Real-World Virological Efficacy and Safety of Ledipasvir and Sofosbuvir in Patients with Chronic Hepatitis C Virus Genotype 2 Infection: A Multicenter Study.
INTRODUCTION
The real-world virological efficacy and safety of interferon-free direct-acting antiviral (DAA) therapy with ledipasvir (LDV) plus sofosbuvir (SOF) were assessed in patients who were chronically infected with hepatitis C virus (HCV) genotype 2.


METHODS
A total of 126 patients with chronic hepatitis C due to HCV genotype 2 infection who were treated with the LDV/SOF regimen were enrolled. The sustained virological response (SVR) rate and safety were analyzed. SVR was assessed in the intention-to-treat (ITT) population as well as in the modified intention-to-treat (mITT) population, which excluded patients with non-virological failure, including those who dropped out before the SVR assessment.


RESULTS
The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively. Subgroup analyses of the mITT population showed no significant differences in SVR rates according to age, sex, HCV genotype (subtype), history of interferon-based therapy, baseline FIB-4 index, or baseline estimated glomerular filtration rate. In all subpopulations, the SVR rates were > 90%. There were no severe adverse events associated with the treatment.


CONCLUSION
The LDV/SOF regimen showed high virological efficacy and acceptable safety in patients with HCV genotype 2 infection.


TRIAL REGISTRATION
UMIN registration no. 000038604.
['Tada|Toshifumi|T|http://orcid.org/0000-0002-0976-6761', 'Kumada|Takashi|T|', 'Okushin|Hiroaki|H|', 'Tani|Joji|J|', 'Takaguchi|Koichi|K|', 'Tsutsui|Akemi|A|', 'Toyoda|Hidenori|H|', 'Yasuda|Satoshi|S|', 'Dohmen|Kazufumi|K|', 'Hiraoka|Atsushi|A|', 'Michitaka|Kojiro|K|', 'Nouso|Kazuhiro|K|', 'Kariyama|Kazuya|K|', 'Kim|Soo Ryang|SR|', 'Kim|Soo Ki|SK|', 'Fujioka|Shinichi|S|', 'Mikami|Shigeru|S|', 'Watanabe|Yuto|Y|', 'Tamai|Tsutomu|T|', 'Atsukawa|Masanori|M|', 'Itokawa|Norio|N|', 'Tanaka|Hironori|H|', 'Tsuji|Kunihiko|K|', 'Ishikawa|Toru|T|', 'Imai|Michitaka|M|', 'Itobayashi|Ei|E|', 'Shibata|Hiroshi|H|', 'Shimada|Noritomo|N|']
Ledipasvir Sofosbuvir Hepatitis C virus Genotype 2 Sustained virological response