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August 2011 HCV Advocate

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In This Issue:

Similarities and Differences between HIV and HCV
Alan Franciscus, Editor-in-Chief


HealthWise: Coming to Terms with Hepatitis C
Lucinda K. Porter, RN


Disability & Benefits: Pre-Existing Conditions Insurance Plan
Jacques Chamber, CLU

HCV Snapshots
Lucinda K. Porter, RN

Clinical Trials
Alan Franciscus, Editor-in-Chief



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Similarities and Differences between HIV and HCV
—Alan Franciscus, Editor-in-Chief

HIV and the hepatitis C virus (HCV) share many of the same characteristics, but there are also some very distinct differences in the way they are transmitted, how long each virus lives outside of the body, disease progression, and treatment.  This article will explore some of the similarities and differences between HIV and hepatitis C.

RNA Viruses
Both HIV and hepatitis C are RNA viruses, but they are different types of RNA viruses—HIV is a retrovirus and HCV is a flavivirus. 

Replication
HIV mainly infects human immune cells (CD4, macrophages, and dendritic cells).  The hepatitis C virus mainly infects liver cells. 

The HIV virus goes through a complex process where the HIV virus inserts its generic material into the host DNA cell and uses the host genetic material to replicate.    HCV on the other hand uses the host’s cell to replicate, but does not insert itself into the host DNA.  These differences have major implications when discussing HIV and HCV treatment and disease progression.

In regards to how much each virus replicates on a daily basis—HIV replicates billions of new viruses vs. the trillions that the hepatitis C virus replicates daily. 

Mutation Rate
HIV has a high mutation rate, but hepatitis C is thought to replicate and mutate at a much higher rate than HIV. 

Vaccines
Studies are underway to find a vaccine for HIV and hepatitis C, but because of the high mutation rate of both viruses it will most likely be a long time (if ever) before a vaccine that will prevent HIV or hepatitis C infection is discovered and available for use.

Prevalence
In the United States it is estimated that more than 4 million Americans are infected with chronic hepatitis C compared to about 1.2 million who are estimated to be infected with HIV.  Worldwide the estimates are in the range of 40 million people infected with HIV compared to 170 million infected with HCV. 

Strains
There are different strains of HIV (HIV-1 and HIV-2) and hepatitis C (genotypes 1, 2, 3, 4, 5 and 6).  In the United States HIV-1 is the most common strain of HIV and genotype 1 is the most common strain of hepatitis C.  

Viral Loads
In people with HIV the viral load affects transmission and disease progression.  A high viral load for someone with HIV is in the range of 5,000 to 10,000 copies/mL.  In contrast a high HCV viral load for people with hepatitis C is any amount higher than 800,000.  Frequently people with HCV have viral load amounts in the millions.   Studies have not found that a high hepatitis C viral load increases transmission of hepatitis C or HCV disease progression.  However, there is some evidence that a high HCV viral load increases the chances of transmission of HCV from a mother to child.

How long do HIV and HCV live outside the body?
Once HIV is exposed to air it lasts only a few moments, but may live longer if blood is present especially in a closed environment such as in a syringe.  Hepatitis C on the other hand has been found to live outside the body for at least 16 hours but no longer than 4 days, and in a syringe for up to 63 days.  This is the reason why, for instance, that exposure to blood through unsafe tattooing carries a risk of transmission of hepatitis C, but it does not carry a risk of transmission of HIV. 

Chronic Infection
All people who are initially infected with HIV will have long-term or chronic infection.  Hepatitis C is different—some people (about 20 to 40%) who are initially infected (acute) will naturally resolve or clear HCV infection.  The other 60 to 80% of people will have long-term or chronic infection.  

Transmission
HIV and hepatitis C are transmitted in similar ways through blood routes although there are clear differences in the risk of transmission.  The hepatitis C virus is about 10 times more concentrated in blood than HIV.  This means that the hepatitis C virus can be transmitted easier when any HCV-infected blood is involved.  

In the United States, the most common way that HIV is transmitted is through anal and vaginal sex.  HIV can also be transmitted by sharing HIV infected needles and an HIV positive mother can pass HIV to her child. 

