Wednesday, September 21, 2022

Genotype Test For Hepatitis C

Taking A Hepatitis C Test

Hepatitis C Treatment of Genotype 1

Hepatitis C testing is conducted on a sample of blood. Blood samples can be collected by a doctor, nurse, technician, or other health care provider from an adult patients vein using a small needle or a skin prick on a childs heel.

For an at-home hepatitis C test, patients collect a blood sample according to the manufacturers directions. Instructions provided in the test kit detail the steps to obtain a small sample of blood and mail it for testing.

How Genotypes Affect Treatment

Medications known as direct acting antivirals, or DAAs, stop the hep C virus from making copies of itself. Some DAAs appear to work well on all hepatitis C genotypes. Others work on only one or some.

Your doctor will probably prescribe some combination of these medications:

  • Velpatasvir

Some pills combine two drugs into one pill.

You’ll probably take these meds for anywhere from 8 to 12 weeks. But they may not be right for everyone because of things like cost or other illnesses.

Your specific genotype can tell your doctor important things about how to use those medications, what to watch for, and other drugs you might need.

For example, you may have a higher chance for cirrhosis if you have genotype 1.

Genotype 3, the second most common subtype worldwide, may not respond as well to DAAs alone. In addition, this type might suggest that:

  • Liver cancer is more likely.
  • Insulin resistance might happen. When your body resists or doesn’t respond to insulin as well as normal, you have a higher chance of heart disease and diabetes.
  • You might need longer, more challenging treatment

Your doctor might adjust or change your DAA treatment if you have:

What Health Professionals Need To Know About Hepatitis C

Hepatitis C is not a vaccine-preventable disease.

Hepatitis C is reportable by laboratories and clinicians to local public health authorities in all provinces and territories.

In Canada:

  • hepatitis C antibody and nucleic acid amplification testing methods for screening the blood supply were implemented in 1992
  • prior to this implementation, thousands were infected with the hepatitis C virus after receiving blood or blood products
  • universal blood supply screening has:
  • virtually eliminated the hepatitis C transmission risk via transfusion
  • significantly improved the quality of the blood supply
  • Consult the national case definition for additional information.

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    Pregnancy And Hepatitis C

    Should pregnant women be tested for HCV antibodies?

    Yes. All pregnant women should be screened for anti-HCV during each pregnancy, except in settings where the prevalence of HCV infection is < 0.1% . Pregnant women with known risk factors should be tested during each pregnancy, regardless of setting prevalence. Any pregnant women testing positive for anti-HCV should receive a PCR test for HCV RNA to determine current infection status.

    Can a mother with hepatitis C infect her infant during birth?

    The overall risk of an infected mother transmitting HCV to her infant is approximately 4%8% per pregnancy . Transmission occurs during pregnancy or childbirth, and no prophylaxis is available to protect the newborn from infection. The risk is significantly higher if the mother has a high HCV viral load, or is coinfected with HIV with which the rate of transmission ranges from 8%15% . Most infants infected with HCV at birth have no symptoms.

    Should a woman with hepatitis C be advised against breastfeeding?

    When should children born to HCV-infected mothers be tested to see if they were infected at birth?

    Can Hepatitis C Be Treated

    Healthy Tips for Hepatitis C Treatment

    Yes, since 2010 enormous progress has been made in the treatment of chronic hepatitis C. New therapies called direct-acting antivirals are pills that act on the virus itself to eradicate it from the body, unlike older medicines like interferon injections which work by stimulating an immune response. These new treatments are very effective and can achieve cure rates of over 90%. In most situations now, there is no need for interferon, which was responsible for many of the side effects previously associated with HCV treatment. The new treatment combinations require shorter treatment durations , have reduced side effects and appear to be effective at all stages of the disease.

    Because these new therapies are very new, they remain very expensive. As such, drug coverage from both government and private companies may require that your liver disease has progressed to a certain stage before they are willing to cover the cost of these drugs.

    Your primary care physician may refer you to a specialist to determine whether you are eligible for treatment. A specialist will help you decide which drug therapy is best for you based on the severity of your liver disease, your virus genotype and whether or not you have been treated in the past.

