ldv/sof 90/400 mg qd non-randomised open-label n = 21 w12 svr 12 niaid synergy gt4 kohli a. lancet...

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



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



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



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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