Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
Status:
Completed
Trial end date:
2019-06-06
Target enrollment:
Participant gender:
Summary
hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given
the complexity of older pegylated interferon containing regimens, formerly the standard of
care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite
their relative simplicity, creating a bottleneck of human resources necessary to fight the
largest infectious epidemic in North America. In addition, stigma and fear over cost has lead
payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of
new infections occur in this population.
This study evaluates the effectiveness of treatment of HCV with elbasvir-grasoprevir in PWIDs
in a real world, community health clinic setting.
There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based
community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory
medication assisted therapy with buprenorphine or extended released injectable naltrexone.
Cohort two maintains active injection drug use with needle exchange and risk reduction
education.
These groups are compared to a 50 patient retrospective cohort of people with substance use
disorders at tertiary care hepatology-based treatment program.
All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks.
The investigators hypothesize there is no difference in sustained viremic response at 12 or
48 weeks post-completion of treatment (SVR 12, 48) when treating patients in a community
health clinic setting as compared to the standard-of-care subspecialty setting.