Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection

被引:34
|
作者
Martinello, M. [1 ,2 ]
Bhagani, S. [3 ]
Gane, E. [4 ]
Orkin, C. [5 ]
Cooke, G. [6 ]
Dore, G. J. [1 ,2 ]
Petoumenos, K. [1 ]
Applegate, T. L. [1 ]
Tu, E. [1 ]
Marks, P. [1 ]
Pagani, N. [7 ]
Grebely, J. [1 ]
Nelson, M. [7 ]
Matthews, G. V. [1 ,2 ]
机构
[1] UNSW Sydney, Viral Hepatitis Clin Res Program, Kirby Inst, Sydney, NSW, Australia
[2] St Vincents Hosp, Dept Infect Dis & Immunol, Sydney, NSW, Australia
[3] Royal Free Hosp, Dept Infect Dis HIV Med, London, England
[4] Auckland City Hosp, New Zealand Liver Transplant Unit, Auckland, New Zealand
[5] Royal London Hosp, Barts Hlth, London, England
[6] Imperial Coll NHS Trust, St Marys Hosp, Dept Infect Dis, London, England
[7] Chelsea & Westminster Hosp, London, England
基金
英国医学研究理事会;
关键词
acute; direct-acting antiviral; hepatitis C; recent; treatment; C VIRUS-INFECTION; ACUTE HEPATITIS-C; INJECT DRUGS; SINGLE-ARM; OPEN-LABEL; SOFOSBUVIR; LEDIPASVIR; PREVENTION; TRIAL; MEN;
D O I
10.1111/jvh.12917
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12weeks are approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 8weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotypes 1a and 1, no subtype) for 8weeks. The primary endpoint was sustained virological response at 12weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. Thirty people (median age 38years, male 93%) commenced treatment (with ribavirin, 97%), of whom 77% (n=23) were HIV-positive, 93% (n=28) had genotype 1a infection and 53% (n=16) had ever injected drugs. Median maximum ALT in the preceding 12months was 433 IU/L (IQR 321, 1012). Acute clinical hepatitis with ALT>10xULN was documented in 83% (n=25); one participant (3%) had jaundice. At baseline, median estimated duration of infection was 30 weeks (range 11, 51), and median HCV RNA was 5.7 log(10) IU/mL (range 2.7, 7.3). SVR12 was achieved in 97% (29/30; early discontinuation at week 2, n=1; per protocol 100%, 29/29). No relapse or reinfection was observed. In conclusion, paritaprevir/ritonavir/ombitasvir and dasabuvir (with ribavirin) for eight weeks were highly effective among HIV-positive and HIV-negative individuals with recent HCV infection. These data support the use of this shortened duration direct-acting antiviral regimen in this population.
引用
收藏
页码:1180 / 1188
页数:9
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