Published: Sunday, February 19, 2012 at 10:23 p.m. Last Modified: Sunday, February 19, 2012 at 10:23 p.m.

LAKELAND | Hope and cure are words some hepatitis C patients haven’t put much stock in, but the approval of two new drugs is causing that attitude to change.

Facts SUPPORT GROUP

The hepatitis C support group meets at 6:30 p.m. Tuesday in Room 201 of Lakeland Regional Medical Center, off the B lobby. A nurse practitioner from Vertex Pharmaceuticals, which markets Incivek, will speak. This is open to anyone with hepatitis C or is interested in the treatment for it. Register at 863-409-4719.

Victrelis and Incivek can make a significant difference, said Dr. James H. Johnson, a Lakeland gastroenterologist who treats those patients and offers a monthly support group.

“We can wipe the slate clean,” he said. “We can use the word ‘cure.’ “

Although not everyone will be cured, he said, clinical trials have shown major successes in reducing the level of the virus in patients and keeping it from going back up once treatment ends. the new drugs were approved in spring 2011.

Hepatitis C is a liver disease that results from infection with hepatitis C virus. it is spread through the blood.

About 3.2 million people in the United States have the disease. more than half don’t realize they’re infected, according to the federal Centers for Disease Control and Prevention.

For some, it’s become almost a life sentence.

Elaine Erb, 54, has been battling hepatitis C for half of her life. This latest round of treatment, Incivek combined with hepatitis medications previously in use, is her third attempt.

In the previous two, she responded well but the virus level came back up when treatment ended.

That makes her a relapser, someone who does well but isn’t able to totally eliminate the disease from her body.

“This is my third time and I’m also zero viral content,” said Erb, who worked in the medical field and at Piper Aircraft before becoming too sick to keep working.

“I just hope it stays this time.”

Ironically, being a previous relapser may make her a winner this time. Because she responded to the previous treatment, the East Polk resident has a better chance of responding favorably to this combination.

“Hepatitis C is a very complex thing,” Johnson said. “The medications have always had a lot of side effects. There are a lot of interactions.”

These new drugs work directly on the virus. They’re used in combination with existing anti-viral therapies like pegylated interferon and ribavirin that boost the immune system’s ability to fight the virus.

This is how the process is designed to work: the new drugs, direct-acting antivirals, prevent the virus from replicating itself. When the level of the virus shrinks, the interferon and ribavirin keep it in check.

Previous therapies alone had a clearance rate of about 40 percent, but combining a new drug with standard therapies had a clearance rate of more than 75 percent. For some patients, Johnson said, therapy will be cut in half from 48 weeks to 24 weeks.

At a January support meeting, patients shared their stories of how the illness and medications affect them.

The new therapy isn’t noticeably easier on them physically or mentally, they said.

Throughout their comments, however, ran a thread of hope and excitement.

“We’re thrilled with the new medications that are available and thrilled with the prospect of people being able to say they’re cured,” said Sue Clements, a nurse who works with Johnson.

“I love these guys,” said Tim Hardee, 57, who is undergoing hepatitis C treatment for the first time. “They are family.”

Hardee, describing hepatitis C as “a time bomb” said he saw the ugliness of end-stage hepatitis C/liver disease when he was in an Orlando jail and helped with palliative care for inmates.

“I had them drop off with hepatitis C in front of me,” the Kathleen resident said.

“I’ve seen them swell up this big and the state didn’t want to spend money to drain them off. … I didn’t want to go out that way.”

In addition to being complex, hepatitis treatment also is costly. Private companies that manufacture the prescription treatment he gets, Merck and Genetech, supply it free to him, Hardee said. He is on Victrelis.

The level of hepatitis C virus in his blood is “at zero detectability” now, Hardee said.

He believes he acquired hepatitis C as a former drug user.

Erb thinks hers came when she worked as a phleboto-mist.

About two-thirds of those who are infected are baby boomers, in large part stemming from IV drug use in the 1970s and 1980s, Johnson said. Needle sticks in the health-care profession are another common cause.

Treatment isn’t easy. Flu-like symptoms, fatigue, nausea, anemia, depression, irritability, sleep disturbances and anxiety occur.

Although the interferon helps the immune system fight the hepatitis C virus, it leaves patients more vulnerable to some other infections, Johnson said.

Erb’s husband, Gary, takes her to the movies but they go to matinees to avoid close contact with people who have colds.

“That’s nice,” another group member said. “That lets you be part of society.”

Getting together at the support group meeting helps boost the morale of people who have hepatitis C, Hardee said.

[ Robin Williams Adams can be reached at or 863-802-7558. Read her blog at robinsrx.blogs.theledger.com. Follow on Twitter at ledgerROBIN. ]

THERE'S new hope for an overlooked epidemic: Two powerful drugs are nearing the market that promise to help cure many more people of liver-attacking hepatitis C – even though most who have the simmering infection don't know it yet.

