Abstract
ObjectiveToward the limited real-world data concerning the treatment response to brand direct-acting antiviral agents (DAAs) therapy, we proposed to evaluate the efficacy and safety of DAAs for the treatment of chronic hepatitis C virus (HCV) in mainland China.MethodsIn this retrospective, single-center, cohort study, all HCV-infected adult patients treated with brand DAA drugs covered by Tianjin local health insurance (Apr 2018–Sept 2019) and responding to other specific inclusion criteria were recruited. The five available DAA regimens included sofosbuvir + ribavirin (SOF + RBV), elbasvir/grazoprevir (EBR/GZR), ombitasvir/paritaprevir/ritonavir/dasabuvir (OBV/PTV/r/DSV) ± RBV, daclatasvir + asunaprevir (DCV + ASV), and SOF + DCV ± RBV. Demographic, virologic, clinical, and adverse effects data obtained during and after DAAs treatment were collected. We evaluated the rate of sustained virological response at 12 weeks post-treatment (SVR12), the incidence of adverse effects, and assessed the factors associated with SVR12.ResultsFour hundred ninety-four patients finished the treatment and completed the 12-week post-treatment follow-up. The overall SVR12 rate was estimated at 96.96%. SVR rates greater than 95% were achieved in most of the HCV genotypes with the exception of GT1a (0%), GT3a (93.33%), and GT3b (88.24%). SVR12 for patients treated with DCV + ASV, EBR/GZR, OBV/PTV/r/DSV ± RBV, SOF + DCV ± RBV, and SOF + RBV for 12 or 24 weeks was 86.67%, 100%, 98.11%, 97.56%, and 95.06%, respectively. Subjects with compensated cirrhosis (92.73%) and prior treatment experience (77.78%) had significantly lower SVR rates when compared to chronic hepatitis C (98.15%) and treatment-naive (97.69%) groups. In Tianjin, the available DAA regimens were generally well-tolerated, and not a single serious adverse event was reported.ConclusionIn this large real-life single-center HCV cohort from China, oral DAAs were highly effective and well-tolerated. Further and larger-scale studies are needed to evaluate their clinical safety and efficacy.
Highlights
Chronic hepatitis C virus (HCV) infection is a significant challenge to public health
The results of real-world investigations on direct-acting antiviral agents (DAAs) efficacy are mostly reported in western countries. They present similar efficacy as observed in clinical trials (Saxena et al, 2017; Berg et al, 2019; Mera et al, 2019). These results revealed the effectiveness of DAAs in some specific categories of patients (Saxena et al, 2017; Mera et al, 2019)
Study Population and Antiviral Regimens. In this single-center—Tianjin Second People’s Hospital— retrospective real-world cohort study, patients meeting the following inclusion criteria were enrolled: (1) ≥18 years old; (2) a history of chronic HCV infection; (3) HCV GT 1, 2, 3, 6, unknown, or mixed; (4) with or without cirrhosis; (5) treatment-naïve or treatmentexperienced with interferon-based regimens; (6) negative results for antinuclear, anti-mitochondria, anti-smooth muscle autoantibodies; (7) with Tianjin local Medical Insurance; (8) treated with available brand DAAs covered by Tianjin local health insurance
Summary
Chronic hepatitis C virus (HCV) infection is a significant challenge to public health. In 2015, an estimated 71 million people were infected with HCV worldwide, and there were approximately 9.8 million HCV viremic people in China (Polaris Observatory, 2017). There, the infection is showing a significant increase in some provinces (Liu et al, 2018). In China, HCV is much more prevalent among older people (Liu et al, 2018), who are more likely to experience chronic liver disease. Long-term HCV infection is a leading cause of hepatic inflammation, extensive fibrosis, cirrhosis, hepatocellular carcinoma (HCC), and liver-related death (Polaris Observatory, 2017). The HCV-related diseases represent an immense health and economic burden in China
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