IntroductionDéveloppée par l'OMS, l’échelle WHOQOL-HIV BREF est un outil standard d’évaluation de la qualité de vie liée à la santé (QVLS) chez les personnes vivant avec le VIH (PVVIH). Cependant, ses propriétés psychométriques sont peu documentées dans des sous-populations spécifiques, comme les PVVIH co-infectées par le virus de l'hépatite C (PVVIH-VHC). Nous avons évalué la version française du WHOQOL-HIV BREF chez les PVVIH-VHC suivies à l'hôpital en France.MethodesL’étude a inclus les PVVIH-VHC de la cohorte française, prospective, multicentrique ANRS CO13 HEPAVIH (première vague, 2005-2009). Un questionnaire auto-administré à l'inclusion a permis d’évaluer le WHOQOL-HIV BREF, avec 6 domaines de la QVLS : physique, psychologique, niveau d'indépendance, social, spirituel et environnemental. La distribution (moyenne, écart-type, coefficients d'asymétrie et aplatissement, taux de réponses extrêmes) des 31 items de l’échelle a été estimée chez les participants ayant répondu aux 2 premiers items (perception globale de la QVLS ; satisfaction par rapport à la santé). Le coefficient α de Cronbach a été calculé pour les 6 domaines. Une analyse factorielle confirmatoire (AFC) a été menée à l'aide d'un modèle d’équations structurelles incluant des covariances entre les items d'un même domaine (Figure 1). Enfin, les moyennes des 6 scores ont été comparées selon le statut de cirrhose, le taux de CD4 et le stade VIH des participants (test de Student).ResultatsLa population d’étude (n=855) était constituée à 69% d'hommes, avec un âge médian de 44 ans [intervalle interquartile : 42–48] et 12% de participants guéris du VHC. Nous avons trouvé une absence d'effet des réponses extrêmes pour 7 items. La consistance interne était acceptable pour 5 domaines (α de Cronbach : 0.68–0.82). L'AFC a montré une adéquation acceptable du WHOQOL-HIV BREF (SRMR=0,049 ; CFI=0,916 ; RMSEA=0,055 [IC 90% : 0,051–0,059]). Enfin, les participants atteints de cirrhose étaient moins satisfaits de leur santé et avaient un score physique inférieur aux participants non-cirrhotiques. De même, les participants avec CD4<200 cellules/mm3 étaient moins satisfaits de leur santé et avaient un niveau d'indépendance inférieur aux autres participants. Enfin, aucune différence significative n'a été détectée selon le stade VIH (A/B/C).ConclusionLa version française du WHOQOL-HIV BREF présente des propriétés psychométriques acceptables chez les PVVIH-VHC, permettant d’évaluer 6 domaines de la QVLS.Mots clés analyse factorielle confirmatoire ; psychométrie ; qualité de vie liée à la santé ; VIH ; VHCDéclaration de liens d'intérêts Les auteurs n'ont pas précisé leurs éventuels liens d'intérêts

Abstract Background Thanks to innovation in treatment, people living with HIV and/or HCV now live longer but are growingly facing non-communicable disease burden. HIV-HCV co-infected patients are at high risk of metabolic complications and liver-related events, which are both associated with hepatic steatosis and its progressive form, non-alcoholic steatohepatitis (NASH), a known risk factor for mortality. The fatty liver index (FLI), a non-invasive steatosis biomarker, has recently drawn attention for its clinical prognostic value, but has never been applied to HIV-HCV co-infected patients. We aimed at testing whether elevated FLI (≥60) was associated with all-cause mortality in co-infected patients. Methods Our study is based on data from ANRS CO13 HEPAVIH, a French national prospective cohort of HIV-HCV co-infected patients. Socio-behavioral and clinical data from patients clinically followed-up were used in the analysis. Using a Cox proportional hazards model for mortality from all causes (983 patients; 4,432 visits), we computed hazard ratios associated with risk factors and confounders. Results After multiple adjustment, individuals with FLI≥60 had almost double the risk of all-cause mortality (adjusted hazard ratio [95% confidence interval]: 1.91 [1.17-3.12], p = 0.009), independently of HCV cure (0.21 [0.07-0.61], p = 0.004), advanced fibrosis (1.77 [1.00-3.14], p = 0.05), history of hepatocellular carcinoma and/or liver transplantation (7.74 [3.82-15.69], p < 10-3), history of indirect clinical signs of cirrhosis (2.80 [1.22-6.41], p = 0.015), and HIV CDC clinical stage C (2.88 [1.74-4.79], p < 10-3). Conclusions An elevated fatty liver index is a risk factor for all-cause mortality in HIV-HCV co-infected patients independently of liver fibrosis and HCV cure. In the present era of nearly 100% HCV cure rates, these findings encourage the more systematic use of non-invasive steatosis biomarkers to help identify co-infected patients with higher mortality risk. Key messages A FLI≥60 is strongly associated with mortality in HIV-HCV co-infected patients. FLI could be calculated routinely to identify most at-risk patients.

