Vertex Presents New Phase 3 Data that Showed People with Hepatitis C Treated
with Twice-Daily Telaprevir Achieved Viral Cure (SVR12) Rates Similar to
Those Treated Three Times Daily
- New Phase 2 data showed approximately 3 of 4 people co-infected with
hepatitis C virus (HCV) and HIV achieved HCV viral cure (SVR24) with
telaprevir combination treatment -
BOSTON -- November 10, 2012
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that new
data from a Phase 3 study in people being treated for hepatitis C for the
first time showed similar rates of viral cure (SVR12, HCV RNA levels < 25
IU/mL 12 weeks after the end of all treatment) when telaprevir was given twice
daily compared to three times daily, the currently approved dosing schedule.
Telaprevir is approved for use in combination with pegylated-interferon and
ribavirin by the U.S. Food and Drug Administration (FDA) and Health Canada
under the brand name INCIVEK^® (telaprevir) tablets for people with genotype 1
chronic hepatitis C virus (HCV) with compensated liver disease (some level of
damage to the liver but the liver still functions), including cirrhosis
(scarring of the liver). In addition, new data from a Phase 2 study
demonstrated that approximately three of four people co-infected with HCV and
HIV achieved an HCV viral cure (SVR24, HCV RNA levels < 25 IU/mL 24 weeks
after the end of all treatment) with telaprevir combination treatment. These
and other new data on Vertex’s medicines in development for hepatitis C were
presented at The Liver Meeting^®, the 63rd Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD).
“INCIVEK is the most prescribed direct-acting antiviral for the treatment of
hepatitis C with more than 50,000 people in the United States treated since
its approval,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and
Chief Medical Officer at Vertex. “We’re encouraged by the new data presented
at AASLD that show consistent and high viral cure rates, even when telaprevir
is given twice instead of three times daily.”
“OPTIMIZE trial: Non-inferiority of twice-daily telaprevir versus
administration every 8 hours in treatment-naïve, genotype 1 HCV infected
Poster Presentation #LB-8
November 12, 2012, 8:00 a.m. – 5:30 p.m. EST
Results of a Phase 3 study showed that 74 percent (274/369) of people with HCV
who were new to treatment and received twice-daily (BID) telaprevir in
combination with pegylated-interferon and ribavirin achieved a viral cure
(SVR12), compared to 73 percent (270/371) of people who received telaprevir
three times a day (q8h). The study met its primary endpoint of
non-inferiority. All study participants received the same total daily dose
(2,250 mg) of telaprevir. Fourteen percent (103/740) of people in the study
were cirrhotic at study entry, and 52 percent (53/103) of them achieved a
viral cure. Adverse events were generally similar between treatment arms and
consistent with the safety profile described in the U.S. prescribing
information for telaprevir and included rash, anemia and pruritis (itchiness).
Vertex plans to submit data supporting this new dosing regimen to the FDA in
2013 for potential inclusion in the U.S. telaprevir label.
“Telaprevir in combination with peginterferon alfa-2a/ribavirin in HCV/HIV
co-infected patients: SVR24 final study results.”
Oral Presentation #54
November 11, 2012, 4:15 p.m. EST
Final results of a Phase 2 study designed to evaluate the safety and
tolerability of telaprevir in combination with pegylated-interferon and
ribavirin in people who are co-infected with HCV and HIV also were presented
at AASLD. Data showed that 74 percent (28/38) of patients who were treated
with telaprevir combination treatment achieved an HCV viral cure (SVR24)
compared to 45 percent (10/22) of those who were treated with
pegylated-interferon and ribavirin alone. Changes in CD4 counts were similar
between the treatment groups and no HIV viral load breakthroughs were observed
in either treatment group during the study. The safety and tolerability of
telaprevir observed in this study was comparable to what has been observed in
HCV mono-infected patients. Adverse events that occurred more frequently (≥10
percent difference) among people treated with telaprevir compared to
pegylated-interferon and ribavirin alone included pruritis (itchiness),
headache, nausea, rash and dizziness.
