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HCV Advocate Newsletter

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August 2009 HCV Advocate

Download English printable version

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In This Issue:

Healthcare Delivery in the U.S.A.— A Personal Observation
Jacques Chambers, CLU

HealthWise: Is there a Cure for Hepatitis C?
Lucinda Porter, RN

Reporting Drug Side Effects
Alan Franciscus, Editor-in-Chief

Needle Exchange: Change is Coming
Liz Highleyman

NHANES III HEV
Alan Franciscus, Editor-in-Chief




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Healthcare Delivery in the U.S.A.: A Personal Observation
—Jacques Chambers, CLU

Editorial

With all the conversation about healthcare and the “promise” of major healthcare reform, perhaps it would be a good time to review how this country ended up with a healthcare delivery system that spends more per capita on health care than almost any other country and still manages to leave almost 50 million uninsured people on the outside looking in.

When I speak of the Healthcare Delivery System, I am really speaking about health insurance. Medical costs today are at a level where very few have sufficient assets to “self-insure” or pay their own medical bills. Without health insurance, there is no access to quality medical care.

First a caution: don’t expect too much to happen from all this discussion; there are a lot of participants interested in little or no change to the current system. Over the past fifty years, there has been a consistent dialogue about the need to overhaul the healthcare delivery system, but not a lot has really changed.

I started in the health insurance industry in 1966, the year after the introduction of Medicare. The general consensus was that I was joining a dying industry. “It won’t be long before Medicare covers everyone and private health insurance is gone.” That was over forty years ago, and the health insurance industry is bigger, stronger and more profitable than ever. Has anything really changed? Not much!

The healthcare delivery system as we know it in this country developed over the years through no real plan or organized design. Medical care has historically been provided on a fee for service basis, with individuals paying their own medical bills or receiving treatment in exchange for bartered goods – chickens, vegetables, etc.  It was part of the independent, capitalist business model this country was founded upon.

Health insurance as we now know it was virtually unknown until the Great Depression. During the 1930’s, in an effort to keep hospitals out of bankruptcy, Blue Cross was born, then Blue Shield was formed to assist doctors in getting their fees paid with cash rather than eggs or bushels of fruit.

Health insurance experienced enormous growth during the 1940s. During and right after World War II, wages were frozen by the federal government. In order to attract and keep valued employees, employers got around the prohibition of wage increases by giving employees, and their families, health insurance at a reasonable rate.

This growth was fueled even further when Congress determined that these new “employee benefits” were not income taxable to the employee. Employers could pay for health insurance and deduct the premiums as a business expense; employees were not taxed on the coverage they received.

The non-profit “Blues” – local Blue Cross and Blue Shield plans –  soon had competition from life insurance companies entering the health insurance business.

This health insurance, provided by “Blues” and for-profit insurance companies which were obtained through employers, became the standard in the United States. Insurance provided through large employers did not require proof of good health since groups of employees always included far more healthy people than sick ones. Persons without access to such group insurance still had to show they were in good health to purchase individual health insurance.

All went along pretty well until the 1960s. During that time, general inflation starting increasing prices, and medical inflation increased even faster. On top of that, medical technology brought about more advanced (and more expensive) medical procedures and pharmaceutical companies developed many new (and expensive) medications. As a result, health insurance rates started rising rapidly as well. In 1970, for example, a family living in a metropolitan city could purchase  a broad plan for about $30 per month for the whole family; today it is closer to $1,000 per month for a family. In 1965 Medicare went into effect and that had a major impact on the rapidly rising medical costs as well.

The last quarter of the 20th century was spent trying to control these spiraling medical costs without much success. Many believed that Health Maintenance Organizations (HMOs) would achieve that goal. There was a brief period during that time that federal law required employers over a certain size to offer an HMO alternate to any other health plan they offered.

While the HMOs were quite successful in reducing the number of days a person spent in the hospital, reining in other charges was not so easy. Just when they became effective at controlling hospital costs by reducing the length of stays, hospital charges were no longer responsible for the major portion of medical costs.

Out-patient procedures with new and expensive diagnostic machines and new and expensive medications started taking up a greater proportion of medical costs. Also the costs of physicians continued to spiral upward as non-HMO plans continued to pay a high percentage of the “usual and customary” charges of physicians.

