Article Text
Abstract
Background Sofosbuvir 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.
Methods A 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.
Results A 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).
Conclusions SOF+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 number CRD42017067928.
- hepatitis C
- liver cirrhosis
- genotype
- adverse drug reactions
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Footnotes
BW and FJ contributed equally.
Contributors BW and FJ: study design, data collection, data analysis, data interpretation, and drafting of the manuscript. YHY: data analysis, data interpretation and critical review of the paper. EO: data collection, data interpretation and critical review of the paper. RCC: study design, data collection, data interpretation and critical revision of the manuscript. CDS, SD, BZ, ZL, NF: data collection, data interpretation and critical review of the paper. MHN: study conception, study design, data collection, data analysis, data interpretation, drafting of the manuscript and supervision of the study. All authors read and approved the final version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RCC: grant/research support, Gilead Sciences. NF: grant/research support: MSD, Gilead Sciences, Bristol-Myers Squibb and Janssen Pharmaceuticals; speaker’s bureau: Gilead Sciences, MSD, Bristol Myers, and Janssen Pharmaceuticals; advisory board: Gilead Sciences, AbbVie and Bristol-Myers Squibb. MHN: grant/research support: BK Kee Foundation, Asian Health Foundation, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceutical, National Cancer Institute, and Pfizer; pharmaceutical; advisory board member or consultant: Dynavax Laboratories, Gilead Sciences, Intercept Pharmaceuticals, Alnylam Pharmaceutical, Bristol-Myers Squibb, Novartis Pharmaceutical and Janssen Pharmaceutical.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
Presented at This study had been presented as poster at the 2017 AASLD Conference.