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HCV Advocate Newsletter

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May 2008 HCV Advocate

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World Hepatitis Awareness
Lucinda Porter, RN

Blood-Borne Pathogens: A Primer
Liz Highleyman

Disability Claim Reviews
Jacques Chambers, CLU

What’s in a Name?
Alan Franciscus, Editor-in-Chief

Deaths Due to HCV Increasing
Alan Franciscus, Editor-in-Chief

Insulin Resistance
Alan Franciscus, Editor-in-Chief



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World Hepatitis Awareness
Lucinda Porter, RN

In March, I had the joy of travelling to Tanzania. I began my trip on the computer – specifically at the Centers for Disease Contol and Prevention (CDC) website. The CDC’s Travelers’ Health section listed the risks, how to avoid them and what to do if prevention fails. The list included diseases not normally found in the U.S, including Yellow Fever, Malaria, Typhoid, and Dengue Fever.

Fortunately I had all the childhood illnesses along with hepatitis A and B immunizations. For once I was grateful for having hepatitis C (HCV), because it meant one less communicable disease to worry about getting. I just had to not give it to anyone, but this is effortless from years of practice.

While browsing the CDC website, I read about a myriad of microorganisms awaiting me in Tanzania.  Thank goodness for all of the politically incorrect Tarzan movies from my youth. These prepared me for African sleeping sickness, carried by the tsetse fly. Other travel risks included the flu, blood clots, sunburn, terrorism, and attack by a lion or hippo. Luckily I returned home without a scratch.

If you are wondering why I am telling you about this, it comes around to a single concept – awareness. The success of the trip depended on my awareness. I could not prepare for or endure the travel without this knowledge. No vaccine or anything I could pack was as precious as being well-informed about the journey ahead.

This principle applies to living with chronic illness, such as HCV. Illness is a journey. It is not a trip we want or plan to take. Nonetheless, it is an expedition through feelings, relationships, hardships, and grace. Knowledge and consciousness equip us to make the best possible voyage.

Despite criticisms about health care access in the U.S., we have it pretty good. Some countries offer better healthcare and there is room for improvement in the U.S. system. However, there is nothing like travel to impoverished areas to appreciate what we have. 

May 19, 20081 is designated as World Hepatitis Awareness Day. Viral hepatitis is the focus of this occasion. The big three of these are hepatitis A, B, and C.  All three are communicable. All three are serious health conditions.  All three are preventable.

According to the World Health Organization (WHO), hepatitis B (HBV) is the 10th leading cause of death worldwide. Approximately 2 billion have had HBV infection and 350 million live with chronic HBV.  Worldwide, HCV is also a threat. WHO estimates the HCV infection rate at around 3% of the world’s population. More than 170 million people live with chronic HCV infection.

An interesting exercise is to look at maps illustrating worldwide prevalence. I used maps from the WHO website. Globally, the majority of the world has a moderate to high combined risk of hepatitis A, B, and C.  North America, Western Europe, Australia, New Zealand and Japan have the lowest infection rates. These change when looking at the distribution based on each virus.  The map doesn’t change much for countries with a low rate of infection for hepatitis B. However, northern Canada, Alaska, and Greenland shift to a moderate to high prevalence category. Southern South America, Cuba and a few other countries in the Caribbean move to the low prevalence side.

The map for hepatitis C is radically different. Bolivia, Egypt, Mongolia, and the Republics of Cameroon and Guinea have a greater than 10% prevalence rate. A fair number of countries fall in the 2.5 to 10% range, including Japan and Brazil. Most of the rest of the world, including the U.S., Canada, Australia, Europe, India, and New Zealand have 1 to 2.5% prevalence. Greenland, Guyana, some countries in Africa, Asia, and four Eastern European countries have a noticeably low HCV rate.  

What does it mean to increase awareness of hepatitis? There are multiple ways to do this. We can start by expanding our knowledge about these diseases. Spend some time browsing reliable web sites. Attend a class or support group. Ask your medical provider about literature and community services.

