The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry

NCT05368974 | Recruiting DMC FDA Drug

• 1 other identifier: Pro00083175
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide.

Conditions

Hepatitis C

Keywords

pregnancy; hepatitis C

Outcome Measures

Primary Outcomes (2)

• Number of adverse pregnancy outcomes

  The primary outcomes measured in the study are adverse pregnancy and birth outcomes documented at the time of the outcome of the pregnancy (primary endpoint). Primary adverse pregnancy outcomes include preterm delivery (\<37 weeks gestational age), stillbirth or fetal demise, and maternal death.

  1 year

• Number of adverse birth outcomes

  Primary adverse birth outcomes include low birth weight (\<2500g), small for gestational age, need for neonatal intensive care, and presence of congenital anomaly.

  1 year

Secondary Outcomes (2)

• Proportion of registry participants achieving SVR12

  12 weeks

• Proportion of infants with HCV infection

  18 months

Interventions

Direct Acting Antivirals DRUG

Direct-acting antiviral exposure during documented pregnancy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with chronic HCV infection and documented pregnancy

You may qualify if:

• Documented pregnancy with: Estimated date of conception by documentation of either 1) date of last menstrual period or 2) ultrasound evaluation Actual date of delivery
• Documented chronic HCV infection prior to or during pregnancy (positive test for HCV RNA or HCV core antigen)
• Documented DAA exposure occurring within 30 days of the estimated date of conception and before the pregnancy outcome (ie, fetal demise, spontaneous abortion, live delivery, etc). Eligible DAA drugs are listed in Appendix 1.

You may not qualify if:

• \- DAA exposures that include ribavirin or interferon will be excluded given their established harm during pregnancy.

Sponsors & Collaborators

• The Task Force for Global Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

The Taskforce for Global Health

Atlanta, Georgia, 30030, United States

RECRUITING

Related Publications (12)

• AASLD & IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C, v2021.1.

  BACKGROUND

• AbdAllah M, Alboraie M, Abdel-Razek W, Hassany M, Ammar I, Kamal E, Alalfy M, Okasha A, El Akel W, Shaaban E, Elbaz T, Hefny Z, Gomaa A, El-Bendary M, El-Serafy M, Esmat G, Doss W, El-Sayed MH. Pregnancy outcome of anti-HCV direct-acting antivirals: Real-life data from an Egyptian cohort. Liver Int. 2021 Jul;41(7):1494-1497. doi: 10.1111/liv.14913. Epub 2021 May 11.

  PMID: 33905164 BACKGROUND

• Benova L, Mohamoud YA, Calvert C, Abu-Raddad LJ. Vertical transmission of hepatitis C virus: systematic review and meta-analysis. Clin Infect Dis. 2014 Sep 15;59(6):765-73. doi: 10.1093/cid/ciu447. Epub 2014 Jun 13.

  PMID: 24928290 BACKGROUND

• Chappell CA, Scarsi KK, Kirby BJ, Suri V, Gaggar A, Bogen DL, Macio IS, Meyn LA, Bunge KE, Krans EE, Hillier SL. Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study. Lancet Microbe. 2020 Sep;1(5):e200-e208. doi: 10.1016/S2666-5247(20)30062-8. Epub 2020 Jul 27.

  PMID: 32939459 BACKGROUND

• Cottrell EB, Chou R, Wasson N, Rahman B, Guise JM. Reducing risk for mother-to-infant transmission of hepatitis C virus: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Jan 15;158(2):109-13. doi: 10.7326/0003-4819-158-2-201301150-00575.

  PMID: 23437438 BACKGROUND

• Kushner T, Cohen J, Tien PC, Terrault NA. Evaluating Women's Preferences for Hepatitis C Treatment During Pregnancy. Hepatol Commun. 2018 Oct 1;2(11):1306-1310. doi: 10.1002/hep4.1264. eCollection 2018 Nov.

  PMID: 30411077 BACKGROUND

• Kushner T, Reau N. Changing epidemiology, implications, and recommendations for hepatitis C in women of childbearing age and during pregnancy. J Hepatol. 2021 Mar;74(3):734-741. doi: 10.1016/j.jhep.2020.11.027. Epub 2020 Nov 25.

  PMID: 33248169 BACKGROUND

• Mok J, Pembrey L, Tovo PA, Newell ML; European Paediatric Hepatitis C Virus Network. When does mother to child transmission of hepatitis C virus occur? Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F156-60. doi: 10.1136/adc.2004.059436.

  PMID: 15724041 BACKGROUND

• Schillie SF, Canary L, Koneru A, Nelson NP, Tanico W, Kaufman HW, Hariri S, Vellozzi CJ. Hepatitis C Virus in Women of Childbearing Age, Pregnant Women, and Children. Am J Prev Med. 2018 Nov;55(5):633-641. doi: 10.1016/j.amepre.2018.05.029.

  PMID: 30342628 BACKGROUND

• Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC Recommendations for Hepatitis C Screening Among Adults - United States, 2020. MMWR Recomm Rep. 2020 Apr 10;69(2):1-17. doi: 10.15585/mmwr.rr6902a1.

  PMID: 32271723 BACKGROUND

• Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Dotters-Katz SK, Kuller JA, Hughes BL. Society for Maternal-Fetal Medicine Consult Series #56: Hepatitis C in pregnancy-updated guidelines: Replaces Consult Number 43, November 2017. Am J Obstet Gynecol. 2021 Sep;225(3):B8-B18. doi: 10.1016/j.ajog.2021.06.008. Epub 2021 Jun 8.

  PMID: 34116035 BACKGROUND

• Yattoo G. Treatment of chronic hepatitis C with ledipasvir/sofosbuvir combination during pregnancy. Hepatol Int. 2018;12(Suppl. 2):S292-3.

  BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• John Ward, MD

  The Taskforce For Global Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Gupta, MD

CONTACT

4043014134; ngupta-consultant@taskforce.org

Lindsey Hiebert

CONTACT

4043014134; lhiebert@taskforce.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 10, 2022
• Study Start: February 11, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)