Journal article
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.
- Grebely J The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia. Electronic address: jgrebely@kirby.unsw.edu.au.
- Conway B Vancouver Infectious Diseases Center, Vancouver, Canada.
- Cunningham EB The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Fraser C Coolaid Community Health Centre, Victoria, Canada.
- Moriggia A Fondazione Epatocentro Ticino, Lugano, Switzerland.
- Gane E Auckland Hospital, Auckland, New Zealand.
- Stedman C Christchurch Hospital and University of Otago, Christchurch, New Zealand.
- Cooper C Ottawa Hospital Research Institute, Ottawa, Canada.
- Castro E Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
- Schmid P Kantonsspital St Gallen, St Gallen, Switzerland.
- Petoumenos K The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Hajarizadeh B The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Marks P The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Erratt A The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Dalgard O Akershus University Hospital, Oslo, Norway.
- Lacombe K Inserm UMR-S1136, Sorbonne Université, Hôpital Saint-Antoine, Paris, France.
- Feld JJ Toronto General Hospital, Toronto, Canada.
- Bruneau J Centre Hospitalier de l'Université de Montréal, Montréal, Canada.
- Daulouede JP Csapa Bizia, Bayonne, France.
- Powis J South Riverdale Community Health Centre, Toronto, Canada.
- Bruggmann P Arud Centres for Addiction Medicine, Zurich, Switzerland.
- Matthews GV The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Kronborg I Footscray Hospital, Footscray, Australia.
- Shaw D Royal Adelaide Hospital, Adelaide, Australia.
- Dunlop A Newcastle Pharmacotherapy Service, Newcastle, Australia.
- Hellard M The Burnet Institute, Melbourne, Australia.
- Applegate TL The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- Crawford S Harm Reduction Victoria, Melbourne, Australia.
- Dore GJ The Kirby Institute, UNSW Sydney, Wallace Wurth Building, UNSW NSW 2052, Australia.
- 2018-11-02
Published in:
- The International journal on drug policy. - 2018
DAA
Drug use
Hepatitis C
Injecting drug users
PWID
Treatment
Adult
Anilides
Antiviral Agents
Carbamates
Drug Administration Schedule
Drug Therapy, Combination
Hepacivirus
Hepatitis C, Chronic
Humans
Macrocyclic Compounds
Male
Medication Adherence
Middle Aged
Opiate Substitution Treatment
Qualitative Research
RNA, Viral
Ribavirin
Ritonavir
Substance Abuse, Intravenous
Sulfonamides
Sustained Virologic Response
Treatment Outcome
Uracil
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.drugpo.2018.10.004
- PMID 30384028
- Persistent URL
- https://roar.hep-bejune.ch/global/documents/266569
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