Prospective Cohort Study: To Provide Evidence & Guidance in Hepatitis C Virus Screening, Comparing the New Birth Cohort Recommendations From the CDC, Versus Classical Traditional Strategies With Established Risk Factors

NCT01813266 | Withdrawn

• 1 other identifier: hepcvirusscreeningtrial
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Although infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more commonly progresses to chronic hepatitis. The acute process is most often asymptomatic. Acute HCV typically leads to chronic infection. Chronic HCV infection is usually slowly progressive. Approximately 5 to 20 percent of chronically infected individuals develop cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for liver transplantation in the United States. Screening for chronic HCV infection is crucial because chronic HCV infection is often asymptomatic, effective treatment is available, and untreated disease carries a high risk of morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening do not all agree. All guidelines recommend screening patients at increased risk for HCV (ie: typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC) recommended screening all persons born between 1945 and 1965. At least two studies suggest that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is cost-effective. The studies estimated that if patients found to be HCV positive were treated with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening based upon a birth cohort in patients without risk factors may lead to more false positive results. Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by Intermountain Healthcare providers have been screened. Ambulatory care physicians are not effectively screening patients. It is unclear whether screening based on risk factors alone versus screening based upon risk factors and birth cohort most effectively manages the burden of chronic HCV infection for patients managed by Intermountain Healthcare providers. It is possible that the Intermountain Healthcare population differs in risk from the U.S. population,making guideline application less certain. A well-designed prospective cohort study is needed to understand the risks and benefits of different HCV screening strategies on diagnostic yield and clinical outcomes. The investigators hypothesize that screening based on a person's history of risk factors will detect chronic HCV infection in 2.7 % of the population tested; this would be according to national average. The investigators further hypothesize that screening based on birth cohort and risk factors will identify roughly the same percentage in the tested population. The investigators anticipate usable data within three months which should give us data to describe and publish the effectiveness of different screening strategies. The investigators will identify patients with chronic HCV infection through this initial study who now require treatment and management. The investigators believe this group could be followed inexpensively for clinical endpoints for many years. This would then definitively define the effectiveness of screening strategies based on good evidence. No study has evaluated clinical outcomes associated with the different screening strategies for chronic hepatitis c virus infection.

Conditions

Chronic Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (3)

• superiority of Hepatitis C virus screening between three different strategies as far as identifying those with chronic hepatitis C virus infection.

  Compare yield of risk based versus risk based and birth cohort screening for hepatitis C virus as a function of number invited to screen. The control group will receive the routine care as delivered normally by local medical practice. This will be conducted in the Salt Lake Area.

  3-4 months

• Cost of testing of screening for HCV.

  Measure the cost of screening testing for HCV and follow up testing.

  3-4 months

• Develop a registry of patients with chronic HCV infection to follow through treatment.

  Have a registry of patients we can follow for long term outcome.

  3-4 months

Secondary Outcomes (1)

• Identify new risk factors for Chronic Hepatitis C virus infection.

  3-4 months

Study Arms (3)

Usual practice in screening for Hepatitis C virus.

Three clinics in this group will use this approach.

USPTF risk factors to screen for chronic HCV infection.

3 internal medicine clinics will use this screening strategy.

USPTF/CDC recommendations to screen for chronic HCV infection.

3 internal medicine clinics.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

residents of Salt Lake County, Utah with pre-stratification to equalized sex, age, and ethnic similarity.

You may qualify if:

• anyone between the ages of 18 and 75 years old.

You may not qualify if:

• anyone who gives a history of chronic Hepatitis C virus infection or who has had a positive lab result in the past.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Publications (10)

• Southern WN, Drainoni ML, Smith BD, Christiansen CL, McKee D, Gifford AL, Weinbaum CM, Thompson D, Koppelman E, Maher S, Litwin AH. Hepatitis C testing practices and prevalence in a high-risk urban ambulatory care setting. J Viral Hepat. 2011 Jul;18(7):474-81. doi: 10.1111/j.1365-2893.2010.01327.x. Epub 2010 May 20.

  PMID: 20497311 BACKGROUND

• Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.

  PMID: 16702586 RESULT

• Velazquez RF, Rodriguez M, Navascues CA, Linares A, Perez R, Sotorrios NG, Martinez I, Rodrigo L. Prospective analysis of risk factors for hepatocellular carcinoma in patients with liver cirrhosis. Hepatology. 2003 Mar;37(3):520-7. doi: 10.1053/jhep.2003.50093.

  PMID: 12601348 RESULT

• Roblin DW, Smith BD, Weinbaum CM, Sabin ME. HCV screening practices and prevalence in an MCO, 2000-2007. Am J Manag Care. 2011;17(8):548-55.

  PMID: 21851142 RESULT

• Sanyal AJ; Governing Board the Public Policy, Clinical Practice, Manpower committees of the AASLD. The Institute of Medicine report on viral hepatitis: a call to action. Hepatology. 2010 Mar;51(3):727-8. doi: 10.1002/hep.23583. No abstract available.

  PMID: 20198626 RESULT

• Smith BD, Morgan RL, Beckett GA, Falck-Ytter Y, Holtzman D, Teo CG, Jewett A, Baack B, Rein DB, Patel N, Alter M, Yartel A, Ward JW; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012 Aug 17;61(RR-4):1-32.

  PMID: 22895429 RESULT

• Duncan CJ, Stewart E, Fox R. Improving targeted screening for hepatitis C in the UK. BMJ. 2012 Oct 3;345:e6525. doi: 10.1136/bmj.e6525. No abstract available.

  PMID: 23034845 RESULT

• Sroczynski G, Esteban E, Conrads-Frank A, Schwarzer R, Muhlberger N, Wright D, Zeuzem S, Siebert U. Long-term effectiveness and cost-effectiveness of screening for hepatitis C virus infection. Eur J Public Health. 2009 Jun;19(3):245-53. doi: 10.1093/eurpub/ckp001. Epub 2009 Feb 5.

  PMID: 19196737 RESULT

• Chou R, Cottrell EB, Wasson N, Rahman B, Guise JM. Screening for hepatitis C virus infection in adults: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Jan 15;158(2):101-8. doi: 10.7326/0003-4819-158-2-201301150-00574.

  PMID: 23183613 RESULT

• Chou R, Hartung D, Rahman B, Wasson N, Cottrell EB, Fu R. Comparative effectiveness of antiviral treatment for hepatitis C virus infection in adults: a systematic review. Ann Intern Med. 2013 Jan 15;158(2):114-23. doi: 10.7326/0003-4819-158-2-201301150-00576.

  PMID: 23437439 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Hepatitis C virues enzyme immunosorbent assay screening; if positivie follow up testing

Study Officials

• brian a clements, d.o.

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 18, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

US (1)