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

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ClinicalTrials.gov Identifier: NCT03057847
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Krans, MD, University of Pittsburgh

Brief Summary:

Incorporating 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 IVDU recidivism, HCV reinfection and health related QOL in women with 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 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.


Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Opioid-use Disorder Drug: Sofosbuvir/Velpatasvir Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label, prospective observational cohort study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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 Name: Epclusa




Primary Outcome Measures :
  1. Number of participants enrolled in HCV treatment [ Time Frame: 12 weeks postpartum ]
    Number of participants enrolled in HCV treatment


Secondary Outcome Measures :
  1. Intravenous Drug Use Recidivism [ Time Frame: 15 months post-treatment ]
    Rate of intravenous drug use recidivism

  2. HCV reinfection [ Time Frame: 15 months post-treatment ]
    Rate of HCV reinfection

  3. Health-related quality of life [ Time Frame: 15 months post-treatment ]
    Health-related quality of life using Promise 57 scale

  4. Number of participants achieving sustained virologic response [ Time Frame: 12 weeks post-treatment ]
    Number of participants with non-detectable HCV RNA at 12 weeks post-treatment

  5. Number of participants reporting treatment side effects [ Time Frame: End of treatment (12 weeks postpartum) ]
    Number of participants reporting treatment side effects using standardized questionnaire

  6. Treatment adherence assessed by medication diaries [ Time Frame: End of treatment (12 weeks postpartum) ]
    Treatment adherence assessed by medication diaries



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 HCV, genotype 1 (1a, 1b), 2 (2a, 2b), 3, 4, 5, 6 infection, defined as a HCV antibody and detectable HCV 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 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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057847


Contacts
Contact: Walitta Abdullah 412-641-6377 abdullahw@upmc.edu

Locations
United States, Pennsylvania
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Wallita Abdullah    412-641-6377    abdullahw@upmc.edu   
Contact: Hollis Laird    412-641-2248    lairdh2@mwri.magee.edu   
Sponsors and Collaborators
Elizabeth Krans, MD
Investigators
Principal Investigator: Elizabeth E Krans, MD, MSc University of Pittsburgh

Responsible Party: Elizabeth Krans, MD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03057847     History of Changes
Other Study ID Numbers: PRO17020116
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents