June 21, 2011

Telaprevir-Based HCV Treatment Benefits All IL28B Genotypes

Caroline Helwick

May 24, 2011 (Chicago, Illinois) — The direct-acting protease inhibitor telaprevir, given in combination with pegylated interferon plus peginterferon/ribavirin (PR), increased the chance of sustained viral response (SVR) across all interleukin (IL) 28B genotypes of hepatitis C virus (HCV), results of a substudy of the ADVANCE trial have shown.

The findings were reported here at Digestive Disease Week 2011 by Ira Jacobson, MD, chief of the division of gastroenterology and hepatology at New York–Presbyterian Hospital/Weill Cornell Medical Center, and Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College in New York City. Dr. Jacobson is also principal investigator for the ADVANCE study.

"Single-nucleotide polymorphisms near the IL28B gene have been strongly associated with the likelihood of SVR in genotype 1 HCV patients treated with PR. During our evaluation of an exploratory diagnostic test that characterizes genetic polymorphisms near the IL28B gene, we investigated the impact of the IL28B genotype on SVR rates in the telaprevir-based regimens," Dr. Jacobson said.

The 3 variations of the IL28B genotype have been associated with a person's response to hepatitis C treatment with PR, Dr. Jacobson noted. In this study, substantial improvements were observed in SVR, or viral cure, across all IL28B genotypes — CC, CT, and TT — for patients treated with telaprevir-based combination therapy, he reported.

In ADVANCE, patients were randomized to receive telaprevir (for 8 weeks or 12 weeks) in combination with PR, followed by PR alone, for a total of either 24 weeks or 48 weeks of treatment. In the response-guided regimen, eligibility for the shorter treatment duration was based on having undetectable HCV at weeks 4 and 12.

The IL28B allele distribution in a sample of 454 patients for whom genotyping was available was consistent with previous reports for treatment-naïve patients: 49% had the CT genotype, 33% had the CC genotype, and 18% had the TT genotype.

The SVR rates in these 454 white patients were 78% for the 12-week telaprevir-based regimen, 65% for the 8-week telaprevir-based regimen, and 38% for the control group treated only with PR.

Patients with the CC allele were the most likely to achieve an SVR, which reached 90% with the 12-week regimen and 84% with the 8-week regimen. In the CC allele population receiving only PR, 68% achieved an SVR. In the other 2 allele subsets receiving 12 weeks of telaprevir, SVR was achieved by 71% of CT patients and 73% of TT patients; in those receiving PR only, SVR was achieved by 25% of CT patients and 23% of TT patients.

"You see that the largest increment in SVR occurred in patients with the T allele," Dr. Jacobson pointed out. Rates exceeded 70%, compared with 25% or less with PR only.

With the 8-week regimen, SVR rates were 57% and 59%, respectively, compared with 25% and 23%, respectively, for the PR regimen in these genotype subsets.

Telaprevir-based regimens also improved rapid viral responses (RVRs) and extended (e)RVR rates across all IL28B genotypes, meaning they had undetectable HCV RNA at weeks 4 and 12. The eRVR rate in the 12-week group was higher than in the placebo group for CC patients (78% vs 15%), for CT patients (57% vs 2%), and for TT patients (45% vs 0%).

"Most eRVR patients achieved an SVR in all groups," he added, including 95% of the CC group, 92% of the CT group, and 80% of the TT group receiving 12 weeks of telaprevir plus PR. "Patients with an eRVR were highly likely to achieve SVR as well."

Nonattainment of eRVR was associated with lower SVR rates across all IL28B genotypes, with the largest decrement in CT/TT patients, the study found.

Andrew Muir, MD, clinical director of hepatology at Duke University Medical Center, Durham, North Carolina, told Medscape Medical News that these findings confirm that all patients benefit from the addition of telaprevir, regardless of their IL28B genotype.

When it became clear that the CC genotype is associated with higher response rates, patients who learned they had the CT or TT genotype tended to have concerns, Dr. Muir said. "These findings change that discussion a lot," he noted. "Those patients now see that they can benefit from treatment as well."

The other value of the study is the finding that a patient is more likely to benefit from a shorter course of treatment if he or she [has genotype] CC," he added. "This may be relevant to some patients — that is, it may make a difference in their enthusiasm for treatment. It's important to have this information in your discussions with patients."

