Wednesday, May 18, 2022

Hepatitis C Viral Load Quest

What Your Hepatitis C Virus Quantitative Real

Hepatitis C Viral Load

When your results show a high viral load, this normally indicates that the infection level is higher. However, for hepatitis C, a high viral load is not related to how you feel and how damaged your liver is. This number is the perfect indicator of how well a treatment is being successful.

If your viral load is less than 615 international units per liter then, your system does not contain any detectable hepatitis C virus. This result could even indicate that the levels are too low to be detected.

If the viral load is higher than 800,000 international units per liter means that the viral count is still high and the treatment needs to be adjusted. If the levels are below that number this indicates a successful treatment. After a period of eight to twelve weeks, if the viral load became undetectable, this marks the end of the treatment. You will no longer need to be treated for hepatitis C but, still need to be tested after a while to check for a relapse.

What The Qualitative Results Mean

The qualitative results indicate that HCV is present in your blood. The test result will be either detected or undetected.

Detected means that you do have the virus in your blood. Undetected means that you dont have the virus in your blood, or you have a tiny amount that cant be detected by this test.

The qualitative test results may still be positive even if your viral load has decreased drastically due to treatment.

Patients With Quantifiable Hcv Rna At Eot By The Abbott Assay Who Achieved Svr12

On the shorter, 6- to 12-week regimens of sofosbuvir and ledipasvir with or without GS-9669 or GS-9451, 23 individuals had HCV RNA TD < LLOQ and another 6 patients had HCV RNA LLOQ at EOT. All 6 participants with quantifiable HCV RNA at EOT were taking the 6-week regimen of sofosbuvir, ledipasvir, and either GS-9669 or GS-9451 . Two patients attained HCV RNA TND < LLOQ at 4 weeks posttreatment, 2 patients at 8 weeks posttreatment, and 2 patients at 12 weeks posttreatment. Notably, HCV RNA LLOQ was measured 2 weeks after completion of therapy in 4 patients and 4 weeks after completion of therapy in 1 patient . Despite the presence of quantifiable virus posttreatment, all 5 of these patients achieved SVR12.

Decline of HCV RNA levels in patients with quantifiable and detectable HCV RNA as measured by the Abbott assay is depicted in Figure . Twenty-two patients with HCV RNA TD < LLOQ at EOT achieved SVR12. Only 1 patient treated with sofosbuvir, ledipasvir, and GS-9669 experienced viral relapse. This patient had HCV RNA levels TD < LLOQ at EOT, a low viral load of 75 IU/mL at week 2 posttreatment, and viral relapse by week 4 posttreatment.

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Diagnosis And Management Of Hepatitis C

THAD WILKINS, MD MARIAM AKHTAR, MD and EUNICE GITITU, MD, Georgia Regents University, Augusta, Georgia

CHRISTINE JALLURI, MD, and JASON RAMIREZ, MD, University of Maryland, Baltimore, Maryland

Am Fam Physician. 2015 Jun 15 91:835-842.

Patient information: See related handout on hepatitis C, written by the authors of this article.

Hepatitis C virus infection is a major cause of chronic liver disease and cirrhosis.1 The World Health Organization reports that there are at least 185 million persons worldwide with the infection, causing 350,000 deaths annually.1 In the United States, an estimated 2.7 million individuals are chronically infected with HCV.2 The burden of HCV infection in the United States is expected to increase because of the high proportion of persons who were infected in the 1960s and 1970s.3 In 2013, the total cost of HCV infection in the United States was estimated at $6.5 billion.4 Chronic HCV infection leads to significantly more lost days of work, decreased productivity, and increased health care costs.5 This article focuses on chronic HCV infection in adults and excludes special groups, such as children, pregnant women, transplant recipients, and persons coinfected with hepatitis B virus or human immunodeficiency virus .

SORT: KEY RECOMMENDATIONS FOR PRACTICE

HCV = hepatitis C virus.

SORT: KEY RECOMMENDATIONS FOR PRACTICE

HCV = hepatitis C virus.

Hepatitis C Reflex Testing

What is Viral Load for Hepatitis C?

