A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin

Lai Wei; Mingxiang Zhang; Min Xu; Wan Long Chuang; Wei Lu; Wen Xie; Zhansheng Jia; Guozhong Gong; Yueqi Li; Si Hyun Bae; Yong Feng Yang; Qing Xie; Shumei Lin; Xinyue Chen; Junqi Niu; Jidong Jia; Tushar Garimella; Anne Torbeyns; Fiona McPhee; Michelle Treitel; Philip D. Yin; Ling Mo

doi:10.1111/jgh.13379

A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin

Lai Wei
, Mingxiang Zhang
, Min Xu
, Wan Long Chuang
, Wei Lu
, Wen Xie
, Zhansheng Jia
, Guozhong Gong
, Yueqi Li
, Si Hyun Bae
, Yong Feng Yang
, Qing Xie
, Shumei Lin
, Xinyue Chen
, Junqi Niu
, Jidong Jia
, Tushar Garimella
, Anne Torbeyns
, Fiona McPhee
, Michelle Treitel

Philip D. Yin, Ling Mo

Department of Internal Medicine

Peking University
The Sixth People's Hospital of Shenyang
Guangzhou No.8 People's Hospital
Kaohsiung Medical University
Tianjin Second People's Hospital
Capital Medical University
Tangdu Hospital, Fourth Military Medical University
Central South University
PLA No. 302 Hospital
Affiliated to Medical School of South East University
Shanghai Jiao Tong University
First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Jilin University
Bristol-Myers Squibb

Research output: Contribution to journal › Article › peer-review

29 Scopus citations

Abstract

Background and Aim: Daclatasvir plus asunaprevir has demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype 1b infection. This study focused on evaluating daclatasvir plus asunaprevir in interferon (±ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan. Methods: Interferon (±ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir 60 mg tablets once daily plus asunaprevir 100 mg soft capsules twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24). Results: Of the 159 patients treated, 89.3% were Chinese, 65.4% were female, and 73.6% were interferon-intolerant. Cirrhosis was present in 32.7% of patients, and 40.3% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2%) patients (100% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4%). SVR24 was higher in patients without baseline NS5A (L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6%), including those with cirrhosis (43/44, 97.7%). Prevalence of baseline NS5A RAVs was low (19/159, 11.9%), particularly in mainland China (10/127, 7.9%). One death (0.6%), five serious adverse events (3.1%), and three grade 4 laboratory abnormalities (1.9%) occurred on treatment; none were considered related to study drugs. Two patients (1.3%) discontinued because of adverse events. Treatment was generally well tolerated regardless of cirrhosis status. Conclusions: Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (±ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.

Original language	English
Pages (from-to)	1860-1867
Number of pages	8
Journal	Journal of Gastroenterology and Hepatology (Australia)
Volume	31
Issue number	11
DOIs	https://doi.org/10.1111/jgh.13379
State	Published - 1 Nov 2016

Bibliographical note

Publisher Copyright:
© 2016 The Authors Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

asunaprevir
daclatasvir
efficacy
hepatitis C
safety

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Wei, L., Zhang, M., Xu, M., Chuang, W. L., Lu, W., Xie, W., Jia, Z., Gong, G., Li, Y., Bae, S. H., Yang, Y. F., Xie, Q., Lin, S., Chen, X., Niu, J., Jia, J., Garimella, T., Torbeyns, A., McPhee, F., ... Mo, L. (2016). A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin. Journal of Gastroenterology and Hepatology (Australia), 31(11), 1860-1867. https://doi.org/10.1111/jgh.13379

@article{2790d051cb4d4aa4a7b11c171d3b9f1d,

title = "A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin",

abstract = "Background and Aim: Daclatasvir plus asunaprevir has demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype 1b infection. This study focused on evaluating daclatasvir plus asunaprevir in interferon (±ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan. Methods: Interferon (±ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir 60 mg tablets once daily plus asunaprevir 100 mg soft capsules twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24). Results: Of the 159 patients treated, 89.3\% were Chinese, 65.4\% were female, and 73.6\% were interferon-intolerant. Cirrhosis was present in 32.7\% of patients, and 40.3\% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2\%) patients (100\% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4\%). SVR24 was higher in patients without baseline NS5A (L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6\%), including those with cirrhosis (43/44, 97.7\%). Prevalence of baseline NS5A RAVs was low (19/159, 11.9\%), particularly in mainland China (10/127, 7.9\%). One death (0.6\%), five serious adverse events (3.1\%), and three grade 4 laboratory abnormalities (1.9\%) occurred on treatment; none were considered related to study drugs. Two patients (1.3\%) discontinued because of adverse events. Treatment was generally well tolerated regardless of cirrhosis status. Conclusions: Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2\%, rising to 98.6\% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (±ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.",

keywords = "asunaprevir, daclatasvir, efficacy, hepatitis C, safety",

author = "Lai Wei and Mingxiang Zhang and Min Xu and Chuang, \{Wan Long\} and Wei Lu and Wen Xie and Zhansheng Jia and Guozhong Gong and Yueqi Li and Bae, \{Si Hyun\} and Yang, \{Yong Feng\} and Qing Xie and Shumei Lin and Xinyue Chen and Junqi Niu and Jidong Jia and Tushar Garimella and Anne Torbeyns and Fiona McPhee and Michelle Treitel and Yin, \{Philip D.\} and Ling Mo",

