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April 2012 HCV Advocate

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In This Issue:

Drugs in Development: Update
Alan Franciscus, Editor-in-Chief

HealthWise: Laughing with Liver Disease
Lucinda K. Porter, RN

HCV Snapshots
Lucinda K. Porter, RN

Disability & Benefits: Maintaining Your Disability Claim in the Internet Age
Jacques Chambers, CLU

HCV Advocate Eblast
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Drugs in Development: Update
—Alan Franciscus, Editor-in-Chief

On March 6, 2012 interim results from an arm of the ELECTRON phase 2 study were released at the Conference on Retroviruses and Opportunistic Infections (CROI).  This particular arm treated HCV genotype 1, prior null responders—the hardest group to retreat—with GS-7977 (HCV polymerase inhibitor) plus ribavirin (RBV) (no interferon (PEG)).  The arm enrolled 10 patients who were treated for 12 weeks with GS-7977 plus ribavirin.  Of the nine patients who were HCV RNA undetectable at the end of treatment, eight patients relapsed within 4 weeks post treatment.  One patient who did achieve SVR12 had favorable predictors of successful response—female, Caucasian, IL28B CC genotype and a low fibrosis score. 

Comments:  This is very disappointing news in the light of all of the positive stories about GS-7977/RBV therapy (without interferon) that have been released.  But it is important to keep in mind a couple of important issues when interpreting these results: 

  • The null responder population is and will be the most difficult to treat population.  GS-7977 plus ribavirin in genotypes 2 and 3 has cure rates in phase 2 studies of up to 100% and HCV genotype 1 treatment-naïve patients in phase 2 studies have had up to 91% cure rates.

  • In this difficult to treat population there is most likely a need to add another direct acting antiviral (DAA) or treat for a longer period of time.  Gilead has an entire portfolio of other DAAs that can be combined with GS-7977 including GS-9256—HCV protease inhibitor, and GS-9190—HCV polymerase inhibitor.

  • There are two other interferon-free collaborations of GS-7977 with other pharmaceutical companies:

    • BMS’s daclatasvir—NS5A inhibitor with GS-7977 with and without RBV, and

    • Tibotec’s TMC435—HCV protease inhibitor with and without RBV.

The bottom line is not to give up hope—we will get to the 100% cure rates for genotypes 1, 2, 3, 4, 5, and 6 eventually—it’s just a matter of finding the right combination of drugs and the optimal treatment durations—that’s what clinical trials are all about.

Source:  Company press release and Bloomberg news.

VX-222, Telaprevir/RBV
On February 29, 2012 Vertex released interim data from their clinical trial of telaprevir (HCV protease inhibitor), and VX-222 (HCV polymerase inhibitor) combined with and without PEG and/or RBV to treat HCV genotype 1a/b treatment-naïve patients.  The interim results released were from two arms that did not include PEG.  Included in this study were treatment duration criteria—patients who were HCV RNA undetectable at week two and eight terminated all treatment at week 12.  In the two interferon-free arms nine of the eleven patients (genotype 1a (5 of 5 pts), genotype 1b (4 out of 6 pts) were HCV RNA undetectable at 4-weeks post-treatment.   

Comments:  This is a small study but with very encouraging interim 4-week post-treatment results.  HCV genotype 1 treatment-naïve patients are typically easier to treat (compared to null responders) and the addition of another DAA surely added to the potency and response rates.  Hopefully, these results will continue through 12 weeks post-treatment (SVR12).  

Source:  Company press release.    

Telaprevir – HIV/HCV Coinfection
On March 5, 2012 Vertex released interim results from a study with telaprevir (TEL), PEG and RBV to treat HCV genotype 1 treatment-naïve patients who are also infected with HIV (HIV/HCV coinfection).  The study is a phase 2 study that has two treatment arms including patients who were treated with the triple HCV therapy:  Part A includes patients who were not on an HIV antiviral therapy (ART) and Part B consists of people who were on an ART therapy (Atripla or Reyatax-based treatment regime for HIV).  TEL/PEG/RBV were given for 12 weeks followed by PEG/RBV (without telaprevir) for 36 weeks.  A total of 62 people were enrolled and of these patients 60 received at least one dose.  Up to 74% (28 of 38 patients—with and without ART therapy) achieved SVR12 compared to 45% (10 of 22 patients) in the group that did not receive telaprevir.  The side effects were similar to what is seen in TEL/PEG/RBV therapy.  