“There are many people with hepatitis C who cannot or should not wait to be
treated given the severity of their disease,” said Kenneth E. Sherman, M.D.,
Ph.D., Director of the Division of Digestive Diseases at the University of
Cincinnati College of Medicine. “People who are co-infected with hepatitis C
and HIV are among those who are most in need of effective new medicines, and
these new data showed that three out of four people were able to clear the
hepatitis C virus with telaprevir combination treatment. We look forward to
the results of the ongoing Phase 3 study.”
INCIVEK^® (telaprevir) tablets is an oral medicine that acts directly on the
hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK
has been prescribed to more than 50,000 patients in the United States.
Approximately three out of four U.S. patients who are prescribed a
direct-acting antiviral for the treatment of genotype 1 chronic hepatitis C
(HCV) receive INCIVEK combination therapy.
In Phase 3 clinical studies, 79 percent of people who had not previously been
treated for HCV achieved a viral cure following treatment with INCIVEK
combination therapy, compared with 46 percent of those who received
pegylated-interferon and ribavirin (P/R) alone. Among people who were treated
previously but did not achieve a viral cure, in the Phase 3 studies: 86
percent of relapsers achieved a viral cure with INCIVEK combination therapy
compared to 22 percent with P/R alone; 59 percent of partial responders
achieved a viral cure compared with 15 percent with P/R alone; and 32 percent
of null responders achieved a viral cure compared with 5 percent with P/R
alone. In addition, many people are eligible to complete treatment with
INCIVEK combination therapy in 24 weeks – half the time required for P/R
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 adults 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 Janssen 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). Janssen
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^®.
IMPORTANT SAFETY INFORMATION
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.
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 If
treatment is not successful and a person does not achieve a viral cure, they
remain at an increased risk for progressive liver disease.^3,4 More than 170
million people worldwide are chronically infected with hepatitis C.^5 In the
United States, up to 5 million people have chronic hepatitis C and 75 percent
of them are unaware of their infection.^6,7 Hepatitis C is four times more
prevalent in the United States compared to HIV.^7 The majority of people with
hepatitis C in the United States were born between 1945 and 1965, accounting
for 82 percent of people with the disease.^8 Hepatitis C is the leading cause
of liver transplantations in the United States and is reported to contribute
to 15,000 deaths annually.^9,10 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.^11
Vertex creates new possibilities in medicine. Our team discovers, develops and
commercializes innovative therapies so people with serious diseases can lead
Vertex scientists and our collaborators are working on new medicines to cure
or significantly advance the treatment of hepatitis C, cystic fibrosis,
rheumatoid arthritis and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, Mass., 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 for three years in
a row, Science magazine has named Vertex one of its Top Employers in the life
Vertex's press releases are available at www.vrtx.com.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including, without
limitation, the statement regarding Vertex’s plans to submit data supporting a
twice-daily dosing regimen to the FDA in 2013 for potential inclusion in the
U.S. telaprevir label. 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 the 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.
^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 Updated June
2010. Accessed September 21, 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 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).
^4 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.
^5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and
treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
^6 Chak, E, et. al. Hepatitis C Virus Infection In USA: An Estimate of True
Prevalence. Liver Intl. 2011;1096 -1098.
^7 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:
Updated January 11, 2010. Accessed September 21, 2012.
^8 Smith, BD, et al. Hepatitis C Virus Antibody Prevalence, Correlates and
Predictors among Persons Born from 1945 through 1965, United States,
1999-2008. AASLD 2011 Annual Meeting.
^9 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral
therapy for hepatitis C in the United States. Hepatology.
^10 Ly KN, et al. The Increasing Burden of Mortality From Viral Hepatitis in
the United States Between 1999 and 2007. Ann Intern Med. 2012;156:271-278.
^11 Pyenson B, Fitch K, and Iwasaki K. Consequences of Hepatitis C Virus
(HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman, Inc. May
2009. Available at: http://www.vrtx.com/assets/pdfs/MillimanReport.pdf
Vertex Pharmaceuticals Incorporated
Erin Emlock or Dawn Kalmar, 617-444-6992
Kelly Lewis, 617-961-7530
Michael Partridge, 617-341-6108
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