Real-world effectiveness of sofosbuvir plus ribavirin for chronic hepatitis C genotype 2 in Asia: a systematic review and meta-analysis

Abstract

BackgroundSofosbuvir plus ribavirin (SOF+RBV) for 12 weeks is the standard treatment for chronic hepatitis C (CHC) genotype 2 (GT2) in most of Asia despite availability of new CHC medications. SOF-RBV real-world effectiveness has only been reported in small and/or single-centre studies. Our goal was to determine the real-world effectiveness of 12-week SOF+RBV therapy for CHC GT2 in Asia.MethodsA systematic search on PubMed and Embase was conducted through 30 June 2017. We identified full articles and conference proceedings of at least 10 adult patients with CHC GT2 treated with SOF+RBV for 12 weeks under real-world setting in Asia.ResultsA total of 2208 patients from 13 studies were included. The pooled sustained virological response 12 weeks after the end of treatment (SVR12) was 95.8% (95% CI 94.6% to 96.9%) with non-significant heterogeneity (I2=34.4%). Anaemia (27.9%) was the most common adverse event (AE), with serious AEs in 2.0% and only 0.7% discontinued therapy prematurely. In subgroup analyses, patients with cirrhosis had 8.7% lower SVR12 than non-cirrhotic patients (P<0.0001), and treatment-experienced patients had 7.2% lower SVR12 than treatment-naïve patients (P=0.0002). Cirrhotic treatment-experienced patients had the lowest SVR12 at 84.5%. There were no significant differences in pooled SVR12 among patient subgroups: RBV dose reduction versus no dose reduction (P=0.30); hepatocellular carcinoma (HCC) versus no HCC (P=0.10); GT 2a versus 2b (P=0.86); and <65 vs ≥65 years of age (P=0.20).ConclusionsSOF+RBV for 12 weeks was safe and effective for patients with CHC GT2 in Asia, although those with cirrhosis and prior treatment failure had a lower pooled SVR12 rate.Trial registration numberCRD42017067928.

Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

“…Among cirrhotic patients who received SOF/RBV, the SVR 12 rates for treatment‐experienced and treatment‐naïve patients were 83.3% and 92.3%, respectively. The 9% gap of SVR 12 rate between these patients was in line with a recent meta‐analysis for Asian HCV‐2 patients receiving SOF/RBV where the SVR 12 rates were 84.5% and 93.3% for treatment‐experience and treatment‐naïve cirrhotic patients, respectively . However, the gap of SVR 12 rate in Western treatment‐experienced and treatment‐naïve HCV‐2 cirrhotic patients who received SOF/RBV for 12 weeks in FISSION, FUSION, and POSITRON trials was about 30% .…”

“…The 9% gap of SVR 12 rate between these patients was in line with a recent meta-analysis for Asian HCV-2 patients receiving SOF/RBV where the SVR 12 rates were 84.5% and 93.3% for treatment-experience and treatment-naïve cirrhotic patients, respectively. 35 However, the gap of SVR 12 rate in Western treatment-experienced and treatment-naïve HCV-2 cirrhotic patients who received SOF/RBV for 12 weeks in FISSION, FU-SION, and POSITRON trials was about 30%. 11,12 Whether extending the treatment duration of SOF/RBV to 16 weeks in East-Asian treatment-experienced HCV-2 cirrhotic patients to improve the SVR 12 rate needs further confirmation.…”

Sustained virologic response rates in patients with chronic hepatitis C genotype 6 treated with ledipasvir+sofosbuvir or sofosbuvir+velpatasvir

“…Also, very encouraging is that our real‐world results are similar to what was obtained in the clinical trials for GT6, as have also been found for other genotypes for Asians . The SVR results for LDV+SOF in our study were similar to a study conducted by Gane et al who studied 126 HCV patients in which 25 were GT6 and were either treatment naïve or treatment experienced and were treated with LDV+SOF for 12 weeks.…”

Twelve weeks of ledipasvir/sofosbuvir all‐oral regimen for patients with chronic hepatitis C genotype 2 infection: Integrated analysis of three clinical trials

“…cirrhotic patients with prior treatment failure) are required to receive treatment for a longer duration. 8,9 The fixed-dose combination of ledipasvir (LDV), a non-structural protein 5A (NS5A) inhibitor, and SOF, an NS5B polymerase inhibitor, is given in a single tablet (90 mg LDV and 400 mg SOF) taken orally once daily. Since 2014, LDV/SOF has been approved in many countries across the world for the treatment of HCV genotypes 1, 4, 5, and 6.…”