Telaprevir was just approved by the US Food and Drug Administration for the treatment of HCV.

Dr. Jacobson reports receiving grant and research support, consulting fees, and other financial benefit from Vertex Pharmaceuticals. Dr. Muir reports financial relationships with Anadys, Genentech, Idera, Medtronic, Merck & Co, Pharmasset, Santarus, Scynexis, Three Rivers Pharmaceuticals, Vertex, and ZymoGenetics.

Digestive Disease Week (DDW) 2011: Abstract 904. Presented May 10, 2011.

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High Demand for New HCV Drugs Could Cause Ethical Problems

Jim Kling

May 27, 2011 — Earlier this month, the US Food and Drug Administration approved the drugs boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex) for the treatment of hepatitis C virus (HCV) infection. The approvals are good news for patients with HCV, but high patient demand could lead to scarcity and ethical challenges for treatment providers, according to a viewpoint article published in the June issue of Hepatology.

HCV is responsible for 120 million infections worldwide and is a leading cause of liver failure mortality, explain authors Andrew Aronsohn, MD, and Donald Jensen, MD, from the Center for Liver Disease, Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medical Center, Illinois. Pegylated interferon and ribavarin have had some effect, but less than half of patients with HCV achieve a sustained virologic response.

Clinical trial results suggest telaprevir and boceprevir will achieve marked improvement in sustained virologic responses in genotype 1 patients compared with current standard of care therapy.

Some patients who are at low risk for near-future progression have deferred therapy in anticipation of the arrival of these drugs. A recent Veterans' Administration study revealed that 50.3% of patients who refused treatment with interferon and ribavirin did so in anticipation of more effective drugs.

These patients will add to the demand for the drugs, complicating efforts to monitor and educate patients, which is already challenging because treatment regimens are complex. In addition, it could place undue demand on healthcare providers. The authors conducted a time analysis study at their own institution and found that the average healthcare provider could initiate treatment in 3 patients with HCV in a week. They anticipate receiving 500 new patients in the weeks after approval of the new drugs.

This situation, if widespread, could lead to scarcity and inequitable distribution of the drugs. Historically, as in the cases of penicillin, insulin, and other new medical developments that were initially scarce, this has led to inequitable and unjust distribution patterns.

Dr. Aronsohn and Dr. Jensen propose a needs-based solution to the dilemma. Highest priority would be given to the sickest patients, and the remaining patients could be prioritized based on need, starting with cirrhotic patients and ending with asymptomatic F0 to F2 patients. Patients could be educated about the need for providing therapy to the most ill patients and informed that waiting for therapy is safe for patients with early-stage disease.

The authors have disclosed no relevant financial relationships.

Hepatology. 2011;6:1789-1791. Abstract

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Also See: HCV Treaters Shortage Editorial - Distributive justice and the arrival of direct-acting antivirals: Who should be first in line?

All-Cause Mortality Is Higher With Chronic Hepatitis C

Megan Brooks

NEW YORK (Reuters Health) June 17, 2011 — Chronic hepatitis C doubles the normal risk of dying early from any cause, a new study shows.

That higher risk persists even after accounting for liver-related morbidity, and patients with chronic hepatitis C virus (HCV) infection should be closely monitored, the study team wrote in the June 10 online issue of Clinical Infectious Diseases.

Dr. Samer El-Kamary, who led the study, said he hopes these results "will encourage clinicians to test their patients for HCV whenever they suspect an infection, and not wait for clear signs of liver disease."

Also, he said in email to Reuters Health, "When HCV infection is diagnosed... consider earlier therapy even if there is no underlying liver disease."

Dr. El-Kamary, of the University of Maryland School of Medicine in Baltimore, and colleagues used the Third National Health and Nutrition Examination Survey (NHANES III) to analyze liver-related and non-liver-related mortality among 16,509 HCV-infected individuals, age 17 and older, in the general US population. HCV status was assessed from 1988 to 1994, with follow-up through 2006.

During a median of 14.3 years, 3,853 deaths occurred. Death rates were highest in those with chronic HCV infection and lowest in HCV-negative individuals.

For every 1000 person-years, there were 11.1 deaths in anti-HCV negative patients, compared with 14.8 and 16.5 deaths in the anti-HCV positive and chronic hepatitis C groups, respectively.

