New hepatitis C treatments may be worth side effects and higher costs

Amanda Mills/Center for Disease Control and Prevention

A blood test can determine if you have hepatitis C, a disease that kills more people than HIV.

by Kristen Kellar
Feb 23, 2012

Two new hepatitis C treatment drugs may be worth increased side effects and an additional cost of $4,000 per week because they may save time and money in the long run, Stanford University researchers have found.

A study released in Tuesday's issue of the Annals of Internal Medicine aimed to determine the cost effectiveness of two drugs, boceprevir and telaprevir, that were approved by the Federal Drug Administration in 2011. They would complement the existing two-drug treatment of ribavirin and peginterferon alfa, which is effective less than 50 percent of time in clearing the infection.

The addition of one of the two new drugs could raise the effectiveness to 75 percent, said Dr. Daniel Ganger, practice director of hepatology at Northwestern Memorial Hospital.

Hepatitis C is a viral disease that can lead to inflammation of the liver and affects between 3 to 4 million people in the United States, according to government reports. A Centers for Disease Control and Prevention study found that more people died from hepatitis C between 1999 and 2007 than from HIV.

"Chronic hepatitis C has a major health impact on those infected, and treatments are expensive, have substantial side-effects, and are not always effective,” said Jeremy Goldhaber-Fiebert, assistant professor of medicine at Stanford, who worked on the study. “The newer drugs are exciting because of their greater potential effectiveness, though their side-effect profiles and higher costs also need to be considered carefully.”

The addition of either boceprevir and telaprevir would decrease the time of treatment. Ganger said the two-drug treatment takes about 48 weeks whereas some patients can complete the new three-drug process in about 24 weeks.

He said that nine out of 10 patients who start the treatment are able to complete it.

“Curing hepatitis C is beneficial, so why not try?” he said, even if the third drug can cause different side effects.

Ganger said some patients complain of feeling more tired than prior to treatment, and may suffer from depression and anemia. “They end up taking many more vitamins than before,” he said.

Those who have more advanced stages of the hepatitis C infection would find the treatment most cost effective, said Goldhaber-Fiebert.

The addition of boceprevir would add an estimated $1,100 a week to the cost of treatment or telaprevir could run $4,100 more a week, resulting in a total treatment cost of nearly $60,000 for those with advanced fibrosis, said the study.

Still, that’s better than paying more than $100,000 for a liver transplant, said Goldhaber-Fiebert.

Ganger said that many insurance companies would cover the two new treatments. He said: “We don’t start [the treatment] until we know they’re covered by insurance.”

Patients who have any degree of liver damage, a sign that the virus has progressed, would be considered for the treatment, Ganger said.

He said most people who have hepatitis C don’t know it; most physicians don’t test for it. But he offers hope for people who do: “It is treatable. It’s a difficult thing to do, but it ends.”

Two new hepatitis C treatment drugs may be worth increased side effects and an additional cost of $4,000 per week because they may save time and money in the long run, Stanford University researchers have found.

A study released in Tuesday's issue of the Annals of Internal Medicine aimed to determine the cost effectiveness of two drugs, boceprevir and telaprevir, that were approved by the Federal Drug Administration in 2011. They would complement the existing two-drug treatment of ribavirin and peginterferon alfa, which is effective less than 50 percent of time in clearing the infection.

The addition of one of the two new drugs could raise the effectiveness to 75 percent, said Dr. Daniel Ganger, practice director of hepatology at Northwestern Memorial Hospital.

Hepatitis C is a viral disease that can lead to inflammation of the liver and affects between 3 to 4 million people in the United States, according to government reports. A Centers for Disease Control and Prevention study found that more people died from hepatitis C between 1999 and 2007 than from HIV.

"Chronic hepatitis C has a major health impact on those infected, and treatments are expensive, have substantial side-effects, and are not always effective,” said Jeremy Goldhaber-Fiebert, assistant professor of medicine at Stanford, who worked on the study. “The newer drugs are exciting because of their greater potential effectiveness, though their side-effect profiles and higher costs also need to be considered carefully.”

The addition of either boceprevir and telaprevir would decrease the time of treatment. Ganger said the two-drug treatment takes about 48 weeks whereas some patients can complete the new three-drug process in about 24 weeks.

He said that nine out of 10 patients who start the treatment are able to complete it.

“Curing hepatitis C is beneficial, so why not try?” he said, even if the third drug can cause different side effects.

Ganger said some patients complain of feeling more tired than prior to treatment, and may suffer from depression and anemia. “They end up taking many more vitamins than before,” he said.

Those who have more advanced stages of the hepatitis C infection would find the treatment most cost effective, said Goldhaber-Fiebert.

The addition of boceprevir would add an estimated $1,100 a week to the cost of treatment or telaprevir could run $4,100 more a week, resulting in a total treatment cost of nearly $60,000 for those with advanced fibrosis, said the study.

Still, that’s better than paying more than $100,000 for a liver transplant, said Goldhaber-Fiebert.

Ganger said that many insurance companies would cover the two new treatments. He said: “We don’t start [the treatment] until we know they’re covered by insurance.”

Patients who have any degree of liver damage, a sign that the virus has progressed, would be considered for the treatment, Ganger said.

He said most people who have hepatitis C don’t know it; most physicians don’t test for it. But he offers hope for people who do: “It is treatable. It’s a difficult thing to do, but it ends.”

