QUESTIONS& ANSWERS

WHAT IS THE HEPATITIS VIRUS ?

The hepatitis C virus is a single stranded RNA virus which appears to be related to pestiviruses and flaviviruses. Replication of Hepatitis C occurs both in liver and peripheral mononuclear cells. Since that time an avalanche of research has occurred regarding the hepatitis C virus, its natural history and treatment Five different viruses(termed A,B,C,D,and E) cause viral hepatitis. Four other viruses that are believed to cause hepatitis have been identified, but not much is known about them. Hepatitis C virus (HCV) accounts for the great majority of what was referred to as non-A, non-B hepatitis. The hepatitis C virus was identified in 1989, and in 1990 a hepatitis C antibody test (anti-HCV) became available to identify individuals exposed to HCV.

WHAT ARE THE TESTS FOR HEPC ?

L1-TheElisa test may have false posiive and negatives. It is followed by the RIBA which is more accurate and a confirmation test. Elisa is usually used as a screening test because it is less expensive. L1- ALT is the best way to track virus C. L1-SGPT an enzyme present in high concentratin in the liver and goes up when liver cells are damaged. The normal range is 0=48 u/l

Well, of course the first test is for positive diagnosis. The basis for diagnosis upon symptoms cannot be relied upon, since many people have no symptoms at all.

The most commonly used laboratory test is an ELISA, This stands for enzyme linked immunosorbant assay.

In this assay recombinant viral proteins form the solid phase of the assay and to this is added the patients sera. If the patient has antibodies against the recombinant viral proteins, then these antibodies link up to the proteins and an indicator system using anti-human,lgG linked to an indicator enzyme reveals this positive finding. See liver biopsy.
WHAT IS THE HISTORY OF HEPC?

Specific information regarding the history of hepatitis C is not yet available. In general, however, chronic hepatitis C appears to be a slowly progressive disease that may gradually advance over 10-40 years. There is some evidence that the disease may progress faster when acquired in middle age or older.

WHAT IS THE CHANCE OF GIVING THE DISEASE TO OTHERS?

HCV can be transmitted through blood transfusions. However, all blood is now tested for the presence of this virus by the antibody test. Other individuals who may come in contact with infected blood, instruments, or needles, such as I.V. drug users, health care workers or laboratory technicians are also at risk of acquiring hepatitis c as are those who undergo tattooing or body piercing.

The risk for transmitting hepatitis C sexually is unknown. There have been occasional documented cases of people with chronic hepatitis C transmitting the virus to their only, long-term sexual partner. The U.S. Public Health Service says that because of the lack of sufficient informatin those with only one, long-term sexual partner need not change their sexual practices.

The Centers for Disease Control and Prevention(CDC) say there is a slight increased risk of becoming infected with hepatitis C if you have multiple sex partners.


Those in close contact with others should consider being vaccinated. There is a risk of contracting hepatitis A through anal/oral contact. Good hygiene, washing hands with soap and water after using the toilet and good common sense are essential.

WHAT IS A VIRAL LOAD?

The use of viral load testing in the management of viral disease is not unique to Hep C. It is also widely used now in the management of HIV disease.

WHAT IS THE DIFFERENCE BETWEEN BEING UNDETECTABLE AND NEGATIVE?

That's a good question. . Being negative means that there is no virus present, and it's actually a term rarely used because the truth is that the virus in reality is undetectable. we really cannot clearly say that there is not virus somewhere else in the body, that doesn't show up in the sample tested.

A given test has only so much capability to detect viral particles. It may be quite good. but it is very difficult, in fact impossible, to assure that a test has definitely measured any possible virus present. Undetectable is often used when a person is in remission or has gone through treatment which was successful and the virus has been subdued and is not active.

WHAT IS THE RR ASSOCIATED WITH VIRAL LOAD READINGS?

The rror is actually quite good. the percentages range in the high 80 and 90. It is a function of the strength of the test being used and the rigor, or standards of the lab using the test. That's part of the problem in comparing one's viral load to someone else's. The fact is that if different labs use different tests or "kits" as they are sometimes called, then the way the viral load is reported out may be different.

Maybe this is a good time to say that the main point the microbiologist I spoke with from the lab this morning stressed was that actually viral load testing is not the best way to monitor one's progression of disease with hep c.

He, and the literature confirms this, said that actually the best way to monitor the activity of the virus in your body is to tract your liver function test, the ALT.

This is the transaminase SGPT. it is an enzyme present in high concentrations in your liver and goes up when liver cells are damaged. The normal adult range of the ALT is from 0-48 U/L. what you should do is keep a time long, and see how it changes over time. If it goes up there may be reason for concern. If it drops, we celebrate. And if it stays the same generally, you can be assured that the virus is basically stable.

AT WHAT POINT OR NUMBER IS A DOCTOR LOOKING FOR IN THE TITER TO KNOW IF YOU RE A RESPONDER OR NONRESPNDER?

It may depend on which test the doctor is using. Generally, the B-DNA test is used to determine whether a person is a good candidate for treatment, and if treatment is working. . It picks up levels over 350,000 particles per ml. and your doctor would be looking for changes from your baseline.