Comments:  There are very encouraging results especially since people who are coinfected with HIV and HCV have a faster HCV disease progression than someone who is HCV mono-infected, and treatment with just PEG/RBV produces less than optimal outcomes for most HIV/HCV coinfected people.  A phase 3 study of TEL/PEG/RBV is currently underway—patients will receive 12 weeks of triple therapy followed by either 12 or 36 weeks of PEG/RBV.   In addition to this study there are other HCV DAAs in phase 3 to treat HCV in people who are also infected with HIV.

Source: Company press release.

Boceprevir – HIV/HCV Coinfection
Interim results from a study of boceprevir (BOC) plus PEG/RBV vs PEG/RBV in 100 HCV genotype 1 HIV coinfected patients were released at the recent CROI conference.  The treatment included a 4-week lead-in in phase of PEG/RBV followed by 44 weeks of triple therapy (BOC/PEG/RBV).  Most patients were on a boosted HIV protease inhibitor antiretroviral therapy (ART).   Sixty-one percent of the group that received boceprevir plus PEG/RBV were HCV RNA negative at week 12 post-treatment (SVR12) compared to 27% in the group that did not receive boceprevir.  The side effects reported were similar to those seen in previous studies of regimes containing boceprevir. 

Comments:  The addition of boceprevir increased the cure rates by 34% and it promising, giving hope to curing more HIV/HCV coinfected people of HCV disease.  It should be noted that last month Merck released results of drug-drug interaction (DDI) between HIV ART medications and boceprevir that will help to provide guidance for treating HIV/HCV coinfected patients with boceprevir.  For more information see last month’s HCV Advocate newsletter.  

Source:  NATAP

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HEALTHWISE: Laughing with Liver Disease
—Lucinda K. Porter, RN

Ages ago, I cut out a B. C. comic strip by cartoonist Johnny Hart. Dr. Peter, a psychiatrist has his back to his patient who is reclining on a rock. The patient says, “I feel lousy, Doc.” Dr. Peter’s advice is, “You need to laugh more. Laughter is the best medicine.” The patient replies, “I must be in the placebo group.”

I agree with Dr. Peter—laughter is the best medicine. It is easy to take, there are no side effects, and the benefits are fabulous. Long-time HCV Advocate readers may recall previous articles I’ve written discussing humor’s affect on the immune system, cardiovascular system, blood pressure, and pain-lowering properties.

I hope you don’t need scientific proof in order to incorporate more laughter into your life. If you do, or if you are feeling like you are in the placebo group, then perhaps you are depressed. Yes, there is a time for seriousness, but I have seen people laugh while facing death, liver biopsies, and yes, even during HCV treatment. Humor is part of being alive.

If nothing in your life brings pleasure or makes you laugh, discuss this with your medical provider. Chronic hepatitis C virus (HCV) doubles the risk for depression, a medical condition for which there is treatment.

Laughter is a hobby of mine. I pursue it professionally and personally. I don’t need encouragement from my medical provider to find ways to laugh. It is a lot easier to do regularly than exercise. If science proved that laughter was harmful, I would not give it up. As Mark Twain said, “Humor is mankind’s greatest blessing.”

I feel so strongly about laughing that in 2009, I started a blog devoted exclusively to lightening up our liver load. The Hepatitis Comics: Levity for the Liver is filled with bile humor and hepatainment, guaranteed to make you groan. Occasionally it is funny, sometimes it is irreverent, and sometimes it is awful. http://hepatitiscomics.blogspot.com

At one point I was concerned that I’d run out of funny things to say. Recently I told my two-time kidney transplant recipient daughter-in-law, “The jokes on my blog are getting a bit weak. After all, there are only so many funny things you can say about the liver and hepatitis.” “That’s weird,” she replied, “Because end-stage renal disease is hilarious.”

