Heptitis Frequently Asked Questions
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Side Effects and Management
A: The definition of Hepatitis is "inflammation of the liver"; the term "acute" means immediate in onset, and "chronic" indicates that the process has been present longer. The definition of chronic hepatitis is further clarified by the presence of abnormal liver injury tests, or transaminases for more than six months.
Viral Hepatitis A does not have a chronic form of hepatitis, when the infection resolves, there is no evidence of liver injury. In Hepatitis B, 10% of patients go on to chronic liver disease and 90% resolve the infection. Unfortunately in Hepatitis C 90% of patients progress to chronic liver disease, cirrhosis and even liver cancer. Chronic Hepatitis caused by any process can, progress to cirrhosis and ultimately hepatocellular cancer.
A: We usually perform AST and ALT (or alanine aminotransferase and aspartate aminotransferase). These are liver injury tests, better known as "transaminases." These tests are markers of inflammation and liver injury and not function. In Hepatitis C as opposed to other forms of liver disease, the level of abnormality or the height of these blood tests though does not correlate with the level of liver injury. These will be markers that will be followed during the course of therapy for hepatitis C.
A: Liver biopsy is the "Gold Standard" test to determine the level of liver injury. Transaminases (AST / ALT) are tests of liver injury not function even though we still call them liver function tests. Laboratory evaluation can suggest the presence of severe liver injury and the possibility of cirrhosis but biopsy is important to confirm the level of scarring and the severity of the injury, especially in Hepatitis C.
A: The liver is located in the right upper quadrant (RUQ) under the rib cage. The biopsy is an outpatient procedure where the rib space and the surrounding tissue is anesthetized, and a special needle is placed into the liver to obtain specimens for assessment. The liver biopsy allows accurate "staging of the severity of disease", through assessment of inflammatory activity, and the degree of scarring or fibrosis. Usually all diseases in the liver are diffuse involving all of the liver tissue equally therefore small pieces of liver tissue will gives all of the information we need.
The biopsy also permits identification of alternative pathologic processes such as alcoholic liver injury. And it may allow us to exclude histologic conditions that require special consideration in treatment and monitoring such as cirrhosis.
The percutaneous (through the skin) route is the method of choice for performing the biopsy. On occasion we will have the biopsy performed by a radiologist using X-Ray, for radiologic guidance. A biopsy can also be obtained laparoscopically or surgically through an abdominal incision.
A: The level of virus in the blood stream or the quantitative PCR test for viral RNA in the case of Hepatitis C does not really tell us about the ability to resolve the infection with therapy, nor does it tell how severe the infection is. It may impart some risk of transmissibility i.e. the higher viral titers may be easier to transmit.
A: In the determination of hepatitis C infection, usually hepatitis C antibody (HCV Ab) is determined first, this indicates past contact with the virus. The antibody does not differentiate between a resolved infection and an active infection. Because this test is indeterminate, we need to proceed to confirmatory assays. Usually the RIBA (or radioimmunoblot assay) is done first and is commonly done by your medical doctor.
Hepatitis C PCR, (which tests specifically for viral RNA is the most sensitive for the detection of hepatitis C. It is also the one marker that will help us determine resolution or cure of the hepatitis C viral infection after treatment has been completed.
A: The tests that we have performed as a baseline are iron studies and ANA (or antinuclear antibody), and other tests of metabolic, genetic, and immunologic liver diseases. On occasion, alternative disorders of the liver are found, and therapy would be altered based on these findings. We usually would perform AST and ALT (or alanine aminotransferase and aspartate aminotransferase). These are liver injury tests, better known as "transaminases." These tests are markers of inflammation and liver injury. In Hepatitis C as opposed to other forms of liver disease, the level of abnormality though does not correlate with the level of liver injury. These will be markers that will be followed during the course of therapy for hepatitis C.
We would normally perform an ultrasound as an imaging study of the liver.
