Showing posts with label HCV tests. Show all posts
Showing posts with label HCV tests. Show all posts

Thursday, January 5, 2012

Roche's Novel Tests for the Management of Hepatitis C Virus Infection

Roche's Novel Tests for the Management of Hepatitis C Virus Infection
By: PR Newswire
Jan. 5, 2012 01:01 AM

PLEASANTON, California, January 5, 2012 /PRNewswire/ --

- Tests change hepatitis C disease and patient management

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its novel, state of the art Hepatitis C virus (HCV) qualitative and quantitative tests received CE mark. The tests detect HCV RNA, which is a crucial marker in the management of hepatitis C infection. In the new era of antiviral HCV therapies, sensitive detection and measurement of HCV RNA play an important role in determining treatment duration and predicting treatment response.

"The two tests provide a holistic solution for the management of hepatitis C infection: from the confirmation of a hepatitis C infection to the prediction and assessment of treatment response," said Paul Brown, Ph.D., Head of Roche Molecular Diagnostics. "Considering the rapidly changing hepatitis C treatment environment, we are pleased to provide two medically relevant tests on one fully automated platform. This offers clinicians the tools to manage their patients effectively and laboratories the automation and flexibility to maximize their workflow efficiency."

COBAS AmpliPrep/COBAS TaqMan HCV Qualitative Test, v2.0(1) is intended for the confirmation of HCV antibody positive specimens and COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 is intended for viral load monitoring and the prediction of virological response to antiviral therapy. Both tests are standardized with the World Health Organization (WHO) International Standard and have a limit of detection and lower limit of quantitation of 15 IU/mL. These characteristics make them medically relevant diagnostic tools in the management of hepatitis C infection.

Roche also offers the COBAS TaqMan HIV-1 v2.0, HBV v2.0, and CMV(2) tests on the same fully automated COBAS AmpliPrep/COBAS TaqMan System.

About Hepatitis C

According to the World Health Organization, hepatitis C virus affects ~200 million people globally, around 170 million people are chronic carriers of hepatitis C virus and most do not know they are infected. About 65-75% of patients develop chronic HCV which can lead to cirrhosis, liver failure and hepatocellular carcinoma.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80'000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

For inquiries, please call Corporate Communications at +1-925-730-8346.

All trademarks used or mentioned in this release are protected by law.

(1) The COBAS AmpliPrep/COBAS TaqMan HCV Qualitative and Quantitatives Tests, v2.0 are not available in the United States
(2) The COBAS AmpliPrep/COBAS TaqMan CMV Test is not available in the United States

Saturday, August 20, 2011

New Rapid HIV, HCV Tests May Improve Point-of-Care Testing

From Medscape Medical News
New Rapid HIV, HCV Tests May Improve Point-of-Care Testing
Emma Hitt, PhD
Authors and Disclosures

August 19, 2011 (Atlanta, Georgia) — A new HIV rapid test platform, designed to deliver test results in 10 minutes, may also detect HIV earlier in the course of infection than currently available rapid tests, new research findings suggest.
The new rapid HIV test is based on the existing OraQuick HIV rapid test platform. Findings regarding the test were presented by Lisa A. Kurtz, a senior scientist at OraSure Technologies, Inc, in Bethlehem, Pennsylvania, during an oral session at the 2011 National HIV Prevention Conference (NHPC) here. Researchers are also working on developing an oral hepatitis C virus (HCV) test.

The currently approved OraQuick ADVANCE Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes. The new test is designed to deliver results in 10 minutes.
The researchers evaluated the new test in commercial seroconversion panels (n = 24) and a worldwide serologic panel representing diverse genotypes (n = 15). Sensitivity was evaluated by using 169 samples derived from patients infected with HIV-2. Specificity was evaluated in 300 plasma and 500 whole-blood specimens.

Results from the tests were compared with those from a third-generation enzyme immunoassay (EIA). The rapid HIV test detected seroconversion within an average of 1.13 days of third-generation EIA (24 panels), which detects seroconversion 15 days before the Western blot.
The prototype assay was 100% concordant when tested in 169 HIV-2 samples. In addition, the new test was also concordant with EIA when tested with 15 worldwide serologic panel specimens detecting all major genotypes.

The test was also 100% specific in both plasma (300/300) and whole-blood (500/500) specimens.

"We will need to establish performance in larger-scale clinical trials in order to support FDA approval," said Ron Ticho, senior vice president of corporate communications. "A key component of the regulatory approvals will also be obtaining a ‘CLIA [certificate of laboratory improvement amendment] waiver,’ which will allow the test to be used outside of laboratory settings, such as in doctor’s offices and clinics," he told Medscape Medical News.
According to Mr. Ticho, rapid tests provide actionable test results while the clinician still has access to the patient being tested. "This will improve linkage to care and prevents loss of patient follow-up."

Oral HCV Swab Test Under Evaluation
In another presentation at the same meeting, Jennifer Fuld, with the New York City Department of Health and Mental Hygiene, presented data on an oral swab rapid HCV antibody test developed by using the same OraQuick technology.

The finger stick version of the OraQuick HCV Rapid Antibody Test was approved on June 25, 2010, and is currently the only available HCV test that uses a finger stick. The current study evaluated the oral swab form of this test and found that overall, 97.5% of rapid test results matched those of the EIA. In 6 of the7 discordant pairs, the rapid test result agreed with the polymerase chain reaction result.

"From our experience in New York City, the rapid hepatitis C antibody test is ideal for high-risk community settings, and might make the difference for some patients between learning their status and not," said lead author Ann Drobnik, MPH, program collaboration and service integration analyst with the New York City Department of Health and Mental Hygiene.
"This is particularly true for those that have poor veins from injection drug use, or who have limited access to care and have difficultly attending multiple appointments and returning for their results," she told Medscape Medical News.

According to Ms. Drobnik, it is likely that the availability of the rapid test will increase the number of people willing to get tested for hepatitis C and the number of providers offering the test.
"It remains to be seen how rapid testing will impact testing services in practice and whether it results in many more people being tested, as the rapid HIV test did. The hepatitis C community is anticipating that testing will be more widely available and that many more people will learn their status," she said.

2011 National HIV Prevention Conference (NHPC): Abstracts 1351 and 1180. Presented August 16, 2011.

Authors and Disclosures
Emma Hitt, PhD
Emma Hitt is a freelance editor and writer for Medscape.Disclosure: Emma Hitt, PhD, has disclosed no relevant financial relationships.Dr. Hitt does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.Dr. Hitt does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Monday, June 27, 2011

Checking up for Hep C and looking after yourself. Part 2

Uploaded by on Jun 27, 2011

Hepatitis C Victoria (HCV):
Infoline 1800 703 003

VAHS (Victorian Aboriginal Health Service):
Phone: 9419 3000 and 9403 3300

VACCHO (Victorian Aboriginal Community Controlled Health Organisation):
Phone: 9419 3350

Phone: 8679 2000

Wulumperi Aboriginal and Torres Strait Islander Sexual Health Unit:
Phone: 1800 458 406

Tuesday, June 21, 2011

Hows It Done? Video Polymerase Chain Reaction (PCR) ) -

Polymerase Chain Reaction (PCR) is a technique to amplify few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. There are three major steps (Denaturation, Annealing and Extension) in a PCR and repeat for 30 or 40 cycles.

More videos at Abnova

Sunday, April 17, 2011

Should Patients with Abnormal Liver Function Tests in Primary Care be Tested for Chronic Viral Hepatitis

Should Patients with Abnormal Liver Function Tests in Primary Care be Tested for Chronic Viral Hepatitis

David T Arnold; Louise M Bentham; Ruth P Jacob; Richard J Lilford; Alan J Girling
Of the 1,236 study patients with an abnormal LFT, 13 had chronic viral hepatitis (nine hepatitis B and four hepatitis C).


Background: Liver function tests (LFTs) are ordered in large numbers in primary care, and the Birmingham and Lambeth Liver Evaluation Testing Strategies (BALLETS) study was set up to assess their usefulness in patients with no pre-existing or self-evident liver disease. All patients were tested for chronic viral hepatitis thereby providing an opportunity to compare various strategies for detection of this serious treatable disease.
Methods: This study uses data from the BALLETS cohort to compare various testing strategies for viral hepatitis in patients who had received an abnormal LFT result. The aim was to inform a strategy for identification of patients with chronic viral hepatitis. We used a cost-minimisation analysis to define a base case and then calculated the incremental cost per case detected to inform a strategy that could guide testing for chronic viral hepatitis.
Results: Of the 1,236 study patients with an abnormal LFT, 13 had chronic viral hepatitis (nine hepatitis B and four hepatitis C). The strategy advocated by the current guidelines (repeating the LFT with a view to testing for specific disease if it remained abnormal) was less efficient (more expensive per case detected) than a simple policy of testing all patients for viral hepatitis without repeating LFTs. A more selective strategy of viral testing all patients for viral hepatitis if they were born in countries where viral hepatitis was prevalent provided high efficiency with little loss of sensitivity. A notably high alanine aminotransferase (ALT) level (greater than twice the upper limit of normal) on the initial ALT test had high predictive value, but was insensitive, missing half the cases of viral infection.
Conclusions: Based on this analysis and on widely accepted clinical principles, a "fast and frugal" heuristic was produced to guide general practitioners with respect to diagnosing cases of viral hepatitis in asymptomatic patients with abnormal LFTs. It recommends testing all patients where a clear clinical indication of infection is present (e.g. evidence of intravenous drug use), followed by testing all patients who originated from countries where viral hepatitis is prevalent, and finally testing those who have a notably raised ALT level (more than twice the upper limit of normal). Patients not picked up by this efficient algorithm had a risk of chronic viral hepatitis that is lower than the general population.

