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. 2019 Oct;49(10):1114-1120.
doi: 10.1111/hepr.13362. Epub 2019 Jun 14.

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

Toshie Mashiba  1 , Kouji Joko  1 , Masayuki Kurosaki  2 , Hironori Ochi  1 , Chitomi Hasebe  3 , Takehiro Akahane  4 , Tetsuro Sohda  5 , Keiji Tsuji  6 , Akeri Mitsuda  7 , Hiroyuki Kimura  8 , Ryoichi Narita  9 , Chikara Ogawa  10 , Koichiro Furuta  11 , Masaya Shigeno  12 , Hiroaki Okushin  13 , Hiroshi Ito  14 , Atsunori Kusakabe  15 , Takashi Satou  16 , Chiharu Kawanami  17 , Ryo Nakata  18 , Haruhiko Kobashi  19 , Takashi Tamada  20 , Yasushi Ide  21 , Hitoshi Yagisawa  22 , Atsuhiro Morita  23 , Tomomichi Matsushita  24 , Kazuhiko Okada  25 , Namiki Izumi  2
Affiliations

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

Toshie Mashiba et al. Hepatol Res. 2019 Oct.

Abstract

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.

Keywords: elbasvir; genotype 1; grazoprevir; hepatitis C virus; resistance-associated substitution.

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Figures

Figure 1
Figure 1
Sustained virologic response rate at 12 weeks after end of treatment (SVR12) with elbasvir/grazoprevir among 353 patients with hepatitis C virus (HCV) genotype 1, grouped by patient characteristics. Although age, sex, presence of cirrhosis, history of hepatocellular carcinoma (HCC), and renal disorder (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) are not significantly associated with SVR, a history of interferon (IFN) therapy significantly decreases the SVR rate.
Figure 2
Figure 2
Sustained virologic response rate at 12 weeks after end of treatment (SVR12) with elbasvir/grazoprevir decreased markedly among 353 patients with hepatitis C virus (HCV) genotype 1 when there was a history of direct‐acting antiviral (DAA) therapy or a non‐structural protein (NS)5A double mutation.
See this image and copyright information in PMC

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