Study of Hepatitis C Treatment During Pregnancy

• Status: Completed
• Trial end date: 2020-02-03
• Target enrollment: 0
• Participant gender: Female

Summary

Sofosbuvir and ledipasvir (LDV/SOF) are new directly acting antiviral drugs for the treatment of hepatitis C (HCV) that are highly effective, orally administered, well tolerated and preclinical evaluations in animal models indicate safe administration during pregnancy. This project will evaluate the safety and pharmacokinetics of antenatal LDV/SOF treatment for 12 weeks during the second and third trimester. If proven to be effective, antenatal treatment of HCV with LDV/SOF will prevent maternal HCV-related liver disease, perinatal transmission of HCV, and community transmission of HCV.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catherine Chappell; University of Pittsburgh
• Collaborators: Gilead Sciences; University of Nebraska
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

1. Age 18 through 39 years (inclusive) at Screening

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 locator information

4. Chronic HCV, genotype 1, 4, 5, 6 infection, defined as HCV antibody detected at least 6 months prior to Screening and detectable HCV RNA viral load at Screening

5. Desired pregnancy at 23 + 0 to 24 + 6 weeks' gestation at Enrollment with gestational dating confirmed by ultrasound

6. Singleton gestation with no known fetal abnormalities

7. Documented negative Hepatitis B testing for current infection (negative HBsAg test) or previous infection (negative anti-HB Core) performed at the screening visit

8. Negative HIV testing at the screening visit

9. 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

Exclusion Criteria:

1. Participant report of any of the following at Screening or Enrollment:

1. Previous treatment for Hepatitis C virus with an NS5A inhibitor or sofosbuvir

2. Use of any medications contraindicated with concurrent use of ledipasvir or sofobuvir according to the most current HARVONI package insert

3. Plans to relocate away from the study site area in the next 1 year and 4 months

4. Current sexual partner is known to be infected with HIV or Hepatitis B virus

5. History of cirrhosis documented by previous liver biopsy or liver imaging tests

2. Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to Enrollment

3. Clinically significant and habitual non-therapeutic drug abuse, not including marijuana, as determined by Protocol Chair

4. At Screening or Enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver (such as evidence of decompensated cirrhosis by ascites, encephalopathy, or variceal hemorrhage), hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C)

5. Has a high risk of preterm birth defined as a history of spontaneous preterm birth at less than 34 weeks of gestation or a shortened cervical length of less than 20 millimeters

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 9 g/dL

3. Platelet count less than 90,000 per mm3

4. International normalized ratio (INR) > 1.5

5. Creatinine greater than 1.4

6. Medical history of cirrhosis

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.