February 22, 2012

Birth Cohort Testing for HCV Saves Lives, Study Suggests

Yael Waknine

February 21, 2012 — Birth cohort testing and treatment for hepatitis C viral infection (HCV) in the primary care setting is cost-effective and could save thousands of lives each year, suggests a study from the US Centers for Disease Control and Prevention (CDC) published online November 4 and in the February 21 issue of Annals of Internal Medicine.

HCV infection is most prevalent among Americans born between 1945 and 1965, and 50% to 75% of those infected are unaware of their status. HCV caused between 7000 and 13,000 deaths in 2005. Experts project that this number will climb to 35,000 a year by 2030 if new case identification strategies are not implemented.

At this time, the CDC recommends HCV-antibody screening only for individuals with known risk factors such as a history of injecting drugs, requiring a blood transfusion before 1992, or receiving chronic hemodialysis.

Using a computer model, David Rein, PhD, principal research scientist, Public Health Research Department, National Opinion Research Center at the University of Chicago, Illinois, and colleagues estimate that screening of the population born between 1945 and 1965, followed by standard treatment for infected individuals with pegylated interferon and ribavirin (PEG-IFN + R), would reduce deaths by 82,300 compared with risk-based screening. The estimated cost of birth cohort screening and treatement is $15,700 per quality-adjusted life-year (QALY) gained.

Adding a direct-acting antiviral drug (DAA) to the treatment of patients identified with genotype 1 disease would prevent 121,000 deaths compared with risk-based screening, at a cost of $35,700 per QALY gained.

"The important things to remember about birth cohort screening are that, first, the strategy would identify over 800,000 people with hepatitis C if it were fully implemented, and second, the strategy is at least as cost-effective as many routinely administered preventive practices such as breast cancer screening or colorectal screening," Dr. Rein said in a news release.

Birth Cohort Screening Identifies More Than 800,000 New Cases

For the study, researchers developed a computer model to simulate the cost-effectiveness of 4 scenarios: no screening or treatment, risk-based screening and treatment with PEG-IFN + R, a 1-time birth cohort screening of people born from 1945 through 1965 with PEG-IFN + R, and birth cohort screening with PEG-IFN + R for patients with HCV genotypes 2 or 3 and PEG-IFN + R and DAA for those with genotype 1 disease, which is the most prevalent in the United States.

The researchers found that birth cohort screening during an annual primary care visit led to the identification of 808,580 more cases than risk-based screening, at a cost of $2874 per diagnosis.

With no screening, an estimated 618,000 birth cohort members would develop decompensated cirrhosis (DCC) or hepatocellular carcinoma (HCC) and die of hepatitis. Under risk-based screening, 14.8 million individuals were tested, 135,000 were treated, and 53,000 achieved sustained virologic response (SVR); 592,000 developed DCC or HCC and died of HCV-related disease.

In contrast, birth cohort screening with standard treatment led to the identification of 1,070,840 new cases among 60.4 million people tested; 552,000 patients were treated, and 229,000 achieved SVR, reducing the death toll to 509,000 (a drop of 82,000 compared with risk-based screening).

Birth cohort screening with DAA plus standard therapy also increased the number of identified cases but increased the number of patients achieving SVR by 311,000 and reduced the number of HCV-related deaths to 470,000 (a decrease of 121,000 deaths vs risk-based screening).

Compared with risk-based screening, birth cohort screening with PEG-IFN + R therapy increased QALYs by 348,000 and medical costs by $5.5 billion, for an incremental cost-effectiveness ratio (ICER) of $15,700 per QALY gained (95% credible interval [CI], $11,500 - $30,100).

Birth cohort screening and treatment with PEG-IFN + R plus DAA as needed led to a 532,000 increase in QALYs at a cost of $19.0 billion, for an ICER of $35,700 per QALY saved (95% CI, $28,200 - $47,200).

"This is a phenomenal incremental cost-effectiveness ratio and will only improve as sustained treatment efficacy increases with newer regimens," write Harvey J. Alter, MD, and T. Jake Liang, MD, from the National Institutes of Health in Bethesda, Maryland, in an accompanying editorial, noting that unlike HIV, HCV is not integrated in the host genome, and therefore is eradicable after only 6 to 12 months of antiviral therapy.

Study limitations include the lack of real-world data on the efficacy of newer HCV drugs; exclusion of uninsured, institutionalized, and homeless patients; and the capping of disease duration at 20 years, making the screening intervention seem slightly less cost-effective.

Identification of Asymptomatic HCV Is Key

"As innovative treatments for hepatitis C follow their now-destined progression, the most burning question will not be whether to treat, but rather how to identify the many chronic HCV carriers who are unaware of their infection and are at risk for cirrhosis, end-stage liver disease, or hepatocellular carcinoma," note Dr. Alter and Dr. Liang.

Effective national implementation of programs for prevention and care similar to that employed to combat the AIDS epidemic is key to achieving a reduction in HCV mortality over time, they note, adding that HCV deaths now outstrip those associated with HIV.

Expansion of HCV screening practices to include routine testing of individuals born between 1945 and 1965 represents a cost-effective strategy and should be implemented as a national health policy, Dr. Alter and Dr. Liang conclude.

The study was supported by grants from the US Centers for Disease Control and Prevention's Division of Viral Hepatitis. The authors and editorialists have disclosed no relevant financial relationships.

Ann Intern Med. 2012;156:263-270, 317-319. Article full text, Editorial extract


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