Hepatitis C Best Practice Guidelines

1. Hepatitis CBest Practice Guidelines Susan Thompson, RN , MPH September 2009

4. Who Should be Tested ? Persons with any history of injection drug use (even once) Recipients of blood transfusion or solid organ transplant before July 1992; recipients of blood clotting factor concentrates made before 1987 Persons on long-term dialysis Children born to HCV positive women Healthcare, emergency medical, and public safety workers after needle sticks, or exposure to HCV positive blood Anyone who is HIV+ Patients with S/S of liver disease Testing should be offered to persons most likely to be infected with HCV. This would include injection drug users, even if drug use was only once years ago, persons who had a blood transfusion or transplant before 1992, persons who used clotting factors produced before 1987, persons on long-term dialysis, children born to HCV positive women, and any healthcare or safety professional after a needlestick or other exposure to blood. Routine HCV testing is not recommended for healthcare workers, emergency medical or public safety workers, pregnant women, or household or non-sexual contacts of HCV positive persons. For persons at potential or unknown risk for HCV infection, the need for testing has not been determined. This includes intranasal cocaine and other non-injecting drug users, persons with a history of body piercing or tattooing, persons with a history of sexually transmitted diseases or multiple sexual partners, and long-term steady partners of HCV positive persons.Testing should be offered to persons most likely to be infected with HCV. This would include injection drug users, even if drug use was only once years ago, persons who had a blood transfusion or transplant before 1992, persons who used clotting factors produced before 1987, persons on long-term dialysis, children born to HCV positive women, and any healthcare or safety professional after a needlestick or other exposure to blood. Routine HCV testing is not recommended for healthcare workers, emergency medical or public safety workers, pregnant women, or household or non-sexual contacts of HCV positive persons. For persons at potential or unknown risk for HCV infection, the need for testing has not been determined. This includes intranasal cocaine and other non-injecting drug users, persons with a history of body piercing or tattooing, persons with a history of sexually transmitted diseases or multiple sexual partners, and long-term steady partners of HCV positive persons.

5. Laboratory tests to detect HCV Hepatitis C antibody EIA�may be reported as S/CO ratio CIA�may be reported as S/CO ratio RIBA�confirmatory test, now less important HCV RNA Qualitative test to detect presence of virus (HCV RNA PCR) Quantitative test to detect amount of virus (HCV RNA PCR) Laboratory Tests to Diagnose HCV Antibodies to HCV do form, however, they do not eradicate the virus and they afford no immunity. Since the development of the enzyme-linked immunosorbent assay (ELISA, or EIA) as the first diagnostic test for antibody to HCV in 1990, a number of improvements and additional diagnostic laboratory tests have been developed. The two most common commercially available serologic assays to test for HCV markers are the second-generation enzyme-linked immunosorbent assay (ELISA-2) and recombinant immunoblot assay (RIBA-2). The RIBA-2 is an approved assay and available in most laboratories. However, it is expensive and cumbersome, can yield indeterminate results, and provides no additional information in high-prevalence populations or for individuals with risk factors and/or other signs of hepatitis. Therefore, the RIBA-2 is usually considered a supplemental test, performed when the diagnosis is in doubt or as confirmation of a positive EIA in low-prevalence populations. Unlike the FIBV tests, the antibody tests for HCV cannot distinguish between current acute infection, chronic infection, or past resolved infection. The presence of ongoing infection is indicated by the presence of HCV RNA in the blood using the reverse transcription polymerase chain reaction (RT-PCR). Gretch DR. Diagnostic tests for hepatitis C. Hepatology. 1997;26(Suppl 1):43S-47S. Laboratory Tests to Diagnose HCV Antibodies to HCV do form, however, they do not eradicate the virus and they afford no immunity. Since the development of the enzyme-linked immunosorbent assay (ELISA, or EIA) as the first diagnostic test for antibody to HCV in 1990, a number of improvements and additional diagnostic laboratory tests have been developed. The two most common commercially available serologic assays to test for HCV markers are the second-generation enzyme-linked immunosorbent assay (ELISA-2) and recombinant immunoblot assay (RIBA-2). The RIBA-2 is an approved assay and available in most laboratories. However, it is expensive and cumbersome, can yield indeterminate results, and provides no additional information in high-prevalence populations or for individuals with risk factors and/or other signs of hepatitis. Therefore, the RIBA-2 is usually considered a supplemental test, performed when the diagnosis is in doubt or as confirmation of a positive EIA in low-prevalence populations. Unlike the FIBV tests, the antibody tests for HCV cannot distinguish between current acute infection, chronic infection, or past resolved infection. The presence of ongoing infection is indicated by the presence of HCV RNA in the blood using the reverse transcription polymerase chain reaction (RT-PCR). Gretch DR. Diagnostic tests for hepatitis C. Hepatology. 1997;26(Suppl 1):43S-47S.

