Comparison of the efficacy of sofosbuvir plus ribavirin in Chinese patients with genotype 3a or 3b HCV infection

et al. 2020

Front. Pharmacol.

Objective: Toward 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. Methods: In 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 posttreatment (SVR12), the incidence of adverse effects, and assessed the factors associated with SVR12. Results: Four hundred ninety-four patients finished the treatment and completed the 12week 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.

Section: A B Csupporting

confidence: 90%

Efficacy and Safety of Direct-Acting Antiviral Therapy in Patients With Chronic Hepatitis C Virus Infection: A Real-World Single-Center Experience in Tianjin, China

Xia

et al. 2020

Front. Pharmacol.

“…In Chinese phase 3 clinical trials, the SVR12 rates in GT3a-infected patients receiving 12 weeks of SOF/VEL and 24 weeks of SOF+RBV were 91% (20/22) (89% [17/19] and 100% [3/3] in patients without and with compensated cirrhosis, respectively) and 100% (58/58), respectively, 45 , 46 similar to those reported among Western GT3-infected patients. 22 , 39 Since the prevalence of Y93H (the predominant NS5A RAS affecting the efficacy of SOF/VEL in GT3a-infected patients) is lower in China, 6 , 23 it is reasonable to anticipate SOF/VEL to have similar or better efficacy in Chinese GT3a-infected patients.…”

Section: Clinical Data For Daas In Gt3-infected Patientssupporting

confidence: 65%

Direct-acting Antiviral Regimens for Patients with Chronic Infection of Hepatitis C Virus Genotype 3 in China

Journal of Clinical and Translational Hepatology

Wei

2021

Self Cite

“…In the phase 3 trial of SOF/VEL, the overall SVR12 of SOF/VEL was 98% (40/41) in genotype 3a patients, but it was 75% (30/40) in genotype 3b patients [23]. A recent study compared the efficacy of SOF plus RBV for 24 weeks in Chinese patients with HCV genotype 3a and 3b and showed that the SVR12 rate in patients with genotype 3b [91% (62/68)] was lower than that in patients with genotype 3a [100% (58/58)] infection [28]. It is suggested that the efficacy of SOF-based regimens may differ between genotype 3a and 3b patients although the present study did not include genotype 3b patients and additional study is needed to clarify this issue.…”

Section: Discussionmentioning

confidence: 99%

High sustained virologic response rates of sofosbuvir-based regimens in Chinese patients with HCV genotype 3a infection in a real-world setting

Han

Fan

et al. 2019

Virol J

Background Patients with hepatitis C virus (HCV) genotype 3 infection remain a difficult-to-cure population. This study evaluated the efficacy and safety of sofosbuvir-based regimen in genotype 3 patients in a real-world setting. Methods HCV genotype 3a-infected adults with compensated liver disease were treated with sofosbuvir (SOF)/velpatasvir (VEL) or SOF/daclatasvir (DCV) with or without ribavirin (RBV) for 12 or 24 weeks, respectively. Efficacy was measured by sustained virologic response at post-treatment week 12 (SVR12). Adverse events were evaluated throughout the treatment and follow-up course. Results A total of 41 genotype 3a-infected patients were included. Of them, 10 patients (24%) had cirrhosis, 3 (7%) had renal impairment, and 2 (5%) failed previous treatment. Nine patients (22%) were treated with SOF/VEL and 32 (78%) with SOF/DCV with or without RBV. SVR 12 was achieved in 100% (9/9) of patients treated with SOF/VEL for 12 weeks and in 97% (31/32) of those treated with SOF/DCV for 12 or 24 weeks. RBV addition and extension of treatment duration did not improve the SVR of SOF/DCV (RR: 1.04; P = 0.99 and RR: 1.09; P = 0.375, respectively). Ten patients with cirrhosis, 1 on hemodialysis and 2 with treatment-experience achieved SVR12. One treatment-naïve non-cirrhotic patient on hemodialysis treated with SOF/DCV for 24 weeks relapsed at week 8 post-treatment. No serious adverse events and relevant laboratory abnormalities were observed. Conclusion SOF/VEL and SOF/DCV are highly efficacious and well tolerated in genotype 3a-infected patients with or without cirrhosis. RBV coadministration and extension of SOF/DCV treatment appear to add no improvement for efficacy. Electronic supplementary material The online version of this article (10.1186/s12985-019-1184-y) contains supplementary material, which is available to authorized users.