LiverHope

The Hepatitis C Generation

Thanks to a disease that lays dormant for up to 30 years, baby boomers well past their wild years are starting to suffer the consequences.

Sarah Kliff / Newsweek.com

Jan 11, 2010 - When Alan Franciscus was diagnosed with hepatitis C in 1996, his first question was, "Am I going to die?" When his doctor assured him that many treatment options were available, he had a second question: "What is hepatitis C?" Looking back, Franciscus, a 61 year-old San Francisco resident says: "One of the most disturbing things to me was I had never heard of it. I really did not know a thing about it."

Franciscus' question, it turns out, is not such a bizarre one to ask. Despite affecting 1 percent of the population, hepatitis C remains a disease generally misunderstood by the general public with little in financial commitments from the federal government. The CDC's National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Prevention had a budget of almost $1 billion for 2008. Only 2 percent of that was allocated to hepatitis B and hepatitis C despite both viruses being five times more prevalent. "No one really knew what hepatitis C was," Franciscus remembers. "A bunch of coworkers thought I got it from eating bad food."

A newly-published Institute of Medicine Report on hepatitis B and C, published today, underscores how this lack of understanding and attention has played out. Although the risk factors for hepatitis C are widely known and completely preventable, the IOM estimates that between 2.7 million and 3.9 million Americans have contracted hepatitis C.

But the most startling detail about hepatitis C may not be its prevalence, but the population it affects. Two-thirds of those with the virus are Baby Boomers, adults in their 50s or 60s who may have experimented with intravenous drugs decades ago. For many of them, the Summer of Love is a hazy, distant memory from their youth. But hepatitis C, which is transferred by contact with infected blood, has a particularly long incubation period, often 20 or 30 years. That means that

the side effects of one drug use in the 1970s could now start to show. "Even though Boomers moved on with their lives, they could be living with an infection that happened many years ago," says John W. Ward, division director for the Center for Disease Control's Division of Viral Hepatitis. "Now, they're aging into a period of their lives when Hepatitis C could become manifest through physical symptoms." One study published last May estimates that, in the next 20 years, total medical costs for Hepatitis C patients will nearly triple, from $30 to $85 billion.

Hepatitis C is a serious challenge for both doctors and public health officials, largely because of its long incubation period. An individual infected with hepatitis C can live the majority of their life not knowing they were infected. In fact, the new IOM report suggests this is usually the case: 75 percent of those with hepatitis C don't even know they have it. And unlike other forms of the hepatitis virus, like A and B, there is no known vaccine. So the virus continues to be transmitted through exposure to infected blood, often injection drug use. Boomers may have also become infected by a blood transfusion or organ transplant before 1992, when officials began screening the blood supply for the disease.

Of those infected with the virus, about 60-70 percent will develop chronic liver disease. For about 40 percent, a months-long regimen of shots and pills will eradicate the virus. But many will continue to live with the disease as a chronic condition; 1 to 5 percent will die of the consequences of liver disease. Some expect to see these conditions become significantly more prevalent as Boomers' cases move from virus to disease. One study, a Milliman Report published in May 2009, predicted that the number of patients with advanced liver disease will be four times greater than it is today by 2029. Cases of cirrhosis, scarring of the liver, will also quadruple.

This means that right now, before that wave hits, is a particularly critical juncture for early detection and treatment of hepatitis C, particularly among the Boomer population. "There's a window of opportunity to identify the disease early," says Ward. Hepatitis C is usually diagnosed with a simple blood test and patients found positive have a number of options in disease management. They can monitor levels of certain liver enzymes, charting any advancement in liver disease, and make lifestyle adjustments to manage the disease such as eliminating alcohol.

So, if the test is so easy, and the risk largely pooled in a specific demographic, why do so many cases go decades undiagnosed? Doctors say it has a lot do with the stigma surrounding liver disease. "If Uncle Bernie says he has cirrhosis, it's like, 'well how much was he drinking?' says Allan Wolkoff, chairman of the American Liver Society and a professor at the Albert Einstein School of Medicine in New York City. "We need to work on that. Good people get liver disease; kids get liver disease. You can get liver disease through little or no fault of your own." In a study of patients in a liver clinic in Iowa, 57 percent of Hepatitis C-positive people reported having experienced stigma associated with their infection. Given that, it's easy to see why well-to-do Boomers rarely get tested for a disease often associated with junkies and alcoholics: neither they, nor their doctors, think to even ask.

Both the IOM and CDC want to change that. The IOM report recommends a comprehensive public education and surveillance campaign, as to increase awareness of the disease, following in the model of HIV/AIDs public awareness campaigns in the 1990s. "As in the case of HIV/AIDS," the report concludes, "increasing general public knowledge about hepatitis B and hepatitis C can be expected to reduce discrimination toward infected people, reduce transmission, and increase early diagnosis and treatment that ultimately save lives." A lot of this, says Wolkoff, hinges on doctors: "there's a certain amount of physician education necessary. Even a small rise in physicians talking about this, talking about it with their patients, could make a big difference.