note = "Publisher Copyright: {\textcopyright} 2016 The Authors Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley \& Sons Australia, Ltd",

year = "2016",

month = nov,

day = "1",

doi = "10.1111/jgh.13379",

language = "English",

volume = "31",

pages = "1860--1867",

journal = "Journal of Gastroenterology and Hepatology (Australia)",

issn = "0815-9319",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "11",

}

Wei, L, Zhang, M, Xu, M, Chuang, WL, Lu, W, Xie, W, Jia, Z, Gong, G, Li, Y, Bae, SH, Yang, YF, Xie, Q, Lin, S, Chen, X, Niu, J, Jia, J, Garimella, T, Torbeyns, A, McPhee, F, Treitel, M, Yin, PD & Mo, L 2016, 'A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin', Journal of Gastroenterology and Hepatology (Australia), vol. 31, no. 11, pp. 1860-1867. https://doi.org/10.1111/jgh.13379

A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin. / Wei, Lai; Zhang, Mingxiang; Xu, Min et al.
In: Journal of Gastroenterology and Hepatology (Australia), Vol. 31, No. 11, 01.11.2016, p. 1860-1867.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin

AU - Wei, Lai

AU - Zhang, Mingxiang

AU - Xu, Min

AU - Chuang, Wan Long

AU - Lu, Wei

AU - Xie, Wen

AU - Jia, Zhansheng

AU - Gong, Guozhong

AU - Li, Yueqi

AU - Bae, Si Hyun

AU - Yang, Yong Feng

AU - Xie, Qing

AU - Lin, Shumei

AU - Chen, Xinyue

AU - Niu, Junqi

AU - Jia, Jidong

AU - Garimella, Tushar

AU - Torbeyns, Anne

AU - McPhee, Fiona

AU - Treitel, Michelle

AU - Yin, Philip D.

AU - Mo, Ling

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Background and Aim: Daclatasvir plus asunaprevir has demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype 1b infection. This study focused on evaluating daclatasvir plus asunaprevir in interferon (±ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan. Methods: Interferon (±ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir 60 mg tablets once daily plus asunaprevir 100 mg soft capsules twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24). Results: Of the 159 patients treated, 89.3% were Chinese, 65.4% were female, and 73.6% were interferon-intolerant. Cirrhosis was present in 32.7% of patients, and 40.3% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2%) patients (100% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4%). SVR24 was higher in patients without baseline NS5A (L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6%), including those with cirrhosis (43/44, 97.7%). Prevalence of baseline NS5A RAVs was low (19/159, 11.9%), particularly in mainland China (10/127, 7.9%). One death (0.6%), five serious adverse events (3.1%), and three grade 4 laboratory abnormalities (1.9%) occurred on treatment; none were considered related to study drugs. Two patients (1.3%) discontinued because of adverse events. Treatment was generally well tolerated regardless of cirrhosis status. Conclusions: Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (±ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.

AB - Background and Aim: Daclatasvir plus asunaprevir has demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype 1b infection. This study focused on evaluating daclatasvir plus asunaprevir in interferon (±ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan. Methods: Interferon (±ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir 60 mg tablets once daily plus asunaprevir 100 mg soft capsules twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24). Results: Of the 159 patients treated, 89.3% were Chinese, 65.4% were female, and 73.6% were interferon-intolerant. Cirrhosis was present in 32.7% of patients, and 40.3% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2%) patients (100% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4%). SVR24 was higher in patients without baseline NS5A (L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6%), including those with cirrhosis (43/44, 97.7%). Prevalence of baseline NS5A RAVs was low (19/159, 11.9%), particularly in mainland China (10/127, 7.9%). One death (0.6%), five serious adverse events (3.1%), and three grade 4 laboratory abnormalities (1.9%) occurred on treatment; none were considered related to study drugs. Two patients (1.3%) discontinued because of adverse events. Treatment was generally well tolerated regardless of cirrhosis status. Conclusions: Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (±ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.

KW - asunaprevir

KW - daclatasvir

KW - efficacy

KW - hepatitis C

KW - safety

UR - https://www.scopus.com/pages/publications/84996520684

U2 - 10.1111/jgh.13379

DO - 10.1111/jgh.13379

M3 - Article

C2 - 27003037

AN - SCOPUS:84996520684

SN - 0815-9319

VL - 31

SP - 1860

EP - 1867

JO - Journal of Gastroenterology and Hepatology (Australia)

JF - Journal of Gastroenterology and Hepatology (Australia)

IS - 11

ER -

Wei L, Zhang M, Xu M, Chuang WL, Lu W, Xie W et al. A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin. Journal of Gastroenterology and Hepatology (Australia). 2016 Nov 1;31(11):1860-1867. doi: 10.1111/jgh.13379

A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin

Abstract

Bibliographical note

UN SDGs

Keywords

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