The advent of Preferred Provider Organizations (PPO) helped control physician fees as they limited payments to contracting (preferred) providers at set rates, while allowing insured persons to have more choice in their providers. Yet medical costs and health insurance premiums have continued to rise at a rate far above the general inflation level.

There have been some incremental changes, due almost entirely to federal legislation regarding employer provided health insurance:

  • Now, a person can obtain health insurance through his/her employer regardless of health history, medical condition, or the size of the employer.  (Health Insurance Portability and Accountability Act of 1996 - HIPAA)
  • Now, once employment ends, the former worker and his/her dependents may legally remain, paying the full premium, on the employer’s plan for an additional 18, 29 or 36 month period, depending on the situation. Many states also allow continuation of coverage for those employees not under the federal continuation law. (COBRA and state mini-COBRA laws)
  • Now, once all possible COBRA continuation coverage ceases, the person has a guaranteed right to purchase a broad individual health policy, again regardless of health condition, and they may keep that policy indefinitely. (HIPAA)
  • Now, many states offer a high risk or pooled health insurance plan for individuals whose health prevents them from purchasing it on the open market.
  • A few (very few) states guarantee the availability of health insurance to anyone regardless of their health as long as they can afford to purchase it.

Despite these adjustments, there are almost 50,000,000 people in this country who don’t have health insurance. Yet medical costs (and health insurance premiums) continue to rise. Over fifteen percent of this country’s gross domestic product is currently being spent on health care, a record that will surely be broken in each of the coming years. Neither the government nor the competition of the marketplace has been able to provide any substantial control over these increasing costs.

The cracks in health insurance are getting wider every year. Most family bankruptcies are due to medical expenses. And health insurance doesn’t always help. Over 60% of those filing for bankruptcy due to medical expenses have or had health insurance. It just didn’t pay enough.

The two largest medical plans, Medicare for the aged and disabled and Medicaid for low income aged and disabled are currently struggling to meet the need within their financial limitations.

The cost of this healthcare delivery system has grown to become a monster that even the federal government is nervous about trying to rein in. To add to Washington’s dilemma, there are those entities that are pretty comfortable with the present system. They are primarily corporations making tremendous profits under the current “system,” such as pharmaceutical manufacturers, health insurance companies, and certain groups of medical providers, hospitals and durable medical equipment suppliers and manufacturers.

Physicians have historically been a part of those opposing change; however, many have found their income dropping due to reduced reimbursement of fees and strict oversight by managed care groups and are adding their voice to the demand for major changes.

So Congress is in between an ever angrier population demanding major reform and very wealthy corporations who are willing to spend millions to sway opinions.

Many argue against a single payer plan, although most countries with such plans cover a greater percentage of their population for less cost. Medicare is one of the largest providers of health insurance and it is able to cover claims with administrative costs of less than 5% of claims with no offset for profit, compared to the 10 to 20% that insurance companies charge.

The health insurance industry and its allies drag out the scary term: “SOCIALIZED MEDICINE” even though there has been absolutely no attempt or even discussion of all medical providers becoming government employees, which socialized medicine would require.

They ask: “Do you want a government bureaucrat standing between you and your doctor?” Well, how many people today, when getting medical care, don’t have an insurance overseer standing between them and their provider, an overseer who is looking at company profits as much or more than at your wellbeing?

Which direction do you think they will go? Which direction do you want it to go? Can voters make a difference against the highly paid lobbyists and the money they throw at Congress? If it weren’t so important to the health of this country’s population and its economy it would be fun to sit and watch.


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HealthWise: Is there a Cure for Hepatitis C?
—Lucinda K.Porter, RN

Occasionally I get distracted by the debate about the curability of chronic hepatitis C virus infection (HCV). No, I don’t have a lot of time on my hands and yes, I have better things to do. But this grinds on me. Before I begin, let me reiterate that my words are my opinion and aren’t necessarily shared by the HCV Advocate, theHepatitis C Support Project, science, or anyone who might actually know what they are talking about.

The question resurfaced when I was reading the newest HCV book on the market—Healing Hepatitis C by Lawford and Sylvestre. They state, “we hope…to show you that it is possible to get through this hepatitis C thing—and to be cured—without surrendering your life to it.”  That’s correct, the word cure was used.

