Abstract
Background: In 2015, Georgia launched world’s first HCV elimination program. Initially, patients with advanced liver disease were prioritized to receive sofosbuvir-based treatment regimen, as it was the only DAA available for all genotypes. Purpose of the study was to assess real-world data of treatment outcome among patients with HCV GEN3 and advanced liver fibrosis with sofosbuvir-based regimens. Methods: GEN3 patients enrolled in the program, received sofosbuvir-based regimens, and had outcome data from April 28 through September 30, 2016 were eligible for the study. Demographic and clinical data were analyzed. Results: A total of 1525 genotype 3 patients were eligible for analysis; most (72.6%) were aged >45 years, majority were males (95.1%), and all (100%) had advanced liver disease (F3 or F4 by METAVIR score based on elastography). Of those who received sofosbuvir/ribavirin (SOF/RBV) for 24 weeks, 449/566 (79.3%) achieved SVR, while 925/959 (96.5%) who received sofosbuvir/pegylated interferon/ribavirin (SOF/PEG/RBV) for 12 weeks achieved SVR (p<.01). Among patients with liver cirrhosis (defined as F4) overall cure rate was 85.7% as opposed to 96.4% for those with F3. Females were more likely to be cured (98.7% vs 89.7%; OR=8.54, 95%CI:1.18-61.87). Patients aged 31-45 years had higher likelihood of achieving SVR compared to patients aged 46-60 years (95.7% vs 87.4%; OR=0.32, 95%CI:0.19-0.53). Independent predictors of SVR were treatment with SOF/PEG/RBV (aOR=6.72, 95%CI:4.49-10.06) and lower fibrosis stage (F3) (aOR=4.18, 95%CI:2.64-6.61). Conclusions: Real-world experience among HCV GEN3 patients with advanced liver fibrosis and treated by sofosbuvir regimen w/o PEGIFN, demonstrated overall high SVR rate.
High sustained viral response among HCV genotype 3 patients with advanced liver fibrosis: real-world data of HCV elimination program in Georgia