ObjectivesStudies evaluating the efficacy and safety of the fixed‐dose combination ledipasvir (LDV)/sofosbuvir (SOF) in patients coinfected with HIV‐1 and hepatitis C virus (HCV) have mainly included treatment‐naïve patients without cirrhosis. We aimed to evaluate the efficacy and safety of this combination in treatment‐experienced patients with and without cirrhosis.MethodsWe conducted a multicentre, open‐label, double‐arm, nonrandomized study in patients coinfected with HIV‐1 and HCV genotype 1 with and without cirrhosis, who had good viral suppression on their antiretroviral regimens. All patients were pretreated with a first‐generation NS3/4A protease inhibitor (PI) plus pegylated interferon/ribavirin. Patients received a fixed‐dose combination of LDV/SOF for 12 weeks, or for 24 weeks if cirrhosis was present. The primary endpoint was a sustained virological response (SVR) 12 weeks after the end of therapy. Secondary endpoints included safety, pharmacokinetics and patient‐reported outcomes.ResultsOf the 68 patients enrolled, 39.7% had cirrhosis. Sixty‐five patients [95.6%; 95% confidence interval (CI): 87.6–99.1%; P < 0.0001] achieved an SVR, with similar rates of SVR in those with and without cirrhosis. Tolerance was satisfactory, with mainly grade 1 or 2 adverse events. Among patient‐reported outcomes, only fatigue significantly decreased at the end of treatment compared with baseline [odds ratio (OR): 0.36; 95% CI: 0.14–0.96; P = 0.04]. Mean tenofovir area under the plasma concentration–time curve (AUC) at week 4 was high, with mean ± SD AUC variation between baseline and week 4 higher in cirrhotic than in noncirrhotic patients (3261.57 ± 1920.47 ng/mL vs. 1576.15 ± 911.97 ng/mL, respectively; P = 0.03). Mild proteinuria (54.4%), hypophosphataemia (50.0%), blood bicarbonate decrease (29.4%) and hypokalaemia (13.2%) were reported. The serum creatinine level was not modified.ConclusionsLDV/SOF provided a high SVR rate in PI‐experienced subjects coinfected with HCV genotype 1 and HIV‐1, including patients with cirrhosis.

SummaryLiver steatosis is common in human immunodeficiency virus (HIV)‐hepatitis C virus (HCV)‐co‐infected patients. Some recent studies have found that cannabis use is negatively associated with insulin resistance in the general population and in HIV‐HCV‐co‐infected patients. Given the causal link between insulin resistance and steatosis, we hypothesized that cannabis use has a positive impact on steatosis. Therefore, we aimed to study whether cannabis use in this population was associated with a reduced risk of steatosis, measured by ultrasound examination. ANRS CO13‐HEPAVIH is a French nationwide multicentre cohort of HIV‐HCV‐co‐infected patients. Medical and socio‐behavioural data from clinical follow‐up visits and annual self‐administered questionnaires were prospectively collected. A cross‐sectional analysis was conducted using data from the first visit where both ultrasound examination data for steatosis (positive or negative diagnosis) and data on cannabis use were available. A logistic regression model was used to evaluate the association between cannabis use and steatosis. Among study sample patients (n = 838), 40.1% had steatosis. Fourteen per cent reported daily cannabis use, 11.7% regular use and 74.7% no use or occasional use (“never or sometimes”). Daily cannabis use was independently associated with a reduced prevalence of steatosis (adjusted odds ratio [95% CI] = 0.64 [0.42;0.99]; P = .046), after adjusting for body mass index, hazardous alcohol consumption and current or lifetime use of lamivudine/zidovudine. Daily cannabis use may be a protective factor against steatosis in HIV‐HCV‐co‐infected patients. These findings confirm the need for a clinical evaluation of cannabis‐based pharmacotherapies in this population. Eudract.ema.europa.eu number, DGS050367.

