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HCV Advocate Newsletter

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October 2010 HCV Advocate

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In This Issue:

REALIZE Top-Line Results
Alan Franciscus, Editor-in-Chief

DISABILITY & BENEFITS: Life Settlements (Cash for Your Life Insurance Policy)
Jacques Chambers, CLU

HealthWise: Finding Safety in Numbers
Lucinda Porter, RN


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

SVR Reduces Risk of Death and Disease
Alan Franciscus, Editor-in-Chief


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REALIZE Top-Line Results
—Alan Franciscus, Editor-in-Chief

In the September 2010 HCV Advocate newsletter I wrote about Merck /Schering’s two phase III studies of boceprevir and Vertex’s phase III study of telaprevir.  The new drugs are HCV protease inhibitors that are given in combination with pegylated interferon and ribavirin.  There is also a video update on the HCV Advocate Website — Click here(See page 9 for a list of video downloads.)  Recently, Vertex released the results from their REALIZE study on the re-treatment of HCV genotype 1 patients who did not achieve a sustained virological response (SVR)* with a previous course of pegylated interferon and ribavirin therapy. 

The study included prior non-SVR patients — 354 relapsers, 124 partial responders, and 184 null response patients.*  There was limited data on the patient population, but it is important to know that 89% of the patients had a high HCV RNA viral load (greater than or equal to 800,000 IU/mL) and that 26% of the patients had cirrhosis—both are considered poor predictors of treatment response. All the patients were HCV genotype 1 evenly divided between subtypes 1a and 1b.

Overall, 65% in the telaprevir containing groups achieved an SVR compared to 17% in the groups that received the current standard of care — pegylated interferon and ribavirin — without telaprevir. The SVR rates of the telaprevir containing groups vs. standard of care groups by type of prior Non-SVR are listed below. 

Type of
Prior Non-SVR
Telaprevir
Containing Groups
Standard of Care
Groups
Relapsers
86% SVR
24%
Partial responders
57% SVR
15%
Null responders
31% SVR
5%

The side effects reported were mild to moderate and the discontinuation rates were similar between all the groups including the groups that did not receive telaprevir.

Vertex has stated that they will complete filing for marketing approval with the Food and Drug Administration (FDA) by the end of 2010.  It is estimated that the FDA will approve the triple combination of telaprevir, pegylated interferon and ribavirin in 2011-2012. 

Please join me on our Website — www.hcvadvocate.org — for a video update.

  Next month we will also publish individual fact sheets on the top-line phase III results for both boceprevir and telaprevir.  Additional information will be released at the 2010 American Association for the Study of Liver Diseases (AASLD) conference and the articles in peer-reviewed journal will most likely be available in 2011.

*Definitions:

Sustained virological response (SVR):  is defined as undetectable HCV RNA (viral load) 24 weeks after the last dose of medicine was taken.

Relapser:  a person who was undetectable at the completion of at least 42 weeks of therapy but who became detectable during the 24 week follow-up period.

Partial responder: a person who achieved at least a 2 log10 reduction in HCV RNA (viral load) at week 12, but who was never HCV RNA undetectable by week 24 of treatment.

Null responder: a person who achieved LESS than a 2 log10 reduction in HCV RNA by week 12.

Example: 2 log drop = 15,000,000 IU/Ml to 150,000 IU/mL; a viral load that starts at 15,000,000 IU/mL and does not decrease to 150,000 IU/mL.

Source:  Company press release


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DISABILITY & BENEFITS: Life Settlements (Cash for Your Life Insurance Policy)
—Jacques Chambers, CLU

Life Settlements are being heavily marketed during the economic recession when many are looking for extra cash, especially persons with serious disease. While the author neither recommends nor rejects the concept, the state of the current market is such that life settlements are not generally recommended but may be appropriate in some circumstances.

Given the current low rates being paid by life settlement companies, it is generally recommended that a life policy not be sold unless it is in danger of lapsing because the premiums are no longer affordable. Consider the alternatives noted below before looking into a life settlement.

It is necessary that anyone considering a life settlement understand the process and be aware of potential problems and pitfalls. Do not rely on any one source of information, especially that of a company wanting to buy your life insurance policy. Look to unbiased experts for advice.

