Tang L, Ward H, Kattakuzhy S, Wilson E, Kottilil S
a Division of Clinical Care and Research , Institute of Human Virology, University of Maryland School of Medicine , Baltimore , MD , USA.
Expert Rev Gastroenterol Hepatol. 2016;10(1):21-36. doi: 10.1586/17474124.2016.1119042. Epub 2015 Dec 11.
Sofosbuvir is the first pan-genotypic direct acting antiviral agent to be approved. This article provides an overview of the pharmacology of sofosbuvir and ribavirin and a comprehensive summary of the phase 2 and 3 studies supporting dual sofosbuvir and ribavirin therapy for chronic hepatitis C infection. With the production of generic formulations of sofosbuvir, we anticipate this regimen leading the first wave for widespread, IFN-free treatment and becoming first line for all genotypes (including genotype 1) for much of the world-in particular in developing and middle income countries. We discuss the continued challenges with this regimen including among patients with decompensated liver disease and post-liver transplant, and renal failure. We address concerns of emerging resistance. We also discuss the future prospects including the global uptake of sofosbuvir and ribavirin for the treatment of all genotypes.
索磷布韦是首个获批的泛基因型直接抗病毒药物。本文概述了索磷布韦和利巴韦林的药理学,并全面总结了支持索磷布韦与利巴韦林联合治疗慢性丙型肝炎感染的2期和3期研究。随着索磷布韦仿制药的生产,我们预计该方案将引领无干扰素广泛治疗的第一波潮流,并成为世界上大部分地区(特别是发展中国家和中等收入国家)所有基因型(包括1型)的一线治疗方案。我们讨论了该方案持续面临的挑战,包括失代偿性肝病患者、肝移植后患者以及肾衰竭患者所面临的挑战。我们还探讨了新出现的耐药性问题。此外,我们也讨论了未来前景,包括索磷布韦和利巴韦林在全球用于治疗所有基因型的情况。