HCV Testing and Linkage to Care

Based on the &#; National Health and Nutrition Examination Survey (NHANES) data among the general noninstitutionalized US population, an estimated 4.1 million people have had HCV exposure (HCV-antibody&#;positive), including 2.4 million with active HCV infection (HCV-RNA&#;positive) (Hofmeister, ). Total HCV burden in the US also includes those not accounted for in NHANES data&#;incarcerated, institutionalized, or unsheltered homeless persons&#;with estimates ranging from 380,000 to 800,000 additional HCV-antibody&#;positive persons (Hofmeister, ); (Edlin, ). Approximately 50% of all infected persons are unaware that they have HCV (Yehia, ); (Holmberg, ); (Denniston, ).
 
HCV screening is recommended because of the known benefits of care and treatment in reducing the risk of decompensated cirrhosis, hepatocellular carcinoma, and all-cause mortality, and the potential public health benefit of reducing transmission through early treatment, viral clearance, and reduced risk behaviors (Chou, ); (Owens, ); (Schillie, ); (Smith, ). 

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HCV is primarily transmitted through percutaneous exposure to infected blood. Other modes of transmission include mother-to-infant and contaminated devices shared for noninjection drug use. Sexual transmission also occurs but is generally inefficient except among HIV-infected men who have unprotected sex with men (Pakianathan, ).

Injection drug use (IDU) poses the greatest risk for HCV infection, accounting for at least 60% of acute HCV infections in the United States. Healthcare exposures are important sources of transmission, including: the receipt of blood products in the US prior to (after which routine screening of the blood supply was implemented); receipt of clotting factor concentrates in the US before ; receipt of blood or blood products in other countries (risk depends on country prevalence and screening practices); long-term hemodialysis; needlestick injuries among healthcare workers; and patient-to-patient transmission resulting from poor infection control practices. Other risk factors include having been born to an HCV-infected mother, incarceration, and percutaneous or parenteral exposures in an unregulated setting. Examples include tattoos received outside of licensed parlors and medical procedures performed internationally or domestically where strict infection control procedures may not have been followed (eg, surgery before implementation of universal precautions) (Hellard, ).

The importance of these risk factors might differ based on geographic location and population (Schillie, ); (Owens, ). An estimated 12% to 39% of incarcerated persons in North America are HCV-antibody&#;positive, supporting the recommendation to test this population for HCV infection (Larney, ); (Allen, ); (Weinbaum, ).

Because of shared transmission modes, persons with HIV infection are at risk for HCV. Annual HCV testing is recommended for sexually active HIV-infected adolescent and adult men who have sex with men. The presence of concomitant ulcerative sexually transmitted infections, proctitis related to sexually transmitted infections, or high-risk sexual or drug use practices may warrant more frequent testing. Sexual transmission is particularly a risk for HIV-infected men who have unprotected sex with men (Hosein, ); (van de Laar, ). Testing sexually active, non-HIV&#;infected persons for HCV and HBV infection before starting and while receiving pre-exposure prophylaxis (PrEP) for HIV prevention should also be considered (Hoornenborg, ); (Volk, ).

Data also support testing in all deceased and living solid organ donors and all recipients because of the risk of HCV infection posed to the recipient (Lai, ); (Jones, ). Although hepatitis C testing guidelines from the US Centers for Disease Control and Prevention (CDC) and the US Preventive Services Task Force (USPSTF) do not specifically recommend testing immigrants from countries with a high HCV prevalence (eg, Egypt and Pakistan), such persons 18 years or older are included in the one-time, opt out HCV testing recommendation.

CDC established risk-based HCV testing guidelines in (CDC, ). These guidelines were expanded in with a recommendation to offer one-time HCV testing to all persons born from through without prior ascertainment of HCV risk factors. This recommendation was supported by evidence demonstrating that persons in this age group had a 6-fold higher prevalence of HCV infection and that a risk-based strategy alone failed to identify >50% of HCV infections, due in part to patient underreporting of their risk and provider limitations in ascertaining risk factor information (Denniston, ). The USPSTF also recommended one-time HCV testing in asymptomatic persons belonging to the through birth cohort as well as other individuals based on exposures, behaviors, and conditions or circumstances that increase HCV infection risk.

Since the birth cohort recommendation was adopted, however, there has been an increase in the number of acute and chronic HCV infections reported in individuals born after (Zibbell, ); (Ly, ); (Suryaprasad, ). The increase in HCV incidence and prevalence among a younger cohort results from the opioid epidemic and increased IDU. This shift in HCV epidemiology and the known failures of risk-based testing warranted an expansion of the recommendation. Accordingly, CDC updated screening recommendations in to include HCV screening at least once in a lifetime for all adults aged &#;18 years as well as HCV screening of all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection (ie, HCV-RNA positivity) is <0.1%. Both recommendations were based on extensive literature review and estimates of the cost-effectiveness of screening. In their recommendation, CDC noted that no states have an estimated HCV-RNA prevalence <0.1% (Schillie, ). USPSTF also recently issued recommendations for one-time, routine, opt-out testing of adults aged 18 through 79 years (Owens, ).