Summary of Main Findings
The BALLETS study is the first GP based study where the entire cohort was comprehensively tested for additional diseases (such as viral hepatitis) after an abnormal LFT, using the full analyte panel and normal reference ranges. We have shown that an abnormal LFT alone does not select out a population where the prevalence rate approaches a threshold which would justify viral screening. We have assessed the validity of the various strategies a GP could adopt, at least as far as viral hepatitis is concerned, when faced with an abnormal LFT of uncertain provenance. The intuitive response for a GP in such a situation would be to repeat the LFT, an approach advocated by current literature. This study shows that this may not be the optimal policy. This strategy is the most expensive, even more so than viral testing all patients, as the costs incurred include repeating the LFT as well as viral testing the majority. The study also shows that if ALT is notably raised (greater than twice the upper limit of normal), then the probability of chronic viral hepatitis is high (nearly 8%), but sensitivity is low. The strategy of testing all people from prevalent countries is the second most efficient, in terms of cost per case detected, and detects almost twice as many cases as the most efficient strategy - testing for viral infection when two conditions (birth in a prevalent country and an ALT greater than twice the upper limit of normal) are satisfied. The relative financial disadvantages of the strategy of repeating the LFT would be even greater if patient costs were included, as the extra visit would have to be factored in.

Previous Literature on LFTs and Liver Diseases
We conducted a literature review using the search strategy shown in Table 8, with the aim of retrieving papers that studied a cohort of patients with abnormal LFT results to provide evidence on the probability of various liver diseases (including chronic viral hepatitis) given abnormal test results. Any such studies would enable the precision of our observations to be strengthened. The search strategy returned 1,448 papers, including a previous review by Dufour et al. (2000).[29]
Only eight studies matched our requirement of following up patients with an abnormal LFT result. Two additional articles were selected from the references of relevant studies. As a result, to the best of our knowledge, there are only ten studies where a cohort of asymptomatic patients with abnormal LFTs were followed up (Table 9). However, one article was written in Korean (only the abstract was translated), so was excluded from our analysis.
Two of the remaining nine English language papers described record linkage studies. One such study was based on the Korean insurance database that was linked with death certificates.[30] This study reported that increased ALT, even within the upper end of the normal range, was associated with eventual death from liver disease. A study carried out in Scotland linked general practice and hospital databases.[31,32] However, this was a retrospective study so a full liver screen was not conducted and follow-up was for a median of four years only, whereas many diseases, including chronic viral hepatitis, have much longer prodromal periods.[33]
The other seven studies were prospective cohort studies, based on testing asymptomatic members of the general population. The famous Dionysos study based on three analytes from the LFT analyte panel[34] is included among these. In this study an impressive 6,917 citizens from two communities in northern Italy were screened. Although they tested all those who had an abnormal LFT (n = 1473) for viral hepatitis, for which they found a prevalence rate of 2.4%, they did not describe the pattern of LFT results in infected patients. Another Italian study by Pendino and colleagues (2005) screened 1,645 inhabitants from a town in southern Italy, with both a LFT (ALT, AST and GGT) and viral screen.[35] The prevalence of viral hepatitis is much higher in this region because of a significant immigrant population, and they performed a more extensive analysis on the impact of viral hepatitis on LFTs. Of the 319 (19.4%) individuals who received an abnormal LFT, nearly 18% were infected with viral hepatitis. However, the LFT missed 34 (40%) of the 92 cases of viral hepatitis present in the community. Perhaps the most comprehensive prospective analysis looking at the effect of viral hepatitis on the individual analytes was carried out on a population of Japanese office workers.[16] The study used data from compulsory health checks, which included an ALT, AST and GGT panel along with certain additional tests, such as a viral screen, that were added for study purposes. They found that ALT was the most sensitive of the three analytes used, detecting nearly half the cases of viral hepatitis, whilst being abnormal in 14% of the cohort (278 abnormal results in 1,973 participants). The remaining four prospectively designed studies were carried out in general practices and were therefore closer in population terms to the BALLETS cohort. However, three of these were restricted to patients with persistently abnormal LFTs over a six month period[36–38] and one of these did not include a test for viral hepatitis. The final prospective study by Whitehead (1999) was small and based on only one analyte.[39]
After this review of the literature we concluded that there has been no published study that fully investigated a cohort of patients in primary care with an abnormal LFT result (from the full LFT analyte panel).

Strengths and Limitations of the Study
The main strength lies in the unique nature of the BALLETS cohort, being the only prospective study that has looked at the consequences of an abnormal LFT from a full analyte panel in primary care. The main limitation of our study relates to the rather small number of cases of chronic viral hepatitis (n = 13) and hence wide confidence limits on the results. That said the results are plausible, in the sense that they are consistent with the pathophysiology of hepatitis and in line with what was found in non-practice settings (see literature review above). They are available for meta-analysis with potential future studies.
We deliberately selected multi-cultural inner city populations in order to provide a sizable sub-group of people from countries where chronic viral hepatitis is common, as a result of infection during infancy (hepatitis B),[40] and iatrogenic infection (hepatitis C).
Our study considers only one disease type, chronic viral hepatitis, while GP decision making must take into account other diseases, such as haemochromatosis, as well as other behavioural and social motivations for testing.[41,42] That said, our conclusion that repeating the LFT "offers more than it delivers," may well apply to diseases such as PBC and haemochromatosis.
Lastly we have presented an analysis for cost minimisation and incremental cost per case detected. This is not a full cost-effectiveness or decision analysis. Donnan et al. did attempt a decision analysis.[32] However this decision analysis was intended to find the most cost-effective strategy in the short term and used a limited time horizon of one year. LFTs are often ordered to prevent poor outcome in the long term, with many serious liver diseases, viral hepatitis included, manifesting over decades. Anxiety resulting from a false positive result was included in the model while long term health gains as a result of successful case finding and treatment were not captured.
Neither our decision analysis, nor that in Donnan's HTA report,[32] considered cost-effectiveness. We tackle this limitation by considering our results in the context of published cost-effectiveness analyses for screening for viral hepatitis (i.e. studies that found screening was cost-effective in populations with high prevalence rates e.g. migrants) and attempt to produce a "fast and frugal heuristic"[28] to guide practice.

Implications for Practice: A Fast & Frugal Heuristic
The intuitively appealing practice of repeating abnormal LFTs (strategy A) gets little support from our analysis. It is the most expensive option, both in absolute terms and in terms of cost per case detected, compared to all five alternative strategies (Table 7) - including that of simply testing everyone for viral infection.
The most important question a doctor can ask a patient with abnormal LFTs is their country of origin. This holds good whether the person settles in an area of high or low ethnic mix, since infections are acquired in infancy (hepatitis B), or as a result of sub-standard medical practices, such as needle sharing (hepatitis C). Once infected, people "take their risk with them" - less people will need to be tested in a low ethnic mix area, but those from prevalent countries still need testing. The strategy of testing people from prevalent countries promises good value for money. In this study, 11 of the 13 cases originated in medium or high risk countries. Thus the prevalence of chronic hepatitis viral infection (positive predictive value) among people with an abnormal LFT who were born in a prevalent country was 6.5% (11/170, 95% CI: 3.7%-11.2%, see table 5), while the prevalence among the home born population (of all ethnic groups) was less than 0.2% (2/1038, CI: 0.05%-0.7%). Our findings support viral testing only in the former group, consistent with the threshold prevalence for both HBV and HCV, of approximately 3% at which population screening becomes cost-effective.[21,43,44]
Four of the strategies, C, D, E and F, entail viral testing in a population where the rate of hepatitis exceeds the 3% threshold for which testing has proven cost-effective in screening programs (Table 5). The cost-effective threshold is probably a little lower in a diagnostic population than in a screening population (costs of inviting people to attend are lower and cases detected might be a slightly higher risk) but no other strategy yields a population with a hepatitis rate exceeding even 2%.
Strategy D (test immigrants from prevalent countries) has a better (lower) incremental cost-effective ratio than C and detects twice as many cases as E. However, the strategy F, testing immigrants from prevalent countries or any people with a very high ALT, is our preferred strategy, being both sensitive and efficient. We therefore recommend the "fast and frugal" heuristic described in Figure 3. This combines strategy F with normal judgement of clinical indications. For example a patient who is an intravenous drug user, or who has recently returned from a trip abroad where they had an attack of hepatitis, would be tested notwithstanding the result of the LFTs. Otherwise we recommend testing all patients with an abnormal LFT who were born in a country of intermediate or high prevalence and all patients for whom the ALT exceeds twice the limit of normal.

The probability of chronic viral hepatitis is low even when the ALT exceeds this limit and the patient does not originate from a medium or high-risk country (1.6%). Nevertheless we advocate testing in these patients for the following reasons:
1. It is hard to ignore a level this high, and the wide confidence levels from our data suggest the need for flexibility.[45]
2. The progression for undetected chronic viral hepatitis is worse for patients with ALT greater than twice the upper limit of normal, and this level has been used as a threshold for treatment in guidelines.
3. If chronic viral hepatitis is not present at this level a more in-depth search for other causes of hepato-cellular damage is indicated.
We draw the line on further viral testing after this algorithm has been followed, unless of course further clinical indicators emerge. The likelihood of a case of viral hepatitis being present following the exclusions in this algorithm is approximately 0.1% in our study. This is considerably below the UK population prevalence.