Objectives The objective of this nested study was to assess the prevalence of psychiatric disorders in a sample of HIV /hepatitis C virus ( HCV )‐coinfected patients according to their HCV status. Methods The nested cross‐sectional study, untitled HEPAVIH‐Psy survey, was performed in a subset of HIV / HCV ‐coinfected patients enrolled in the French Agence Nationale de Recherche sur le SIDA et les Hépatites Virales ( ANRS ) CO 13 HEPAVIH cohort. Psychiatric disorders were screened for using the Mini International Neuropsychiatric Interview ( MINI 5.0.0). Results Among the 286 patients enrolled in the study, 68 (24%) had never received HCV treatment, 87 (30%) were treatment nonresponders, 44 (15%) were currently being treated and 87 (30%) had a sustained virological response ( SVR ). Of the 286 patients enrolled, 121 patients (42%) screened positive for a psychiatric disorder other than suicidality and alcohol/drug abuse/dependence, 40 (14%) screened positive for alcohol abuse/dependence, 50 (18%) screened positive for drug abuse/dependence, 50 (17.5%) were receiving an antidepressant treatment and 69 (24%) were receiving an anxiolytic. Patients with an SVR did not significantly differ from the other groups in terms of psychiatric disorders. Patients receiving HCV treatment screened positive less often for an anxiety disorder. The highest rate of drug dependence/abuse was among HCV treatment‐naïve patients. Conclusions Psychiatric disorders were frequent in HIV / HCV ‐coinfected patients and their rates were comparable between groups, even for patients achieving an SVR . Our results emphasize the need for continuous assessment and care of coinfected patients, even after HCV clearance. Drug addiction remains an obstacle to access to HCV treatment. Despite the recent advent and continued development of directly acting antiviral agents ( DAA s), it is still crucial to offer screening and comprehensive care for psychiatric and addictive disorders.

Results Fifty HIV+/HCV+ coinfected pts (n=44 men (88%), median age 50 years [40-74], median CD4 cell count 334/mm3 [58-1621], n=28 Child A cirrhosis (60%)) developed HCC. Thirty-one (63%) pts presented cirrhosis decompensation before HCC diagnosis. At HCC diagnosis, median serum aFP was 20.4 [1.9-198,900] ng/ml, 38 (76%) pts had a nodular tumor (median main diameter 23.5 [11-70] cm) and 12 (24%) pts an infiltrating form (62.5 [10-130] cm), p=0.007. Tumor portal thrombosis was diagnosed in 14 (28%) pts. A curative or a palliative procedure was further performed in 22 (44%) pts and 20 (40%) pts, respectively. The 2-years and 4-years overall survival rates were 51% and 28%, respectively. Age (p=0.0005), infiltrating or nodular tumor (p= 0.0009) and tumor portal thrombosis (p=0.004) were associated to survival. In a Cox model, two prognostic factors of deaths were found: prior episode of cirrhosis decompensation (aRR 11.43 [3.01-43.34], p=0.0003) and tumor portal thrombosis (aRR 4.66 [1.19-18.27], p=0.03), adjusted on age, CD4 cell count and the therapeutic strategy for HCC. Conclusions Cirrhosis decompensation and tumor portal thrombosis significantly impact the survival of HIV+/HCV+ pts with HCC. Our results suggest new rules of screening HCC in HIV+/HCV+ pts with advanced liver disorders.

The aim of this study was to describe the proportion of liver‐related diseases (LRDs) as a cause of death in HIV‐infected patients in France and to compare the results with data from our five previous surveys.

Évaluer le recours à la consultation pré-TH chez les pts coinfectés VIH-VHC ayant une cirrhose décompensée ou un carcinome hépatocellulaire (CHC). Tous les pts inclus dans la cohorte ANRS CO13 HEPAVIH depuis 2006 et ayant une indication potentielle de TH (décompensation de cirrhose (DPC) et/ou CHC), étaient éligibles. Les taux de consultation pré-TH, de bilans pré-TH, et d’inscriptions sur liste de TH ont été étudiés. Les pts éligibles et les inscrits sur liste de TH ont été comparés aux non-inscrits à leur dernier suivi. Parmi 92 pts ayant une indication potentielle de TH (62 DPC, 17 CHC, et 13 DPC + CHC), 85 questionnaires ont été retournés. L’âge médian était 50 ans, le % d’hommes de 81 %, le nombre médian de CD4 de 313/mm 3 , la charge virale VIH < 50 copies/mL chez 79 %. Le score médian d’élastométrie était à 28 kPa (IQR : 14,3–46,4), le taux d’albumine à 33 g/L (IQR : 28–39), et le prothrombine à 75 % (IQR : 62–84). 64 % des pts avaient reçu au moins un traitement anti-VHC. Seuls 32 % des pts avaient bénéficié d’une consultation pré-TH. Les principales raisons de non-consultation étaient une évolution trop rapide vers le décès (13,5 %) et un suivi trop irrégulier (12 %). Seize pts avaient été inscrits sur liste de transplantation. Les pts non-inscrits sur liste avaient des valeurs d’albumine et de plaquettes plus élevées que les inscrits (albumine : 34 vs 26,7 g/L, p = 0,03, plaquettes : 82,5 vs 56 Giga/L, p = 0,04). Seuls 10 pts (6DPC, 2 CHC, 2 DPC + CHC) ont été transplantés après un délai médian depuis l’inscription sur liste de 71 jours (IQR : 41–520). Le recours à la consultation pré-TH reste très insuffisant (32 %) pour les pts coinfectés VIH-VHC ; 47 % des pts (47/92) avaient une contre-indication manifeste. Seul un patient sur 10 ayant une indication a été transplanté à ce jour, attestant de la nécessité d’une approche mieux coordonnée et systématisée.

