Real-world effectiveness and safety of OBT/PTV/r and dasabuvir for patients with chronic HCV genotype 1b infection in China: A multicenter prospective observational study

Abstract

Background and aimReal-world data on the effectiveness and safety of treatment with the direct-acting antiviral agent-based regimen are limited on the Chinese mainland. The aim of this study was to conduct a multicenter, prospective, real-world study of ombitasvir/paritaprevir/ritonavir (OBT/PTV/r) combined with dasabuvir (DSV) in hepatitis C virus (HCV) genotype 1b-infected non-cirrhotic or compensated cirrhotic Chinese adult patients. Materials and methodsGenotype 1b-infected patients were enrolled at eight sites in China. Patients received 25/150/100 mg of OBT/PTV/r once daily combined with 250 mg of DSV twice daily for 8 weeks or 12 weeks. Sustained virological response at 12 weeks post-treatment (SVR12) and the incidence of adverse events were assessed. We have also evaluated the effect of intensive questioning of patients who were overdue for SVR12 testing. Intention-to-treat (ITT) and modified ITT (mITT) populations were used in the analysis. ResultsOne hundred forty patients were included, among whom 90.0% (126/140) were newly diagnosed, 9.3% (13/140) had compensated cirrhosis, 92.9% (130/140) received 12 weeks of treatment, and 7.1% (10/140) received 8 weeks of treatment. In the mITT population, the virological response rate at week 4 was 96.4% (108/112), and at the end of treatment was 100% (102/102). Among these patients, 139 patients completed 12 weeks of treatment, and 73 patients were followed-up. All followed-up patients achieved SVR12. There was no adverse event-related discontinuation. Serious adverse events during treatment were reported in two (1.4%) patients, and none were considered to be drug-related. Sixty-six (47.1%) patients did not return to receive the HCV RNA test at 12 weeks post-treatment. ConclusionsThe rate of SVR12 was consistent with Phase III clinical studies. OBT/PTV/r combined with DSV showed effectiveness in Chinese adult patients, and both tolerability and safety profile were favorable. However, patient compliance should be further improved in the real world.