TY - JOUR
T1 - Ledipasvir and sofosbuvir for 12 weeks for hepatitis C virus genotype 2 infection
T2 - A propensity score matched analysis
AU - The Kyushu University Liver Disease Study (KULDS) Group
AU - Ogawa, Eiichi
AU - Nomura, Hideyuki
AU - Nakamuta, Makoto
AU - Kawano, Akira
AU - Dohmen, Kazufumi
AU - Kajiwara, Eiji
AU - Satoh, Takeaki
AU - Koyanagi, Toshimasa
AU - Takahashi, Kazuhiro
AU - Ooho, Aritsune
AU - Azuma, Koichi
AU - Furusyo, Norihiro
AU - Kato, Masaki
AU - Shimoda, Shinji
AU - Hayashi, Jun
N1 - Funding Information:
We are grateful to the patients and doctors who assisted in the investigation: Dr Naoki Yamashita from Kyushu Medical Center; Dr Kimihiko Yanagita from Saiseikai Karatsu Hospital; Dr Yasunori Ichiki from JCHO Kyushu Hospital; Dr Masami Kuniyoshi from Kyushu Rosai Hospital; Dr Chie Morita from JR Kyushu Hospital; and Dr Hiromasa Amagase from Amagase Clinic. We are also grateful to Yoshitaka Etoh for his excellent laboratory work on RAS testing.
Publisher Copyright:
© 2019 The Japan Society of Hepatology
PY - 2020/2/1
Y1 - 2020/2/1
N2 - Aim: Hepatitis C virus genotype 2 is common in East Asia, sub-Saharan Africa, and Latin America. However, many countries in these areas lag behind other areas of the world in government approval for new direct-acting antivirals. The aim of this study was to evaluate the treatment outcome of ledipasvir/sofosbuvir (LDV/SOF) for patients with chronic hepatitis C virus genotype 2 infection. Methods: This is a two-part multicenter, real-world cohort study. Study 1 consisted of 58 consecutive patients who were treated with LDV/SOF for 12 weeks. Study 2 used propensity score matching for LDV/SOF (n = 58) and glecaprevir/pibrentasvir (n = 207) treatment groups (1:1) with a set of clinically important variables. Sustained viral response 12 weeks after the end of treatment (SVR12) and adverse events were evaluated in both studies. Results: In study 1, the overall SVR12 rates of the intention-to-treat and modified intention-to-treat populations were 94.8% (55/58) and 96.5% (55/57), respectively. High SVR12 rates were observed in almost all subgroups, including older age, compensated cirrhosis, and treatment experience. In study 2, propensity score matching of the entire study population yielded 52 matched pairs with similar baseline characteristics. There were no statistically significant differences between the LDV/SOF (96.1%) and glecaprevir/pibrentasvir (98.0%) groups in the overall SVR12 rates of the modified intention-to-treat populations, and their rates of treatment discontinuation and adverse events were similar. Conclusions: Treatment with LDV/SOF for hepatitis C virus genotype 2 resulted in a high rate of SVR12 and excellent tolerability. The outcomes of LDV/SOF were very similar to those of glecaprevir/pibrentasvir.
AB - Aim: Hepatitis C virus genotype 2 is common in East Asia, sub-Saharan Africa, and Latin America. However, many countries in these areas lag behind other areas of the world in government approval for new direct-acting antivirals. The aim of this study was to evaluate the treatment outcome of ledipasvir/sofosbuvir (LDV/SOF) for patients with chronic hepatitis C virus genotype 2 infection. Methods: This is a two-part multicenter, real-world cohort study. Study 1 consisted of 58 consecutive patients who were treated with LDV/SOF for 12 weeks. Study 2 used propensity score matching for LDV/SOF (n = 58) and glecaprevir/pibrentasvir (n = 207) treatment groups (1:1) with a set of clinically important variables. Sustained viral response 12 weeks after the end of treatment (SVR12) and adverse events were evaluated in both studies. Results: In study 1, the overall SVR12 rates of the intention-to-treat and modified intention-to-treat populations were 94.8% (55/58) and 96.5% (55/57), respectively. High SVR12 rates were observed in almost all subgroups, including older age, compensated cirrhosis, and treatment experience. In study 2, propensity score matching of the entire study population yielded 52 matched pairs with similar baseline characteristics. There were no statistically significant differences between the LDV/SOF (96.1%) and glecaprevir/pibrentasvir (98.0%) groups in the overall SVR12 rates of the modified intention-to-treat populations, and their rates of treatment discontinuation and adverse events were similar. Conclusions: Treatment with LDV/SOF for hepatitis C virus genotype 2 resulted in a high rate of SVR12 and excellent tolerability. The outcomes of LDV/SOF were very similar to those of glecaprevir/pibrentasvir.
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U2 - 10.1111/hepr.13437
DO - 10.1111/hepr.13437
M3 - Article
AN - SCOPUS:85075450862
SN - 1386-6346
VL - 50
SP - 174
EP - 181
JO - Hepatology Research
JF - Hepatology Research
IS - 2
ER -