FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
-79% of people treated for the first time achieved a SVR (viral cure)
with INCIVEK combination treatment-
-Vertex launches a comprehensive financial assistance and patient
support program-
-Conference call today at
on the commercialization of INCIVEK-
the
(telaprevir) tablets for a broad group of 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 (in-SEE-veck) is approved for people who are new to
treatment, and for people who were treated previously but who did not
achieve a viral cure (relapsers, partial responders and null
responders). INCIVEK is given for 12 weeks in combination with
pegylated-interferon and ribavirin, two other medicines approved to
treat hepatitis C. After the first 12 weeks, all patients stop receiving
INCIVEK and continue treatment with pegylated-interferon and ribavirin
alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK
combination treatment, more than 60 percent of people treated for the
first time, as well as those who relapsed after previous therapy, are
expected to complete all treatment in 24 weeks — half the time needed if
they were to take pegylated-interferon and ribavirin alone. All other
patients will receive a total of 48 weeks of treatment. INCIVEK will
arrive in pharmacies this week.
INCIVEK (750 mg) is given as two 375-mg tablets three times daily for 12 weeks. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses. (Photo: Business Wire)
The approval of INCIVEK was based on data from three Phase 3 studies,
which showed that people who received INCIVEK combination treatment
achieved significantly higher rates of sustained viral response (SVR, or
viral cure) compared to those who received pegylated-interferon and
ribavirin alone, regardless of their prior treatment experience:
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People new to treatment: |
79 percent vs. 46 percent |
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People who were treated previously but did not achieve a viral cure: |
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– Relapsers: |
86 percent vs. 22 percent |
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– Partial responders: |
59 percent vs. 15 percent |
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– Null responders: |
32 percent vs. 5 percent |
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INCIVEK (750 mg) is given as two 375-mg tablets three times daily. It is
packaged in weekly boxes that include daily blister strips to help
patients keep track of their doses.
Rash and anemia are the most serious side effects associated with
INCIVEK. The most common side effects reported with INCIVEK combination
treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or
rectal problems, and taste changes.
“Hepatitis C can lead to liver failure, cancer and the need for a
transplant, and for the past decade, the best we could offer patients
was a year of difficult treatment that resulted in a viral cure for
fewer than half of them,” said
of Gastroenterology and Hepatology,
principal investigator for a Phase 3 study of INCIVEK. “With INCIVEK, 79
percent of people new to treatment achieved a viral cure.”
“Today marks a turning point in the fight against hepatitis C,
particularly for people who have been living with this silent disease
for decades, hoping for a better chance of a viral cure,” said
Emmens, Chairman, President and Chief Executive Officer of Vertex. “The
approval of INCIVEK was only possible thanks to more than 4,000 people
who volunteered for our clinical studies, the doctors, nurses and
coordinators who managed the studies, and our own pioneering scientists
who have worked for more than 15 years to bring this new medicine to
people with hepatitis C.”
Vertex has 200 field-based employees across
a 115-person sales team, who are ready to support the introduction of
INCIVEK. The sales team has an average of more than 14 years of
experience bringing medicines to people who need them, including eight
years of direct experience with antiviral medicines for diseases such as
hepatitis C.
Helping People with Hepatitis C Get INCIVEK
The people who work at Vertex understand that medicines can only help
patients who can get them. With that in mind, the company today
introduced a comprehensive financial assistance and patient support
program to help people get INCIVEK who might not otherwise be able to
afford it. The program will help people with hepatitis C learn about
insurance benefits for their medicines, give INCIVEK for free to
eligible patients who do not have insurance and provide coverage for
co-pay or co-insurance costs associated with INCIVEK for people who meet
certain program criteria. Additionally, patients will have access to
nurses through a 24-7 hotline by which they can receive support,
guidance and educational materials about hepatitis C and its treatment.
Vertex will also provide nurses and doctors with educational tools and
resources so they can offer support and care to people with hepatitis C
before, during and after the treatment process.
For eligible patients, the program includes the following:
-
Insurance Benefits Research and Support: Vertex case managers willresearch patients’ insurance benefits for INCIVEK combination
treatment, assist people with insurance appeals and help guide them to
other forms of financial support, including Vertex’s free medicine and
co-pay programs;
-
Free Medicine Program: Vertex will give INCIVEK for free to people who
do not have insurance and have an annual household income of
$100,000 or less; and
-
Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to
20 percent of the total cost of INCIVEK for people who have private
insurance plans that cover INCIVEK, regardless of their household
income. For people covered by government insurance, Vertex will also
make donations to the independent, non-profit
Patient Access Network Foundation, which has a fund to provide co-pay support to people
taking hepatitis C medicines.
More information about this program is available by calling
1-855-837-8394 or visiting www.INCIVEK.com.