Surprisingly, two-thirds of hepatitis C sufferers are thought to be baby boomers who’ve harboured since their younger, perhaps wilder, years a virus that can take two or three decades to do its damage.

What could be a treatment revolution is spurring the government to consider if it’s time to start screening aging baby boomers for hepatitis C, just like they get various cancer checks.

"We’re entering a whole new era of therapy," says Dr John Ward, hepatitis chief at the Centres for Disease Control and Prevention. "We really want to begin that clarion call for action for this population who’s at risk."

Today’s two-drug treatment for hepatitis C cures only about 40 per cent of people with the most common variety of the virus, and causes some grueling side effects. Now major studies show that adding a new drug – either Vertex Pharmaceuticals’ telaprevir or Merck & Co’s boceprevir – can boost those cure rates as high as 75 per cent. and they allow some people to cut treatment time in half, to six months, thus lessening how long they must deal with those side effects.

If the Food and Drug Administration approves the drugs - a decision widely expected this summer - they would be the first that work by directly targeting the hepatitis C virus. Specialists draw comparisons to the early 1990s when potent combination therapies emerged to treat AIDS. Many recently diagnosed patients are postponing therapy to await these new drug cocktails in hopes of a better chance at a faster cure, says Dr Paul Pockros, hepatology chief at the Scripps Clinic in La Jolla, California, who helped test telaprevir.

However, the bigger impact could come if more people get tested for hepatitis C, a blood-borne virus. It’s often stigmatised as a risk only to people who inject illegal drugs. But the virus could have begun festering from a blood transfusion before 1992, when testing of the blood supply began.

Lapses in infection control in health facilities still occasionally expose people today. So could even a one-time experiment with drugs way back in college, something doctors are reluctant to ask a now middle-aged, button-downed patient to reveal, says Ward.

"It cuts across every segment of society," adds Dr Arun Sanyal of Virginia Commonwealth University, past president of the American Association for the Study of Liver Diseases. "I can tell you our hepatitis C treatment clinic is a great social equaliser."

About 3.2 million Americans, and 170 million people worldwide, have chronic hepatitis C. in the US, new infections have dropped dramatically - although the disease’s toll is rising as people infected decades earlier reach ages where their livers start showing damage. Hepatitis C already is a leading cause of liver transplants, and it kills about 12,000 US patients a year, a number expected to triple within 20 years.

Most people find out they’re infected like Brian Graham of Briarcliff Manor, New York, during a routine check-up that spotted elevated liver enzymes. He’d never heard of hepatitis C and had no obvious risk factors. But tests showed the virus had begun to scar his liver. So over the last decade he tried three rounds of traditional treatments, with increasingly tough side effects, to no avail.

"I didn’t want to die of liver disease or cancer or suffer the prospect of having to tee up for a liver transplant. Scary stuff," says mr Graham, now 56.

Enter the new drugs. They work by blocking an enzyme named protease that’s key for the virus to reproduce. But they must be taken together with standard medications - ribavirin pills plus injections of interferon-alpha - that are thought to boost the immune system.

According to studies presented at a recent medical meeting, 67 per cent to 75 per cent of patients given treatment including either boceprevir or telaprevir, respectively, had what doctors call a cure. That’s defined as no sign of the hepatitis C virus six months after their last dose. Importantly, only about a quarter of black patients are helped by standard therapy but adding one of the new drugs more than doubled their cure rates.

People getting their first-ever treatment did best, but the studies also found improvements in hard-to-treat patients like mr Graham.

"The fourth time did the trick," says mr Graham, who volunteered for an early telaprevir study and says he’s been hepatitis-free for three years.

The new drugs do add side effects to the flulike symptoms and other complaints of existing treatment. Telaprevir’s main risk is a rash that is sometimes severe, and boceprevir’s is anemia.

"The future looks very bright beyond telaprevir and boceprevir," notes Dr Fred Poordad of Cedars-Sinai Medical Centre in Los Angeles, who has studied both drugs and consults for several companies. he points to additional drugs in earlier-stage testing that promise to target more types of hepatitis C and perhaps eventually allow for pill-only, interferon-free treatment.

Manufacturers haven’t said how much the new drugs will add to the price of treatment that already can cost $30,000, albeit far cheaper than a liver transplant.

A stickier issue: Not everyone suffers serious liver damage and it’s hard to predict who will, raising questions about exactly who needs treatment even as drug companies help push for more screening."

That’s a concern, acknowledges Jeff Levi of the nonprofit Trust for America’s Health, also a screening proponent. But when to treat is a doctor-patient decision, and "anyone with chronic infection you do want to be monitoring so you can intervene at the right moment," he adds.

