Journal of gastroenterology · 2018
Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Toyoda Hidenori, Atsukawa Masanori, Takaguchi Koichi, Senoh Tomonori, Michitaka Kojiro, Hiraoka Atsushi, Fujioka Shinichi, Kondo Chisa, Okubo Tomomi, Uojima Haruki, Tada Toshifumi, Yoneyama Hirohito, Watanabe Tsunamasa, Asano Toru, Ishikawa Toru, Tamai Hideyuki, Abe Hiroshi, Kato Keizo, Tsuji Kunihiko, Ogawa Chikara, Shimada Noritomo, Iio Etsuko, Deguchi Akihiro, Itobayashi Ei, Mikami Shigeru, Moriya Akio, Okubo Hironao, Tani Joji, Tsubota Akihito, Tanaka Yasuhito, Masaki Tsutomu, Iwakiri Katsuhiko, Kumada Takashi
Аннотация
BACKGROUND: The real-world virological efficacy and safety of an interferon (IFN)-free direct-acting antiviral (DAA) therapy with elbasvir (EBR) and grazoprevir (GZR) were evaluated in Japanese patients chronically infected with hepatitis C virus (HCV) genotype 1.
METHODS: The rate of sustained virologic response (SVR) and safety were analyzed in patients who started the EBR/GZR regimen between November 2016 and July 2017. SVR rates were compared based on patient baseline characteristics.
RESULTS: Overall, 371 of 381 patients (97.4%) achieved SVR. Multivariate analysis identified a history of failure to IFN-free DAA therapy and the presence of double resistance-associated substitutions (RASs) in HCV non-structural protein 5A (NS5A) as factors significantly associated with failure to EBR/GZR treatment. The SVR rates of patients with a history of IFN-free DAA therapy and those with double RASs were 55.6 and 63.6%, respectively. In all other subpopulations, the SVR rates were more than 90%. There were no severe adverse events associated with the treatment.
CONCLUSIONS: The EBR/GZR regimen yielded high virological efficacy with acceptable safety. Patients with a history of failure to IFN-free DAA therapy or with double RASs in HCV-NS5A remained difficult to treat with this regimen.
METHODS: The rate of sustained virologic response (SVR) and safety were analyzed in patients who started the EBR/GZR regimen between November 2016 and July 2017. SVR rates were compared based on patient baseline characteristics.
RESULTS: Overall, 371 of 381 patients (97.4%) achieved SVR. Multivariate analysis identified a history of failure to IFN-free DAA therapy and the presence of double resistance-associated substitutions (RASs) in HCV non-structural protein 5A (NS5A) as factors significantly associated with failure to EBR/GZR treatment. The SVR rates of patients with a history of IFN-free DAA therapy and those with double RASs were 55.6 and 63.6%, respectively. In all other subpopulations, the SVR rates were more than 90%. There were no severe adverse events associated with the treatment.
CONCLUSIONS: The EBR/GZR regimen yielded high virological efficacy with acceptable safety. Patients with a history of failure to IFN-free DAA therapy or with double RASs in HCV-NS5A remained difficult to treat with this regimen.
Предметные рубрики MeSH
AgedAged, 80 and overAmidesAntiviral AgentsBenzofuransCarbamatesCyclopropanesDrug Resistance, ViralDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusHepatitis C, ChronicHumansImidazolesJapanMaleMiddle AgedMultivariate AnalysisQuinoxalinesRetrospective StudiesSulfonamidesSustained Virologic ResponseLactams, Macrocyclic