Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease

Persons for Whom Routine HCV Testing Is Recommended

Testing should be offered routinely to persons most likely to be infected with HCV who might require medical management, and testing should be accompanied by appropriate counseling and medical follow-up. In addition, anyone who wishes to know or is concerned regarding their HCV-infection status should be provided the opportunity for counseling, testing, and appropriate follow-up. The determination of which persons at risk to recommend for routine testing is based on various considerations, including a known epidemiologic relationship between a risk factor and acquiring HCV infection, prevalence of risk behavior or characteristic in the population, prevalence of infection among those with a risk behavior or characteristic, and the need for persons with a recognized exposure to be evaluated for infection.

Persons Who Have Ever Injected Illegal Drugs

Health-care professionals in primary-care and other appropriate settings routinely should question patients regarding their history of injecting-drug use, and should counsel, test, and evaluate for HCV infection, persons with such histories. Current injecting-drug users frequently are not seen in the primary health-care setting and might not be reached by traditional media; therefore, community-based organizations serving these populations should determine the most effective means of integrating appropriate HCV information and services into their programs.

Testing persons in settings with potentially high proportions of injecting-drug users (e.g., correctional institutions, HIV counseling and testing sites, or drug and STD treatment programs) might be particularly efficient for identifying HCV-positive persons. HCV testing programs in these settings should include counseling and referral or arrangements for medical management. However, limited experience exists in combining HCV programs with existing HIV, STD, or other established services for populations at high risk for infection with bloodborne pathogens. Persons at risk for HCV infection through limited or occasional drug use, particularily in the remote past, might not be receptive to receiving services in such settings as HIV counseling and testing sites and drug and STD treatment programs. In addition, whether a substantial proportion of this group at risk can be identified in these settings is unknown. Studies are needed to determine the best approaches for reaching persons who might not identify themselves as being at risk for HCV infection.

Persons with Selected Medical Conditions

Persons with hemophilia who received clotting factor concentrates produced before 1987 and long-term hemodialysis patients should be tested for HCV infection. Educational efforts directed to health-care professionals, patient organizations, and agencies who care for these patients should emphasize the need for these patients to know whether they are infected with HCV and encourage testing for those who have not been tested previously. Periodic testing of long-term hemodialysis patients for purposes of infection control is currently not recommended ⁽⁶¹⁾. However, issues surrounding prevention of HCV and other bloodborne pathogen transmission in long-term hemodialysis settings are currently undergoing discussion, and updating recommendations for this setting is under development.

Persons with persistently abnormal ALT levels are often identified in medical settings. As part of their medical work-up, health-care professionals should test routinely for HCV infection persons with ALT levels above the upper limit of normal on at least two occasions. Persons with other evidence of liver disease identified by abnormal serum aspartate aminotransferase (AST) levels, which is common among persons with alcohol-related liver disease, should be tested also.

Prior Recipients of Blood Transfusions or Organ Transplants

Persons who might have become infected with HCV through transfusion of blood and blood components should be notified. Two types of approaches should be used -- a) a targeted, or directed, approach to identify prior transfusion recipients from donors who tested anti-HCV positive after multiantigen screening tests were widely implemented (July 1992 and later); and b) a general approach to identify all persons who received transfusions before July 1992. A targeted notification approach focuses on a specific group known to be at risk, and will reach persons who might be unaware they were transfused. However, because blood and blood-component donor testing for anti-HCV before July 1992 did not include confirmatory testing, most of these notifications would be based on donors who were not infected with HCV because their test results were falsely positive. A general education campaign to identify persons transfused before July 1992 has the advantage of not being dependent on donor testing status or availability of records, and potentially reaches persons who received HCV-infected blood from donors who tested falsely negative on the less sensitive serologic test, as well as from donors before testing was available.

• Persons who received blood from a donor who tested positive for HCV infection after multiantigen screening tests were widely implemented. Persons who received blood or blood components from donors who subsequently tested positive for anti-HCV using a licensed multiantigen assay should be notified as provided for in guidance issued by FDA. For specific details regarding this notification, readers should refer to the FDA document, Guidance for Industry. Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV. (This document is available on the Internet at http://www.fda.gov/cber/gdlns/gmphcv.txt.)

  Blood-collection establishments and transfusion services should work with local and state health agencies to coordinate this notification effort. Health-care professionals should have information regarding the notification process and HCV infection so that they are prepared to discuss with their patients why they were notified and to provide appropriate counseling, testing, and medical evaluation. Health-education material sent to recipients should be easy to understand and include information concerning where they can be tested, what hepatitis C means in terms of their day-to-day living, and where they can obtain more information.

• Persons who received a transfusion of blood or blood components (including platelets, red cells, washed cells, and fresh frozen plasma) or a solid-organ transplant (e.g., heart, lung, kidney, or liver) before July 1992. Patients with a history of blood transfusion or solid-organ transplantation before July 1992 should be counseled, tested, and evaluated for HCV infection. Health-care professionals in primary-care and other appropriate settings routinely should ascertain their patients' transfusion and transplant histories either through questioning their patients, including such risk factors for transfusion as hematologic disorders, major surgery, trauma, or premature birth, or through review of their medical records. In addition, transfusion services, public health agencies, and professional organizations should provide to the public, information concerning the need for HCV testing in this population. Health-care professionals should be prepared to discuss these issues with their patients and provide appropriate counseling, testing, and medical evaluation.

Health-Care, Emergency Medical, and Public Safety Workers After Needle Sticks, Sharps, or Mucosal Exposures to HCV-Positive Blood

Individual institutions should establish policies and procedures for HCV testing of persons after percutaneous or permucosal exposures to blood and ensure that all personnel are familiar with these policies and procedures (see text box) ⁽¹⁴¹⁾. Health-care professionals who provide care to persons exposed to HCV in the occupational setting should be knowledgeable regarding the risk for HCV infection and appropriate counseling, testing, and medical follow-up.

IG and antiviral agents are not recommended for postexposure prophylaxis of hepatitis C. Limited data indicate that antiviral therapy might be beneficial when started early in the course of HCV infection, but no guidelines exist for administration of therapy during the acute phase of infection. When HCV infection is identified early, the individual should be referred for medical management to a specialist knowledgeable in this area.

Children Born to HCV-Positive Women

Because of their recognized exposure, children born to HCV-positive women should be tested for HCV infection ⁽¹⁵⁸⁾. IG and antiviral agents are not recommended for postexposure prophylaxis of infants born to HCV-positive women. Testing of infants for anti-HCV should be performed no sooner than age 12 months, when passively transferred maternal anti-HCV declines below detectable levels. If earlier diagnosis of HCV infection is desired, RT-PCR for HCV RNA may be performed at or after the infant's first well-child visit at age 1-2 months. Umbilical cord blood should not be used for diagnosis of perinatal HCV infection because cord blood can be contaminated by maternal blood. If positive for either anti-HCV or HCV RNA, children should be evaluated for the presence or development of liver disease, and those children with persistently elevated ALT levels should be referred to a specialist for medical management.