Free the Cure: Hope for patients with Hep C.

New hope in the battle against hepatitis C

The Daily Tribune (dailytribune.com),

Serving Southeastern Oakland County

Saturday, June 18, 2011

By Maryanne Kocis MacLeod
Daily Tribune Staff Writer

More than 4 million Americans are living with Hepatitis C, an infection caused by a virus that attacks the liver causing inflammation. The vast majority don’t know they have it.

“Hepatitis C can lead to liver failure, cancer and the need for transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half,” said Ira Jacobson, M.D., chief of the division of gastroenterology and hepatology, Weill Cornell Medical College. Jacobson is also the principal investigator in a recent study of a new, FDA-approved drug, INCIVEK, shown to cure 79 percent of those treated.

“This is a major leap forward in the battle against Hepatitis C,” said Stuart Gordon, M.D., director of hepatology at Henry Ford Hospital in Detroit. “Treatment results in the irradiation of the virus, which is quite remarkable. When people achieve this cure, physical damage is reversed.”

As a result, Hepatitis C, contracted through blood transfusions before 1990 or sharing dirty needles, is perhaps the only viral infection that can currently be cured, Gordon said.

“In the next five years, we’ll probably have this disease licked,” Gordon said.

That’s an especially relevant development given the current progression of the disease.

“As this group of patients gets older, the problems get worse,” Gordon said. “We could have dire circumstances over the next decade if we don’t turn this around.”

Commerce Township’s Robert Kress is one of the lucky ones.

Like the majority of patients, Kress did not know he was infected until about four or five years ago, when a Red Cross worker uncovered an anomaly in his blood.

“It was shocking,” said Kress, 60, a DTE lineman for the past 41 years. He traced the infection back to a blood transfusion he received in his mid-20s as part of treatment for a collapsed lung. “You conjure ideas of how life is going to continue. You expect to live a long, healthy life. Then suddenly you find out: Maybe it’s not going to be a great senior year.”

Through education, Kress learned that Hepatitis C was treatable but not curable. Under Gordon’s care, he started the standard treatment, which includes pegylated-interferon and ribavarin, designed to keep the virus in check — to a point.

“I never had to take time off work, but it does zap your energy level,” Kress said.

After being invited to participate in the blind study — “I didn’t know if I would get the new drug or not” — his energy level continued to lag. Although he developed a common allergic reaction to the new drug — extreme itching — and had to stop treatment before the trial was complete, Kress has been virus-free for one year.

“The regiment is fairly complicated,” Gordon said. “INCIVEK has to be administered in combination with the standard two-drug treatment, via injections a few times a day. It takes a motivated patient, committed for the entire course of therapy, 24 to 48 weeks, depending on a patient’s response.”

“I feel great,” said Kress, whose energy has returned to pre-treatment levels. “We live on a lake and enjoy water sports; we’re traveling again, and around the house I can do everything I’m told to do.”

That includes repair work and painting. Most recently Kress and his wife Gail remodeled their kitchen. In July, they’re planning to take a trip to the East Coast in their motor home.

“We are so pleased with the course this treatment has taken,” Gordon said. “We are offering hope.”

Youth on Fire: Heroin and Hep C everywhere.

I read this last night and wept. This thing is going after our kids with a vengeance. It's already bigger than AIDS. What's it going to take for us to step up the to fight with everything we've got? How will kids get help while they still have hope if they're too afraid of arrest?

We can't just keep throwing addicts into prison and leaving them to die there, but in America, chains and cages for our people seem to be all we're willing to invest our resources in. How is that either good public health policy or justice?

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Hepatitis C Spikes Among Young Heroin Users

By Martha Bebinger

WBUR

Sep. 9, 2010, 6:27 AM

BOSTON — Heroin, a drug that claims nearly two lives in Massachusetts every day, killed a young woman in Cambridge late last month. She had just turned 18 when she overdosed alone in a bathroom.

“It was a real tragedy, it always is,” says Michael May, the outreach coordinator at Youth on Fire, a teen drop-in center in Cambridge. “She was really young, had been using for a long time and was a pretty key fixture in the community around here.”

May worked with the girl he can’t name and worries that the epidemic he fights every day is gaining steam.
“This summer has been very intense for heroin use in this area,” May says. “And we’ve been getting a lot of kids who, rather than a slow progression into injection drug use, have kind of jumped right into it.”

Needle Use On The Rise

This signals trouble for diseases transmitted through needles, which are also on the rise. The Department of Public Health says infection rates for Hepatitis C in 15- to 25-year-olds have almost doubled since 2002. But there’s no money in this year’s budget for Hep C prevention or to treat new patients.

Hepatitis C is passed through blood in needles, on cotton and on other equipment drug users share. It is 10 times more infectious through a needle stick than HIV. If untreated, Hep C inflames, scars and can ruin your liver.

Dan Church, an epidemiologist at the Department of Public Health, says a spike in Hep C among young heroin users is an urgent matter.

