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

Management of Hepatitis C Virus (HCV) Infection in Pregnant Women With Opioid Use Disorder (OUD): the Potential of an Integrated Medical Home Model: Phase IV Trial of Sofosbuvir/Velpatasvir (SOF/VEL) in Postpartum Women With Chronic HCV

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 Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic; Opioid-use Disorder
• Intervention / Treatment: Drug: Sofosbuvir/Velpatasvir

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: Epclusa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment	Number of participants initiating HCV treatment	Delivery to 10 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous Drug Use Recidivism	Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening	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	15 months post-treatment
Health-related Quality of Life	Health-related quality of life using Promise 57 scale	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	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	End of treatment (12 weeks postpartum)
Number of Missed Treatment Doses	Treatment adherence assessed by missed treatment doses	End of treatment (12 weeks postpartum)

Collaborators and Investigators

• Sponsor: Elizabeth Krans, MD
• Investigators: Principal Investigator: Elizabeth E Krans, MD, MSc, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): February 24, 2022

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Narcotic-Related Disorders; Substance-Related Disorders; Hepatitis; Hepatitis A; Hepatitis C; Opioid-Related Disorders; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: STUDY19030088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No