It was just what I needed to hear. My new mantra, “Hepatitis C is hilarious.” When I say it, I feel like I am kicking HCV in the teeth. If I laugh at HCV, maybe it will want to move on to a more serious liver, say in one of those politicians who votes against viral hepatitis funding.

I created The Hepatitis Comics after hearing an NPR story about a cancer blogger and other young patients who embrace the therapeutic value of humor. I figured if they could find humor in cancer, then liver disease was fair game. For instance, why did I have to wear a yellow hospital gown when I had jaundice? Everyone knows blondes look terrible in yellow.  

In addition to humor, blogging helps me make sense of this disease that ransacks my liver. I find power when I write and laugh about HCV. The one place that HCV can’t attack me is my funny bone.

Others have been using humor and blogging to transform pain into wholeness, such as the Cancer is Hilarious http://cancerisnotfunny.blogspot.com and Smart Ass Cripple blogs http://smartasscripple.blogspot.com. These writers give the middle finger to their conditions, and who is going to feel sorry for someone who calls himself a smart-ass cripple.

April is the month that celebrates humor. All right, maybe April Fool’s Day is a one day event, but why stop there? So instead of talking about humor, I’ll finish the column with a few liver-related jokes.

  • Sam was on his death bed, and his wife and children were gathered around him. Suddenly the aroma of chopped liver filled the room. Sam perked up a bit and said to his wife, “That’s it; one last time before I die I must have some of your delicious chopped liver.” Sam’s wife looked at him sadly and said, “Sorry Sam, it’s for after.”

  • Three handsome male dogs are walking down the street when they see a beautiful, enticing, female Poodle. The dogs fall all over themselves as they scramble to be the one to reach her first. Arriving in front of her at the same time, the dogs are speechless before her beauty. Aware of her effect on the three suitors, she tells them, “The first one who can use the words “liver” and “cheese” together in an imaginative, intelligent sentence can go out with me.”

The sturdy, muscular black Lab speaks up quickly, “I love liver and cheese.”

“Oh, how childish,” said the Poodle. “That shows no imagination or intelligence whatsoever.” She turned to the tall, shiny Golden Retriever and said “How well can you do?” “Ummmm…I HATE liver and cheese,” blurts the Golden Retriever. “My, my,” said the Poodle. “That’s just as dumb as the Lab’s sentence.”

She then turns to the last of the three dogs and says, “How about you, little guy?” The Chihuahua gives her a smile, and turns to the Golden Retriever and the Lab and says, “Liver alone. Cheese mine.”                       

  • What do you get if you throw a grenade into a French kitchen? (answer at end)

Okay, the last one wasn’t liver-related, but since the other jokes were so jaundiced, I had to leave you laughing. Next month I’ll try to be more serious.

Riddle Answer: Linoleum Blown Apart

About Lucinda
Lucinda Porter, RN is the author of Free from Hepatitis C: Your Complete Guide to Healing Hepatitis C.  She is a nurse, writer, educator, mother, wife, and a bit of a clown.  Lucinda has been with the Hepatitis C Support Project since 1998.  Her articles have appeared in a number of publications, including the HCV Advocate, Liver Health Today, Hepatitis magazine, the Union and the San Jose Mercury News.  Lucinda is hepatitis C positive and positively believes in the power of humor. She thinks that laughter is a worthy pursuit and invites others with liver disease to add mirth to their health regimen. Lucinda has two blogs, a serious one at www.LucindaPorterRN.com and the Hepatitis Comics at http://hepatitiscomics.blogspot.com

New National HCV Helpline Launched

On February 1, 2012 a new HCV helpline was launched that promises "One Call – Lots of Help."

The helpline includes an up-to-date national database of 25,000 referral resources and a secure shared caller database for counseling continuity. The volunteers who staff the helpline are specially trained peer counselors using a structured approach to help callers navigate through screening, diagnosis, medical evaluation, and treatment. Additionally, the counselors will follow-up with the callers to help them make and follow through with their hepatitis C-related decisions.

