Incorporating Hepatitis C Virus (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 intravenous drug use (IVDU) recidivism, HCV reinfection and health related Quality of Life (QOL) in women with opioid use disorder (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 sustained virologic response (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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
32
Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
Number of participants initiating HCV treatment
Time frame: Delivery to 10 months postpartum
Intravenous Drug Use Recidivism
Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening
Time frame: 15 months post-treatment, up to 18 months
HCV Reinfection
Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests
Time frame: 15 months post-treatment
Health-related Quality of Life
Health-related quality of life using Promise 57 scale
Time frame: 15 months post-treatment
Number of Participants Achieving Sustained Virologic Response (SVR)
Number of participants with non-detectable Hepatitis C Virus (HCV) Ribonucleic acid (RNA) post-treatment as measured by SVR testing
Time frame: End of treatment (12 weeks postpartum) up to 18 months
Number of Participants Reporting Treatment Side Effects
Number of participants reporting treatment side effects using standardized list
Time frame: End of treatment (12 weeks postpartum)
Number of Missed Treatment Doses
Treatment adherence assessed by missed treatment doses
Time frame: End of treatment (12 weeks postpartum)
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