To ensure complete and timely diagnosis of HCV, HCV reflex testing is recommended following a reactive hepatitis C antibody screening test. Reflex testing means the laboratory will perform the hepatitis C antibody test, and if the result is positive, the laboratory will immediately perform an HCV RNA test on the same specimen. If the subsequent HCV RNA test is negative, HCV infection is effectively ruled out for most patients. If the reflex HCV RNA test is positive, a diagnosis of active HCV infection has been confirmed, and the individual should be referred directly for HCV care and treatment.

Reflex testing obviates the need for the patient to return for follow-up testing should the initially HCV antibody test be reactive. If the RNA test is negative, the work-up is done, and the patient may be reassured.

  • Rationale for reflex testing:

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Results From The Qualitative Test

Doctors use the qualitative HCV RNA PCR test to determine whether or not the hepatitis C virus is present in the blood.

If the virus is present, the test will be positive. If the test does not detect the virus, the result will be negative.

If the result is positive, a person will then need a quantitative HCV RNA PCR test. For this reason, many doctors now prefer to skip the first test and use the quantitative test straight away.

The quantitative test results show how much HCV is in the body. However, whether low or high, the viral load does not reflect levels of damage to the liver.

Other blood tests, ultrasounds, and, rarely, a liver biopsy will help a doctor determine overall liver health.

After using an HCV RNA PCR test to confirm the presence of HCV, doctors will work out which strain of the virus is active in the body. This helps a doctor plan the course of treatment.

The primary goal of treatment is to bring down the viral load in the body until it is entirely free of the virus. Doctors know this as a sustained virologic response .

SVR occurs when the virus is undetectable for 12 weeks or longer after treatment.

Achieving SVR is the best outcome of treatment, as it often means the person is free from hepatitis C, or that treatment has cured hepatitis C.

Doctors will also combine treatments with other tests that monitor for complications of HCV, including cirrhosis and liver cancer.

Viral Loads During Treatment

Checking your virus count before, during, and after treatment tells your doctor if and how well your drugs are working. A rising viral load doesnât always mean youâre getting sicker, and a drop in the virus count isnât a sign that youâre on your way to being cured.

Unlike with HIV, where lower viral counts usually mean longer, healthier life, HCV viral loads donât say much about how fast your hep C is progressing or how your disease might turn out. For that, your doctor will need to check your liver enzymes and your liver tissues and run other tests.

Usually, your hep C treatment will be the same no matter how high or low your viral load is. Your doctor will use your virus levels to monitor how you respond to the medication. The drugs youâre prescribed will depend less on your viral count than on your overall health, genetic makeup of your HCV, and other things.

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Performance Of Rapid Hiv Tests

Currently, six rapid HIV tests are approved by the US Food and Drug Administration for clinical use : OraQuick Advance , Uni-Gold Recombigen , Reveal G3 , Multispot , and two recently approved systems from Chembio, the Clearview HIV 1/2 STAT-PAK, and Clearview Complete HIV 1/2 . Each is based on immunochemical methods in which antibody-target antigen interactions produce a colorimetric result. The Clearview assays employ identical immunochromatographic test strips and differ only in user interface. Two of the assays, Uni-Gold Recombigen and Reveal G3, are not approved for the detection of HIV-2, and Multispot stands alone among the rapid assays in its ability to not only detect, but also to differentiate HIV-1 from HIV-2 infection. In addition, the performance of a first-generation rapid HIV-1 assay, the Single Use Diagnostic System HIV-1 was extensively studied before its removal from clinical use. The information gleaned from these studies and from those involving current methods describes the role of rapid HIV assays in decreasing HIV transmission and improving HIV care. As new testing protocols and strategies are being defined, other tests are being studied and will certainly be subjects of approval applications soon.13

Table 1. FDA-approved rapid HIV tests

Test Name
$18.50gp41, gp120

Data from Centers for Disease Control and Prevention , manufacturers’ package inserts, and Food and Drug Administration.

