Vertex Announces New Data that Showed High Viral Cure Rates with a Total of
12 and 24 Weeks of Telaprevir Combination Treatment Among People with
Genotype 1 Hepatitis C Who Have the IL28B CC Genotype
- Interim analysis of the Phase 3b CONCISE study showed SVR12 rates of 87
percent with 12 total weeks of treatment and 97 percent with 24 total weeks of
treatment among people who achieved RVR and completed 12 weeks of treatment -
AMSTERDAM -- April 24, 2013
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new data
from an interim analysis of the exploratory global Phase 3b CONCISE study
evaluating the potential to shorten total treatment with telaprevir
combination therapy to 12 weeks in certain people with genotype 1 chronic
hepatitis C virus (HCV) infection who have the IL28B CC genotype. In the
CONCISE trial, telaprevir was administered twice daily in combination with
pegylated-interferon and ribavirin. Of the 239 people in the study, 159 people
completed 12 weeks of telaprevir combination treatment and had undetectable
hepatitis C virus at week four of treatment (rapid viral response, or RVR) and
were eligible to be randomized. One hundred seven^1 people were randomized to
receive no further treatment and 52 people were randomized to receive an
additional 12 weeks of treatment with pegylated-interferon and ribavirin
alone, for a total of 24 weeks of treatment. In the 12-week total treatment
group, of the 85 people with data available at the time of the interim
analysis, 87 percent (74/85) had undetectable hepatitis C virus 12 weeks after
the end of treatment (SVR12). In the 24-week treatment group, of the 30 people
with data available at the time of the interim analysis, 97 percent (29/30)
This study includes people with genotype 1 chronic HCV who were new to
treatment or who had relapsed after at least one prior course of treatment
with pegylated-interferon and ribavirin alone. Approximately one-third of
people with hepatitis C have the ‘CC’ genotype, which has been associated with
higher sustained viral response (SVR, or viral cure) rates and faster response
to interferon-based treatment. The safety profile of telaprevir combination
therapy observed in the CONCISE study through the time of the interim analysis
was similar to that seen in previously reported clinical trials. The interim
results of this study will be presented at the 48th Annual Meeting of the
European Association for the Study of the Liver (EASL) in Amsterdam,
Netherlands, April 24 to 28, 2013 (poster #881).
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 HCV infection with compensated liver disease (some level of damage to
the liver but the liver still functions), including cirrhosis (scarring of the
liver). INCIVEK’s approved dosing schedule is two 375mg tablets three times
daily, and it is given for 12 weeks in combination with pegylated-interferon
and ribavirin. 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.
CONCISE is a randomized, placebo-controlled, global, multi-center Phase 3b
study designed to evaluate the safety and efficacy of a 12-week regimen of
telaprevir tablets in combination with pegylated-interferon and ribavirin in
people with genotype 1 chronic HCV infection who have the IL28B CC genotype.
In this study, telaprevir was dosed as three 375mg tablets twice daily. The
study includes 239 people with hepatitis C who are new to treatment as well as
those who relapsed after at least one prior course of treatment with
pegylated-interferon and ribavirin alone. The primary endpoint of the study is
the proportion of randomized people who achieve a sustained viral response
(HCV RNA < lower limit of quantification) 12 weeks after the last planned dose
of study drug (SVR12). All study participants were assigned to receive
telaprevir in combination with pegylated-interferon and ribavirin for 12
weeks. People who continued all study drugs for 12 weeks and achieved a rapid
viral response to treatment (measured as undetectable HCV RNA at week 4) were
randomized 2:1 to receive no further treatment or an additional 12 weeks of
pegylated-interferon and ribavirin alone. People who did not achieve a rapid
viral response or who did not continue all study drugs for 12 weeks were
assigned a total pegylated-interferon and ribavirin treatment duration of 24
or 48 weeks based on virologic response.
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 60,000 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) are prescribed 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 treatment
with P/R alone.
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^® (telaprevir) should always be used in combination with peginterferon
alfa and ribavirin. INCIVEK combination treatment may cause serious side
effects including skin rash and serious skin reactions, anemia (low red blood
cell count) that can be severe, and birth defects or death of an unborn baby.
Skin rashes are common with INCIVEK combination treatment. Sometimes these
skin rashes and other skin reactions can become serious, require treatment in
a hospital, and may lead to death. Patients should call their healthcare
provider right away if they develop any skin changes during treatment with
INCIVEK. Their healthcare provider will decide if they need treatment or if
they need to stop INCIVEK or any of their other medicines. Patients should not
stop taking INCIVEK combination treatment without talking with their
healthcare provider first.
Patients' healthcare providers will do blood tests regularly to check for
anemia. If anemia is severe, the healthcare providers may tell them to stop
INCIVEK combined with peginterferon alfa and 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. Females who can become pregnant and
females whose male partner takes these medicines must have a negative
pregnancy test before starting treatment, every month during treatment, and
for 6 months after treatment ends. Patients must use two forms of effective
birth control during treatment and for 6 months after all treatment has ended.
These two forms of birth control should not contain hormones, as these 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.
The most common side effects of INCIVEK combination treatment include itching,
nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids,
discomfort , burning or itching around or near the anus), 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 provider about
any side effect that bothers them or doesn't go away.
Please see full Prescribing Information including Boxed Warning, and the
Medication Guide for INCIVEK 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.^2 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 Unlike HIV and hepatitis B virus, chronic hepatitis C
can be cured.^3 If treatment is not successful and a person does not achieve a
viral cure, they remain at an increased risk for progressive liver
More than 170 million people worldwide are chronically infected with hepatitis
C.^6 In the United States, up to 5 million people have chronic hepatitis C and
75 percent of them are unaware of their infection.^7,8 Hepatitis C is four
times more prevalent in the United States compared to HIV.^8 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.^9 Hepatitis C is the
leading cause of liver transplantations in the United States and is reported
to contribute to 15,000 deaths annually.^10,11 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.^12
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.
^1 One person had genotype 6 HCV infection and was excluded from the efficacy
analysis but included in the safety analysis.
^2 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 March 29, 2013.
^3 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.
^4 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).
^5 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.
^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 Chak, E, et. al. Hepatitis C Virus Infection In USA: An Estimate of True
Prevalence. Liver Intl. 2011;1096 -1098.
^8 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 March 29, 2013.
^9 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.
^10 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral
therapy for hepatitis C in the United States. Hepatology.
^11 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.
^12 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
Accessed March 29, 2013.
Vertex Pharmaceuticals Incorporated
Erin Emlock, 617-341-6992
Nikki Levy, 617-341-6992
Michael Partridge, 617-341-6108
Kelly Lewis, 617-961-7530
Press spacebar to pause and continue. Press esc to stop.