NIAID SYNERGY

NIAID SYNERGY GT4 Study: LDV/SOF in genotype 4
Ledipasvir and sofosbuvir for hepatitis C genotype 4: a proof-of-concept, single-centre, open-label phase 2a cohort study
Kohli A. Lancet Infect Dis. 2015 Sep;15(9):1049-54

Anti-HCV
Ledipasvir
Sofosbuvir
Genotype
4
Treatment history
Naive
IFN-Experienced

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Design


Stopping rule : HCV RNA detectable with < 2 log 10 IU/ml reduction at W4

Objective

  • SVR12 (HCV RNA < 12 IU /ml) , with 95% CI, by intention-to-treat analysis

Baseline characteristics and outcome


* Patient with failure : non adherent, withdrew from study

Adverse events, N

Summary

  • Patients with chronic HCV genotype 4 infection were successfully treated with a 12 week course of LDV/SOF
    • SVR12 was 100 % for patients who received all 12 weeks of study drugs, irrespective of previous treatment status and underlying liver fibrosis
    • All patients on therapy had HCV RNA below the lower limit of quantification by W4
  • This is the first report of a single-pill, all-oral, interferon-free, ribavirin-free treatment for patients with HCV genotype 4
  • Limitations
    • Small sample size
    • No randomisation