The most common way that hepatitis C is transmitted is from sharing HCV-infected needles and drug preparation and using tools.   Transmission routes of hepatitis C that are less common but still possible include sexual, and mother-to-child.

Treatment
Hepatitis C can be cured—this is because the hepatitis C virus does not integrate into the host’s DNA when it is replicating (see above).  It’s a different story with HIV because HIV inserts itself into the host’s DNA.   As a result, HIV treatment is aimed at lowering HIV viral load, increasing or stabilizing CD4 cell counts and preventing long-term consequences of infection. 

Drug Resistance
The medications used to treat HIV can lead to drug resistance because they are direct antiviral medications.  The newly approved protease inhibitors used in combination with pegylated interferon and ribavirin for people infected with HCV genotype 1 can also lead to drug resistance.  

People infected with HCV genotypes 2 or 3 are only prescribed pegylated interferon and ribavirin—these two medications do not lead to drug resistance. 

Thank you to Heather Lusk for review and input.  


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Healthwise: Coming to Terms with Hepatitis C
—Lucinda K. Porter, RN

Recently a friend told me that she is going deaf. She has a family history of late-onset deafness, and six weeks ago, she lost 80% of her hearing. As she told her story, I felt stricken, as if I were going deaf. My feelings must have registered on my face, as she quickly reassured me. She had a huge smile, as she told me she has dealt with this and she was truly at peace with her situation.

I, on the other hand, was not OK with this. I wanted to shout, “But wait—you have had time to deal with this. I am processing this on the spot and I am not ready to glow about this. I need a little time.” Ignoring my inner panic attack, I enunciated something supportive, exaggerating the movement of my lips in case she was reading them and not hearing my words. Later I went home and cried.

Thinking about it now, what strikes me are the many facets of coming to terms with illness. I have always been somewhat dismissive about having hepatitis C (HCV). I have had many years to get used to this virus, along with the potential complications it brings. It’s old news by now. Occasionally it’ll come up in conversation that I am HCV-positive. People look so sad when I tell them; much like I reacted upon learning of my friend’s hearing loss.

Coping with illness, whether it is our own or someone else’s, is a process. There are many theories about this process, studied by scholars such as Edward A. Suchman and Abraham Maslow. I reviewed about a dozen theories and concluded that it is virtually impossible to lump all HCV patients into a single model, but that when it comes to describing how we come to terms with living with this virus, Elisabeth Kübler-Ross’s Stages of Grief seems to fit best.

Kübler-Ross was a psychiatrist who worked with the dying and their families. In her book, On Death and Dying, she wrote about five stages of grief that follow the diagnosis of a terminal illness. Theorists have noted that these stages can apply to other life events, such as coming to terms with having a chronic illness. Family and friends of patients may go through these stages too.

Before discussing the five stages, it’s important to know the following:

  • not everyone goes through all stages
  • you don’t have to go through the stages in order
  • you can repeat a stage
  • you can stay in a stage indefinitely

Stage 1 is denial. In this stage, the patient ignores, minimizes, or completely denies that there is anything wrong. Denial can be subtle and complicated. For instance, assuming he’s been told to avoid alcohol, an HCV patient who still drinks may be having a problem with denial. Perhaps he doesn’t want to believe that alcohol can hurt him. Is he denying the HCV or an alcohol problem, or both?

There may be shock and disbelief in the first stage. The patient may wonder if this is really happening. Acceptance may occur on an intellectual level, but not on an emotional one.

Denial has a protective function. It allows patients and loved ones to maintain the illusion that everything is all right and that life will remain the same, even if this isn’t true.

Stage 2 is anger. This is an uncomfortable stage for patients and those around them. Resentment, hostility, and rage may be expressed. “Why me?” is a typical question, although it really is more an exclamation, “Why me!”

It may help to understand the reason why someone might feel angry about having HCV. This is not an easy diagnosis to have, and the treatment for it is difficult, time-consuming, very expensive and is not guaranteed to work. Having a chronic illness means life-style changes, and it affects relationships. Anger keeps us from feeling powerless.  

