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

• Published in: Hepatology research Vol. 49; no. 10; pp. 1114 - 1120
• Main Authors: Mashiba, Toshie, Joko, Kouji, Kurosaki, Masayuki, Ochi, Hironori, Hasebe, Chitomi, Akahane, Takehiro, Sohda, Tetsuro, Tsuji, Keiji, Mitsuda, Akeri, Kimura, Hiroyuki, Narita, Ryoichi, Ogawa, Chikara, Furuta, Koichiro, Shigeno, Masaya, Okushin, Hiroaki, Ito, Hiroshi, Kusakabe, Atsunori, Satou, Takashi, Kawanami, Chiharu, Nakata, Ryo, Kobashi, Haruhiko, Tamada, Takashi, Ide, Yasushi, Yagisawa, Hitoshi, Morita, Atsuhiro, Matsushita, Tomomichi, Okada, Kazuhiko, Izumi, Namiki
• Format: Journal Article
• Language: English
• Published: Netherlands Wiley Subscription Services, Inc 01.10.2019; John Wiley and Sons Inc
• Subjects: Antiviral agents; elbasvir; genotype 1; Genotypes; grazoprevir; Hepatitis; Hepatitis C; hepatitis C virus; Mutation; Original; Patients; Proteinase inhibitors; resistance‐associated substitution; hepatitis C virus; grazoprevir; genotype 1; resistance-associated substitution; elbasvir
• ISSN: 1386-6346; 1872-034X
• DOI: 10.1111/hepr.13362

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.