Plus, people with hepatitis C should avoid alcohol and consider other liver-protection steps - and know how to avoid infecting others, he stresses.

Stay tuned: The CDC has begun a study at four hospitals - in New York, Detroit, Houston and Birmingham, Alabama - to see if a one-time hepatitis C test for baby boomers makes sense. Among the boomers, black men in their 50s are at particular risk. CDC plans new guidelines next year.

Meanwhile, "start that conversation" at a routine doctor’s visit by asking about hepatitis C risks and testing, Dr Ward advises boomers.

CAMBRIDGE, MASS.–(BUSINESS WIRE)–

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has completed the submission of a new Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex’s investigational treatment for people with hepatitis C. The NDA submission is supported by results from three Phase 3 studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before but did not achieve a sustained viral response (SVR, or viral cure). The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment.

“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. “We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”

Highlights of the Telaprevir Phase 3 Data Included in the Submission

all Phase 3 studies met their primary endpoints and results below are from the treatment arms where telaprevir was started immediately in combination with pegylated-interferon and ribavirin for the first 12 weeks of treatment.

in people with hepatitis C who were new to treatment (treatment-naïve):

• Up to 75% achieved a viral cure with telaprevir-based combination therapy, compared to 44% of people who received pegylated-interferon and ribavirin alone;
• A majority (58% in ADVANCE and 65% in ILLUMINATE) were eligible to reduce their treatment time by half – from 48 weeks to 24 weeks; and
• Data showed there was no benefit to extending total treatment from 24 weeks to 48 weeks in people whose virus was undetectable at weeks 4 and 12 with telaprevir-based therapy.

in the three major subgroups of people with hepatitis C who had not achieved a viral cure with a prior course of treatment (treatment-experienced):

• 83% of prior relapsers, 59% of prior partial responders and 29% of prior null responders achieved a viral cure with telaprevir-based combination therapy compared to 24%, 15%, and 5% of people in these subgroups, respectively, who received pegylated-interferon and ribavirin alone. these results were achieved with a simultaneous start of all three drugs for the first 12 weeks followed by pegylated-interferon and ribavirin alone for an additional 36 weeks.

The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment arm were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

More Effective Therapies Needed to Improve Viral Cure Rates

Hepatitis C is a serious disease, typically without symptoms, which affects up to 3.9 million people in the United States. Hepatitis C can lead to scarring of the liver (cirrhosis), resulting in liver failure, liver cancer and the need for liver transplantation. Approved medicines for people with genotype 1 hepatitis C are given for a year, and less than half of people treated with these therapies achieve a viral cure.4,5,6 Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. to date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.

“In our trials, starting patients with 12 weeks of telaprevir-based combination therapy significantly improved viral cure rates compared to treatment with currently approved medicines, even in groups of people considered the most difficult to treat,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We’re also encouraged by telaprevir data that showed most patients new to therapy were able to achieve high viral cure rates and reduce their total treatment time by half.”

Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America and Tibotec has rights in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.

Vertex was granted fast Track designation by the FDA for telaprevir in 2005. in mid-2010, as part of the fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete.

Data from Phase 3 Studies in all Major Patient Types, Including the most Difficult-to-Treat

The Phase 3 studies evaluated people with genotype 1 hepatitis C who were new to treatment as well as those who had previously received treatment but did not achieve a cure, including people who have traditionally responded poorly to approved medicines. in Phase 3 studies, telaprevir was given to people three times a day in combination with pegylated-interferon and ribavirin for the first 12 weeks of therapy followed by either 12 weeks or 36 weeks of Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) alone for a total treatment time of either 24 weeks or 48 weeks. The ability to shorten treatment time from 48 weeks to 24 weeks for people new to treatment was based on their response to therapy at weeks 4 and 12. People who did not achieve a viral cure with a prior course of therapy received a total of 48 weeks of treatment. in October 2010, Vertex announced the start of a Phase 3 study to evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen.

ADVANCE: Pivotal study in 1,095 people who were new to treatment

The primary endpoint of ADVANCE was SVR, defined as the proportion of people who had undetectable viral load (HCV RNA) both at the end of treatment and 24 weeks after the end of treatment. The secondary endpoint was to evaluate the safety of telaprevir when dosed in combination with pegylated-interferon and ribavirin. ADVANCE also evaluated the ability to reduce total treatment time by half – from 48 weeks to 24 weeks, which was guided by a patient’s response to therapy (undetectable viral load at weeks 4 and 12).