Stage 3 is fear. Kübler-Ross described this stage as bargaining, but when applying her model to discuss illness, fear is often substituted. In this stage, patients immerse themselves in alternatives. They may not want to discuss treatment, let alone try it. Fear takes over. They may believe myths about HCV, such as it can’t be cured or that they will lose all their hair during treatment.

At its worst, patients may feel extreme guilt or remorse in this stage. They may think they are being punished for past behaviors. Guilt, remorse, and shame can be tormenting.

The fear stage is extremely painful because it is powerlessness without hope or a solution. Education, taking control of one’s health, getting the facts straight and HCV support groups may help one to move through this stage.

Stage 4 is depression or grief. The patient grieves over what is lost. Although this stage is painful, sadness and grief are often necessary ingredients to help patients move to acceptance. Withdrawal, isolation or depression may occur. If these feelings continue, are extreme, or there are thoughts of self-harm, medical help is advised. HCV support groups may help a person move through this stage.

Stage 5 is acceptance. When we face HCV squarely, we may feel a lifting of the burden of illness. There still may be moments of denial, fear, anger, or sadness, but generally we accept having this virus and it ceases to dominate our lives.

Most patients experience more than one of these stages of illness, but some skip over them and go directly to acceptance. They accept the diagnosis, and move on to problem solving. Their response is, “OK, I have this, so what am I going to do about it?” They learn everything they can about HCV, or they simply follow medical advice and get on with their lives.

Those around us go through these stages. My hearing-impaired friend was in the acceptance stage; I was sad and in stage 4. After a few days, I moved to denial and now I am trying to accept her condition.   

Although it may be helpful to understand what stage we are in, our response to having HCV may be complicated by other factors. For instance, when it comes to having HCV, I don’t like sympathy and I reject it as if it is a hot potato. When I broke a bone in my foot, I wanted tons of sympathy. I assume this is because I wasn’t going to die from a broken metatarsal, so sympathy from others seems uncomplicated. Although I am unlikely to die from HCV, it is always looming in the background. Sympathy from others brings HCV into the foreground, a place where it can be too uncomfortable.

The bottom line is that we deal with illness in our own way and in our own time. The chronic nature of HCV presents us with opportunities to look at it, or avoid it, or to use the potentially transformative nature of illness to learn and grow from it.

One way to cope with illness can be found in the words of Kübler-Ross. During an interview, she said, “In Switzerland I was educated in line with the basic premise: work work work. You are only a valuable human being if you work. This is utterly wrong. Half working, half dancing - that is the right mixture. I myself have danced and played too little.” No matter what stage you are in, may it include lots of dancing.


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Disability & Benefits: Pre-Existing Conditions Insurance Plan
—Jacques Chambers, CLU

The federal Affordable Health Care Act does not open the private health insurance market to persons with medical conditions until 2014, however, there is a gradual movement in that direction going on now.

Waiting until 2014 to get health insurance is a very long wait for someone with a pre-existing condition that keeps them out of the private market, especially if it is someone who does not currently have health insurance. To solve that dilemma, the Act provides for temporary programs called Pre-Existing Conditions (health) Insurance Plan (PCIP). The Plan is temporary and will last only until insurance companies are required to cover anyone who requests coverage in 2014.

There is a PCIP plan in each state for persons who have a pre-existing medical condition that prevents them from getting health insurance through the individual health insurance market. However, there are strict limitations on who can purchase this insurance.

These programs were designed not just to help people who cannot purchase health insurance, but they were also planned as a method to help move some of the “uninsurable” people not having current coverage into the market to ease the pressure of everyone applying for coverage at once when 2014 arrives. Because these plans have not been well advertised, however, enrollments have been much lower than expected.

The Plans

  • Cover a broad range of health benefits, including primary and specialty care, hospital care, and prescription drugs. All covered benefits are available, even to treat a pre-existing condition.
  • Don’t charge a higher premium just because of the medical condition.
  • Don’t base eligibility on income.

