Abstract
BackgroundThe 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.MethodsACTIVATE 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).ResultsAmong 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).ConclusionsThis 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
Highlights
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 hepatitis C virus (HCV) genotypes 2/3 infection
The primary analysis from this study demonstrated that cirrhosis (vs. no/mild fibrosis [adjusted odds ratio 0.33, 95% confidence intervals (95% confidence intervals (CIs)) 0.13, 0.86]) predicted reduced sustained virologic response (SVR), while response at week 4 was associated with increased SVR [11]
These data suggest that shortening HCV therapy has the potential to increase treatment completion among people who inject drugs (PWID)
Summary
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. Adherence [3,4,5,6] and treatment completion [3] are associated with sustained virologic response (SVR). Adherence to HCV therapy is often defined measuring “80/80 adherence”, or the receipt of ≥80% of scheduled doses for ≥80% of the scheduled treatment period [7]. This definition combines the two distinct concepts of treatment completion and missed doses during therapy. Understanding the two concepts individually is important for understanding adherence in this population of PWID
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