CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

1 University of Campania Luigi Vanvitelli, Naples, Italy, 2 University of Naples Federico II, Naples, Italy, 3 University of Padova, Padova, Italy, 4 Seconda Università degli Studi di Napoli, Napoli, Italy, 5 L’ A. O. San Giovanni di Dio e Ruggi d’Aragona, Salerno, Italy Background: The IFN-free regimens yield a sustained virological response rate at week 12 (SVR12) of approximately 95%, even in patients with cirrhosis. However, an important unresolved question is how long follow-up should last after stopping treatment and when effectively a patient is considered free of HCV infection. Aim: The aim of the present study was to identify, among the patients with failure to DAA regimen, those with a late relapse (after the achievement of a sustained virological response at week 12) and to characterize the clinical, epidemiological and virological features of these patients. Methods: 129 HCV patients with non-response to an IFN-free regimen were enrolled. Sanger sequencing of NS3, NS5A and NS5B was performed at failure by home-made protocols Results: Of the 129 patients enrolled, 8 (6.2%) experienced a breakthrough, 15 (11.7%) non-response, 99 (76.7%) a relapse by week 12 after the end of DAA therapy, and 7 (5.4%) a late relapse (after week 12; median 24 weeks, range 24-72). Table 1 shows the clinical and virological data of the 7 patients with a late relapse. For 2 of the 7 patients with a late relapse a serum sample collected before the start of the DAA regimen was available; phylogenetic analysis showed no change in sequences of NS3, NS5A and NS5B regions, suggesting a reactivation of the initial HCV strain. The prevalence of patients with RASs was higher in the 7 with a late relapse than in the 99 with a relapse by week 12. In fact, at least one RAS or RASs in all 3 regions of HCV was more frequently identified in the first group (100% vs. 66.7%, p=0.09; and 28.6% vs. 5%, p=0.06, respective); however, because of the low number of patients with a late relapse, these differences were not significant to the statistical analysis. Moreover, a RAS in the NS5A region was observed in all patients with a late relapse and in 53 (53.5%, p=0.018) in those with a relapse by week 12. Conclusion: In conclusion, our real-life study demonstrates that a late relapse may occur in patients who had obtained an SVR12 with a DAA treatment. This is in good agreement with the data recently published by Sarazzin and coworkers (Sarrazin C. et al. Clin Infect Dis. 2017, PMID: 27737953) but partially disagrees with the indication of the international guidelines suggesting a post-treatment follow-up of 12 weeks. Thus, further studies on a larger patient population are needed to clarify this topic.

1 Rigshospitalet, Copenhagen, Denmark, 2 University College London, London, UK, 3 Odense University Hospital, Odensen, Denmark, 4 Royal Free Hospital, London, UK, 5 Helsinki University Central Hospital, Helsinki, Finland, 6 CHU de Nice, Nice, France, 7 University of Munich, Munich, Germany, 8 Bonn University Hospital, Bonn, Germany, 9 University of Modena and Reggio Emilia, Modena, Italy, 10 San Raffaele Scientific Institute, Milan, Italy, 11 Serviço de Doenças Infecciosas, Lisbon, Portugal, 12 Hospital Clinic of Barcelona, Barcelona, Spain, 13 University Hospital of Bern, Bern, Switzerland Background: Previous studies have found changes in lipids and inflammatory biomarkers after HCV cure, but there is little data on clinical endpoints in HIV/HCV coinfected persons. We investigated the impact of HCV coinfection status and clearance of HCV-RNA following treatment on the risk of non-AIDS malignancies (NADM), cardiovascular disease (CVD) and end-stage liver disease (ESLD) in HIV/HCV infected persons in the EuroSIDA study. Methods: All HIV positive persons with known HCV status after January 2001 were included and stratified into five groups based on time-updated HCV-RNA and use of HCV treatment: 1) HCV-uninfected, 2) spontaneously resolved HCV infection, 3) Chronic untreated HCV infection, 4) Successfully treated HCV infection, 5) HCV-RNA positive despite previous HCV treatment. Separate analyses were performed with each clinical event (fatal and non-fatal) ESLD (including hepatocellular carcinoma, HCC), NADM (excluding HCC) and CVD (myocardial infarction, stroke, angioplasty, coronary bypass, carotid endarterectomy). Poisson regression was used to compare incidence rates between HCV groups. Results: A total of 15,524 HIV positive persons were included. The majority were male (74%), White (87%), on cART (85%) and current smokers (55%) with a median (IQR) age of 41 (35-49) years and CD4 cell count of 446 (290-641) cells/ µl. During a median of 6.6 (IQR 2.3–12.6) person years of follow up (PYFU), a total of 694 CVD, 710 NADM and 375 ESLD events occurred; crude incidence rates/1000 PYFU (95% CI) were 6.1 (5.7–6.6) for CVD, 6.2 (5.8–6.7) for NADM and 3.2 (2.9–3.6) for ESLD. In univariable and multivariable analysis, there were no differences in incidence of both NADM and CVD between those who were untreated, had cleared HCV-RNA after HCV treatment and those with chronic infection (figure). In contrast, the incidence of ESLD was significantly lower among persons who had cleared HCV-RNA after treatment compared to those with chronic infection, and similar to those with spontaneous HCV-RNA clearance. Conclusion: Although HCV cure has been shown to perturb levels of lipid and inflammatory biomarkers, studies of HIV/HCV coinfected persons have lacked power to focus on clinical events. We found no evidence of any impact of HCV infection status or HCV treatment on incidence of both NADM and CVD in coinfected persons while successful HCV treatment significantly lowered the incidence of ESLD to what was observed for those with spontaneous HCV-RNA clearance.

Poster Abstracts

565 CLINICAL OUTCOMES IN PERSONS COINFECTED WITH HIV AND HCV: IMPACT OF HCV TREATMENT Lars Peters 1 , Amanda Mocroft 2 , Jens D. Lundgren 1 , Jan Gerstoft 1 , Line D. Rasmussen 3 , Sanjay Bhagani 4 , Inka Aho 5 , Christian Pradier 6 , Johannes Bogner 7 , Jürgen K. Rockstroh 8 , Cristina Mussini 9 , Adriano Lazzarin 10 , Fernando Maltez 11 , Montse Laguno 12 , Gilles Wandeler 13 , for the EuroSIDA Study

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