Screening Baby Boomers for HCV Would Triple Diagnosis Rate

Caroline Helwick

May 09, 2011

May 9, 2011 (Chicago, Illinois) — Age-based screening for hepatitis C virus (HCV) infection, especially targeting baby boomers, would lead to fewer cases of advanced liver disease and related deaths than the current risk-based screening practice, researchers have demonstrated using a Markov model. They presented their findings here at Digestive Disease Week 2011.

"Current risk-based HCV screening practices are often limited to people who have symptoms of liver disease or who are considered high risk," said Lisa McGarry, MPH, lead author and director of health economics and outcomes research at Ingenix Life Sciences — a health, technology, and consultant service headquartered in Somerset, New Jersey. "A shortcoming of this approach is that symptoms of HCV infection might not appear for 20 years or more, which is one reason for the high percentage of undiagnosed cases of HCV," she noted.

The US Preventive Services Task Force currently does not recommend screening the general population, but advocates screening for HCV risk factors in primary care and testing people at high risk. However, approximately three quarters of HCV-infected people in the United States are unaware of their condition, the Institute of Medicine has determined, according to Ms. McGarry.

"Considering the particularly high HCV infection rates among baby boomers, it was important to explore the implications of a targeted age-based birth-cohort screening approach," she said, noting that risk-based screening "has not been very successful."

Epidemiologically Based Mathematical Model Revealed Projections

A Markov model of the natural history of HCV and subsequent liver disease was developed to determine the distribution of undiagnosed people with HCV infection and their disease progression in 2010. The investigators then ran the model forward to produce a lifetime estimate of HCV-related outcomes under each screening scenario. This included the number of people screened, diagnosed, treated, and achieving sustained viral response, and the number of cases of liver disease and death resulting from advanced liver disease.

The model was very detailed, Ms. McGarry noted. For example, it accounted for faster disease progression in males, in patients older at baseline, and in patients older at diagnosis.

The researchers then compared the implications of targeted screening of adults born between 1946 and 1970 with the current practice of risk-based screening.

The model suggested the following:

  • Among the 102 million people 40 to 64 years of age, some 1.3 million are infected with HCV but remain undiagnosed.

  • Of these, 35% of will have stage F3 to F4 fibrosis, reflecting the long duration of infection in the population.

  • With birth-cohort screening, 78.7 million people would (ideally) be tested; with risk-based screening, 8 million would be tested.

  • Of these, 1.3 million people would be diagnosed with HCV with birth-cohort screening, compared with 427,000 with risk-based screening, and 742,000 would be treated, compared with 235,000.

  • Birth-cohort screening could prevent 113,000 cases of compensated cirrhosis, 53,000 cases of decompensated cirrhosis, 28,000 cases of hepatocellular carcinoma, 6,000 liver transplants, and 48,000 HCV-related deaths.

When the investigators expanded birth-cohort screening to those born from 1946 to 1970 (40 to 65 years of age in 2010), the model estimated that wider screening would prevent an additional 24,000 cases of compensated cirrhosis, 11,000 cases of decompensated cirrhosis, 6,000 cases of hepatocellular carcinoma, 1300 liver transplants, and 11,000 deaths.

Age-based screening would lead to higher overall costs nationally ($45.1 billion vs. $32 billion), Ms. McGarry acknowledged, but would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion). The cost of extending the lives of the affected individuals would be $25,279 per quality-adjusted life-year gained (QALY), she said.

"This approach appears to provide good value for the money, in addition to preventing advanced clinical outcomes," she suggested.

Commenting on the findings, Zobair M. Younossi, MD, MPH, director of the Center for Liver Diseases at Inova Fairfax Hospital in Falls Church, Virginia, noted that the study, the first to examine birth-cohort screening outcomes for HCV, "provides compelling evidence for putting age-based screening guidelines into practice."

"The cost of just over $25,000 per QALY gained through earlier detection and treatment is below the [American] willingness-to-pay thresholds and compares favorably with the economics of screening for many other serious diseases."

He added that the findings are especially encouraging, given the potential impact of new antiviral treatments for HCV, "which were not even considered in the study."

Adrian Di Bisceglie, MD, from St. Louis University School of Medicine, in Missouri, moderated a press briefing on the topic, and noted that the US Department of Health and Human Services will soon release an action plan for viral hepatitis. "Last year, the Institute of Medicine issued a report on screening, so the government has been thinking about this topic and is poised to announce an action plan. I think this study will be important in that context. Healthcare providers and third-party payers will need to be looking at strategies such as this one," he said. "Screening this birth cohort makes sense. There is no approach that will allow us to capture every infected person, unless we screen everyone, but this would allow the highest probability of capturing the greatest proportion of affected persons, and it's doable."

Support for the study was provided by Vertex Pharmaceuticals. Ms. McGarry, Dr. Younossi, and Dr. Di Bisceglie have disclosed no relevant financial relationships.

Digestive Disease Week (DDW) 2011: Abstract 477. Presented May 8, 2011.

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