Consisting of pegylated interferon and ribavirin, the currently approved Hepatitis C antiviral treatment is only about 50 percent effective for those with the most common genotype in America — Hepatitis C genotype 1. With an estimated four to five million Americans at risk of advanced liver disease because of chronic infection with the Hepatitis C virus, a 50 percent success rate is far too low.
Also referred to as combination therapy, experts have been predicting for a while that pegylated interferon and ribavirin need a third medication to increase the chance for curing Hepatitis C. The specifics of the three studies differ slightly from one another. The three Phase III trials designed to test telaprevir, include:. For the purpose of defining what successful Hepatitis C treatment entails, investigators and clinicians use a sustained viral response SVR as their determination of success.
SVR is considered to be attained if zero Hepatitis C genetic material is detectable immediately following the end of treatment and 24 weeks after the end of treatment. The announcement included:. Since the addition of telaprevir to the current standard Hepatitis C treatment yields far better results in about half the time, many currently infected people are eagerly anticipating this treatment being available to the public.
McHutchison and Dr. Andrew J. Adrian M. Natalie H. Ruben A. Eric M. Nathalie Adda, Leif Bengtsson, Dr. Abdul J. Sankoh, Dr. Tara L. Kieffer, Dr. Shelley George and Dr. Robert S. Weill Cornell physician-scientists have been responsible for many medical advances — including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.
NewYork-Presbyterian is the 1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.
In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. For more information, visit www. Read our disclaimer for details. Results First Posted : July 21, Last Update Posted : August 8, Study Description. A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a Peg-IFN-alfa-2a and ribavirin RBV.
FDA Resources. Arms and Interventions. Outcome Measures. FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 higher scores indicated higher influence of fatigue. AE: any adverse change from the subject's baseline pre-treatment condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med.
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