Speak up and speak out. Gather courage and talk to others about viral hepatitis. Encourage testing for those with risk factors. Write to your state and federal representatives. Emphasize the need for better funding for health care in general and hepatitis in particular. Visit www.house.gov to contact your congressperson and
www.senate.gov for your senator.

Spread the word, not the virus. Tell others how to avoid getting it or giving it. Start a support group. Identify community resources. Add a square to the Hep C Quilt Project. www.geocities.com/
hepcquilt
.

Raise consciousness but not self-consciousness. Let’s face it – it is a drag having a communicable disease. Some have tried treatment and are still stuck with HCV. We may not have any control over the virus but we do have control over our attitude. Make peace with this, because being at war with your self is an even bigger drag.

Put your money where your mouth is. There are many fine non-profit organizations that need every dime we can spare – especially in this economy. Put a quarter in a jar every day and in a year, it amounts to over $90. Choosing a $1 cup of coffee over a $4 espresso drink would save $3, amounting to over $1000 annually. If a million of us did this, we would raise significant funds.

One of the places I visited in Tanzania was the Olduvai Gorge. I stood on the spot where the Leakeys found our earliest ancestors.  It was a palpable reminder that we are all sons and daughters of those before us; sisters and brothers of those who share our planet. Margaret Mead said, “Never doubt that a small group of thoughtful committed people can change the world. Indeed, it is the only thing that ever has.” The future is in our hands.

Additional Resources:

Centers for Disease Control and Prevention
www.cdc.gov

World Health Organization
www.who.int/en

1Other organizations use different dates for Hepatitis Awareness.


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In the United States, more people die from lack of health insurance than from hepatitis C. Approximately 1 in 6 people have no health insurance. The rate of uninsured children is at 11.7%.   For more information about healthcare in this country and the presidential candidates’ healthcare proposals, visit the following websites:



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Blood-Borne Pathogens: A Primer
Liz Highleyman

In late February, many were shocked to learn that perhaps 40,000 people had potentially been exposed to blood-borne pathogens – including hepatitis C virus (HCV), hepatitis B virus (HBV), and HIV – through improper procedures at a Las Vegas endoscopy clinic. The situation cast a spotlight on the persistent problem of so-called “nosocomial” disease transmission in healthcare settings.

The Las Vegas outbreak came to light when three cases of acute hepatitis C were reported within a short period. To date, six patients of the Endoscopy Center of Southern Nevada have been identified with acute hepatitis C, five of whom received injected anesthesia at the clinic on the same day in September; genetic testing later confirmed that these individuals were infected with the same HCV strain.

The patients were apparently infected through inappropriate reuse of anesthesia drug vials and, possibly, syringes. After it became apparent that these practices had been going on for years – potentially exposing thousands of patients – all individuals who had received anesthesia injections at the clinic since 2004 were encouraged to undergo testing for HBV, HCV, and HIV, representing the largest ever public health breach of its kind in the United States.

The local outbreak led Nevada officials to investigate other clinics in the state, which turned up more than a dozen with major or minor deficiencies in infection control procedures. Nosocomial hepatitis C transmission has also occurred among individuals receiving anesthesia for colonoscopy in New York City, patients of a dermatologist in Michigan, and residents of a Los Angeles retirement center who underwent unsafe blood glucose testing. The largest such U.S. outbreak involved 99 patients at a Nebraska cancer clinic who were infected through reuse of syringes to flush their catheters with saline during chemotherapy.

Blood-borne Viruses

By the time HCV was identified as a distinct pathogen in 1989, healthcare professionals were already well aware of the dangers of blood-borne exposure to hepatitis B, and the HIV/AIDS epidemic beginning in the early 1980s led to the widespread adoption of so-called “universal precautions.”

Blood-borne pathogens are spread when the blood of an infected person comes into contact with that of another individual. This may occur, for example, through sharing drug injection equipment, reuse of needles on more than one patient, or accidental needle-stick accidents in a healthcare setting. Transmission may also occur through reuse of other types of medical equipment such as scalpels and endoscopes.