To be eligible for these PCIP plans:

  • You must be a citizen or national of the United States or reside in the U.S. legally.
  • You must have been without health coverage for at least the last 6 months. Please note that if you currently have insurance coverage that doesn’t cover your medical condition or are enrolled in a state high risk pool, you are not eligible for the Pre-Existing Condition Insurance Plan.
  • You must have a pre-existing condition or have been denied health coverage because of your health condition.

Obviously, the requirement of having been without health insurance at least six months severely limits who can enroll in these plans, but the purpose of the program was to start making coverage available to persons without insurance, not to draw people from the current health insurance market.

In order to qualify for coverage, you will need to provide one of the following documents:

 A letter from a doctor, physician assistant, or nurse practitioner dated within the past 12 months stating that you have or had a medical condition, disability, or illness. This letter must include your name and medical condition, disability, or illness and the name, license number, state of licensure, and signature of the doctor, physician assistant, or nurse practitioner.

OR

A denial letter from an insurance company licensed in your state for individual insurance coverage (not health insurance offered through a job) that is dated within the past 12 months. Or, you may provide a letter dated in the past 12 months from an insurance agent or broker licensed in your state that shows you aren’t eligible for individual insurance coverage from one or more insurance companies because of your medical condition.

OR

An offer of individual insurance coverage (not health insurance offered through a job) that you did not accept from an insurance company licensed in your state that is dated within the past 12 months. This offer of coverage has a rider that says your medical condition won’t be covered if you accept the offer.

OR

If you are under age 19 OR if you live in Massachusetts or Vermont, an offer of individual insurance coverage (not health insurance offered through a job) that you did not accept from an insurance company licensed in your state that is dated within the past 12 months. This offer of coverage must show a premium that is at least twice as much as the Pre-Existing Condition Plan premium (the monthly payment you make to an insurer to get and keep insurance) for the Standard Option in your state.

Twenty-seven states have elected to set up and administer their own PCIP. The remaining twenty-three states along with the District of Columbia have elected to let the federal Department of Health and Human Services administer the programs in their state.

The federally-administered Pre-Existing Condition Insurance Plan offers three plan options – the Standard Plan, the Extended Plan, and the Health Savings Account (HSA) Plan. These plans have different levels of premiums, calendar year deductibles, prescription deductibles, and prescription co-pays. Each of the three plan options provides preventive care (paid at 100%, with no deductible) when you see an in-network doctor and the doctor indicates a preventive diagnosis.

For other care, there is a deductible before PCIP pays for your health care and prescriptions. After you pay the deductible, you will pay 20% of medical costs in-network. The maximum you will pay out-of-pocket for covered services in a calendar year is $5,950 in-network/$7,000 out-of-network. There is no lifetime maximum or cap on the amount the plan pays for your care.

States that administer their own plan design their own programs within the federal guidelines. Deductibles and co-pays vary and some do have a lifetime limit of $1,000,000, but all are broad in that they provide coverage in and out of the hospital, in doctor’s offices, X-rays and lab tests, and coverage for prescription drugs.

Premiums vary depending on the state you live in. But as an example, if you live in a state where the U.S. Department of Health and Human Services provides coverage, the premium for an 50-year-old enrollee may range between $214 and $559 per month, depending on the state of residence. The federally administered PCIP program developed its premiums by considering individual market premiums, and to reflect underlying cost differences in local health care markets such as cost, pricing and utilization practices, which results in some variation from state to state.

To find the PCIP for your state and to enroll on line in a federally administered state, go to https://www.pcip.gov/


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HCV Snapshots
—Lucinda K. Porter, RN
Alan Franciscus, Editor-in-Chief

Article: Association of Caffeine Intake and Histological Features of Chronic Hepatitis –Costentin C, Roudot-Thoraval F, Zafrani ES, Medkour F, Pawlotsky JP, Mallat A, Hezod C
Source: Journal of Hepatology June 201; Volume 54, Issue 6, Pages 1123-1129

When looking at chronic hepatitis, evidence points to a relationship between caffeine consumption and improved liver tissue and lab results. Wanting to know more about this, a French team examined the impact of caffeine consumption on the liver in patients with chronic hepatitis C virus infection (HCV). There were 238 study subjects all with HCV (154 men and 84 women). Participants averaged about 408 mg of caffeine daily, mostly in the form of coffee (2 cups dally).  Data were independently analyzed to remove other factors, such as alcohol and cigarette use.

