caa a22 4500 551316489 CHVBK 20190115031848.0 cr unu---uuuuu 181213e201812 xx s 000 0 eng 10.1016/j.drugpo.2018.10.004 doi (SERVAL)BIB_8F707FC7C0D0 30384028 pmid 000454374200013 isiid 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 [Elektronische Daten] [J. Grebely, B. Conway, E.B. Cunningham, C. Fraser, A. Moriggia, E. Gane, C. Stedman, C. Cooper, E. Castro, P. Schmid, K. Petoumenos, B. Hajarizadeh, P. Marks, A. Erratt, O. Dalgard, K. Lacombe, J.J. Feld, J. Bruneau, J.P. Daulouede, J. Powis, P. Bruggmann, G.V. Matthews, I. Kronborg, D. Shaw, A. Dunlop, M. Hellard, T.L. Applegate, S. Crawford, G.J. Dore] 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. 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). 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 &gt; 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. 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. Grebely J. aut Conway B. aut Cunningham E.B. aut Fraser C. aut Moriggia A. aut Gane E. aut Stedman C. aut Cooper C. aut Castro E. aut Schmid P. aut Petoumenos K. aut Hajarizadeh B. aut Marks P. aut Erratt A. aut Dalgard O. aut Lacombe K. aut Feld J.J. aut Bruneau J. aut Daulouede J.P. aut Powis J. aut Bruggmann P. aut Matthews G.V. aut Kronborg I. aut Shaw D. aut Dunlop A. aut Hellard M. aut Applegate T.L. aut Crawford S. aut Dore G.J. aut The International journal on drug policy 62(2018-12), 94-103 62<94-103 2018 62 1 article serval SERVAL 700 1- Grebely J. aut SERVAL 700 1- Conway B. aut SERVAL 700 1- Cunningham E.B. aut SERVAL 700 1- Fraser C. aut SERVAL 700 1- Moriggia A. aut SERVAL 700 1- Gane E. aut SERVAL 700 1- Stedman C. aut SERVAL 700 1- Cooper C. aut SERVAL 700 1- Castro E. aut SERVAL 700 1- Schmid P. aut SERVAL 700 1- Petoumenos K. aut SERVAL 700 1- Hajarizadeh B. aut SERVAL 700 1- Marks P. aut SERVAL 700 1- Erratt A. aut SERVAL 700 1- Dalgard O. aut SERVAL 700 1- Lacombe K. aut SERVAL 700 1- Feld J.J. aut SERVAL 700 1- Bruneau J. aut SERVAL 700 1- Daulouede J.P. aut SERVAL 700 1- Powis J. aut SERVAL 700 1- Bruggmann P. aut SERVAL 700 1- Matthews G.V. aut SERVAL 700 1- Kronborg I. aut SERVAL 700 1- Shaw D. aut SERVAL 700 1- Dunlop A. aut SERVAL 700 1- Hellard M. aut SERVAL 700 1- Applegate T.L. aut SERVAL 700 1- Crawford S. aut SERVAL 700 1- Dore G.J. aut SERVAL 773 0- The International journal on drug policy 62(2018-12), 94-103 62<94-103 2018 62 BK010053 XK010053 XK010000 SERVAL SERVAL SERVAL article