Peter T Frame MD, in, 2003

Human Immune System Human Hepatocyte Chimeric Mouse Model

Hepatitis b viral loads

The optimal way to assess the role of the immune system in response to HCV infection and to explore virus-induced immunopathogenesis in a setting comparable to humans would be to use mice harboring both human immune cells and human hepatocytes . The study by Washburn et al. described above paved the road to the development of such an animal model. However, the selection of human immune cells on murine MHC instead of HLA molecules may have precluded the development of very efficient T and B cell responses. An alternative approach would thus be to use hepatodeficient and immunodeficient HLA-expressing mice in order to allow the engraftment of HLA matched human hematopoietic stem cells and human hepatocytes. The selection of immune cells on HLA molecules and the recognition of the hepatocytes as being from self might give a better view of the immune response against HCV and allow the design of efficient vaccines and new therapeutic products.

The hu-IS/hu-Hep mouse model would certainly be the best model to assess the immune responses against HCV, to decipher more deeply the immunopathogenesis developed during chronic infection, to explore HCV-host interactions during acute infection and to unravel the mechanisms leading to virus eradication as well as to develop vaccines and new therapeutic approaches.

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Pathophysiology And Natural History

There are six known genotypes of HCV. The most common genotypes in the United States, comprising 97% of all U.S. HCV infections, are 1 , 2, and 3.9

The mechanism of hepatocyte damage induced by HCV infection is not completely understood but may involve direct cell injury and a local immune-mediated mechanism that causes a chronic inflammatory state.10,11 Acute HCV infection progresses to chronic disease in 50% to 80% of patients and clears spontaneously in 20% to 50% of patients.10 Of persons with chronic disease, 20% will develop cirrhosis, end-stage liver disease, and/or hepatocellular carcinoma.12

Figure 1 illustrates the natural history of HCV infection.10

Figure 1.

Natural history of hepatitis C virus infection.

Reprinted with permission from Pawlotsky JM. Pathophysiology of hepatitis C virus infection and related liver disease. Trends Microbiol. 2004 12:97.

Figure 1.

Natural history of hepatitis C virus infection.

Reprinted with permission from Pawlotsky JM. Pathophysiology of hepatitis C virus infection and related liver disease. Trends Microbiol. 2004 12:97.

Appropriate Uses Of The Hcv Rna Test

There are 4 major reasons that HCV RNA tests are used:

  • To confirm a positive HCV Ab result and make the diagnosis of current HCV infection
  • To measure a patient’s baseline viral load prior to starting HCV therapy
  • To monitor a patient’s response to therapy
  • To determine whether a patient has achieved a sustained virologic response
  • More rarely, HCV RNA is used when either very acute HCV infection is suspected or a false HCV Ab is suspected.

    It would not be appropriate to repeatedly order HCV RNA viral load screening for a patient who is not on or was recently on HCV treatment, or to use the HCV viral load to determine the severity of the patient’s infection or the patient’s risk of developing significant liver disease.

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    Predictive Ability Of Hcv Rna At Eot For Svr12

    All 55 patients receiving sofosbuvir and ribavirin had HCV RNA TND < LLOQ by both the Roche and Abbott assays at EOT . However, only 38 patients achieved SVR12 and the remaining 31% of patients experienced viral relapse.

    Predictive ability of hepatitis C virus RNA at end of treatment for sustained virologic response after 12 weeks of treatment . Left: Percentage of patients with HCV RNA less than the lower limit of quantification at EOT is presented in patients treated with sofosbuvir and ribavirin for 24 weeks , sofosbuvir and ledipasvir for 12 weeks , sofosbuvir, ledipasvir, and GS-9669 for 6 weeks , and sofosbuvir, ledipasvir, and GS-9451 for 6 weeks by both the Roche and Abbott assays. Similarly, the percentage of patients with HCV RNA target not detected < LLOQ at EOT is also presented for each treatment regimen . The positive predictive value and negative predictive value for the assays are presented below the corresponding bars on each graph. Right: Percentage of patients who achieved SVR12 for each treatment regimen. Abbreviation: N/A, not applicable.

    The Quest For Safe And Effective Treatments Of Chronic Hepatitis C In Patients With Kidney Impairment

    What Are Extrahepatic Manifestations?

