A 12-week regimen of elbasvir/grazoprevir is an effective treatment option for patients with hepatitis C genotype 1b, according to results published online in the Journal of Gastroenterology.
The retrospective analysis included data from 11 phase 2/3 clinical trials:
- C-SURFER (ClinicalTrials.gov identifier: NCT02092350)
- C-EDGE Co-Infection (ClinicalTrials.gov identifier: NCT02105662)
- C-EDGE treatment-naive (ClinicalTrials.gov identifier: NCT02105467)
- C-EDGE treatment-experienced (ClinicalTrials.gov identifier: NCT02105701)
- C-WORTHy (ClinicalTrials.gov identifier: NCT01717326)
- C-CORAL (ClinicalTrials.gov identifier: NCT02251990)
- C-EDGE COSTAR (ClinicalTrials.gov identifier: NCT02105688)
- C-EDGE IBLD (ClinicalTrials.gov identifier: NCT02252016)
- C- SALT (ClinicalTrials.gov identifier: NCT02115321)
- Japan phase 2/3 study (ClinicalTrials.gov identifier: NCT02203149)
- C-EDGE Head-2-Head (ClinicalTrials.gov identifier: NCT02358044)
The studies included participants with hepatitis C genotype 1b who received elbasvir 50 mg plus grazoprevir 100 mg once daily for 12 weeks (n=1070). Each study included in the analysis had a primary end point of sustained virologic response 12 weeks after completion of therapy (hepatitis C RNA < 15 IU/mL).
After 12 weeks, 97.2% (n=1040) of participants achieved sustained virologic response. Of the 30 participants who did not achieve sustained virologic response, 15 relapsed and 15 had nonvirologic failure.
Sustained virologic response rates were high for patients with compensated cirrhosis (188 of 189, 99.5%), HIV coinfection (51 of 54, 94.4%), and baseline viral load >800,000 IU/mL (705 of 728, 96.8%).
Serious adverse events occurred in 3.2% (n=34) participants, 9 of which occurred in the follow-up period.
The researchers conclude, “EBR/GZR for 12 weeks represents a highly effective treatment option for cirrhotic people with HCV GT1b infection, without the need for a ribavirin-containing regimen.” They also discussed that, “SVR12 was high in treatment-naive and -experienced participants, and remained >95% regardless of race, sex, baseline viral load, HIV co-infection, or presence of compensated cirrhosis”.
Stefan Zeuzem has served a consultant for AbbVie, BMS, Gilead, Janssen, and Merck/MSD. Lawrence Serfaty has received personal fees from MSD, Gilead, Janssen, Bristol-Myers Squibb, and AbbVie. John Vierling has received grants or other payments from AbbVie, Bristol-Myers Squibb, Conatus, Genentech, Genentech, Gilead, Gilead, Merck, Novartis, and Sundise. Wendy Cheng has received personal fees from Merck for participation on a Medical Education Expert Input Forum. Jacob George has received personal fees from MSD, AbbVie, Gilead, Pharmaxis, and Bristol-Myers Squibb. Jan Sperl has received research grants from Gilead and Janssen-Cilag and personal fees for speaker/advisor roles with Gilead, Janssen-Cilag, Merck, and AbbVie. Simone Strasser has received personal fees from MSD/Merck, Gilead Sciences, AbbVie, Bristol-Myers Squibb, and Janssen. Hiromitsu Kumada has received grants from MSD KK during the conduct of the study and personal fees from MSD KK, GSK, Tanabe-Mitsubishi, Bristol-Myers Squibb, and Janssen and has a patent SRL licensed. Peggy Hwang, Michael Robertson, Janice Wahl, Eliav Barr, Rohit Talwani, and Heather Platt are employees of and hold stock in Merck & Co., Inc.
Zeuzem S, Serfaty L, Vierling J, et al. The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection. [published online January 17, 2018] J Gastroenterol. doi: 10.1007/s00535-018-1429-3