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July 2009 HCV Advocate

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In This Issue:

Pregnancy Drug Categories
Alan Franciscus, Editor-in-Chief

HealthWise: Hepatitis C and Metabolic Syndrome
Lucinda Porter, RN

FDA Takes Action on Acetaminophen
Liz Highleyman

Book Review - Healing Hepatitis
Lucinda Porter, RN

Consequences of Hepatitis C - Cost of a Baby boomer Epidemic of Liver Disease
Alan Franciscus, Editor-in-Chief

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Pregnancy Drug Categories
Alan Franciscus, Editor-in-Chief

Which drugs are safe to take while a woman is pregnant?  If a woman becomes pregnant while on therapy is there a risk to the fetus?  If a woman is pregnant, which drugs increase the risk of birth defects?  To help guide medical providers and patients, the Food and Drug Administration (FDA) has established certain categories that for the most part define what is safe and what is not safe.  But there are gray areas within most of the categories.  This is why it is so important to seek medical advice—medical providers base decisions on a variety of factors, such as does the risk outweigh the benefit, personal experience using a certain drug and the latest medical research. 

The categories are only applied to medications that have been approved by the FDA.  Over-the-counter medications (OTC), herbs and most supplements are not assigned a pregnancy classification unless they have been previously scrutinized by the FDA.  In these instances medical providers will use their previous experience or information from scientific sources to advise what is safe or unsafe to take.  

In a perfect world every drug would have solid scientific data on humans to advise about the potential risk of medications, but this isn’t always the case in the real world.  There are many reasons why studying a drug in humans isn’t feasible or why pharmaceutical companies don’t pursue these trials, such as the obvious risk of exposing certain drugs to pregnant women, the cost of studying the issues and the potential lawsuits the pharmaceutical companies may be exposed to.  As a result much of the information about medications and pregnancy is based on test tube or animal studies and anecdotal information about drugs that have a long history of use. 

“If a woman is pregnant or thinking about becoming pregnant she should talk with her doctor about any prescribed medications, over-the-counter medications, herbs, and/or supplements that she is taking or thinking of taking.”

Pregnancy Categories:*

Category A: 
In human studies, pregnant women used the medicine and their babies did not have any problems related to using the medicine.

Category B:
In humans, there are no good studies.  But in animal studies, pregnant animals received the medicine, and the babies did not show any problems related to the medicine.


In animal studies, pregnant animals received the medicine, and some babies had problems.  But in human studies, pregnant women used the medicine and their babies did not have any problems related to using the medicine.

Category C: 
In humans, there are no good studies.  In animals, pregnant animals treated with the medicine had some babies with problems.  However, sometimes the medicine may help the human mothers and babies more than it might harm them.


No animal studies have been done, and there are no good studies in pregnant women.

Category D:
Studies in humans and other reports show that when pregnant women use the medicine, some babies are born with problems related to the medicine.  However, in some serious situations, the medicine may still help the mother and the baby more than it might harm them.

Category X: 
Studies or reports in humans or animals show that mothers using the medicine during pregnancy may have babies with problems related to the medicine.  There are no situations where the medicine can help the mother or baby enough to make the risk of problems worth it.  These medicines should never be used by pregnant women.

*Source:  Food and Drug Administration


FDA Approved Medications
for Treating HBV and HCV.

Tenofovir (Viread)
Telbivudine (Tyzeka)
Interferon (Intron A)
Pegylated interferon alfa-2a (Pegasys)
Pegylated interferon alfa-2b (PegIntron)
Entecavir (Baraclude)
Adefovir (Hepsera)
Lamivudine (Epivir-HB)
Ribavirin (Rebetol, Copegus, etc.)

Ribavirin warning:  Ribavirin has been shown to cause birth defects and miscarriages.  Women of childbearing age, their male partners, and female partners of male patients taking ribavirin must use at least two forms of effective contraception during treatment and during  the six-month post-treatment follow-up period. 