    Stella De Nicola

    UO Gastroenterologia ed Epatologia, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano, Università degli Studi di Milano, Milan, Italy

    Alessio Aghemo

    UO Gastroenterologia ed Epatologia, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano, Università degli Studi di Milano, Milan, Italy

    Stella De Nicola

    UO Gastroenterologia ed Epatologia, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano, Università degli Studi di Milano, Milan, Italy

    Alessio Aghemo

    UO Gastroenterologia ed Epatologia, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano, Università degli Studi di Milano, Milan, Italy

    See Articles on Page 798, 802, 807

    Figure 1

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    Hepatitis C Pcr Quantitative Blood Test

    The Hepatitis C RNA PCR Quantitative test is used to look for infections with the Hepatitis C virus. This test looks for the genetic material of the virus. Because viral genetic material may be detectable earlier than antibodies which develop in response to an infection, PCR testing can be used to screen for a recent exposure. Quantitative PCR testing, also known as viral load testing, is often ordered to monitor how effective a persons treatment is at controlling the virus. This test is also useful as a confirmation for people who have had a positive result from a HCV Abs test. Results for this test are quantitative, meaning they will provide a numerical result for the level of the virus in a persons body.Hepatitis C is a virus spread through contact with infected blood. Nearly 80% of Hepatitis C infections develop into chronic Hepatitis. The number of people worldwide with chronic Hepatitis C infections is around 150 million. Chronic Hepatitis C infections can lead to serious health complication such as Cirrhosis and Liver Cancer. Many HCV infections display no symptoms. When symptoms do occur, some of the most common include:

    Fever Grey feces Jaundice

    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.

    Detection Period:

    Requirements:

    Description:

    Hepatitis C Antibody Blood Test

    The Hepatitis C Abs test is the most commonly ordered screening for Hepatitis C infections. This test looks for antibodies which develop in response to an infection. These antibodies are usually detectable at 4-12 weeks or greater after exposure. Results for this test are quantitative and will indicate a reactive , nonreactive , or in some cases, equivocal result. Hepatitis C is a virus spread through contact with infected blood. Nearly 80% of Hepatitis C infections develop into chronic Hepatitis. The number of people worldwide with chronic Hepatitis C infections is around 150 million. Chronic Hepatitis C infections can lead to serious health complication such as Cirrhosis and Liver Cancer. Many HCV infections display no symptoms. When symptoms do occur, some of the most common include:

    Fever Grey feces Jaundice

    Hepatitis C can be spread in a variety of ways. Some of the most common include intravenous drug use, improperly cleaned or sterilized tattoo and piercing equipment, sexual contact, blood transfusions , and from an infected mother to her infant during birth. The Hepatitis C Abs test is most commonly ordered as a routine screening. This test can be ordered by anyone who is concerned they have been exposed to the Hepatitis C virus regardless of whether they are experiencing symptoms or not. For a recent exposure, the Hepatitis C RNA PCR Qualitative test may be more accurate.Turnaround time for the Hepatitis C Abs test is usually 1 business day.

    Detection Period:

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    What To Know About Hepatitis C Testing

    The HCV RNA PCR test is a blood test that helps a doctor diagnose hepatitis C. The test measures the level of the hepatitis C virus in the bloodstream.

    Hepatitis C is an infection that causes scarring in the liver and reduces function in this vital organ. Severe HCV can lead to liver failure. However, early diagnosis can reduce the risk of severe infection.

    In this article, we look at how the test works and what the results mean.

    The HCV RNA PCR test is a blood test. A lab technician looks for the genetic material of the HCV virus, or its ribonucleic acid . They use a process called a polymerase chain reaction .

    The results of the HCV RNA PCR test help a doctor recommend different ways of reducing the viral load. The viral load indicates how many HCV viral particles are in the blood.

    If a doctor suspects that a person has HCV, they will recommend this test early on in the diagnostic process, even if it is not the first test they carry out.

    The test can detect the presence of the virus itself, rather than the antibodies that the body creates in response to the virus.

    This means that a person does not have to wait until symptoms of the infection develop for a diagnosis.

    It can take an average of 68 weeks for antibodies to become detectable after an HCV infection begins. However, a doctor can identify the virus itself after about 1-2 weeks by using PCR or another means of direct virus detection.

    Doctors use the HCV RNA PCR in one of two ways:

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