January 27, 2023
We are pleased to have the opportunity to express our views regarding the Centers for Disease Control and Prevention’s (CDC) proposed new Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
As Hepatitis C Virus (HCV) infection rates dramatically increase among reproductive-aged individuals, we appreciate the CDC’s efforts to increase earlier diagnosis and treatment in perinatally exposed children. Although perinatally-exposed infants and children can be treated and cured, the current low rate of infant testing means that most infants go undiagnosed for years. Research estimates perinatal HCV exposure affects as many as 40,000 children annually in the United States, resulting in about 2,700 to 4,000 new HCV infections.1 A 2020 study of more than 384,000 mother-infant pairs enrolled in Tennessee Medicaid from 2005 to 2014 found that only about 23% of HCV-exposed infants underwent any HCV testing in the first 24 months of life.1 The new recommendation for universal HCV testing of pregnant patients and the proposed CDC recommendations for infant testing are likely to reduce missed diagnoses and improve the rate of referral to appropriate care among perinatally-exposed infants. However, testing of pregnant women is not in and of itself sufficient to ensure early diagnoses and treatment of their children.
NCHR agrees that the scientific evidence supports the CDC’s proposed recommendations for HCV testing of all infants and children born to pregnant mothers with confirmed or probable HCV. In addition, we agree that the proposed guidance, including initial HCV RNA testing at two to six months of age, will lead to earlier identification of affected infants and referral to appropriate care. Most important, more children will receive curative treatment and avoid the harm caused by chronic HCV infection.
Research indicates that HCV RNA testing done between two to six months of age is reliable for diagnosing perinatal HCV infection with 100% sensitivity and specificity.2 Given these data and the importance of reducing missed opportunities for diagnosis, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend considering HCV RNA testing as early as two months of age, consistent with the CDC’s proposed recommendations.3
We share experts’ concerns regarding the higher cost of the HCV RNA test compared to an antibody-based test and the fact that treatment will need to be delayed until the child is three years of age. We encourage the CDC to help persuade companies to lower the cost of the HCV RNA test and evaluate if any treatments before age three are safe and effective. NCHR appreciates the opportunity to comment on CDC’s proposed new Recommendations for Hepatitis C Testing Among Perinatally Exposed Infants and Children. We support the CDC’s efforts to increase the timely diagnosis of HCV infection and to reduce the impact of perinatal HCV exposure.
National Center for Health Research can be reached at info@center4research.org or (202) 223-4000.
- Lopata SM, McNeer E, Dudley JA, et al. Hepatitis C Testing Among Perinatally Exposed Infants. Pediatrics. 2020;145(3):e20192482. doi:10.1542/peds.2019-2482
- Gowda C, Smith S, Crim L, Moyer K, Sánchez PJ, Honegger JR. Nucleic Acid Testing for Diagnosis of Perinatally Acquired Hepatitis C Virus Infection in Early Infancy. Clinical Infectious Diseases. 2021;73(9):e3340-e3346. doi:10.1093/cid/ciaa949
- AASLD, IDSA. HCV in Children.; 2022. https://www.hcvguidelines.org/unique-populations/children