A: It should be noted that all of the laboratory tests do not really help with the staging of the disease. There are tests of liver synthetic function, which may give us a clue to the extent of liver injury, and the possible presence of cirrhosis, yet the definitive evaluation of the condition and stage of the disease will be done at the time of liver biopsy. It is clear that patients may have normal transaminases, or tests of liver injury, and may have extensive cirrhosis. On occasion high transaminases may suggest only modest inflammation in Hepatitis C.
A: The use of Tylenol by patients who have active alcoholism and alcoholic injury are at risk for liver failure. The risk is present even in those who take moderate doses of Tylenol drink alcohol. Patients on treatment for hepatitis C will be encouraged to be abstinent from alcohol. Those patients with significant liver injury from active alcohol intake will not be treated until that liver injury improves, and there is no alcohol for at least 6 months to a year.
Using small doses of Tylenol to help with the side effect management of Rebetron will not present a concern, and will be suggested. You should take no more than 6 regular strength Tylenol a day or 4 extra strength in a 24-hour period of time.
A: At the current time combination therapy is the treatment of choice and is recommended by most hepatologists. Although interferon in many will produce long-term lasting remission in a small percentage of patients ~(20%), studies suggests that combination therapy will increase the chances of long-term sustained response ~(40%) significantly enough to make combination therapy the initial treatment of choice. Now that PEG Ð Intron (Shering product) and Pegasys (Roche product) is available it is likely that combination therapy with these Interferon products plus Ribavirin will be the treatment of choice.
Interferon alpha-2b plus ribavirin (REBETRON)Òis the combination currently in use. Interferon is dosed at 3 million units three times a week, given as a subcutaneous (in the skin) injection, combined with ribavirin tablets (1000 or 1200 mg) daily dosing depends upon weight. It is likely that we will use weight based dosing of the Pegylated interferon as well.
The standard course of therapy is 48 weeks, on rare occasionÕs a 24wk course can be followed. Usually the 24-week treatment regimen will be reserved for genotypes other than 1 a, b. (see Genotype below)
Therapy will only be continued for the full 48 weeks if the virus becomes undetectable in the blood by three months (12 weeks). On occasion this will be extended to 24 wks. The goal of therapy is to completely eradicate the virus (sustained response or cure) or to slow disease progression of the disease. Studies suggest that we can improve histology (microscopic picture of liver injury), which will impact our decision to continue therapy.
After treatment is initiated, the presence of persistent viremia (positive PCR) after three months predicts a poor response and therapy is usually but not always discontinued. With Interferon alone the suspected sustained virologic response is 15%. Sustained virologic response means the absence of the virus six months after the cessation of the therapy. Currently, combination therapy, Rebetron, is more effective at achieving viral clearance than interferon alone (near 40% sustained response)
A: There are a number of different methods by with interferon is administered. Most of the time, a multi-dose pen is available and is probably being used more frequently. This syringe is premixed with 2 weeks or 6 doses of medicine. Occasionally, a premixed syringe will be necessary based on insurance company preference. More recently with the approval of Pegylated interferon and weight based dosing. There will be a need to reconstitute powder and draw the appropriate dose into the syringe.
A: Twelve weeks is usually the period of time when initial viral response is expected although the earlier the better. If at the 12-week mark the hepatitis C viral level has not dramatically reduced or is absent, treatment may be discontinued. It is also at that time, on occasion, a dose change may be offered.
A: The hepatitis virus is made up of highly variable strains. All strains can be grouped based upon their biochemical and genetic make up. There are 6 major genotypes and many subtypes of HCV found throughout the world. In North America, genotypes 1,2,3 are most common, with genotype 1 found in approximately 70-75 % of individuals. Genotype 2 and 3 is found in approximately 25%.
A: Studies have actually shown that HCV genotype is correlated with response to interferon alpha (IFN-a) and combination therapy with Rebetron. Sustained virologic response to treatment in patients with genotype1 was 29%, while the response in non-1-genotypes was 66%. Patients with genotype 1 infection benefited from 48 vs. 24 weeks of combination therapy. Whereas, 24 weeks was likely to be of benefit for genotypes other than 1.
A: Your genotype is a blood test and will be done in the course of your evaluation. The level will be reported as a type.