In a subset of 9,378 participants, after adjusting for all covariate risk factors, HCV-positive status was associated with a 2.11 higher all-cause mortality rate compared with HCV-negative status. Chronic HCV status was linked with a 2.37-fold higher all-cause mortality rate.

Anti-HCV positive individuals and chronically HCV-infected individuals also had a roughly 20-fold and 26-fold higher rate of liver-related mortality, respectively.

However, non–liver-related deaths were not significantly associated with HCV status, the authors found.

On the other hand, extrapolating their data to the population at large, they discovered that 57.8% of the estimated 31,163 deaths due to any cause that occur annually among the 2.46 million American adults with chronic hepatitis C are directly attributable to chronic HCV infection.

Similarly, they say 52.6% of the estimated 33,759 deaths that occur in the 3.2 million HCV-positive adults are attributable to the presence of anti-HCV.

Among the estimated 9,390 annual liver-related deaths among anti-HCV positive individuals and the 9,569 annual liver-related deaths among chronic HCV-infected individuals, 94.9% and 96.2% were attributable to HCV, respectively.

"This study suggests that mortality among HCV-infected individuals in the general US population is higher than previously described," the authors note.

"Given these findings, and the greater availability and affordability of various HCV testing methods, perhaps increased testing, earlier therapy, and closer monitoring of all HCV-positive individuals, particularly those with non-liver-related morbidities, should be considered by health care providers," they conclude.

The question is: Can anti-HCV therapy mitigate the lifespan hit imposed by HCV infection?

Dr. El-Kamary said: "We know that among those with liver disease, successful treatment definitely improves patients' survival. However, since HCV therapy is almost exclusively offered to those with liver disease, little is known about the impact on those without liver disease. We hope that this study will encourage others to evaluate the impact of treatment on HCV-infected patients without liver disease."

In May 2011, the US Food and Drug Administration approved 2 new drugs for HCV: telaprevir (Incivek, Vertex Pharmaceuticals) and boceprevir (Victrelis, Merck & Co).

At the time, Edward Cox, director of the FDA drug center's office of antimicrobial products said these two drugs present "important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition."

Clin Infect Dis. Published online June 10, 2011. Abstract

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HepatitisRxAssist program from BioPlus Specialty Pharmacy helps patients secure needed medications, manage side effects, and adhere to their treatment plan for the best possible outcomes with the new protease inhibitor medications.

BioPlus Specialty Pharmacy (BioPlus), one of the nation's leading specialty pharmacies, is announcing today enhancements to their hepatitis C patient support program called HepatitisRxAssist. The FDA's recent approval of two new drugs for the treatment of the hepatitis C virus (HCV) – Victrelis (boceprevir) from Merck and Incivek (telaprevir) from Vertex – makes this program more useful than ever for hepatitis C patients.

Victrelis and Incivek are both protease inhibitors and have each been shown to greatly increase the viral cure rate in HCV when given in addition to standard hepatitis C treatments. Each of these protease inhibitors can only be used as part of a three drug combination (along with peginterferon alpha and ribavirin), and not as a single drug treatment.

The overriding goal of the HepatitisRxAssist program is to ensure treatment and improve outcomes. BioPlus tracks compliance statistics for all its treatment programs. The latest data, which includes more than 19,700 BioPlus patients being treated for HCV, oncology, rheumatoid arthritis, psoriasis, Crohn's disease, and other conditions, shows that BioPlus achieves a 91 percent compliance rate at discharge. The compliance rate for retail and mail-order pharmacies is only 50 percent.

The HepatitisRxAssist program supports physicians by providing administrative help in handling the complex paperwork for starting triple therapy. The new hepatitis triple therapy can be challenging for patients for several reasons, including the high cost of treatment, multiple pills needed each day on a strict schedule, injection training, and the high likelihood of side effects. The intensive monitoring for safety and efficacy by a specialized clinical pharmacist and support staff in the HepatitisRxAssist program helps patients successfully address each of these treatment hurdles.

“These two new protease inhibitors, while signifying a new era of treatment, also present new treatment challenges. Here at BioPlus, we work with HCV patients in every step of navigating these challenges so that the potential for greater cure rates is realized for as many patients as possible,” says Dr. Stephen Vogt, president and CEO of BioPlus.