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    What Does The Test Measure

    Hepatitis C testing identifies antibodies to the hepatitis C virus, detects viral RNA, and/or determines the strain of hepatitis C. Hepatitis C testing may involve several different tests:

    • Hepatitis C antibody test: Antibodies are a part of the bodys response to an infection. Testing for hepatitis C antibodies determines whether or not a patient has been exposed to the hepatitis C virus at some point in their life. If this test is positive, the next step is to test for hepatitis C RNA which can tell you if you have a current infection.
    • Hepatitis C RNA test: RNA is a type of genetic material from the hepatitis C virus that can be detected in the blood. If test results are positive after a hepatitis C antibody test, doctors use a hepatitis C RNA test to look for and/or measure the amount of the virus in the blood. Qualitative HCV RNA tests can detect the presence of HCV RNA, while quantitative HCV RNA tests measure the amount of HCV RNA. Understanding the amount of HCV in the blood helps to monitor response to treatment.
    • Genotype test: There are at least six types of hepatitis C, which are also called strains or genotypes. Treatment for hepatitis C depends on the strain, so genotype testing to guide treatment is performed in patients who are diagnosed with an HCV infection.

    Hepatitis C Virus Genotypes

    An important variable for all patients with chronic hepatitis C virus is the”genotype” of HCV with which they are infected. This is the strain of the virus towhich they were exposed when they were infected, often many years prior to theirevaluation, and it is determined by a simple blood test. Genotypes of HCV aregenetically distinct groups of the virus that have arisen during its evolution. Approximately 75% of Americans with HCV have genotype 1 of the virus, and 20-25% have genotypes 2 or 3, with small numbers ofpatients infected with genotypes 4, 5, or 6. Most patients with HCVare found to have only one principal genotype, rather than multiple genotypes. Genotype 4 is much more common in Africathan in many other parts of the world, genotype 6 is common in Southeast Asia, andeach area of the world has its own distribution of genotypes.

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    Preparation Prior To Transport

    Centrifuge if using SST. Serum or plasma must be removed from the clot within 6 hours of collection. Place specimen in a biohazard bag and seal. Specimens should be stored frozen and shipped to PHOL on ice packs or dry ice.

    Upon separation plasma/serum may be stored in secondary tubes for up to 3 days at 2°C to 8°C or at -70°C or colder for longer term.

    A Patients Triumph Over Hepatitis C

    Treatment for Hepatitis C Genotypes – Dr. Anantharaman Ramakrishnan

    Connie Welch knows the angst of being diagnosed with Hepatitis C, and she also knows what it is like to triumph over the disease.

    Welch told Healthline, I contacted Hep C in an unusual way. In 1992 I had foot surgery, and two years later I was contacted and told that a convicted drug felon, who worked at the center at the time as a scrub tech, would take a vial of medicine and shoot up with the syringe with the patients IV bag, put normal saline back into that same syringe and put it back on the tray.

    Welch, who has two children, was in complete shock to learn this news. It was horrific. It was very scary learning about Hep C and that there was not a cure. The doctor sat me and my husband down for an hour and a half and explained everything about Hep C.

    After being tested three times, Welch learned that her Hepatitis C was active and doing damage. She has had two liver biopsies and three treatments in a course of 20 years. I was tested for my genotype and Im genotype 1.

    Following a three-drug combination treatment, which included the drug Incivek for the first four weeks of the treatment, Welch went nondetected. The treatment lasted 24 weeks. I am now two years post treatment and Im still nondetected. I just received a new diagnosis and they said I am Hep C resolved, which means cured. In 2012, I did my last treatment. I was able to receive a cure. That was pretty phenomenal, said Welch.

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    Criteria To Distinguish A New Case From An Existing Case

    All jurisdictions are encouraged to track negative HCV viral detection tests to document both spontaneous clearance of infection or sustained viral response to HCV treatment. Cases that have evidence of having cleared the infection at time of initial report or are considered false positive should not be reported to CDC.