The Bottom Line: Patients with HCV who drank the most coffee (3 or more cups a day) tended to have the least amount of inflammation of the liver cells. Researchers did not find a strong association between caffeine consumption and liver fibrosis progression, and suggest further studies. These findings suggest that caffeine or coffee may offer some protection to the liver.

Editorial Comment: There have been quite a few studies looking at the relationship between coffee consumption and HCV. For instance, research published in the June 2011 issue of Gastroenterology showed that HCV patients who drank three or more cups of coffee daily were three times more likely to respond to HCV treatment than patients who didn’t drink coffee.

Since coffee is made of more than a thousand constituents, it is impossible to state which component might be related to lower inflammation scores, or if the reason is related to the coffee at all. For instance, perhaps there is something else that coffee drinkers do or take that is related to improved liver inflammation. A double blind, randomized placebo-controlled study using caffeine would be an excellent tool for gaining more understanding about this.

Article: A Sustained Virologic Response Reduces Risk of All-Cause Mortality in Patients With Hepatitis C – Backus L, Boothroyd D, Phillips B, Belperio P, Halloran J, Mole L
Source: Clinical Gastroenterology and Hepatology June 2011; Volume 9, Issue 6, Pages 509-516

This large Veterans Administration (VA) study looked at HCV patients who were treated with pegylated interferon and ribavirin between January 2001 and June 2007. Patients with liver cancer or HIV were not included in this analysis. Subjects included 12,166 with genotype 1, 2904 with genotype 2, and 1794 with genotype 3. The sustained viral response rates (SVR) were 35% for genotype 1, 72% for genotype 2, and 62% for genotype 3.

There were many comorbidities in each group. In the follow-up period of roughly 3.8 years, approximately 1% of the patients died, not necessarily from HCV. The numbers were: 1119 genotype-1 patients, 220 genotype-2 patients, and 196 genotype-3 patients. However, an SVR substantially reduced mortality risk for each genotype.

The Bottom Line: SVR is linked with significantly improved survival rate for all causes of death.

Editorial Comment: This is a large and important study. VA patients tend to have more significant medical issues than non-VA patients. This improved survival rate is a compelling endorsement for HCV treatment.

Article: Racial Differences in Hepatitis C Treatment Eligibility –Melia M, Muir A, McCone J, Shiffman M, King J, Herrine S, et al.
Source: Hepatology July 2011; Volume 54, Issue 1, Pages 70–78

In the U.S. there is a disproportionately high number of HCV infections among blacks when compared to non-black patients. Blacks are also less likely to respond to peginterferon/ribavirin treatment. This was a retrospective analysis of 4,469 subjects at 118 treatment centers. Of the patients who were treated, 19% were black. However, 65% of blacks were more likely to be ineligible for treatment than nonblacks were. Reasons ranged from failure to complete evaluations, low white blood cell count (neutropenia), anemia, and increased glucose or creatinine levels.

The Bottom Line: The researchers in this study concluded that uncontrolled medical conditions and neutropenia negatively affected black patients’ eligibility for HCV treatment. The researchers recommended increasing the potential for HCV treatment eligibility through better management of chronic health problems, such as diabetes and kidney disease. Also recommended were more liberal entry requirements, particularly for neutrophil counts.

Editorial Comment: Medical disparities are a tragic but real concern. There are racial, gender, age, and socioeconomic disparities, to name a few. I applaud the researchers in this study for bringing this to the forefront. This is especially timely, as blacks are showing improved SVR rates with the new triple therapies using an HCV protease inhibitor. It is critical that everyone who wants to be treated is given the opportunity.