Source

Also See:

1. New Hepatitis C Treatment
2. New Protease Inhibitors for the Treatment of Chronic Hepatitis C
3. Benefits of hepatitis C treatment outweigh costs for patients with advanced disease

Point-of-Care HCV iPhone/iPad App from Projects In Knowledge®

Implementing DAA Therapy in Practice

LITTLE FALLS, N.J., Feb. 23, 2012 /PRNewswire/ -- Projects In Knowledge (PIK) has released its free point-of-care HCV Care & Guidance iPhone/iPad app, giving clinicians mobile access to this widely used, dynamic practice tool.

HCV Care & Guidance provides peer-reviewed, practical education about direct-acting antiviral (DAA) therapies, an exciting new treatment option for patients with hepatitis C virus (HCV) infection. Nurses/NPs, physician assistants, gastroenterologists, and infectious disease specialists who treat patients with HCV infection need a keen understanding of the stringent dosing and administration requirements of DAA agents to ensure optimal efficacy.

The app contains continually updated information on HCV infection, guidance on selecting treatment candidates, and other helpful tools. Also included is a video of PIK's live symposium, titled "Paradigm Shift in HCV Standard of Care Treatment: DAAs," presented at a major hepatology conference. Each activity in the app offers complimentary CME/CE credit.

The app quickly earned a positive review from iMedicalApps, an independent online publication that reviews mobile medical technology and applications. iMedicalApps noted the "high-quality information pertaining to the use of DAAs" and "well-organized content and smooth user interface." The editors concluded that the HCV Care & Guidance app "features well-presented, high-quality, and clinically useful information for clinicians who manage Hepatitis C infection."

"Our Care & Guidance app is an excellent tool to help busy clinicians stay informed about hepatitis and encourage patient screening and testing," said Patty Peterson, CCMEP, Senior Vice President at PIK. "Its release also coincides nicely with the Centers for Disease Control and Prevention's efforts to increase awareness of viral hepatitis, including its Know More Hepatitis campaign and designation of May 19, 2012, as National Hepatitis Testing Day."

About Projects In Knowledge

Projects In Knowledge is a fully accredited provider of cutting-edge educational programs for physicians and other clinicians. Since 1980, our mission has been to improve the quality of healthcare in the United States and abroad by delivering exceptional professional education, with demonstrated results, using creative, effective, and easily accessible instructional modalities. Learn more about us and view our CME/CE/CPE programs at www.projectsinknowledge.com.

PROJECTS IN KNOWLEDGE, TXREPORTER, and CLINICIANS CHANNEL are registered trademarks of Projects In Knowledge, Inc. MEDIMAGE CASES and LIVING MEDICAL ETEXTBOOK are trademarks of Projects In Knowledge, Inc.

SOURCE Projects In Knowledge

Source

Vertex vows to race ahead with interferon-free combo for hep C

February 23, 2012 — 10:50am ET | By John Carroll

Determined to try and keep pace with rival next-gen hepatitis C treatments in the pipeline, Vertex ($VRTX) today unveiled a slate of somewhat positive interim midstage results for an all-oral combo regimen that includes its game-changing drug Incivek along with the experimental VX-222--its non-nucleoside polymerase inhibitor--and ribavirin.

The standard goal for new hepatitis C drugs is the sustained elimination of all signs of the virus by week 12, allowing patients to stop treatment, though developers are aiming for the fastest cure rates possible. Vertex noted that 11 of 46 treatment naïve patients with the genotype 1a and 1b virus met the criteria of having "undetectable hepatitis C virus at weeks two and eight of treatment and were therefore eligible to stop all treatment at 12 weeks. Nine of these 11 patients achieved SVR4 (undetectable hepatitis C virus four weeks after the end of all treatment)." Data showed that viral loads were below the "lower limit of quantification" for 83% of the patients at week 12.

Based on the data, Vertex says it will push ahead with a Phase IIb study of the interferon-free combo, anticipating that investigators can nail late-stage data for an NDA to the FDA as early as late 2014--keeping on an ambitious development schedule.

"Our ultimate goal is to develop well-tolerated, interferon-free treatment regimens with high viral cure rates and short treatment durations for people with hepatitis C," said Vertex CSO Peter Mueller. "We believe we're well-positioned to achieve this goal by exploring various combinations within our portfolio that includes Incivek, VX-222 and two structurally-distinct nucleotide polymerase inhibitors."

Those two nucleotide polymerase inhibitors he referred to are ALS-2200 and ALS-2158, which were licensed in from Alios and perhaps represent Vertex's best shot at gaining an edge over treatments being studied at rival companies. Vertex said today that it has begun the first 7-day viral kinetic studies of ALS-2200 and ALS-2158 in people with genotype 1 hepatitis C. Safety and viral kinetic data from these studies are expected in the second quarter of 2012, enabling the launch of midstage studies in the second half of 2012.

Source

Also See: Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C

Idenix Pharmaceuticals Reports Fourth Quarter and Year End 2011 Financial Results and Provides Pipeline Update

February 23, 2012

CAMBRIDGE, Mass., Feb. 23, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the fourth quarter and year ended December 31, 2011 as well as the advancement of its hepatitis C virus (HCV) development pipeline.