As the recent Las Vegas outbreak illustrates, blood-borne viruses can be transmitted via reuse of syringes – even if a new needle is attached – as well as through shared vials containing drugs drawn up through a needle. Such contamination may occur even if no blood is visible. The same has been demonstrated in studies showing that viruses may be transmitted via shared syringes, spoons or “cookers,” and mixing water for illegal drug injection, even if needles themselves are not reused. Reuse of needles or ink pots for tattooing may also transmit these pathogens. Shared personal care equipment such as razors, nail files, and toothbrushes also present a rare but potential risk.

HBV is easier to transmit through blood contact (as high as a 30% chance per needle-stick exposure) than either HCV (about 2% per exposure) or HIV (about 0.3%). Both hepatitis viruses can live longer than HIV in syringes or in dried blood. The risk of infection rises with exposure to larger amounts of blood and if the source patient has a higher viral load. Beyond direct blood exposure, these viruses can be transmitted through contact with broken skin or mucous membranes (e.g., eyes, nose, mouth). Sexual transmission may also occur, especially through activities that involve trauma or blood. Since donated blood and organs are now routinely tested for blood-borne viruses, this route of transmission has become rare in developed countries.

Besides HBV, HCV, and HIV, viral hemorrhagic fevers such as Ebola are also blood-borne, but are seldom seen in the United States. The pathogens that cause diseases such as malaria and West Nile virus are also found in blood, but are transmitted via insect “vectors” rather than through direct blood contact.

Universal Precautions

The idea behind universal precautions is to regard blood and certain bodily substances from all individuals as potentially infectious, rather than trying to guess who might be at high risk. Universal precautions apply to blood, semen, vaginal secretions, cerebrospinal fluid, amniotic fluid, and fluids of the heart (pericardial), lungs (pleural), joints (synovial), and abdominal cavity (peritoneal), as well as tissues and organs. According to U.S. Centers for Disease Control and Prevention (CDC) guidelines, universal precautions for blood-borne infections do not apply to urine, feces, vomit, sweat, tears, nasal secretions, sputum, or saliva unless they are likely to contain blood, as may occur during dental procedures; however, these substances are linked to various other types of diseases such as hepatitis A and tuberculosis.

Universal precautions include use of personal protective equipment such as gloves, face masks, goggles, and gowns; gloves should be changed after each patient. Equipment contaminated with blood should never be used on another person unless properly sterilized. Needles and syringes should only be used for a single patient; safety devices with a retractable needle are increasingly used to prevent needle-stick injuries. Much medical equipment is intended to be used on a single patient and then discarded. Reusable equipment should be fully sterilized, for example using an autoclave. Sterilization is a more thorough procedure than disinfection using chemical germicides, which do not kill all pathogens as well as high heat. Persons whose work could potentially put them or others at risk – including first aid providers and housekeeping staff – should be adequately trained in proper infection control procedures.

The CDC has a set of recommended protocols in case of exposure to blood-borne pathogens. For exposures to HCV and HIV, the agency recommends baseline antibody testing as soon as possible, then again after 4-6 months. This allows for the “window period” the body needs to produce enough antibodies to be detected by the tests. Infection can be identified sooner (4-6 weeks) by testing for viral genetic material (DNA or RNA). For suspected HCV infection, alanine aminotransferase (ALT) should also be measured at baseline and after the window period.

If an exposure is recognized immediately, post-exposure prophylaxis, or “PEP,” is available for HBV using the hepatitis B vaccine and/or immune globulin (within seven days, but preferably with 24 hours), and for HIV using a one-month regimen of antiretroviral drugs (starting within 72 hours, but the sooner the better). Healthcare workers and anyone else at risk should be vaccinated against HBV, which is now included as a routine childhood immunization. At this time, there is neither a vaccine nor a recommended PEP regimen for hepatitis C.

