NIAID ERADICATE Open-label W12 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve HIV infection on stable ART ≥ 8 weeks and HIV RNA < 50 c/ml.

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Presentation transcript:

NIAID ERADICATE Open-label W12 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve HIV infection on stable ART ≥ 8 weeks and HIV RNA < 50 c/ml and CD4 ≥ 100/mm 3 or no ART and CD4 ≥ 500/mm 3 No cirrhosis Osinusi A. JAMA 2015; 313: Acceptable ARV : FTC/TDF + EFV or RAL or RPV LDV/SOF 90mg/400 mg : 1 pill qd  Objective –Primary endpoint : SVR 12 (HCV RNA < 12 IU/ml) by intention to treat, with 2-sided 95% CI LDV/SOF SVR 12 N = 50  Design NIAID ERADICATE Study: LDV/SOF for genotype 1 in HIV co-infection

N = 50 Median age, years58 Female26% BMI, kg/m 2, median26 IL28B CC genotype16% HCV RNA log 10 IU/ml, median6.0 Genotype 1a / 1b78% / 20% CD4 cells/mm 3 < ≥ 350 2% 18% 80% No ART ART : EFV / RAL / RPV / RAL + RPV / RAL + EFV 26% 30% / 20% / 13% / 11% / 4% / 2% HCV RNA < 12 IU/ml on treatment : W4 / W8 / W12100% / 100% / 100% SVR 12, N (%)49/50 (98%) Relapse, N (%)1 (2%) = genotype 1b, IL28B TT Resistance testing (deep sequencing) in relapse NS5A NS5B baseline : Y93H, relapse : Y93H No S282T Baseline characteristics and outcome NIAID ERADICATE Osinusi A. JAMA 2015; 313:1232-9

NIAID ERADICATE Study: LDV/SOF for genotype 1 in HIV co-infection  Adverse events –Serious adverse events : 1 (pneumonia) –No discontinuation due to adverse event –Common adverse events, mostly grade 1 : Nasal congestion 16%) Myalgia (14%) Headache (10%) Fatigue (10%) Diarrhea (8%) Nausea (6%) Constipation (6%) Urinary tract infection (6%) –Grade 4 events : 4 (pneumonia, decrease neutrophil count, elevated AST, CK elevation) –No significant changes in serum creatinine or eGFR NIAID ERADICATE Osinusi A. JAMA 2015; 313:1232-9

NIAID ERADICATE Study: LDV/SOF for genotype 1 in HIV co-infection  Summary –In this open-label, uncontrolled, non randomised study, LDV/SOF single tablet regimen was associated with high rates of SVR in patients with HCV genotype 1 and HIV co-infection, similar to that observed inpatients monoinfected with HCV genotype 1 –Most adverse events were mild (grade 1-2) and clinically manageable –Limitations Low sample size Exclusion of cirrhosis Restriction in antiretroviral regimen (exclusion of PI and NNRTI) Exclusion of patients with low CD4 cell counts NIAID ERADICATE Osinusi A. JAMA 2015; 313:1232-9