TY - JOUR
T1 - Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection
T2 - The ACTIVATE study
AU - Cunningham, Evan B.
AU - Hajarizadeh, Behzad
AU - Dalgard, Olav
AU - Amin, Janaki
AU - Hellard, Margaret
AU - Foster, Graham R.
AU - Bruggmann, Philip
AU - Conway, Brian
AU - Backmund, Markus
AU - Robaeys, Geert
AU - Swan, Tracy
AU - Marks, Philippa S.
AU - Quiene, Sophie
AU - Applegate, Tanya L.
AU - Weltman, Martin
AU - Shaw, David
AU - Dunlop, Adrian
AU - Bruneau, Julie
AU - Midgard, Håvard
AU - Bourgeois, Stefan
AU - Thurnheer, Maria Christine
AU - Dore, Gregory J.
AU - Grebely, Jason
AU - The ACTIVATE Study Group
AU - Shaw, Ineke
AU - Siriragavan, Sharmila
AU - Axten, David
AU - Horschik, Tina
AU - Sharma, Shawn
AU - Eevers, Anita
AU - Andreassen, Jessica
AU - Melkeraaen, Ingunn
AU - Widder, Nicole
AU - Lesneuck, Kristof
AU - Kotsoros, Barbara
AU - Hazelwood, Susan
AU - Holland, Rohan
AU - Von Bibra, Sally
AU - Powis, Jeff
AU - Mason, Kate
AU - Ryder, Stephen
AU - Jack, Kate
AU - Scheidegger, Claude
AU - Huber, Christine
AU - Ferguson, Catherine
AU - Staehelin, Cornelia
AU - Lacalamita, Melanie
AU - Fragomeli, Vincenzo
AU - Sevehon, Alison
N1 - Copyright the Author(s) 2017. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2017/6/13
Y1 - 2017/6/13
N2 - Background: The aims of this analysis were to investigate treatment completion and adherence among people with ongoing injecting drug use or receiving opioid substitution therapy (OST) in a study of response-guided therapy for chronic HCV genotypes 2/3 infection. Methods: ACTIVATE was a multicenter clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b (PEG-IFN) and self-administered ribavirin for 12 (undetectable HCV RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Outcomes included treatment completion, PEG-IFN adherence, ribavirin adherence, and sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment). Results: Among 93 people treated, 59% had recently injected drugs (past month), 77% were receiving OST and 56% injected drugs during therapy. Overall, 76% completed treatment. Mean on-treatment adherence to PEG-IFN and ribavirin were 98.2% and 94.6%. Overall, 6% of participants missed >1 dose of PEG-IFN and 31% took <95% of their prescribed ribavirin., Higher treatment completion was observed among those receiving 12 vs. 24 weeks of treatment (97% vs. 46%, P < 0.001) while the proportion of participants with 95% on-treatment ribavirin adherence was similar between groups (67% vs. 72%, P = 0.664). Receiving 12 weeks of therapy was independently associated with treatment completion. No factors were associated with 95% RBV adherence. Neither recent injecting drug use at baseline nor during therapy was associated with treatment completion or adherence to ribavirin. In adjusted analysis, treatment completion was associated with SVR (aOR 23.9, 95% CI 2.9-193.8). Conclusions: This study demonstrated a high adherence to directly observed PEG-IFN and self-administered ribavirin among people with ongoing injecting drug use or receiving OST. These data also suggest that shortening therapy from 24 to 12 weeks can lead to improved treatment completion. Treatment completion was associated with improved response to therapy. ACTIVATE trial registration number: NCT01364090 - May 31, 2011.
AB - Background: The aims of this analysis were to investigate treatment completion and adherence among people with ongoing injecting drug use or receiving opioid substitution therapy (OST) in a study of response-guided therapy for chronic HCV genotypes 2/3 infection. Methods: ACTIVATE was a multicenter clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b (PEG-IFN) and self-administered ribavirin for 12 (undetectable HCV RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Outcomes included treatment completion, PEG-IFN adherence, ribavirin adherence, and sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment). Results: Among 93 people treated, 59% had recently injected drugs (past month), 77% were receiving OST and 56% injected drugs during therapy. Overall, 76% completed treatment. Mean on-treatment adherence to PEG-IFN and ribavirin were 98.2% and 94.6%. Overall, 6% of participants missed >1 dose of PEG-IFN and 31% took <95% of their prescribed ribavirin., Higher treatment completion was observed among those receiving 12 vs. 24 weeks of treatment (97% vs. 46%, P < 0.001) while the proportion of participants with 95% on-treatment ribavirin adherence was similar between groups (67% vs. 72%, P = 0.664). Receiving 12 weeks of therapy was independently associated with treatment completion. No factors were associated with 95% RBV adherence. Neither recent injecting drug use at baseline nor during therapy was associated with treatment completion or adherence to ribavirin. In adjusted analysis, treatment completion was associated with SVR (aOR 23.9, 95% CI 2.9-193.8). Conclusions: This study demonstrated a high adherence to directly observed PEG-IFN and self-administered ribavirin among people with ongoing injecting drug use or receiving OST. These data also suggest that shortening therapy from 24 to 12 weeks can lead to improved treatment completion. Treatment completion was associated with improved response to therapy. ACTIVATE trial registration number: NCT01364090 - May 31, 2011.
KW - Adherence
KW - Hepatitis C
KW - Injection drug use
KW - PWID
KW - Treatment
UR - http://www.scopus.com/inward/record.url?scp=85020708406&partnerID=8YFLogxK
U2 - 10.1186/s12879-017-2517-3
DO - 10.1186/s12879-017-2517-3
M3 - Article
C2 - 28610605
AN - SCOPUS:85020708406
VL - 17
SP - 1
EP - 12
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
SN - 1471-2334
IS - 1
M1 - 420
ER -