More Work Needed

Although procedures for preventing transmission of blood-borne viruses are well established and the vast majority of healthcare workers follow universal precautions, some providers regrettably fail to heed these recommendations for reasons ranging from poor training to ill-advised attempts to save money by reusing equipment. Such problems are more likely in ambulatory outpatient centers like the Las Vegas clinic, while hospitals usually have stricter infection control protocols.

A German study presented at the 4th International AIDS Society Conference last summer in Sydney, Australia, showed that among HIV positive gay men, having undergone surgery was a risk factor for HCV infection – along with unprotected sex and intranasal drug use – demonstrating that nosocomial transmission remains a concern even in industrialized countries with a sophisticated healthcare infrastructure.

While the recent U.S. outbreak is cause for concern, it may also spur greater action. “[T]his could represent the tip of an iceberg and we need to be much more aggressive about alerting clinicians about how improper this practice is,” said CDC Director Dr. Julie Gerberding, referring to syringe and vial reuse. She also emphasized the need to “invest in our ability to detect these needles in a haystack…so we recognize when there has been a bad practice and patients can be alerted and tested.”



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Disability Claim Reviews
Jacques Chambers, CLU

Persons receiving disability benefits will be asked periodically to confirm their status as disabled whether the benefits come from a disability insurance policy or Social Security. Both are discussed below.

Social Security Continuing Disability
Reviews

Whether you are collecting Social Security Disability (SSDI) or Supplemental Security Income (SSI), your medical records will be reviewed periodically to see if you are still disabled enough for benefits to continue.

Social Security calls these medical reviews “Continuing Disability Reviews,” or CDRs. They should not be confused with the financial reviews that SSI recipients receive every year to confirm their financial eligilbility for SSI.

Each time Social Security reviews your medical file, they set the schedule for the next medical review. Your initial Notice of Award of benefits will tell you approximately when they next plan to review your medical record to determine if you remain disabled.

For claims in which they expect to see some medical improvement, they tend to schedule the next review for three years. For claims in which they do not expect to see improvement, they schedule the next review in five to seven years. Claimants disabled due to hepatitis C are usually scheduled for review in five to seven years, however, in some cases, they will schedule it sooner. However, Social Security is so backlogged, many reviews are delayed, some indefinitely.

Because of these reviews, it is important that you continue to report all your symptoms to your physician and make sure they are entered into the record.

When it’s time for a CDR, Social Security will send you one of two forms:

  • Short Form CDR (SSA-455-OCR-SM)
  • Long Form CDR (SSA-454-BK)

The “right” way to fill them out depends on which CDR form you are sent.

The short form (SSA-455-OCR-SM) is the “easy” one. It is only two pages long and is read by computer (OCR stands for Optical Character Reader). Since it is sent primarily to beneficiaries who have a low probability of medical improvement, this is probably the form you will receive.

This is good in that the short form assumes you are still disabled unless you give them reason to question that. A human only looks at the short form if the computer kicks it out for one reason or another. If it isn’t sent to a human for further review, then your benefits continue uninterrupted.

Assuming you are still disabled and that your condition has not measurably improved, there are some things you can do to see that the computer accepts the form without sending it for further review:

Fill out the form exactly as instructed. Use a box for each letter or number. If the boxes run out, stop, even if it’s mid-word.

No new information. The goal of this form is to simply confirm the information they already have, so you don’t want to include any changes, not even administrative changes such as an address change on this form. New information will cause the form to be kicked out for human review.

Use original diagnosis. Under “Reason for Last Visit,” use the same diagnosis for which you were approved.

The long form (SSA-454-BK) is 10 pages and is very similar to the original forms that you filled out when you first applied for Social Security Disability. It primarily asks for the names and addresses of all your providers. They will obtain your medical records directly from them.

This form not only goes to persons whose condition is expected to improve, it is also sent to persons whose short form was “kicked” by the computer, and is also randomly sent to persons as part of a trial or study that Social Security may be conducting.

