To initiate same-day hepatitis C testing and treatment, hepatitis B status must be known

The FDA’s recent authorization of a rapid, point-of-care test to diagnose current hepatitis C virus infection is a major victory, but it would be malpractice to initiate same-day HCV treatment if a patient’s hepatitis B virus status is unknown.

Without a rapid test to simultaneously screen for past or current HBV infection, it is impossible to start HCV treatment on the same day as HCV RNA testing if a patient has not already had HBV testing.

While the direct-acting antiviral (DAA) medicines used to treat HCV are highly effective at curing HCV infection, the FDA has issued a black box warning for every DAA drug and combination regimen used to treat HCV, warning of the risk for fulminant hepatitis, liver failure and/or death due to HBV reactivation when initiating DAAs in patients with past or current HBV infection who were not already receiving antiviral therapy for HBV.

The boxed warning, which is the FDA’s strongest safety-related warning for prescription drugs, indicates that all patients should be tested for current or prior HBV infection before starting treatment with DAAs for HCV.

Since HBV and HCV have multiple shared risk factors, several individuals in the United States are coinfected with HBV and HCV and would be at risk for HBV reactivation if DAAs are prescribed to treat their HCV infection without first initiating antivirals for HBV.

Therefore, to implement a same-day testing and treatment strategy, it will be essential to have FDA authorization of point-of-care tests to screen for current and prior HBV infection, in addition to the newly authorized point-of-care test for current HCV infection. Until the FDA has authorized a point-of-care test for HBV, it will be critical for the FDA and other entities to avoid publishing statements on the ability of the newly authorized HCV RNA point-of-care test to provide single-visit HCV testing and treatment, as this information is misleading and can result in medical malpractice when these statements lack information on the requirement for simultaneous HBV testing, since the FDA has already warned that HBV testing must be performed prior to HCV treatment initiation.

Further, it is encouraging that efforts are being made at the highest levels of government to address viral hepatitis, but it is essential for all federal, state and local initiatives that aim to increase HCV testing and treatment to include simultaneous HBV testing, as this is clinically required prior to starting DAAs to treat HCV. In addition, for all HBV testing performed as a part of these initiatives, it is important to provide HBV vaccination for all susceptible individuals and linkage to care for those with chronic HBV.

From a clinical perspective, to achieve our nation’s goal of viral hepatitis elimination, it will be critical for clinicians to follow current clinical guidelines and universally screen adults for HBV and HCV, implement universal HBV vaccination for all individuals who are susceptible to HBV infection, and provide linkage to care and treatment for all individuals with chronic HBV and HCV.

References:

• ACIP recommends universal hepatitis B vaccination for adults aged 19 to 59 years. https://www.healio.com/news/infectious-disease/20211103/acip-recommends-universal-hepatitis-b-vaccination-for-adults-aged-19-to-59-years. Published Nov. 3, 2021. Accessed July 5, 2024.
• CDC recommends hepatitis B testing for all adults. https://www.healio.com/news/infectious-disease/20230309/cdc-recommends-hepatitis-b-testing-for-all-adults. Published March 9, 2023. Accessed July 5, 2024.
• FDA permits marketing of first point-of-care hepatitis C RNA test. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test. Published June 27, 2024. Accessed July 5, 2024.
• Pockros PJ. Gastroenterol Hepatol. 2017;13(9):536-540.