The HepatitisRxAssist program encompasses a team of BioPlus professionals that work on behalf of the patient to review the insurance benefit plan, get authorizations, identify alternative financial aid (if necessary), provide home delivery of medications, assist with the management of side effects, and provide 24/7 phone access to pharmacists including nights, weekends, and holidays.

This high touch, patient-centric support program also includes these key features:

• An initial consult with a Doctor of Pharmacy for every patient starting the new triple therapy. This 30 minute consult includes an assessment of the patient, education for the patient about the medication protocol, and detailed explanation of the plan of care to ultimately provide the best possible care with our experienced clinicians.

• Hands-on injection training with a nurse either in the patient's home or in a group setting so that patients feel comfortable and confident administering their own medication injections.

• On the day medications are started, BioPlus staff will check on the patient to provide a dose reminder, as well as answer any questions or clarify the medication schedule to ensure the patients are properly starting their treatment.

• This patient contact will be repeated weekly for the first four weeks of medication therapy and continued, if needed, to ensure the patients are staying compliant throughout their course of therapy and ultimately achieve successful outcomes.

• A dose reminder system using texts, e-mail, or phone calls to further assist the patients in staying compliant to their therapy.

• The patient's physician can review all of this information about the patient from a portal on the BioPlus website in order to keep our prescribers updated on the status of their patients.

“With the availability of this new triple therapy regimen, backed by our support program, we're expecting significant gains in the number of patients clearing the virus to obtain a sustained viral response and, as an added benefit, patients may even have shorter treatment times,” Dr. Vogt adds.

Hepatitis C is the most common chronic blood-borne disease in the United States. This virus attaches to liver cells, where it then multiplies to cause inflammation and a shutdown of normal liver cell functions. For the majority of people infected with HCV, the disease becomes a chronic condition and can lead to co-morbidities, such as cirrhosis or cancer.

About BioPlus Specialty Pharmacy

Florida-based BioPlus is a pharmacist-owned national specialty infusion pharmacy company designed to provide high-touch services and specialty pharmaceuticals for patients with chronic diseases such as arthritis, hepatitis C, cancer, and others. Licensed in all 50 states, BioPlus is one of the nation's largest independent specialty pharmacies. Accredited by the Community Health Accreditation Program (CHAP), patients can contact the Pharmacy toll free at 1-888-292-0744.

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Directly acting antivirals against hepatitis C virus

J Antimicrob Chemother. 2011 Jun 7. [Epub ahead of print]

Soriano V, Vispo E, Poveda E, Labarga P, Martin-Carbonero L, Fernandez-Montero JV, Barreiro P.

Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain.

Abstract

The approval of directly acting antivirals (DAA) for the treatment of chronic hepatitis C virus (HCV) infection will represent a major breakthrough for the 180 million persons infected worldwide. Paradoxically, hepatitis C is the only human chronic viral disease that can be cured, as all other pathogenic viruses infecting humans either display self-limited courses or establish non-eradicable persistent infections. Until now, treatment of chronic hepatitis C consisted of the combination of peginterferon-α plus ribavirin, which provided limited rates of cure and was associated with frequent side effects. Several DAA have been identified that inhibit the NS3 protease, the NS5B polymerase or the NS5A replication complex, and have entered the final steps of clinical development. These molecules, coupled with significant progress made in the recognition of more potent and safe interferon forms (e.g. interferon-λ) and host protein targets (e.g. alisporivir), are opening a new era in hepatitis C therapeutics. The expectations are so great that, to some extent, it is reminiscent of what happened in 1996 in the HIV field when the introduction of the first protease inhibitors as part of triple combinations revolutionized antiretroviral therapy. To maximize treatment success and reduce the likelihood of drug resistance selection, a proper individualization of hepatitis C therapy will be required, choosing the most convenient drugs and strategies according to distinct viral and host profiles. The complexity of HCV therapeutics has reached a point that presumably will lead to the birth of a new specialist, the HCV doctor.

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Public Supports Universal Hepatitis C Screening

Jim Kling

June 20, 2011 — A new study indicates that patients support universal screening for hepatitis C virus (HCV) infection, even in the absence of prior consent or communication of negative results. The study was published online June 6 in BMC Infectious Diseases.

Between 2.9 and 3.7 million people in the United States are infected with HCV, and about 70% are unaware of it. Between 20% and 30% of the infected patients will go on to develop cirrhosis. HCV is the most common cause of liver failure among liver transplant patients.

