Hepatitis C Study Shows Superior Viral Cure Rate

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Hepatitis C Study Shows Superior Viral Cure Rate

04 Nov 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. son, chief of the Division of Gastroenterology and

Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical

Center, and the Astor Distinguished Professor of Medicine at

Weill Cornell Medical College. Dr. son 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. son 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. son, 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. son, 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. son has

received consulting fees and/or grant support from Vertex, Roche

(maker of peginterferon) and Schering-Plough (maker of ribavirin).

Hepatitis C

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.

For more information, patients may call (866) NYP-NEWS.

Source:

Kamateh

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill

Cornell Medical College

Article URL: http://www.medicalnewstoday.com/articles/206564.php

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Bill Eastman

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