Research in context
Evidence before this study
In April, 2013, we did a search of PubMed for all papers published in English between January, 1990, and April, 2013, using the keywords “HCV genotype 5”, “HCV genotype 5 treatment”, and “HCV genotype 5 epidemiology”. This study was designed in the first half of 2013, before any all-oral regimens for hepatitis C virus (HCV) infection had been approved. At the time of study design, many reports had described the use of directly acting antivirals as part of interferon-based or all-oral regimens for HCV, but very few patients with HCV genotype 5 were included. The recommendation in the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America and the European Association for the Study of the Liver (EASL) guidelines for patients with HCV genotype 5 infection to receive 12 weeks of triple therapy with sofosbuvir, ribavirin, and pegylated interferon-alfa was based on data from a single patient with HCV genotype 5 in the NEUTRINO trial.
Added value of this study
To our knowledge, this study is the first to assess a treatment regimen consisting entirely of directly acting antivirals in patients with HCV genotype 5 infection. 12 weeks of a fixed-dose combination tablet of ledipasvir-sofosbuvir once per day resulted in sustained viral responses in 39 (95%) of 41 patients at 12 weeks after the end of treatment. Treatment was equally successful irrespective of whether patients were treatment naive or treatment experienced.
Implications of all the available evidence
Based on the results of this study, the AASLD treatment guidelines have been modified such that ledipasvir-sofosbuvir for 12 weeks is now the recommended treatment for patients with HCV genotype 5 infection who are treatment naive or treatment experienced. EASL treatment guidelines also recommend treatment with ledipasvir-sofosbuvir for 12 weeks in patients with HCV genotype 5 infection.