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Healthwise: Hepatitis C and Metabolic Syndrome
—Lucinda Porter, RN

"Hepatitis C Patients with Metabolic Syndrome Are at Greater Risk of Death," wrote Liz Highleyman, reporting on research presented at the 2009  European Association for the Study of the Liver meeting.  This research is a wake-up call for those with chronic hepatitis C virus infection (HCV). This month, we’ll discuss metabolic syndrome—how to avoid it or manage it if you already have it.

Experts don’t agree on the definition or even if metabolic syndrome is an actual disease. Generally recognized is that there are a collection of signs, warning of potential problems, such as heart disease, stroke, and diabetes.  Those with HCV and metabolic syndrome are at risk for early death.

The National Heart Lung and Blood Institute developed the following guidelines to identify who is at risk for metabolic syndrome. The more of these a person has the greater the risk for serious medical complications. These signs include:

  • A large waist – greater than 35 inches for women and 40 inches for men. Certain genetic risk factors, such as having a family history of diabetes or being of Asian descent, waist circumference limits are 31 to 35 inches for women and 37 to 39 inches for men
  • Abnormal triglycerides – 150 mg/dL or higher or if you are being treated for high triglycerides
  • Low HDL cholesterol – less than 40 mg/dL in men or less than 50 mg/dL in women or if you are being treated for high cholesterol
  • Raised blood pressure – 130 mmHg systolic (the top number) or higher or 85 mmHg diastolic (the bottom number) or higher, or if you are being treated for high blood pressure
  • Elevated fasting blood sugar (blood glucose) – 100 mg/dL or higher, or you are being treated for high blood sugar

Some people have uncontrollable risk factors for metabolic syndrome. These include:

  • Age – the risk increases with age
  • Race – African Americans, Latinos and Asians have a higher risk
  • Other diseases – polycystic ovary syndrome, personal or family history of diabetes

There does seem to be a link between HCV and metabolic syndrome, but research has yet to state unequivocally that HCV is a risk factor. What is known is that having the two is a risk factor for early death.

Here is the good news – the warning signs for metabolic syndrome can be managed, reduced and often eliminated by lifestyle changes. Yes, lifestyle changes. Did I hear someone groan? Yet another reason to manage our weight and stay physically active!

Those of you who are still reading this article, congratulations. Perhaps you are like me – not thrilled about reducing calories and exercising more – but even less thrilled about the alternative. Let’s talk about the alternative. If it was just premature death, then there wouldn’t be much to discuss. Some of us cry, “I’d rather die than spend the rest of my life on a treadmill and eating celery.” However, it doesn’t work that way. Typically people who are unhealthy spend the last third of life in decay and discomfort.

Simply put, it isn’t like one day we are out frolicking around, eating fried chicken and a pint of Ben and Jerry’s Cherry Garcia and suddenly we keel over in bliss. Rather, it takes decades – we slow down, we ache, take medication, do less, enjoy less, go to the hospital and doctor a lot, get tubes inserted in places where we don’t want tubes, maybe have a stroke and can’t walk or talk, and on and on this goes. By the way, Ben Cohen of Ben and Jerry’s had a coronary bypass following a heart attack in 2001.

Or, we can get some help and change our lives – for the better. Easy? Of course not. I understand. I am writing this during one of the worst brain fog episodes I have had in years. I’d rather sleep than exercise, but physical fitness is non-negotiable for me. I do something every day – rain or shine. It’s the law. Worth it? Absolutely.

There are tricks to making lifestyle changes. The first trick is to find out what works for you. Look at where you have been successful in the past. What worked and what didn’t? What motivates you? Do you work better alone, with a partner or in a group? Do rewards help?

If you are at risk for metabolic syndrome, aim for the following:

  • Quit smoking.
  • Lose weight – A 5 to 10% weight reduction can yield significant benefits.
  • Get into shape – Experts recommend 30 to 60 minutes daily of moderately intense exercise, such as brisk walking, gardening, dancing. If that is too much, do something  such as Tai Chi, yoga, or parking your car at the far end of the parking lot.
  • Eat a high-fiber diet with lots of vegetables and fruit and lean protein.
  • Strive for 7 to 9 hours of sleep every night.