A: An end-treatment response is considered when a negative hepatitis C viral level or PCR in noted at 24 or 48 weeks, depending on when the therapy is to be discontinued. If the hepatitis C viral level remains negative for six months following this time period, it is considered a sustained response, or cure. One would have to be negative more than six months following cessation of therapy for the sustained response, or cure, to be suggested.
A: In the majority of cases therapy is continued for 48 weeks. On occasion, 24 weeks of treatment can be offered. The decision is frequently based upon several factors that are evaluated individually. The first is the severity of disease and the likelihood of response. On occasion, subgroups can be defined. Those most likely to respond are patients without cirrhosis, low serum HCV RNA level of less than 2 million copies/ml, an HCV genotype of other than 1 A or B (2,3,etc) and females less than 40 years old.
A: Counseling of a patient with Hepatitis C should always include the discussion of risk factors, natural history, and the modes of transmission. Patients are encouraged to eliminate risk factors, such as intravenous drug use (IDU), risky sexual practices, and to make appropriate life-style modifications or changes such as the abstinence from alcohol. It is suggested that infection occurs rapidly after initiation of IDU, with about 60 Ð 90% of Intravenous Drug Users becoming infected within 6 months to 1 year of beginning use.
DO NOT SHARE TOOTHBRUSHES OR RAZOR BLADES. BE CAREFUL NOT TO CONTAMINATE OTHERS WITH BLOOD FROM SCRAPES AND INJURY.
Side Effects and Management
A: The side effects of the treatment can be difficult but manageable. The constitutional or flu like symptoms are: Fatigue, headache, joint pains, muscle aches, and fever.
The toleration of therapy requires a good mental attitude, and drinking a lot of fluid during the course of treatment. The fatigue can be a matter of attitude. It can be significant if you let it. An exercise program, and a good healthy diet can be very helpful.
Mild hair loss is common, secondary to drying of the scalp. Using a good conditioner and avoiding a hot hair blow dryer will minimize this problem.
Headache can be a factor as well. If it occurs discontinuing caffeine can be helpful. * Side effects pageÉ.
FLUIDS PLAY A MAJOR ROLE IN ALLEVIATING MANY OF THE SIDE EFFECTS AND SYMPTOMS.
A: The side effects can be serious, including neutropenia or a low white blood cell count secondary to Intron A, and hemolytic anemia secondary to Ribavirin. The CBC or complete blood count is done often to monitor these side effects. If the Hemoglobin or White blood cell count decreases to critical levels the medication dose will be decrease or discontinued depending upon the severity of the abnormality.
A: Psychological problems of depression, anxiety and trouble sleeping can be difficult and debilitating. Bipolar disorder (Manic depressive illness) as well as moderate to severe Major depression are contraindications to treatment. It is very frequent that antidepressant therapy will be started at the beginning of therapy or during treatment. Prior to the initiation of therapy it may be necessary to have a psychiatric consultation. Most of the side effects are manageable. On occasion therapy will be discontinued.
Sleep disturbances are common as well and should be treated accordingly.
A: Parenteral routes (Blood Contamination) are the primary mode of transmission of Hepatitis C. The two most common risk factors are sharing of needles contaminated with blood, even once, and transfusion of blood or blood products prior to 1992. Sharing of blood in other ways also increases the risk of transmission. The transmission is most effective with large volume or repeated percutaneous (through the skin) exposure to blood as through transfusion or transplantation from infectious donors, sharing of equipment during injection drug use, of inadvertent contamination of supplies shared by patients undergoing chronic hemodialysis.
You should not share toothbrushes or razor blades at home. Kitchen utensils, toilets, silverware and glasses are not a concern. The risk of transmission from mother to child is approximately 5%.
Risks of transmission by sexual contact is also very low, and the cumulative risk to a partner in a monogamous relationship for ten to twenty years has been calculated to be less than 5%. With the risk during a single sexual contact being negligible.
A: The combination therapy costs about $10,000 to $15,000 per year, with a typical course of treatment lasting about 6-12 months.
Most insurance plans cover this therapy, but inform us of your plan so that we can help process the coverage.
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