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Vertex Announces Presentation of New Data from Hepatitis C Development Program at AASLD Annual Meeting
These accepted abstracts are now available on the AASLD website at: https://www.aasld.org/lm2012.
ALS-2200 (VX-135) Presentations
1. "ALS-2200, a Novel Once-Daily Nucleotide HCV Polymerase Inhibitor,
Demonstrates Potent Antiviral Activity over 7 Days in Treatment-Naïve
Genotype 1 (GT1) Patients."
2. "Preclinical Characterization of ALS-2200, a Potent Nucleotide
Polymerase Inhibitor for the Treatment of Chronic Hepatitis C."
3. "Analysis of ALS-2200, a Novel Potent Nucleotide Analog, Combination
Drug Interactions in the Hepatitis C Virus (HCV) Subgenomic Replicon
INCIVEK (telaprevir) Presentations
1. "Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in
HCV/HIV Co-infected Patients: SVR24 Final Study Results."
2. "Evaluation of Liver and Plasma HCV RNA Kinetics and Telaprevir
Levels in Genotype 1 HCV Patients Treated with Telaprevir using Serial
Fine Needle Aspirates."
3. "The Safety of Telaprevir in the Absence of Interferon and/or
Ribavirin: Analysis of On-Treatment Data from the ZENITH Trial."
4. "Factors Predictive of
5. "Rate of Disappearance of Telaprevir Resistant Variants Using Clonal
and Population Sequence Data from Phase 3 Studies."
6. "Deep Sequencing of the HCV NS3/4A Region Confirms Low Prevalence of
the Telaprevir-Resistant Variants Both at Baseline and End of Study."
1. "VX-222, Telaprevir and Ribavirin in Treatment-Naïve Patients with
Genotype 1 Chronic Hepatitis C: Results of the ZENITH Study
2. "Effect of Hepatic Impairment on the Pharmacokinetics of VX-222:
Results From a Multicenter Phase 1 Study."
About ALS-2200 (VX-135) and VX-222
ALS-2200 (VX-135) is a uridine nucleotide analogue pro-drug that appears
to have a high barrier to drug resistance based on in vitro
studies. It is designed to inhibit the replication of the hepatitis C
virus by acting on the NS5B polymerase. In vitro studies of the
compound showed antiviral activity across all genotypes, or forms, of
the hepatitis C virus, including genotypes more prevalent outside of
Vertex gained worldwide rights to ALS-2200 through an exclusive
worldwide licensing agreement signed with
VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. Vertex has worldwide commercial rights for VX-222.
INCIVEK® (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.
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 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
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.
2 Pearlman BL and
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 Chak, E, et. al.
11 Smith, BD, et al. Hepatitis C Virus Antibody Prevalence,
Correlates and Predictors among Persons Born from 1945 through 1965,
12 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact
of antiviral therapy for hepatitis C in
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