If you are overweight and have had trouble losing those pounds, consider using the one tool that has consistently shown to help with weight loss – a journal. To gain control of what we eat, there is nothing like looking at it in black and white. You can do this online or on paper, but either way, you need a tracking system. Calorie counting is a good one, particularly with the Internet. Some links are provided at the end of this article.

If you keep a journal, set 3 to 5 goals. Make them reasonable, specific and achievable. A goal of “getting healthy” is too general. More specific is “lose 12 pounds in 6 months” and “walk 30 minutes daily at least 5 times a week.” Write 3 reasons why you have these goals. Examples are “to lower blood pressure, to feel better, and to not have to buy a new belt.”

Look at these reasons and goals every day. Use them to remind you why health matters. If you fall off the wagon, don’t beat yourself up. That just leads to more problems. Also, don’t quit, but recommit.  If we all quit every time we had a setback, we’d never get anywhere.

Declining health is a drag. It is a hard time to make changes, but start slow, take baby steps and be patient. Although it takes time, time passes either way. Doesn’t it make sense to watch time pass while we are taking a walk rather than playing solitaire?  Besides, what do we have to lose, besides our waistlines and misery?

Further Information

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FDA Takes Action on Acetaminophen
—Liz Highleyman

The pain reliever acetaminophen is generally safe for most people when used as directed, but it can cause life-threatening liver injury if taken at high doses or by individuals at risk for hepatotoxicity.

As acetaminophen toxicity remains one of the leading causes of acute liver failure in the United States—accounting for an estimated 50,000 emergency room visits and 500 deaths annually, according to the American Association for the Study of the Liver—the Food and Drug Administration (FDA) has mandated stronger warnings and stricter regulation of the drug.

Acetaminophen Liver Toxicity
Acetaminophen, like many drugs, is metabolized by the liver. If the normal processing pathway is overwhelmed by a high dose, a different pathway known as the cytochrome P450 system takes over. This leads to production of a metabolite, NAPQI, that is toxic to liver cells.

If acetaminophen toxicity is diagnosed in its early stages—which can be difficult due to nonspecific symptoms and sometimes slow onset—N-acetylcysteine (NAC) can be administered as an antidote; NAC restores the natural antioxidant glutathione, which detoxifies NAPQI. But as liver damage progresses, decompensation may occur, necessitating a liver transplant in the most severe cases.

A significant proportion of acetaminophen-related liver toxicity is due to intentional overdose, typically a suicide attempt. Most cases of serious liver damage occur in people who have taken at least 10-15 grams­—much more than twice the recommended total daily adult dose of 4 grams (4,000 mg).

However, accidental overdoses are also common, accounting for about half of all cases, in part because the drug is present in so many products. In addition to the familiar Tylenol brand, acetaminophen—also known as APAP or paracetamol—is an ingredient in hundreds of prescription painkillers (often combined with narcotics such as hydrocodone or oxycodone) and over-the-counter or OTC products (including many cold, cough, and sinus remedies) (see sidebar for a partial list). This ubiquity increases the likelihood that people will unknowingly mix acetaminophen-containing products, thereby exceeding the maximum recommended dose.

Drinking even a small amount of alcohol while taking acetaminophen—or a few hours before or after doing so—increases the risk of liver toxicity. Research indicates that people with pre-existing liver disease, including chronic viral hepatitis, have an elevated risk of acetaminophen-related hepatotoxicity, although most hepatitis B or C patients with compensated liver disease can safely use the drug at recommended doses. Finally, some individuals are prone to acetaminophen toxicity at or near the recommended amount for unknown reasons, possibly having to do with genetic factors.

