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LDV/SOF 90/400 mg qd Non-randomised Open-label N = 21 W12 SVR 12 NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print ≥ 18 years Chronic HCV Genotype 4 Treatment-naïve or experienced HCV RNA ≥ 2,000 IU/ml Compensated cirrhosis allowed No HBV or HIV co-infection Design Objective –SVR 12 (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 W4
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LDV/SOF 12W N = 21 Mean age, years55 Female33% White / Black52% / 43% Genotype : 1a / 1b55% / 45% Fibrosis stage 0-2 / 3 / 457% / 10% / 33% HCV RNA > 800,000 IU/ml62% Treatment-experienced : (IFN or PEG-IFN) + RBV), n (%)8 (38%) Relapse, n3 Null response, n1 Non response, n4 SVR 12 (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; Juky 15, ePub ahead of print NIAID SYNERGY GT4 Study: LDV/SOF in genotype 4
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LDV/SOF 12W N = 21 Serious adverse event0 Discontinuation for adverse event0 Adverse events in ≥ 10% of patients Diarrhea2 Fatigue3 Nausea2 Upper respiratory infection2 Grade 3 laboratory abnormalities5 Decreased absolute neutrophil count1 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
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Summary –Patients with chronic HCV genotype 4 infection were successfully treated with a 12 week course of LDV/SOF SVR 12 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
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