Operational Highlights

IDX184 Program

The Company's lead program, IDX184, is a pan-genotypic oral nucleotide polymerase inhibitor for the treatment of HCV. In July 2011, Idenix initiated enrollment of treatment-naive HCV-infected patients into a 12-week phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin. In January 2012, the Company reported an interim analysis from this study of the first 31 patients who completed 28 days of treatment demonstrating favorable safety and antiviral activity. At 12 weeks, the Complete Early Virologic Response (cEVR < 25 IU/mL) was 93% for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm (n=16) of the study (intent-to-treat analysis). The side effect profile of the combined therapy has remained consistent with the known safety profile for pegylated interferon and ribavirin.

In February 2012, the U.S. Food and Drug Administration removed the partial clinical hold on IDX184 after review of the interim phase IIb data and the independent Data Safety Monitoring Board's recommendation to continue the study. The Company has now begun enrollment of an additional 30 patients under expanded enrollment criteria in the ongoing phase IIb clinical trial. Additionally, the Company anticipates implementing a broad phase IIb program with IDX184, focusing on the evaluation of interferon-free direct-acting antiviral (DAA) combination regimens, in the coming months.

IDX719 Program

In January 2012, the Company initiated a phase I clinical study of IDX719, its NS5A inhibitor candidate. The first part of the study is evaluating the safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers at single doses ranging from 5 to 100 mg. Dosing up to 50 mg has been completed in healthy volunteers and to date IDX719 has been well tolerated. A cohort of eight HCV genotype 1-infected patients received single doses of IDX719 of either 1, 5, 10 or 25 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log(10), 2.6 log(10), 3.3 log(10) and 3.7 log(10), respectively. A 3-day proof-of-concept segment of the study in treatment-naive genotype 1 HCV-infected patients is expected to begin in the second quarter of 2012 with additional cohorts of genotype 2, 3, or 4 HCV-infected patients to be added during the study.

Nucleotide Discovery Program

In January 2012, Idenix selected two nucleotide inhibitors, IDX19368 and IDX19370, as potential clinical candidates from its novel nucleotide prodrug discovery program. IDX19368 has demonstrated strong potency in preclinical studies and as a result the Company has chosen IDX19368 as its lead candidate and expects to submit an investigational new drug application (IND) for IDX19368 in mid-2012. The Company continues to identify new promising compounds and evaluate multiple candidates for further development from this discovery program.

"Our focus for 2012 will be to build on the progress we made last year through the continued advancement of our pipeline of novel HCV drug candidates," said Ron Renaud, Idenix's President and Chief Executive Officer. "Now that the partial clinical hold has been removed for IDX184, we will be able to explore the full potential of this promising nucleotide polymerase inhibitor in combination with other DAAs in a broad phase IIb program. The early results are promising for IDX719, our NS5A inhibitor, in HCV patients and we look forward to completing the phase I clinical trial, as well as initiating a phase I study for our next-generation nucleotide inhibitor, IDX19368. We believe that the potent and pan-genotypic profiles of our drug candidates support their potential role in future HCV combination regimens."

Fourth Quarter and Year End 2011 Financial Results

Continue Reading …

Autoantibody Diagnostics in Autoimmune Liver Diseases

By jamal, on February 23rd, 2012

ORGENTEC Diagnostika (www.orgentec.com) has developed four new laboratory tests for the diagnosis of autoimmune liver diseases. These tests are now on the market. They are based on ELISA technology and were specifically developed for fully automated analysis with Alegria®.

The new tests systems, called Anti-Sp100, Anti-gp210, Anti-LKM-1, and Anti-SLA, reliably detect specific autoantibodies that are characteristic of various autoimmune liver diseases. The tests thus also allow for reliable differentiation between these autoimmune diseases and other diseases of the liver, such as viral infections, based on blood samples.

Autoimmune liver diseases are caused by a malfunctioning immune system. This category of diseases includes autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC). As it is mostly the case, these diseases are treatable if they are detected early; if left untreated, they can lead to severe symptoms and considerable damage to the liver.

If a physician is dealing with ambiguous symptoms or needs to clarify unusual blood values, the detection of characteristic autoantibodies provides a clear indicator of autoimmune liver diseases. For instance, if Sp100 or gp210 antibodies are detected, it is most likely a case of primary biliary cirrhosis. Antibodies against LKM-1 or SLA are indicative of autoimmune hepatitis.

The triggers of autoimmune liver disease are largely unknown. They may be caused by previous or on-going infections. It is also possible that genetic predisposition may favour the development of these disorders.

For the first time, these newly introduced laboratory tests, Anti-SP100, Anti-gp210, Anti-LKM-1, and Anti-SLA, allow for the individualised, rapid, and fully automated detection of the corresponding autoantibodies. They are suitable for cost-efficient differential diagnostics or for the differentiation of positive screening results from other ELISA, immunoblot tests or immunofluorescence assays.

Based in Mainz, ORGENTEC Diagnostika is a global leader in the development and marketing of test systems for autoimmune diagnostics and serological tests for infectious disease. ORGENTEC has developed numerous highly specific ELISA test systems, immunoblot and immunofluorescence tests, the Alegria® random access analyser, and the rheumachec® rapid test. – www.orgentec.com

Source

50 ways to love your liver

Wendell Fowler also can be followed at chefwendellfowler.blogspot.com

Published February 23rd, 2012

By Wendell Fowler

Apparently Hannibal Lecter didn’t know the liver relates to almost every vital function of the holy temple, or he wouldn’t have suggested it be consumed with a glass of Chianti.