Objectives: The objective of this study was to assess to what extent HIV/HCV co-infected patients under-report alcohol use to their physician with respect to self-reports from self-administered questionnaires (SAQ) and identify correlates of alcohol underreporting during face-to-face medical interviews (FMI). Design: ANRS-0013-HEPAVIH is a French multi-center cohort of HIV/HCV co-infected patients.Methods: Data were collected at enrolment using both SAQ and FMI while clinical data were retrieved from medical records. Alcohol consumption was assessed through SAQ and compared with FMI patient reports. Correlates of underreporting alcohol consumption during FMI with respect to SAQ were identified using logistic regression analysis.Results: Among 544 patients, 37% were classified as alcohol abusers according to AUDIT-C in the SAQ. During FMI, 14% underreported alcohol consumption. The following correlates were independently associated with underreporting alcohol consumption in FMI: not receiving HIV treatment, being followed up by a hepatologist for HCV infection and reporting a history of injecting drug use. Conclusions: These results highlight the difficulties in alcohol consumption assessment which HCV specialists may face when suggesting to their HIV/HCV co-infected patients that they cease drinking completely. Patient awareness about the real need to reduce their alcohol use before starting HCV therapy may also contribute to underreporting. Innovative strategies for alcohol risk-reduction, including the promotion of controlled consumption and access to multidisciplinary teams, should be implemented for HIV/HCV co-infected patients in order to reduce barriers to HCV treatment. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

BACKGROUND:Anti-tumour necrosis factor (TNF) therapy may be associated with opportunistic infections (OIs). OBJECTIVE:To describe the spectrum of non-tuberculosis OIs associated with anti-TNF therapy and identify their risk factors. METHODS:A 3-year national French registry (RATIO) collected all cases of OI in patients receiving anti-TNF treatment for any indication in France. A case-control study was performed with three controls treated with anti-TNF agents per case, matched for gender and underlying inflammatory disease. RESULTS:45 cases were collected of non-TB OIs in 43 patients receiving infliximab (n=29), adalimumab (n=10) or etanercept (n=4) for rheumatoid arthritis (n=26), spondyloarthritides (n=3), inflammatory colitis (n=8), psoriasis (n=1) or other conditions (n=5). One-third (33%) of OIs were bacterial (4 listeriosis, 4 nocardiosis, 4 atypical mycobacteriosis, 3 non-typhoid salmonellosis), 40% were viral (8 severe herpes zoster, 3 varicella, 3 extensive herpes simplex, 4 disseminated cytomegalovirus infections), 22% were fungal (5 pneumocystosis, 3 invasive aspergillosis, 2 cryptococcosis) and 4% were parasitic (2 leishmaniasis). Ten patients (23%) required admission to the intensive care unit, and four patients (9%) died. Risk factors for OIs were treatment with infliximab (OR=17.6 (95% CI 4.3 - 72.9); p<0.0001)or adalimumab (OR=10.0 (2.3 to 44.4); p=0.002) versus etanercept, and oral steroid use >10 mg/day or intravenous boluses during the previous year (OR=6.3 (2.0 to 20.0); p=0.002). CONCLUSION:Various and severe OIs, especially those with intracellular micro-organisms, may develop in patients receiving anti-TNF treatment. Monoclonal anti-TNF antibody rather than soluble TNF receptor therapy and steroid use >10 mg/day are independently associated with OI.

ss Open Acce Oral presentation OA04-01. Safety and immunogenicity of LIPO-5, a HIV-1 lipopeptide vaccine: results of ANRS VAC18, a phase 2, randomized, double-blind, placebo-controlled trial D Salmon-Ceron*1,3, C Durier2, C Desaint10, Cuzin4, M Surenaud5, Y Henin10, J Lelievre6, B Bonnet7, G Pialoux8, I Poizot-Martin9, N Ben Hamouda5, A Jackson5, C Flys5, C Guerin10, J Aboulker2, J Choppin5 and O Launay10