Efficacy and safety of ruzasvir 60mg and uprifosbuvir 450mg for 12weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4 or 6 infection

被引：5

作者：

Lawitz, Eric ^{[1
]}

Poordad, Fred ^{[1
]}

Anderson, Leah J. ^{[2
]}

Vesay, Michelle ^{[2
]}

Kelly, Michelle M. ^{[2
]}

Liu, Hong ^{[2
]}

Gao, Wei ^{[2
]}

Fernsler, Doreen ^{[2
]}

Asante-Appiah, Ernest ^{[2
]}

Robertson, Michael N. ^{[2
]}

Hanna, George J. ^{[2
]}

Barr, Eliav ^{[2
]}

Butterton, Joan ^{[2
]}

Kowdley, Kris, V ^{[3
]}

Hassanein, Tarek ^{[4
]}

Sahota, Amandeep ^{[5
]}

Gordon, Stuart C. ^{[6
]}

Yeh, Wendy W. ^{[2
]}

机构：

[1] Univ Texas Hlth San Antonio, San Antonio, TX USA

[2] Merck & Co Inc, Kenilworth, NJ USA

[3] Swedish Med Ctr, Seattle, WA USA

[4] Southern Calif GI & Liver Ctr, Coronado, CA USA

[5] Kaiser Permanente Southern Calif, Los Angeles, CA USA

[6] Henry Ford Hosp, Detroit, MI 48202 USA

来源：

JOURNAL OF VIRAL HEPATITIS | 2019年 / 26卷 / 06期

关键词：

genotype; hepatitis C virus; NS5A protein; NS5B polymerase; safety; GRAZOPREVIR; SOFOSBUVIR; REGIMEN; PARTICIPANTS; DACLATASVIR; C-CREST-2; RIBAVIRIN; CIRRHOSIS; PHASE-2; PART;

D O I：

10.1111/jvh.13079

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

In clinical trials, the three-drug regimen of ruzasvir (RZR) 60mg, uprifosbuvir (UPR) 450mg and grazoprevir 100mg, with or without ribavirin, has demonstrated promising efficacy and excellent tolerability across a wide range of hepatitis C virus (HCV)-infected individuals. The present study assessed the efficacy and safety of the two-drug combination of RZR 60mg plus UPR 450mg administered for 12weeks in participants with HCV genotype (GT) 1-6 infection. In this open-label clinical trial, treatment-naive or -experienced and cirrhotic or noncirrhotic participants with chronic HCV GT1-6 infection received RZR 60mg plus UPR 450mg orally once daily for 12weeks (NCT02759315/protocol PN035). The primary efficacy endpoint was sustained virologic response at 12weeks after the end of therapy (SVR12). One hundred and sixty participants were enrolled. SVR12 rates were 96% (52 of 54) in participants with GT1a infection; 100% (15 of 15) in those with GT1b infection; 97% (28 of 29) in those with GT2 infection; 77% (30 of 39) in those with GT3 infection; 90% (18 of 20) in those with GT4 infection; and 67% (2 of 3) in those with GT6 infection. Drug-related adverse events (AEs) reported by >5% of participants were fatigue (n=10, 6.3%) and diarrhoea (n=9, 5.6%). Five participants reported a total of 11 serious AEs, none considered drug-related. One participant experienced on-treatment alanine aminotransferase/aspartate aminotransferase elevations that resolved without intervention. Data from the present study indicate that the combination of RZR 60mg plus UPR 450mg once daily for 12weeks was well tolerated overall but was effective only for certain genotypes.

引用

页码：675 / 684

页数：10

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