ILLUMINATE: Supplemental study in 540 people to evaluate shorter treatment durations in people who were new to treatment

The primary endpoint of the study was SVR in two telaprevir-based treatment arms of people whose virus was undetectable at week 4 and week 12 of treatment (eRVR, extended rapid viral response). these patients were randomized to either 24 weeks or 48 weeks of total therapy. ILLUMINATE was designed to evaluate whether there was any benefit to extending therapy from 24 weeks to 48 weeks in people who met these criteria. There was no control arm of pegylated-interferon and ribavirin alone in the study.

in both the ADVANCE and ILLUMINATE studies, telaprevir-based combination therapy also resulted in improved SVR rates in various subgroups of people with characteristics known to limit response to approved medicines such as race/ethnicity or stage of liver fibrosis. Data from these studies were presented in November 2010 at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

REALIZE: Pivotal study in 662 people who did not achieve a viral cure with previous therapy

The primary endpoint of the study was SVR in each of the two telaprevir treatment arms compared to the control arm, and for the three subgroups of people included in the study. REALIZE is the only Phase 3 study to date of a direct-acting antiviral medicine to include all three major subgroups of people with hepatitis C who did not achieve a viral cure with a previous course of therapy:

• Relapser: defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period;
• Partial Responder: defined as a person who achieved at least a 2 log10 (100 times) reduction in viral load (HCV RNA) at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and
• Null Responder: defined as a person who experienced a less than 2 log10 drop in viral load at week 12 of a prior course of therapy.

in REALIZE, people received 48 weeks of total therapy, which included 12 weeks of telaprevir combined with pegylated-interferon and ribavirin. one of the telaprevir treatment arms was designed to evaluate, for the first time, whether viral cure rates could be further improved by starting pegylated-interferon and ribavirin alone for the first four weeks of treatment (delayed start) compared to a simultaneous start of telaprevir in combination with these medicines. There was no clinical benefit observed with the telaprevir delayed-start treatment arm in any of the subgroups of patients compared to the simultaneous-start arm. Final results from REALIZE, including safety and efficacy data, will be presented at an upcoming medical meeting.

Safety and Tolerability Information for ADVANCE, ILLUMINATE and REALIZE

The safety and tolerability results of telaprevir-based combination regimens were consistent across the Phase 3 studies. The most common adverse events (AEs) were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia with the majority being mild or moderate in severity. Rash and anemia occurred more frequently in the telaprevir treatment arms compared to the control arms.

Rash was primarily characterized as eczema-like, manageable and resolved upon stopping telaprevir. More than 90% of rash was mild to moderate and was primarily managed with the use of topical corticosteroids and antihistamines. Anemia was primarily managed by reducing the dose of ribavirin. Erythropoiesis-stimulating agents (ESAs) were used in only 1% of people in the Phase 2 and Phase 3 studies. Discontinuation of all drugs due to either rash or anemia during the telaprevir/placebo treatment phase was 1% to 3% in the telaprevir treatment arms.

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.2 Up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2

Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR, 4,5,6 or viral cure.1 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8,9,10,11 in the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 by 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11

Additional resources for media are available at: investors.vrtx.com/press.cfm.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with other pharmaceutical companies. Vertex’s product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer and pain.

Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Lexiva is a registered trademark of the GlaxoSmithKline group of companies.

PEGASYS® and COPEGUS® are a registered trademarks of Hoffman-La Roche.

References:

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

2 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. available at: cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed may 25, 2010.

3 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. 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 may 25, 2010.

4 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.

5 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.

6 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.

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 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.

9 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.

10 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.

11 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. natap.org/2009/HCV/051809_01.htm. Updated may 2009. This report was commissioned by Vertex Pharmaceuticals, inc.

12 Picchio G, et al. Discrepancies between definitions of null response to treatment with peginterferon alfa-2a and ribavirin: Implications for new HCV drug development. [poster 289]. in: Program and Abstracts of the 2010 International Liver Conference by the European Association for the Study of Liver Disease. . Athens, Greece: April 2010.

13 United States Food and Drug Administration. Chronic hepatitis C virus infection: developing direct-acting antiviral agents for treatment. federalregister.gov/articles/2010/09/14/2010-22806/draft-guidance-for-industry-on-chronic-hepatitis-c-virus-infection-developing-directacting-antiviral. Updated September 14, 2010. Accessed September 14, 2010.

Special Note regarding Forward-looking Statements

this press release contains forward-looking statements, including statements regarding (i) the potential that the FDA’s review time for the telaprevir NDA will be reduced from 10 months to six months; (ii) Vertex’s commitment to working closely with the FDA to make telaprevir available as quickly as possible; (iii) Vertex being encouraged by telaprevir data that showed most patients new to therapy were able to achieve high viral cure rates and reduce their total treatment time by half and (iv) the expectation that final results from REALIZE will be presented at an upcoming medical meeting. 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 Vertex could experience unforeseen delays in obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based therapy 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 vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

Copyright Business Wire 2010