The long form should be filled out just as thoroughly and completely as when you initially applied for disability benefits. On this form, it is important to note any changes in your medical condition, especially new infections, symptoms or diagnoses. Make sure your doctors are alerted to the review and that they submit new medical records since your last review promptly.

Be sure to make copies of the completed CDR, including the short form, before sending it in. This will facilitate the next review when it comes.

The CDR performed by Social Security is entirely different from the periodic reviews conducted by disability insurance carriers. Social Security does not necessarily “try” to find reasons to terminate benefits. Current medical records that show you are still under a doctor’s care and that you still have the condition and the symptoms that prevented you from working initially are usually all that is needed to continue your Social Security benefits without interruption.

Disability Insurance Medical Reviews

Insurance companies also periodically review the medical records of claimants to see if they still meet the contract definitions of disability. However, insurance companies have an interest in terminating claims if possible. First, and foremost, insurance companies are profit-making organizations and every claim they can stop paying adds to their profit line.

Also, disability insurance contracts typically change the definition of disability, usually after the first two or three years of the claim. The definition usually shifts from unable to perform the duties of….”Your regular occupation” to “Any suitable occupation based on education, training or experience.” This second definition is not as narrow as the first so it makes it easier for the insurance company to terminate the claim, if they can find any job that you could possibly do.

In addition to reviewing claims on a regular basis, insurance companies will also review claims when the definition of disability changes and when a “book” of disability claims is sold to another carrier or the claims administration is shifted to a new administrator, who has usually promised to “clean up” the book of “questionable” claims. This will almost always be extensive reviews and multiple claim terminations.

The general rule is: Always appeal a termination of benefits, unless you are actually returning to work. There is an unproved theory that insurance companies, with their knowledge of numbers and statistics, know that a large number of terminated claimants will accept the decision without appeal. That makes it worth while to argue with the few who do try to appeal the termination of benefits.

There are several things you can do that will give you an advantage when the review occurs:

• Have all your doctors note in your record that you are to be contacted if an insurance company requests your medical records.

• Make sure doctors continue to note all of your symptoms in your record each time you see them. Ask them to enter any anecdotal evidence you give about how a symptom interfered with your daily life.

• Be thorough and accurate with any questionnaires you are asked to fill out.

When filling out continuing disability questionnaires, you want to be very thorough. If they don’t leave enough space to answer the question fully, use additional sheets, clearly labeled. In addition to noting your symptoms, note the severity and frequency. When possible, include an anecdote that illustrates your disability.

Don’t rely on checking off boxes in the questionnaire, if it does not explain your situation. Refer to additional pages and expand on why you checked (or didn’t check) what you did.

It is especially important to be very accurate with your answers. You certainly want to fully explain just how your condition affects you, but be careful about exaggerating your disability. For example, don’t say you never leave your house unless you are actually bedridden. You can still be disabled yet be able to go shopping for groceries, make trips to the doctor and even visit friends.

Surveillance does occur. Although it is not a routine occurrence, insurance companies will occasionally hire investigators to follow a claimant and videotape their activities. While this sometimes makes the news when a “disabled” claimant is caught participating in a triathlon or reshingling a roof, surveillance rarely yields such damning evidence.

More often than not, it will be simply a record of you going to the doctor or to the store, or watering your lawn. While these acts do not prove lack of disability, insurance companies will treat them as if they do, especially if your questionnaire suggested otherwise.

Insurance companies especially like to contrast such surveillance with statements you make in the questionnaire. By “catching” you in a “lie,” the insurance company makes all your statements suspect. In addition, they will be sure to point out anything that could possibly be considered “immoral” or “questionable” such as going into a bar or club, just to keep you defensive.

One client, whose symptoms included cognitive impairment, was followed as she ran several errands. The insurance company claimed that a person with cognitive impairment wouldn’t be able to travel that easily from one place to another. They neglected to tell the consulting physician that the claimant was going to places that she had gone to many times before and was very familiar with the routes.

