CI: 65.8%-97.2%),95.5%(95%CI: 69.2%-99.5%),97.1%(95%CI: 82.3%-99.6%),and 96.9%(95%CI: 80.8%-99.6%),respectively,and the SVR12 rates of 92.1%(95%CI: 83.8%-96.3%)in cirrhotic patients and 98.1%(95%CI:96.2%-99.1%)in non-cirrhotic patients.In GT 1-6 HCV infection patients,the 12 weeks' regimen of SOF/VEL achieved relapse rates of 2.1%(95%CI: 0.5%-9.3%),1.7%(95%CI:0.3%-8%),9.8%(95%CI: 2.7%-30.1%),3.0%(95%CI: 0.4%-18.4%),1.4%(95%CI:0.1%-18.7%),3.1%(95%CI: 0.4%-19.2%),respectively,and the relapse rates of 7.3%(95%CI: 3.6%-14.0%)in cirrhotic patients and 1.2%(95%CI: 0.5%-3.0%)in non-cirrhotic patients.(2)In cirrhotic patients with HCV infection,SOF/VEL(400 mg/100 mg)achieved SVR12 rates of GT1(90.4% vs.94.9%),GT2(87.5% vs.100%),and GT4(100% vs.100%)was similar to SOF/VEL(400 mg/100 mg)+RBV(p>0.05).However,the SVR12 rate of SOF/VEL was significantly lower than SOF/VEL+RBV(69.2% vs.92.3%,RR=0.80,95%CI: 0.67-0.95,p=0.01)in GT3 HCV infection.In non-cirrhotic patients,SOF/VEL achieved SVR12 rates of GT1(96.1% vs.87.8%),GT2(91.7% vs.88.5%),and GT3(100% vs.100%)was no obvious difference with SOF/VEL+RBV(p>0.05).There was no significant statistical difference in relapse rates of GT1(4.9% vs.6.2%),GT2(8.3% vs.11.5%),and GT3(16.5% vs.3.1%)between SOF/VEL and SOF/VEL+RBV.SOF/VEL had obviously higher relapse rate than SOF/VEL+RBV in cirrhotic patients(9.9% vs.3.3%,RR=3.22,95%CI: 1.07-9.71,p=0.04).The relapse rate of SOF/VEL was similar to SOF/VEL+RBV in non-cirrhotic patients(4.5% vs.7.9%,RR=0.43,95%CI:0.17-1.09,p=0.08).There was no significant difference in the incidence of discontinuation(RR=0.60,95%CI: 0.17-2.19,p=0.44)and serious adverse events(RR=1.17,95%CI:0.69-1.98,p=0.56)between SOF/VEL and SOF/VEL+RBV.SOF/VEL+RBV had obviously higher rate of the overall adverse events than SOF/VEL(RR=0.90,95%CI:0.83-0.97,p=0.008).Conclusion:(1)SOF/VEL(400mg/100mg)was highly effective in CHC patients with GT 1-6,including treatment-experienced and cirrhotic patients,with SVR12 rates > 95% and relapse rates ? 3.1%,except for GT3(SVR12 rate = 89.0%,relapse rate = 9.8%).(2)There was no significant difference in the efficacy between SOF/VEL and SOF/VEL+RBV in CHC patients,except for cirrhotic patients with GT3 HCV infection.The incidence of adverse events in SOF/VEL were obviously lower than SOF/VEL+RBV.(3)For cirrhotic patients with GT3 HCV infection,adding RBV to SOF/VEL was associated with a significant improvement of SVR12 rate(69.2% vs.92.3%).The addition of RBV to this regimen could significantly decrease the relapse rate(9.9% vs.3.3%)in cirrhotic patients with HCV infection. |
PDF Full Text Request