Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers

NCT03038763 | Completed

• 1 other identifier: 826229
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to determine the prevalence of hepatitis C in the adult children of female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C testing was either not available or was not standard of care. Because of this, participants' children may be unaware of participants' risk of hepatitis C.

Conditions

Hepatitis C; Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• HCV prevalence

  Prevalence of HCV in adult children of female baby boomers who have or have had HCV

  Within 1 week of labwork at first study visit

Secondary Outcomes (2)

• Liver fibrosis

  Within 2 weeks of diagnosis of HCV

• HCV genotype

  Within 6 weeks of diagnosis of HCV

Study Arms (2)

Mothers

Black or white mothers who have or have had hepatitis C and were born between 1945-1964. Participants must have at least one child over the age of 18.

Other: Eligibility Screening

Adult Children

Adult children of Black or white mothers who have or have had hepatitis C and were born between 1945-1964. From speaking with these mothers, it must be possible that participants were exposed to hepatitis C virus while in the womb.

Diagnostic Test: HCV test

Interventions

Eligibility Screening OTHER

Investigators will call eligible mothers to screen for the possibility that eligible mothers may have passed HCV on to adult children. Investigators will consent these mothers to contact the adult child(ren), as the child(ren) must be informed of the mother's HCV status, if not already known.

Mothers

HCV test DIAGNOSTIC_TEST

Adult children will be invited to Penn or a Penn affiliate to have labwork, testing HCV antibody and HCV quant. If the quant comes back positive, investigators will also test genotype and fibrosure.

Adult Children

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult children of women born between 1945-1965 who have or have had hepatitis C Women born between 1945-1965 who have or have had hepatitis C Investigators will only be recruiting subjects who are black or white as hepatitis C is most common in these two populations. Using these populations maximizes the generalizability of our results. HCV is not only significantly less common among Asian women and women of other races, but these women also represent a minority of the patient population at Penn.

You may qualify if:

• Mothers:
• Born between 1/1/45-12/31/64
• Black or white race
• Active or prior infection with hepatitis C
• Have at least one living adult child over the age of 18
• Children:
• ≥18 years of age
• Born to mother with current or prior HCV infection, with likely timing of HCV acquisition prior to or during pregnancy
• Mother gave informed consent for child to be approached for study participation

You may not qualify if:

• Mothers:
• \- Unwilling to disclose hepatitis C status to children

Sponsors & Collaborators

• University of Pennsylvania: lead
• Gilead Sciences: collaborator

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (13)

• Rein DB, Smith BD, Wittenborn JS, Lesesne SB, Wagner LD, Roblin DW, Patel N, Ward JW, Weinbaum CM. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012 Feb 21;156(4):263-70. doi: 10.7326/0003-4819-156-4-201202210-00378. Epub 2011 Nov 4.

  PMID: 22056542 BACKGROUND

• Voelker R. Birth cohort screening may help find hepatitis C cases. JAMA. 2012 Mar 28;307(12):1242. doi: 10.1001/jama.2012.337. No abstract available.

  PMID: 22453559 BACKGROUND

• AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.

  PMID: 26111063 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

• Kuncio DE, Newbern EC, Johnson CC, Viner KM. Failure to Test and Identify Perinatally Infected Children Born to Hepatitis C Virus-Infected Women. Clin Infect Dis. 2016 Apr 15;62(8):980-5. doi: 10.1093/cid/ciw026. Epub 2016 Jan 20.

  PMID: 26797211 BACKGROUND

• Kabiri M, Jazwinski AB, Roberts MS, Schaefer AJ, Chhatwal J. The changing burden of hepatitis C virus infection in the United States: model-based predictions. Ann Intern Med. 2014 Aug 5;161(3):170-80. doi: 10.7326/M14-0095.

  PMID: 25089861 BACKGROUND

• Mast EE, Hwang LY, Seto DS, Nolte FS, Nainan OV, Wurtzel H, Alter MJ. Risk factors for perinatal transmission of hepatitis C virus (HCV) and the natural history of HCV infection acquired in infancy. J Infect Dis. 2005 Dec 1;192(11):1880-9. doi: 10.1086/497701. Epub 2005 Oct 28.

  PMID: 16267758 BACKGROUND

• Poynard T, Imbert-Bismut F, Munteanu M, Messous D, Myers RP, Thabut D, Ratziu V, Mercadier A, Benhamou Y, Hainque B. Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004 Sep 23;3(1):8. doi: 10.1186/1476-5926-3-8.

  PMID: 15387887 BACKGROUND

• Poynard T, Imbert-Bismut F, Munteanu M, Ratziu V. FibroTest-FibroSURE: towards a universal biomarker of liver fibrosis? Expert Rev Mol Diagn. 2005 Jan;5(1):15-21. doi: 10.1586/14737159.5.1.15.

  PMID: 15723588 BACKGROUND

• Patel K, Benhamou Y, Yoshida EM, Kaita KD, Zeuzem S, Torbenson M, Pulkstenis E, Subramanian GM, McHutchison JG. An independent and prospective comparison of two commercial fibrosis marker panels (HCV FibroSURE and FIBROSpect II) during albinterferon alfa-2b combination therapy for chronic hepatitis C. J Viral Hepat. 2009 Mar;16(3):178-86. doi: 10.1111/j.1365-2893.2008.01062.x. Epub 2008 Oct 24.

  PMID: 19175870 BACKGROUND

• Sebastiani G, Castera L, Halfon P, Pol S, Mangia A, Di Marco V, Pirisi M, Voiculescu M, Bourliere M, Alberti A. The impact of liver disease aetiology and the stages of hepatic fibrosis on the performance of non-invasive fibrosis biomarkers: an international study of 2411 cases. Aliment Pharmacol Ther. 2011 Nov;34(10):1202-16. doi: 10.1111/j.1365-2036.2011.04861.x. Epub 2011 Oct 9.

  PMID: 21981787 BACKGROUND

• Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.

  PMID: 9121257 BACKGROUND

• Thein HH, Yi Q, Dore GJ, Krahn MD. Estimation of stage-specific fibrosis progression rates in chronic hepatitis C virus infection: a meta-analysis and meta-regression. Hepatology. 2008 Aug;48(2):418-31. doi: 10.1002/hep.22375.

  PMID: 18563841 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

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; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Goldberg, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: May 11, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)