A Little  History
This industry got its start early in the AIDS crisis, and they were called “viatical settlements.” Persons with a desperate need for cash and a very short life span were able to sell their life insurance policies to investors who would pay them cash for the right to own and become the beneficiary of their life insurance policy when they passed away. For example, if a person had a $100,000 life insurance policy and a six month life expectancy, the investor would give them $75,000 - $85,000 cash, then when the person passed away the investor would collect the $100,000 life insurance benefits making a “profit” from the difference between the amount collected from the insurance company and the amount paid for the policy.

However, the development of new treatments for HIV made it virtually impossible to accurately estimate the life expectancy of a person with HIV/AIDS. Some investors are still waiting for their investment to mature (i.e., waiting for the insured to die) so they can recoup their investment.

The  Current Market
In order to survive, some viatical companies have looked to expand their market beyond the terminally ill. The name “life settlement” was adopted and is used generally to describe the same process as a viatical settlement, but now, instead of purchasing the policies of the terminally ill, they are buying the policies of persons who are elderly or have other chronic medical conditions, such as HCV.

The price these investors are willing to pay for a life insurance policy is directly dependent on the life expectancy of the insured, since it is the death benefit of the life insurance policy that provides the return on their investment. It stands to reason that the amount being paid for the policies of the elderly and chronically ill are substantially lower than the policies of a person with a relatively accurate life expectancy of only six months to two years. In many cases, the offer is less than 25% of the face amount of the policy.

What Life Insurance Can Be Sold?
Almost anyone is a possible candidate for selling their life insurance and most types of life insurance policies are marketable. Some things to be aware of:

  • The life insurance policy must be at least two years old.
  • Any kind of life insurance is “sellable”: term life, whole life, occasionally even group life.
  • The policy should be fairly large. While policies of any size are technically sellable, most companies are interested primarily in policies of $100,000 or more.
  • The policy should be underwritten by a reputable life insurance company with a solid financial rating.

Alternatives to Life Settlements
Before considering a life settlement, consider any alternatives. Sell your life insurance as the source of last resort. However, If you have a life insurance policy that you are considering letting expire because it is no longer needed or the premiums are a financial burden, then selling the policy may be a viable alternative. It would make more sense to sell it, even for a very low percentage rather than just let it expire for non-payment of premium.

There are also other ways to realize cash from your life insurance policy. Accelerated Benefits is a provision that is on many policies and is designed to provide money for persons dealing with a terminal illness and a short life span, usually twelve months or less. Under this provision, the insurance company will advance from 25% to 50% of the face amount to the insured while still living, with the remainder still going to your named beneficiary.

Some types of life insurance policies, called whole life or universal life, contain savings features that may be tapped into either by surrendering the policy or by borrowing some or all of the accumulated cash values.

Even an interest free advance of money from a relative or friend with an agreement to repay them by making them a partial beneficiary under the life policy can be better than actually selling the policy.

How to Sell Your Life Insurance Policy
Once you have decided that you want to sell your life insurance policy, the first step is to find potential buyers.

Contact your state Department of Insurance to see if viatical or life settlement companies have to be licensed in your state. If so, they will provide you a list of licensed companies. Contact several of these companies and briefly describe your policy and your medical condition. Those that are interested will send you paperwork to complete. You should try to get at least three bids to help determine the market value of your policy.

Once you have decided which companies you are going to consider, contact your state Department of Insurance, the state Attorney General’s office, and the Better Business Bureau to see if there have been complaints filed against them. 

Upon submitting the initial paperwork to the settlement company, they will:

  • Obtain your medical records for review and estimate your life expectancy.
  • Confirm the existence and details of your policy with the insurance company.
  • Require the current beneficiary to acknowledge the beneficiary change and agree not to challenge it.

What Else Should You Know About Life Settlements?
If you are currently receiving any needs based benefits such as Medicaid, food stamps, or SSI (Supplemental Security Income), the cash you receive for selling your policy may cause you to lose eligibility for these programs.