This analysis indicates that the strategy of repeating LFTs in asymptomatic patients, advocated by current guidelines, is less sensitive and far more expensive than viral testing those patients born in countries where viral hepatitis is prevalent. Despite few cases of viral hepatitis the data on costs of the various strategies is strong and the results of prevalence rates within the cohort are consistent with other literature. The finding that a notably raised ALT level was also effective at identifying infected patients inspired the construction of a "fast and frugal" heuristic that might aid GPs who are faced with abnormal LFTs in asymptomatic patients, with regards to viral hepatitis. Our proposal addresses the diagnostic problem by identifying a clear high-risk population originating in prevalent countries. The residual population who are not immigrants from such countries are at low risk. However, this should not override clinical judgement. Its overall cost in other settings will depend on the relative proportions of patients in these risk-strata, but our results suggest that the cost of automatic testing of high-risk individuals will be repaid in terms of additional cases detected.
Clearly the situation might change as vaccination catches on in developing countries and needle hygiene improves. The key points to emerge are that:
1) it is more efficient to determine country of origin with a view to viral testing, than to simply repeat the LFT;
2) it is more cost-effective to test the whole LFT positive population for viral hepatitis, than to repeat the LFT with a view to viral testing if it remains positive.

  • Background

  • Methods

  • Results

  • Discussion

  • Conclusions

  • ,

  • See Full Data Here

    Thursday, April 14, 2011

    Hepatitis C; Understanding the Basic Metabolic Profile (BMP)

    Understanding the Basic Metabolic Profile (BMP)

    The Basic Metabolic Profile (BMP) is a group of tests that examine blood chemistry, that is, the components of blood excluding red and white blood cells and platelets.

    The tests which make up a BMP may vary slightly between labs or institutions, but generally they will provide the physician with information about serum electrolytes, blood sugar and kidney function.

    The tests described in this article include:




    Carbon Dioxide



    Blood Urea Nitrogen (BUN)


    Anion Gap

    The normal range for serum sodium in the adult is 135 to 148 mEq/L.

    Sodium (Na) aids in the regulation of the body's fluid balance, and along with potassium, maintains the electrical potential in the body that allows nerves to operate properly.

    The fluids containing sodium are found almost entirely in extracellular (outside the cell) spaces, such as blood vessels. Sodium levels are maintained by the ingestion of sodium in food, and it is excreted through sweat, urine and feces.
    Common causes of decreased serum sodium (hyponatremia) include:

    Decreased sodium intake / increased sodium loss

    Excess water ingestion



    Administration of diuretics

    Kidney disease

    Addison’s disease

    Edema and/or ascites.
    Common causes of increased sodium (hypernatremia) include:

    Increased sodium intake / decreased sodium loss

    Excessive free water loss, such as sweating, burns

    Diabetes insipidus

    Osmotic diuresis.

    The normal range for serum potassium in the adult is 3.5 to 5.5 mEq/L.

    Potassium (K), as opposed to sodium, is found almost entirely inside the cells of the body. Proper levels of potassium are critical to the normal function of muscles, including the heart.

    Abnormal levels of potassium can cause severe irregularities in the heart's rhythm and ability to contract. Potassium is ingested in the diet and is excreted in urine.

    Common causes of decreased potassium (hypokalemia) include:

    Diuretic use without potassium replacement

    Administration of IV fluids without potassium

    Alcoholic cirrhosis


    Crohn's disease

    Cushing's syndrome.
    Common causes of increased potassium (hyperkalemia) include:

    Kidney disease or failure

    Rapid administration of IV fluids containing potassium

    Burns and crushing injuries, trauma

    Myocardial infarction (heart attack)

    Addison's disease.

    The normal range for serum chloride in the adult is 95 to 105 mEq/L.

    Chloride (Cl) works with sodium to maintain the balance of fluids in the body, and aids in the regulation of the acid / base balance. It is an anion (negatively charged particle) found mainly in extracellular spaces.

    Chloride abnormalities can cause increased nervous system irritability, exaggerated reflex responses, decreased respiration, weakness, stupor and coma.

    Alterations in chloride levels are unusual, but are found in association with other electrolyte imbalances.

    Common causes of deceased chloride (hypochloremia) include:

    Vomiting, diarrhea, or gastrointestinal suctioning

    Administration of diuretics

    Administration of IV fluids without electrolyte replacement.
    Common causes in increased chloride (hyperchloriemia) include:


    Acid/base imbalances

    Administration of medications containing chloride.
    Carbon Dioxide

    The normal range for serum carbon dioxide in the adult is 23 to 30 mEq/L or 23 to 30 mmol/L.

    Carbon dioxide (CO2) is an anion (negatively charged ion) that assists in acid / base balance and helps maintain the electrical neutrality of fluids both inside and outside cells.

    In solution, carbon dioxide (CO2) combines with water (H2O) to form carbonic acid (H 2CO3). Higher levels of CO2 in the blood create an acidic condition (acidosis), and low levels create an alkaline condition (alkalosis).

    Levels of CO2 are regulated by the kidneys and CO2 is expelled by the lungs during respiration.

    Alterations in the concentration of this electrolyte do not occur in isolation; that is, abnormalities in CO2 are always related to a co-existing disease or condition.

    Common causes of increased serum carbon dioxide (acidosis) include:

    Diseases / conditions that decrease respiration


    Congestive heart failure

    Uncontrolled diabetes


    Kidney disease / failure


    Certain medications and poisons.
    Common causes of decreased serum carbon dioxide (alkalosis) include:

    Diseases / conditions that increase respiration (hyperventilation)

    Fluid losses from the GI tract (vomiting, suctioning)

    Administration of diuretics

    Administration of steroids

    Cushing's disease

    Salicylate intoxication

    Excessive administration of medications containing bicarbonate.

    The normal range for serum calcium in the adult is 9 to 10.5 mg/dL, or 2.25 to 2.75 mmol/L.

    Calcium (Ca) is found primarily in the body in the form of bones and teeth; however, about 10% is found in the blood, in the form of a cation (positively charged ion) that plays an important role in the function of nerves and coagulation of blood.

    When levels of serum calcium are low, the body produces hormones that remove calcium from bone to supplement serum calcium.

    Because serum calcium plays an important role in nerve function, alterations in calcium levels can cause serious symptoms. These include decreased or exaggerated muscle tone, abnormal reflexes, severe gastrointestinal problems, such as nausea, vomiting, cramping and constipation, and disorders of the central nervous system, like lethargy, depression, convulsions and coma.

    In extreme cases, pathological bone fractures can occur as a result of prolonged calcium loss.

    Common causes of decreased serum calcium (hypocalcemia) include:

    Diseases of the small intestine, interfering with calcium absorption

    Excessive protein intake

    Administration of blood with citrate

    Common causes of increased serum calcium (hypercalcemia) include:

    Prolonged immobilization


    Diseases involving the breakdown of bone

    Excessive ingestion of vitamin D

    Kidney diseases / failure.

    The normal range for serum glucose in the adult is 70 to 110 mg/dL.

    Glucose (Glu) is a form of sugar that circulates in the blood to provide metabolic fuel for all body processes. Carbohydrates and sugars are ingested through food, broken down and absorbed in the small intestine, and are stored in the liver in the form of glucose.

    The most common cause of abnormal blood sugar levels is Diabetes Mellitus, a disease in which serum glucose is consistently elevated as a result of decreased or absent insulin production, insulin resistance, or both.

    The physical consequences of persistently elevated serum glucose / diabetes are many, and affect almost every body system.

    The symptoms of decreased levels of serum glucose (hypoglycemia) can include sweating, anxiety, rapid pulse, and headache. If serum glucose drops to below 50 mg/dL, the patient may have loss of consciousness, and perhaps convulsions.

    Common causes of increased serum glucose (hyperglycemia) include:

    Diabetes Mellitus

    Administration of certain steroids and hormones

    Administration of total parenteral nutrition

    Administration of diuretics

    Diseases of the pancreas.
    Decreased serum glucose (hypoglycemia) is not common, but causes may include:

    Administration of insulin or other hypoglycemic medication


    Exposure to severe cold


    Prolonged fever

    Diseases of the pancreas

    Decreases in pituitary or adrenocortical function.
    Blood Urea Nitrogen

    The normal range for blood urea nitrogen in the adult is 4 to 22 mg/dL.

    Blood urea nitrogen (BUN) is a waste product of protein metabolism. It is produced by the liver and excreted in the urine.

    Abnormal elevations of BUN are most commonly caused by diseases of the kidney, prostate, and urinary tract, and the patient may have symptoms characteristic of fluid overload: decreased urine output, weight gain, edema, and distended neck veins. The skin may be yellowed and easily bruised, and the patient's mental state may be affected.

    Decreased BUN is uncommon, but common causes may include:

    Liver failure, inhibiting protein metabolism

    Negative nitrogen balance (when protein breakdown exceeds protein intake)



    Prolonged IV therapy in patients receiving inadequate oral nutrition

    Common causes of increased blood urea nitrogen (azotemia) include:

    Kidney diseases / failure

    Diseases decreasing the ability to excrete urine

    Increased protein metabolism

    Breakdown of muscle tissue (starvation, anorexia nervosa)




    Gastrointestinal bleeding

    Administration of corticosteroids

    Administration of tetracyclines


    The normal range for serum creatinine in the adult is 0.6 to 1.2 mg/dL. The ideal BUN:creatinine ratio is 20:1.

    Creatinine (Cr) is a nitrogen-based waste product that is produced as a result of protein metabolism in muscle tissue. Creatinine is produced at a very steady rate and is not subject to rapid fluctuations. It is excreted by the kidneys.