“It’s very alarming to see these numbers of cases with a disease that we really have not seen in this age group for quite some time.” So I think it’s very important that we start thinking about how we can prevent Hepatitis C and provide them education so they will not continue to transmit this disease unknowingly to other people,” Church says.

That is happening. Heroin users and counselors say Hep C is everywhere.

“Once I found out about Hep C, it was just like, yeah, everyone has Hep C,” says Gabe, a 23-year-old who fears arrest if he gives his last name. He started shooting heroin nine years ago but says he only uses occasionally these days.

Gabe does not have Hep C. He tries to keep a few clean needles on him as he moves between Boston and his other home base, Chicago, hopping freight trains, but it doesn’t always work out.

“I’ve definitely gone back and grabbed my old needles off the ground; I don’t know if someone used them, or somebody else’s got dropped there,” Gabe says.

“I generally kept them hidden in one spot but sometimes, you know…”

In Cambridge, and in the the state’s three other needle exchange programs, counselors work Hep C into their prevention talks even though state funding was eliminated this year. May, from Youth on Fire, has a list of precautions he urges users to take. But he knows they may not stick to them in the heat of the moment.

“If somebody’s in a hurry, if they’re sick, it’s just now, now, now,” May says, “and then after they get well is when the rational thinking comes back into play.”

What’s also scary, May says, is that many users aren’t too worried about Hep C.

Johnny, a 24-year-old who also won’t give his last name because he worries about being apprehended by police, sleeps in the woods and hangs out at “Youth on Fire” during the day. He has Hep C.

“It just makes you tired, that’s it. I mean, people can live with it for the rest of their lives right and not die,” he says.

Johnny may be able to manage Hep C with a good diet, rest and no drugs or alcohol. But even if he gets worse, he says he won’t seek treatment because “I heard it makes people really sick and it can kill you.”

Treating Hep C

Hepatitis C is difficult to treat. The drugs won’t kill but they can make patients feel like they have the flu on and off for six months to a year and are only effective in 30 to 40 percent of cases. But on the medical side, things may be looking up.

“We’re really on the dawn of a new era of treatment for Hep C,” says John Ward, director of the division of viral hepatitis at the Centers for Disease Control. “The drugs we have now aren’t specific for the virus.”
Ward says new drugs that are specific to Hep C could be on the market next year.

“When those [new drugs] come on, it will probably double the likelihood of being cleared of this virus and having to go through about half the weeks of treatment,” Ward says.

Ward is understandably excited about better treatment options. In addition to the new wave of young people infected with Hep C, one in 30 Baby Boomers have it, according to the CDC. They could have been infected through a blood transfusion if it occurred before 1992 or in a non-licensed tattoo parlor, but the main way people get Hep C is through intravenous drug use. Cynthia Jorgesen, who runs education and training programs at the CDC, says many people don’t want to recall a past that might have included Hep C.

“Because of that association with negative connotations,” she says, “a lot of people don’t assume they’re at risk because they’re not ‘one of those people.’ ”

Baby Boomers And Hep C

Sixty-five to 75 percent of Baby Boomers who have Hep C don’t know it. Ward says that’s because “they call Hep C the silent epidemic. You can live for decades and don’t know you are infected. The liver doesn’t complain much until it is very, very ill. So you don’t get sick often until it’s too late to help the liver.”

The CDC says death rates are expected to triple in the next 10 to 20 years if the Boomers don’t find out they have Hep C before they get seriously ill.

Most health insurance plans cover a Hep C screening if there’s reason to think you need one. The Department of Public Health is hoping word about Hep C will spread faster than the virus until there’s money again for prevention and new treatment.

Boceprevir trials: New Hope for Hep C Treatment

Good news from the Indiana University School of Medicine:

New Anti-Viral Drug Shows Promise for Dramatic Improvement in Hepatitis C Treatment

August 8, 2010

 

INDIANAPOLIS -- Adding a direct acting anti-viral drug to the standard treatment regimen for hepatitis C significantly increases the cure rate in the most difficult to treat patients, according to a research report published Monday in the online edition of the journal The Lancet.

The research team, led by Paul Kwo, M.D., of Indiana University School of Medicine, reported that adding the drug nearly doubled the treatment’s effectiveness when given for 48 weeks in one treatment arm of the study.

An estimated 3.2 million Americans and 170 million people worldwide are infected with the hepatitis C virus, but many do not know it. In the United States, 70 percent of affected individuals are infected with genotype 1 hepatitis C, the most difficult to treat. Although there may be no symptoms for years, long-term infection can cause cirrhosis and the disease is a leading cause of liver cancer and liver transplantation. Hepatitis C infections occur mainly through transmission of infected blood, such as via injection drug use, and there is no vaccine.

Currently fewer than half of patients with genotype 1 hepatitis C are treated effectively by the standard combination of two drugs, peginterferon alfa-2b plus ribavirin, which is typically given for 48 weeks. The treatment can be difficult for some patients due to anemia and other side effects.

