Direct-acting antivirals now ready for prime time

Interim analysis of a Phase II study show that an interferon (IFN)- and ribavirin (RBV)-free regimen of daclatasvir (NS5A inhibitor), asunaprevir (protease inhibitor) and BMS-791325 (non-nucleoside NS5B inhibitor) achieved, overall, an SVR4 of 92% (46/50), SVR12 of 94% (30/32), and SVR24 of 94% (15/16) in treatment-naive genotype (GT) 1 patients, mainly GT1a and IL28B non-CC. Patients were initially randomised (1:1) to daclatasvir 60mg QD, asunaprevir 200mg BID, and BMS-791325 75mg BID for a period of 24 or 12 weeks. Following one month of safety observation, a second cohort was randomized (1:1) to the same regimen but including BMS-791325 150mg BID (24 or 12 weeks). The primary end point was HCV RNA

AVIATOR

• Latest results from the AVIATOR study , using a combination of ABT-450/r (HCV protease inhibitor dosed with ritonavir 100 mg) with ABT-267 (NS5A inhibitor) and/or ABT-333 (non-nucleoside NS5B inhibitor) +/- ribavirin, demonstrate impressive SVR12 in patients with chronic HCV GT1 infection. The overall intention-to-treat SVR12 rate for 12-week treatment with three DAAs in combination with ribavirin was 98.7% (78/79) in treatment-nave patients, and 93% (42/45) in null responders.

EASL Secretary General Prof. Mark Thursz commented further: "With such high success rates and increased safety and tolerability with novel DAAs, patients can be optimistic about oral treatment regimens in the not-too-distant future."

Disclaimer: The data referenced in this release is based on the submitted abstract. More recent data may be presented at the International Liver Congress 2013.

###

Notes to Editors

Worldwide estimates indicate that approximately 200 million people are chronically infected with the hepatitis C virus and at risk of developing liver cirrhosis and/or liver cancer. Every year, 3 million people are infected with hepatitis C and more than 350,000 people die from hepatitis C-related liver diseases.

About EASL

EASL is the leading European scientific society involved in promoting research and education in hepatology. EASL attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

EASL's main focus on education and research is delivered through numerous events and initiatives, including:

• The International Liver CongressTM which is the main scientific and professional event in hepatology worldwide
• Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year
• Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of hepatology
• Journal of Hepatology published monthly
• Participation in a number of policy initiatives at European level

About The International Liver CongressTM 2013

The International Liver Congress 2013, the 48th annual meeting of the European Association for the study of the Liver, is being held at the RAI Convention Centre in Amsterdam from April 24 28, 2013. The congress annually attracts in excess of 9000 clinicians and scientists from around the world and provides an opportunity to hear the latest research, perspectives and treatments of liver disease from principal experts in the field.

1 Jacobson, I et al, TREATMENT WITH SOFOSBUVIR+RIBAVIRIN FOR 12 WEEKS ACHIEVES SVR12 OF 78% IN GT2/3 INTERFERON- INELIGIBLE, -INTOLERANT, OR -UNWILLING PATIENTS: RESULTS OF THE PHASE 3 POSITRON TRIAL. Presented at the International Liver Congress 2013

2 Lawitz, E et al, SOFOSBUVIR + PEGINTERFERON + RIBAVIRIN FOR 12 WEEKS ACHIEVES 90% SVR12 IN GENOTYPE 1, 4, 5, OR 6 HCV INFECTED PATIENTS: THE NEUTRINO STUDY. Presented at the International Liver Congress 2013

3 Ferenci, P et al, FALDAPREVIR PLUS PEGYLATED INTERFERON ALFA-2A AND RIBAVIRIN IN CHRONIC HCV GENOTYPE-1 TREATMENT-NAVE PATIENTS: FINAL RESULTS FROM STARTVERSO1, A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III TRIAL. Presented at the International Liver Congress 2013

4 Jacobson, I et al, SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAVE PATIENTS; RESULTS FROM QUEST-1, A PHASE III TRIAL. Presented at the International Liver Congress 2013

5 Manns M, et al, SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAVE PATIENTS; RESULTS FROM QUEST-2, A PHASE III TRIAL. Presented at the International Liver Congress 2013

6 Gane EJ, et al, ALL-ORAL SOFOSBUVIR-BASED 12-WEEK REGIMENS FOR THE TREATMENT OF CHRONIC HCV INFECTION: THE ELECTRON STUDY Presented at the International Liver Congress 2013

7 Everson, GT et al, INTERIM ANALYSIS OF AN INTERFERON (IFN)- AND RIBAVIRIN (RBV)-FREE REGIMEN OF DACLATASVIR (DCV), ASUNAPREVIR (ASV), AND BMS-791325 IN TREATMENT-NAIVE, HEPATITIS C VIRUS GENOTYPE 1-INFECTED PATIENTS. Presented at the International Liver Congress 2013

8 Kowdley, KV et al, SAFETY AND EFFICACY OF INTERFERON-FREE REGIMENS OF ABT-450/R, ABT-267, ABT-333 +/- RIBAVIRIN IN PATIENTS WITH CHRONIC HCV GT1 INFECTION: RESULTS FROM THE AVIATOR STUDY. Presented at the International Liver Congress 2013

9 EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. European Association for the Study of the Liver. Journal of Hepatology 2011;55:245

10 Hepatitis C Fact Sheet. World Health Organisation factsheet. Available at http://www.who.int/mediacentre/factsheets/fs164/en/index.html. Last accessed 28.03.13

---

[ | E-mail | Share ]

?

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Source: http://www.eurekalert.org/pub_releases/2013-04/eaft-dan042413.php

intc tupac andrew shaw hologram pulitzer prize winners nfl 2012 schedule gmail down