About INCIVEK
INCIVEK is an oral medicine that acts directly on the hepatitis C virus
protease, an enzyme essential for viral replication. The Phase 3
registration studies evaluated INCIVEK in combination with Pegasys®
(pegylated-interferon alfa-2a) and Copegus® (ribavirin) in
people with hepatitis C who were new to treatment as well as those who
were treated previously with pegylated-interferon and ribavirin but who
did not achieve a viral cure, including:
-
Prior Relapsers: Defined as people whose
hepatitis C virus was undetectable after a full course of previous
treatment, but whose virus became detectable during the follow-up
period;
-
Prior Partial Responders: Defined as
people who achieved at least a 2 log10 reduction in
hepatitis C virus at week 12, but whose hepatitis C virus never became
undetectable by week 24 of a prior course of therapy; and
-
Prior Null Responders: Defined as people
who achieved a less than 2 log10 reduction in hepatitis C
virus at week 12 of a prior course of therapy.
Vertex developed telaprevir in collaboration with Tibotec BVBA and
in
commercialize telaprevir in
East and certain other countries.
commercialize telaprevir in
United States, telaprevir will be marketed with the brand name INCIVEK.
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
Who should not take INCIVEK?
Do not take INCIVEK if you are pregnant or may become pregnant,
or if you are a man with a sexual partner who is pregnant.
Do not take INCIVEK if you are taking certain medicines as there could
be serious side effects. If these drugs are taken together, this can
cause you to have too much or not enough INCIVEK or your other medicines
in your body. It can also cause side effects that can be serious or
life-threatening. These medicines include: alfuzosin hydrochloride
(Uroxatral®), atorvastatin (Lipitor®, Caduet®),
ergot containing medicines such as methylergonovine (Methergine®),
lovastatin (Advicor®, Altoprev®, Mevacor®),
pimozide (Orap®), rifampin (Rifadin®, Rifamate®,
Rifater®), sildenafil citrate (Revatio®) or
tadalafil (Adcirca®) for the lung problem pulmonary artery
hypertension (PAH), simvastatin (Zocor®, Vytorin®,
triazolam (Halcion®).
Talk to your healthcare provider before taking INCIVEK if any of the
above applies to you. Your healthcare provider may need to change the
amount of medicines you take.
Tell your healthcare provider about all the medicines you take,
including prescription and non-prescription medicines, vitamins, and
herbal supplements. INCIVEK and other medicines can affect each other.
Serious Side Effects
INCIVEK can cause serious side effects, including:
-
Birth defects or death of an unborn baby
INCIVEK combined withpeginterferon alfa and ribavirin may cause birth defects or death of
your unborn baby. If you or your sexual partner is pregnant or plan to
become pregnant, do not take these medicines. You or your partner
should not become pregnant while taking INCIVEK with peginterferon
alfa and ribavirin and for 6 months after treatment is over.
You
must have a negative pregnancy test before starting treatment, every
month during treatment, and for 6 months after your treatment ends.
You must use 2 effective methods of birth control during treatment and
for 6 months after all treatment has ended. These 2 forms of birth
control should not contain hormones, as these may not work as well
during treatment with INCIVEK. Talk to your healthcare provider about
the forms of birth control you should use during this time.
Two
weeks after stopping INCIVEK, you can use a hormonal form of birth
control as one of your two forms of birth control.
If you
or your partner becomes pregnant during treatment or within 6 months
after stopping these medicines, tell your healthcare provider right
away. Contact the Ribavirin Pregnancy Registry right away by calling
1-800-593-2214. The Registry collects information about what happens
to mothers and their babies if the mother takes ribavirin while
pregnant.
-
Skin reactions: Mild skin rashes are common with INCIVEK combination
treatment. Sometimes these skin rashes and other skin reactions can
become severe and require treatment in a hospital.
Call
your healthcare provider right away if you develop any skin changes
with these symptoms: rash with or without itching, blisters or skin
lesions, mouth sores or ulcers, red or inflamed eyes like “pink eye”
(conjunctivitis), swelling of your face, or fever.
Your
healthcare provider will decide if these changes may be a sign of a
serious skin reaction. Your healthcare provider will also decide if
you need treatment for your rash or to stop INCIVEK or your other
medicines. Never stop taking INCIVEK combination treatment without
talking to your healthcare provider first.
-
Do not take INCIVEK alone to treat chronic hepatitis C infection. It
must be used with peginterferon alfa and ribavirin to treat chronic
hepatitis C infection.
-
Low red blood cell count (anemia) that can be severe. Tell your
healthcare provider if you have any of these symptoms of anemia:
dizziness, shortness of breath, tiredness, or weakness.