Adding the drug boceprevir increased the cure rate to as high as 75 percent in those who received 48 weeks of the three-drug combination therapy, compared to 38 percent of those in the control group, who received the standard two-drug treatment for 48 weeks, said Dr. Kwo, associate professor of medicine at the IU School of Medicine. The two-year phase 2 trial was conducted at 67 sites with 520 patients in the U.S., Canada and Europe.

In the boceprevir study, known as the SPRINT-1 trial, researchers tested several different options to evaluate the effectiveness of the combination therapy:

• To test whether the addition of boceprevir could make it possible to shorten treatment times, some patients were randomly selected to receive the three-drug combination for 28 weeks, some for 48 weeks.
• Researchers also investigated whether a 4 week lead-in with the standard two-drug combination prior to the addition of boceprevir to the treatment regime could improve sustained virologic response rates. The goal was to see if allowing the interferon and ribavirin to reach steady state levels -- which would activate the immune system and reduce virus levels -- before adding boceprevir would improve the response rates as well as reduce the virus’ ability to develop resistance to boceprevir, said Kwo.
• In another arm of the trial, researchers tested whether a lower dose of ribavirin could reduce the anemia side effects while still treating the virus effectively.

“Both 28- and 48-week boceprevir regimens significantly increased sustained virologic response  rates – which is the best definition of a cure we have – compared to the 48 week control,” said Dr. Kwo. “The 48-week treatment arm with 4 weeks of peg interferon lead-in and 44 weeks of peg interferon, ribavirin, and boceprevir led to the largest improvement over the control group ever reported. That’s very impressive.”
Boceprevir, a product of Merck & Co., is an HCV protease inhibitor – a compound designed to block a function key to viral reproduction in the cell. Boceprevir directly targets the hepatitis C virus, Kwo noted, while peginterferon and ribavirin are less specific, acting more generally to stimulate the body’s virus-fighting immune system.

The best results were reported for the 103 patients who were treated for four weeks with the standard two drug regiment, followed by 44 weeks of the three-drug regimen including boceprevir: 75 percent of these patients tested negative for evidence of the virus six months after the end of treatment. Results for the other treatment arms were:

• 67 percent of those who received the three drug regimen for 48 weeks with no lead-in treatment tested negative for the virus (103 patients).
• 56 percent of those who received the two-drug lead-in for four weeks, followed by 24 weeks of the three drug treatment tested negative for the virus (103 patients).
• 54 percent of those who received the three-drug treatment for 28 weeks with no lead-in tested negative for the virus (107 patients).
• 38 percent of the control group, who received the standard two-drug treatment for 48 weeks tested negative for the virus (104 patients).

Patients receiving the low-dose of ribavirin did not fare as well – just 36 percent were virus-free after 48 weeks of treatment.

“Based on this phase 2 study, it appears that if this drug receives final approval approximately two-thirds of patients will be able to be treated successfully with 28 weeks of treatment and one-third will need 48 weeks of treatment, though this will require confirmation from the phase 3 trials, from which preliminary results were recently released,” said Dr. Kwo.

The research was funded by Schering Corp. a division of Merck & Co., which provided assistance with the trial, data collection and analysis, and the manuscript.

Hep C treatment: Time is of the essence.

Daily Checkup: Alcohol still risk, but viral hepatitis, fatty liver disease main causes of cirrhosis

BY Katie Charles

New York Daily News

Friday, July 16th 2010, 4:00 AM

As the chief of the division of liver diseases at Mount Sinai, Scott Friedman is a hepatologist who does research on how scar tissue forms in the liver.

Who’s at risk
“Fibrosis” is a term doctors use to describe the scarring of the liver that builds up over time as the result of liver damage. “Over many years, that scarring progresses and culminates in cirrhosis, which refers to an end-stage fibrosis,” says Friedman. “By then, the blood flow through the liver is impaired, and liver function may be compromised.”

A healthy liver has many vital functions, like detoxifying the blood, synthesizing critical proteins and hormones, fighting off infection and metabolizing sugars, fats and proteins.

Advanced fibrosis and cirrhosis are major public-health concerns that dramatically increase your chance of developing liver cancer.

“Liver cancer is the fastest-rising cancer in the U.S. and the third-leading cause of cancer mortality worldwide,” says Friedman. “The bulk of patients with cirrhosis in this country have it from hepatitis B or C − about 5.3 million Americans are living with chronic viral hepatitis.”

The second-leading cause of fibrosis is called “fatty liver disease,” in which fat accumulates in the liver and eventually leads to scarring. “Obese patients often overlook the risk of liver damage,” says Friedman. “Obesity often goes hand in hand with metabolic syndrome, which is associated with elevated blood lipids and blood pressure, insulin resistance and pro-thrombotic and an inflammatory state.” Fatty liver disease often improves after weight-loss regimens like bariatric surgery.

The underlying cause for fibrosis can also be alcohol abuse or rarer conditions like autoimmune diseases of the liver. “Alcohol abuse is definitely a risk factor, but the vast majority of patients with fibrosis and cirrhosis don’t abuse alcohol,” says Friedman. The old association linking cirrhosis solely with alcohol abuse no longer holds true now that viral hepatitis and fatty liver disease are the two primary causes of fibrosis and cirrhosis.

