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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

Jason Grebely, Brian Conway, Evan B Cunningham, Chris Fraser, Alberto Moriggia, Ed Gane, Catherine Stedman, Curtis Cooper, Erika Castro, Patrick Schmid, Kathy Petoumenos, Behzad Hajarizadeh, Phillipa Marks, Amanda Erratt, Olav Dalgard, Karine Lacombe, Jordan J Feld, Julie Bruneau, Jean-Pierre Daulouede, Jeff Powis, Philip Bruggmann, Gail V Matthews, Ian Kronborg, David Shaw, Adrian Dunlop, Margaret Hellard, Tanya L Applegate, Sione Crawford, Gregory J Dore & D3FEAT Study Group

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.
   
citation Grebely J, Conway B, Cunningham E B, Fraser C, Moriggia A, Gane E, Stedman C, Cooper C, Castro E, Schmid P, Petoumenos K, Hajarizadeh B, Marks P, Erratt A, Dalgard O, Lacombe K, Feld J J, Bruneau J, Daulouede J P, Powis J, Bruggmann P, Matthews G V, Kronborg I, Shaw D, Dunlop A, Hellard M, Applegate T L, Crawford S, Dore G J, D3FEAT Study Group . 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. Int J Drug Policy 2018; 62:94-103.
   
type journal paper/review (English)
date of publishing 29-10-2018
journal title Int J Drug Policy (62)
ISSN electronic 1873-4758
pages 94-103
PubMed 30384028
DOI 10.1016/j.drugpo.2018.10.004