qd Nonrandomised Openlabel N 21 W12 SVR 12 NIAID SYNERGY GT4 Kohli A Lancet Infect Dis 2015 Sep159104954 18 years Chronic HCV Genotype 4 Treatmentnaïve or experienced ID: 602817
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Slide1
LDV/SOF 90/400 mg
qd
Non-randomisedOpen-label
N = 21
W12
SVR
12
NIAID
SYNERGY GT4
Kohli
A. Lancet Infect Dis. 2015 Sep;15(9):1049-54
≥ 18 yearsChronic HCV Genotype 4Treatment-naïve or experiencedHCV RNA ≥ 2,000 IU/mlCompensated cirrhosis allowedNo HBV or HIV co-infection
Design
ObjectiveSVR12 (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 log
10
IU/ml
reduction
at
W4Slide2
LDV/SOF 12W
N = 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, n3Null response, n1Non response, n4SVR12 (HCV RNA < 12 IU/ml), % (95% CI)95% (76-100) *Relapse0
* Patient with failure : non adherent, withdrew from study
Baseline characteristics and outcome
NIAID SYNERGY GT4
Kohli A. Lancet Infect Dis. 2015 Sep;15(9):1049-54
NIAID SYNERGY
GT4
Study
: LDV/SOF
in
genotype
4Slide3
LDV/SOF 12W
N = 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
5Decreased absolute neutrophil count1Hyperglycemia (patients with type 2 diabetes)2Hypophosphatemia (prior history of hypophosphatemia)1Thrombocytopenia (Grade 2 at baseline)1
Adverse events,
N
NIAID SYNERGY GT4
Kohli A. Lancet Infect Dis. 2015 Sep;15(9):1049-54
NIAID SYNERGY
GT4
Study
: LDV/SOF
in
genotype
4Slide4
Summary
Patients with chronic HCV genotype 4 infection were successfully treated with a 12 week course of LDV/SOFSVR12 was 100% for patients who received all 12 weeks of study drugs, irrespective of previous treatment status and underlying liver fibrosisAll 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.LimitationsSmall sample sizeNo
randomisationNIAID
SYNERGY GT4
Kohli A. Lancet Infect Dis. 2015 Sep;15(9):1049-54NIAID SYNERGY GT4
Study: LDV/SOF in
genotype 4