The Liver Meeting 2016 Hep C Abstract Highlights (Part1)

The Liver Meeting 2016 Hep C Abstract Highlights (Part1)The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

Hepatitis C Treatment Topics to be Presented at The Liver Meeting 2016 (Part I)

  • GS-4997, an Inhibitor of Apoptosis Signal-Regulating Kinase (ASK1), Alone or in Combination with Simtuzumab for the Treatment of Nonalcoholic Steatohepatitis (NASH): A Randomized, Phase 2 Trial, by Rohit Loomba, et al. (LB-3)

Summary: “ASK1 is a serine threonine kinase that promotes hepatic inflammation and fibrosis in the setting of oxidative stress. Our aim was to describe the preliminary efficacy of GS-4997, a selective inhibitor of ASK1, alone or in combination with simtuzumab (SIM), in patients with NASH and moderate to severe liver fibrosis.” (Loomba, et al.) This study found that a 24-week course of GS-4997 reduced liver fibrosis and lowered hepatic stiffness in patients with NASH and moderate to severe fibrosis.

  • EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults with renal impairment and Chronic Hepatitis C Virus Genotype 1 – 6 Infection, by Edward J. Gane, et al. (LB-11)

Summary: Currently, severe renal impairment still limits treatment options for those with hepatitis C. This study showed that a fixed dose of GLE/PIB (glecaprevir/pibrentasvir) taken once  a day for 12 weeks was well tolerated by patients with severe renal impairment, without any serious side effects. 99% of patients achieving SVR4, hep C cure.

  • A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study, by Ira M. Jacobson, et al. (LB-12)

Summary: This study compared treatment with sofosbuvir/velpatasvir/voxilaprevir for 8 weeks with treatment with sofosbuvir/velpatasvir (brandname Epclusa) for 12 weeks in patients with genotype 1-6 hepatitis C, who had or didn’t have liver cirrhosis, and who hadn’t previously been treated with a direct-acting antiviral agent (DAA). The most common side effect were headache, fatigue, diarrhea and nausea while taking SOF/VEL, and diarrhea and nausea while taking SOF/VEL/VOX.
Clinical Trial Results:

SVR4 % Total GT1 GT2 GT3 GT4 GT5 GT6 Other
SOF/VEL/VOX 8 Weeks 96 (482/ 501) 95 (221/ 233) 97 (61/ 63) 100 (92/ 92) 94 (17/ 18) 94 100 (30/ 30) 100 (2/2)
SOF/VEL 12 Weeks 98 (432/ 440) 99 (229/ 232) 100 (53/ 53) 97 (86/ 89) 96 (55/ 57) 100 (9/9)
  • A Novel Single Daily Fixed Dose Combination of Sofosbuvir 400 mg + Ribavirin 1000mg + EGCG400 mg is Superior to the Standard of Care as an Anti-Viral and Safer Causing less Hemolysis in Patients with Chronic Hepatitis C, by Gamal Shiha, et al. (LB-14)

Summary: Sofosbuvir has improved hep C treatments and outcomes, however, it is extremely costly and there is a risk of selecting viral escape mutants so a new combination, focusing on other steps in the infection process, may be better. Therefore, EHCV (Catvira) formulation composed of sofosbuvir / ribavirin / epigallocatechin gallate 400 mg (EGCG) is being developed. SVR 12 and SVR 24 for EHCV (Catvira) show results similar to those reached by the current standard of care, but with a much faster rate of viral load decline, for both treatment experienced and treatment naive genotype 4 hep C patients.

  • Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients with HCV Genotype 2, 4, 5, or 6 Infection without Cirrhosis Following an 8-Week Treatment Duration (SURVEYOR-II, Part 4), by Tarek I. Hassanein, et al. (LB-15)

Summary: The hepatitis C virus genotypes (GTs) 2, 4, 5 and 6 are everywhere and together make up approximately 23% of global hep C infections. With these genotypes being so widespread, it is important to have treatments and improving treatments for them as well. In previous phase 2 studies, SVR12 rates of 98% and 100% were achieved following treatment with GLE/PIB for 8 weeks in GT2 infected patients or 12 weeks in GT 4-6 infected patients. This study, SURVEYOR-II Part 4, looked at the safety and efficacy of 8-week GLE/PIB treatment in patients with GT4-6 infection, and a larger group of GT2-infected patients.  The study’s results were as follows:

SVR4 % Total GT2 GT4 GT5 GT6
GLE/PIB 8 Weeks 98 97 (141/145) 98 (45/46) 100 (2/2) 100 (10/10)

Lastly, more information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.