  • There are income tax implications. Current federal law makes the money you receive from selling a life policy income tax exempt only if your life expectancy is 2 years or less. If your life expectancy is longer than that, you may owe income taxes on almost the entire amount of money you receive. While you should ask about this with the life settlement company, you definitely should also get some tax advice from a qualified professional before going through with the sale. NOTE: The IRS will be aware of the sale because the settlement company is required to file with the IRS a 1099LTC on each sale.
  • Life settlement companies have different privacy policies. You should ask the settlement company about their policy. Do they give your name to the investors? Who, outside the company, would see information about you, your medical condition, and the sale?
  • Since the company cannot collect on its investment until you pass away, they will need to keep track of you. Ask how they maintain contact with you. If your doctor agrees, ask the company to obtain updates on you through him or her. You really don’t need someone calling you periodically just to see if you’re still alive.
  • Don’t let the company rush or push you into making your decision. Take your time and consider all options. As with any investment, be skeptical of any deal that must be accepted quickly. Many states even require a 15 to 30 day period after the sale during which you can void it without penalty.
  • Make sure the money to buy your policy is accessible. While some companies may have cash on hand; others will have to take your policy to the investment market and “shop” for a buyer, which can substantially delay the sale.
  • Insist that the funds be deposited into an escrow account with a reputable, independent financial institution before you sign the final papers. This assures you that the funds are available to complete the sale.
  • Insist on a timely payment. Once the paperwork is signed, the only further delay would be while the insurance company changes the ownership of your life insurance policy. Once that is completed the money should be available to you within two or three business days. Never accept periodic payments; get the full amount in one lump sum.
  • This is not a good source of quick cash. Do not expect this process to go quickly.



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Healthwise: Finding Safety in Numbers
—Lucinda K. Porter, RN

Over the years I have said, “The majority of those infected with chronic hepatitis C virus (HCV) will die with this virus, not of this virus.”  I balance this statement with other equally important information, such as:

  • We can’t accurately predict who will be the ones who will have more serious damage, leading to cirrhosis, liver cancer, or death.
  • Death is just one of the consequences of HCV.  Living with this chronic illness can be a struggle for some, even in situations in which there has been no significant liver disease.
  • Living with HCV affects us mentally, spiritually, and socially.  Physical death is serious and final, but many patients experience metaphorical deaths as they try to come to terms with what it means to have HCV.

Recently I read a well-written blog (hepatitiscnewdrugs.blogspot.com) by Tina (last name unknown), pointing out that when we say most of us will die with rather than of HCV, we do a huge disservice.  This blogger is concerned that this may be interpreted to mean that HCV isn’t serious, and thus, we don’t need to take action.  She makes an impassioned plea to the HCV community to “understand the magnitude of this disease.”

She’s right, especially because what we know in 2010 is different from what we knew ten or more years ago.  When I was first diagnosed, I was told that I had non-A, non-B hepatitis and that it was nothing to worry about.  When HCV was identified, we began to learn more about it, including that it was a progressive disease that affected the entire body as well as the liver. 

Now there is more evidence to examine.  At the 2009 meeting of the American Association for the Study of Liver Diseases (AASLD), Gary Davis and colleagues1 forecasted the future for HCV.  There will be a significant increase in HCV-related deaths and complications in the years between 2010 and 2030.  This is because the majority of those with HCV, aging Baby Boomers, will have had this virus for a long time, and typically, HCV causes its greatest damage after 20 or more years.  If HCV is left untreated, advanced liver disease will quadruple in the next 10 years—from 30,000 to 150,000 cases annually.  HCV-related liver cancer will triple from 5,000 to 15,000 annual cases.  In short, if HCV-positive Baby Boomers are not treated, the mortality predictions are bleak. 

A side note: Davis and colleagues also reported that there will be a gradual decline in the prevalence of HCV.  This is because many of us will die, mostly from conditions unrelated to HCV; also, the number of new HCV cases is declining.  Acute HCV, infection that is less than 6 months old, is much easier to treat than chronic HCV.  This, coupled with advances in treatment for chronic HCV, means that future generations will have a very different experience of HCV.