Signs and symptoms
One of the challenges of diagnosing and treating liver disease is that it most often develops stealthily.

“The liver is so resilient that it can compensate for years of disease, and the patient may have no symptoms until the disease is very progressed,” says Friedman. “In reality, many patients have advanced fibrosis but have no symptoms.”

The very late manifestation of symptoms means that it is even more important to identify if people are at risk and screen them to catch the disease early.

“People at high risk of liver disease include Asian immigrants, who are more prone to hepatitis B, and patients with evidence of metabolic syndrome, who are at high risk of fatty liver disease,” says Friedman. Other risk factors for hepatitis include people who got blood transfusions before 1990 and people who engage in high-risk behavior like needle-sharing. Alcohol abuse is still a risk factor, even if it is no longer the most common underlying cause.

New evidence shows that simple blood tests can do an excellent job of identifying a patient’s risk of liver disease. “We screen for ALT − alanine aminotransferase − an enzyme that enters the bloodstream if the liver is damaged,” says Friedman. “An elevated ALT level without explanation merits followup.”

Traditional treatment
“We have no treatments approved to attack the scarring in the liver yet,” says Friedman. “But we have some excellent treatments for the underlying diseases.”

There are effective medical therapies for hepatitis B and C. “For hepatitis B, the main drugs are molecules that block the multiplication of the virus,” says Friedman. “The hepatitis C treatments are a combination of the drugs interferon and an immunomodulatory drug called ribavarin, which together boost the immune system to fight the virus.”

New drugs that attack the hepatitis C virus directly are expected to be available next year. For patients with fatty liver disease, weight-loss regimens also reduce liver damage. “Anything from diet and exercise and medications to bariatric surgery can have great results,” says Friedman.

If alcohol abuse is the underlying cause, patients are usually required to enroll in a 12-step rehab program.

Once the liver disease progresses to the point of impairing liver function, doctors treat the resulting symptoms. “We try to treat all the liver problems and screen for liver cancer,” says Friedman. “For select patients, liver transplantation may be necessary.”

But doctors hope they can help more patients control their liver damage before it gets to that point. “There is now evidence that if we treat the underlying liver disease, even cirrhosis is reversible,” says Friedman.

Doctors are making liver disease an increasingly manageable illness through prevention, early detection and the treatment of fibrosis before it progresses too far.

Research breakthroughs

Some of the most exciting liver disease research is being done at the molecular level.

In 1985, Friedman identified the cell type that’s responsible for the formation of scarring tissue.

“Basically, we’ve gone from uncovering [what] causes scar formation to soon being able to treat and prevent fibrosis with medication,” says Friedman. “Our hope is that if we develop new treatments for fibrosis, we’ll be able to prevent the development of cirrhosis.”

Questions for your doctor

Hepatitis is a major public health risk, so be proactive about asking your doctor, “Am I at risk of hepatitis?”

Follow up with, “Should I be vaccinated for hepatitis A and B?” Another good question is, “Do I have any risk factors for liver disease?” and “Is my ALT elevated?”

What you can do

• Know your risk level.
  That means knowing the risk factors of liver disease — especially hepatitis and fatty liver disease — and knowing your ALT level. “If your ALT level is abnormal on even one reading, you should have it followed up,” says Dr. Scott Friedman. 

• Get informed.
  The American Liver Foundation has great patient information on support services and advocacy. See www.liverfoundation.org. 

• See a specialist.
  “If there’s evidence of chronic liver disease based on virus or blood tests, see a liver specialist,” says Friedman.

• Support liver disease research.
  “It’s a terribly underfunded research area,” says Friedman, who recommends giving to the American Association for the Study of Liver Disease at www.aasld.org.

Hep C risk and treatment for prisoners.

----------------From The HCV Advocate----------------

Hepatitis C Infection in Prisons

William Cassidy, M.D.
Louisiana State University-Health Science Center

Due to the epidemiology of hepatitis C (HCV), a higher percentage of inmates are HCV infected than in the general population. Depending on the prison system, 13 to 54% of inmates have hepatitis C. Recent Centers for Disease Control and Prevention (CDC) recommendations are that all incoming inmates be screened for HCV and those infected be evaluated for the presence of liver damage and the need for treatment.

This presents opportunities and challenges. Opportunities in that: 1) expensive treatment which requires close follow up is available for a group of people who quite likely would be uninsured if they were not incarcerated; 2) that those with a history of alcoholism and drug abuse are under enforced sobriety which may improve treatment outcomes; 3) and that these patients can be exposed to educational programs on how to decrease the risk of progressive liver disease and transmission of the infection.

The challenges are that: 1) prisons have restricted budgets and treating HCV is expensive; 2) the ability to address side effects of interferon may be limited because of the expense of hematologic growth factors, restrictions upon the use of sedatives and security issues inherent in the correctional setting.