Historically when anyone eliminates HCV for six or more months after treatment ends, we say that person had a sustained virological response to treatment or SVR. We don’t pronounce them cured. Yet, studies have repeatedly found that 95 to 100% of the time, the virus does not return once there is an SVR.  Two recent studies show long term SVRs in 99.2 to 100% of those followed.

A brief Internet search was encouraging.  Many others are using the “c” word when describing responses to HCV treatment. Here are a few instances of clear use of the word cure:

  • A Viral Illness That Can Be Silent and Hard to Treat but Also Cured, by Peter Jaret – New York Times (August 14, 2008)
  • “I tell my patients who achieve a sustained virologic response to go home and get on with their lives,” said Mark Swain, professor of medicine at the University of Calgary in Canada.  “I tell them that there is less than a 0.5 percent chance that the disease will ever return.” Science Daily (April 12, 2007) 
  • If that isn’t hopeful enough, keep reading. Swain pointed that of 997 SVRs, only 8 later retested positive for HCV. Of those 8, there was no way to prove if HCV had resurfaced or if these were new infections. In the one case that they could get good samples, the patient in fact had been re-exposed, rather than had a relapse of previously treated HCV. Further, of the 8 patients who had tested positive, only one of these had completed a full course of treatment.
  • Cure For Hepatitis C Announced By Researcher, Science Daily (May 22, 2007).  Another participant in the same long term follow-up study was Mitchell Shiffman, MD, professor, Virginia Commonwealth University (VCU) and chief of hepatology and medical director of VCU’s Liver Transplant Program.  “We at VCU are encouraged by this data because it is rare in the treatment of life-threatening viral diseases that we can tell patients they may be cured,” Shiffman said.
  • “A 4-year follow-up of patients with chronic hepatitis C virus (HCV) infection who achieve a sustained viral response (SVR) to interferon-alpha-2b strongly suggests that they are cured,” French investigators report in the Liver International (April 2009). In Clichy, France, Dr. Sarah Maylin and colleagues followed 157 HCV patients who achieved SVR after treatment with interferon-alpha-2b and a control group of 23 patients with detectable HCV RNA and normal serum alanine levels. Followed for 4 years, all 157 patients sustained undetectable HCV. Dr. Maylin and colleagues wrote, “These results strongly suggest that HCV infection is cured in patients who achieve an SVR.”

The cure vs. SVR issue bothers me because the phrase sustained virological response seems cold, guarded and technical. Cure feels warm and hopeful.  Yet what stops us from declaring that HCV is curable? Is it the fact that only about half of those who undergo HCV treatment actually obtain an SVR? If so, I challenge this logic. We can cure pneumonia, but not everyone survives it. Just because not everyone responds to HCV treatment doesn’t mean it can’t be cured.

Perhaps what stops us from declaring that HCV is curable is that pesky problem of the .5 to 1% who later turn up HCV positive. Although this number is small, it is still too big. Or is it? Am I really going to let a mere fraction of individuals—people who actually may be cured but later get re-exposed to HCV—influence whether HCV can be labeled curable?

I believe there is another factor that tugs at me—prompting me to use the safer term—SVR. It’s fear. Fear of being wrong, of leading others astray, of having too much hope. I’ve lived with HCV for over 20 years. I was told that it was incurable and I came to terms with that reality. Am I ready to shift my thinking about this? If Diana Sylvestre, Mitch Shiffman and others say that HCV is curable, then this is good enough for me. I am officially on the bandwagon. HCV is curable.

I’ll concede that I am nitpicking, because the real issue is not what word to use, but what the impact is when HCV is permanently eliminated. The average patient needs darn good reasons before devoting a chunk of their future to a treatment that leaves many feeling lousy for 6 to 12 or more months. And here we come to the heart of the issue—why eradicating HCV matters—because those who have an SVR are likely to have improved liver tissue, lower incidence of liver cancer, a higher life expectancy1 and better quality of lives.2

Just because I believe there is a cure, doesn’t mean I will run out and get treated. I have been through it twice and it’s a big commitment. Although the results were fantastic because I saw a huge improvement in the condition of my liver, it makes sense to wait until there is a compelling reason to try it again. In the meantime, I take great delight in supporting others, celebrating their successes and knowing that one day, I may be cured. 