Current therapies achieve about a 50% cure rate, and broad implementation could reduce HCV complications by 16% to 42%.

Current screening guidelines direct physicians to screen patients when they have one or more risk factors, such as injected drug use, having received a blood transfusion before 1992, or elevated liver function tests. However, such screening is complicated because patients may not admit to past behaviors such as drug abuse, among other limitations, including not capturing other potential risk factors such as possible remote iatrogenic transmission.

To gauge the public's opinion on potential HCV screening programs, in August 2010 the researchers, led by Phillip O. Coffin, MD, MIA, from the Division of Allergy and Infectious Diseases, University of Washington, Seattle, conducted a survey at 5 outpatient clinics of a major public urban medical center in Seattle. The response rate was 85.8% (200 responses of 233 patients surveyed). The study group had a median age of 47 years and included 55.3% women. Of the participants, 56.3% were white, 32.7% were black, 9.5% said they had been tested positive for HCV, and 2.5% reported testing positive for HIV.

The survey included 3 options: universal testing without being informed of the test or being told of negative results (48% preferred this option); testing with an opportunity to opt out, and without being informed of negative results (37% preferred); and testing based on clinician judgment (15% preferred).

Limitations of the study include the lack of both generalizability and disease confirmation status reported by the participants. In addition, the respondents were not asked all of the same questions, which limited comparisons. This was also a quantitative, not qualitative, analysis, which may alter results.

"[P]atients appear to place a higher priority on being tested than they do on the process of informed consent or the receipt of negative results. These findings should inform the priorities of clinicians, public health officials, and clinical risk managers," the authors conclude.

Dr. Coffin’s work is supported by a grant from the National Institute of Allergy and Infectious Diseases. The authors have disclosed no relevant financial relationships.

BMC Infect Dis. Published online June 6, 2011. Full text

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How the Immune System Responds to Hepatitis A Virus

ScienceDaily (June 21, 2011) — A surprising finding in a study comparing hepatitis C virus (HCV) with hepatitis A virus (HAV) infections in chimpanzees by a team that includes scientists from the Texas Biomedical Research Institute sheds new light on the nature of the body's immune response to these viruses.

Understanding how hepatitis C becomes chronic is very important because some 200 million people worldwide and 3.2 million people in the U.S. are chronically infected with HCV and are at risk for progression to cirrhosis and liver cancer. Hepatitis C associated liver disease is the most common indication for liver transplantation, while liver cancer due to HCV infection is now the most rapidly increasing cause of cancer death in the U.S.

"Remarkably, we found that HAV was more adept at evading the innate immune response than HCV, the virus that ultimately causes chronic infections," said Robert E. Lanford, Ph.D., a Texas Biomed virologist. The novel findings demonstrate that HAV is the stealthier virus when it comes to evading the innate immune response, despite the lack of persistent infections.

Hepatitis C infections are characterized by a failure of the immune system to combat and eliminate the virus. "We suspect this failure of the immune system shares attributes with other persistent viruses such as HIV and hepatitis B virus," said Lanford. By comparing two similar viruses that infect the liver, one that is always cleared by the immune system, HAV, and one that frequently evades the immune response, HCV, the team hoped to unravel the mystery of how HCV causes lifelong persistent infections.

The research team involved scientists from Texas Biomed in San Antonio, the University of North Carolina (UNC) at Chapel Hill, and Nationwide Children's Hospital in Columbus, Ohio. The study performed in chimpanzees at Texas Biomed's Southwest National Primate Research Center (SNPRC) and funded by the National Institutes of Health, is published June 20 in Proceedings of the National Academy of Sciences U.S.A.

The new study points out the critical need for more information about how the immune system reacts to HCV. It also reinforces the importance of chimpanzee research in this effort. The chimpanzee, the only animal model susceptible to HCV infection, was critical for probing the molecular differences in gene expression in the liver related to infection by the two viruses.

Examination of the adaptive immune system by co-author Christopher M. Walker, Ph.D., of Nationwide Children's Hospital in Columbus, Ohio, found that the T cell response to HAV was unique as well. "We expected the immune response to kill all HAV infected cells in a short time frame, and yet we could detect the genome of the virus in the liver for up to one year, long after symptoms of the disease were resolved," Lanford explained.

