ldv/sof 90/400 mg qd non-randomised open-label n = 21 w12 svr 12 niaid synergy gt4 kohli a. lancet...
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LDV/SOF 90/400 mg qd
Non-randomisedOpen-label
N = 21
W12
SVR12
NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print
≥ 18 yearsChronic HCV Genotype 4
Treatment-naïve or experienced
HCV RNA ≥ 2,000 IU/mlCompensated cirrhosis
allowedNo HBV or HIV co-infection
Design
Objective– SVR12 (HCV RNA < 12 IU/ml), with 95% CI, by intention-to-treat analysis
NIAID SYNERGY GT4 Study: LDV/SOF in genotype 4
Stopping rule : HCV RNA detectable with < 2 log10 IU/ml reduction at W4
LDV/SOF 12WN = 21
Mean age, years 55
Female 33%
White / Black 52% / 43%
Genotype : 1a / 1b 55% / 45%
Fibrosis stage 0-2 / 3 / 4 57% / 10% / 33%
HCV RNA > 800,000 IU/ml 62%
Treatment-experienced : (IFN or PEG-IFN) + RBV), n (%) 8 (38%)
Relapse, n 3
Null response, n 1
Non response, n 4
SVR12 (HCV RNA < 12 IU/ml), % (95% CI) 95% (76-100) *
Relapse 0* Patient with failure : non adherent, withdrew from study
Baseline characteristics and outcome
NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print
NIAID SYNERGY GT4 Study: LDV/SOF in genotype 4
LDV/SOF 12WN = 21
Serious adverse event 0
Discontinuation for adverse event 0
Adverse events in ≥ 10% of patients
Diarrhea 2
Fatigue 3
Nausea 2
Upper respiratory infection 2
Grade 3 laboratory abnormalities 5
Decreased absolute neutrophil count 1
Hyperglycemia (patients with type 2 diabetes) 2
Hypophosphatemia (prior history of hypophosphatemia) 1
Thrombocytopenia (Grade 2 at baseline) 1
Adverse events, N
NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print
NIAID SYNERGY GT4 Study: LDV/SOF in genotype 4
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
NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print
NIAID SYNERGY GT4 Study: LDV/SOF in genotype 4