The new national helpline is a collaboration between five national nonprofits.

For more information visit www.help4hep.org/

Need help and support? Call 877-HELP-4-HEP (877-435-7443)

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HCV Snapshots
Lucinda K. Porter, RN

Article: Coffee Consumption and Reduced Self-Reported Side Effects in HIV-HCV Co-Infected Patients during PEG-IFN and Ribavirin Treatment – M. Patrizia Carrieri, et al.
  Source: Journal of Hepatology March 2012; Volume 56, Issue 3, Pages 745-747

In certain situations, coffee consumption seems to have a protective effect on the liver, particularly for reducing the risk of fibrosis and cirrhosis. Research also suggests that coffee-drinkers may have improved response to hepatitis C virus (HCV) treatment. This study examined the side effects and coffee-intake of 106 patients with HIV/HCV coinfection while undergoing HCV treatment with peginterferon and ribavirin.

The Bottom Line: Those who drank 3 or more cups of coffee a day reported lower severity of side effects than non-coffee drinkers did, even after adjusted for gender, age, liver fibrosis and history of opioid use.

Editorial Comment: Before you order a triple-latte, remember that caffeine may interfere with sleep, so drink your caffeine early in the day. Also, be sure you are drinking plenty of water to make up for the potential diuretic effects of coffee.

Article: Higher Serum Testosterone Is Associated with Increased Risk of Advanced Hepatitis C–Related Liver Disease In Males – Donna L. White, et al.
  Source: Hepatology March 2012; Volume 55, Issue 3, pages 759–768

This cross-sectional study enrolled 308 HCV-positive veterans. Approximately half the participants were African-American; the mean age was 57 years. Those with higher serum levels of testosterone were at greater risk of liver fibrosis and inflammation. The greatest likelihood of liver damage was among those with the highest testosterone levels.

The Bottom Line: In HCV-infected men, elevated serum testosterone levels are associated with an increased risk of both advanced liver fibrosis and inflammation.

Editorial Comment: Reduced estrogen levels in menopausal women may affect liver disease and response to HCV treatment. This testosterone study gives insight into hormone levels in men with HCV and opens the door to further research and understanding. 

Articles: 1) Critical Review of the Use of Erythropoietin in the Treatment of Anaemia during Therapy for Chronic Hepatitis C – F. Stickel, et al.
2) Impact of Erythropoietin on Sustained Virological Response to Peginterferon and Ribavirin Therapy for HCV Infection: A Systematic Review And Meta-Analysis – S.M. Alavian, et al.
  Source: Journal of Viral Hepatitis February 2012; Volume 19, Issue 2, pages 77–93

Erythropoietin (EPO) is a growth factor sometimes used to stimulate red blood production. EPO is an injectable medication,  sometimes used to manage HCV treatment-related anemia. The use of EPO for this purpose is not well-tested, nor is it approved by the FDA for this indication.  These two articles examine EPO’s use during HCV treatment.

The first article makes recommendations based on a panel of Swiss experts who reviewed the latest EPO and HCV treatment data. The consensus recommended intervention if hemolytic anemia causes hemoglobin (Hgb) levels to fall below 100 g/L (10 g/dL in U.S.). The same is true for a hematocrit (Hct) below 30%. EPO is recommended for genotype 1 patients. The evidence is less convincing but may support using EPO for patients with pre-existing anemia, other genotypes, liver transplant recipients and those with cardiovascular or pulmonary disease.

These data used peginterferon and ribavirin (RBV), and although research using EPO during triple therapy is largely unexplored, the panel said that anemia rates will likely increase, and with it the need for EPO.

The second article conducted a meta-analysis of 257 subjects in four clinical trials who developed anemia during HCV treatment, of which 157 had RBV reduction. Those who received EPO had a better chance of reaching a sustained viral response (SVR) – 67% versus 37% in non-EPO group.

The Bottom Line: EPO appears to be a better choice than RBV dose reduction for managing anemia during HCV treatment.