The CDC may also play a role, particularly in the testing of Boomers. Right now, the organization recommends that anyone who ever tried injected illegal drugs or had a blood donation prior to 1992 be tested. But patients may make compliance with such a regulation difficult—they may not, for example, volunteer information about that one time at Woodstock—the CDC is considering a blanket, age-based screening recommendation. "We're launching studies to see if it's feasible and makes sense," says Ward, the CDC official. "Just like everyone over 50 should have a check for colon cancer, it might fit into an age-based checklist of preventative services."

Franciscus did not know much about hepatitis C when he was diagnosed. But he quickly learned one thing: there was not nearly enough information available to patients like him. So he founded the HCV Advocate, a newsletter that now gets 400,000 visits online each month and is his new, full-time job. He regularly speaks across the country, to health providers and educators, on the subject. "The key is going to be public awareness and educating medical providers, to ask questions and get people tested," says Franciscus. "If you catch it early, nobody will die from Hepatitis C."

Roslyn News - January 14, 2010 - What does 2010 have in store for people with hepatitis C? For the patient, it will likely be a year to wait and observe what happens with many of the new medications being evaluated in clinical trials. From the provider side, 2010 will be an exciting year. There are several new medications being introduced into clinical trials and some of the more advanced new medications are likely to complete their pre-approval evaluation this year.

While there is lots of chatter regarding new medications for hepatitis C, it is important to understand that the new medications are in addition to the current therapies. They are not replacement therapies. This means that the current standard treatment of interferon and ribavirin will not disappear. Future treatment regimens will be comprised of at least three drugs, interferon, ribavirin, plus a third or perhaps a fourth new agent. While the current interferons that are currently approved for therapy are pegylated interferon alfa 2a or 2b, newer interferons and new delivery systems of already approved interferons are being introduced as well into the research arena.

Most of the new clinical trials are evaluating previously untreated patients with genotype 1. Unfortunately, there are limited studies being planned for previous non-responders to pegylated interferon or for relapsers to the same regimen despite the vast number of patients who fall in to these categories. The good news is these patient populations have been studied with a treatment regimen of three drugs including interferon, ribavirin and a protease inhibitor with excellent outcomes. There are also limited data available for the use of any of these new compounds in genotypes other than type 1.

When can the public expect that these new medications will become available? While we are not able to assure when the next agent will be approved by the FDA, two different protease inhibitors seem poised to be approved for the treatment of hepatitis C in the latter half of 2011. Both of these agents are oral agents which will be used in combination with pegylated interferon and ribavirin; and the sustained viral response rates with the triple therapy is significantly better than with dual therapy, although the side effect profile with the three drugs is greater. Therefore, the use of these products requires significant experience by the physicians and their staffs. These agents also offer hope for the non-responder and relapse patient, and hopefully, their approval will offer the chance of a sustained viral response to many patients with hepatitis C.

In addition to these new agents, the team at Duke has identified a genetic polymorphism near the IL28B gene which can predict response to therapy with standard pegylated interferon and ribavirin. If this proves to be a real finding and a commercial assay can be developed, it may become available for routine testing which would allow physicians to predict response to therapy prior to initiating treatment. This would differentiate those patients requiring the new triple therapies versus those who will do well with standard dual therapy.

So what are patients to do in the interim? My suggestion is to continue current evaluations and discussions of what therapies are available now and what may be best for the individual patient in the future. For some, watchful waiting may be appropriate, while in others, initiation of treatment at this time may be the best treatment course. Either way, a little education will go a long way in best understanding and treating hepatitis C.

Jan. 20, 2010 (HealthDay News) -- A new class of compounds is able to inhibit replication of the hepatitis C virus (HCV) in laboratory tests, say U.S. scientists.

If they prove effective in humans, these compounds may offer an important new treatment option for patients infected with HCV, according to the Stanford University School of Medicine researchers. Current treatments for hepatitis C are only partially effective and often toxic.

HCV "infects over 150 million people worldwide, many of whom don't even know they have it. Chronic hepatitis C infection is the No. 1 cause of liver cancer and liver transplantation in the United States," study senior author Dr. Jeffrey Glenn, Associate Professor of Gastroenterology and Hepatology and Director of Stanford's Center for Hepatitis and Liver Tissue Engineering, said in a news release.

The new class of compounds disrupts HCV's replication cycle by interfering with a process that doesn't ordinarily occur in uninfected cells. This means that HCV replication can be stopped with little or no toxicity to human cells.

The study was published online Jan. 20 in the journal Science Translational Medicine.

It could take a year to 18 months of preclinical and animal testing before these new compounds can be tested in human clinical trials, Glenn said.

He and his colleagues have equity in a privately held company to which Stanford has licensed intellectual property relevant to the new compounds.

Receive FREE treatment in a national study if you qualify. Study participants need to be treatment naïve, Hepatitis C - genotype 1. Treatment will include interferon, ribavirin and Schering Plough’s protease inhibitor – Boceprevir.

