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

NCT03057847 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY19030088
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic; Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment

  Number of participants initiating HCV treatment

  Delivery to 10 months postpartum

Secondary Outcomes (6)

• Intravenous Drug Use Recidivism

  15 months post-treatment, up to 18 months

• HCV Reinfection

  15 months post-treatment

• Health-related Quality of Life

  15 months post-treatment

• Number of Participants Achieving Sustained Virologic Response (SVR)

  End of treatment (12 weeks postpartum) up to 18 months

• Number of Participants Reporting Treatment Side Effects

  End of treatment (12 weeks postpartum)

Study Arms (1)

SOF/VEL

EXPERIMENTAL

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

Interventions

Sofosbuvir/Velpatasvir DRUG

Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period

Also known as: Epclusa

SOF/VEL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Able and willing to provide written informed consent to be screened for and take part in the study procedures
• Able and willing to provide adequate contact information
• 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
• Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
• Documented negative Hepatitis B testing within 3 months prior to enrollment
• Negative human immunodeficiency virus (HIV) testing within 3 months prior to enrollment
• 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
• Plans to deliver at Magee-Womens Hospital of University of Pittsburgh Medical Center (UPMC)

You may not qualify if:

• Participant report of any of the following at Screening or Enrollment:
• Previous treatment for Hepatitis C virus with a sofosbuvir based regimen
• Use of any medications contraindicated with concurrent use of sofosbuvir/velpatasvir according to the EPCLUSA package insert
• Plans to relocate away from the study site area in the next 18 months
• Current sexual partner is known to be infected with HIV or Hepatitis B virus
• History of decompensated cirrhosis (history of variceal bleed, ascites or hepatic encephalopathy)
• Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment
• 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
• Breastfeeding or pumping and feeding infant breastmilk
• 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)
• Has any of the following laboratory abnormalities at Screening:
• Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10 times the upper limited of normal
• Hemoglobin less than 10 g/dL
• Platelet count less than 90,000 per mm3
• International normalized ratio (INR) \> 1.5

Sponsors & Collaborators

• Elizabeth Krans, MD: lead

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Opioid-Related Disorders

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Due to lower than expected enrollment numbers and thus, insufficient power for multivariable analytic approaches, we were unable to perform the analyses originally proposed for this study. Thus, we had to adjust our statistical analysis plan to fit the number of participants actually enrolled in the study which now consists of largely descriptive and bivariate statistics.

Results Point of Contact

• Title: Dr. Elizabeth Krans
• Organization: University of Pittsburgh

kransee@upmc.edu

412-641-3532

Study Officials

• Elizabeth E Krans, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm, open-label, prospective cohort study

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 20, 2017
• Study Start: January 30, 2018
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)