Phase 3 Results of Hepatitis C Study: Superior Sustained Viral Response Rates Achieved With Telaprevir-Based Combination Therapy
Outcomes Achieved Regardless of Race or Stage of Liver Disease<br /><br />Overall Rates of Discontinuation for Side Effects Were Lower Than in the Earlier Studies<br /><br />NewYork-Presbyterian/Weill Cornell's Dr. Ira Jacobson Presents Pivotal Results at Annual Meeting of American Association for the Study of Liver Diseases
Nov 2, 2010
For patients with the most common form of hepatitis C being treated for the first time, the addition of an investigational hepatitis C–specific protease inhibitor called telaprevir to the current standard therapy markedly improved their sustained viral response (SVR or viral cure) rate.
The lead investigator reporting the results of the ADVANCE trial is Dr. Ira M. Jacobson, chief of the Division of Gastroenterology and Hepatology at NewYork–Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College. Dr. Jacobson presented these pivotal Phase III results today at the 61st Annual Meeting of the American Association for the Study of Liver Diseases in Boston.
Dr. Jacobson noted that 75 percent of patients treated with a telaprevir–based combination regimen for 12 weeks, followed by 12 or 36 weeks of the standard therapy of pegylated–interferon alfa–2a and ribavirin alone, achieved a viral cure. This compared to 44 percent of people treated with 48 weeks of pegylated–interferon and ribavirin alone. In addition, new data from the study showed that 62 percent of African–Americans achieved a viral cure with the telaprevir–based regimen compared to 25 percent of African–Americans who were treated with pegylated–interferon and ribavirin alone. Additionally, 62 percent of patients with advanced liver fibrosis (cirrhosis or scarring of the liver) achieved a viral cure with the telaprevir regimen compared to 33 percent who were treated with pegylated–interferon and ribavirin alone.
"These groundbreaking data, showing sustained viral response in 75 percent of patients who received 12 weeks of telaprevir combination therapy, highlight telaprevir as a potential new therapy that, if approved by the FDA, could dramatically improve the future treatment of hepatitis C," says Dr. Jacobson, who is also a hepatologist and Medical Director the Center for the Study of Hepatitis C at NewYork–Presbyterian Hospital/Weill Cornell Medical Center. "In contrast to the standard treatment time of 48 weeks, the majority of patients who achieved sustained viral response in the ADVANCE study received only 24 weeks of total therapy."
The results confirm the findings of the U.S. phase 2 PROVE1 study, which was co–authored by Dr. Jacobson, and the European PROVE2 study; both studies were published in the April 30, 2009 New England Journal of Medicine. Overall rates of discontinuation for side effects were lower in ADVANCE than in the earlier studies.
The most common adverse events (>25% of people) reported in both studies, regardless of treatment arm, were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, influenza–like symptoms and pyrexia. The majority of these adverse events were mild to moderate.
Telaprevir is being developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex provided funding for the study. Dr. Jacobson has received consulting fees and/or grant support from Vertex, Roche (maker of peginterferon) and Schering–Plough (maker of ribavirin).
Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the hepatitis C virus (HCV), which is spread primarily through contact with the blood of an infected person. HCV is a serious public health concern, affecting 3.4 million individuals in the United States. There are six major genotypes of the hepatitis C virus, which are indicated numerically. About 70 percent of hepatitis C patients in the United States have genotype 1. Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person's risk for developing chronic liver disease, cirrhosis or death. It is the leading reason for liver transplantation in the United States. Co–infection with HIV is common, and rates among HIV positive populations are higher. Many but not all people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs, or by having received a blood transfusion over 20 years ago.
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NewYork–Presbyterian Hospital/Weill Cornell Medical Center
NewYork–Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork–Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork–Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. 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.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain–injured patient. NewYork–Presbyterian Hospital also comprises NewYork–Presbyterian Hospital/Columbia University Medical Center, NewYork–Presbyterian/Morgan Stanley Children's Hospital, NewYork–Presbyterian Hospital/Westchester Division and NewYork–Presbyterian/The Allen Hospital. 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.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit www.nyp.org and www.med.cornell.edu.
Linda Kamateh 212-821-0560 [email protected]