References

1HCSP’s Medical Writers Circle: Treatment of Chronic Hepatitis C: Impact on Natural History by Emmet Keeffe, MD

2HCSP’s Medical Writers Circle: Health Related Quality of Life and Hepatitis C by David Bernstein, MD


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Reporting Drug Side Effects
—Alan Franciscus, Editor-in-Chief

Prior to the release of a new medication, clinical studies are conducted that ‘test’ a drug for safety, effectiveness and other important issues before marketing approval.  Safety is given the highest priority when testing a new drug.  To recap the clinical trial process:

  • Pre-clinical trials are conducted basically in a test tube.
  • Phase 1 trials are small studies (~20-80 people) that evaluate the safety, determine a safe dose and identify side effects.  Phase 1 studies involve both healthy people (without the condition or disease) and patients with the condition for which the drug is intended.
  • Phase II studies are larger studies (~100-300 patients) that continue to evaluate the safety and effectiveness of the drug in patients with the targeted condition.  If you look at HCV drugs in development you will find that the vast majority of drugs that reach phase II studies are cancelled due to lack of effectiveness or safety concerns.  Since more patients are using the experimental drug it will give a better picture of the safety and effectiveness.
  • Phase III studies are large studies (~1,000-3,000 patients) that continue to evaluate safety and effectiveness and also compare the new drug to the standard of care.  If a drug is found to be as effective as the current standard of care and if there are no extreme safety issues, the pharmaceutical company will apply to the FDA for marketing approval.  Phase III studies have a much larger patient population and, as a result, will give a much better picture of the safety and effectiveness  of the study drug.
  • Phase IV or post-marketing studies are conducted to find out about treating sub-populations with the same condition that may not have been included in the original studies or for the treatment of a different condition. 

Nevertheless, sometimes drugs slip through the cracks, and the results can be life-threatening. The problem is that most clinical trials study the ‘easiest’ populations so that the results are more favorable to the pharmaceutical company.  Also, even though there are between 1,000-3,000 people being treated, no complete picture develops until the drug is released to the general public (with that condition). 

In the FDA Drug Safety Newsletter, an overview of the FDA approved drug atomoxetine (brand name Strattera) was discussed.  Atomoxetine was approved on November 26, 2002 as the first non-stimulant medication for the treatment of attention deficit hyperactivity disorder (ADHD) in children (ages 6 and above) and adults.  In the period between 2002 to 2007 about 3.3 million people received a prescription of atomoxetine (about 64% were children 17 years or younger).  Liver injury was only found after the drug was approved.  In 2004, after 2 published reports, the FDA added a bolded warning about severe liver injury associated with the drug.  Six additional reports of serious liver injury since 2004 were reported to the FDA, which prompted a revised product label that included stronger language in 2007. 

The FDA also advised healthcare professionals and patients to be aware and report any further cases to the FDA’s MedWatch.  Between January 2005 and March 19, 2008 there have been six more events reported to the Adverse Events Reporting System (AERS).  Based on these reports the FDA is continuing to monitor the adverse events.  

Again all of these events were AFTER the drug was FDA approved.  This is important information to know and as providers and patients we must report any adverse events directly to the FDA.  This will be even more important when the newer HCV drugs are approved and marketed so that any severe or potentially life-threatening conditions can be avoided. 

Reporting adverse events
Report serious adverse events to FDA’s MedWatch reporting system by completing an online form at www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mail using the pre-paid postage address form provided online (5600 Fishers Lane, Rockville, MD 20852-9787), or by telephone (1-800-FDA-1088).  

Source:
FDA Drug Safety Newsletter www.fda.gov/cder/dsn/default.htm, Volume 2/number 1/2009

See also: “What the Heck is Hepatotoxicity?” by Lucinda K. Porter, HCV Advocate, June 2009.


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Needle Exchange: Change is Coming
—Liz Highleyman

Needle exchange is among the most effective strategies for preventing transmission of viral hepatitis, HIV, and other blood-borne diseases among injection drug users (IDUs). While the proportion of people who contract HIV through shared needles has fallen to about 10%, injection drug use remains the largest risk factor for hepatitis C virus (HCV) transmission in the U.S. But the “War on Drugs,” stigma against IDUs, and concern regarding crime and “sending the wrong message” about drug use have made needle exchange programs controversial and thrown up roadblocks to wider implementation.