    Creatinine and BUN both measure kidney function, but in slightly different ways. It is clinically useful to evaluate the ratio of BUN to creatinine when conducting a diagnostic assessment.

    Dehydration and protein breakdown can cause elevation in BUN, but may affect serum creatinine only slightly or not at all. However, if both BUN and serum creatinine are elevated, this strongly suggests the presence of primary kidney disease.

    Common causes of increased serum creatinine include:

    Kidney diseases / failure

    Administration of diuretics, sulfonamides, chloramphenicol, ascorbic acid

    Use of marijuana

    Diet high in red meat.
    Decreased serum creatinine is rare, but has been associated with muscular dystrophy.

    Anion Gap

    The normal range for anion gap is 12 to 18 mmol/L; however, newer, more sensitive test equipment may have a reference range of -4 to 7 mmol/L.

    The anion gap is a figure calculated by subtracting the number of anions (chloride and bicarbonate, the negatively charged electrolytes) from the cations (sodium and potassium, the positively charged electrolytes).

    The remainder, the "gap," is composed of unmeasured electrolytes, organic ions, and plasma proteins.

    An increased anion gap indicates that presence of an excess of the unmeasured anions which can occur when surplus hydrogen ions have been introduced into the body.

    Surplus hydrogen ions can shift the pH (the measure of acid / base balance) of the body towards an acid state, or acidosis.

    Common causes of an increased anion gap include condition or diseases that induce acidosis, such as:

    Diabetic ketoacidosis

    Lactic acidosis

    Kidney failure associated with increased BUN

    Various drug or chemical toxicities.
    Summary of Normal Ranges (Adult)

    Sodium: 135 to 148 mEq/L

    Potassium: 3.5 to 5.5 mEq/L

    Chloride: 95 to 105 mEq/L

    Carbon Dioxide: 23 to 30 mEq/L or 23 to 30 mmol/L

    Calcium: 9 to 10.5 mg/dL, or 2.25 to 2.75 mmol/L

    Glucose: 70 to 110 mg/dL

    BUN: 4 to 22 mg/dL

    Creatinine: 0.6 to 1.2 mg/dL

    BUN / Creatinine ratio: 20:1

    Anion Gap: 12 to 18 mmol/L (older equipment)
    Anion Gap: -4 to 7 mmol/L (newer equipment)

    McFarland M, Grant M. Nursing Implications of Laboratory Tests, 3rd ed. Delmar Publishers Inc

    Sunday, March 20, 2011

    Research on Hepatitis C Virus Detailed by Scientists at OraSure Technologies, Inc.

    New research, 'Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid,' is the subject of a report. "The availability of a highly accurate, rapid, point-of-care test for hepatitis C virus (HCV) may be useful in addressing the problem of under-diagnosis of HCV, by increasing opportunities for testing outside of traditional clinical settings. A new HCV rapid test device (OraQuick?? HCV Rapid Antibody Test), approved recently in Europe for use with venous blood, fingerstick blood, serum, plasma, or oral fluid was evaluated in a multi-center study and performance compared to established laboratory-based tests for detection of HCV," scientists writing in the Journal of Virological Methods report (see also Hepatitis C Virus).

    "The HCV rapid test was evaluated in prospective testing of subjects with signs and/or symptoms of hepatitis, or who were at risk for hepatitis C using all 5 specimen types. Performance was assessed relative to HCV serostatus established by laboratory methods (EIA, RIBA and PCR) approved in Europe for diagnosis of hepatitis C infection. Sensitivity to antibody in early infection was also compared to EIA in 27 seroconversion panels. In addition, the reliability of the oral fluid sample for accurate detection of anti-HCV was assessed by studying the impact of various potentially interfering conditions of oral health, use of oral care products and consumption of food and drink. In this large study of at-risk and symptomatic persons, the overall specificities of the OraQuick?? HCV Rapid Antibody Test were equivalent (99.6-99.9%) for all 5 specimen types and the 95% CIs substantially overlapped. Overall sensitivities were virtually identical for venous blood, fingerstick blood, serum and plasma (99.7-99.9%). Observed sensitivity was slightly lower for oral fluid at 98.1% though the upper CI (99.0%) was equal to the lower CI for venous blood and fingerstick blood. Most of the HCV positive subjects which gave nonreactive results in oral fluid had serological and virological results consistent with resolved infection. Sensitivity for anti-HCV in early seroconversion was virtually identical between the HCV rapid test and EIA. Detection of anti-HCV in oral fluid appeared generally robust to conditions of oral health, consumption of food and drink and use of oral care products. The OraQuick?? HCV Rapid Antibody Test demonstrated clinical performance that was equivalent to current laboratory-based EIA," wrote S.R. Lee and colleagues, OraSure Technologies, Inc.

    The researchers concluded: "This new, HCV rapid test appears suitable as an aid in the diagnosis of HCV infection and may increase testing opportunities due to its simplicity and flexibility to use multiple specimen types, including fingerstick blood and oral fluid."

    Lee and colleagues published their study in the Journal of Virological Methods (Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. Journal of Virological Methods, 2011;172(1-2):27-31).

    Additional information can be obtained by contacting S.R. Lee, OraSure Technologies, Inc., 220 East First Street, Bethlehem, PA 18015 USA.

    Keywords: City:Bethlehem, State:PA, Country:United States, Antibodies, Blood Proteins, Digestive System Diseases, Flaviviridae Infections, Gastroenterology, Globulins, HCV, Hepatitis C Virus, Hepatitis Viruses, Hepatology, Human Hepatitis, Immunoglobulins, Immunology, Infectious Disease, Liver Diseases, RNA Viruses, Viral, Virology.

    This article was prepared by Lab Business Week editors from staff and other reports. Copyright 2011, Lab Business Week via

    To see more of the, or to subscribe, go to

    Thursday, March 3, 2011

    Hepatitis C: Viral Load Test

    Viral load is the amount of virus present in the bloodstream. It is expressed as the amount of viral genetic material (RNA) per milliliter of blood. Viral load is not related to the amount of liver damage, or to how sick someone is.
    Types of HCV Viral Load Tests
    There are two categories of HCV viral load tests:

    Qualitative viral load tests — These tests determine the presence of HCV RNA in the blood. This type of test is usually used to confirm chronic infection with HCV. If viral RNA is detected, a positive result is reported; if viral RNA is not detected, the test result is negative.
    Quantitative viral load tests — These tests measure the amount of virus in one milliliter of blood. They are often used to assess whether or not treatment with interferon or interferon plus ribavirin is likely to be successful and, later, if treatment is working.
    When you get back the result of your Hepatitis C RNA quantitative test, and when the lab was able to determine the amount of virus in your blood, then it is important to write down not only the number, but also in what units this number is given.
    I) Volume

    The volume of blood, that the number refers to, is usually one milliliter.

    But some labs give the number for 20 microliters = 1/50 milliliter. So in these cases you have to multiply the result of the viral load by 50 to get the number for 1 milliliter.

    II) Amount of Virus

    Unfortunately, there are several ways to express the viral load. So, in order to be able to compare different results, you have to know how to convert these numbers to some standard format, which let’s say is just the plain number of viruses per milliliter, like 1.5 Million/ml, or 1,500,000/ml. (both of these numbers are the same).

    a) Measure by weight

    Sometimes, the lab reports the amount of genetic material found by its weight. 1 pg (pico-gram) of genetic material corresponds to about 1 million virus equivalents, so, if your lab result is given in picograms, just multiply the lab result by 1,000,000, and you have the number of viruses.

    b) Measure by virus count

    i) Plain numbers

    Often the virus count is expressed as a plain number, like 1.73 million, or 1,730,000 or 1730000. Millions sometime are abbreviated by the prefix “M” (Mega). So when you see 1.73 Meq/ml, it means 1.73 Mega-equivalents/ml or again 1730000 equivalents/ml..

    ii) Exponential format

    Large numbers are often expressed in exponential form, that means a number, multiplied by 10 with an exponent. To convert this to normal numbers, append as many zeroes to a “1″ as the exponent says, and multiply this with the number. In some lab report, the viral load was “Hep C RNA Quant 17.3 x 10(exp) 5 equivalents/ml”. So, with 5 as exponent, you have to append 5 zeroes to a “1″, that gives 100000, and multiply this with the number 17.3, that gives 1730000 as the viral load. Normally this would be written 1.73×10(exp)6, or 1.73×106 , (which are again the same number).

    17.3×105 = 1.73×106 = 1,730,000

    iii) Logarthmic format

    Now, recently some people express these numbers also in logarithmic form (logarithmic transformed number).


    6.24 is the logarithmic transformed number of the viral load of our above example. A result of 3.5 for a viral load, that someone reported, seems to be such a number (unless he forgot to write down a “10″ and an exponent). You need a calculator to convert this. You have to use the function 10x , where you have to replace x with the logarithmic number, in the above case 3.5. The result would be: 103.5 = 3162 virus equivalents per milliliter.

    When you take the logarithmic number from the first example, 6.24, you have to calculate 106.24 = 1730000 , and here we have the original number of virus equivalents again. If you don’t have a calculator, you can estimate the order of magnitude of a viral load expressed as a logarithmic number. From the logarithmic number, you take the first digit (left of the point) and add 1 to this number. This gives you the number of digits that your viral load has (expressed as a plain number).

    Example: Logarithmic number 6.24

    Left of the point is “6″. 6+1 = 7

    The number that gives the viral load is 7 digits long, that means it is between 1,000,000 and 9,999,999 (digit # 1 234 567)

    The next digit (right of the point of the logarithmic number) shows whether you are high or low in the range.