    If evidence indicating resolution of infection is received after a confirmed chronic case has been reported to CDC, the case report does not need to be modified as it was a confirmed case at the time of initial report. However, negative HCV viral detection test results received on confirmed chronic cases, subsequent to an initial positive result, should be appended to case reports, as feasible, and considered for the purpose of data analysis by each jurisdiction.

    For probable chronic cases, the presence of a negative HCV viral detection test result, in the absence of criteria that would allow for confirmation, indicates that a case should not be classified as probable chronic and should not be reported to CDC.

    A new chronic case is a newly reported case that does not have evidence of being an acute case of HCV infection. A confirmed acute case may be classified as a confirmed chronic case if a positive HCV viral detection test is reported one year or longer after acute case onset. A confirmed acute case may not be reported as a probable chronic case . For purposes of incidence and prevalence calculations, confirmed chronic HCV cases should be counted.

    Do Genotypes Change Over Time

    A viruss genotype usually stays the same. Genetic changes, or mutations, can occur at random or in response to the environment. Some mutations are harmless, but others can affect how well a patient responds to treatment. New HCV treatments include more than one drug to prevent drug resistance from happening by targeting more than one step in the virus life cycle. However, if patients miss treatment doses, this can lead to genetic mutations, which cause resistance to HCV treatment .

    HARDER TO TREAT GENOTYPE 3

    Genotype 3 is the second most common HCV subtype in the world, particularly in Northern Europe, South Asia, and Southeast Asia. It can pose more difficult health problems for people with HCV, including more rapid progression of liver disease, increased rates of steatosis , and a higher risk for cancer . Genotype 3 has been associated with unique characteristics, such as how it creates resistance to insulin and how it causes the liver to break down fats, which make it harder to treat with DAAs.

    People infected with genotype 3 are the most challenging to treat if they:

    • have previously tried treatment
    • have cirrhosis, and
    • have , which is a life-threatening condition leading to liver failure.

    Genotype 3 often requires longer treatment and does not achieve strong cure rates. There are lower cure rates in patients with cirrhosis.

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    Hepatitis C Genotype Test

    The Hep C Genotyping test is used to help determine which strain of Hepatitis C a person has. There are 6 major types of Hepatitis C and at least 50 subtypes. Genotype 1 is the most common strain of Hep C accounting for 75% of cases in the United States. Determining the specific type of Hepatitis C infection that a person has can help their doctor to determine the best course of treatment. Results for this test will provide the Hep C type and in some cases will also provide the subtype A genotyping test may not be effective for people with a low viral level.

    A Hep C Genotype test is typically ordered after someone has been diagnosed with a Hepatitis C infection. Test results should be interpreted by a doctor to help determine which type of medication will be most effective in treating a person’s Hep C.

    This test is not intended as a screening for Hep C. For an initial screening, a Hepatitis C Antibody test is ordered most commonly.

    Turnaround for this test is typically 3-6 business days.

    Note: Result turn around times are an estimate and are not guaranteed. Our reference lab may need additional time due to weather, holidays, confirmation/repeat testing, or equipment maintenance.

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    Which Hepatitis C Genotype Tests Are Available

    How Long Will I Test Positive for Hepatitis C Antibodies?

    In June 2013, the FDA approved the Abbott RealTime HCV Genotype II test, which, by analyzing a sample of an infected patients blood plasma or serum, can differentiate HCV genotypes 1, 1a, 1b, 2, 3, 4, and 5. This test is approved for use in adult, non-immunocompromised patients with known chronic HCV infection but has not been approved for diagnostic use or as a screening test for HCV genetic material. FDA approval was based partly on a comparison of the test’s accuracy with that of a validated gene-sequencing method.

    Other genotype tests are available, including the following, although none have been approved by the FDA :

    • Trugene HCV 5’NC Genotyping Kit: Based on direct sequencing followed by comparison with a reference sequence database
    • Line Probe Assay : Based on reverse hybridization of PCR amplicons on a nitrocellulose strip coated with genotype-specific oligonucleotide probes
    • Versant HCV Genotyping Assay 2.0: Next-generation line-probe assay
    References
  • World Health Organization. Hepatitis C: fact sheet. Available at . Updated: October 2017 Accessed: January 23, 2018.

