Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection
Status:
Recruiting
Trial end date:
2023-08-30
Target enrollment:
Participant gender:
Summary
Incorporating HCV treatment into opioid maintenance treatment program clinical protocols is
an innovative health care delivery model that has been associated with improved HCV treatment
uptake in non-pregnant, drug-using populations. This "medical home" approach would combine
HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise
of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into
one comprehensive clinical care model. The purpose of this study is to evaluate the
feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment
program on adherence to HCV treatment regimens and evaluate the rate of IVDU recidivism, HCV
reinfection and health related QOL in women with OUD during the first postpartum year.
The protocol involves three separate study phases. All 3 study phases will occur with support
from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment
and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood
and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will
undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum.
Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8
and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months
after treatment completion. Treatment effectiveness and SVR will be evaluated at 3 months and
rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health
related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment
completion.