Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection

Phase 4

Completed

• Conditions: Opioid-use Disorder; Hepatitis C, Chronic
• Interventions: Drug: Sofosbuvir/Velpatasvir

• Registration Number: NCT03057847
• Lead Sponsor: Elizabeth Krans, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Study Start: 2018-01-30
• Primary Completion: 2022-02-24
• Study Completion: 2022-02-24
• Results First Submitted: 2023-02-16
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Results First Posted: 2023-05-06
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF/VEL	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

Primary Outcome Measures

Name	Time	Method
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment	Delivery to 10 months postpartum	Number of participants initiating HCV treatment

Secondary Outcome Measures

Name	Time	Method
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
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
HCV Reinfection	15 months post-treatment	Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests
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
Health-related Quality of Life	15 months post-treatment	Health-related quality of life using Promise 57 scale

Trial Locations

Locations (1)

Magee Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States