The large meaty organ processes everything we ingest, breathe and absorb through the skin, and plays a major role in digestion and metabolism, regulating production, storage and release of sugar, fats and cholesterol. The liver fires up protective immune function, thins or thickens blood, assists lymph flow, converts food to energy, removes ammonia, makes bile that breaks down fats, stores extra blood for emergencies and filters your blood of the stew of pollutants inhaled daily. It produces enzymes, hormones, blood proteins and clotting factors. Finally, the liver assists the temple with house cleaning by filtering infectious organisms and poisons from the blood and eliminating the toxic bilge. Regular medical care, a healthy, sun-blessed living diet, moderate exercise and controlling stress support it.

Ancients knew the liver and bile are critical to a healthy appetite. When bile doesn’t flow smoothly, you lose your appetite. The ancients felt too much or too little blood loss during menstruation was related to poor liver function and interfered with storing and releasing blood. Chinese and Ayurvedic healing medicine relate anger with poor liver and gallbladder function. Someone chronically angry would be prescribed liver therapy to open, cleanse and cool the liver and bile.

Pharmaceuticals with alarming side effects, street drugs, Chemotherapy, over-the-counter medications, excess alcohol, Tylenol, antibiotic drugs, fried and fatty foods and toxic substances in the American food supply brutalize the loyal, hardworking organ. Cut down on the amount of deep-fried and fatty foods that you and your family consume. Doctors believe the risk of gallbladder disorders (including gallstones, a liver-related disease) can be reduced by avoiding high fat and cholesterol rich foods. Desserts, snacks and sugary thirst-quenchers are high in calories because of the sugar and fat they contain.

Your liver adores beets and beet greens, preferably organically grown, since they are the richest source of betaine, a natural liver detoxifier and bile thinner, and aren’t sprayed with liver-stressing chemicals. Shred raw beets then combine the beauties with a drizzle of raw flax oil, honey and lemon juice or puree them in a blender with orange juice. That’s right: raw.

Explore culinary seasonings that sustain the liver: lemon juice, onion, vinegar, garlic, pepper, mustard, cloves, sage, thyme, turmeric, cinnamon and licorice. Milk thistle has been used for centuries in Germany as a liver stimulator and rejuvenator. Eat more high-fiber foods, such as fresh fruits and vegetables, whole grain breads, ground flax or chia seed, brown rice and quinoa and granola. Fresh food provides the best preventive maintenance and contains nutrition that enriches the liver. Include them regularly in your cooking. Next, get over your fear of healing cruciferous broccoli, cauliflower, Brussels sprouts, berries, green tea, yogurt, whole grains, beans, nuts and seeds and red grapes.

Revere your liver so it won’t end up in a pan smothered with sautéed onions.

Source

Q&A: What You Need to Know About Hepatitis C

Marc Phares / Getty Images

Hepatitis C kills more Americans than HIV. How does the virus spread?

By Maia Szalavitz | @maiasz | February 23, 2012

The Centers for Disease Control and Prevention (CDC) reported this week that the hepatitis C virus (HCV) now kills more Americans annually than HIV, the virus that causes AIDS. Most of the deaths occur in middle-aged adults — 3% of baby boomers are infected — and about half of people infected don’t know they have the virus.

Like HIV, HCV is spread through contact with contaminated blood and less commonly through sex. Hepatitis C is now the leading cause of liver transplant, but newly approved drugs can cure the disease before it gets that far — current clinical trials also suggest improvements in treatment are on the horizon — if people are screened and treated in time. Since hepatitis C typically doesn’t cause symptoms until serious damage has been done, early screening is crucial.

Healthland spoke with Dr. John Ward, who heads the CDC’s effort to fight hepatitis C, about who is at risk of infection, how the disease is really spread and why it’s important to know your hepatitis C status now.

How likely is HCV transmission during sex?

It’s a very unusual mode of transmission. That’s not to say it doesn’t happen, but it’s so infrequent that we don’t recommend condom use. [Dr. Ward is referring here to vaginal intercourse in monogamous heterosexual couples in which one partner is infected.] It hasn’t shown to be spread that way through sexual contact as a mode of transmission in the U.S.

HCV is not expressed in the secretions and body fluids people [usually] get exposed to during sex, in contrast to HIV and hepatitis B, which are found in vaginal secretions and semen.

One exception that has become a problem is among HIV-positive gay men — there, a multitude of studies has shown that HCV transmission is not only found, but is becoming more common as an STD among men who have sex with men who are HIV positive. The reason for that could be that because of their lower level of immunity, they may get higher levels of HCV in their blood or they may engage in sexual practices where there is more blood contact such as rectal intercourse. Some of them are also having a large number of sex partners.

What proportion of hepatitis C infections is due to IV drug use?

At least 50% of current cases are related to injection drug use, perhaps more as many cases are reported to the CDC without a risk [factor] identified.

HCV is much more transmissible than HIV [through blood]. The numbers of injection drug users infected are several-fold higher than the number infected with HIV because it’s so much more easily transmissible.

Needle exchange does help in preventing transmission of HCV but it’s not as effective as it is against HIV.

MORE: Clean Needles Saved My Life. Now Congress Wants to Ban Funding for Needle Exchange

Is Generation X at even greater risk than baby boomers? Household survey data suggest that drug use peaked overall in the early 1980s, among Gen Xers rather than boomers.

