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New guidelines for managing hepatitis C

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    Contemporary OB/GYN® Archive Oct. 1, 2002 HEPATITIS C New guidelines for managing hepatitis C Recognizing the infectionWhat constitutes effective
    Message 1 of 1 , Nov 17, 2002
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      Contemporary OB/GYN� Archive
      Oct. 1, 2002


      HEPATITIS C
      New guidelines for managing hepatitis C
      Recognizing the infectionWhat constitutes effective treatment?Who
      should be treated?


      By Paul Cerrato, Managing Editor
      The latest NIH Consensus Development Statement on the disease offers
      some important advice for ob/gyns on perinatal transmission.

      Once upon a time, hepatitis C was considered somewhat of an oddity,
      an unclassifiable disorder given the stepchild designation "non-A,
      non-B hepatitis." In 1989, however, researchers discovered the
      specific virus that caused hepatitis C, and shortly after that, they
      realized that the majority of patients with non-A, non-B disease were
      in fact infected with the newly discovered microbe. Now it's
      estimated that nearly 4 million Americans have hepatitis C and it's
      believed to be the leading cause of liver disease in this country.



      In 1997, the NIH convened the first consensus development conference
      to make recommendations on managing the disorder. But in the last 5
      years, our knowledge of hepatitis C has increased dramatically,
      prompting the government to convene another conference. Here are the
      highlights from their consensus statement.

      Recognizing the infection
      There are six major genetic variants of the hepatitis C virus (HCV),
      and 70% to 75% of Americans who are infected have genotype 1, which
      responds relatively poorly to treatment. By one conservative
      estimate, 69% of the 3.9 million Americans with HCV have a chronic
      infection.

      Persons at greatest risk for the disease include IV drug users,
      infants born to infected mothers, transplant patients, and those who
      received blood products before 1992.

      In the words of the NIH consensus panel: "The risk of perinatal
      transmission is approximately 2% for infants of anti-HCV-seropositive
      women. When a pregnant woman is HCV RNA positive at delivery, this
      risk increases to 4% to 7%. Higher HCV RNA levels appear to be
      associated with a greater risk. HCV transmission increases to up to
      20% in women co-infected with HCV and HIV. There are no prospective
      studies evaluating the use of elective cesarean section for the
      prevention of mother-to-infant transmission of HCV. However, avoiding
      fetal scalp monitoring and prolonged labor after rupture of membranes
      may reduce the risk of transmission to the infant. There are
      currently no data to determine whether antiviral therapy reduces
      perinatal transmission. Ribavirin and interferons are contraindicated
      during pregnancy. Breastfeeding does not appear to transmit HCV.
      Infants born to HCV-positive mothers should be tested for HCV
      infection by HCV RNA tests on two occasions between the ages of 2 and
      6 months and/or have tests for anti-HCV after 15 months of age.
      Positive anti-HCV in infants prior to 15 months of age may be due to
      transplacental transfer of material anti-HCV antibody."

      Typically viral RNA will appear in a woman's blood within 1 to 3
      weeks of exposure. Within 4 to 12 weeks, the patient will usually
      have elevated serum alanine aminotransferase (ALT). It's uncommon for
      patients to have symptoms during this acute phase but some will
      present with malaise, weakness, anorexia, and jaundice. ALT levels
      usually drop after several weeks.

      The older a patient is when she contracts the infection, the more
      likely it will progress into a chronic condition. Other risk factors
      for chronic disease include being male or immunosuppressed, heavy
      alcohol use, and the use of hepatotoxic drugs.

      In the words of the NIH consensus development statement: "The
      diagnosis is often suggested by abnormalities in ALT level and is
      established by EIA [enzyme immunoassay] followed by confirmatory
      determination of HCV RNA."1 The NIH report also states that chronic
      infection is diagnosed if HCV RNA is detected in a patient's blood at
      least intermittently for 6 months or more.

      EIA, which measures antibodies to the virus, is suitable for
      screening patients who are at risk for the infection and is
      recommended as the initial test for those with clinical liver
      disease. A negative EIA rules out chronic infection in an
      immunocompetent patient but the test can on rare occasion be falsely
      negative among patients with immune deficiencies and those on
      hemodialysis.

      What constitutes effective treatment?
      One of the most important advances in the treatment of hepatitis
      since the last NIH conference has been the use of combined
      interferon/ribavirin therapy. In chronic sufferers, three large
      clinical trials have shown that pegylated interferon plus ribavirin
      is more effective than either standard interferon plus ribavirin or
      pegylated interferon alone. Pegylated interferon (either alpha 2a or
      alpha 2b) attaches polyethylene glycol to the interferon molecule,
      producing a sustained effect. Such longer-acting formulations allow
      clinicians to replace three injections a week with one, improving
      patient compliance.

      In the three trials that used this drug combination, researchers saw
      a response rate between 42% and 46% for patients with genotype 1
      disease who were treated for 48 weeks. The response rate was 76% to
      82% among type 2 and 3 patients. It also appears that these latter
      two groups do well on a 24-week regimen that incorporates a lower
      dose of ribavirin.

      On the downside, however, adverse effects of interferon/ribavirin
      cause about 10% to 14% of patients to stop treatment. Major reactions
      include flu-like symptoms, hematologic abnormalities, and
      neuropsychiatric symptoms. Severe hemolysis has also been reported in
      patients with renal insufficiency and lactic acidosis in HIV-infected
      patients.

      Who should be treated?
      The NIH consensus panel devoted a great deal of attention to this
      issue. To quote the consensus statement: "Treatment is recommended
      for patients who are at increased risk for progression to cirrhosis."
      Those at risk have detectable HCV RNA, their liver biopsy indicates
      portal or bridging fibrosis, and they have at least moderate
      inflammation and necrosis. Most also have persistently elevated ALT
      levels.

      One of the most problematic groups, however, are patients with
      chronic hepatitis C who have normal or only mildly elevated ALT
      levels. While most of these patients have a histologically mild form
      of the disease, some will likely progress to advanced fibrosis and
      cirrhosis. Experts continue to debate whether they should be treated.
      Among the factors to weigh when deciding whether to treat these
      patients are how motivated they are, the viral genotype, symptoms,
      the presence of hepatic fibrosis, the patient's age, and the severity
      of co-existing disorders.

      The NIH statement recommends periodic monitoring for those with mild
      liver disease, that is, those who have persistently elevated ALT
      levels but no fibrosis and minimal necroinflammatory changes.

      The role of interferon and ribavirin in patients with decompensated
      cirrhosis is uncertain and these patients should be referred to
      clinical trials until the drugs are proven safe and effective. The
      other option, of course, is liver transplantation.

      The jury is still out on how to treat acute hepatitis C as well.
      Since it often goes undetected, study populations have been small,
      making it hard to generalize. The NIH panel sums up the situation
      this way: "Although high [response rates] have been seen in small,
      uncontrolled trials with interferon monotherapy, recommendations on
      whether treatment is necessary, the timing of therapy, and which
      regimen to use remain open."

      REFERENCE

      National Institutes of Health Consensus Development Conference
      Statement. Management of Hepatitis C: 2002, June 10-12, 2002. (For a
      copy of the statement and supporting materials, see
      http://consensus.nih.gov/cons/116/116cdc_intro.htm .



      Paul Cerrato. New guidelines for managing hepatitis C. Contemporary
      Ob/Gyn 2002;10:100,103.

      Copyright � 2002 and published by Medical Economics Company at
      Montvale, NJ 07645-1742. All rights reserved.


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