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

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.

Effectiveness of Elbasvir and Grazoprevir Combination and 1-year Follow-up Hepatic Function for HCV Genotype 1b Infection: Results From a Chinese Real-world Cohort.

“…In this study, side effects were reported in 39 patients. Although the reported AE incidence in this study was only slightly higher than that in some real-world studies [15,16], most of AEs were mild in severity. During treatment, the hyperbilirubinemia observed was the most common adverse event; however, the severity was mainly graded 1 or 2 and lasted only 2-4 weeks for most patients.…”

“…Epidemiological studies reported that HCV genotype 1 infection was the most prevalent genotype in the world and China [11][12][13]. As a powerful antiviral regimen for HCV-1b has been demonstrated in clinical studies, there are several reports on the outcomes of EBR /GZR treatment in real-world clinical practice [14][15][16]; however, there are few reports from the Chinese mainland. Chinses patients in the real world are more heterogeneous and have more complications comparing with those in RCT studies, and there are differences in viral infection pathways, races from other countries such as Europe and the United States, therefore, it is worthwhile for us to discuss the real effect of this regimen on hepatitis C patients in China.…”

The transition in the etiologies of hepatocellular carcinoma-complicated liver cirrhosis in a nationwide survey of Japan

“…Our previous report on the survey on the etiologies of LC revealed that the contribution of viral hepatitis remarkably decreased, and the ratio of HCV-related LC dropped to < 50% after 2014. We considered that this was due to recent advances in treatment for viral hepatitis [ 13 – 18 ] and official measures that are provided in Japan such as the financial support system for patients to receive antiviral treatment [ 5 , 6 ]. However, in the current study, viral hepatitis was shown to remain a major cause of HCC in Japan, although the contribution had gradually decreased during the recent decade.…”

Viral and host factors are associated with retreatment failure in hepatitis C patients receiving all‐oral direct antiviral therapy

“…Our recent reports showed that the coexistence of NS5A and NS5B RAS was associated with SOF/LDV treatment failure . Some reports showed that the coexistence of NS5A was associated with DAA treatment failure . Uemura et al .…”