The potential threat of HCV is underscored in the Milliman Report.2 Here are a few choice quotes:

  • Our projections suggest that without improvements to the current low effective treatment rate, the U.S.  healthcare system will be burdened with more HCV-infected patients progressing to cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma, and ultimately, more patients requiring liver transplants.
  • As the Baby Boomers age, the consequences of HCV infection will become an important cost issue for commercial payers and an even more important cost issue for Medicare.  Over the next 20 years, total annual medical costs for patients with HCV infection are expected to more than double, from $30 billion to over $85 billion, and remain elevated.  Medicare shows the most dramatic cost change, increasing fivefold from $5 billion to $30 billion.” 3

Given this, I reflected on my reasons for saying, “the majority of those infected with HCV will die with this virus rather than of it.”  There are two reasons, the first being to reassure.  I find it comforting to know that of the 3.2 million people with HCV, only a small fraction will succumb to it, albeit succumbing to anything is hardly reassuring.  The second reason is to bring perspective.  While it is understandable that we are concerned about liver disease, we are susceptible to plenty of other medical problems. 

According to the latest data (2006) from the Centers for Disease Control and Prevention there are 2,426,264 annual deaths.4  The U.S. Census Bureau estimates that there are more than 309 million people in this country.  The leading causes of death are:

  • Heart disease: 631,636
  • Cancer: 559,888
  • Stroke (cerebrovascular diseases): 137,119
  • Chronic lower respiratory diseases: 124,583
  • Accidents (unintentional injuries): 121,599
  • Diabetes: 72,449
  • Alzheimer’s disease: 72,432
  • Influenza and Pneumonia: 56,326
  • Nephritis, nephrotic syndrome, and nephrosis: 45,344
  • Septicemia: 34,234

What does this have to do with HCV?  Everything.  It means that while we are weighing our options—whether it is considering treatment or reviewing the merits of milk thistle—we need to get annual flu shots, exercise every day, eat a healthy diet, schedule regular cancer screenings, and wear our seat belts.  It is not enough to treat HCV—the entire body needs attention, because health is a package deal. 

While we are taking care of our bodies, consider treatment.  Despite the fact that HCV is treatable, many are reluctant to try.  Can you imagine the reaction if medical science announced that there was a treatment for HIV that took a year, had a 50% success rate and had lots of side effects that would reverse when the medications were stopped? I bet HIV patients would be delighted.  Yet we HCVers hesitate, since on the whole, we aren’t saddled with lots of HCV symptoms and imminent death. 

The fact that we need to take HCV seriously does not mean that we have to live with fear and anxiety.  Worrying doesn’t change the facts and it does nothing to help our health; in fact, worry is more likely to hurt our health than to help it.  What I wish for all of us is that we are free from worry, while still acting responsibly. 

Endnotes
1. Aging of Hepatitis C Infected Persons in the United States: A Multiple Cohort Model of HCV Prevalence and Disease Progression G. L. Davis; M. J. Alter; H. B. El-Serag; T. Poynard; L. W. Jennings.  Abstract 1613, AASLD 2009 annual meeting
2.  Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease” B. Pyenson; K. Fitch; K. Iwasaki.  The Milliman Report was commissioned by Vertex Pharmaceuticals www.vrtx.com/millimanreport.html
3.  ibid.
4.  Centers for Disease Control and Prevention’s National Center for Health Statistics  www.cdc.gov/nchs



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HCV Snapshots
—Lucinda K. Porter, RN

Article: Hepatitis C Virus-Related Chronic Liver Disease in Elderly Patients:  An Italian Cross-Sectional Study by Gramenzi, A., Conti, F., Felline, F., Cursaro, C., Riili, A., Salerno, M., Gitto, S., Micco, L., Scuteri, A., Andreone, P., Bernardi, M.