Google Yourself. What does the internet have to say about you? The insurance company will check. One client found himself the subject of surveillance and an attempted termination just because he was listed as a Vice-President on a small non-profit organization’s website. This only meant he went to one board meeting a month and otherwise did nothing, but that listing generated a full claim review including surveillance. It happened to be a gay organization, and they made sure to note that the claimant hugged many men in greeting them.

Treat all Continuing Disability Reviews as carefully as you did the original claim. Be accurate and thorough, but there’s no need to exaggerate excessively. And always appeal any attempt to terminate the claim if you and your doctor believe you are still disabled.

For more intormation, be sure to check out the HCSP Guide, A Guide to Hepatitis and Disability, and the other articles on disability and benefits found on our site


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What's in a Name?
Alan Franciscus, Editor-in-Chief

Have you noticed that a drug can have many different names?  It can become very confusing when you are trying to understand which drug is used to treat which condition, especially when you consider that the same drug may have different names. On the surface it might appear that the naming of drugs is a random act, but the reality is that there are some pretty strict guidelines when it comes to assigning a drug a certain name.  This article will focus on how a name is given to a particular drug and I will use ribavirin and telaprevir as examples of the chemical, generic and brand names. 

Background

There are different agencies within the United States that oversee and approve the various names given to drugs.  The United States Adopted Names (USAN) Council assigns the generic name and The Food and Drug Administration (FDA) approves the brand name of a drug.

It is important to note that in order to understand the names of drugs a basic understanding of the steps involved in the naming and development of a drug is needed.  A company that develops a drug is given a patent for the drug itself, the way it is made, the condition that it was developed to treat, and the method of delivering the drug into the body.  When a patent is issued the company acquires exclusive rights to a drug for 20 years, but realistically a company only has exclusivity for 10 years since it generally takes at least 10 years from development to marketing approval for treating a particular condition. A patent can also be extended for additional time period.  Once a drug goes off patent it can be sold under a generic name.  When a company wants to manufacture and distribute a generic drug, it must test the drug and send the appropriate application for approval to the FDA.  The clinical information that is sent to the FDA must prove that the generic form of the drug is equivalent to the brand name drug in the delivery, absorption and effectiveness.  Because the generic manufacturer did not have to spend the money required for research, development and marketing of the brand name drug, the costs associated with a generic drug are usually much lower.  However, not all drugs go generic because there may be difficult or costly manufacturing processes that wouldn’t bring about profits for the generic company, or the drug could have little or limited commercial value even if it is inexpensive to manufacture. 

Chemical Name

When a drug is developed or newly discovered it is given a chemical name, which is the molecular structure of the drug.  USAN assigns the chemical name. 

Telaprevir has two chemical names:

1. Cyclopenta[c]pyrrole-1-carboxamide, (2S)-2-cyclohexyl-N-(pyrazinylcarbonyl)glycyl
-3-methyl-L-valyl-N-[(1S)-1-[(cyclopropylamino)oxoacetyl]butyl]octahydro-, (1S,3aR,6aS)- 2. (1S,3aR,6aS)-2-[(2S)-2-[[(2S)-cyclohexyl[(pyrazinylcarbonyl)
amino]acetyl] amino]-3,3-dimethylbutanoyl]
-N-[(1S)-1-[(cyclopropylamino)oxoacetyl]butyl] octahydrocyclopenta[c]pyrrole-1-carboxamide


Ribavirin’s chemical name is:  1-(β-D-Ribofuranosyl)
-1H-1,2,4-triazole-3-carboxamide. 


The USAN also assigns code designations to make it easier to use and identify the drugs.  The code designations for telaprevir is VX-950, LV-570310, VRT-111950, MP-242 and the code designations for ribavirin are ICN-1229, ICN1229, and ICN 1229. 

