CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

526 HCV Ag Core’s Screening Performance in Mono-Infected, HIV- and HBV-Coinfected Patients Léa Duchesne 1 ; Richard Njouom 2 ; Frédéric L. Lissock 2 ; Ghislaine FloreTamko-Mella 2 ; Alexandre Soulier 3 ; Stephane Chevaliez 3 ; Karine LaCombe 4 ; Nicolas Rouveau 5 ; Lila Poiteau 3 ; Sandrine Rallier 6 1 INSERM, UMR-S 1136, Paris, France; 2 Inst Pasteur of Cameroon, Yaounde, Cameroon; 3 INSERM U955, Créteil, France; 4 Sorbonne Univs, Paris, France; 5 Natl Agency of Rsr on AIDS and Viral Hepatitis, Paris, France; 6 Natl Reference Cntr for Viral Hepatitis B, C and Delta, Hosp Henri Mondor, Univ Paris-Est, Créteil, France Background: HCV chronic infection diagnosis currently relies on anti-HCV antibody (HCV-Ab) detection. As it cannot differentiate an active infection from a resolved one, its diagnosis must be confirmed by HCV-RNA measurement which is scarcely available in resource-limited settings. Quantifying HCV core antigen (AgC), a marker of viral replication, could shorten this algorithm if used as a one-step tool. The aim of this study was to assess the performance of the AgC quantification for the diagnostic of chronic HCV in a serum bank of HCV mono- and HCV-HBV or HCV-HIV co-infected patients from Cameroon and the influence of co-infections on the test’s results. Methods: The quantification of the AgC was performed by an automated assay (Abbott Diagnostics) in 465 HCV-Ab negative samples and 544 HCV-Ab and HCV-ARN positive Results: Among these 1009 sera, 335 were un-infected, 489 were HCV mono- infected, 27 of 78 HIV-infected were co-infected with HCV and 28 of 107 HBV –infected were HCV-HBV. No statistical association was found between the AgC level and our covariates (age, gender, HBV or HIV co-infection). The correlation between AgC and HCV ARN was good in the mono-infected group (r=0.75, p<0.00001) and in the HIV co-infected group (r=0.83, p<0.00001) but lower in the HBV co-infected one (r=0.58, p<0.001). The assay had a sensitivity of 95.7% and a specificity of 99.7% in the mono and un-infected group, corresponding to an AUC of 0.99 (95% CI: 0.98-1.0). In the HBV and HIV-infected groups it has a sensitivity of 96.4% and 100%, a specificity of 96.2% and 88.2%, an AUC of 0.98 (95% CI: 0.95-1.0) and 0.99 (95% CI: 0.97-1.0), respectively. No significant difference between the three AUC was observed (p=0.69). In the mono-infected group the PPV was 98.1%, the NPV 99.3%, LR+=319 and the LR-=0.043. In the HBV and HIV-infected groups we respectively found a PPV of 80.2% and 57.6%, a NPV of 99.4% and 100%. Conclusions: AgC quantification displayed high specificity and sensitivity; in addition neither HIV nor HBV coinfection influenced its discrimination capacity. Then it represents a reliable HCV diagnosis tool and, being less costly than viral load tests, could ease HCV screening, notably in resource-limited settings. Prognostic Value of Transient Elastography and FIB-4 in HIV/HCV Coinfection Cristina Díez 1 ; Juan Berenguer 1 ; Rivero-Juárez Antonio 2 ;Víctor Hontañón 3 ; Leire Pérez-Latorre 1 ; Francisca Cuenca 2 ; Luz Martín-Carbonero 4 ; Antonio Rivero 2 ; José M. Bellón 1 ; Juan González-García 4 1 Hosp General Universitario Gregorio Marañón, Madrid, Spain; 2 Hosp Universitario Reina Sofía, Córdoba, Spain; 3 Hosp Universitario La Paz, Madrid, Spain; 4 Inst for Hlth Rsr of La Paz Univ Hosp, Madrid, Spain Background: FIB-4 outperforms liver biopsy as a predictor of outcomes in patients with HIV/HCV coinfection. Our aimwas to compare the prognostic value of transient elastography (TE) and the FIB-4 index in patients with HIV/HCV coinfection. Methods: The study was carried out in 3 institutions. We identified patients with at least 1 determination of liver stiffness who were both HIV+ and HCV-RNA+ and had compensated chronic hepatitis C. Baseline was the date of the first TE determination. The main outcome was liver-related events (LRE), namely, liver decompensation (DEC) or hepatocellular carcinoma (HCC), whichever occurred first. We used ROC curves and time-dependent ROC curves (ROC[t]) (Biometrics 2000; 56:337-344) to determine the ability of category, CDC clinical category, CD4+ cell nadir, alcohol intake, and achievement of SVR. Results: The study sample comprised 1,159 patients who met the inclusion criteria and had undergone determination of TE and FIB-4 between 24/09/2003 and 01/01/2015. After a median follow-up of 5.8 years, 255 patients achieved sustained viral response (SVR), 65 died, and 75 had LRE (67 DEC and 17 HCC). Baseline fibrosis by TE was ≤7.1 in 539 patients, >7.1 and <9.5 in 182 patients, and ≥9.5 in 438 patients. Fibrosis by FIB-4 was ≤1 in 453 patients, >1 and <3.25 in 520 patients, and ≥3.25 in 186 patients. The AUROCs (95%CI) for LRE for TE and FIB-4 were 0.854 (0.805–0.902) and 0.670 (0.595–0.743), respectively ( P ≤.001). The AUROCs for overall death (OD) and the composite end-point of OD/LRE (whichever occurred first) were also significantly higher for TE than for FIB-4. The figure shows time-dependent AUC plots for LRE for TE and FIB-4 up to 5 years; the estimated AUROC(t) at 3 and 5 years for TE and FIB-4 was 0.919 and 0.713 and 0.852 and 0.694, respectively. The adjusted hazard ratio (95%CI) of LRE was 18.7 (9.00-38.7) for advanced fibrosis assessed by TE ( P <.001) and 5.36 (3.22-8.93) for advanced fibrosis assessed by FIB-4 ( P< .001). Conclusions: TE outperformed FIB-4 as a predictor of clinical outcomes. These findings support the prognostic role of TE in patients with HIV/HCV coinfection. samples (n=1020) collected in patients from the Pasteur Center of Cameroon. Its performance was assessed by calculating its sensitivity and specificity, and building ROC curves in order to compare its results to the gold standard (ELISA and/or PCR) with the Area Under the Curve (AUC). 527 TE and FIB-4 to predict outcomes. We also assessed the association between advanced fibrosis— TE (≥9.5) or FIB-4 (≥3.25)—and LRE using multivariate Cox regression analysis taking into account death as a competitive risk. The variables for adjustment were age, sex, HIV transmission

Poster Abstracts

205

CROI 2016