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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 -
"INCIVEK is the most prescribed direct-acting antiviral for the
treatment of hepatitis C with more than 50,000 people in
"OPTIMIZE trial: Non-inferiority of twice-daily telaprevir versus
administration every 8 hours in treatment-naïve, genotype 1 HCV infected
Poster Presentation #LB-8
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
"Telaprevir in combination with peginterferon alfa-2a/ribavirin in
HCV/HIV co-infected patients: SVR24 final study results."
Oral Presentation #54
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
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
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 alone.
INCIVEK was approved by the
Vertex developed telaprevir in collaboration with Janssen and Mitsubishi
Tanabe Pharma. Vertex has rights to commercialize telaprevir in
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
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 and other life-threatening diseases.
Founded more than 20 years ago in
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
2 Pearlman BL and
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.
8 Smith, BD, et al. Hepatitis C Virus Antibody Prevalence,
Correlates and Predictors among Persons Born from 1945 through 1965,
9 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact
of antiviral therapy for hepatitis C in
10 Ly KN, et al. The Increasing Burden of Mortality From
Viral Hepatitis in
11 Pyenson B, Fitch K, and
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