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Int J Drug Policy. 2018 Dec;62:94-103. doi: 10.1016/j.drugpo.2018.10.004. Epub 2018 Oct 29.

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.

Author information

1
The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia. Electronic address: jgrebely@kirby.unsw.edu.au.
2
Vancouver Infectious Diseases Center, Vancouver, Canada.
3
The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
4
Coolaid Community Health Centre, Victoria, Canada.
5
Fondazione Epatocentro Ticino, Lugano, Switzerland.
6
Auckland Hospital, Auckland, New Zealand.
7
Christchurch Hospital and University of Otago, Christchurch, New Zealand.
8
Ottawa Hospital Research Institute, Ottawa, Canada.
9
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
10
Kantonsspital St Gallen, St Gallen, Switzerland.
11
Akershus University Hospital, Oslo, Norway.
12
Inserm UMR-S1136, Sorbonne Université, Hôpital Saint-Antoine, Paris, France.
13
Toronto General Hospital, Toronto, Canada.
14
Centre Hospitalier de l'Université de Montréal, Montréal, Canada.
15
Csapa Bizia, Bayonne, France.
16
South Riverdale Community Health Centre, Toronto, Canada.
17
Arud Centres for Addiction Medicine, Zurich, Switzerland.
18
Footscray Hospital, Footscray, Australia.
19
Royal Adelaide Hospital, Adelaide, Australia.
20
Newcastle Pharmacotherapy Service, Newcastle, Australia.
21
The Burnet Institute, Melbourne, Australia.
22
Harm Reduction Victoria, Melbourne, Australia.

Abstract

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-naïve 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 (G1a) or without ribavirin (G1b) 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 G1a. 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.

KEYWORDS:

DAA; Drug use; Hepatitis C; Injecting drug users; PWID; Treatment

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