The data I’m aware of suggest that injection drug use was more common when the boomers were in their 20s and 30s. And they were not as mindful of safe ways to inject as [people] were beginning in the ’90s because of HIV-prevention campaigns. … We’re worried now that we’re seeing increased case reports linked to drug use in people [injecting] things like Oxycontin.

What is the risk of hepatitis C associated with dialysis or blood transfusions?

The blood supply is very well protected by screening, and blood transfusions are very safe from HCV. Where [transmission] does tend to occur is in outpatient settings like dialysis clinics, but also where people are getting injections, particularly repeated injections: cancer chemotherapy and pain management are the ones that come to mind.

We see too many outbreaks of hepatitis C in health-care settings because of poor infection control. There was a large outbreak several years ago in a colonoscopy clinic. Proper infection control was not followed in that setting. It’s not so much needles being reused, it’s syringes being reused or [injectable] pain medication getting contaminated because it’s used for multiple patients.

What can you do to protect yourself in these situations?

The patient can always ask the provider, ‘Are you following good infection control practices? Has that syringe been used by another person?’ The great majority of the time [there is good infection control]. But it never hurts for patients to reinforce the message that they are concerned about safety. It’s another way of reinforcing best practices.

We have 3 million people living with HCV and they cycle through the health care system and because it’s so transmissible, when you have a lapse in infection control, that HCV is going to get transmitted.

Can hepatitis C be spread through cocaine straws or bills?

It is possible to transmit through cocaine straws — you can get blood contact that way. Some studies have related it to snorting cocaine. Also to tattooing, not in the usual tattoo parlors, but in recreational or amateur tattooing among young people or people who are incarcerated.

MORE: FDA Approves New Drug to Treat Hepatitis C

I understand there are new medications that make HCV much more treatable.

The benefits of screening and care have gone up in the last year with the licensing of two new drugs, which when added to the drugs previously used, result in [viral] clearance — or essentially a cure — for about 70% people treated with three-drug therapy. It has also shortened the duration of therapy from 48 to 24 weeks.

Does treatment still include interferon, which can cause the side effect of depression?

Pegylated interferon is still part of the regimen, but the other exciting aspect of HCV treatment is that the pipeline is very rich with new drugs in clinical trials. Just two weeks ago, [researchers found] an all-oral non-interferon regimen that achieved high rages of cure.

The whole concept of HCV treatment has changed in the last three to four months. It’s going from a condition that’s difficult to treat to one that’s going to be easy to treat in just the next three to four years.

Should people wait to get treated?

Some people need to be treated now because of the status of their liver disease, but it’s important for all people with HCV [to know their status] so they can understand where are they in the course of the disease and can make informed decisions, like, Can I wait? or Do I need to be treated now? And what can I do to protect my liver, such as lowering alcohol use or getting vaccinated against hepatitis B and A. The benefits of knowing your status and being in care are increasing.

MORE: Study: The Threat of Hepatitis Is Underestimated

Maia Szalavitz is a health writer for TIME.com. Find her on Twitter at @maiasz. You can also continue the discussion on TIME Healthland’s Facebook page and on Twitter at @TIMEHealthland.

Source

Vaccines for HIV

“Being a mathematician myself, I find this article of particular interest.”

Released:2/23/2012 9:00 AM EST
Source:Biophysical Society

A New Design Strategy

Newswise — San Diego, Calif. – HIV has eluded vaccine-makers for thirty years, in part due to the virus’ extreme ability to mutate. Physical scientists and clinical virologists from the Massachusetts Institute of Technology (MIT) and the Ragon Institute in Cambridge, Mass., have identified a promising strategy for vaccine design using a mathematical technique that has also been used in problems related to quantum physics, as well as in analyses of stock market price fluctuations and studies of enzyme sequences. The team, led by Arup Chakraborty of MIT and Bruce Walker of the Ragon Institute, will give an update on its work at the Biophysical Society 56th Annual Meeting, held Feb. 25-29 in San Diego, Calif.

Vaccines prime the immune system to target molecular signatures associated with a particular pathogen. But HIV’s ability to mutate has made it difficult to identify reliable vaccine targets. In their search for a new type of target, the team from the Ragon Institute did not focus on individual amino acids. Instead, the researchers sought to identify independently evolving groups of amino acids where, within each group, amino acids mutate in tandem (meaning that they rely on one another to maintain the viability of the virus). In particular, they looked for groups of amino acids within which combinations of mutations would have a greater chance of making the virus unviable. By staging a multi-pronged attack against these regions of HIV, the researchers reasoned, they might be able to trap the virus between two bad choices: be destroyed by the immune system, or mutate and destroy itself.

With a mathematical tool called random matrix theory, the team searched for high-order evolutionary constraints in the so-called Gag region of HIV. The researchers were looking for collectively co-evolving groups of amino acids with a high number of negative correlations (meaning multiple mutations would destroy the virus) and a low number of positive correlations (meaning the virus could survive multiple mutations). They found this combination in a region, which they call Gag sector 3, that is involved in stabilizing the protein shell of the virus: too many mutations here, and the virus’ structure would collapse.

Interestingly, when the team studied HIV-infected individuals whose bodies are naturally able to fend off the virus’ attacks – so-called “elite controllers” – they found that these individuals’ immune systems preferentially targeted Gag sector 3 over other proteins.