Generic Name

USAN also assigns the generic name of the drug.  The generic name can be derived from the chemical name, structure, formula or the treatment that the drug is being tested to treat.  The generic name is used when referring to a drug itself rather than a particular brand name of a drug. 

The generic names given to the above mentioned drugs are telaprevir and ribavirin. 
 

Brand Name

Now comes the juicy part – developing a brand name.  There is a lot riding on the brand name. Millions of dollars in future revenues may be tied to it.  The process of coming up with a brand name before it is approved by the FDA is complicated and costly process.  The pharmaceutical company may hire a marketing or name branding firm to come up with the brand name.  The branding firm will generally come up with 10-20 potential names after an exhaustive search of over 40 countries to make sure that the brand name has not been previously used and will research the name in various languages to make sure that the brand name doesn’t mean something else in a different language. 

The potential names will then be field tested with physicians and patients to narrow down the choices to a few that are submitted to the FDA for approval.  The FDA will research the brand names to make sure that the brand name doesn’t imply a health claim or that it isn’t likely to be confused with another drug, which could potentially lead to a physician writing the wrong prescription and/or a pharmacist filling the wrong prescription.    

Probably the most recognized brand name is Viagra for erectile dysfunction.  Ask almost anyone about Viagra and they will know what it is used for.  It has become so synonymous with erectile dysfunction that the name is used for almost any drug or herb that a company is marketing for erectile dysfunction.  On another level the name Viagra resembles other powerful words like the English ‘vie’ to ‘fight’ and it is similar to other English words such as vigor, vitality, and victory,  ‘Agra’ suggests aggression so if you put these meanings together you have a product that is male orientated with connotations of aggression and vitality—all words that symbolize male sexual potency.  A more literal translation is seen with Viagra’s competitor Levitra which is taken from the word elevate.  But these types of implied meanings are not the only factors that are taken into consideration when naming a drug.  The newer drug names often have a letter incorporated into them that is considered unusual to help with reinforcing name recognition.  The most commonly incorporated letters into brand name drugs include X, Z, C and D.  Think about the most recent anti-depressant brand name drugs like Zoloft, Paxil, and Prozac.  These names convey a sense of super powers and are not easily forgotten. 

A brand name has not been approved for telaprevir because it is currently in clinical trials and has not been approved by the FDA for the treatment of any condition.   However, ribavirin now has many, many brand and generic names because it has been marketed for many years for different indications and as a generic drug.  The most common brand names of ribavirin include Schering Plough’s Rebetol, Roche’s CoPegus and Three Rivers’ Riabsphere – all used in combination with interferon to treat hepatitis C – and Virazole, a ribavirin formulation that is inhaled, to treat respiratory syncytial virus (RSV) in children.  Generic versions of ribavirin to treat hepatitis C are marketed by Sandoz, Teva Pharmaceutical Industries and Warrick Pharmaceuticals (the generic arm of Schering Plough).


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Deaths Due to HCV Increasing
Alan Franciscus, Editor-in-Chief

A new study titled ‘Changing Trends in Hepatitis C-Related Mortality in the United States, 1995-2004,” by M. Wise and colleagues, was released in March 2008.  An analysis from the study found that there was a dramatic increase in the number of hepatitis C-related deaths in the period from 1995 to 2004.  

Analysis

In order to come up with the best possible number of deaths attributed to hepatitis C, the authors analyzed death certificate data and included any deaths as HCV-related if:     

  • Hepatitis C was the underlying cause of death,
  • Chronic liver disease was the underlying cause and hepatitis C was a contributing cause, or
  • HIV was the underlying cause and chronic liver disease and hepatitis C were contributing causes

Results

When death certificate data was analyzed using the above criteria it was found that there were 56,409 hepatitis C-related deaths from 1995 to 2004.  From the period 1995 to 2004 the actual death rate rose from 1.09 per 100,000 persons to 2.44 per 100,000.  The overall rates of deaths due to hepatitis C were higher from 1995 to 1999 than 2000 to 2004, but the mortality rate among persons aged 55-64 continued to increase.  