Source: Journal of Viral Hepatitis May 2010

One group of people that is attracting a great deal of attention is the aging Baby Boomer population with chronic hepatitis C virus infection (HCV).  As they head into their retirement years, researchers want to know how HCV affects the elderly, particularly those who have been infected for a long time.  This Italian study compared HCV-positive adults under age 65 years (386 participants) to those 65 or greater (174 participants).  Results showed that over the course of two years, 51% of those over age 65 had advanced liver disease, defined as cirrhosis or liver cancer (hepatocellular carcinoma), compared to 26% for those under age 65.  The over 65 group had more symptoms than the younger group, but roughly half of the older patients did not know they had HCV.  Older patients were less likely to have undergone HCV treatment, and those who had, reported that treatment was harder to tolerate. 

The Bottom Line: The face of HCV is changing with the aging population.  Older patients face a greater chance of having advanced liver disease that may be harder to treat.  HCV testing and treatment for younger patients may help to prevent future risks of cirrhosis and hepatocellular carcinoma. 

Food for Thought: Studies such as this bring up a lot of questions about health care policy.  Does it make sense and is it humane for uninsured people to have to wait until their Medicare years to find out that they have HCV-related cirrhosis, rather than find a way to test and treat them when they are younger?

 

Article: Evaluation of Depression as a Risk Factor for Treatment Failure in Chronic Hepatitis C by Peter Derek Christian Leutscher, Martin Lagging, Mads Rauning Buhl, Court Pedersen, Gunnar Norkrans, Nina Langeland, Kristine Mørch, Martti Färkkilä, Simon Hjerrild, Kristoffer Hellstrand, Per Bech

Source: Hepatology August 2010

Depression is a common side effect of antiviral therapy for chronic hepatitis C virus infection (HCV).  If severe enough, depression may lead to early discontinuation of HCV medications.  In this study, researchers used a depression screening tool to evaluate depression of patients undergoing HCV treatment (combination of peginterferon alfa-2a and ribavirin).  Using a questionnaire called the Major Depression Inventory (MDI), 325 subjects with HCV were evaluated for major depression before starting HCV medications.  Major depression is defined as the existence of five or more symptoms for at least 2 weeks.  (For more information about depression, check out the HCV Advocate’s Fact Sheets and Guides.)

Prior to starting treatment, 6% had major depression.  An additional 37% were diagnosed with depression during treatment, but only 32% were noted to have depression during medical interviews.  In other words, the MDI screening tool was able to identify more patients with depression than were diagnosed during face-to-face interviews. 

The Bottom Line: Researchers concluded that a) depression may be missed during routine medical exams, b) depression potentially threatens the outcome of HCV therapy if patients are forced to discontinue prematurely, and c) the MDI may be a useful tool for recognizing depression in patients. 

Food for Thought: If you have ever been or are currently being treated for HCV outside of a clinical trial, has your medical provider asked you to fill out a questionnaire to screen for depression?

 

Article: PSI-7977 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection

Source: Pharmasset, Inc. Press Release

PSI-7977 is a polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection manufactured by Pharmasset, Inc.  In a recent Phase 2 study of PSI-7977, given in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin), HCV genotype 1 patients who had never been treated before, underwent a 28-day regimen.   Results were compelling enough to earn fast track status from  the U.S. Food and Drug Administration (FDA).  Fast track status is an accelerated FDA review process to help get drugs out that may treat serious diseases for which there is an unmet or under met need.

The Bottom Line: More research is needed, particularly around the safety of PSI-7977, but it certainly looks like more HCV treatments are on the horizon. 

Food for Thought: Fast track status means that drugs will have a faster review process.  Do you have concerns about this, or do you think that HCV is a serious enough problem to warrant a faster review process?

 

Article: Chronic Hepatitis C in the State Prison System: Insights into the Problems and Possible Solutions by Joanne C.  Imperial

Source: Expert Review Gastroenterology and Hepatology 4(3), 355–364 (2010)

There are approximately 3.4 million people in the U.S. with chronic hepatitis C virus (HCV) infection.  The prevalence in prisons is 10 to 20 times greater than the general population.  With cirrhosis, liver cancer (hepatocellular carcinoma) and death as possible outcomes of HCV, Dr. Imperial identified potential problems with the burgeoning HCV population in the correctional system. 

