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September 2011 HCV Advocate

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In This Issue:

NYC: Sexual Transmission of HCV Among HIV Positive Men
Alan Franciscus, Editor-in-Chief

Important Updates at the HCV Advocate

HealthWise: Looking Back at Hepatitis C
Lucinda K. Porter, RN

Disability & Benefits: Medicare—
Getting the Most Out of It

Jacques Chamber, CLU

HCV Snapshots
Lucinda K. Porter, RN

Clinical Trials
Alan Franciscus, Editor-in-Chief

HCV Advocate Eblast
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NYC: Sexual Transmission of HCV Among HIV Positive Men
—Alan Franciscus, Editor-in-Chief

Hepatitis C virus (HCV) is transmitted by exposure to HCV-infected blood.  The most common transmission route of HCV in the United States is from sharing needles and drug preparation tools (works) to inject drugs.  The hepatitis C virus can be spread through sex, but it is not a particularly efficient route of transmission (0-3%)—at least in heterosexual people who are in a long-term monogamous relationship.  The rate of sexual transmission in other populations hasn’t been well-studied except for some studies from Europe and Australia which have found higher rates of sexual transmission of HCV in HIV-positive men.  This is particularly worrisome because of the accelerated HCV disease progression in people who are also infected with HIV. 

A recent report in MMWR (Weekly/Vol.60/No. 28) summarized the findings of a study conducted in New York City, NY from October, 2005 to December, 2010 and adds to the growing body of evidence of sexual transmission of HCV.  During this period Mount Sinai evaluated 74 HIV-positive MSM (men who have sex with men) with no reported injection drug use.  These men recently tested positive for HCV antibodies in addition to elevated levels of alanine aminotransferase (ALT) indicating liver cell inflammation.  The mean age of the study participants was 39 years old.  The ethnic/racial characteristics of the group consisted of 41 non-Hispanic whites, 14 non-Hispanic blacks, 18 Hispanics and one Asian.  Eighty one percent (60 patients) had no symptoms; 19% (14 patients) had jaundice (yellowing of the skin and whites of the eyes); median ALT level was 665 U/L (range:  72-5,291 U/L).  Ninety-one percent (65) had a previous negative HCV-antibody test. 

The researchers set up a case-control study of this group to find out the role of sexual transmission in 53 patients (control group) matched by age and race/ethnicity and with no reported injection drug use.  All participants completed self-administered questionnaires about their sexual practices and drug use during the 12 month period PRIOR to being diagnosed, or, in the case of the control group, prior to answering the questionnaire.

The researchers found that the most important predictors of HCV infection included unprotected receptive anal intercourse with ejaculation, and sex while high on methamphetamine (non-injection).  These results support similar findings of sexual transmission in MSM’s in Europe and Australia. 

This study identifies the risk factors for sexual transmission of HCV among HIV-positive men.  It should also strengthen the messages regarding risk factors for sexual transmission among HIV-positive men including risk reduction strategies.  It is critically important that initiation of antiviral treatment for acute HCV infection be offered and encouraged for everyone who is diagnosed with acute HCV because the vast majority of people treated in the acute phase can be cured of HCV.  It is even more important for people with HIV since pegylated interferon plus ribavirin cures less than 1/3 of people who are coinfected with HIV and chronic HCV genotype 1.  

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Important Updates at the HCV Advocate

We have updated over 200 of our Easy C's, Basics and HCSP Fact Sheets as well as our comprehensive Guides about hepatitis C to include the latest information about hepatitis C, including the newly approved HCV protease inhibitors.  We have also produced new fact sheets to provide our readership with important information about boceprevir and telaprevir, such as the Easy C fact sheet shown below.

It is also important to know that we give approval to download, copy and distribute any of our hepatitis B and hepatitis C materials as long as www.hcvadvocate.org or www.hbvadvocate.org are referenced.