At the moment, the study authors are working to extend their methods to HIV proteins beyond Gag. The team is also developing elements of the active components of a vaccine that would prime the immune system to selectively target Gag sector 3 proteins. They expect to begin testing in animal models soon.

The presentation, “Analysis of collective coevolution in HIV proteins suggests strategies for rational vaccine design,” will be presented by Dr. Chakraborty’s graduate student Karthik Shekhar at 12:30 p.m. on Sunday, Feb. 26, 2012, in the San Diego Convention Center, Room 24ABC. ABSTRACT: http://tinyurl.com/6sz7kuf

###

This news release was prepared for the Biophysical Society (BPS) by the American Institute of Physics (AIP).

ABOUT THE 2012 ANNUAL MEETING
Each year, the Biophysical Society Annual Meeting brings together over 6,000 research scientists in the multidisciplinary fields representing biophysics. With more than 4,000 poster presentations, over 200 exhibits, and more than 20 symposia, the BPS Annual Meeting is the largest meeting of biophysicists in the world. Despite its size, the meeting retains its small-meeting flavor through its subgroup meetings, platform sessions, social activities, and committee programs.

The 56th Annual Meeting will be held at the San Diego Convention Center (111 W. Harbor Drive, San Diego, CA 92101), located three miles from the San Diego International Airport and less than one mile from the Amtrak station. The San Diego Trolley has two stops directly in front of the Center at Harbor Drive/First Avenue and Harbor Drive/Fifth Avenue.

QUICK LINKS
Meeting Home Page:
http://www.biophysics.org/2012meeting/Main/tabid/2386/Default.aspx
Housing and Travel Information: http://www.biophysics.org/2012meeting/AccommodationsTravel/HotelInformation/tabid/2479/Default.aspx
Program Abstracts and Itinerary Planner:
http://www.abstractsonline.com/plan/start.aspx?mkey=%7B5B4BAD87%2D5B6D%2D4994%2D84CE%2DB3B13E2AEAA3%7D

PRESS REGISTRATION
The Biophysical Society invites credentialed journalists, freelance reporters working on assignment, and public information officers to attend its Annual Meeting free of charge. For more information on registering as a member of the press, contact Ellen Weiss, Director of Public Affairs and Communications (eweiss@biophysics.org, 240-290-5606), or visit http://www.biophysics.org/2012meeting/Registration/Press/tabid/2477/Default.aspx.

ABOUT BPS
The Biophysical Society (BPS), founded in 1956, is a professional scientific society established to encourage development and dissemination of knowledge in biophysics. The Society promotes growth in this expanding field through its annual meeting, monthly journal, and committee and outreach activities. Its 9000 members are located throughout the U.S. and the world, where they teach and conduct research in colleges, universities, laboratories, government agencies, and industry. For more information on the Society or the 2012 Annual Meeting, visit www.biophysics.org.

Source

Cure for Hepatitis C in two years (?)

Written by RTN Reporter

Thursday, 23 February 2012

A NEW combination of investigational drugs that successfully suppress the genotype 1 infection of Hepatitis C, the most difficult to treat, could become a reality within the next two years. In Spain, the virus affects around 800,000 people, causing cirrhosis and also cancer of the liver.

Dr. Jacob George, Professor of Gastroenterology and Hepatic Medicine at the University of Sydney in Australia, announced the findings at the Conference of the Asian Pacific Association for the Study of Liver Diseases, held in Taipei (Taiwan), promising results from a phase II study published in The New England Journal of Medicine.

Patients in whom treatment was not effective exclusively with PEG-interferon alfa and ribavirin were given a combination of two antiviral agents (daclatasvir and asunaprevir), eradicating the virus from the blood in "all patients who participated in the trial." The infection commonly occurs through needles; surgical practices; transfusions or transplants performed without correct hygiene measures. It may also be the result of unhygienic tattooing or piercing.

Source

Janssen launches hep C support programme

Published on 23/02/12 at 03:00pm

Janssen has launched a hepatitis C support programme for patients in the UK to help with medicine adherence and healthy living.

It is tailored for those taking Janssen’s hep C pill Incivo (telaprevir) along with Roche’s injectable interferon treatments Pegasys and Copegus.

The MYINCIVO support programme, which was launched this week, will be run with Bupa Healthcare.

Together they will offer an SMS text dose reminder service to help with drug adherence, promote healthy eating and lifestyle to manage the disease long-term, and help patients deal with possible side effects from Incivo.

MYINCIVO comes several months after Incivo was launched in the UK for patients with genotype-1 chronic hepatitis C.

Incivo is a new type or oral protease inhibitor for the disease, and competes with Merck’s oral hep C pill Victrelis.

Both drugs are undergoing a NICE appraisal to assess whether they should be routinely funded on the NHS in England.

Dr Peter Barnes, medical director at Janssen, said: “We recognise that treatment for hep C can be challenging and demands significant commitment from patients.

“We also recognise that the addition of telaprevir, one of a new class of medicines which directly targets the hep C virus, to the current standard treatment adds another element of complexity.

“That is why today we are launching this programme to support patients 24 hours a day, seven days a week for the full duration of their treatment if they are initiated on a telaprevir based treatment regimen.”