Highlights from this expert review are:

  • High prevalence of HCV in prisons.
  • Significantly more cases of advanced HCV in the prison population.
  • Multiple factors in prisons that potentially contribute to the HCV problem, including injection drug use, tattoos, alcohol use, and substandard diets.
  • Inadequate HCV screening in the correctional system.
  • Need for education and treatment for incarcerated HCV patients.
  • HCV treatment obstacles, such as inadequate budget, poor medical records system, and stigmatization associated with HCV.
  • Need for transition programs to help inmates from prisons receive consistent medical follow-up after they have been released back into the community.
  • Education, harm-reduction counseling, support and treatment for inmates would have a positive effect on the public health.

The Bottom Line: If HCV services in the correctional system are not improved, we will continue to place a burden on our public health and safety.

Food for Thought: There is a myth that those in U.S. prisons have access to healthcare, but the fact is that the care is very poor, underfunded and entrenched in a complicated structure.  I have seen women in prison whose symptoms were dismissed as cries for attention; many died as a result.  It seems to me that people who are healthy when they are released have a better chance of earning a living and turning their lives around as well, while preventing further transmission of HCV.


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SVR Reduces Risk of Death and Disease
—Alan Franciscus, Editor-in-Chief

A recently released study found that people with advanced fibrosis and cirrhosis who are treated with pegylated interferon plus ribavirin benefit from achieving an SVR. 

Even more interesting is that people who had complete viral suppression during therapy, but who did not achieve an SVR, had some improvements in liver health. 

“Outcome of sustained virological responders with histologically advanced chronic hepatitis C,” by T.R. Morgan and colleagues (Hepatology. 2010 Sep;52(3):833-44), looked at the effects of treatment with pegylated interferon plus ribavirin on liver disease progression, liver transplantation and death. 

Data was available on 140 patients who achieved an SVR, 309 patients who had a non-response and 77 patients who had viral breakthrough (BT –patients who became undetectable but then HCV RNA detectable during therapy) or relapsed (R).  The patients were evaluated every 3 months for 3 ½ years followed by evaluations every 6 months. 

The authors measured the outcomes based on all cause death, liver-related death, liver transplantation, decompensated cirrhosis/disease, and liver cancer (HCC).  The mean follow-up period for all groups was 79 to 86 months.  At 7.5 years the rate of death/transplantation (from all causes) and liver-related death and disease were as listed in the following table. 

 

SVR
Group
BT/R Group
Non-Response
Group
All death/
Transplantation
2.2%
4.4%
21.3%
Liver disease/
death
2.7%
8.7%
27.2%

Another important finding was that various laboratory tests such as platelet count and albumin levels continued to improve after the patients achieved an SVR indicating improvement in liver functioning.  It was noted that even after achieving an SVR patients should continue to be monitored for liver cancer.

“Overall, our data indicate that patients with chronic hepatitis C and advanced hepatic fibrosis who achieve SVR have a marked reduction in the risk for death or liver transplantation, or of liver-related complications, and continued improvement in laboratory markers of liver function in the 5-6 years following successful viral eradication,” the authors concluded. 

Comments:  This is really good news for people with hepatitis C who achieve an SVR or viral cure for it clearly shows that successful treatment with the eradication of HCV can lead to a longer life, better liver function and improved overall health.    Almost as good is the news that in people who become HCV RNA (viral load) undetectable while on treatment the chances of dying from HCV are greatly reduced even in the absence of achieving an SVR. Now if we just had HCV medications that worked for everyone and were well-tolerated – that would be the best news of all.  Don’t hold your breath for this development, but eventually that day will come.   

Be Sure to Check Out Our Streaming Videos:

  • Top-Line Phase III Data: Boceprevir & Telaprevir (Video & Slide Presentation)
  • Kelly Zirbes of “Kelly’s Lot” on Stigma
  • Taking Care — Documentary on hepatitis C
  • Release Relapse — Documentary on opiate addictions 
  • Living with Hepatitis C — Available in English, Spanish and Portuguese
  • Getting Through: Stories of HIV/Hepatitis C Co-Infection
  • An Interview with Dr. Mark Sulkowski — Video on Treatment of Hepatitis C in Co-infected Individuals Intended for Health Care Providers

www.hcvadvocate.org/hepatitis/
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