The B-DNA test may be negative, while your PCR (another viral load test) is positive. that may still be an indicator that you are a good candidate for interferon treatment.

Let me say a word about the PCR. It's the other main viral load test used, and is the most sensitive test available. PCR stands for polymerase chain reaction .. A PCR test takes a sample of the blood and amplifies the nucleic acid associated with the virus many millions of times. this is the chain reaction which is actually a copying process. It brings the nucleic acid up to detectable levels. the process is consistent and thereby enables us to assess how much of the original virus is present.

One other thing to not is that this test is more sensitive to some strains or genotypes of HCV than others. (And we know there are 6 genotypes and more than 30 subtypes of HCV RNA.)
MY DOCTOR SAYS I HAVE A VIRAL LOAD BUT NOT HOW MUCH, WHAT'S A LOW RANGE? WHAT'T A HIGH RANGE?

That's why it's not a good idea for patients with different genotypes to compare viral load test results.

A low viral load means that the virus is probably not very active, and therefore there are fewer particles in your blood for the test to pick up. numbers are hard to quote because it really depends on the kind of test the lab did and what their standards are. you can get this information from your doctor.

If you are told your viral load test is high, that's reason for concern. It means that the virus is active. Your doctor would probably also do a series of evaluations of your liver, such as the ALT, to determine if there was actually an impact on liver function.

WHAT IS THE SIGNIFICANCE OF QUAL AND QUANT PCR?

Everyone should also remember that this is a moving target. Viral loads tend to fluctuate from time to time. Qual, or "qualitative" evaluation is actually usually the first measure that is done. It is highly sensitive to the virus, however may have false positives. A quant, or "quantitative" test is then done to be more specific and either confirm a qual positive, or identify that it may be a false positive.

When a determination is first being made as to whether someone is HCV positive, labs take many precautions and do multiple tests to rule out any errors that are a function of the test themselves and not the true status of the person being tested. One test is not done.
WHAT IS THE ELISA TEST?

The ELISA is the test that is sensitive but may have false positives and negatives. It is followed by the RIBA which is more accurate and a confirmation test.

The ELISA is usually used as a screening test because it is less expensive. And expense is an issue with these tests. For instance, a viral load test usually costs about $200. In consideration of how much information it yields, compared to say multiple ALT's over time, it is not generally recommended for use multiple times. Unless of course someone is being evaluated as a candidate for interferon treatment.

IS THERE ANY SIGNIFCANCE TO RISES AND FALLS IN VIRAL LEVELS.?

Yes, there is significance to changes in viral levels, however always remember that there are many factors involved in assessing these levels. Obviously one wants their viral load / level to go down because it means the virus is under control or in remission. But also remember that your body is influenced by many things that may also influence the virus and cause it to fluctuate. Your natural immune system is your first line of defense and when it is strong you have the potential to have an impact on your viral load. when you first line of defense goes down,(such as fighting off other seasonal viruses) then the HCV has a window of opportunity and may take advantage of it and replicate faster. That's why it is so crucial for people with HCV and other virus to commit to maintaining a strong natural immune system.

IS IT POSSIBLE TO HAVE A HIGH VIRAL LOAD WITHOUT THE VIRUS BEING ACTIVE?

You may have a high viral load from previous activity of the virus. Also, if you have had it for a long time. That's why some clinicians don't really use the viral load test as an indicator of your disease status. It may be high and stable, or it may be low and active. what we are interested in is the health of your liver ultimately, so other less complex and expensive test may be better ways to closely monitor any changes in your liver's health. And don't forget, what genotype of HCV you have may make a difference.

Let me share an analogy I saw with people living with HIV disease. They also use a viral load test to track their disease status. The target of the HIV is the T-Cell, like the HCV invades the liver. Just as we monitor viral load, we also keep a careful watch on a person's T-Cell count. that's really where the damage is done. a person may have a low viral load, and still have dropping T-Cells, in which case there is concern. Likewise there may be a higher viral load, however no indication of T-Cell demise.

When some pcr's are done, the results are back in a week to 10 days but many take 4-6 weeks. why the differences?

Here you see local laboratory differences. It could also be a function of how many tests are run in your lab. In smaller communities, the test may not be done everyday, and therefore it would take longer. It's really about the kind of 'Kit" a lab uses and also the volume of tests they may be running. Another factor is that these tests just aren't done in all labs and sometimes are sent away for processing, which can add a lot of time to getting your results.

Regardless of viral load i.e.: 400,000 vs 2 mil, does the viral load really give any indication on how aggressive the virus is in your liver?

I wanted to be sure to mention that one of the limitations of viral load tests is that they only test for viral particles found in the blood. and even if none are detected there (undetectable) they may still be in other parts of the body, such as in white blood cells.

Remember this is only a measure of the amount of particles in the sample that was drawn on a specific day and time. the aggressiveness of the virus in your liver is not a function of number only. it involves the genotype of you HCV and also the strength of your liver, your general state of health.