MYINCIVO is intended to complement the care being provided by a patient’s hep C specialist doctor. Patients’ partners, carers or family members can also access the programme, where appropriate.

This programme builds on Janssen’s hep C community site http://www.HelpEveryPersonC.co.uk/, which was launched last year.

This site provides interactive map data on the prevalence of hep C by locality, details of local support groups, treatment centres and stories from people living with the disease.

Ben Adams

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The silent rise of hepatitis C: By the numbers

The hepatitis C virus: Nearly two-thirds of the 3.2 million Americans who have hepatitis C were born between 1945 and 1964. Photo: BSIP/Corbis

More than 3 million Americans are infected with the potentially fatal liver disease — and half of them don't even know it

Posted on February 22, 2012, at 6:20 PM

The hepatitis C virus: Nearly two-thirds of the 3.2 million Americans who have hepatitis C were born between 1945 and 1964. Photo: BSIP/Corbis

Hepatitis C is officially more deadly to U.S. adults than HIV is, according to a new study from the Centers for Disease Control. Health experts are quite pleased with the country's falling HIV rates, but warn that these new figures prove the need for expanded screening methods for hepatitis C, a liver disease commonly spread through shared needles. Here, a look at the rise of America's new "silent" killer, by the numbers:

3.2 million
Americans infected with hepatitis C

50
Percent of those Americans who don't know they have the disease

2/3
Ratio of infected Americans who are baby boomers. The spread "has a lot do do with casual needle injection-drug use back in the 1960s, 70s, and 80s," says Amy Norton at Reuters.

1/33
Ratio of Americans born between 1945 and 1964 who have hepatitis C

18,000
New hepatitis C infections per year

75 to 85
Percentage of hepatitis C infections that become chronic, potentially causing "serious diseases like cirrhosis (scarring of the liver) and liver cancer," says Norton.

15,100
Americans killed by hepatitis C in 2007, the most recent year for which data is available

12,700
Americans killed by HIV in 2007

82,000
Estimated deaths that could be prevented if all Americans born between 1945 and 1965 agreed to a one-time hepatitis C screening, according to the CDC. "Most people don't know they're infected with hepatitis C until decades later," says Rita Rubin at Web MD, "when routine blood tests uncover liver damage caused by the virus over time."

$2,900
Cost of screening an adult for hepatitis C

45
Percent of hepatitis C patients who are cured if treated with two generic medicines, interferon and ribavirin

70
Percent of hepatitis C patients who are cured if two recently approved drugs, Incivek and Victrelis, are added to the regimen

$50,000
Cost of the Incivek treatment

$26,000 to $48,000
Cost of the Victrelis treatment

$100,000
Low-end cost of a liver transplant

Sources: Associated Press, Reuters, Web MD

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Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C

February 23, 2012

- Company plans to start Phase 2b study in Q3 2012 to evaluate this interferon-free combination regimen in a total treatment duration as short as 12 weeks -

- Vertex also announces the advancement of its broad portfolio of direct acting antivirals, including its two structurally-distinct nucleotide polymerase inhibitors -

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced interim data from two treatment arms of the Phase 2 ZENITH study evaluating an interferon-free (all-oral) treatment regimen of the non-nucleoside polymerase inhibitor VX-222 in combination with INCIVEK ^®(telaprevir) tablets and ribavirin in people with genotype 1a or 1b hepatitis C who were new to treatment. Interim data showed that viral loads were below the lower limit of quantification ( < 25 IU/mL: < LLOQ) for 80 percent (37/46) of patients with genotype 1 hepatitis C at week two and 83 percent (38/46) of patients with genotype 1 at week 12.

ZENITH was designed with strict response-guided criteria that determined whether a patient was eligible to stop all treatment at 12 weeks. Eleven patients met the criteria of having undetectable hepatitis C virus at weeks two and eight of treatment and were therefore eligible to stop all treatment at 12 weeks. Nine of these 11 patients achieved SVR4 (undetectable hepatitis C virus four weeks after the end of all treatment). Data from ZENITH have been submitted for presentation at a medical meeting in the first half of 2012.

Additional interim results from two interferon-free arms of ZENITH announced today showed:

Click table to enlarge 

The three drug regimen was generally well-tolerated. The majority of adverse events were reported as mild. There were no cases of moderate or severe rash and no discontinuations due to rash or anemia in the interferon-free study arms. There were two discontinuations due to adverse events in the genotype 1b arm of the study.

Vertex Advances INCIVEK, VX-222 and Ribavirin Combination Regimen

Based on these data, and pending discussions with regulatory agencies, the company intends to pursue a Phase 2b study evaluating multiple interferon-free combination regimens of INCIVEK, VX-222 and ribavirin with total treatment durations as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C who are new to treatment. The new study will not use response-guided treatment criteria. If successful, data from this study will be used to design a Phase 3 program with the goal of submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vertex's first interferon-free regimen for genotype 1 (1a and 1b) patients by the end of 2014 or beginning of 2015, pending regulatory discussions.

"Since its approval INCIVEK has been used to treat tens of thousands people with hepatitis C and we're committed to further improving the care of those living with this disease by evaluating multiple interferon-free regimens," said Peter Mueller, Ph.D., Executive Vice President, Global Research and Development, and Chief Scientific Officer for Vertex. "Our ultimate goal is to develop well-tolerated, interferon-free treatment regimens with high viral cure rates and short treatment durations for people with hepatitis C. We believe we're well-positioned to achieve this goal by exploring various combinations within our portfolio that includes INCIVEK, VX-222 and two structurally-distinct nucleotide polymerase inhibitors."