Revised Labeling
On April 28, the FDA issued a final rule requiring manufacturers of OTC pain relievers and fever reducers to revise product labeling to include warnings about potential safety risks, including liver damage associated with acetaminophen and gastrointestinal bleeding due to nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin and ibuprofen.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches,” Charles Ganley, MD, director of FDA’s Office of Nonprescription Drugs, stated in an agency press release. “However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the new rules, manufacturers must prominently list all active ingredients in a product both on the external packaging and on the bottle. The label must warn of the risk of severe liver damage with acetaminophen and stomach bleeding with NSAIDs. These changes must be made by April 29, 2010.

The full revised rules, formally titled “Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use”—consisting of 25 pages in the Federal Register—are available online at http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf.

What Took So Long
Many clinicians and consumer advocates consider the new warning long overdue. FDA advisory panels have recommended a liver toxicity warning for acetaminophen on several occasions (in 1977, 1988, 1993, and most recently 2002) but this was never formally adopted—an outcome some advocates attribute to pharmaceutical industry lobbying. However, in 1998 the agency did require a label warning stating, “If you consume three or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.”

In 2004, the FDA launched a public education campaign about the risks of acetaminophen, but the effort was small and poorly funded. That same year, the agency asked state pharmacy boards to consider requiring stronger labeling on prescription acetaminophen products, but by 2008, none had done so. Some companies voluntarily strengthened their side effects warnings, but not enough to satisfy FDA officials.

In December 2006, the FDA issued proposed labeling requirements for OTC acetaminophen products, and in 2007 the agency’s Center for Drug Evaluation and Research convened a multidisciplinary working group to discuss the issues of acetaminophen-related liver injury and possible prevention measures. This group devised a report with options to be presented for public discussion and comment, which provides the basis for the agency’s latest actions.

Further Steps
On June 29 and 30, after the HCV Advocate went to press, the FDA held a joint meeting of the Drug Safety and Risk Management Advisory Committee, the Anesthetic and Life Support Drugs Advisory Committee, and the Nonprescription Drugs Advisory Committee to discuss the public health problem of liver injury related to acetaminophen in OTC and prescription products and to consider further steps the agency might take to reduce the risk.

“The association between acetaminophen and liver injury is not common knowledge. Consumers are not sufficiently aware that acetaminophen can cause serious liver injury, and their perceptions may be influenced by the marketing of the products,” the FDA wrote in its meeting announcement. “Current labeling on OTC products may be overlooked, as can the patient information provided with dispensed prescriptions. Programs to educate the public about safe use of acetaminophen have been small and encountered a number of obstacles. Advertisements of OTC drugs often emphasize the effectiveness of products, but are not subject to the same requirements to offset such messages by providing warning information as prescription products. Also, acetaminophen is available in retail outlets in large quantities (e.g., 500 tablets per bottle) which may contribute to the perception that the ingredient is unlikely to be harmful.”

Possible measures include lowering the recommended single dose and cumulative daily dose, reducing the amount of acetaminophen in maximum strength tablets and liquid pediatric formulations, removing acetaminophen from combination products, and restricting the number of pills that can be sold at one time. Such a restriction might help reduce intentional overdoses, but likely would not reduce the risk for people who develop liver toxicity at or near the recommended dose. The U.K. instituted acetaminophen pack-size restrictions in 1998, but whether this has decreased deaths due to toxicity remains subject to debate.

Outcomes of the FDA committee meeting will be covered in future issues and on the HCV Advocate web site (www.hcvadvocate.org).


Common Products Containing Acetaminophen
(Not a complete list)


Alka-Seltzer Plus

*Certain products under this brand name.

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Book Review: Healing Hepatitis
Lucinda Porter, RN

Book Review – Healing Hepatitis C: A Patient and a Doctor on the Epidemic's Front Lines Tell You How to Recognize When You Are at Risk, Understand Hepatitis C Tests, Talk to Your Doctor About Hepatitis C, and Advocate for Yourself and Others, by Christopher Kennedy Lawford and Diana Sylvestre, Harper Paperbacks, 2009, paperback, 208 pages, $14.99

There are a number of good books about hepatitis C (HCV). I have read most of them. When I ordered Healing Hepatitis C, I expected it to be much like the others. What I didn’t expect is that I would pick it up and not want to put it down until I finished it. Yes, it was that good.