"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how hepatitis C becomes a chronic infection," said co-author Stanley M. Lemon, M.D., of UNC.

"The surprising and exciting results of this research program further highlight the critical value of the chimpanzee model in research on hepatitis," said John L. VandeBerg, Ph.D., Texas Biomed's chief scientific officer and SNPRC director

Others on the study included Deborah Chavez, M.S., and Bernadette Guerra, B.S., of Texas Biomed; Kathleen Brasky, D.V.M, of SNPRC; Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D., of UNC; Yan Zhou, Ph.D., Nationwide Children's Hospital; and Alan S. Perelson, Ph.D., of the Los Alamos National Laboratory.

Journal Reference:
 
1. Robert E. Lanford, Zongdi Feng, Deborah Chavez, Bernadette Guerra, Kathleen M. Brasky, Yan Zhou, Daisuke Yamane, Alan S. Perelson, Christopher M. Walker, and Stanley M. Lemon. Acute hepatitis A virus infection is associated with a limited type I interferon response and persistence of intrahepatic viral RNA. PNAS, June 20, 2011 DOI: 10.1073/pnas.1101939108

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Also See: Acute Hepatitis A Evades Immune System More Effectively Than Chronic Cousin
Benefit Concert to be Held in New York on July 27, the Eve of World Hepatitis Day

WHITEHOUSE STATION, N.J., June 21, 2011 /PRNewswire/ -- Merck (NYSE: MRK) (known as MSD outside the United States and Canada) today announced that Rock 'n Roll Hall of Famer Gregg Allman will work together with the company and the American Liver Foundation on Tune In to Hep C, a public health campaign to help raise awareness of chronic hepatitis C virus infection. To help turn up the volume around hepatitis C a benefit concert featuring The Allman Brothers Band will be held in New York on July 27, the eve of World Hepatitis Day.

This week marks the one-year anniversary of Allman's liver transplant, which he received after his liver had become damaged from chronic hepatitis C infection. Allman has returned to performing and recording music, and now wants to help raise awareness of hepatitis C.

"I'm excited to be working with Merck and the American Liver Foundation because there are many people who have been diagnosed with chronic hepatitis C, but aren't taking action. I want to tell them, don't wait. Doing nothing is not an option; they need to talk with their doctor," said Allman, a founding member of The Allman Brothers Band. "I made the decision to take action and talk to my doctor, so that I could get back to making the music I love. I want others to take that action too, and if I can help make that happen, I've done my job."

Nearly 3.2 million Americans have chronic hepatitis C virus infection, a potentially serious disease that can damage the liver over time and lead to cirrhosis, end-stage liver disease and liver cancer. Many people infected with chronic hepatitis C do not know that they have the virus – approximately 60 to 80 percent of people infected with chronic hepatitis C virus do not have symptoms.

The American Liver Foundation (ALF) joined the Tune In to Hep C campaign to help elevate awareness of this important public health issue. ALF is a national organization advocating for those living with liver disease and their families, and provides education, support and research for the prevention, treatment and cure of liver disease.

"We are thrilled to work with Merck and Gregg Allman to help educate and empower patients with chronic hepatitis C – this has been a focus of the American Liver Foundation for 35 years," said Newton Guerin, acting CEO and chief operating officer, ALF. "People don't often talk openly about their hepatitis C, which contributes to misinformation and isolation for those infected with the virus. Gregg's willingness to share his story will open the door for meaningful dialogue that can help reduce stigma and the lack of understanding surrounding chronic hepatitis C."

Merck recently announced the Hope Against Hepatitis C initiative, in which the company restated its long-standing commitment to supporting the hepatitis C community through a variety of public-private partnerships that will involve public education, patient support programs and collaborative research efforts. Working with Gregg Allman and the ALF is an example of this ongoing commitment.

"When a person like Gregg Allman comes forward to speak about his personal experience, it is extremely powerful, and we are grateful to him for his commitment to helping motivate other people with chronic hepatitis C to take action," said Mark Timney, president, Global Human Health - U.S. Market, Merck.

About the Benefit Concert

The concert, Tune In to Hep C Presents The Allman Brothers Band, will take place at The Beacon Theatre in New York City on July 27, the eve of World Hepatitis Day. The Beacon Theatre has special meaning for Allman, who has played there every year since 1991 with the exception of 2007, when the band had to cancel their performance because Allman was too ill from his chronic hepatitis C to play. Tickets will go on sale tomorrow, Wednesday, June 22 at 12:00PM EDT. Tickets are available at LiveNation.com, Ticketmaster.com, select Ticketmaster locations and charge by phone at 800-745-3000. Tickets also will be available at The Beacon Theatre box office beginning June 23.

