Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy

被引:20
|
作者
Grebely, Jason [1 ]
Conway, Brian [2 ]
Cunningham, Evan B. [1 ]
Fraser, Chris [3 ]
Moriggia, Alberto [4 ]
Gane, Ed [5 ]
Stedman, Catherine [6 ,7 ]
Cooper, Curtis [8 ]
Castro, Erika [9 ]
Schmid, Patrick [10 ]
Petoumenos, Kathy [1 ]
Hajarizadeh, Behzad [1 ]
Marks, Phillipa [1 ]
Erratt, Amanda [1 ]
Dalgard, Olav [11 ]
Lacombe, Karine [12 ]
Feld, Jordan J. [13 ]
Bruneau, Julie [14 ]
Daulouede, Jean-Pierre [15 ]
Powis, Jeff [16 ]
Bruggmann, Philip [17 ]
Matthews, Gail V. [1 ]
Kronborg, Ian [18 ]
Shaw, David [19 ]
Dunlop, Adrian [20 ]
Hellard, Margaret [21 ]
Applegate, Tanya L. [1 ]
Crawford, Sione [22 ]
Dore, Gregory J. [1 ]
机构
[1] UNSW, UNSW Sydney, Kirby Inst, Wallace Wurth Bldg, Sydney, NSW 2052, Australia
[2] Vancouver Infect Dis Ctr, Vancouver, BC, Canada
[3] Coolaid Community Hlth Ctr, Victoria, BC, Canada
[4] Fdn Epatoctr Ticino, Lugano, Switzerland
[5] Auckland Hosp, Auckland, New Zealand
[6] Christchurch Hosp, Christchurch, New Zealand
[7] Univ Otago, Christchurch, New Zealand
[8] Ottawa Hosp Res Inst, Ottawa, ON, Canada
[9] CHU Vaudois, Lausanne, Switzerland
[10] Kantonsspital St Gallen, St Gallen, Switzerland
[11] Akershus Univ Hosp, Oslo, Norway
[12] Sorbonne Univ, Hop St Antoine, INSERM, UMR S1136, Paris, France
[13] Toronto Gen Hosp, Toronto, ON, Canada
[14] Ctr Hosp Univ Montreal, Montreal, PQ, Canada
[15] Csapa Bizia, Bayonne, France
[16] South Riverdale Community Hlth Ctr, Toronto, ON, Canada
[17] Arud Ctr Addict Med, Zurich, Switzerland
[18] Footscray Hosp, Footscray, Vic, Australia
[19] Royal Adelaide Hosp, Adelaide, SA, Australia
[20] Newcastle Pharmacotherapy Serv, Newcastle, NSW, Australia
[21] Burnet Inst, Melbourne, Vic, Australia
[22] Harm Reduct Victoria, Melbourne, Vic, Australia
基金
英国医学研究理事会;
关键词
Hepatitis C; Treatment; PWID; Drug use; Injecting drug users; DAA; HEPATITIS-C VIRUS; SUSTAINED VIROLOGICAL RESPONSE; ACTING ANTIVIRAL AGENTS; TERM CLINICAL-OUTCOMES; 1-INFECTED PATIENTS; RISK-FACTORS; OPEN-LABEL; INFECTION; EFFICACY; SAFETY;
D O I
10.1016/j.drugpo.2018.10.004
中图分类号
R194 [卫生标准、卫生检查、医药管理];
学科分类号
摘要
Background: Direct-acting antiviral therapy for hepatitis C virus (HCV) infection is safe and effective, but there are little data among people who have recently injected drugs. This study evaluated the efficacy, and safety of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for chronic HCV genotype (G) 1 among people with recent injecting drug use and/or receiving OST. Methods: D3FEAT is an international open-label study that recruited treatment-naive participants with recent injecting drug use (previous 6 months) and/or receiving OST with chronic HCV G1 infection between June 2016 and February 2017 in seven countries. Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir with (Gla) or without ribavirin (Gib) administered twice daily in a one-week electronic blister pack (records timing of each dose) for 12 weeks. The primary endpoint was undetectable HCV RNA 12 weeks post-treatment (SVR12). Results: Among 87 participants (median age 48 years), 23% were female, 8% had cirrhosis, and 90% had Gla. Overall, 71% were receiving OST, 61% injected in the previous six months, 45% injected in the previous month, and 15% injected > daily. Treatment completion was 97% (84 of 87). There were no virological breakthroughs, but three discontinuations (loss to follow-up, n = 1; non-adherence, n = 1; incarceration, n = 1). SVR was 91% (79 of 87, 95% CI, 83%-96%). Five participants who completed treatment did not have SVR (loss to follow-up, n = 1; death, n = 1; virologic relapse, n = 3). Drug use prior to and during treatment did not impact SVR12. Treatment-related adverse events were observed in 46 (53%) patients (six grade 3, no grade 4). Five (6%) patients had at least one serious adverse event (two possibly/probably related to therapy; nausea and myoclonus). Two cases of reinfection were observed. Conclusion: Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for 12 weeks is effective among people with HCV genotype 1 with recent injecting drug use and/or receiving OST.
引用
收藏
页码:94 / 103
页数:10
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