Advancing Development of Two Nucleotide Polymerase Inhibitors

As part of a broad strategy to develop interferon-free regimens, Vertex and its collaborator Alios BioPharma are conducting Phase 1 studies of two structurally-distinct nucleotide polymerase inhibitors, known as ALS-2200 and ALS-2158. Vertex announced today that it has begun the first 7-day viral kinetic studies of ALS-2200 and ALS-2158 in people with genotype 1 hepatitis C. Safety and viral kinetic data from these studies are expected in the second quarter of 2012, which could enable the initiation of Phase 2 studies in the second half of 2012 to evaluate multiple interferon-free combination regimens of ALS-2200, ALS-2158, INCIVEK, VX-222 and/or ribavirin.

About ZENITH

ZENITH is an ongoing Phase 2 study that enrolled 152 people with genotypes 1a and 1b chronic hepatitis C who had not been previously treated to evaluate multiple response-guided treatment regimens with VX-222, Vertex's non-nucleoside polymerase inhibitor in development, in different combinations with INCIVEK, Pegasys^® (pegylated-interferon alfa-2a) and Copegus^® (ribavirin), three medicines approved to treat hepatitis C. In all arms, patients were eligible to stop all treatment at 12 weeks if they had undetectable hepatitis C virus at weeks 2 and 8. The primary endpoint of the study is safety and tolerability. The secondary endpoint is on-treatment antiviral activity and the proportion of people in each treatment arm who achieve a sustained viral response.

About INCIVEK and VX-222

INCIVEK ^® (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK is the most prescribed direct-acting antiviral for the treatment of adults with genotype 1 chronic hepatitis C and has been used to treat more than 25,000 people in the United States.

INCIVEK was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and by Health Canada in August 2011 for use in combination with pegylated-interferon and ribavirin for people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK is approved for people who are new to treatment, and for people who were treated previously with interferon-based treatment but who did not achieve a sustained viral response, or viral cure (relapsers, partial responders and null responders).

Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK (in-SEE-veck). Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In September 2011, telaprevir was approved in the European Union and Switzerland. Telaprevir is known as INCIVO^® in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries. In September 2011, telaprevir was approved in Japan and is known as Telavic^®.

VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. Vertex has worldwide commercial rights for VX-222.

About ALS-2200 and ALS-2158

ALS-2200 and ALS-2158 are nucleotide analogues that appear to have a high barrier to drug resistance based on non-clinical and in vitro studies. Both compounds are designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Each compound is structurally distinct (adenosine and uracil) and has its own unique mechanism of action, which supports the potential for developing these compounds together as a dual nucleotide regimen and as part of combination therapy regimens, including regimens with INCIVEK and VX-222. Data from in vitro studies showed that both ALS-2200 and ALS-2158 had a synergistic effect when combined together and with INCIVEK and VX-222. Additionally, in vitro studies of both compounds showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.

Vertex gained worldwide rights to ALS-2200 and ALS-2158 through an exclusive worldwide licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research program.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.¹ Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.¹ Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.¹

Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.² However, approximately 60 percent of people do not achieve SVR,^3,4,5 or viral cure,⁶ after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.^7,8

More than 170 million people worldwide are chronically infected with hepatitis C.⁶ In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.⁹ Hepatitis C is four times more prevalent in the United States compared to HIV.⁹ The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.¹⁰ Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.^11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.⁹

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

Vertex's press releases are available at www.vrtx.com.

Special Note About Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including Dr. Mueller's statements in the sixth paragraph of this press release and statements regarding (i) Vertex's plan to start a Phase 2b study in Q3 2012 to evaluate this interferon-free combination regimen in a total treatment duration as short as 12 weeks; (ii) Vertex's plan to advance its broad portfolio of direct acting antivirals; (iii) the company's intent to pursue a Phase 2b study evaluating multiple interferon-free combination regimens and the potential design of this study; (iv) the company's plan to use data from the Phase 2b study to design a Phase 3 program with the goal of submitting an NDA for its first interferon-free regimen by the end of 2014 or beginning of 2015; and (v) the data that the company expects to receive from ongoing studies of ALS-2200 and ALS-2158 in the second quarter of 2012 and the possible initiation of Phase 2 studies involving ALS-2200 and/or ALS-2158 in the second half of 2012. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the interim data presented in this press release may not be predictive of the final outcomes from this clinical trial; the outcomes from any future clinical trials of VX-222, ALS-2200 and/or ALS-2158 may not be favorable and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

IMPORTANT SAFETY INFORMATION

Indication

INCIVEK™ (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.

Important Safety Information

INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.

INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.

INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.

Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.

(VRTX - GEN)

References:

¹ Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed February 22, 2012.

² Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.

³ Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.

⁴ Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.

⁵ McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.

⁶ Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.

⁷ Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).

⁸ Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.

⁹ Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed February 22, 2012.

¹⁰ Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed February 22, 2012. This report was commissioned by Vertex Pharmaceuticals, Inc.

¹¹ Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.

¹² Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.

Vertex Contacts:
Media:
Dawn Kalmar
Erin Emlock
Zach Barber
617-444-6992
mediainfo@vrtx.com
or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755

Source: Vertex Pharmaceuticals Incorporated

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