Your
healthcare provider will do blood tests regularly to check your red
blood cell count during treatment. If your anemia is severe your
healthcare provider may tell you to stop taking INCIVEK. If this
happens, do not start taking it again.
What should I tell my healthcare provider before taking INCIVEK?
Tell your healthcare provider if you:
-
have certain blood problems such as anemia
-
have liver problems other than hepatitis C infection
-
have hepatitis B, HIV infection, or any problems with your immune
system
-
have a history of gout or high uric acid levels in your blood
-
have had an organ transplant
-
plan to have surgery
-
have any other medical condition
-
are breastfeeding
How should I take INCIVEK?
Take INCIVEK exactly as your healthcare provider tells you. Take 2
INCIVEK pills 3 times a day, 7 to 9 hours apart, with food. Eat a meal
or snack containing about 20 grams of fat within 30 minutes before you
take each dose. Talk to your healthcare provider about examples of food
you can eat.
If you miss a dose within 4 hours of when you usually take it, take your
dose with food as soon as possible. If you miss a dose and it is more
than 4 hours after the time you usually take it, skip that dose only and
take the next dose at your normal time. Do not stop taking INCIVEK
unless your healthcare provider tells you to. If your healthcare
provider tells you to stop, you should not start taking it again, even
if the reason for stopping goes away. If you take too much INCIVEK, call
your healthcare provider or local
nearest emergency room right away.
Common Side Effects of INCIVEK Combination Treatment
The most common side effects include itching, nausea, diarrhea,
vomiting, anal or rectal problems (including hemorrhoids, discomfort or
burning around or near the anus, itching around or near the anus), taste
changes, and tiredness. Tell your healthcare provider about any side
effect that bothers you or doesn’t go away.
These are not all the possible side effects of INCIVEK. For more
information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
to the
You may also report side effects to
at 1-877-824-4281.
Please see full Prescribing Information for INCIVEK including the
Medication Guide available at www.INCIVEK.com.
For healthcare providers who are interested in information about
INCIVEK, you can also call 1-877-824-4281.
Conference Call Information
Vertex will host a conference call and webcast today, May, 23, 2011 at
price of INCIVEK and Vertex’s new financial assistance and patient
support program. The conference call will be webcast live and a link to
the webcast may be accessed from the ‘Events & Presentations’ page of
Vertex’s website at www.vrtx.com.
To listen to the call on the telephone, dial 1-866-501-1537 (
States and
providing a podcast MP3 file available for download on the Vertex
website at www.vrtx.com.
The conference ID number for the live call and replay is 68267164. The
call will be available for replay via telephone commencing
at
phone number for
international replay number is 1-706-645-9291. Following the live
webcast, an archived version will be available on Vertex’s website until
recommended that users register at least 15 minutes prior to the
scheduled webcast.
INCIVEK™ is a trademark of
PEGASYS® and COPEGUS® are registered trademarks of
Hoffmann-La Roche.
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 is curable.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
have chronic hepatitis C and 75 percent of them are unaware of their
infection.9 Hepatitis C is four times more prevalent in
United States compared to HIV.9 The majority of people with
hepatitis C in
accounting for two of every three people with chronic hepatitis C.10
Hepatitis C is the leading cause of liver transplantations in
States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12
By 2029, total annual medical costs in
people with hepatitis C are expected to more than double, from
billion in 2009 to approximately
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, epilepsy and other
life-threatening diseases.
Founded more than 20 years ago in
worldwide research programs and sites in the U.S.,
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, as amended,
including statements regarding (i) Vertex’s sales team being ready to
support the introduction of INCIVEK, (ii) Vertex’s financial assistance
and patient support programs and its commitment to help people who might
not otherwise be able to afford INCIVEK receive it and (iii) the use of
INCIVEK as a treatment for people with genotype 1 chronic hepatitis C
virus infection. 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, risks related
to the commercialization of INCIVEK and the other risks listed under
Risk Factors in Vertex’s annual report and quarterly reports filed with
the
website at www.vrtx.com.
Vertex disclaims any obligation to update the information contained in
this press release as new information becomes available.
For more information and to view Vertex’s press releases, please visit www.vrtx.com.
(VRTX – GEN)
1
Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf.
Accessed
2 Pearlman BL and
Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis
C Virus Infection: A Cure and
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
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
10
Pyenson B, Fitch K,
Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm.
Updated
commissioned by
11
MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral
therapy for hepatitis C in
2009;50(6):1750-1755.
12 Davis GL, Alter MJ,
Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected
persons in
and disease progression. Gastroenterology. 2010;138:513-521.
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Vertex::
Media:
Barber617-444-6992 or mediainfo@vrtx.com
or
Investors:
Partridge, 617-444-6108
Osborne, 617-444-6057
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