Interested? Call our study coordinators at 612-347-7683. ~~ Minneapolis Medical Research Foundation

Patients with More Difficult to Treat Forms of Hepatitis C Are Half as Likely to Treat the Disease

November 10, 2009 - A new study by Mount Sinai researchers has for the first time found that patients with more difficult to treat forms of hepatitis C are half as likely to initiate treatment for the disease, when compared to patients with hepatitis C that is easier to treat. Marital status also affected whether patients chose treatment, as did whether or not they had other diseases. The study is published in the November 1 issue of Journal of Health Care for the Poor and Underserved.

"Overall, only about 30 percent of hepatitis C patients choose to initiate treatment for the disease," said Thomas McGinn, MD, senior study author and Chief of General Internal Medicine at Mount Sinai School of Medicine. "It's a huge problem that needs to be addressed. This study confirms that genotype is a major barrier to treatment. We hope these findings will lead to changes in how physicians approach patient care in a way that increases the rate of treatment initiation."

Researchers analyzed all patients referred to Mount Sinai's Primary Care Treatment and Screening Program for Hepatitis C between January 2003 and May 2007. The analysis included all hepatitis C clinic patients who were eligible for treatment and to whom treatment was offered.

Of the 168 treatment-eligible patients, 41 began treatment and 127 chose not to. Patients with genotypes 1 and 4 of the disease, which are less responsive to treatment, were less likely to initiate treatment, as were unmarried patients and patients with multiple diseases, or medical comorbidities. Age, gender, language, race, and other risk factors were not found to be significant in the study. Researchers found that:

"More research is needed to determine why these factors affect treatment initiation," said Dr. McGinn. "Because of existing studies on other diseases, we were not surprised that marital status and comorbidities were contributing factors to low treatment rates. However, this is the first study to associate hepatitis C genotype with lower rates of treatment initiation.

"Duration of treatment may be a factor," said McGinn. "Genotypes 1 and 4 of the disease require longer treatment courses, about 9 to 12 months, versus an average of 6 months for genotypes 2 and 3. It's possible the longer duration discourages patients from choosing treatment.

"Furthermore, patients with genotypes 1 and 4 often need a liver biopsy, which many patients incorrectly think are extremely painful. As a result of this study, Mount Sinai has started a program called 'Biopsy Buddies,' in which a patient who has already undergone a liver biopsy consults with a patient who needs one. We're hopeful that by building more support systems for patients we will increase the likelihood that they will choose to receive treatment."

January 11, 2010 - A hepatitis C virus (HCV) treatment regimen including Genentech’s Pegasys (pegylated interferon-alpha-2a) is superior to a regimen including Schering-Plough’s PEG-Intron (pegylated interferon-alpha-2b), according to two studies published in the January issue of Gastroenterology. The studies did not include people living with HIV, however.

New types of HCV treatment are on the horizon. However, the compounds furthest along in development must still be paired with the two existing drugs: pegylated interferon and ribavirin.

There has been some question as to which pegylated interferon, Pegasys or PEG-Intron, is superior in terms of treatment success. HCV treatment is deemed successful if a person achieves and sustains undetectable HCV levels for six months after completing a course of HCV treatment. This is called a sustained virological suppression, or an SVR.

To determine which pegylated interferon is more likely to achieve an SVR, two studies were conducted in people with HCV—people with HIV were not included in either study.

In the first study, Maria Grazia Rumi, MD, from the Università degli Studi di Milano in Milan, and her colleagues compared the two treatments, combined with ribavirin in 219 people with HCV. In the second study, Antonio Ascione, MD, from the Center for Liver Disease at Fatebenefratelli Hospital in Napoli, Italy, compared the two treatments in 320 people.

In both studies, people who received Pegasys were significantly more likely to achieve an SVR than people who received PEG-Intron — 66 percent in the Pegasys group compared with 54 percent in the PEG-Intron group in Rumi’s study and 68.8 percent compared with 54.4 percent in Ascione’s study. Side effects were similar in both groups in both studies. The difference in efficacy was independent of the genotype, or strain, of HCV of the participants (for example, genotype 1, 2, 3 or 4).

In a special commentary appearing alongside the studies in Gastroenterology, Stefan Seuzem, MD, from Goethe University in Frankfurt concludes, “It took eight years to characterize the differences between the two drugs in detail. At the dawn of new direct antiretroviral drugs against the HCV we need now to investigate how important the observed differences between the peginterferons are in combination with [the latest experimental drugs].”

January 10, 2010 - Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex: "Phase 3 data for telaprevir, our lead drug candidate for the treatment of hepatitis C virus infection, will begin to emerge in the spring of 2010 to support the planned submission of a New Drug Application in the second half of this year.”

“Our more than decade-long commitment to improving patient care in HCV is unwavering, and the Phase 3 program for telaprevir will remain our primary focus over the coming year. Importantly, we also recognize the need for continued innovation in the treatment of this disease, and we are preparing to initiate the first clinical trial combining telaprevir with the investigational HCV polymerase inhibitor VX-222 this quarter."