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For the CDC testing guidelines, a systematic review included a harm assessment for HCV screening during pregnancy. This review was augmented by input from subject matter experts, studies not captured through the formal literature review, and the peer-review process. Despite several plausible harms (including insurability and employability issues, legal ramifications and potential loss of infant custody, unnecessary cesarean deliveries, and unnecessary avoidance of breastfeeding), CDC concluded that identified or potential harms did not outweigh the benefits of HCV screening (Schillie, ).

Generally, routine HCV testing is cost-effective because of increasing HCV incidence and prevalence among people who inject drugs (PWID) and the decreasing cost of DAA therapy. Many patients at greatest risk for HCV infection and transmission do not readily report their highly stigmatized risk activities. Studies conducted in US urban emergency departments, for example, reveal that 15% to 25% of patients with previously unidentified HCV infection were born after and/or have no reported history of IDU and are, therefore, missed by even perfect implementation of risk-based testing guidance (Schechter-Perkins, ); (Hsieh, ); (Lyons, ). Reinfection among those actively using drugs is common, but because HCV testing is a low-cost intervention and therapy is both highly effective and cost-effective, routine testing provides good economic value (ie, cost-effectiveness) even when many people need to be tested and treated more than once during their lifetime.

Several cost-effectiveness studies published since release of the birth cohort recommendations have demonstrated that routine, one-time HCV testing among all adults in the US would likely identify a substantial number of HCV cases that would otherwise be missed, and that doing so would be cost-effective. One research group employed simulation modeling to compare several versions of routine guidance, including routine testing for adults aged &#;40 years, &#;30 years, and &#;18 years. The investigators found that routine HCV testing for all adults &#;18 years was cost-effective compared to risk-based screening guidance, and potentially cost-saving compared to testing only those aged &#;30 years or &#;40 years (Barocas, ). The study further demonstrated that routine testing remained cost-effective unless HCV infection had no impact on healthcare utilization and no impact on quality of life. Another research team similarly found that routine HCV testing for all adults aged &#;18 years is likely cost-effective compared to risk-based screening guidance, provided the HCV prevalence among those born after is >0.07% (Eckman, ). Notably, these studies reached similar conclusions despite being conducted independently and employing different simulation modeling approaches. Further, a variety of studies have tested the cost-effectiveness of routine HCV testing in specific venues, including correctional settings (He, ), substance use treatment centers (Schackman, ); (Schackman, ), and federally qualified health centers (Assoumou, ). All of these studies demonstrated that routine HCV testing and treatment was cost-effective, even when linkage to HCV treatment after testing was poor and the rate of HCV reinfection among injection drug users was high.

Analyses focusing on pregnant women have demonstrated similar findings. One analysis calculated an incremental cost-effectiveness ratio (ICER) of $2,826 per quality-adjusted life-year (QALY) gained for universal screening of pregnant women compared with risk-based screening at an HCV-RNA positivity prevalence of 0.73% (Chaillon, ). Although real-world data informing screening during each pregnancy are lacking, a modeled analysis suggested that hepatitis C screening during each pregnancy would be cost-effective. Using a hepatitis C prevalence of 0.38% among pregnant women, the analysis found that universal hepatitis C screening during the first trimester of each pregnancy compared with the practice of risk-based screening had an ICER of $41,000 per QALY gained (Tasillo, ). Universal screening reduced HCV-attributable mortality by 16% and increased the proportion of infants identified as HCV-exposed from 44% to 92%. ICER remained &#; $100,000 per QALY gained if hepatitis C prevalence was higher than 0.16% (Schillie, ). 

Evidence regarding the frequency of HCV testing in persons at risk for ongoing exposures to the virus is lacking. Clinicians should, therefore, determine the periodicity of testing based on the risk of infection or reinfection. Because of the high incidence of HCV infection among PWID and HIV-infected men who have unprotected sex with men, HCV testing at least annually using an assay that detects HCV RNA (ie, a quantitative HCV-RNA test) if they have been previously exposed, is recommended among such individuals (Newsum, ); (Aberg, ); (Witt, ); (Bravo, ); (Linas, ); (Wandeler, ); (Williams, ).

Implementation of clinical decision support tools or prompts for HCV testing in electronic health records could facilitate reminding clinicians of HCV testing when indicated (Hsu, ); (Litwin, ).

*OraSure provides information regarding reimbursement (including, in some instances, potentially applicable CPT, HCPCS and/or analogous state or local codes or designations) for background purposes only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice. The provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Any decision regarding specific coding is at the discretion of the healthcare professional, and provision of this information does not guarantee or facilitate reimbursement. OraSure makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, insurance provider, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies or specific billing questions or concerns. Nothing herein is intended to promote or facilitate the purchase or use of products outside of their approved or cleared indications, and appropriate use of products should be based on the healthcare professional&#;s medical judgment.

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