Most prison systems are treating at least some HCV infected inmates. To standardize management, many prison systems have developed standardized protocols. Different systems take different approaches. Texas and Pennsylvania treat without performing liver biopsies. If a patient is infected, does not have a contraindication and desires treatment, he is treated. Other systems such as Louisiana, Georgia and the Federal Bureau of Corrections require a biopsy prior to treatment and only treat those with significant fibrosis. This approach is based upon the variability of the natural history of HCV.

To understand this approach, it is important to realize that when chronic HCV infection causes death, it does so by first causing cirrhosis (i.e., severe scarring of the liver). Technically, it is not HCV which causes death, it is the cirrhosis which HCV causes. This may seem to be splitting hairs but the importance of the distinction is apparent when it is realized that as many as 80% of HCV infected patients will not develop cirrhosis and therefore ultimately die with their infection but not die because of HCV. Ideally, therefore, those HCV infected patients treated first would be those at greatest risk of developing cirrhosis.

The question, then, is, are all HCV patients equally at risk for developing cirrhosis? The simple answer is no. Concomitant alcoholism, obesity, and hepatitis B or human immunodeficiency co-infections increase the risk for cirrhosis. Even if these factors are not present, some HCV patients will develop cirrhosis and some will not.

There are 3 major subgroups of HCV patients as regards risk for cirrhosis. These groups are called slow, intermediate and rapid fibrosers and are related to the amount of scarring in a patient’s liver biopsy compared to how long he or she has been infected.

The amount of scar tissue is quantified or “staged” on a scale of 0-4. Stage 0 is no scar tissue, stage 1 is minimal, stage 2 is moderate, stage 3 is moderate-to-severe and stage 4 is severe scarring of the liver. Stage 4 is also called cirrhosis.

Another term used is the “fibrosis index.” The fibrosis index is the stage of liver scarring divided by the number of years the patient has presumably been infected.

For example, if someone had a blood transfusion in 1968, and is diagnosed with HCV in 2003, it is presumed that they have been infected for 35 years. If they have a liver biopsy revealing stage 1 fibrosis, their Fibrosis Index is calculated as: stage 1/35 years or 0.029 stages of fibrosis per year infected. This suggests that it will take another 35 years to progress to stage 2. This person is clearly at low risk of developing cirrhosis. Since at this rate he will not develop cirrhosis for at least 70 years, even if cured of HCV, his life is not prolonged.

In another example, assume that the patient shared needles with a known HCV infected drug user 10 years prior to his liver biopsy. If the patient has stage 2 fibrosis now, his Fibrosis Index is 0.2 (stage 2/10 years = 0.2) suggesting that he will progress 2 stages every 10 years. This patient is at high risk for developing cirrhosis in most treatment protocols; treating him would be a priority.

These concepts of the variable progression of HCV and the Fibrosis Index apply to all HCV infected patients whether they are incarcerated or not. They are more important in correctional treatment protocols, however, due to the higher percentage of the inmate population who are HCV infected. The sheer numbers infected can overwhelm the resources available to treat infected inmates in even the most generous prison system. Using the Fibrosis Index allows triage of HCV infected inmates as to their relative risk of death from cirrhosis and prioritizing treatment to those at greatest risk.

If treatment is given, it may be with peg interferon, which is given once weekly, and ribavirin. For cost reasons, some systems are still using thrice weekly interferon and ribavirin. Most systems follow the National Institutes of Health Consensus Conference recommendations that therapy can be stopped at week 12 if there has not been either a 2 log decrease in HCV RNA relative to the baseline HCV RNA or a negative HCV RNA if the initial viral load was too low to fall 2 logs. Additionally, these treatment protocols stop treatment after 24 weeks for patients infected with genotypes 2 and 3.

In addition to treatment, the incarcerated HCV infected individual is ideally given information about reducing risk of disease progression and of infecting others. This includes information about abstaining from alcohol after discharge, avoidance of blood exposure and maintenance of ideal body weight. The CDC also has recently recommended that all HCV inmates be vaccinated for hepatitis A and B if not already protected.

The future of HCV management in prisons will see increasing standardization of protocols. Liver biopsies will be required by most for scientific and financial reasons and also because the Federal Bureau of Prisons’ recently published guidelines incorporates liver biopsy. Although the Federal Bureau does not dictate what states do, it is influential is establishing what the standard of care is.

There will hopefully be more research protocols made available for inmates to enroll in. Because of past abuses, it was made practically impossible to enroll inmates into drug treatment research protocols. This has been relaxed somewhat but is still extremely difficult and rarely done. Although these restrictions were originally instituted to protect inmates from exploitation, they now have the effect of denying access to cutting edge treatments. With the advent of informed consents, institutional research boards, prisoner advocacy groups and other entities, it is reasonable to assume that the past abuses could now be avoided.

In summary, HCV infection disproportionately affects inmates. Recent CDC recommendations are that incoming inmates be screened for infection and treated where indicated. This presents opportunities and challenges to the prison system. Understanding the natural history of HCV infection allows treatment to be focused upon those at highest risk of dying from HCV induced cirrhosis. The CDC also recommends education efforts directed towards minimizing disease progression and the infection of others with HCV. CDC also recommends HAV and HBV vaccination for HCV infected inmates.