Healthwise: Looking Back at Hepatitis C
—Lucinda K. Porter, RN

If you haven’t heard the news, this year the Food and Drug Administration approved two new drugs for patients with genotype-1 chronic hepatitis C virus infection (HCV)—boceprevir (Victrelis) and telaprevir (Incivek). Both are protease inhibitors and each is combined with peginterferon and ribavirin to form a powerful triple therapy approach to destroy HCV.

This turning point means that HCV has met its match. To put this in perspective, scientists are having more success at fighting HCV than they are at curing the common cold. This pivotal moment is a good time to look at the history of HCV.

What is HCV?
HCV is a small RNA-virus, approximately 50 nm in size. It is the lone member of the hepacivirus genus in the family Flaviviridae. Yellow Fever is in the same family (but not the same genus). Flavus is yellow in Latin, a color that some people turn if they have Yellow Fever or HCV. (Here is a little more trivia about yellow: the medical term for the yellowish color is jaundice, which indicates liver damage. The word jaundice comes from the French for yellow.)

When HCV enters the body, it relies on liver cells to sustain it so it can multiply. This multiplication is called viral replication and HCV may do this up to a trillion times daily.

Once HCV infects the liver cell it uses RNA in order to replicate. HCV does not kill the liver cell directly.1 It is more like a hostage-taker than a murderer. Sensing danger, the body’s immune system tries to destroy the unwanted virus, but HCV usually wins. The body keeps trying to clear the virus, a process that slowly destroys the liver. Sometimes in the first six months after exposure, the immune system triumphs over HCV. When this happens, people are left with  the HCV-antibody but not the actual virus.

History of the Virus
The earliest reports of viral hepatitis were in the 5th century B.C. The physician, Hippocrates, of the famed Hippocratic Oath, reported outbreaks of jaundice in Greece. Jaundice outbreaks occurred during various wars, including the Civil War. These were likely due to hepatitis A and B, although these viruses had not yet been formally identified. In 1952, Joseph Stokes, Jr. lectured about two hepatitis viruses—hepatitis A and B. Hepatitis B was isolated in 1963; hepatitis A in 1973.

Soldiers returning from the Asian theaters in World War II and Korea had a high incidence of viral hepatitis. Vaccination practices to prevent Yellow Fever and other diseases contributed to viral transmission. However, scientists were aware of the existence of another virus that attacked the liver. Military personnel had the signs and symptoms of a hepatitis virus that acted somewhat differently that hepatitis A and B, which eventually became known as a third type of viral hepatitis.

This third type of viral hepatitis (which we now know was HCV) was transmitted to many who served in Vietnam. The need for blood transfusions meant that medics, nurses and soldiers were exposed to HCV-infected blood. Unsafe service-related vaccination programs also spread HCV. Some soldiers in the field and back home coped with trauma by turning to injection drug use, further spreading HCV among those who shared drugs and related paraphernalia. 

In the 1970’s, Harvey Alter and colleagues from the National Institutes of Health demonstrated that there was a post-transfusion hepatitis that was neither hepatitis A nor B. It was named non-A, non-B hepatitis. No one thought it posed much of a threat and patients were told not to worry about it. Interestingly, forward-looking researchers kept blood samples of many of the returning soldiers of World War II and by process of elimination diagnosed them with non-A, non-B hepatitis.

In 1989, researchers from Chiron Corporation, collaborating with the Centers for Disease Control and Prevention (CDC) published research that identified HCV—the new name for non-A, non-B hepatitis. The credit for the discovery and subsequent patent awards are plagued with controversy and litigation. Michael Houghton and two colleagues from Chiron are credited with the discovery, although Daniel Bradley from the CDC played an important role. In 2000, Alter and Houghton received the prestigious Lasker Award for Clinical Medical Research.

This year, W. Ian Lipkin and colleagues from Columbia University announced the discovery of a canine HCV. This discovery brings up the theory that HCV may have been transmitted to humans via man’s best friend, perhaps as much as 500 to 1000 years ago. I thought it was bad enough that dogs gave us fleas.

