| [ Summary ] |
In a multicenter Phase 3 study, high rates of sustained virologic response (SVR) were observed among Japanese patients with chronic hepatitis C virus (HCV) infection who received 12 weeks of treatment with Harvoni® (combination of the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir) for genotype (GT)-1 infection. Subsequently, in July 2015, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) as the first once-daily, single-tablet regimen for the treatment of HCV infection. Although Harvoni has only been used to treat elderly patients with advanced fibrosis, the drug was found to be safe, simple, and well-tolerated when used in real-life treatment. We aim to investigate whether Harvoni mitigated the risk of HCV infection, similar to Interferon, and study the reason for treatment failure and hepatitis B virus reactivation in patients with SVR. We inferred that treatment with Harvoni could be insufficient for patients who failed treatment with daclatasvir and asunaprevir, and physicians must familiarize themselves with the results of new clinical trials for HCV. |