In onsite hepatitis C virus (HCV) care delivered to people who inject drugs (PWID) in opioid agonist therapy programs, a greater adherence was associated with directly observed therapy when compared with self-administered individual treatment, according to a study recently published in Annals of Internal Medicine.
The HCV epidemic in the United States and other developed nations is related to illicit drug use. Acute HCV infections have increased more than 2.9-fold from 2010 to 2015 and the disease has resulted in approximately 15,000 deaths annually. As a result of the advent of direct-acting antiviral (DAA) treatment, HCV treatment outcomes have improved substantially and DAA agents are associated with nearly 100% sustained virologic response or HCV cure.
PWID are a center point of the HCV epidemic; these people face many challenges with adherence, mental illness, lack of positive social support, homelessness, poor adherence-related skills, and low HCV‑related knowledge. Further, opioid agonist therapy programs are ideal settings in which to co-locate HCV therapy. However, it is not known whether intensive models of care in the DAA era can improve HCV outcomes in PWID in opioid agonist therapy programs.
Therefore, this randomized, controlled trial determined whether group treatment or directly observed therapy was more effective when compared with self-administered individual treatment in promoting adherence and achieving sustained virologic response in PWID receiving opioid agonist therapy (ClinicalTrials.gov identifier: NCT01857245).
In total, 150 participants with genotype 1 HCV infection who were willing to receive HCV therapy on site in 1 of 3 opioid agonist therapy programs in Bronx, New York were included. Participants were randomly assigned to 1 of 3 study groups: directly observed therapy (n=51), group treatment (n=48), and self-administered individual treatment (n=51). Participants’ mean age was 51 years, 65% had positive urine drug testing results during the 6 months before treatment, and 75% reported a history of injecting drugs. The primary outcome was adherence, which was measured using electronic blister packs; the secondary outcome was HCV treatment completion and sustained virologic response 12 weeks after treatment completion.
The treatment completion rate was 97%, with no significant differences among the 3 groups (P =.53). However, overall adherence was 78% and was higher in participants in the directly observed therapy group (86%) compared with participants in the self-administered individual treatment group (75%; P =.001). There was no significant difference in overall adherence between the self-administered individual treatment group and the group treatment group (80%; P =.29). Further, the overall sustained virologic response rate was 94% and was also higher in the directly observed therapy group (94%) compared with the group treatment group (94%) and the self-administered individual treatment group (90%); however, this difference was not statistically significant (P =.152).
Overall, the study authors concluded that, “All models of onsite HCV care resulted in high treatment completion and [sustained virologic response] rates despite ongoing drug use, thereby supporting treatment of PWID in the [opioid agonist therapy] setting.”
Disclosure: Dr. Akiyama reports personal fees from Gilead Sciences outside the submitted work. Dr. Litwin reports grants from Gilead Science during the conduct of the study and grants and personal fees from Gilead Sciences and Merck Pharmaceuticals outside the submitted work.
Akiyama MJ, Norton BL, Arnsten JH, Agyemang L, Heo M, Litwin AH. Intensive models of hepatitis C care for people who inject drugs receiving opioid agonist therapy: a randomize controlled trial [published online April 9, 2019]. Ann Intern Med. doi:10.7326/M18-1715