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

Publication

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

Journal Paper/Review - Oct 29, 2018

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

Citation

Grebely J, Feld J, Bruneau J, Daulouede J, Powis J, Bruggmann P, Matthews G, Kronborg I, Shaw D, Dunlop A, Hellard M, Applegate T, Crawford S, Dore G, Lacombe K, Dalgard O, Conway B, Cunningham E, Fraser C, Moriggia A, Gane E, Stedman C, Cooper C, Castro E, Schmid P, Petoumenos K, Hajarizadeh B, Marks P, Erratt A, 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)

Journal

Int J Drug Policy 2018; 62

Publication Date

Oct 29, 2018

Issn Electronic

1873-4758

Pages

94-103

Brief description/objective

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.