History of HCV Treatment
Treatment for chronic HCV infection began in the early 1990s with interferon-alfa. The response rates were low, ranging from 10% to 20%.2 This injectable drug worked by boosting the immune system, rather than by specifically attacking the virus. It is like giving a gun to people to fight off intruders. If you are a good shot, you win the fight; if you aren’t, you are overwhelmed with intruders.

In 1998, the oral drug ribavirin was added to interferon. The success rates increased dramatically, averaging 37% to 43%, but so did the side effects.3  We still don’t know precisely how ribavirin works, other than it seems to weaken HCV. A good way of looking at HCV treatment is that ribavirin cuts the leg off HCV making it easier for interferon to finish the job.

The treatment advance occurred in 2002 with the approval of pegylated interferon-alfa, a processthat makes interferon more durable and effective. Combined with ribavirin, the average patient could expect about a 52% permanent response.4  Pegylated interferon compared to plain interferon is like the difference between a handgun and an automatic weapon.

The newest weapons in our arsenal are two protease inhibitors—boceprevir and telaprevir. These drugs directly target HCV and prevent the virus from replicating. Protease inhibitors are like precision-guided weapons designed to destroy a specific virus. In case any HCV is hiding, you finish the job with peginterferon and ribavirin. The triple therapy approach is approved for genotype 1 patients with results hovering around 79%.5 Patients with genotypes 2 or 3 will continue to use peginterferon and ribavirin without the need for a third drug. This group has good response rates at 82%.4

Reviewing the history of HCV gives me perspective. Yes, HCV is still looming large. Yes, not everyone can or will be treated with 100% cure rates. Nevertheless, we have still come a long way in a short time and our weapons are improving. This allows us to work on prevention and creating a world free of HCV.

Further Reading:
A Brief History of Hepatitis C,
by Alan Franciscus
/factsheets _pdf/Brief_History_HCV.pdf

1 The exact mechanism of how HCV damages the cell is not completely understood. A 2009 University of Alberta study showed direct cell death in mice who were infected with HCV. The Cell Biology of Hepatitis C Virus, Joyce, M and Tyrrell, D L J. Microbes and Infection 2010. www.hepatitistechnologies.com

2 National Institutes of Health Consensus Development Conference Statement: Management of Hepatitis C Hepatology March 1997 
3 Rebetol, Intron and Rebetron product information
4 Compilation of data from product information of peginterferon alfa-2a with ribavirin (Pegasys/Copegus) and peginterferon alfa-2b with ribavirin (PegIntron/Rebetron)
5 Incivek (telaprevir) prescribing information

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Disability & Benefits: Medicare—Getting the Most Out of It
—Jacques Chambers, CLU

Medicare is generally an excellent health plan. Whether you choose original fee-for-service Medicare or one of the many Medicare Advantage alternative plans, coverage is provided that is typically broader than most privately insured health plans. However, because of the flexibility built into the coverage, there are choices that Medicare beneficiaries can make that will give them the best possible coverage for the least out-of-pocket expense.

Persons covered under a Medicare Advantage (such as a Medicare HMO or PPO or another plan provided by an insurance carrier) should work with the administrators and providers within that plan, as they must refer you to doctors and medical providers that are part of their contracting network.

On the other hand, persons covered under original fee-for-service Medicare are allowed to choose their own doctors and other medical providers. Making a mistake in that selection can be very expensive if you select the wrong provider.

With original Medicare, your out-of-pocket costs can vary substantially depending on what physician you use. There are three types of physician coverage based on the physician’s choice of practice:

  • Physicians who accept Medicare Assignment – Ask your doctor’s insurance or billing clerk if the doctor “accepts Medicare Assignment.” If so, he or she can only collect 20% of the Medicare Allowable Amount from you and 80% of the Medicare Allowable Amount from Medicare regardless of their “normal” charge for that procedure.

    • Example: The doctor charges $300 for a service. Medicare says that $200 is the Medicare Allowable Amount for that service. Since the doctor has accepted Medicare Assignment, they will collect $160 from Medicare (80% of Medicare Allowable Amount) and cannot bill you for more than $40 (20% of $200).