7. Keeping your liver healthy No alcohol or reduce intake as much as possible Get vaccinated against Hepatitis A and B Monitor diet-avoid fats Drink lots of water and other fluids Reduce stress with exercise Develop a support network Learn all you can�knowledge is power

9. Preventing HCV Transmission CDC recommends: -- Covering cuts and sores on the skin -- Never sharing items that might have blood on them * personal care (razors, toothbrushes) * home therapy (needles) -- Never donating blood, body organs, other tissue Do not share razors, toothbrushes, scissors, nail clippers Do not donate blood or blood products, semen, or body fluids In multiple partner relationships practice safe sex In single partner relationships discuss the risk of transmission Inform health care providers, such as dentists or others who may come into contact with your blood. What is the risk of transmitting HCV through medical or dental work? Medical and dental procedures done in most settings in the United States do not pose a risk for the spread of HCV. There have, however, been some reports that HCV has been spread between patients in hemodialysis units where supplies or equipment may have been shared between patients. 1. CDC, Viral Hepatitis C, Frequently Asked Questions, http://www.cdc.gov/ncidod/diseases/hepatitis/c/faq.htm#7aDo not share razors, toothbrushes, scissors, nail clippers Do not donate blood or blood products, semen, or body fluids In multiple partner relationships practice safe sex In single partner relationships discuss the risk of transmission Inform health care providers, such as dentists or others who may come into contact with your blood. What is the risk of transmitting HCV through medical or dental work? Medical and dental procedures done in most settings in the United States do not pose a risk for the spread of HCV. There have, however, been some reports that HCV has been spread between patients in hemodialysis units where supplies or equipment may have been shared between patients. 1. CDC, Viral Hepatitis C, Frequently Asked Questions, http://www.cdc.gov/ncidod/diseases/hepatitis/c/faq.htm#7a

10. Injection drug use If active users�Works, sets, gizmos, rigs. Cooker, spoon, cotton, water, filter�whatever you call them, use them safely if you inject drugs. Take care of yourself and your friends. Always provide risk reduction counseling, education -- Help client develop a risk reduction plan -- Encourage to decrease or stop using and injecting -- Encourage active participation in substance abuse treatment program

11. Sexual Transmission of HCV To reduce risk Limit number of partners Use latex condoms Get vaccinated against hepatitis B -- Also get vaccinated if at risk for hepatitis A (MSM) Although consistent data are lacking regarding the extent to which sexual activity contributes to HCV transmission, persons having multiple sex partners are at risk for STDs. Counseling and education to prevent initiation of high-risk sexual practices is important, especially for adolescents. Persons who are at risk for STDs should be counseled regarding what they can do to minimize the risk for becoming infected or of transmitting infections to others, including the need for vaccination against hepatitis B. Sexually active men who have sex with men (MSM) should also be vaccinated against hepatitis A.Although consistent data are lacking regarding the extent to which sexual activity contributes to HCV transmission, persons having multiple sex partners are at risk for STDs. Counseling and education to prevent initiation of high-risk sexual practices is important, especially for adolescents. Persons who are at risk for STDs should be counseled regarding what they can do to minimize the risk for becoming infected or of transmitting infections to others, including the need for vaccination against hepatitis B. Sexually active men who have sex with men (MSM) should also be vaccinated against hepatitis A.

12. Mother-to-Infant Transmission of HCV Risk of transmission about 4-6% Risk increases in the presence of HIV co-infection No need to avoid pregnancy or breastfeeding Consider bottle feeding if nipples cracked/bleeding Test infants born to HCV-positive women (not before 18 months) Consider testing any children born since mother became HCV+ Women with chronic hepatitis C usually have uneventful pregnancies, provided that the liver disease is stable and the woman has not progressed to decompensated cirrhosis. Transmission of the hepatitis C virus to the newborn is uncommon, occurring less than 5% of the time. The likelihood of transmission is increased in the presence of HIV. The risk of transmitted HCV may also be increased by the presence of very high HCV viral loads at the time of childbirth. HCV antibodies will usually be present in the newborn up to 6 months or longer due to passive transfer from the mother. For this reason, testing of the newborn should not occur until 15-18 months. Breast feeding has not been associated with the transmission of HCV and is considered safe. Treatment of pregnant women with hepatitis C should be delayed until after delivery. This is because ribavirin, a common medication for chronic hepatitis C, may cause birth defects. Women with chronic hepatitis C usually have uneventful pregnancies, provided that the liver disease is stable and the woman has not progressed to decompensated cirrhosis. Transmission of the hepatitis C virus to the newborn is uncommon, occurring less than 5% of the time. The likelihood of transmission is increased in the presence of HIV. The risk of transmitted HCV may also be increased by the presence of very high HCV viral loads at the time of childbirth. HCV antibodies will usually be present in the newborn up to 6 months or longer due to passive transfer from the mother. For this reason, testing of the newborn should not occur until 15-18 months. Breast feeding has not been associated with the transmission of HCV and is considered safe. Treatment of pregnant women with hepatitis C should be delayed until after delivery. This is because ribavirin, a common medication for chronic hepatitis C, may cause birth defects.