HCV Advocate: Treating HCV in Prison.

Here's an American take on harm reduction and treatment for HEP C in jail/prison. Check out the HCV Advocate newsletter if you haven't already - they have each monthly issue in a downloadable format. And here are their top 10 downloads (fact sheets) for April - both in English and Spanish. Great resoruce.

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Treating Hepatitis C in Prison
October 2009 HCV Advocate

Liz Highleyman

Hepatitis C is much more common among people in jails and prisons compared to the population as a whole, and it is estimated that about one-third of people with HCV in the U.S.  – approximately 1.5 million – pass through the correctional system each year.

In recent years an increase in the number of prisoners with advanced HCV-related liver disease and growing public health awareness about the need for treatment has collided with ever-rising healthcare costs and, now, a stubborn recession eating away at correctional system budgets. 

How Common Is It?

The high prevalence of hepatitis C in prisons is largely attributable to the fact that sharing drug use equipment is an efficient means of transmission, and a substantial proportion of prisoners are incarcerated for drug-related offenses.  

Epidemiological studies have observed prison HCV infection rates in various areas the U.S.  ranging from about 10% to more than 50% (averaging around 30%-40%), compared with approximately 2% for the general population.  A recent California study found about half of women and 40% of men entering state prisons had hepatitis C, while a survey of shorter-term jail inmates in Chicago, Detroit, and San Francisco found an infection rate of 13%.

Many individuals enter prison already HCV-infected, but a significant number acquire the virus behind bars.  In addition to injection drug use – which occurs despite strict rules and the challenges of obtaining drugs and needles – inmates may contract HCV through non-sterile tattooing or exposure to blood during fights.

Furthermore, increasing evidence indicates that sexual transmission of HCV is more common than previously believed, especially when it involves “rough sex,” exposure to blood, or concurrent infection of HIV or other sexually transmitted diseases.  Coerced unprotected anal sex would presumably be particularly risky.

Advocates and public health experts have urged prisons to adopt harm reduction strategies such as condoms, clean needles, and methadone maintenance.  The World Health Organization recommends that prisoners should have access to condoms and bleach for cleaning injection equipment, and several countries and some U.S.  states have implemented various harm reduction measures.  But officials in most jurisdictions oppose this approach, arguing that it condones prohibited behavior. 

Whom to Treat, and When?
The Centers for Disease Control and Prevention (CDC) recommends that all incoming inmates should be screened for HCV, and those who test positive should be evaluated for treatment.  But these guidelines are not mandatory, and states have widely varying polices.  Some jurisdictions do not offer routine antibody screening, fearing that testing would obligate them to provide treatment. 

Incarcerated people may not receive appropriate hepatitis C treatment for a variety of reasons, potentially turning a limited term of incarceration into a death sentence.  Cost is the most commonly cited factor.  A year of treatment with pegylated interferon plus ribavirin costs around $25,000.  Jails holding short-term inmates have an incentive to withhold treatment so the expense becomes someone else’s problem.  Longer-term institutions may delay therapy so long that prisoners are eventually released or become too sick to benefit.  

Many clinicians have traditionally been unwilling to offer hepatitis C treatment to people with conditions assumed to predict poor adherence or response, including ongoing drug use.  Some feel similarly about giving interferon to people with pre-existing depression or other psychiatric conditions.  

While incarceration often leads to “enforced abstinence,” and most prisons offer 12-step programs, many inmates manage to continue using drugs behind bars.  Older guidelines recommended that patients should be abstinent from drugs or alcohol for at least six months before starting hepatitis C treatment.  According to current National Institutes of Health and AASLD guidelines, however, active drug users and those receiving maintenance therapy such as methadone should not automatically be denied treatment.  

Treatment for chronic hepatitis C is indicated when people begin to experience liver disease progression.  But a majority of people with chronic hepatitis C never go on to develop advanced disease, and therefore may not need therapy.  The challenge is determining in advance who falls within which group in a prison setting.

Many prisoners who were infected with HCV years or decades ago are now reaching the later stages of disease, with rising rates of advanced fibrosis, cirrhosis, hepatocellular carcinoma (HCC), and end-stage liver failure.  Recent analyses of inmates of the Texas Department of Criminal Justice, for example, found that 54 people per 100,000 had HCC and 131 per 100,000 had end-stage liver disease. 

In a presentation to the NCCHC (National Commission on Correctional Health Care), hepatologist Bennet Cecil estimated that about 20% of prisoners with hepatitis C have advanced liver disease, so about 6% of all prisoners – 20% of the one-third believed to be HCV-infected – are potentially eligible for treatment.

Liver disease progression is best determined by liver biopsy; a significant proportion of patients experience disease progression despite persistently normal liver enzyme (ALT and AST) levels.  As with HCV antibody screening, prison jurisdictions vary in their policies regarding biopsies – which are themselves expensive – and treatment.  Liver transplantation is even more restricted due to its extremely high cost, the shortage of donor livers, and the associated political controversy.

