- A truncated 8-week course of elbasvir/grazoprevir (EBR/GZR; Zepatier) may be appropriate for treatment-naive patients with low HCV-1b viral loads or without significant NS5A resistance-associated substitutions (RAS) and mild fibrosis.
Why this matters
- Abbreviated regimens can lower cost and enhance compliance.
- EGALITE trial of 82 patients with HCV-1b and mild or moderate (20.7%) fibrosis, randomly assigned to receive 8 or 12 weeks of EBR/GZR based on viral load and IL28B genotype.
- Primary endpoint: sustained virologic response at 12 weeks posttherapy (SVR12).
- Funding: Merck & Co., Inc., Kenilworth, NJ, USA, Taiwan Liver Research Foundation, Kaohsiung Medical University and University Hospital, Taiwan Ministry of Health and Welfare.
- SVR12 rates were similar with the 8- and 12-week regimens (87.8% vs 100.0%; P=.055).
- Per-protocol analysis: 90.0% vs 100% (P=.055).
- 8-week course yielded a lower SVR12 rate in presence of high baseline viral load (>1.5 million IU/mL: 79.0% vs 100.0%; P=.042) and baseline NS5A-Y93 RAS >15% (40.0% vs 97.1%; P=.004).
- 12-week course was more effective with both factors (100% vs 40.0%; P=.002).
- 5 patients relapsed after the 8-week course (vs 12 weeks, 0); 1 had HCV-6; the other 4 had Y93 RAS >99% at posttreatment week 12.
- IL28B genotype was not prognostic (P=1.00).
- Open-label design.
- Elastography-defined fibrosis.