NIAID ERADICATE Open-label W12 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve HIV...
4
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; 313:1232-9 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
-
Upload
ruby-morton -
Category
Documents
-
view
213 -
download
1
Transcript of NIAID ERADICATE Open-label W12 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve HIV...
NIAID ERADICATE
Open-label
W12≥ 18 years
Chronic HCV infectionGenotype 1
Treatment naïveHIV infection on stable ART ≥ 8 weeks and
HIV RNA < 50 c/ml and CD4 ≥ 100/mm3
or no ART and CD4 ≥ 500/mm3
No cirrhosis
Osinusi A. JAMA 2015; 313:1232-9
Acceptable ARV : FTC/TDF + EFV or RAL or RPVLDV/SOF 90mg/400 mg : 1 pill qd
Objective– Primary endpoint : SVR12 (HCV RNA < 12 IU/ml) by intention to treat, with 2-
sided 95% CI
LDV/SOF SVR12N = 50
Design
NIAID ERADICATE Study: LDV/SOF for genotype 1 in HIV co-infection
NIAID ERADICATE Study: LDV/SOF for genotype 1 in HIV co-infection
N = 50Median age, years 58
Female 26%
BMI, kg/m2, median 26
IL28B CC genotype 16%
HCV RNA log10 IU/ml, median 6.0
Genotype 1a / 1b 78% / 20%
CD4 cells/mm3
< 200200-350≥ 350
2%18%80%
No ARTART : EFV / RAL / RPV / RAL + RPV / RAL + EFV
26%30% / 20% / 13% / 11% / 4% / 2%
HCV RNA < 12 IU/ml on treatment : W4 / W8 / W12 100% / 100% / 100%
SVR12, N (%) 49/50 (98%)
Relapse, N (%) 1 (2%) = genotype 1b, IL28B TT
Resistance testing (deep sequencing) in relapseNS5ANS5B
baseline : Y93H, relapse : Y93HNo 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 eGFRNIAID 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