The overall increases were greater in males than females (144% vs. 81%) and were also greater among non-Hispanic blacks (170%) and Native Americans (241%) vs. non-Hispanic whites (124%) and Hispanics (84%).  The higher rates of death in males, non-Hispanic blacks and Native Americans most likely reflect the higher prevalence of HCV in these groups. 

The reason for the small decline in HCV-related deaths between 2000 – 2004 is unclear.  It could be one of those quirks in research or the decline could be due to improvements in HCV medical care, treatment outcomes (ie. pegylated interferon and ribavirn therapy), and improved long term survival following liver transplantation made within the last decade.  If the downward trend in HCV-related deaths continues and we have more testing and better medications to treat HCV, there is a possibility that the huge future disease burden earlier predicted could be avoided or dramatically reduced.

The authors concluded that “Overall, hepatitis C mortality has increased substantially since 1995” and that “These results also highlight the need for measures to prevent progression of chronic liver disease among persons already infected with HCV and the importance of ongoing analysis of mortality trends.” 

Reference:
Wise, M, et al Changing Trends in Hepatitis C-Related Mortality in the United States, 1995-2004.  Hepatology.  Vol. 47, No. 4, 2008.


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Insulin Resistance
Alan Franciscus, Editor-in-Chief

Insulin resistance (IR) is a condition that is considered ‘pre- diabetes.’ There has been speculation that insulin resistance may be linked to HCV infection, but until now there has not been a great deal of research to validate this theory.  Now a study published in Gastroenterology titled “Insulin Resistance in Chronic Hepatitis C:  Association with Genotypes 1 and 4, Serum HCV RNA Level, and Liver,”  by Moucaria, R and colleagues, is providing some very compelling clinical data that the hepatitis C virus may indeed cause insulin resistance in people with chronic hepatitis C genotype 1 and 4. 

  • Metabolic syndrome is defined as a cluster of conditions – excess weight, high triglycerides (fats), low levels of HDL or good cholesterol, high blood pressure and high blood glucose or sugar levels in the blood.
  • Insulin resistance is a condition where blood cells are not able to adequately process glucose or blood sugars.  Increased glucose in the blood will give a signal to the pancreas that it needs to release more insulin, which then leads to high levels of insulin and glucose in the bloodstream.

In their prospective study, 600 consecutive unselected patients with either chronic hepatitis B (100 patients) or chronic hepatitis C (500 patients) were enrolled.  All the participants were evaluated for insulin resistance, and metabolic syndrome before undergoing a liver biopsy to stage and grade liver damage. 

What the authors found was insulin resistance in 32.4% of the 462 non-diabetic chronic hepatitis C patients, and IR was associated with metabolic syndrome, significant fibrosis, or severe steatosis. Fifteen percent of the 145 chronic hepatitis C participants without  metabolic syndrome or significant fibrosis were diagnosed with insulin resistance, and the diagnosis of insulin resistance was associated with HCV genotype 1 and 4, high serum HCV RNA (viral load) level, and moderate-to-severe necroinflammation (cell inflammation and death). 

Fifty-one percent the 454 non-cirrhotic chronic hepatitis C participants were found to have significant fibrosis and this was associated with male sex, age greater than 40 years old, insulin resistance, moderate-to-severe necroinflammation, and severe steatosis.  The degree or severity of fibrosis was also found to be associated with insulin resistance even without steatosis.

It was also found that the overall incidence of insulin resistance was dramatically lower in the chronic hepatitis B group (5%) compared to the chronic hepatitis C group (35%).

The authors noted that, given the high numbers of insulin resistance in their study, routine management of hepatitis C should include an assessment of insulin resistance.

Reference
Moucaria, R, et al. Insulin Resistance in Chronic Hepatitis C:  Association with Genotype 1 and 4, Serum RNA Level, and Liver Fibrosis, Gastroenterology Vol. 134, Issue 2, Pages 415-423 (February 2008)


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