Proceeds from the benefit concert will be donated to community-based organizations that provide education and support services to people with chronic hepatitis C.

About Gregg Allman

Allman is a legendary performer who is both a founding member of The Allman Brothers Band and a critically acclaimed solo artist. He has several gold records to his credit and his distinctive voice placed him on the Rolling Stone list of the "100 Greatest Singers of All Time." More than 40 years down the road, Allman still loves making and performing music as much as ever.

In addition to his singing and playing, Allman wrote many of The Allman Brothers Band's most memorable signature hits, including the classics "Whipping Post" and "Dreams" from their self-titled debut album, "Midnight Rider" and "Please Call Home" from their second album "Idlewild South," and "Melissa" from 1972's classic "Eat A Peach" album. The Allman Brothers Band went on to become the principal architects of Southern rock and were inducted into the Rock 'n Roll Hall of Fame in 1995. Allman's latest solo album "Low Country Blues" was released in 2011, debuting at No. 5 on the Billboard Top 200, the highest chart position of his solo career, and continues to gain critical acclaim and commercial success.

About The American Liver Foundation

The American Liver Foundation (ALF) is the nation's leading nonprofit organization promoting liver health and disease prevention. ALF provides research, education and advocacy for those affected by liver-related diseases, including hepatitis.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://www.merck.com/.

Forward-Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (http://www.sec.gov/).

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ScienceDaily (June 20, 2011) — Ongoing research into the problem of how Hepatitis C becomes a chronic disease has uncovered a deeper mystery about its sister strain, Hepatitis A.

Hepatitis C is a continuing public health problem, which is difficult to measure because symptoms occur months to years after infection. The World Health Organization estimates as many as 2 to 4 million people in the United States may have chronic Hepatitis C, and most do not know they are infected. More than a third of those who are long-term carriers may develop chronic liver disease or liver cancer.

"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how Hepatitis C becomes a chronic infection," says Stanley M. Lemon, MD, professor of microbiology and immunology and a member of UNC Lineberger Comprehensive Cancer Center and the Center for Translational Immunology.

Lemon and his colleagues thought that Hepatitis C might become chronic by disrupting the host's interferon response -- part of the innate immune system that protects the body against any kind of 'foreign' invader.

However, their study, published on-line in the Early Edition of the journal Proceedings of the National Academy of Sciences U.S.A., came up with some surprising findings.

In comparing data from experiments with Hepatitis A and Hepatitis C, the team found that Hepatitis A virus, which causes only acute, self-limited disease, is more efficient at inhibiting the host's interferon response, and that the virus can actually linger in the body for almost a year.

"These results undermine the theory that evasion of the interferon response is a key mechanism in the development of chronic Hepatitis C -- the outcome of infection with these viruses is very different, highlighting how little we understand the unique environment within the liver for virus-host interactions," Lemon notes.

"It is actually the acute infection, Hepatitis A, that is stealthier at evading the interferon response."

In addition to Lemon, the research team included Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D. from UNC-Chapel Hill; Robert Lanford, PhD, of the Texas Biomedical Research Institute and the Southwest National Primate Research Center; Deborah Chavez, MS, and Bernadette Guerra, BS, from the Texas Biomedical Research Institute; Kathleen Brasky, DVM, of the Southwest National Primate Center; Yan Zhou, PhD, and Christopher Walker, PhD, of the Center for Vaccines and Immunity at Nationwide Children's Hospital in Columbus, OH; and Alan Perelson, PhD, from Los Alamos National Laboratory.

The research was funded by the National Institutes of Health.

Journal Reference:

1. Robert E. Lanford, Zongdi Feng, Deborah Chavez, Bernadette Guerra, Kathleen M. Brasky, Yan Zhou, Daisuke Yamane, Alan S. Perelson, Christopher M. Walker, and Stanley M. Lemon. Acute hepatitis A virus infection is associated with a limited type I interferon response and persistence of intrahepatic viral RNA. PNAS, June 20, 2011 DOI: 10.1073/pnas.1101939108

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