Rapid improvements in hepatitis C virus (HCV) therapy have significantly increased the cure rate of chronic hepatitis C[9, 10]. However, this therapy truly entered the DAA era with its approval in Apr 2018 in China. Epidemiological studies reported that HCV genotype 1 infection was the most prevalent genotype in the world and China[11–13]. As a powerful antiviral regimen for HCV-1b has been demonstrated in clinical studies, there are several reports on the outcomes of EBR /GZR treatment in real-world clinical practice[14–16]; however, there are few reports from the Chinese mainland. Chinses patients in the real world are more heterogeneous and have more complications comparing with those in RCT studies, and there are differences in viral infection pathways, races from other countries such as Europe and the United States, therefore, it is worthwhile for us to discuss the real effect of this regimen on hepatitis C patients in China. This real-world cohort study from the Chinese mainland was aimed to observe the efficacy and safety of the EBR /GZR for hepatitis C patients, and the liver function in the 1-year follow-up period after treatment.
Through the inclusion of compensatory cirrhosis patients, our study showed that the overall SVR12 rate in patients receiving EBR /GZR was excellent (99.5%) and was slightly higher than the response rates(98.2%)in the clinical trials from the Asia–Pacific region and Russia[6]. Of the 47compensated cirrhotic patients in our study, 100% of patients achieved a virological response at the end of treatment, and 46 patients (97.6%) achieved SVR12, which was similar to the previous real-world studies[14, 17, 18]. Although SVR12 was considered to be hepatitis C virus cure[19], in our study, one cirrhosis patient relapsed 48 weeks posttreatment after receiving SVR12. Long term follow-up of patients with liver cirrhosis after HCV treatment was still necessary.
During the treatment, liver function improved significantly and more than 91% of patients had normal ALT levels at the end of treatment. At 48 weeks posttreatment, 97.2% of patients' ALT levels and 95.3% of patients' AST levels remained normal. We found that overall liver function was relatively stable and there was no progression of decompensated cirrhosis during the 48-week follow-up.
In this study, 9 patients with chronic renal failure and regular dialysis completed 12 weeks of antiviral treatment with EBR /GZR without drug reduction. Previous studies on patients with advanced kidney disease have suggested that EBR /GZR is well tolerated[20]. All 9 patients achieved SVR12 and SVR48 in our study which was consistent with our previous findings[21], indicating that this regimen had good therapeutic effect and tolerance in renal failure patients.
Our data showed the safety and tolerability (including renal safety) of EBR /GZR. One patient discontinued treatment for 6 weeks because of his original disease, while no patient discontinued because of drug interactions. In this study, side effects were reported in 39 patients. Although the reported AE incidence in this study was only slightly higher than that in some real-world studies[15, 16], most of AEs were mild in severity. During treatment, the hyperbilirubinemia observed was the most common adverse event; however, the severity was mainly graded 1 or 2 and lasted only 2–4 weeks for most patients. In general, EBR /GZR was well tolerated and safe in clinical practice.
Since DAA in China has been available in the past year and is expensive, there are few large sample reports about the real-world study. Although this study reflects the real-world data of HCV-1b patients, several limitations existed in our study. First, the patients in this study came from two medical centers, while they were limited in one region and the sample size was small. Second, there was potential bias in the doctor prescriptions and incomplete patient records in the real-world efficacy evaluation. Moreover, our study included patients with chronic hepatitis C and compensatory cirrhosis and lacked data on a large sample of cirrhotic patients.