Since 1988 the U.S. government has banned the use of federal funds to support needle exchange, by means of a clause in Congressional budget legislation. However, an end to this policy may finally be in sight. In July, House Democrats in the Labor, Health, and Human Services subcommittee removed the relevant language from a major appropriations bill for the fiscal year 2010.

“Scientific studies have documented that needle exchange programs, when implemented as part of a comprehensive prevention strategy, are an effective public health intervention for reducing HIV infections and do not promote drug use,” said House Appropriations Committee Chair David Obey (D-WI). “The judgment we make is that it is time to lift this ban and let state and local jurisdictions determine if they want to pursue this approach.”

Brief History
While some liberal free clinics in the 1960s-1970s made sterile injection equipment available to IDUs in an effort to prevent hepatitis B virus (HBV) transmission, the current incarnation of needle exchange programs in the U.S. began in the late 1980s, a time when HIV transmission was near its peak, stigma against IDUs was rampant, and HCV (formerly classified as “non-A/non-B” hepatitis) had just been identified as a unique virus.

AIDS activists in cities such as Boston, New York, Philadelphia, San Francisco, and Tacoma—often spearheaded by members of ACT UP—began providing syringes and other injection equipment on an underground basis. Initially, these efforts involved roving activists in areas where IDUs congregated; San Francisco’s Prevention Point, for example, became known for wheeling around supplies in a baby buggy. The Lower East Side Needle Exchange pioneered the fixed-site storefront exchange, and Tacoma’s Point Defiance was the first to receive public funding.

The federal funding ban dates from the same period. In addition to a clause in the annual Department of Labor, Health, and Human Services appropriations act, needle exchange funding prohibitions have also been included over the years in drug control legislation and in the Ryan White CARE Act. The ban remained in effect under George H.W. Bush and Bill Clinton, despite relentless pressure from activists; Clinton said he was wrong and expressed support for needle exchange only after he left office.

Advocates argued that the federal funding ban hampered a proven effective strategy for preventing disease transmission, and activists carried out numerous demonstrations over the years demanding its repeal. As evidence of the benefits mounted, an increasing number of state and local public health departments began financing needle exchange programs on their own.

There was little hope for change under the George Bush administration, but activists were heartened when Barack Obama voiced support for repealing the ban during his presidential campaign. Once in office, however, Obama did not act as quickly as advocates wished. In the months following his inauguration, a statement supporting needle exchange disappeared from the White House website and a major budget proposal left the ban wording in place.

With a growing sense of impatience, activists stormed the Capitol rotunda on July 10, demanding more domestic and global action on HIV/AIDS including repeal of the funding restrictions; 26 people were arrested. The House subcommittee proposal to delete the ban came later the same day.

Evidence of Efficacy
Both anecdotal evidence and formal studies indicate that needle exchange reduces the risk of HIV, HBV, and HCV transmission among IDUs. Cleaning injection equipment with bleach—another intervention often recommended in the late 1980s and 1990s—is not nearly as beneficial.

Legislation prohibiting federal funding stated that the ban was to remain in effect until the President, Surgeon General, or Secretary of Health and Human Services certified that needle exchange was proven effective in preventing disease transmission and did not encourage illegal drug use. But a growing body of evidence—including studies funded by the federal government itself—did not lead to policy change.

The National Commission on AIDS (1991), the University of California at San Francisco (1993), and the National Research Council and Institute of Medicine, part of the National Academy of Science (1995), all conducted research reviews and concluded that needle exchange programs reduce HIV transmission risk behavior and do not increase drug use. All recommended that the federal funding ban should be lifted and access to sterile syringes should be increased.

There is less research in the field on HCV than on HIV, but the fact that HCV can live longer than HIV outside the body—even in dried blood—suggests that clean injection equipment may be even more beneficial in preventing HCV transmission.

Though a direct association is difficult to demonstrate in formal studies, it is clear that rates of hepatitis C and HIV prevalence (total infections) and incidence (new infections) among IDUs have fallen dramatically since the late 1980s, corresponding to the implementation of needle exchange programs. In New York City, for example, HIV prevalence declined from 54% in 1990 to 13% in 2001, while HCV prevalence fell from 90% to 63%.