  • Physicians who do NOT accept Medicare Assignment – If your doctor does not accept Medicare Assignment, he or she is still limited in what you can be charged. In addition to the 20% of the Medicare Allowable Amount, he or she may bill you an additional 15% of the Medicare Allowable Amount.

    • Example: Doctor charges $300; Medicare Allowable Amount is $200. In this case, in addition to billing you $40 (20% of Medicare Allowable Amount), he or she can also bill you an additional $30 (15% of the $200 Medicare Allowable Amount) for a total out-of-pocket expense of $70.

  • Private Contracts – There are some physicians, not as many as the press would have you believe, who refuse to participate in the Medicare Program at all. Medicare will not pay anything for charges from this physician. The physician is required to notify you of this before you incur any charges and must offer you a private contract in which you state that you understand that Medicare will not cover any of the bill and agree to pay the full fee yourself.

    • NOTE: The doctor cannot pick and choose among patients; if the doctor refuses to accept Medicare for you, he or she must refuse to accept any Medicare payment from all patients; it can’t be done selectively. If you have a Medigap policy it will not pay anything to this doctor either. Your choice is to agree to pay the doctor in full out of your own pocket or seek treatment from another physician.

Hospitals (called Acute Care Hospitals) are covered by Medicare as long as they are licensed to operate by the appropriate oversight agencies. Note, however, that your out-of-pocket payment will differ whether you are an in-patient or outpatient of the hospital. Staying overnight in a hospital does not automatically mean you are an in-patient. You should ask the hospital if you have questions.

For Medicare to pay certain types of claims at all, you must use Medicare-Certified or Medicare Approved providers. This applies to services or products provided by Home Health Agencies, Hospice Facilities, Durable Medical Equipment, and providers of Prosthetics/Orthotics.

While it appears at first that people enrolled in original fee-for-service Medicare are on their own, there is considerable assistance available on-line. Their website, www.medicare.gov, provides a lot of information. I strongly recommend you spend some time on the site exploring and seeing what is available.

There is an area where you can find physicians by name, location, and/or medical specialty. The site will also state whether or not the physician accepts Medicare Assignment. It is recommended that you confirm that when contacting the doctor’s office.

It also has a section that lets you compare hospitals and their procedures. For example, you can get a list of hospitals in your area. From that, you can select certain procedures or medical conditions and the section will show up to three hospitals side by side, showing the patient opinions, the number of procedures performed, and other ratings and numbers that will help you select the best hospital for your specific needs.

In addition to comparing acute care hospitals, there are also sections that allow you to compare nursing homes, home health agencies, and suppliers of medical equipment.

In addition, you can obtain information on the Medicare benefits, order a Medicare card, and find other information about Medicare.  There is even a tool that allows you to plan for long-term care needs although Medicare, other than Hospice Care, does not cover custodial care.

You can also compare various Medicare health plans in your area. During each annual enrollment period (October 14 – December 7 of each year) you are encouraged to enter your current medications in the Compare Drug Plans section to confirm that the Part D Drug Plan you are enrolled in is still best for you based on the medications you currently take. There is also information on qualifying for Extra Help with your Part D out-of-pocket costs.

There is an opportunity, without charge, to set up your own My Medicare site by choosing a username and password. This site is available only to you. It allows you to enter information on your current providers; review claims that have been processed or are currently in process, and print out copies of Medicare Summary Notices (the sheets that show how a claim was processed).

As you may be aware, Medicare changed August 1 so that Preventive Services are available without any deductible or co pay. My Medicare tracks your use of Preventive Services and lets you see when you last used a particular preventive service and should consider having it repeated.

Medicare is excellent coverage, but, as with any insurance plan, the more active you are in learning about your choices, and making wise ones, the better it will work for you.