The Federal Bureau of Prisons recommends treatment according to AASLD criteria, but states set their own policies.  Some offer treatment as seldom as they can get away with, leading to several legal challenges based on the premise that withholding standard-of-care therapy violates the Eighth  Amendment prohibition against cruel and unusual punishment.

Treatment Effectiveness

A growing body of evidence shows that people in correctional settings and former inmates can be successfully treated for hepatitis C, though sustained response rates tend to be lower than those observed in clinical trials.

In the October 1, 2008 issue of Clinical Infectious Diseases, D.  Maru and colleagues reported findings from a study of inmates at Connecticut Department of Correction facilities treated with pegylated interferon plus ribavirin during 2000-2006.  Sustained virological response (SVR) rates were 43% for patients with HCV genotype 1 and 59% for those with genotypes 2 or 3.  This compares with overall average response rates of about 50% for genotype 1 and 70%-80% for genotypes 2 or 3 for the hepatitis C population as a whole.

More recently, K. Chew and colleagues reported in the August 2009 Journal of Clinical Gastroenterology that inmates at Rhode Island Department of Corrections facilities treated with the same regimen had somewhat lower SVR rates, 18% for genotype 1 and 50%-60% for genotypes 2 and 3.  

Hepatitis C treatment in correctional settings presents numerous challenges.  A disproportionate number of prisoners are black, and a large body of research shows that people of African descent respond less well to interferon-based therapy.  But surprisingly, the Connecticut and Rhode Island studies did not see differences in sustained response rates between black and white patients.

Many prison inmates with hepatitis C are coinfected with HIV, which both accelerates liver disease progression and impairs response to treatment.  Side effects of interferon-based therapy can be difficult under the best of circumstances, but dealing with depression, fatigue, and malaise can be even harder given the hardships of life on the inside.  Furthermore, frequent transfers between facilities and release before treatment is completed can lead to interruption of therapy and treatment failure.

On the other hand, incarceration also offers some unique opportunities.  As noted, an estimated one-third of people with hepatitis C pass through correctional facilities annually, many of whom belong to underserved populations and might not otherwise have access to HCV screening and treatment.  

Treatment in prison allows for directly observed therapy, frequent monitoring of early response and drug tolerance, and counseling and support around adherence and side effects management.  It is critical, however, to provide pre-release planning to ensure continuation of care in the community.

Both treated inmates and those who do not need treatment can receive education about how to prevent HCV transmission (including using condoms and not sharing needles) and encouraging liver-healthy habits such as limiting alcohol consumption and maintaining a healthy weight.  In addition, those who are not already immune should be offered hepatitis A and B vaccination.

It should also be emphasized that successful treatment does not protect against future infection, and there is no vaccine for hepatitis C.  A study reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy in September found that 22% of current or former prisoners in Vancouver who achieved sustained response to interferon-based therapy became re-infected with HCV.  Re-infection was mostly attributable to injection drug use (76%), though 15% had other known risk factors including tattooing, piercing, sexual activity, or direct contact with blood during a fight.

Changing Policies
While there is ample research indicating that many inmates need hepatitis C treatment and interferon-based therapy can be successful in prison settings, evidence is not always enough to encourage greater access to appropriate care.  

Many states are unwilling to shoulder the cost of treatment, and some that once provided relatively good care have scaled back in the wake of the ongoing budget crisis.  In California, in fact, the budget deficit is so severe that the state is releasing prisoners early.

But deferring treatment can be “penny wise and pound foolish.” Treatment at earlier disease stages can prevent more serious consequences requiring much more expensive management later on. 

As reported in the November 2008 issue of Hepatology, a mathematical modeling study by J.  Tan and colleagues showed that without using biopsies to determine disease stage, treating all HCV-infected inmates with pegylated interferon plus ribavirin would be cost-saving for all ages and genotypes.  This strategy, however, would expose many people who do not need therapy to unnecessary side effects.  If pretreatment biopsies were performed, treatment was still cost-saving for prisoners of all ages and genotypes found to have advanced fibrosis or cirrhosis.

Some studies suggest that interferon-based therapy may help slow liver disease progression even if it does not produce a sustained virological response.  Furthermore, inmates who are treated and cured will not go on to transmit HCV to others, either in prison or in the community after release.  

Given these benefits – and the humanitarian imperative to provide good care for people in government custody – advocates and legislators are working to expand access to hepatitis C education and treatment.

In the future, new treatment options may help turn the tide.  Directly-targeted oral agents may be better tolerated, produce higher response rates, and be effective with a shorter course of therapy, tipping the balance toward prompt, presumptive treatment.

Selected References:

Chew, K. et al.  Treatment Outcomes with Pegylated Interferon and Ribavirin for Male Prisoners With Chronic Hepatitis C.  Journal of Clinical Gastroenterology 43(7): 686-691.  August 2009.

Farley, J. et al.  Treatment of HCV infection in intravenous drug users in inmates of correctional institutions, Canada: four year follow up − significant likelihood of reinfection.  49th Interscience Conference on Antimicrobial Agents and Chemotherapy.  San Francisco.  September 12-15, 2009.  Abstract H-219.