In 1998, Clinton’s Secretary of Health and Human Services, Donna Shalala, acknowledged that there was evidence that needle exchange was effective—and could help protect politically popular “innocent victims” such as babies born to drug-using women—but she declined to lift the funding ban. Clinton’s Surgeon General, David Satcher, was in favor, but his views did not prevail, leading him to declare, “One of the worst things that can happen in this country is for us to say, if the science doesn’t agree with our perspective, then we want to suppress the science.”

Despite this intransigence at the upper levels of the federal government, a growing list of health and civil rights organizations expressed their support for needle exchange and opposition to the ban over the years, including the Infectious Disease Society of America, American Medical Association, American Public Health Association, American Psychiatric Association, American Academy of Pediatrics, NAACP, and the National Urban League.

Current Status
The February 10, 2009 online edition of Addiction featured an overview of the current status of needle exchange programs in the U.S. based on the latest in a series of surveys conducted by the North American Syringe Exchange Network (NASEN), a coalition of needle exchange providers and advocates.

The surveys began in the mid-1990s, as these programs were becoming more mainstream. In some cases informal exchanges were taken over by local health departments (as in Boston) or established AIDS service organizations (as in San Francisco), while elsewhere they grew into formal service agencies themselves (as with the Lower East Side Harm Reduction Center).

Surveys were mailed to program executive directors and follow-up interviews were conducted by telephone or e-mail. Since the first survey in 1996, response rates have ranged from 70% to 88%. The most recent results extend through 2007.

The study authors reported that the number of needle exchange programs known to NASEN increased from 68 in 1994-1995 to 186 in 2007. The total number of syringes exchanged by these programs skyrocketed from 8.0 million to 29.5 million per year over the same period. Despite the federal funding ban, total annual budgets rose from $6.3 to $19.6 million, with state and local contributions increasing from $3.9 to $14.4 million.

Many early needle exchange programs required a one-for-one exchange, with IDUs required to bring back used syringes in order to receive new ones; many also restricted the number of needles given to a single individual. Over time, more programs began to allow distribution without exchange and some permitted “secondary exchange,” allowing participants to receive a larger number of syringes to distribute to their associates. In 2007, 89% of surveyed programs permitted secondary exchange while 76% encouraged it.

In addition to clean needles, exchange programs typically provide other supplies and services including additional injection equipment (e.g., “cookers,” cotton filters, clean rinse water), condoms, referrals to substance abuse treatment, naloxone to treat overdoses, and HIV, HBV, and HCV counseling and testing. In 2007, at least 40% of survey participants provided these services.

“While syringe exchange has remained controversial in the United States, there has been very substantial growth in numbers of programs, syringes exchanged, and program budgets,” the researchers concluded. “Utilizing secondary exchange to reach large numbers of injecting drug users and utilizing syringe exchange programs as a new platform for providing health and social services beyond basic syringe exchange have been the two major organizational strategies in the growth of syringe exchange programs in the United States.”

Lifting the Ban
In order to become effective, the repeal of the needle exchange funding ban still must be approved by the full House and the Senate and signed into law by President Obama. Nevertheless, advocates were quick to praise this promising first step.

“Syringe-exchange programs are cost-effective, prevent disease, serve as a bridge to health care services for hard-to-reach populations, protect communities and law enforcement officials, and provide a gateway to substance-abuse treatment for injection-drug users, according to studies on the programs,” the AIDS Action Committee stated. “Removal of the federal funding ban empowers communities by giving them the freedom to use their federal funds for HIV prevention strategies that best fit their local needs, including syringe-exchange programs.”

“Providing clean syringes is proven to be one of the most effective public health interventions since the polio vaccine,” said Jennifer Flynn of Health GAP. “It is clear that it works, and now we urge the Congress to follow Chairman Obey’s lead in giving local health experts the freedom to use every possible resource to make it widely available.”

Lifting the needle exchange funding ban would allow programs to reach a larger number of at-risk people. The Harm Reduction Coalition estimates that only about 20% of the approximately 1 million IDUs in the U.S. currently use needle exchange programs.

