15 research outputs found
Cost-effectiveness of full versus targeted monitoring of randomized controlled trials
International audienc
A survey on French hospital physicians' certification to the Good Clinical Practices
International audienc
Ensuring quality control in a clinical trial during the COVID-19 pandemic: The experience of the Inserm C20-15 DisCoVeRy study in France
International audienceMeeting Abstract PM2-02
Ledipasvir/sofosbuvir chez les patients co-infectés par le VIH et un VHC de génotype 1 prétraités par un inhibiteur de la protéase NS3/A4 du VHC (étude ANRS HC31 SOFTRIH)
National audienceIntroduction Lâassociation fixe dâantiviraux directs ledipasvir/sofosbuvir (LDV/SOF), disponible sous la forme dâun comprimĂ© unique, nâa pas Ă©tĂ© Ă©tudiĂ©e spĂ©cifiquement chez les patients chroniquement infectĂ©s par un VHC de gĂ©notype 1 (G1), co-infectĂ©s par le VIH et en Ă©chec dâun traitement prĂ©alable incluant un inhibiteur de la protĂ©ase (IP) NS3/A4 du VHC. Nous avons Ă©valuĂ© lâefficacitĂ© et la tolĂ©rance de cette combinaison dans cette population de patients, historiquement considĂ©rĂ©s comme trĂšs difficiles Ă traiter (Ă©tude ANRS HC31 SOFTRIH). Patients et mĂ©thodes Les patients infectĂ©s de maniĂšre chronique par un VHC G1, co-infectĂ©s par le VIH et sous traitement antirĂ©troviral stable (ARV), en Ă©chec dâun traitement anti-VHC antĂ©rieur par interfĂ©ron pĂ©gylĂ©/ribavirine/IP NS3/A4 ou ayant interrompu prĂ©cocement ce traitement pour intolĂ©rance, ont Ă©tĂ© inclus dans cette Ă©tude prospective. Tous les patients ont reçu la combinaison fixe LDV/SOF (90 mg/400 mg), une fois par jour pendant 12 semaines ou 24 semaines en cas cirrhose hĂ©patique. Les patients pouvaient Ă©galement recevoir les ARVs suivants : tenofovir, emtricitabine,lamivudine, raltegravir, efavirenz, rilpivirine, enfuvirtide. Les critĂšres de jugement dâefficacitĂ© Ă©taient lâobtention dâune rĂ©ponse virologique soutenue, dĂ©finie par un ARN VHC indĂ©tectable 4 semaines (RVS4) ou 12 semaines (RVS12, critĂšre principal) aprĂšs lâarrĂȘt du traitement. La survenue dâeffets indĂ©sirables (EIs) et les paramĂštres biologiques standards incluant la numĂ©ration des lymphocytes CD4 et lâARN VIH ont Ă©tĂ© Ă©tudiĂ©s. RĂ©sultats Soixante-huit patients avec un G1a (82,5 %), un G1b (13 %) ou un autre G1 (4,5 %) ont Ă©tĂ© inclus : hommes 79 % ; Ăąge moyen 52 ans ; mĂ©diane de lâARN VHC (6,2 Log UI/mL) et des lymphocytes CD4 (629/mm3) Ă lâinclusion ; cirrhose compensĂ©e (40 %). Soixante-cinq patients Ă©taient Ă©valuables pour les critĂšres virologiques. Soixante-deux patients (95,4 %) ont obtenu une RVS4 (prĂ©lĂšvement sanguin non disponible chez 1 patient, ARN VHC dĂ©tectable infĂ©rieur au seuil de quantification chez 2 patients). Tous les patients (100 %) ont obtenu une RVS12. Deux patients ont prĂ©sentĂ© un rebond virologique VIH confirmĂ©. Aucun patient nâa interrompu prĂ©cocement le traitement de lâĂ©tude pour intolĂ©rance. Les EIs constatĂ©s chez plus de 10 % des patients Ă©taient les suivants : fatigue (19,1 %), pression artĂ©rielle Ă©levĂ©e (14,7 %), cĂ©phalĂ©es (11,8 %). Conclusion Si les Ă©tudes ERADICATE [1] et ION-4 [2] ont rĂ©cemment montrĂ© une efficacitĂ© et une tolĂ©rance trĂšs bonnes de lâassociation LDV/SOF chez les patients co-infectĂ©s par le VIH, notre Ă©tude apporte des rĂ©sultats supplĂ©mentaires chez les patients historiquement considĂ©rĂ©s comme trĂšs difficiles Ă traiter, incluant ceux prĂ©sentant une cirrhose hĂ©patiqu
A survey on French hospital physicians' certification to the Good Clinical Practices
National audienceGood clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigatorsâ selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the âBretagne recherche clinique hospitaliĂšre networkâ: Rennes, Saint Malo, Saint Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigatorsâ GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of allphysicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals