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

Article: Hepatitis C Virus Infection in USA: An Estimate of True Prevalence – Chak E, Talal A H, Sherman K E, Schiff E A, Saab S
Source: Liver International September 2011; Volume 31, Issue 8, Pages 1090-1101

The prevalence of chronic hepatitis C virus (HCV) infection in the United States is usually stated as 3.2 million people. This figure is based on data from the National Health and Nutrition Examination Survey (NHANES) conducted by the Centers for Disease Control and Prevention (CDC). Many experts think that the number of Americans exposed to HCV is actually higher than the CDC estimate, since the survey did not count populations that traditionally have a higher rate of HCV, such as the incarcerated, the homeless, military personnel, and those housed in institutions. In an abstract presented at the 2005 American Association for the Study of Liver Diseases Conference (Abstract 65122), Brian Edlin of Cornell University estimated the prevalence at 5 million.

Researchers in this 2011 study searched multiple sources for data on populations not sampled by NHANES. Their conservative estimate adds an additional 1.9 million HCV-positive people, bringing the total to 5.2 million people in the U.S. with this disease.

The Bottom Line: This research confirms that there are more people in the U.S. with HCV than officially estimated. This is not because HCV is more infectious than believed—it is because the original surveys were not properly conducted.

Editorial Comment: Experts tell us that in the next ten years, HCV will place a huge burden on our healthcare system. These warnings are based on the NHANES survey, so one can only imagine what it will mean if there are 1.9 million more people with this virus. We need to confront and contain this problem. This means test more people, provide better education, treat more people, and strengthen our prevention strategy.

Article: Multiple Ascending Dose Study of BMS-790052, an NS5A Replication Complex Inhibitor, In Patients Infected With Hepatitis C Virus Genotype 1 – Nettles R E, Gao M, Bifano M, Chung E, Persson A, et al.
Source: Hepatology August 2011 accepted articles

BMS-790052 is an NS5A replication complex inhibitor currently under study by Bristol-Myers Squibb. BMS-790052 interferes with viral replication by targeting the NS5A protein part of the hepatitis C virus. The purpose of this study was to see if BMS-790052 is a feasible HCV treatment agent, and if so, at what dose. This was a double-blind, placebo-controlled study that enrolled 30 HCV, genotype 1 subjects to receive either placebo or BMS-790052, at various doses and durations.

The Bottom Line: All doses and durations of BMS-790052 were well-tolerated. Viral load dropped rapidly and substantially; viral rebound occurred approximately 7 days after dosing. It is worth noting that although this was a very small study, genotype 1b subjects seemed to respond better to BMS-790052 than did those with genotype 1a.

Editorial Comment: This is an encouraging study BUT it is small and in the early stages. Phase III studies using BMS-790052 with peginterferon and ribavirin are scheduled to begin September 2011. See page 7 of this newsletter for more about BMS-790052.

Article: A Prospective Study of the Rate of Progression in Compensated, Histologically Advanced Chronic Hepatitis C – Dienstag J L, Ghany M G, Morgan T R, Di Bisceglie A M, Bonkovsky H L, et al.
Source: Hepatology August 2011; Volume 54, Issue 2, Pages 396–405

The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial was a prospective study that began in 2000. The goal was to follow 1050 subjects with advanced HCV who had previously failed treatment. Subjects with bridging fibrosis or cirrhosis were randomly assigned to receive a “maintenance therapy” of low dose peginterferon or no medication. The study was intended to last 3.5 years but was extended to 8 years.

There were no benefits to the low-dose peginterferon. These patients incurred the same rate of HCV-related medical complications as those who were not taking peginterferon. In fact, the death rate was slightly higher for those taking low-dose peginterferon and medication side effects made it difficult for patients to take.

Researchers observed that the annual death from any cause and transplant rates were 2.2% among patients with non-cirrhotic fibrosis and 5.3% in those with cirrhosis. Subjects with bridging fibrosis had an annual cirrhosis rate close to 10%. The annual rate from compensated to decompensated cirrhosis averaged 6%. A large body of information has been collected from the HALT-C study. For instance, this study confirmed that decreasing platelet counts is a good predictor of medical outcome. (Patients with platelets less than 100,000 mm2 are 14 times more likely to need a liver transplant or die than patients with platelets above 200,000 mm2.)