    In case you have a logarithmic number *and* a blood volume other than 1 ml, you have to convert the logarithmic number to a plain number *first*, and then correct it to correspond to 1 ml !

    Therefore it is important to have a close look at your lab report and see in what units the result is given!

    There is still no general agreement on what Viral Load is considered low and what is high in Hepatitis C. This interpretation makes sense for people not currently being treated – for someone who is 6 months into an INF + RIBA trial, even 200,000 could be considered a high titer.

    (Numbers are Virus Equivalents per Milliliter)

    below 200,000 very low (undetectable by *bDNA* test)

    200,000 to 1,000,000 low

    1,000,000 to 5,000,000 medium

    5,000,000 to 25,000,000 high

    above 25,000,000 very high

    Once again, please note that this information is not written by an MD or medical expert. Nothing can (or should) take the place of appropriate medical care.
    Posted at Avail Clinical On February 4th, 2011
    HCV Viral Load Tests
    Alan Franciscus, Editor-in-Chief
    Liz Highleyman
    Viral load tests are blood tests that measure HCV ribonucleic acid (RNA, or genetic material) in the blood. The presence of viral RNA indicates that the virus is actively replicating (reproducing and infecting new cells). A viral load test is usually first done after a person has tested positive for exposure to HCV based on an antibody test. A blood sample is taken and the amount of HCV RNA in a milliliter of blood is measured. Viral load tests confirm whether an individual is actively infected with HCV. Viral load test results were previously measured in number of copies, but are now typically reported in terms of International Units per milliliter (IU/mL).

    Types of HCV Viral Load Tests
    There are two categories of HCV viral load tests:

    Qualitative viral load tests — These tests determine the presence of HCV RNA in the blood. This type of test is usually used to confirm chronic infection with HCV. If viral RNA is detected, a positive result is reported; if viral RNA is not detected, the test result is negative.

    Quantitative viral load tests — These tests measure the amount of virus in one milliliter of blood. They are often used to assess whether or not treatment with interferon or interferon plus ribavirin is likely to be successful and, later, if treatment is working.

    There are currently three tests commonly used for HCV viral load testing:

    Polymerase chain reaction (PCR) — PCR tests detect HCV RNA in the blood, which indicates current active infection. This type of quantitative PCR test is very sensitive, and can measure as few as 50 IU/mL.

    Branched-chain DNA (bDNA) — The bDNA method quantitative viral load testing is easier (and cheaper) to use for a large number of samples, but only measures viral loads greater than 500 IU/mL. This means that if a person has a viral load below 500 IU/mL, HCV could be present in the blood but not detected by the test.

    Transcription-mediated amplification (TMA) — TMA technology allows for the amplification and detection of nucleic acids (components of genetic material) in the blood. This test can measure as few as 5-10 IU/mL. This newer test appears easier and cheaper to use, streamlining test processing and producing consistent, reliable, and more rapid results.

    Interpreting Viral Load Test Results
    HCV viral load is often reported as low or high.
    Expressed as copies/mL:
    ·Low: less than 2 million copies
    ·High: more than 2 million copies

    Expressed as International Units (IU/mL):
    ·Low:less than 800,000 IU/mL
    ·High:more than 800,000 IU/mL

    If no HCV RNA is found by a test, a person’s viral load is said to be undetectable. Note that whether viral load is undetectable depends on which test is used. PCR and TMA tests can measure viral loads much lower than those a bDNA test can detect. Importantly, the blood of an individual with a very low viral load may still contain HCV even though the current tests cannot measure it; that is, the virus may not have been truly eradicated from the body.

    Viral load test results can vary depending on how a blood sample is handled and stored. Furthermore, results may vary from lab to lab. For this reason, most experts recommend that people should get their viral load testing done by the same laboratory each time, so that results are more comparable.

    Changes in viral load are sometimes expressed in terms of logs. A log change is a 10-fold increase or decrease. For example, a change from 1,000,000 IU/mL to 10,000 IU/mL is a 2-log decrease.

    Converting copies per milliliter to Inter-national Units
    There is no standard conversion formula for converting the amount of HCV RNA reported in copies per milliliter to the amount reported in International Units. The conversion factor ranges from about one to about five HCV RNA copies per IU. Usually the lab report will list the conversion from IU/mL to copies/mL.

    See Table 1 for a conversion of common viral load tests from IUs to copies.

    Table 1: Conversion Chart

    Assay Conversion Factor Amplicor HCV Monitor v2.0
    (manual procedure) 1 IU/mL = 0.9 copies/ml Cobas Amplicor HCV Monitor v2.0
    (semi-automated procedure) 1 IU/mL = 2.7 copies/ml Versant HCV RNA 3.0 Quantitative Assay 1 IU/mL = 5.2 copies/ml LCx HCV RNA Quantitatiive Assay 1 IU/mL = 3.8 copies/ml SuperQuant 1 IU/mL = 3.4 copies/ml

    Uses of Viral Load Test Results
    Viral load test results have many uses, such as confirming active HCV infection, and predicting and measuring HCV treatment response before, during, and after therapy. Higher HCV viral loads may be associated with a greater risk of HCV transmission, particularly transmission from mothers to infants during pregnancy or birth. Viral load has not been correlated with the risk of sexual transmission. Furthermore, a correlation between HCV viral load and disease progression has not been shown.

    Confirming active HCV infection — After a person has tested positive for HCV antibodies, an HCV viral load test is usually performed to confirm active HCV infection. This test is necessary because in up to 25% of people exposed to HCV, the virus can be cleared on its own.

    Before treatment — Viral load measurement can help predict how well HCV treatment will work.
    The lower the pre-treatment viral load, the more likely it is that a person will respond to current HCV therapies.

    During treatment — A decrease in viral load while on therapy indicates that treatment is working. A treatment is said to produce a complete virological response if it reduces viral load to an undetectable level. After 12 weeks of antiviral treatment, a 2-log drop in viral load or elimination of detectable HCV is an indication that the medications are working. If a person does not achieve a 2-log drop in viral load or elimination of detectable HCV after 12 weeks, it is unlikely that he or she will be able to eradicate HCV from his or her body. Viral load tests during treatment can also detect viral breakthrough, or increases in viral load that occur after a previous undetectable test result.

    After treatment — Viral load measurements can be used after cessation of therapy to monitor for relapse—that is, to see if the virus becomes detectable again after being undetectable when treatment was completed.

    Friday, February 25, 2011

    Scripps Health ;IL28B Genetic Testing to Hepatitis C Patients Now Available

    Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients
    Individualized Therapies Now Available for Drug Treatment of Hepatitis C

    "Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect."

    SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) -- Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.

    The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.

    A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.

    "This is a huge step forward in the movement toward individualized medicine," said Dr. Pockros, "As a physician, knowing what drug therapies will have benefit and which ones won't based on a patient's IL28B genotype is significant because we are able to be more targeted in our approach to treatment."

    This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.

    Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.

    Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.
    Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response.

    The hepatitis C genetic testing is the latest example of Scripps' leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel). Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.

    Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at

    This information was brought to you by Cision

    Wednesday, February 9, 2011

    Summarize of the most common blood tests

    Also See;Hey, I Have A Question About HCV Tests And My Liver
    Blood tests help doctors review your chemical make-up

    Published: Wednesday, February 09, 2011, 12:03 AM

    Blood carries many secrets about our health. Pumped by the heart and circulated through your body, blood supplies tissues and organs with vital nutrients and oxygen and, at the same time, draws toxins and waste products for disposal.

    By testing your blood, a doctor can review the chemical make-up of your system, evaluate how well your organs are working, diagnose diseases, learn whether you have risk factors for heart disease or monitor your response to medications.

    Interestingly, although blood tests are an excellent diagnostic tool, many adults don’t understand why they are done. Among the respondents in a statewide poll conducted by the Pennsylvania Medical Society’s Institute for Good Medicine, nearly 60 percent of those who had blood work did not know what it was for.

    To help demystify blood tests, we interviewed Dr. Kathryn M. Frantz of Susquehanna Internal Medicine Associates in Camp Hill and Judy Darr, PinnacleHealth’s laboratory administrative director, to summarize the most common blood tests, why they are given and what the results can prove.

    Comprehensive Metabolic Panel (CMP)

    What is it?

    This is the No. 1 test in reviewing the body’s chemistry, as well as the status of the kidneys and liver.

    What does it measure?

    BUN (blood urea nitrogen) and creatinine are waste products that are filtered out of the blood by the kidneys and are indicators of kidney function. Increased levels might point to a kidney problem. High creatinine might indicate the possible malfunction or failure of the kidneys.

    Enzymes are found in the liver and other tissues. Bilirubin is a waste product of the liver. High levels of any of these indicate dysfunction, disease or inflammation.

    Calcium guards against osteoporosis. Abnormal levels might be a sign of kidney problems, bone or thyroid disease, cancer, malnutrition or other disorders.

    Glucose is the type of sugar your body uses for energy. Abnormal levels might indicate diabetes.

    Electrolytes are the minerals that help maintain fluid levels and acid-base balance in the body. They include potassium, sodium, CO2 (bicarbonate and carbon dioxide) and chloride. Electrolyte imbalance can be present with a wide range of acute and chronic illnesses.

    Why is it given?

    It’s given to patients who take Lipitor or another medication that might affect the liver, or to patients who take medicines that might affect the kidneys, such as diuretics (commonly known as water pills), blood pressure pills or antidepressants. It’s often part of an overall physical check-up for adults who have not had recent blood work. According to Frantz, every one of the components revealed in the CMP relates to a medical issue. The Basic Metabolic Panel (BMP), is similar to the CMP, but does not include liver function results.

