Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan

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, Kazúo; Tsuji, Kiichiro; 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

doi:10.1007/s00535-018-1473-z

Cited by 27 publications

(33 citation statements)

References 43 publications

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“…SVR12 rates remained high across other important participant subgroups, including those with compensated cirrhosis, with a baseline viral load > 2 000 000 IU/mL, and aged ≥ 65 years, but SVR12 was lower in participants with GT1a infection. These data support the findings from the EBR/GZR phase 3 clinical development program in both Asian and white individuals and are also consistent with several recent studies reporting SVR rates of 94–98% in Japanese individuals with HCV GT1 infection following treatment with EBR/GZR …”

Section: Discussionsupporting

confidence: 91%

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

Wei

Kumada

Perumalswami

et al. 2019

J of Gastro and Hepatol

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Background and Aim Estimates suggest that in Asia, more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials. Methods This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis. The primary end point was sustained virologic response at 12 weeks after completion of therapy (SVR12). Results Seven hundred eighty Asian participants from 15 countries were included in this analysis. SVR12 was achieved by 756/780 (96.9%) of all participants, including 748/772 (96.9%) of those who received elbasvir/grazoprevir for 12 weeks and 8/8 (100%) of those who received elbasvir/grazoprevir plus ribavirin for 16 weeks. In the genotype 1b‐infected population, the SVR12 rate was 691/709 (97.5%), and there was no impact of age, high baseline viral load, or presence of cirrhosis. The most frequently reported adverse events were nasopharyngitis (8.0%), upper respiratory tract infection (5.4%), and diarrhea (5.2%). Twenty participants receiving elbasvir/grazoprevir for 12 weeks reported a total of 25 serious adverse events, and 7 (0.9%) discontinued treatment because of an adverse event. Conclusion Elbasvir/grazoprevir administered for 12 weeks is an effective and generally well‐tolerated treatment option for Asian individuals with hepatitis C virus genotype 1b infection.

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Section: Discussionsupporting

confidence: 91%

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

Wei

Kumada

Perumalswami

et al. 2019

J of Gastro and Hepatol

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“…Therapy with EBR/GZR achieved a high SVR rate and high tolerability in the present study based on actual clinical practice, similar to a Japanese phase III trial. As in the report by Toyoda et al ., the SVR rate was consistent regardless of various factors such as age, sex, eGFR, and HCC treatment history. Patients with chronic renal disorders, including those on dialysis, also showed a comparable SVR rate.…”

Section: Discussionsupporting

confidence: 83%

“…Only 2.9% (10/353) of patients in the current study showed treatment failure, and these patients had a history of DAA therapy or a double mutation at NS5A‐L31/‐Y93. Investigations have found that few patients who fail to respond to DAA treatment respond to EBR/GZR therapy . However, SVR was achieved in six of seven patients who had a history of DAA therapy but no double mutation at NS5A‐L31/‐Y93 in the present study.…”

Section: Discussioncontrasting

confidence: 64%

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

Mashiba

Joko

Kurosaki

et al. 2019

Hepatology Research

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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.

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“…Although daclatasvir/asunaprevir and ombitasvir/paritaprevir/ritonavir are less effective for patients with NS5A RASs, a randomized phase 2/3 study conducted in Japan suggested that EBR/GZR is highly effective for these patients. However, a multicenter, real‐world study reported that reduced efficacy of EBR/GZR in patients with both the preexisting NS5A L31 and Y93 RASs and in those with a history of treatment failure with IFN‐free DAA …”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study

Atsukawa

Tsubota

Toyoda

et al. 2018

J of Gastro and Hepatol

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Real-world virological efficacy and safety of elbasvir and grazoprevir in patients with chronic hepatitis C virus genotype 1 infection in Japan

Abstract: 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.

Cited by 27 publications

References 43 publications

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

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

Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study

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