Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia

摘要

Background: Georgia has one of the highest HCV prevalence in the world and launched the world’s first nationalHCV elimination programs in 2015. Georgia set the ambitious target of diagnosing 90% of people living with HCV,treating 95% of those diagnosed and curing 95% of treated patients by 2020. We report outcomes of Sofosbuvir(SOF) based treatment regimens in patients with chronic HCV infection in Georgia.Methods: Patients with cirrhosis, advanced liver fibrosis and severe extrahepatic manifestations were enrolled in thetreatment program. Initial treatment consisted of SOF plus ribavirin (RBV) with or without pegylated interferon (INF).Sustained virologic response (SVR) was defined as undetectable HCV RNA at least 12 weeks after the end oftreatment. SVR were calculated using both per-protocol and modified intent-to-treat (mITT) analysis. Results forpatients who completed treatment through 31 October 2018 were analyzed.Results: Of the 7342 patients who initiated treatment with SOF-based regimens, 5079 patients were tested for SVR.Total SVR rate was 82.1% in per-protocol analysis and 74.5% in mITT analysis. The lowest response rate wasobserved among genotype 1 patients (69.5%), intermediate response rate was achieved in genotype 2 patients(81.4%), while the highest response rate was among genotype 3 patients (91.8%). Overall, SOF/RBV regimensachieved lower response rates than IFN/SOF/RBV regimen (72.1% vs 91.3%, P 0.0001).In multivariate analysis being infected with HCV genotype 2 (RR =1.10, CI [1.05–1.15]) and genotype 3 (RR = 1.14, CI[1.11–1.18]) were associated with higher SVR. Patients with cirrhosis (RR = 0.95, CI [0.93–0.98]), receiving treatmentregimens of SOF/RBV 12 weeks, SOF/RBV 20 weeks, SOF/RBV 24 weeks and SOF/RBV 48 weeks (RR = 0.85, CI [0.81–0.91];RR = 0.86, CI [0.82–0.92]; RR = 0.88, CI [0.85–0.91] and RR = 0.92, CI [0.87–0.98], respectively) were less likely to achieve SVR.Conclusions: Georgia’s real world experience resulted in high overall response rates given that most patients had severeliver damage. Our results provide clear evidence that SOF plus IFN and RBV for 12 weeks can be considered a treatmentoption for eligible patients with all three HCV genotypes. With introduction of next generation DAAs, significantlyimproved response rates are expected, paving the way for Georgia to achieve HCV elimination goals.