Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3, Clinical Trial = Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3, Clinical Trial

다국어 초록 (Multilingual Abstract)

Aims: Chronic hepatitis C virus (HCV) infection remains a major health threat in China, affecting at least 10 million people, with approximately 58% having genotype (GT) 1 infection. There is a critical need for simple, all oral, direct-acting antiviral regimens to treat GT1 HCV in this region. Treatment with ledipasvir (LDV)/sofosbuvir (SOF) results in high sustained virologic response rates 12 weeks after therapy (SVR12) in GT1 HCV infected patients in clinical trials and real-world settings. This study evaluated the efficacy and safety of LDV/SOF for 12 weeks in Chinese patients with chronic GT1 HCV infection.
Methods: Treatment experienced and treatment naïve patients with chronic GT1 HCV infection with no cirrhosis or with compensated cirrhosis were eligible to enroll in a single-arm, openlabel trial to receive a fixed dosed combination of LDV/SOF 90/400 mg daily for 12 weeks. The primary efficacy endpoint was SVR12 using the CAP/CTM HCV 2.0 assay (LLOQ =15 IU/mL) and the primary safety endpoint was adverse events (AEs) leading to LDV/SOF discontinuation.
Results: A total of 206 Chinese patients were enrolled and treated. Of these, 50% were male, 16% had compensated cirrhosis, 49% were treatment-experienced, 76% had IL28B CC genotype, and 100% had GT1b HCV infection. The mean (range) age and body mass index of enrolled subjects were 47 (21-72) years and 23 (14-34) kg/m2, respectively. The overall SVR12 rate is 100% (206/206). All 32 patients with cirrhosis (15 of whom were treatment-experienced), achieved SVR12. There were no discontinuations due to AEs. No serious or severe AEs were assessed by the investigator as related to study drug and there were no deaths.
Conclusions: Treatment with the single tablet regimen of LDV/SOF for 12 weeks resulted in 100% SVR12 and was well tolerated in treatment experienced and treatment naïve GT1 HCVinfected Chinese patients with and without cirrhosis.