14. More important messages� HCV is not spread by: sneezing ,hugging, coughing, sharing eating utensils or drinking glasses, or casual contact HCV + persons should not be excluded from: work, school, play, child-care or other settings on the basis of their HCV status. HCV+ persons are not required to disclose their status to employers

16. HCV Case Classification Past or Present (non-acute) HCV cases are not currently reportable in NC. Only Acute HCV cases that meet CDC clinical case definition are reportable by physicians in North Carolina. There is no �probable� status. To summarize, only acute cases that are laboratory confirmed are reportable in NC. Past or present cases, those that are non-acute, are not currently reportable in NC. To summarize, only acute cases that are laboratory confirmed are reportable in NC. Past or present cases, those that are non-acute, are not currently reportable in NC.

17. Hepatitis C, Acute CDC Case Definition, 2007 Clinical Case Definition: An acute illness with a discrete onset of any sign or symptom consistent with acute viral hepatitis (eg., anorexia, abdominal discomfort, nausea, vomiting) and either a) jaundice, or b) serum alanine aminotransferase (ALT) levels > 400 IU/L. Laboratory Criteria for Diagnosis: One or more of the following three criteria: Antibodies to hepatitis C virus (Anti-HCV) screening-test-positive with a signal to cut-off ratio predictive of a true positive as determined for the particular assay as defined by CDC. OR Hepatitis C virus Recombinant Immunoblot Assay (HCV RIBA) positive OR Nucleic Acid Test (NAT) for HCV RNA positive AND, meets the following two criteria: IgM antibody to hepatitis A virus (IgM anti-HAV) negative , AND IgM antibody to hepatitis B core antigen (IgM anti-HBc) negative CONFIRMED: a case that meets clinical case definition, is laboratory confirmed, and is not known to have chronic HCV In North Carolina, only acute hepatitis C viral infection is reportable; chronic, past or present hepatitis C is not reportable. There are approximately 28,000-35,000 new acute hepatitis C infections which occur in the US each year. However, only 20-30% of these are actually diagnosed. This is because most people with acute hepatitis C are either asymptomatic or have very vague symptoms. There will be few people who meet the clinical criteria of the case definition you see here. In terms of laboratory criteria, elevations in ALT usually occur 6 to 8 weeks after infection. As the disease progresses, the levels decrease. To meet the CDC case definition for acute infection, the ALT levels must be 7 times greater than the upper limit of normal. (The normal range is approximately 0-45 IU/L). In addition, tests for HBV and HAV must be negative. To confirm a diagnosis of acute hepatitis C, an antibody test for HCV must be positive with confirmation by RIBA or HCV RNA testing OR with a signal to cut-off ration great than or equal to 3.8 if using certain enzyme immunoassays. All patients who meet this case definition should be reported to the local health department. Case reports of acute hepatitis C are then transmitted weekly by state health departments to CDC via the National Electronic Telecommunications System for Surveillance (NETSS). In North Carolina, only acute hepatitis C viral infection is reportable; chronic, past or present hepatitis C is not reportable. There are approximately 28,000-35,000 new acute hepatitis C infections which occur in the US each year. However, only 20-30% of these are actually diagnosed. This is because most people with acute hepatitis C are either asymptomatic or have very vague symptoms. There will be few people who meet the clinical criteria of the case definition you see here. In terms of laboratory criteria, elevations in ALT usually occur 6 to 8 weeks after infection. As the disease progresses, the levels decrease. To meet the CDC case definition for acute infection, the ALT levels must be 7 times greater than the upper limit of normal. (The normal range is approximately 0-45 IU/L). In addition, tests for HBV and HAV must be negative. To confirm a diagnosis of acute hepatitis C, an antibody test for HCV must be positive with confirmation by RIBA or HCV RNA testing OR with a signal to cut-off ration great than or equal to 3.8 if using certain enzyme immunoassays. All patients who meet this case definition should be reported to the local health department. Case reports of acute hepatitis C are then transmitted weekly by state health departments to CDC via the National Electronic Telecommunications System for Surveillance (NETSS).

19. QUESTIONS