I am acquainted with one of the authors, Diana Sylvestre. A physician, researcher, and faculty member at the University of California, San Francisco, Sylvestre’s passion is working with disenfranchised patients. Her warmth shines through the pages. The other author, Christopher Kennedy Lawford (yes, of the Kennedy-Lawford family) provides good humored insight from the patient’s perspective. His story is inspirational and honest.

Healing Hepatitis C is different from most of theother HCV books. The format is a dialog between the two authors, but it manages to come across as if the authors are speaking to the reader. Although I enjoyed it immensely, this style may not appeal to everyone. My only criticism of the book is sometimes I wasn’t sure which author was narrating.

Lawford expands the dialog concept when he converses between “Sober Chris” and “Junkie Chris.” I don’t know how other readers will find this, but it worked for me. It illustrates some of the turmoil that we experience over this disease, particularly regarding treatment. I assume that patients who have not wrestled with addiction will still be able to relate to the inner struggles that seem to go with living with HCV.

Lawford and Sylvestre address the core issues and fears associated with HCV treatment that many of us have.  This is the magic of this book. It is real yet it reads like a novel. The book is not highly technical yet it succeeds in getting across a lot of information without boring the reader. The Online Resource section provides tools for the reader wanting to know more about various aspects of HCV.

Healing Hepatitis C offers genuine hope for HCV patients. It can be summarized best in the authors’ own words, “…we hope to walk you through the process of facing the diagnosis and treatment head-on, to show you that it is possible to get through this hepatitis C thing—and to be cured—without surrendering your life to it.” That sounds like inspiration to me.

Review by Lucinda K. Porter, RN

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Consequences of Hepatitis C: Cost of a Baby Boomer Epidemic of Liver Disease
—Alan Franciscus, Editor-in-Chief

In May 2009 a report commissioned by Vertex Pharmaceuticals, and compiled by Milliman on the future disease burden of hepatitis C (HCV) was released.  The report estimated the future cost of hepatitis C over a 20-year period. 

The authors noted a couple of caveats or limitations of the study: First, the analysis did not factor in development and use of more effective medications to treat hepatitis C, such as the new HCV protease and polymerase inhibitors that could dramatically reduce both future deaths as well as the financial impact of HCV disease progression; secondly, the authors also noted that the report is based on the NHANES study that grossly underestimated the prevalence of HCV in the United States. 

Key points of the report:

  • HCV is called the baby boomers’ disease because most people infected with HCV were born between 1946 and 1964. 
  • The highest prevalence of HCV is among Americans who were born in the early 1950’s – during the baby boomer generation.
  • An estimated 78% of people infected with hepatitis C do not know they are infected with hepatitis C. 
  • As the HCV baby boomers age, complications and the associated healthcare costs will greatly increase.  This will place a very heavy burden on the U.S. health care system that will affect both the public and private sectors.  
  • The African American community will be the hardest hit because of the higher HCV infection rates.   
  • The total annual medical cost for hepatitis C is expected to increase from $30 billion in 2009 to over $85 billion in 2024.  Medicare costs are expected to increase from $5 billion to $30 billion. 

The authors concluded, “In the absence of improved and accessible treatments that can alter the progression of disease, payers, especially Medicare, will feel the impact of a baby boomers’ advanced liver disease epidemic.

In addition to the new and more effective treatments that offer hope of reducing the HCV disease burden is the introduction of new HCV antibody test – the Orasure HCV Rapid Oral Antibody test.  The new test will be easier to use for mass screenings and will help to identify some of the 78% of people who have hepatitis C and don’t know it.  Integrating the newly diagnosed as early as possible into medical services to manage and treat hepatitis C is the best possible strategy for reducing the future HCV disease burden.  But the real tipping point will only come if there are massive amounts of dollars pumped into HCV research to provide expanded testing, management and treatment.  One can only hope!

The entire report can be viewed on the Vertex Pharmaceuticals Web site:  http://www.vrtx.com/millimanreport.html

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