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Real‐world efficacy of elbasvir and grazoprevir for hepatitis C virus (genotype 1): A nationwide, multicenter study by the Japanese Red Cross Hospital Liver Study Group

2019; Wiley; Volume: 49; Issue: 10 Linguagem: Inglês

10.1111/hepr.13362

1872-034X

Toshie Mashiba, Kouji Joko, Masayuki Kurosaki, Hironori Ochi, Chitomi Hasebe, Takehiro Akahane, Tetsuro Sohda, Keiji Tsuji, Akeri Mitsuda, Hiroyuki Kimura, Ryoichi Narita, Chikara Ogawa, Koichiro Furuta, Masaya Shigeno, Hiroaki Okushin, Hiroshi Ito, Atsunori Kusakabe, Takashi Satou, Chiharu Kawanami, Ryo Nakata, Haruhiko Kobashi, Takashi Tamada, Yasushi Ide, Hitoshi Yagisawa, Atsuhiro Morita, Tomomichi Matsushita, Kazuhiko Okada, Namiki Izumi,

HIV/AIDS drug development and treatment

Aim The present study aimed to determine the real‐world efficacy and safety of the non‐structural protein (NS)5A inhibitor elbasvir (EBR) combined with the NS3/4A protease inhibitor grazoprevir (GZR) in patients with hepatitis C virus (HCV) genotype 1 (GT1) infection. Methods This study retrospectively evaluated the rate of sustained virologic response at 12 weeks post‐treatment (SVR12) and the safety of EBR/GZR treatment in 159 men and 194 women with a median age of 72 years, and it assessed factors associated with the SVR12 rate. The attending physicians were responsible for selecting candidate patients for EBR/GZR in this retrospective study. Results Treatment outcomes for EBR/GZR were good in direct‐acting antiviral (DAA)‐naïve patients, of whom 99.4% achieved SVR. Of 353 patients, 10 (2.9%) had treatment failure. Of these patients, eight previously underwent DAA therapy, and the remaining two had NS5A‐L31/Y93 double mutation. The SVR rate was 50% (8/16 patients) in patients who previously underwent DAA therapy, and 18.2% (2/11 patients) in patients with NS5A‐L31/Y93 double mutation. On multivariate logistic regression analysis, NS5A‐Y31/Y93 double mutation (odds ratio 356.3; 95% confidence interval, 23.91–16 940; P < 0.0001) was identified as an independent predictor of treatment failure. No serious adverse events were observed with EBR/GZR therapy. Conclusions The SVR rate of EBR/GZR would have been 100% in patients without either a history of DAA therapy or double mutation. This combination of drugs could be safely given and is, thus, considered a highly useful first‐line treatment for DAA‐naïve patients with HCV.