Editorial Comment: There are some serious risks associated with EPO, but no EPO-related adverse events were reported in either of these analyses. These studies are compelling and recommendations regarding the use of EPO during HCV treatment are long overdue.

Note: Since EPO is not approved for HCV treatment-related anemia, it may not be covered by insurance. EPO is expensive, and as mentioned earlier, does carry significant risks. 

Article: Occupational Transmission of Hepatitis C in Healthcare Workers and Factors Associated with Seroconversion: UK Surveillance Data – S.E. Tompkins, et al.
  Source: Journal of Viral Hepatitis March 2012; Volume 19, Issue 3, pages 199–204

This study analyzed data collected from UK healthcare workers with occupational exposure to HCV in 1997 to 2007. From this, fifteen cases of HCV seroconversion following clear exposure with a potentially contaminated needle were identified. The seroconversion rate was just slightly above 2%.

The Bottom Line: Deeper needle stick injuries and more complicated blood sampling procedures were more likely to yield HCV-seroconversion than superficial injuries were. The researchers noted that most of these HCV exposures were preventable, and recommended increased healthcare education. 

Editorial Comment: There is something oddly comforting knowing that healthcare workers who have constant exposure to HCV-positive blood have only about a 2% rate of seroconversion, and that much of the exposure is preventable. It reinforces my belief that it doesn’t take much for us to protect our family, friends and others who usually have less exposure to our blood. For information about HCV transmission prevention, see HCSP’s Fact Sheet series, such as www.hcvadvocate.org/hepatitis/

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Disability & Benefits: Maintaining Your Disability Claim in the Internet Age
—Jacques Chambers, CLU

There is no such thing as “Permanent Disability” for programs that pay disability benefits whether it is from private insurance companies or Social Security Disability (SSD & SSI). Unlike workers’ compensation, Veterans’ benefits, and other specialized programs, insurance and Social Security only agree to pay benefits AS LONG AS you are disabled. 

Because of that, your medical condition will be periodically reviewed to see if you remain eligible to continue to receive benefits, i.e., whether or not you still meet the plan’s definition of disability. This usually involves periodic questionnaires to you and/or your physician or even a review of your medical records.

Added to that now, thanks to the information/internet age, there is a new source of information, and insurance companies are taking full advantage of the new opportunities to check on what their claimants are doing. Social Security hasn’t yet extensively gotten involved in this, but that may change someday soon. 

While this should not be a cause of worry for persons receiving benefits who are still unable to do any gainful employment, it must be kept in mind that insurance companies are profit-making organizations and have a financial incentive to pay as little out in claims as they can. While they may claim that their goal is to only pay benefits to “eligible” claimants, unfortunately, too often they will expand minor issues until they become “proof” that a claimant can work and benefits should be stopped.

If you are unable to do either your old job or any suitable employment (based on the disability definition of your disability plan), you need to be aware of the fact that, in addition to the expensive and only rarely used method of following and videotaping you, insurance companies are now able to follow claimants’ activities quietly and inexpensively thanks to the popular trend in social media. 

One of the first steps an insurance company uses in reviewing a claimant’s activity is to search the claimant’s name on a web browser such as Google, Safari, or others. One claimant was listed as a member of the board of directors on a small non-profit organization’s website. Even though that involved only attending one two-hour board meeting a month, it led the insurance company to open a full-scale review of the claimant and an attempt to terminate his benefits. The attempt was unsuccessful, but only at the expense of a lot of stress and several months without income.

Then there is the social media, Facebook, LinkedIn, Google+, MySpace and many others. These have grown to the point that, according to one study, 22% of the time people in the U.S. spend on line is spent using some form of social media.

These are the sites where people post their photos of their latest vacation, pictures of family activities, and hobbies. Again, while these are usually innocuous descriptions of a person’s activities, taken out of context they can be used to support a claim of ability to work. One client and his spouse posted pictures of a trip to Argentina. What they failed to show was that they were visiting the spouse’s family with the goal of possibly moving there to stretch their limited disability income. It also didn’t show the careful planning that went into the trip, making sure there was adequate medication with proper documentation for customs, limiting time spent traveling and apartment hunting during the day to allow sufficient time for rest.