  • Frank C, Mohamed MK, Strickland GT, et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet. 2000 Mar 11. 355:887-91. .

  • Kim A. Hepatitis C virus. Ann Intern Med. 2016 Sep 6. 165 :ITC33-ITC48. .

  • Bonkovsky HL, Mehta S. Hepatitis C: a review and update. J Am Acad Dermatol. 2001 Feb. 44:159-82. .

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    Tests After The Diagnosis

    Once the doctor knows you have hep C, theyâll do tests to find out more about your condition. This will help determine your treatment. They could include:

    • Genotype tests to find out which of the six kinds of hepatitis C you have.
    • Liver function tests. They measure proteins and enzymes levels, which usually rise 7 to 8 weeks after youâre infected. As your liver gets damaged, enzymes leak into your bloodstream. But you can have normal enzyme levels and still have hepatitis C.
    • Tests to check for liver damage. You might get:
    • Elastography. Doctors use a special ultrasound machine to feel how stiff your liver is.
    • Liver biopsy. The doctor inserts a needle into your liver to take a tiny piece to examine in the lab.
    • Imaging tests. These use various methods to take pictures or show images of your insides. They include:

    Can I Take The Test At Home

    At-home hepatitis C tests are available that allow patients to collect a blood sample at home and mail it to a laboratory for testing. Test samples are collected through pricking a finger with a sharp object, called a lancet, thats included in the test kit.

    At-home HCV testing is a form of hepatitis C antibody testing and does not test for hepatitis C RNA or the strains genotype. Testing for hepatitis C at home is not a substitute for testing performed by a health care professional, and positive test results may need to be confirmed by laboratory-based testing.

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    Chronic Hepatitis C Infection

    Approximately 25% of those infected with the HCV will spontaneously clear the virus within 6 months. However, in most cases , the infection will become chronic. Chronic hepatitis C is often asymptomatic.

    Some individuals with chronic hepatitis C infection experience:

    • nausea
    • malaise
    • abdominal pain

    Fluctuating alanine aminotransferase levels are characteristic. In addition, thrombocytopenia may be an indication of cirrhosis. Thrombocytopenia is known to increase with the severity of liver disease.

    The late sequelae of chronic hepatitis C infection include:

    • liver fibrosis or cirrhosis
    • hepatocellular carcinoma

    Cirrhosis and hepatocellular carcinoma may develop over a period of 20 to 30 years depending on factors such as sex, age, and level of alcohol consumption. Approximately 1% to 5% of individuals with chronic hepatitis C infection will develop hepatocellular carcinoma.

    If cirrhosis develops, individuals may experience:

    • ascites

    The diagnosis of hepatitis C requires 2 types of tests:

  • hepatitis C antibody test
  • hepatitis C ribonucleic acid test
  • Retreatment Of Persons With Prior Peginterferon And Ribavirin Failure

    Hepatitis C Treatment of Genotype 2 & 3

    The latest version of the AASLD-IDSA HCV Guidance no longer provides specific recommendations for retreatment of persons with a history of peginterferon plus ribavirin therapy, with or without an earlier generation direct-acting antiviral agent . The AASLD-IDSA HCV Guidance notes that these individuals respond to retreatment similar to treatment-naïve persons, thus implying the treatment approach should be the same as with treatment-naïve individuals. Although the pool of persons with a history of failure with a peginterferon-based regimen who need retreatment is small and diminishing, there are some individuals with this treatment history who need retreatment and may require special consideration that differs from that of treatment-naïve individuals. The following outlines a few of these key considerations based on available data and previous guidance that should be noted when retreating an individual with a history of prior treatment failure with peginterferon plus ribavirin, with or without an earlier generation DAA . Note that except for the 8-week option of glecaprevir-pibrentasvir , when retreating these individuals with first-line DAA combinations that have pangenotypic activity , the treatment will be the same as their treatment-naïve counterparts.

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