    Complete Blood Count (CBC)

    What is it?

    The CBC is a common test that gives your doctor a baseline measurement of the concentration of white blood cells, red blood cells and platelets in your blood. If the cell populations are within normal limits, you might not require another CBC until your health status changes or your doctor feels that it is necessary.

    What does it measure?

    A CBC reveals the number of your cells, information on the distribution of white cells, the size of red cells and a statistical analysis of those cells.

    Why is it given?

    Symptoms or medical problems such as fatigue, shortness of breath, belly pain, chest pain, arthritis or previous anemia often merit a CBC in order to give a proper diagnosis. Also, it’s given if you have other diseases such as malaria, leukemia, sickle cell anemia or are awaiting surgery. Significant increases in white blood cells might help confirm an infection. A decrease in the number of red blood cells (anemia) might indicate a problem or loss of these cells. A platelet count that is low or extremely high also can be a sign of a bone marrow disease such as leukemia. .
    Lipid Screen or Lipid Panel

    What is it?

    It screens the cholesterol levels in your body.

    What does it measure?

    HDL — High-density lipoproteins or “good” cholesterol. It takes cholesterol away from cells and transports it to the liver for removal.

    LDL — Low-density lipoproteins or “bad” cholesterol. It contains the greatest percentage of cholesterol and deposits it on artery walls.

    Triglycerides — Fat in the blood responsible for providing energy to cells.

    Why is it given?

    Patients at risk for coronary heart disease, hypertension or diabetes receive the test. Elevated cholesterol is associated with an increased risk of heart disease. Fasting is generally required for the test.

    Hemoglobin A1c

    What is it?

    Routinely given to diabetics or those whose sugar is borderline. The test monitors the patient’s glucose control over time.

    The test provides a picture of the average amount of glucose in the blood over the last few months, which helps the doctor and diabetic patient determine if the measures being taken to control this disease are working or need adjustment.

    Why is it given?

    Diabetics need to keep their blood glucose levels close to normal, and this helps minimize the complications caused by chronically elevated levels. Fasting before the test is often required.

    Thyroid Stimulating Hormone (TSH) Test

    What is it?

    The TSH test is most often used as a screening test for fatigue, weight gain, weight loss, anxiety, severe diarrhea or constipation.

    What does it measure?

    The test measures the levels of TSH, a hormone made and released by the pituitary gland. The pituitary can sense whether there is enough thyroid hormone in the bloodstream and releases TSH when it detects insufficient thyroid hormone.

    Why is it given?

    It helps diagnose a thyroid condition, such as hypothyroidism or hyperthyroidism.

    Prothrombin Time (P-TIME)

    What is it?

    It’s a test that measures how quickly your blood clots.

    What does it measure?

    Prothrombin is a protein produced by the liver that aids in your blood clotting. During this process, prothrombin turns into thrombin. The P-Time test measures the time it takes for this to occur.

    Why is it given?

    It’s used to check for bleeding problems, especially if you are going to have surgery or are taking a blood-thinning medication. Patients taking these medicines might have the P-Time done frequently to monitor the medication’s effectiveness.

    Visit PennLive

    Dr. Jeff Hersh: Understanding blood tests
    By Dr. Jeff Hersh.
    GateHouse News Service
    Posted Feb 08, 2011 @ 12:11 PM

    Q: I had a routine blood test, and my doctor told me my white blood cell count was low. Should I be worried?

    A: Several different types of white blood cells fight bacterial, fungal, viral and/or parasitic infections, as well as serving other functions. In adults, a white blood cell count less than 3,500 cells per microliter is considered low; the normal threshold in children varies with age.
    White blood cells are made in the bone marrow and are released into the blood stream. They then circulate in the blood stream or take up residence in the vascular endothelium system or certain body tissues/organs. Old white blood cells are cleared from the blood stream by the spleen and liver.

    The white blood cell count is measured by evaluating the concentration of white blood cells in the bloodstream. Falsely low measurements can occur due to clumping of the white blood cells or from other factors.

    A truly low white blood cell count can be from a congenital cause or it can be acquired. There are many different congenital conditions that cause low white blood cell counts. An acquired low white blood cell count can be due to:

    Decreased bone marrow production: This may be due to infections (viral infections are the most common cause), medication reactions (the second most common cause), certain congenital conditions, medication effects (such as from chemotherapy agents) or from cancer/infections/other conditions that infiltrate the bone marrow "crowding out' its ability to produce normal white blood cells. In addition, certain autoimmune conditions can affect the hormones that trigger white blood cell production, hence "turning off the switch" that tells the bone marrow to produce white blood cells. There are also many conditions that may directly affect the cells that make the white blood cells, causing ineffective production of normally functioning cells. High thyroid levels and/or certain vitamin or mineral deficiencies (such as B-12 or folate deficiencies) can cause inadequate white blood cell production as well.
    Increased destruction of white blood cells in the bloodstream: This may be due to autoimmune conditions (possibly triggered by medication reactions) or many other conditions.
    Increased clearance of white blood cells (even normally functioning ones): This may be due to an enlarged spleen (from whatever cause).

    Using them up faster than they can be replaced: Overwhelming infections can do this.
    Migration of the cells out of the bloodstream: In some conditions white blood cells can migrate to the vascular endothelium or other tissue pools/organs.

    The type, risk and severity of any clinical problem from low white blood cells depends on the type of white blood cells that are affected and how severe the deficit is. Many of the conditions that cause a low white blood cell count are benign, causing minimal or no clinical problems. However, since white blood cells are one of the main ways the body fights infections, a low white blood cell count can lead to an increased risk of infection.

    Polymorphonuclear cells (PMNs) are the most common type of white blood cells and, hence, low white blood cells almost always implies a low PMN count. Since PMNs fight bacterial infections, overall this is the most common infection from low white blood cells.
    Low white blood cell count is more common in African Americans; 5 percent to 10 percent of black Americans have low neutrophil counts, as opposed to less than 1 percent of white Americans. Thankfully, this is usually due to a benign inherited condition, so most of these patients do not have clinical problems.

    In patients with a mildly decreased white blood cell count noted on a routine blood test who do not have a history of infections, other testing may not be required. However, in patients with a history of infections, or those with other concerning results of their blood test, other testing may be indicated.

    For example, if transient neutropenia is suspected (a condition where a patient's PMNs drop for several days every few weeks, predisposing them to infection) blood tests to check their white blood cell count may be required several times per week for several weeks. If decreased cell production is suspected, a bone marrow biopsy may be required. If an autoimmune condition is suspected screening tests for a collagen vascular disease or other testing may be needed. If a chronic infection is suspected -- for example, HIV infection -- other tests may be indicated.
    Many patients with low white blood cells do not require treatment. However, good dental care (since this can be a source of infection) and increased vigilance when they have a fever or appear ill is indicated.

    Depending on the cause of the low white blood cells, some patients may benefit from antibiotics to minimize their risk of acquiring an infection. For example, certain HIV patients are put on specific types of antibiotics.
    For some patients -- like those receiving chemotherapy for certain cancers -- medications that stimulate the bone marrow to increase production of white blood cells may be beneficial.
    A low white blood cell count should trigger a discussion with your health care provider. He or she can evaluate your history and risk factors, as well as the other details of the test results, and determine what other testing and/or treatments may be required.

    Jeff Hersh, Ph.D., M.D., F.A.A.P., F.A.C.P., F.A.A.E.P., can be reached at
    MetroWest (Mass.) Daily News
    Copyright 2011 The Milford Daily News.
    Some rights reserved

    Tuesday, January 25, 2011

    Hepatitis C Treatment; What Do I Need To Know?

    Road Less Traveled; By Lana Gramlich.

    When telaprevir and boceprevir are ready to use for the treatment of HCV many people who are now being warehoused/waiting will be embarking on treatment for the first time. Deciding on treating HCV can be a difficult choice to make. This blog has put together a few facts on disease progression and tips to help navigate through that difficult process. "The information has been collected from the sources listed below." If this isn't your first time on treatment, a special word of encouragement goes out to everyone who is still on the front-line continuing to fight this disease; may these new drugs be the cure you have waited for and deserve.
    Recommendations : Hepatitis C

    Specific clinical recommendations for Hepatitis C :
    Persons with HCV infection should be vaccinated against hepatitis A and B
    Abstinence from alcohol is recommended for persons with chronic HCV infection
    Persons with chronic HCV infection and cirrhosis should avoid hepatotoxic drugs
    For persons with chronic HCV infection and cirrhosis, surveillance for hepatocellular carcinoma should be considered.

    Who Should Not Treat Hepatitis C ?

    Contraindications To Treatment

    2010 Guidelines:
    Absolute contraindications to treatment of HCV infection include active alcohol or substance abuse, active autoimmune hepatitis or other condition known to be exacerbated by interferon and ribavirin, known hypersensitivity to medications used to treat HCV infection, and pregnancy or lack of compliance with adequate contraception.

    Other absolute contraindications to treatment of HCV infection are severe concurrent cardiopulmonary disease; uncontrolled major depressive illness, psychosis, or bipolar disorder; and untreated hyperthyroidism. Relative contraindications to treatment of HCV infection include laboratory values suggesting decompensated cirrhosis, and baseline hematologic and biochemical indices.

    For ribavirin only, renal failure is an absolute contraindication

    Treatment with ribavirin should be avoided in patients with ischemic cardiovascular and cerebrovascular disease and in patients with renal insufficiency.