Some programs allow members to limit access to their sites, however, many members don’t bother to engage such limits. Even then, the barriers aren’t foolproof. Also, many people when asked to link to another, often link up without knowing or remembering for sure if they actually know that person or not. They just don’t want to offend them if they should know them. Insurance companies won’t try to link under the company name.

Again, the purpose of this is not to help healthy people hide their abilities in order to continue to obtain benefits, but to alert disabled persons entitled to benefits that someone may be watching and may try to take information out of context that can trigger a stressful review and possibly even a termination of benefits.

Below is a brief review of other methods insurance companies and Social Security use to review claimants’ eligibility to continue receiving benefits.

Disability Benefits from Insurance Companies
During the initial period of a disability claim, most insurance companies send a questionnaire for you and your physician to complete quarterly and review medical records less frequently. However, insurance companies cannot be counted on to adhere to any particular “schedule.”
After two years of benefits, most disability policies shift the definition of disability from “your occupation” to “any occupation for which you are reasonably suited by education, training, or experience.” That change almost always triggers a medical review and is the most opportune time for them to attempt to terminate benefits.

If you continue to be disabled and unable to return to work, it is important that you actively ensure that your records continue to reflect that fact. First, instruct all of your physicians to notify you any time they are contacted by the insurance company. Ask the doctor to put a note to that effect at the front of your medical file. Also request that he/she forward to you a copy of any questionnaire they complete from the insurance company. Ideally, you can make an appointment and you and your doctor can complete it together.

You may also want to caution your physician to be wary of questionnaires that pretend to save the physician’s “valuable time” by having her/him just check off some boxes. Such questionnaires usually don’t give the physician enough choices to accurately describe your condition. The insurance company will use the statement beside the checked box as if it were a statement actually made by your physician. If your physician is willing, she/he should return such questionnaires without checking any boxes but attach, instead, a narrative letter, which describes your current symptoms and condition and answers the questions asked on the form.

Also, you should not lose track of your symptoms. That may sound strange, but many people accommodate some symptoms so well and for so long that they forget they have the symptoms. Also, most people start feeling better when they leave work, especially after completing all the necessary paperwork and establishing eligibility for all the benefits to which they are entitled. However, some improvement in how you feel because your stress level is reduced is not the same as the elimination of all symptoms, or the ability to return to work. Your medical record must reflect that.

It is important, every time you visit the doctor, that she/he enters into the medical record a list of your symptoms and some estimate of their severity. Take a list of your symptoms and their severity with you to each visit. If the doctor is busy, he/she can simply attach them to the office notes. This should be done at every visit, even if the symptoms don’t change from one visit to the next.

These recommendations are especially important for the beneficiary whose symptoms are primarily “subjective,” as insurance companies are reluctant to continue paying benefits solely because of symptoms that are “self-reported.” If your symptoms are fatigue, diminished mental acuity, pain, or other symptoms that aren’t easily measurable with a lab test, then you should make a special effort to see that a record of the continuation of these symptoms is regularly entered into your medical record.

Social Security
Social Security conducts Continuing Disability Reviews (CDR) beginning between two and seven years after the initial approval. They do this with both SSI and SSDI, this is in addition to the annual financial reviews performed on beneficiaries collecting SSI. The time interval in the disability reviews is based on the likelihood of medical improvement.

The sending of CDRs has lagged lately due to staff shortages and the greatly increased number of applications due to the slow economy, however a new wave of questionnaires is being sent to beneficiaries. There two forms they use.

The short form is an Optical Character Reader form that is reviewed by computer. If you are still disabled, the goal is simply to see if you are still being treated for your condition and if there has been little or no improvement in your condition. The long form asks for much more detail and will usually involve Social Security obtaining records from your treating physicians.

While Social Security will sometimes determine that a person is no longer disabled enough to receive benefits, that would only happen after a thorough review of current medical records and allows an opportunity to appeal the decision. You will know if Social Security is looking that closely at your medical condition since they are required to obtain a medical release from you and would ask you to complete the long form questionnaire.

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