Article: Pregnancy Outcomes Associated with Viral Hepatitis – Reddick K, Jhaveri R, Gandhi M, James, A, Swamy, G
Source: Journal of Viral Hepatitis July 2011; Volume 18, Issue 7, Pages 394–398

This nationwide study looked at the relationship between pregnancy-related complications and hepatitis B virus (HBV) and hepatitis C virus (HCV). The study analyzed data from 297,664 pregnant women, of whom 1446 had HBV, HCV or both. The pregnancy-related complications that were followed included gestational diabetes, preterm birth, intrauterine growth restriction, pre-eclampsia, Cesarean delivery, antepartum hemorrhage and cholestasis. Since HBV and HCV are associated with high-risk behaviors, such as smoking and substance use, data were analyzed with this in mind.

Women with HBV had an increased risk for preterm birth but decreased risk for Cesarean delivery. HCV-positive women had a higher rate of gestational diabetes. Those with both HBV/HCV had a higher risk of antepartum hemorrhage.

The Bottom Line: Women with HBV, HCV, or HBV/HCV coinfection have an increased risk for pregnancy-related complications.

Editorial Comment: So many of the pregnancy-related studies have to do with the transmission of viral hepatitis. This research is fresh and interesting. It arms medical providers with information to be used in management and counseling of obstetric patients.

Article: Rapid Virological Response as a Predictor of Sustained Response in HCV-infected Patients with Persistently Normal Alanine Aminotransferase Levels – Puoti C, Barbarini G, Picardi A, Romano M, Pellicelli A, et al.
Source: Journal of Viral Hepatitis June 2011; Volume 18, Issue 6 Pages 393-399

When it comes to hepatitis C (HCV) treatment, there is no better predictor of potential response to treatment than the rapid virological response (RVR). However, the RVR in patients who have persistently normal alanine aminotransferase (ALT) levels has not been studied. This research looked at 137 HCV patients with normal ALT levels, treated with peginterferon alfa 2a and ribavirin.

The Bottom Line: Overall, 92% of patients with RVR were able to clear HCV, whereas only 38% of those without rapid response cleared the virus. Of note, patients with genotype 2 or 3 have a high chance of achieving SVR anyway, so testing for RVR is not recommended.

Editorial Comment: This appears to be the first concrete evidence that patients with persistently normal ALT levels may be managed in much the same way as HCV patients with elevated ALT levels.


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Clinical Trials
—Alan Franciscus, Editor-in-Chief

DEB025 (alisporivir) is a cyclophilin inhibitor that works by blocking the replication process of the hepatitis C virus in the region of the HCV NS5A.  DEB025 is not a direct acting antiviral because it works by inhibiting host factors responsible for replication rather than targeting specific viral proteins.  This means that it is less likely to lead to drug resistance and could potentially be used to treat a wide range of diseases. 

Phase II studies of the combination of DEB025 plus pegylated interferon and ribavirin (PEG/RBV) produced sustained virological response or SVR (undetectable HCV RNA or viral load 24 weeks post therapy) in up to 76% of people who took the triple combination for 48 weeks compared to 55% in the group that received PEG/RBV but not DEB025.

DEB025 is in phase III studies.  Information from www.clinicaltrials.gov  (identifier: NCT01318694) for this study includes: 

  • A randomized study—a computer program will assign the participant to a certain study arm
  • Placebo (sugar pill) arm is included in this study
  • Double-blinded—neither the investigator (nurse or doctor) or the patient—is told who will receive the study drug
  • The arm used to compare the effectiveness of DEB025 plus PEG/RBV to the  standard of care arm (SOC) is pegylated interferon plus ribavirin and a placebo pill.  This study does not contain an arm that receives an HCV protease inhibitor
  • Treatment duration will be either 24 or 48 weeks
  • Treatment response, duration and stopping will be measured at week 4, week 12, and thereafter
  • Participants who do not achieve HCV RNA undetectable at certain time points will be offered open-label access (to all drugs) for 48 weeks and participants will be followed for an additional 24 weeks—the follow-up period

If you are interested in learning more about this clinical trial go to www.clinicaltrials.gov  and input HCV phase III, DEB025


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