Multaq Lawsuit
Diagnosis
Diagnosis of hepatitis D virus infection is determined by blood testing. In acute co-infection, IgM and IgG antibodies to hepatitis D virus are detectable during the course of infection. IgM antibodies will be detected earlier after acute infection and IgG later or while the patient is recovering. IgG antibody concentrations in blood generally fall to levels that cannot be detected after the acute infection resolves. There is no reliable marker that persists to indicate past infection with hepatitis D virus. In hepatitis D virus superinfection, high levels of both IgxVI and IgG antibodies against the hepatitis D virus become detectable after infection. Both IgM and IgG antibodies persist in serum as long as the patient remains infected.
Hepatitis D virus co-infection often is not diagnosed. In cases in which acute hepatitis B is not too severe, the doctor will not search for hepatitis D co-infection. If liver disease is unusually severe in a highrisk individual, testing for antibodies against hepatitis D virus may be performed and the diagnosis of acute co-infection made. In chronic hepatitis D, which occurs usually as superinfection, the presence of IgG antibodies in blood against hepatitis D virus, in a patient with detectable blood HBsAg, establishes the diagnosis. Testing will usually be performed in a patient with known chronic hepatitis B whose condition deteriorates.
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While tests for IgG against hepatitis D virus are commercially available in the United States, tests for IgM antibodies are available only in research laboratories. Tests for a hepatitis D virus protein known as hepatitis D antigen and PCR tests for hepatitis D virus RNA are also available in research laboratories. They are not part of routine diagnostic testing, however. Tests for hepatitis D antigen and viral RNA directly detect the presence of virus in the patient’s blood.
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Prevention
Because the hepatitis D virus needs hepatitis B’ virus to replicate, coinfection can be prevented if hepatitis B virus infection is prevented. Patients immune to hepatitis B infection cannot get infected with the hepatitis D virus. Therefore, vaccination against hepatitis B virus will eliminate the chance of contracting hepatitis D. As a result, universal vaccination for hepatitis B should theoretically eliminate hepatitis D as a human disease.
Individuals not immune to hepatitis B infection, who have knowingly been exposed to the hepatitis B and hepatitis D viruses, can receive passive immunization with hepatitis B immune globulin (HBIG). Prevention of hepatitis B virus infection by HBIG will not permit hepatitis D virus infection. No vaccine exists to prevent hepatitis D virus superinfection of persons with chronic hepatitis B virus infection. In these cases, prevention rests entirely upon avoiding high-risk behaviors. High-risk sexual activities should be avoided and latex condoms used. Intravenous drugs should not be used.
Treatment
Treatment of acute hepatitis D virus co-infection is supportive. Either the patient gets better spontaneously or develops fulminant hepatic failure. Emergency liver transplantation is an option for fulminant hepatic failure. In chronic hepatitis D infection, treatment with interferon alpha is a consideration. Although not much data are available at present, some studies suggest that higher doses of interferon alpha, such as 10 million units every day, are necessary in hepatitis D co-infection compared to the 5 million units used every day for chronic hepatitis B.
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