Hennessey, K. et al.  Prevalence of infection with hepatitis B and C viruses and co-infection with HIV in three jails: a case for viral hepatitis prevention in jails in the United States.  Journal of Urban Health 86(1): 93-105.  January 2009.

Maru, D. et al.  Clinical outcomes of hepatitis C treatment in a prison setting: feasibility and effectiveness for challenging treatment populations.  Clinical Infectious Diseases 47(7): 952-961.  October 1, 2008.

Tan, J. et al.  Treating hepatitis C in the prison population is cost-saving.  Hepatology 48(5): 1387-1395.  November 2008.

Remak: The Scandal of HEP C

Marin Scope Article 4-26-10

The Scandal of Hepatitis C

By Bill Remak, B.Sc. MT, B. Public Health, SGNA, AHCJ. (wmremak@pacbell.net ) Chair, National Association of Hepatitis Task Forces and California Hepatitis C Task Force and Fred S. Mayer, RPh, MPH, President, PPSI, Inc. ppsi@aol.com

I am a native of Marin and after over 40 years of dealing with liver disease the hidden truth comes to the surface and is revealed for all to know and to take a stand. I want to share with you a short clip from the Canadian media from 1994 about hepatitis C. The same situation occurred in the United States but was suppressed by the CDC which instituted a badly managed "Look Back" program to attempt to contact patients that received transfusions from tainted blood and advise them to get tested.

The testing and screening of blood at blood banks for HCV was not in place until April 1992 in the US, yet from 1987 there was a test developed by the Chiron Corporation (now Novartis, Inc.) that indicated the presence of the hepatitis c virus in the blood. So why did it take five years to make our blood supply safe? Since then from time to time there have been concealed reports of contaminated blood from Blood Banks and Dialysis Centers throughout the country as recent as 2005.

Japan, Ireland and Canada have had cases judged in favor of the health consumers (by their highest judicial courts) that unwittingly received tainted blood products and were awarded compensation for their suffering. The United States Government has never owned up to their neglegence and their continued actions to downplay the concern has continued for nearly 18 years despite the appeal by the last five Surgeon Generals to take heed of this major health crisis.Those that have had surgeries prior to 1992 and may have received blood products during surgery should be tested.

Our governments focus on IV drug users as a high risk population not only is irresponsible because it neglects the rest of society but it also has helped generate a terrible stigma toward people that have the disease that in some cases may take years to reverse. It is a disservice to ignore the general population and it should be considered unconstitutional to not treat people fairly with potential exposure to chronic medical conditions or infectious diseases because one assumes that the condition was acquired as a result of lifestyle or behavioral issues.

Anyone in society should have the benefit of the doubt to obtain some piece of mind and determine if only because of the preventative aspect of early detection, the ability to obtain a test to determine if they have a potentially deadly illness. Please pass this link on to others who have been impacted by this disease and let them know that I am accepting volunteers across the country to advocate for the rights of patients with chronic liver disease and to help dispel the notion that this is a self inflicted disease caused only by behavior and lifestyles.

Our veterans, health workers and people that have unknowingly received tainted blood from tattoos, piercings and surgeries have been openly ostracized for having the disease and victimized and discriminated against by health care plans and policy wonks that have manipulated our Federal CDC agencies and Public Health Departments into targeting people with HIV/AIDS, drug users and prisoners as the most likely in society to be carriers therefore creating a stigma that influences negatively the quality of care.

Even if this is considered the highest risk population it is dumbfounding that healthcare should be assigned by giving some people preferential treatment over others and flies in the face of discrimination. It is time to say enough! We must stop this tremendous insult to injury and harm that occurred and continues to impact our citizens and hold our government accountable for their failure to activate a responsible prevention program and concealing information and control to make a safe national blood supply.

Feel free to contact me. Watch this clip. It happened here in the USA! Pretending it did not happen will not make the problem go away. We have had 35 major outbreaks in the last ten years throughout the country involving hundreds of thousands of patients at hospitals and clinics. Could it happen in Marin? Remember, Naomi Judd? She got a needle stick while working as a nurse at Marin General Hospital in the 70’s. It did not take much.

We need to be careful. This has a greater than 7 times more transmissible risk than HIV/AIDS as a blood borne pathogen.

Bill Remak, B.Sc. MT, B. Public Health, SGNA, AHCJ.

Chairman, California Hepatitis C Task Force

Steering & Communications Committee Member,

California Chronic Care Coalition

Chair, National Association of Hepatitis Task Forces

Secretary of the Board of Directors, FAIR Foundation

(Fair Allocations In Research)
149 Wyndham Way, Suite #223
Petaluma, Ca. USA
94954-3875
office 707 773-4922
cell 707 364-1802
fax 415 276-5893
wmremak@pacbell.net

www.californiahcvtaskforce.org

www.chroniccareca.org

www.NAHTF.org

www.fairfoundation.org

www.evidencebasedhealthcare.org