    Why Should I Treat HCV ?

    Justification for Treatment

    Treatment goals in patients with HCV infection are to delay or prevent progression of fibrosis and to prevent the development of cirrhosis.

    Natural history studies indicate that 55% to 85% of individuals who develop acute hepatitis C will remain HCV-infected. Spontaneous resolution is more common among infected infants and young women than among persons who are older when they develop acute hepatitis.

    Chronic HCVinfection has relevance for the infected persons as well as for their contacts: the former are at risk for progression to cirrhosis and/or HCC, the latter are at risk of acquiring the infection through exposure to the virus.

    The risk of developing cirrhosis ranges from 5% to 25% over periods of 25 to 30 years.

    Prospective studies of women and children infected at a young age and followed for 20 to 30 years report low rates of cirrhosis, 1% to 3%.

    Retrospective studies of patients referred to tertiary care facilities document higher rates of cirrhosis, 20% to 25%, but this figure may be inflated by referral bias.

    Progression to cirrhosis may be accelerated in persons who are of older age, who are obese, who are immunosuppressed (e.g.,HIV co-infected), and who consume more than 50g of alcohol per day, although the precise quantity of alcohol associated with fibrosis progression is unknown. Persons with HCV-related cirrhosis are at risk for the development of hepatic decompensation (30% over 10 years) as well as hepatocellular carcinoma (1% to 3% per year).

    Identifying individuals at risk for developing progressive disease is difficult. Presently, the preferred approach is to assess the degree of fibrosis on liver biopsy, using avalidated staging system such as the Ishak, IASL, Metaviror Batts-Ludwig staging systems.

    Persons with no or minimal fibrosis (Ishak stage 0-2; Metavir, IASL andBatts-Ludwig stage 0-1) have a low risk for liver-related complications and liver-related death (over the next 10 to 20 years). Infection with HCV can also cause extrahepatic diseases including mixed cryoglobulinemia, types II and III. Indeed, symptomatic cryoglobulinemia is an indication for HCV antiviral therapy regardless of the stage of liver disease.

    However, the presence of bridging fibrosis (for example Metavir stage 3, ) is an important predictor of future progression to cirrhosis and therefore an indication for treatment.
    The Biopsy
    Examples Of Staging According To The Metavir Score;

    What Does My METAVIR Score Mean?

    The fibrosis is graded on a 5-point scale from 0 to 4.

    The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3.


    Stages of fibrosis (F)

    F0 = no fibrosis

    F1 = portal fibrosis without septa

    F2 = portal fibrosis with few septa

    F3 = numerous septa without cirrhosis

    F4 = cirrhosis

    Activity score:

    Amount of inflammation (A for activity)

    A0 = no activity

    A1 = mild activity

    A2 = moderate activity

    A3 = severe activity

    Other scoring systems are available, such as the Knodell score (also called the histologic activity index, or HAI). However, the METAVIR score is simple to use and is popular in many clinics

    Scoring system for chronic hepatitis C (the Metavir Score System).

    *Note F1-F4 On Figure

    Conversion ; FibroTest and fibrosis stages

    Conversion between FibroTest and fibrosis stages using METAVIR, Knodell and Ishak fibrosis scoring systems (upper panel).

    Conversion between ActiTest and activity grades using METAVIR, Knodell and Ishak necroinflammatory activity scoring systems (lower panel).


    Hepatic Consequences

    Individuals with CHC (Chronic Hepatitis C) are at increased risk of liver related morbidity and mortality.

    HCV infection was associated with 27% of all US liver transplants performed in 2007, and US-based studies demonstrated that up to 51%–55% of HCC patients have anti-HCV antibodies. There is also a link between steatosis and liver fibrosis in HCV-infected patients, as well as a potential association between HCV infection and HCC or, as described more recently, of intrahepatic cholangiocarcinoma (ICC). In some ethnic groups such as Latinos the course of HCV infection is more aggressive, with a higher risk of cirrhosis than other ethnic groups. Furthermore, disease progression is more rapid in patients who are coinfected with HCV and HIV. Coinfected patients have approximately double the risk of cirrhosis or decompensation than those infected with HCV alone.

    Fibrosis and Cirrhosis

    Progressive hepatic fibrosis leading to cirrhosis is the major complication of chronic HCV infection and accounts for almost all HCV-related morbidity and mortality. Early studies suggested little, if any, fibrosis progression during the first decade of infection, followed by a slow, regular progression during the next 15 years, increasing to an intermediate rate during the subsequent decade.

    In a German cohort study of 1833 women infected with HCV-contaminated immunoglobulin, 0.5% of patients developed cirrhosis after 25 years. Similarly, in a study of 376 HCV-infected women conducted by the Irish Hepatology Research Group, 51% of patients had fibrosis after 17 years, but only 2% had probable/definite cirrhosis. These estimates of cirrhosis rates are considerably lower than those from the US multicohort study and the widely cited US military study (approximately 35%). Fibrosis outcomes of 184 women from the same cohort were followed up for the subsequent 5 years; 49% showed no change in fibrosis, 24% showed regression, and 27% showed progression.

    Recent data reinforce the potential for severe liver disease to develop in some patients. Among 485 plasma donors infected during the early 1970s, 34% had stage F3/F4 fibrosis (bridging fibrosis), cirrhosis, or HCC after 31 years; their 35-year cumulative survival was 84% versus 91%–95% for the general population. Similarly, a study of 300 black and white Americans with untreated HCV infection found that 29% of patients had stage F3/F4 fibrosis after 20 years, and 4.7% had confirmed cirrhosis. It should be noted, however, that these studies could have selected patients with severe disease.

    The nonlinear progression of fibrosis was recently confirmed in a meta-analysis of 111 HCV studies. The mean annual stage-specific transition probabilities were for stage F0 to F1, for F1 to F2, 0.120 for F2 to F3, and 0.116 for F3 to F4. Although the estimated prevalence of cirrhosis was 16% after 20 years, there was wide variation between studies, suggesting that fibrosis is a highly unpredictable process.

    Infection duration is a major risk factor for severe fibrosis, with the progression rate in a 50-year-old being almost 3 times that in a 20-year-old. Age at time of infection is also important. In a biopsy analysis of 247 treatment-na├»ve HCV patients, progression rates were 0.13, 0.14, 0.27, and 0.36 fibrosis units/year for patients aged ≤19, 20–24, 25–36, and >36 years at infection, respectively. Age >36 years (vs ≤36 years) at time of infection was independently associated with faster progression. Men infected before age 50 have been identified as comprising the majority of cases of cirrhosis today (73.6%), whereas men aged >50 years when infected have faster disease progression compared with other age groups.

    Several other factors, including sex, baseline fibrosis, HCV genotype, HIV/HBV coinfection, and alcohol consumption, also influence fibrosis progression . Identifying these factors can be useful when determining prognosis and advising patients on minimizing liver damage. Indeed, a recent study suggested that HCV genotype 3 might pose a particularly high risk of progressive fibrosis.
    Insulin resistance has been linked with fibrosis, and several studies have reported that this relationship remains significant, irrespective of HCV genotype.

    In addition, serum aminotransferase level elevations and the degree of hepatocellular necrosis/inflammation on biopsy have been found to predict fibrosis progression. Genetic factors might also play a role in fibrosis progression. Recent data indicate that the cirrhosis risk score, which is based on the association of 7 host genes, might help to differentiate HCV patients at high versus low risk of progressing toward cirrhosis, including those with early or mild CHC. Steatosis has also been linked to fibrosis progression, as has regular cannabis use. There is evidence of an association between cigarette smoking and hepatitis fibrosis, but not all studies have verified such an association.

    Hepatocellular Carcinoma

    The greatest increase in US cancer deaths from 1995–2004 was in those caused by cancers of the liver and bile duct, of which HCC comprised about 76%. This might be attributed to the increasing incidence of HCV-related HCC because rates for HBVrelated and alcohol-related HCC have remained stable during recent years. The incidence of HCV-related HCC in the United States is projected to peak in 2019 at 14,000 cases/year. In a large US database, the proportion of HCV-related cases of HCC among HCC patients aged ≥65 years doubled from 11% in 1993–1996 to 21% in 1996–1999. During the past decade, the fastest increase in HCC incidence has affected Hispanics and whites. In multivariate analysis HCV infection was an independent predictor for the development of HCC.

    Furthermore, maintenance therapy with peginterferon did not reduce the 5-year incidence of HCC in the HALT-C cohort.Comparisons of US and Japanese HCV strains suggest that the US HCV epidemic began about 2 to 3 decades after that in Japan. This has led to speculation that the burden of HCC in the United States might eventually equal that currently seen in Japan as HCV-infected individuals age and their infection duration increases. In Japan, HCV-related HCC accounts for 80% of all HCC cases, and the rate of HCC among HCV-infected men has risen from 17.4/100,000 in 1972–1976 (32,335 deaths) to 27.4/100,000 in 1992–1996 (109,365 deaths).
    A recent Italian study of 214 HCV-infected patients with Child–Pugh class A cirrhosis showed that HCC developed at a rate of almost 4%/year. HCC was the first complication to occur in 55 (27%) patients; after 17 years, HCC had developed in 68 (32%) patients.

    In another cohort of 416 patients with uncomplicated Child–Pugh class A HCV-related cirrhosis, the incidence of HCC was 13.4% at 5 years, and the 5-year HCC death rate was 15.3%, with the hazard rate of HCC tending to increase over time.

    Several factors influence the risk of HCC in patients with HCV-related cirrhosis.