People often acquire easily-transmitted HCV soon after starting to inject. Some studies, including a Swedish analysis presented at this year’s EASL meeting, show continued substantial HCV incidence even in areas where HIV incidence among IDUs has dropped. Research also reveals HCV reinfection among IDUs who have undergone successful hepatitis C treatment, underlining the need to reach young injectors sooner and maintain prevention practices over the long term.

In an era of continued stigma against IDUs, needle exchange programs are a vital link to other services, often providing the primary connection to health care for hard-to-reach populations and serving as a bridge to drug treatment and therapy for HIV and viral hepatitis. Research has shown that integrated programs that provide multiple services produce the most favorable outcomes.

“Regardless of the setting, the value of syringe exchange programs as an evidence-based public health response to blood-borne viruses and injection-related injuries is overwhelming,” Lisa Maher and Jenny Iversen from the University of New South Wales wrote in an editorial in the June 24, 2009 online edition of Addiction. “We know what works and we have the evidence. However, if we are serious about increasing access to health care for people who inject drugs then we need to confront the stigma and discrimination that injection drug users continue to encounter in mainstream health-care settings around the world.”

References

  • National Commission on AIDS. The Twin Epidemics of Substance Abuse and HIV. 1991.
  • P. Lurie et al. The Public Health Impact of Needle Exchange Programs in the United States and Abroad. University of California, 1993.
  • National Research Council and Institute of Medicine. Preventing HIV Transmission: the Role of Sterile Needles and Bleach. National Academy Press, 1995. 
  • D.C Des Jarlais et al. Reductions in hepatitis C virus and HIV infections among injecting drug users in New York City, 1990-2001. AIDS 19 Suppl 3: S20-S25.October 2005.
  • D.C Des Jarlais et al. Doing harm reduction better: syringe exchange in the United States. Addiction. February 10, 2009 (Epub ahead of print).
  • A. Widell et al. Continued heavy transmission of HCV in a needle exchange program that is associated with minimal transmission of HIV. A nine year longitudinal cohort study. 44th Annual Meeting of the European Association for the Study of the Liver. Copenhagen, Denmark. April 22-26, 2009.
  • L. Maher and J. Iversen. Syringe exchange in the United States: doing the simple things better? Addiction. June 24, 2009 (Epub ahead of print).



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NHANES III – HEV
—Alan Franciscus, Editor-in-Chief

In the past, it was believed that hepatitis E was only a problem in developing countries due to contaminated water supplies.  It was also believed that in industrialized countries the majority of HEV infections were among people who had visited countries where HEV infection was widespread.  

However, over the last few years, studies and news reports have surfaced that are painting a different picture on HEV infections in industrialized countries such as the United States.  In the U.S., there is little information about the prevalence of HEV mainly because of the lack of surveillance and testing even though there have been small studies that have hinted that the prevalence of HEV is more widespread than previously believed.  Recently, a large study on the prevalence of HEV was published that will give us a better picture of the estimated number of people in the U.S. who have been infected with HEV.  The study results are somewhat alarming and should, at the very least, promote more dialogue about the need for more strategies for testing and educating the public about the risk factors and ways to prevent the transmission of HEV.  The higher prevalence should also help to support the development of an effective vaccine to prevent HEV infection.   

HEV Basics
The hepatitis E virus is a hepatotropic, single stranded RNA virus.  The main transmission route of HEV is fecal-oral due to HEV contaminated water supplies, but other sources of infection have been identified.  The largest outbreaks of HEV usually occur in developing countries, but  less severe disease outbreaks also occur in industrialized countries.   

HEV has 4 genotypes numbered 1 through 4 and 24 subtypes.  HEV has been found in humans, and animals—genotype 1 and 2 is found only in humans whereas genotypes 3 and 4 have been found in humans and animals (pigs, boar, and deer).    Genotypes 1 and 2 are mainly found in the subtropical and tropical areas of Asia, Africa, and the Americas.  Genotype 3 is found worldwide and genotype 4 is confined mostly to Asia. 

Genotype distribution is indicative of transmission modes.  For instance, genotypes 1 and 2 are mainly from contaminated water, whereas genotypes 3 and 4 can be transmitted from pigs or other animals to humans. 

