Hepatitis C, Chronic, Opioid-use Disorder
Conditions
Brief summary
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.
Interventions
Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Sponsors
Elizabeth Krans, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Single arm, open-label, prospective cohort study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Able and willing to provide written informed consent to be screened for and take part in the study procedures 3. Able and willing to provide adequate contact information 4. Chronic Hepatitis C Virus (HCV), genotype 1 (1a, 1b), 2 (2a, 2b), 3, 4, 5, 6 infection, defined as a HCV antibody and detectable HCV ribonucleic acid (RNA) viral load at screening 5. Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound 6. Documented negative Hepatitis B testing within 3 months prior to enrollment 7. Negative human immunodeficiency virus (HIV) testing within 3 months prior to enrollment 8. Per participant report at screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation 9. Plans to deliver at Magee-Womens Hospital of University of Pittsburgh Medical Center (UPMC)
Exclusion criteria
1. Participant report of any of the following at Screening or Enrollment: 1. Previous treatment for Hepatitis C virus with a sofosbuvir based regimen 2. Use of any medications contraindicated with concurrent use of sofosbuvir/velpatasvir according to the EPCLUSA package insert 3. Plans to relocate away from the study site area in the next 18 months 4. Current sexual partner is known to be infected with HIV or Hepatitis B virus 5. History of decompensated cirrhosis (history of variceal bleed, ascites or hepatic encephalopathy) 2. Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment 3. Ongoing illicit drug use evidenced by positive urine drug screen with appropriate confirmatory testing for anything other than marijuana since the first prenatal visit that cannot be explained by a prescribed medication 4. Breastfeeding or pumping and feeding infant breastmilk 5. At screening or enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C) 6. Has any of the following laboratory abnormalities at Screening: 1. Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10 times the upper limited of normal 2. Hemoglobin less than 10 g/dL 3. Platelet count less than 90,000 per mm3 4. International normalized ratio (INR) \> 1.5 5. Glomerular filtration rate (GFR) \< 40 7. Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment | Delivery to 10 months postpartum | Number of participants initiating HCV treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV Reinfection | 15 months post-treatment | Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests |
| Health-related Quality of Life | 15 months post-treatment | Health-related quality of life using Promise 57 scale |
| Intravenous Drug Use Recidivism | 15 months post-treatment, up to 18 months | Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening |
| Number of Participants Reporting Treatment Side Effects | End of treatment (12 weeks postpartum) | Number of participants reporting treatment side effects using standardized list |
| Number of Missed Treatment Doses | End of treatment (12 weeks postpartum) | Treatment adherence assessed by missed treatment doses |
| Number of Participants Achieving Sustained Virologic Response (SVR) | End of treatment (12 weeks postpartum) up to 18 months | Number of participants with non-detectable Hepatitis C Virus (HCV) Ribonucleic acid (RNA) post-treatment as measured by SVR testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SOF/VEL Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Sofosbuvir/Velpatasvir: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 16 |
Baseline characteristics
| Characteristic | SOF/VEL |
|---|---|
| Age, Continuous | 29.88 years STANDARD_DEVIATION 4.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 12 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
Number of participants initiating HCV treatment
Time frame: Delivery to 10 months postpartum
Population: Number of participants initiating HCV treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF/VEL | Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment | 21 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF/VEL | HCV Reinfection | 0 Participants |
Secondary
Health-related Quality of Life
Health-related quality of life using Promise 57 scale
Time frame: 15 months post-treatment
Population: Data was not collected and will not be reported due to lack of survey development
Secondary
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
Population: Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF/VEL | Intravenous Drug Use Recidivism | 3 Participants |
Secondary
Number of Missed Treatment Doses
Treatment adherence assessed by missed treatment doses
Time frame: End of treatment (12 weeks postpartum)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SOF/VEL | Number of Missed Treatment Doses | 2 doses |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF/VEL | Number of Participants Achieving Sustained Virologic Response (SVR) | 13 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF/VEL | Number of Participants Reporting Treatment Side Effects | 12 Participants |