    Generally, HCC risk is increased in patients aged >50 years or those infected when aged >50 years, patients with longer duration of infection, men, overweight or diabetic patients, and patients with advanced cirrhosis or elevated alpha-fetoprotein Other possible risk factors include the presence of steatosis, HCV genotype 1b, Asian/African American race and occult HBV infection. As for hepatic fibrosis, an association between cigarette smoking and HCV-related HCC has been suggested in some studies but not others. Chronic HCV-related inflammation might increase HCC risk by shifting hepatocytic transforming growth factor– beta signaling from tumor suppression to fibrogenesis.

    HCC generally develops after cirrhosis is established, signifying the likely importance of long-standing necrosis and regeneration, an environment of extensive scarring, in its pathogenesis. HCV might influence hepatocarcinogenesis through the oncogenic effects of its core protein, which might augment oxidative stress. It might also alter the signaling cascade of mitogen-activated protein kinase and activating factor 1, thereby activating cellcycle control. Liver angiogenesis and the neovascular response, plus genomic changes that deregulate components of the Jak/STAT pathway in early carcinogenesis, might also promote HCV-related hepatocarcinogenesis. Additional mechanisms have also been proposed.

    Starting Treatment


    How Will I Know If Treatment Is Working ?

    Your doctor will look at several kinds of lab results to keep track of your treatment response.
    A viral load test or PCR will be used to see how much hepatitis C virus is in your blood, it's the most common way to evaluate hepatitis C treatment.

    A PCR/viral load test will be given at baseline(start of treatment) , 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, follow up at 4 weeks, 12 weeks, 24 weeks and one year. (depending on treatment duration).

    Response Guided Therapy

    Treatment will be response guided which is done by viral load monitoring during treatment. This is intended to enable the physician to determine the duration of combination therapy based on a patients viral response. The quantitative HCV RNA level (viral load test) is used to assess response to therapy and as a guide to discontinue treatment.

    A negative viral load test after "four weeks" of therapy is predictive of sustained virologic response. In contrast, failure to achieve a 100-fold reduction in viral load by week 12 of therapy has a strong negative predictive value for sustained virologic response and suggests that treatment is likely ineffective and should be stopped."

    Changes in viral load are sometimes expressed in terms of logs: a 1-log change means a 10-fold increase or decrease; a 2-log change is a 100-fold increase or decrease.

    What Is A 2 Log Drop?

    Example: 2 log drop = 15,000,000 IU/Ml to 150,000 IU/mL; a viral load that starts at 15,000,000 IU/mL and does not decrease to 150,000 IU/mL or lower.

    A "sustained virologic response" means that the virus remains undetectable 6 or more months after you complete treatment.

    Additional Information;

    In SOC = pegylated interferon and ribavirin Laboratory evaluations to monitor during treatment

    What Kind Of Doctor Should I See?

    Before choosing a physician ask him/her how many patients they have treated with HCV and for how long. If possible go through a teaching hospital/university which is on the cutting edge of these therapies. You should use a Gastroenterologist or a Hepatologist. .

    ;What is a Gastroenterologist? .

    A Gastroenterologist is a physician with dedicated training and unique experience in the management of diseases of the gastrointestinal tract and liver.

    What Is A Hepatologist ?

    A physician who successfully completes a hepatology fellowship is considered a hepatologist. Most hepatologists, although not all, are also gastroenterologists. These doctors have successfully completed both a hepatology and a gastroenterology fellowship. Occasionally, gastroenterologists who have not completed a fellowship in hepatology nonetheless focus their medical practice primarily on the diagnosis and treatment of people with liver disease. While these physicians do not have a separate diploma in the field of liver disease, they may also be considered hepatologists.

    Read More Here; What Is A Hepatologist ? What Is A Gastroenterologist?

    Liver Biopsy, Should I or Shouldn't I ?

    According to the 2010 Guidelines: a liver biopsy should be considered in patients with chronic hepatitis C infection if the patient and health care provider wish information regarding fibrosis stage for prognostic purposes or to make a decision regarding treatment. Currently available noninvasive tests may be useful in defining the presence or absence of advanced fibrosis in persons with chronic hepatitis C infection, but should not replace the liver biopsy in routine clinical practice .

    Also See: Liver Biopsy and Noninvasive Tests For Fibrosis

    Noninvasive tests for liver disease, fibrosis, and cirrhosis: Is liver biopsy obsolete?

    Tests before and during HCV therapy:

    You will be asked to give a medical history and have a complete medical examination; including but not limited to an eye examination, an EKG (a tracing by machine that shows how well your
    heart is working), and/or a cardiac stress test, if the provider thinks they are needed.

    A pregnancy test for female patients

    *Note; It is also recommended that men and women should not consider pregnancy for 6 months after discontinuation of the drug.

    Thyroid function should be monitored every 12 weeks while on treatment.

    Genotype test; Viral genotyping is used to determine the kind, or genotype, of the virus. There are 6 major types of HCV; the most common in the U.S. and difficult to treat is (genotype 1), genotypes 2 or 3 have a better response rate to HCV treatment. Genotyping is often ordered before treatment is started to give an idea of the likelihood of success and how long treatment may be needed.

    PCR=Viral Load or Quantitative HCV tests measure the number of viral RNA particles in your blood. Viral load tests are often used before and during treatment to help determine response to treatment .

    As mentioned above; A PCR (viral load test) is at baseline , 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. (depending on treatment duration).


    The IL28B Gene

    Updated; As reported On Feb 25 2011

    Scripps Health ;IL28B Genetic Testing to Hepatitis C Patients Now Available

    .In the last two years there has been notable research on the IL28B gene in relation to treatment response. However at this time the protocol for pre-testing has not been established.

    How is the IL28B gene related to Hepatitis C ?

    Variations in the IL28B gene have recently been linked to better treatment response among people with chronic hepatitis C virus

    From HCV Advocate : The gene is a variation of IL28B (interleukin 28B) which triggers our body to make more of a type of natural interferon called lambda interferon. This natural interferon has also been found to help naturally suppress the hepatitis C virus. In people who take interferon plus ribavirin therapy the presence of a certain variation of IL28B gives them a two-fold increased chance of achieving a sustained virological response (HCV RNA negative 24-weeks post treatment) compared to those who do not have this gene variation.

    Additional Information; IL28B At HCV New Drug Research and Liver Health

    IL28B Gene Patterns and Liver Transplant Outcomes in Hepatitis C Patients

    Do IL28B Gene Variations Affect Liver Disease Progression in People with Hepatitis C ?

    If You Have Cirrhosis And Achieve SVR

    However, patients who achieve an SVR but who have cirrhosis are at risk for comlications including HCC and therefore should continue to be monitored periodically.

    Also See; (See AASLD guidelines on Management ofHepatocellular Carcinoma).

    There is no role for a post treatment liver biopsy among those who achieve an SVR.

    After treatment is completed;
    A PCR is given at 4 weeks, 12 weeks, 24 weeks and one year.

    Side Effects:

    Consequently, telaprevir has been combined with pegylated-interferon and ribavirin in clinical trials. This triple combination is more effective but has a higher rate of adverse events (notably rash) than the standard of care, despite the shorter duration of therapy. In boceprevir anemia has been seen during clinical trials.

    Addtional Information; For SOC

    Hepatitis C Treatment Adverse Event Monitoring

    Hepatitis C: White Blood Count During Therapy

    Hepatitis C: Anemia And Other Side Effects During Treatment

    New Drugs

    Telaprevir and Boceprevir/Less Side Effects?


    Needle Stick Risk; If a family member will be injecting the medication; Please use caution and replace the cap on the syringe as soon as you withdraw the needle.

    Injection Guide

    Dealing with Used Sharps Responsibly:

    A Guide for Patients Improper disposal of needles and other medical sharps can cause needle-stick injuries, especially for garbage collectors. Please throw your used needles away safely. Needles, sharps or sharps containers should not be included in your household trash. Collection programs for these items are available in many locations throughout the country. You may also return the full sharps container to your physician.

    Treating with telaprevir or boceprevir

    Telaprevir and Boceprevir Understanding The Chance For A Cure

    Tip From Dr. Pockros;

    Hepatitis C New Drugs:Telaprevir,Boceprevir Potential for Misuse Is ‘Huge’

    The designs of the phase III trials on which the Food and Drug Administration approval will be based, as well as the resulting treatment regimens, are fairly complex, said Dr. Pockros, "so there will be lots of opportunities to screw things up." For example, he hypothesized, "I am sure that some patients are going to be put on telaprevir for 44 weeks with a 4-week pegylated interferon/ribavirin lead-in [even though the lead-in strategy was evaluated for boceprevir, not telaprevir], and other patients might be put on boceprevir for 12 weeks with no lead-in." For optimal safety and efficacy, Dr. Pockros stressed, physicians must have a good understanding of the treatment regimens, particularly in special populations, and they must actively and frequently monitor for antiviral resistance.

    Additionally, physicians should anticipate problems with adherence, which is already an issue for some patients on standard therapy, he said, noting that – despite the shorter treatment duration – adding a third drug with its own set of side effects to the mix may not be realistic for patients with a history of poor compliance. The objective for physicians should be "to keep our eyes on the ball," said Dr. Pockros. "Our primary goal moving forward with all of the new drugs is going to be eradicating the virus." Paul J. Pockros, M.D., is head of the division of gastroenterology/hepatology and director of the Liver Research Consortium at the Scripps Clinic in La Jolla, Calif. He disclosed relationships with Vertex and Tibotec, which are involved in the development of telaprevir, and Merck, which manufactures boceprevir.

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