Tag Archives: MK-8408

Grazoprevir and Elbasvir at the Liver Meeting 2016

Grazoprevir and Elbasvir at the Liver Meeting 2016As we begin to look back on 2016, this post highlights some of the presentations that took place at the Liver Meeting 2016 about the hep C treatments grazoprevir and elbasvir.

Grazoprevir and Elbasvir

  • #74C-ISLE: Grazoprevir/Elbasvir plus Sofosbuvir in Treatment- naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks
Treatment Naive Treatment Experienced
Arm 1, 8 weeks + RBV Arm 2, 12 weeks without RBV Arm 3, 12 weeks without RBV Arm 4, 12 weeks with RBV Arm 5, 16 weeks without RBV
Treatment Week 4 87% 74% 71% 88% 71%
Treatment Week 8 100% 100% 100% 100% 100%
  • #76Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naive Subjects with Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial

Summary: Hepatitis C contributes significantly to the overall liver disease burden in the Asia Pacific region and Russia where the seroprevalence rates vary from 1-5% and genotype (GT) 1b accounts for about half of infections. Conclusion: A 12-week regimen of EBR/GZR is effective and well-tolerated in GT1 and GT4-infected, treatment-naive patients in the Asia Pacific/Russia region.

Genotype SVR12 Rate
Overall (232/250) 92.8%
GT1a (23/26) 88.5%
GT1b (185/187) 98.9%
GT4 (2/2) 100%
GT6 (22/35) 62.9%
  • #110Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST-1 & 2)

Summary: Treatment was generally well tolerated, with no cardiac or renal safety signals seen. One GT1-infected patient died due to a study drug-unrelated bacterial sepsis The most common side effects, in >5% of all patients, were fatigue, headache, and nausea.

Patients SVR8/12 Rate
126 GT1-infected patients who recieved 8 or 12 weeks of treatment 100%
85 patients (46 GT1a/39 GT1b) who received 12 weeks of therapy 100%
  • #112High Sustained Virologic Response (SVR) Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST-1 & 2)

Summary: To evaluate a retreatment regimen for patients who had failed therapy with a 3-drug direct-acting antiviral (DAA) combination: MK-3682, an NS5B polymerase inhibitor, grazoprevir, an NS3/4A protease inhibitor, and either elbasvir or MK-8408, which are NS5A inhibitors. All of the patients achieved SVR. The most common (>10%) side effects were headache, fatigue, nausea, rash, pruritus, insomnia, decreased hemoglobin, and cough.

  • #193Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE)

Summary: Patients who have failed an NS5A-containing DAA treatment regimen (Harvoni or Zepatier) are an unmet medical need because there isn’t enough data to guide physicians in their management. This study found that the treatment MK-3682/Grazoprevir/MK-8408 did well.

Arm Proportion of Patients with HCV RNA <15 IU/mL
Treatment Week 4 Treatment Week 8
16 weeks + RBV 39/42 (93%) 35/35 (100%)
24 weeks without RBV 44/49 (90%) 38/38 (100%)

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.