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

Abstract

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.

Global real‐world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts

“…The expanding use of DAAs in clinical practice in recent years has provided an opportunity to assess their effectiveness and safety in real‐world cohorts, outside the controlled settings of clinical trials. Several real‐world cohorts have evaluated SOF/VEL effectiveness and safety in varying settings, with the results being similar to those of clinical trials 10,15‐24 …”

“…Several real-world cohorts have evaluated SOF/VEL effectiveness and safety in varying settings, with the results being similar to those of clinical trials. 10,[15][16][17][18][19][20][21][22][23][24] In this integrated real-world analysis, data from 12 clinical practice cohorts across different real-world settings in Canada, Europe and the USA were pooled to allow the evaluation of the real-world effectiveness of SOF/VEL for 12 weeks without ribavirin (based on the label or physician discretion) in the largest available heterogeneous HCV patient population and to investigate any patient characteristics affecting the risk of not achieving SVR. (Table 1)…”

Sofosbuvir-based therapies achieved satisfactory virological response in Chinese with genotypes 3 and 6 infection: a real-world experience from a centre

“…27 Another real-world study from China showed that genotype 3a infected patients yield high and similar SVR12 rate in SOF/VEL and SOF + DCV ± RBV regimens. 28 However, the number of patients enrolled were small and the SVR12 rate on 3b sub-type with cirrhosis wasn't shown. In present study, patients with genotype 3 infection achieved SVR12 rates over 90% even high to 100% except for SOF + RBV and SOF/VEL regimens.…”

Association of the Sialylation of Antibodies Specific to the HCV E2 Envelope Glycoprotein with Hepatic Fibrosis Progression and Antiviral Therapy Efficacy

“…However, a considerable percentage of patients with HCV genotype 1 infection does not respond to IFN-RBV therapy due to drug resistance and/or poor tolerability. In treatment with direct-acting antivirals (DAA), the SVR rates may exceed 80% irrespective of genotype though an interferon-based therapy may be still beneficial in DAAresistant patients [40][41][42][43]. HCV has been involved in the triggering of autoimmune diseases with the development of mostly non-organ-specific autoantibodies (NOSA), and this was associated with a more severe histological and biochemical profile of hepatitis C infection [44][45][46][47].…”