Normally, infection with acute HEV will resolve and the infected individual will develop antibodies that are protective against future infection. However, one study found that eight organ transplanted patients (HEV genotype 3 with severely compromised immune systems) had elevated liver enzymes and HEV RNA (viral load) over time, which would mean that HEV could lead to chronic infection.  But it is unclear if this is a true chronic infection or just due to a weakened immune system that can’t resolve the infection.   Deaths associated with HEV are uncommon except that pregnant women and their unborn babies are at risk of death especially during the third trimester of pregnancy—although this is mostly confined to developing nations.  In industrialized nations deaths related to HEV are rare and mostly occur in people who have received organ transplants that have severely suppressed immune systems.  Having another hepatitis virus could also lead to a more severe form of disease.

There are no vaccines to protect against HEV but there are many that are in phase I and phase II clinical trials. 

Epidemiology
In the current study, 18,695 participants in the Third National Health and Nutrition Examination Survey (NHANES III) were tested for HEV antibodies.  Participants were 6 years of age or older.  The study period was 1988 through 1994.  The overall prevalence of HEV antibodies in the non-institutionalized U.S. population was 21%.  The breakdown of the prevalence of HEV by race, sex, race/ethnicity, country of birth, and geographic region are shown in Table 1.

The key findings of the study: 

  • HEV infection was uncommon among children, but became more common as people aged.
  • People in the Midwest had the highest regional estimates and interestingly the Midwestern region of the U.S. has the largest swine (pigs, hogs, and boar) population.  
  • The highest incidence of HEV was found in the metropolitan areas.
  • Risk factors for HEV included:
    • Having a well as a source of tap water.
    • Having HAV antibodies was associated with significantly lower odds of having HEV antibodies.
    • Having a pet in the household.
    • Having a dog in the household.
    • Consuming liver or other organ meats more than once per month.
    • Having HCV.

The authors concluded that their study suggests that HEV is common in the general U.S. population.  Previous studies in the U.S. suggested that the prevalence of antibodies to HEV was mostly due to people who traveled or who were from developing countries with a high prevalence of HEV.  But in this study the authors theorized that many of the infections may have originated in the U.S. and may have been spread by exposure to swine. In this study and in previous studies the association between eating liver or other organ meats has been found to be a highly plausible route of infection.   It is also interesting to note that this would explain why acute infection of HEV is rarely reported because HEV from genotype 3 (from swine) is believed to be less severe and acute symptoms may not necessitate a trip to a medical provider for testing and treatment.  Of note: HEV has been found in pig livers sold in U.S. grocery stores.  Another possible reason is that there is currently no HEV antibody test licensed in the U.S.; so even if HEV is suspected there is little in the way of diagnostic tests that medical providers have at their disposal. 

Table 1. Prevalence of antibody to hepatitis E virus (anti-HEV) for selected demographic variables among participants (age 6 years) in the Third National Health and Nutrition Examination Survey, 1988–1994.

Variable Samples tested, no.
(n p 18,695)
Positive for anti-HEV,a
% (95% CI)
Sex    
   Female 10,124 20.4 (18.3–22.5)
   Male 8571 21.6 (19.3–23.9)
Race/ethnicity    
   Non-Hispanic    
     White
      (reference)
7052 22.1 (19.8–24.4)
    Black 5312 14.5 (13.1–15.9)b
    Mexican
    American
5527 20.3 (18.3–22.3)
    Other 804 20.2 (16.5–23.9)
Country of birthc    
   United States
    (reference)
15,051 20.1 (18.1–22.0)
   Mexico 2357 30.9 (28.9–32.9)b
   Other 1233 26.2 (22.9–29.5)b
Region of residence    
   South (reference) 8168 14.7 (12.3–17.0)
   Northeast 2372 20.8 (16.5–25.1)b
   Midwest 3655 26.6 (22.4–30.8)b
   West 4500 25.0 (20.9–29.1)b

NOTE. Seroprevalence estimates were weighted (1) to denote the total civilian noninstitutionalized US household population in the age groups covered, (2) to account for oversampling, and (3) to account for nonresponse to the household interview and physical examination but not for nonresponse to phlebotomy. CI, confidence interval; reference, reference group.
a Of 18,695 samples tested, the percentage (95% CI) of samples that were anti-HEV positive was 21.0% (19.0%–22.9%).
b P<.05, compared with the reference group.
c The total no. of samples shown is <18,695, because of incomplete reporting.


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