Argument for a Doppler echocardiography during exercise in assessing asymptomatic patients with severe aortic stenosis
HCV eradication does not protect from fibrosis progression in patients with fibrosing cholestatic hepatitis after liver transplantation
International audienceINTRODUCTION: Hepatitis C virus (HCV) may recur after liver transplantation (LT) in the severe form of fibrosing cholestatic hepatitis (FCH). The prognosis dramatically improved by the use of direct acting antivirals (DAAs). The aim of the present study was to describe the change in histological features of FCH after virological eradication. METHODS: From the ANRS CUPILT cohort we included 17 patients who presented FCH and at least two graft biopsies, one before DAA-treatment and one after. A single expert pathologist, blinded for clinical outcome, retrospectively confirmed the diagnosis of FCH and progression of fibrosis. RESULTS: Diagnosis of FCH was made after a median [IQR] 6.0 [3.1-11.8] months after LT, and the median interval between diagnosis and onset of treatment was 1.2 [0.7-6.1] months. The rate of viral eradication was 94.1%. The median delay between the pre-treatment and the treatment biopsies was 12.5 [11.1-20.0] months. Between the end of treatment and the second biopsy, the delay was 5.3 [0.6-7.4] months. Fibrosis stage worsened in 10 patients (58.8%); 6 patients had cirrhosis (35.3%). Chronic rejection appeared in 4 (23.5%) patients. CONCLUSION: Our results suggest that, despite viral eradication in patients presenting FCH after LT, fibrosis progression was observed in half of patients. This should encourage monitoring fibrosis progression despite HCV cure
O109 : Treatment of severe HCV-recurrence after liver transplantation using sofosbuvir-based regimens: The ANRS CO23 CUPILT study
International audienceno abstrac
Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients after Liver Transplantation: Results from the ANRS CO23 CUPILT Study
International audienceBackground - A recurrence of hepatitis C virus (HCV) after liver transplantation affects survival in human immunodeficiency virus (HIV)/HCV coinfected patients. This study assessed the efficacy and safety of sofosbuvir (SOF)-based regimens in HIV/HCV coinfected patients after liver transplantation. Methods - Twenty-nine HIV/HCV coinfected transplanted patients receiving tacrolimus-, cyclosporine-, or everolimus-based immunosuppressive therapy were enrolled in the Compassionate Use of Protease Inhibitors in Viral C Liver Transplantation cohort. Their antiviral treatment combined SOF, daclatasvir with or without ribavirin (n = 10/n = 6), or SOF, ledipasvir with or without ribavirin (n = 2/n = 11). Results - The median delay between liver transplantation and treatment initiation was 37.5 months (interquartile range [IQR], 14.4-99.2). The breakdown of HCV genotypes was G1, 22 patients (75.9%); G3, 3 patients (10.3%); and G4, 4 patients (13.8%). The treatment indications were HCV recurrence (â„ F1 n = 23) or fibrosing cholestatic hepatitis (n = 6). Before starting SOF, the HCV viral load and CD4 count were 6.7 log10 IU/mL (IQR, 5.9-7.2) and 342 cells/mm (IQR, 172-483), respectively. At week 4, the HCV viral load was less than 15 IU/mL in 12 (42.9%) patients. The overall sustained virological response 12 was 96.6%. No significant drug-drug interactions were observed. Conclusions - SOF-based treatment regimens produced excellent results in HIV/HCV coinfected patients after liver transplantation, suggesting an important change in their prognosis
Should we keep using Ribavirin to Treat Hepatitis C Recurrence after Liver Transplantation? Results from the CO23 ANRS Cupilt Study
International audienceEASL International Liver Congress, APR 13-17, 2016, Barcelona, SPAI