The Bottom Line: Although the original goal of seeing if HCV patients would benefit from long-term, low-dose peginterferon did not pan out, the data from the HALT-C study has provided valuable information about HCV natural history. HALT-C provides information about many areas of interest related to HCV—such as obesity, ALT levels, iron overload, brain function, and the use of Complementary and Alternative Medicine. This information translates into significant tools for medical providers.

Editorial Comment: More than a thousand patients participated in the HALT-C study, submitting to rigorous testing and data collection, including three liver biopsies. Thank you for your service. For more information, go to www.haltctrial.org

Article: Changes in Depressive Symptoms and Impact on Treatment Course among Hepatitis C Patients Undergoing Interferon-alfa and Ribavirin Therapy: A Prospective Evaluation – Chapman J, Oser M, Hockemeyer J, Weitlauf J, Jones S, Cheung R
Source:The American Journal of Gastroenterology August 2011

Note to Readers: This Snapshot is based on the abstract from an advance on-line publication. Although I did not read the original article, I decided to use it for two reasons: 1) the content is interesting, and 2) it provides a good example of why we can’t draw conclusions from a little information. The irony is that this applies to Snapshots. Do not make medical decisions solely on what you read—talk to a trusted medical provider. 

Depression is a common side effect of HCV treatment. This prospective study measured depression prior to and throughout treatment, looking for changes and assessing the relationship between depression and treatment outcome. There were 129 mostly male subjects. Before treatment, 91 had minimal symptoms of depression; 28 had mild symptoms; and 10 were moderately depressed.

The Bottom Line: Depression increased during HCV treatment. Patients with mild depression prior to taking antiviral therapy had the greatest increase of depression during treatment.

Patients who were minimally depressed prior to treatment were more likely to stop treatment early and were less likely to respond to treatment than patients who were mildly or moderately depressed.

Editorial Comment: This research surprised me. Since I only reviewed the abstract and not the entire study, I have more questions than answers. For instance, what role, if any, did antidepressant medications play in this? Depression is a treatable condition, but can be harder to manage during HCV treatment. It leads me to wonder if patients who were already depressed had some experience handling the condition, whereas those without depression may have found it too much to handle. I could also speculate that patients with depression might have already been taking antidepressants. When the full article is available, I will try to get answers to these questions and report back to readers.

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Clinical Trials
—Alan Franciscus, Editor-in-Chief

Phase III:  BMS 790052: BMS 790052 is an NS5A inhibitor that is currently in clinical trials to treat HCV genotype 1 treatment-naïve and treatment-experienced patients in combination with pegylated interferon, ribavirin and other DAA’s.  

The combination of BMS 790052 (QD—once-a-day dose) pegylated interferon plus ribavirin to treat HCV genotype 1 treatment-naïve patients has been found to produce SVR12 rates of up to 92% in people treated for 48 weeks.                 

Information from www.clinicaltrials.gov (identifier:  NCT01389323) includes:

  • This is an open-label study—this means that everyone in the study will receive the study drugs (BMS-790052, pegylated interferon and ribavirin), single arm—no comparator arm

  • Treatment duration (24 or 48 weeks total treatment) will be response-guided—that is, if a person is HCV (viral load) negative at certain time points (usually week 4 and 12) all treatment medications are stopped at week 24. 

  • The dosing for the trial is:

    • BMS-790052 is pill (60mg) taken once a day.  Participants will only take BMS-790052 for 24 weeks (in combination with pegylated interferon plus ribavirin)
    • Pegylated interferon afla-2a (Pegasys) is once-a-week injection for either 24 or 48 weeks depending on type of on-treatment response

    • Ribavirin is a pill (either 1000 or 1200 mg—based on body weight); the dose is divided in two and taken twice daily for either 24 or 48 weeks depending on type of on-treatment response. 

  • The trial is projected to enroll 230 patients who have never been treated with interferon, ribavirin or a direct acting antiviral

  • The trial will enroll Blacks/African Americans, Latinos, and White/Caucasians

  • Study participants will be tested for IL28B variation (CC,CT or TT genotype)

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