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EASL 2012: International Liver Congress Focuses on Hepatitis C Treatment, Metabolic Liver Disease

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The 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012) brought together more than 9000 participants this week in Barcelona to discuss the latest research in the field of liver disease.

This year's International Liver Congress is the largest to date, largely reflecting an increased interest in hepatitis C treatment spurred by the development of direct-acting antiviral (DAA) agents.

An opening press conference on Thursday highlighted new data showing the growing burden of liver disease in Europe. People infected with hepatitis C virus (HCV) years or decades ago are now developing advanced liver disease including cirrhosis and hepatocellular carcinoma (HCC).

EASL Vice Secretary Markus Peck from the Medical University of Vienna reported that liver disease accounts for 1.8% of deaths in the European Union, representing an estimated 170,000 people per year. The burden of disease could be reduced by expanded screening and treatment for viral hepatitis and policies that discourage excessive alcohol consumption.

Metabolic liver disease is also a growing concern, as obesity rates in European countries approach those in the U.S. Frank Lammert from Saarland University Hospital noted that a significant proportion of people with fatty liver disease develop HCC without first developing cirrhosis. He reported new data from Denmark showing that children with high body mass index (BMI) have a higher risk of developing liver cancer as adults.

EASL Secretary General Mark Thursz presented some highlights of conference presentations on interferon-free DAA regimens for hepatitis C. With regard to difficult side effects, interferon treatment "is a bit like [cancer] chemotherapy, not a course of antibiotics," he said.

Thursz reviewed promising findings from studies of several all-oral regimens in various patient populations:

  • HCV NS5B polymerase inhibitorGS-7977 + ribavirin (ELECTRON);
  • GS-7977 + HCV NS5A replication complex inhibitor daclatasvir;
  • HCV protease inhibitor BI201335 + polymerase inhibitor BI207127 (SOUND-C2);
  • Ritonavir-boosted HCV protease inhibitor ABT-450 + non-nucleoside polymerase inhibitor ABT-333 + ribavirin.

"I can imagine the first interferon-free regimen being available in 2 years," Thursz said, "but don’t hold me to it."

Until then, a more tolerable option may be pegylated interferon lambda, now in Phase 2b testing. Receptors for this type of interferon are expressed on fewer cell types, mainly in the liver, suggesting it may cause fewer systemic adverse events. In the EMERGE trial, pegylated interferon lambda suppressed HCV as well as pegylated interferon alfa but was associated with fewer side effects, especially musculoskeletal and flu-like symptoms.

Finally, Thursz discussed use of early sustained virological response (SVR) data. Traditionally, SVR24 -- or continued undetectable HCV RNA at 24 weeks after the end of treatment -- has been considered the "gold standard" for a cure. Regulatory authorities in the U.S. and Europe recently decided that 12-week SVR data (SVR12) were acceptable for demonstrating effectiveness in clinical trials. Some studies, however, have started to report 4-week SVR findings, which Thursz cautioned may not be long enough to detect relapse.

A representative from the European Liver Patients Association (ELPA) spoke at the presser to emphasize the need for more clinical trials of new therapies for hepatitis C patients with the greatest need and highest risk of progression to end-stage liver disease and death, including those with cirrhosis and people with HIV/HCV coinfection.

4/20/12

References

TL Berentzen, M Gamborg, C Holst, et al. Childhood Body Size and the Risk of Hepatocellular Carcinoma. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012. Abstract 110.

EJ Gane, CA Stedman, RH Hyland, et al. ELECTRON: Once Daily PSI-7977 plus RBV in HCV GT1/2/3. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012. Abstract 1113.

M Sulkowski, D Gardiner, E Lawitz, et al. Potent Viral Suppression with All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (NS5B Inhibitor), +/-Ribavirin, in Treatment-Naive Patients with Chronic HCV GT1, 2, or 3. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012. Abstract 1422.

V Soriano, E Gane, P Angus, et al. The Efficacy and Safety of the Interferon-free Combination of BI201335 and BI207127 In Genotype 1 HCV Patients With Cirrhosis - Interim Analysis From SOUND-C2. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012. Abstract 1420.

E Lawitz, F Poordad, KV Kowdley, et al. A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subject. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012. Abstract 13.

S Zeuzem, A Arora, B Bacon, et al. Peginterferon Lambda-1a (Lambda) Compared to Peginterferon Alfa-2a (Alfa) in Treatment-Naive Patients with HCV Genotypes (G) 2 or 3: First SVR24 Results From Emerge Phase IIb. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012. Abstract 10.

JM Pawlotsky, SK Sarin, G Foster, et al. Alisporivir plus Ribavirin is Highly Effective as Interferon-Free or Interferon-Add-On Regimen in Previously Untreated HCV-GT2 or GT3 patients: SVR12 results from VITAL-1 Phase 2b. 47th Annual Meeting of the European Association for the Study of the Liver (EASL 2012). Barcelona, April 18-22, 2012.Abstract 1405.