CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

analysis. Controls with a nominal value of 50cp/mL and 0cp/mL were used to evaluate sensitivity and specificity, respectively. Controls with nominal values ≥100 cp/mL (175-1,500,000cp/mL) were used to evaluate precision, accuracy, and linearity (not all concentrations were included in each data set). Variance components models of log10 recovery (with effects for laboratory and assay run) were used to obtain concentration-specific estimates of log10 recovery (CSER). CSER values were related to log10 nominal concentration in a regression model to estimate the slope and residual SD, which were used to evaluate linearity. Targets for linearity were established using historical VQA data. Results: Even though detection limits varied across the assays, sensitivity for RT, AR, RC, and GX was similar based on a 50cp/mL control (false negative rates: 0.15%, 0.36%, 0.17%, 0.00%). Specificity was also similar (false positive rates: 0.02%, 0.02%, 0.00% and 0.00%). The residual SD of log10 recovery across all control samples was 0.14, 0.13, 0.11, and 0.08 (target of <0.15) and the CSER (min, max) for the combined data set was 0.053 (-0.244, 0.275), -0.020 (-0.205, 0.047), 0.130 (0.009, 0.337), and 0.083 (-0.109, 0.181) for RT, AR, RC, and GX, respectively. Linearity targets were exceeded in the RT assay indicating that log10 recovery varied with concentration (targets for linearity: slope=0.56, SD(resid)=0.96, SEM=0.91); no problems with linearity were noted in the other assays (Figure 1). Conclusion: EQA data provide a valuable resource for comparing HIV-1 RNA assay performance. Sensitivity, specificity, and precision were comparable across the four assays. However, systematic differences in log10 CSER were noted, with RC demonstrating the highest average log10 recovery and RT demonstrating a lack of linearity primarily due to lower CSER in samples with higher nominal values.

was determined histologically or non-invasively, through liver stiffness measurement. We report here baseline characteristics of patients and available data on end of treatment (EOT). Efficacy of treatment was defined as undetectable HCV-RNA in patients’ blood sample obtained twelve weeks after the end of therapy (sustained virological response). Results: In total, 1178 patients were enrolled (mean age, 60±15 years; 581 males, 49.4%). Most common etiologies were HCV 1b (n=432; 36.8%) and HCV 2 (n=405; 34.5%). One hundred and twenty-three patients (10.5%) were infected from genotype-3 HCV. METAVIR score was F0 in 269 patients (22.9%), F1 in 477 (40.6%), F2 in 209 (17.8%), F3 in 92 (7.8%) and F4 in 103 (8.8%). The wide majority of patients showed normal (CKD1; n=572, 48.7%) or mildly impaired (CKD2; n=472, 40.2%) renal function; 28 subjects had kidney failure (CKD5; 2.4%). Ninety patients (7.7%) were diabetics. Laboratory parameters were as follows: creatinine, 1.02±1.17 mg/dl; bilirubin, 0.76±0.44 mg/dl; hemoglobin, 14.2±1.6 g/dl; platelets, 206874±64111/µl; ALT 45±38 U/L and AST 55±56 U/L. Most patients (n=918; 78.1%) were treatment-naïve. Planned duration of Glecaprevir/Pibrentasvir treatment was 8 weeks for 1067 patients (90.8%), 12 weeks for 102 (8.7%) and 16 weeks for 5 (0.4%). At the time of analysis, data concerning EOT were available for 1178 patients 100% of the total). Almost all of them reached EOT (99.5%). Data on sustained virological response at 12 weeks after EOT are not complete at the time of the present analysis we then here reported data on 885 patients showing a prevalence of 99.3% of SVR. SAE, not related to the drug, were documented in 1% of patients and 8.5% of AE (mostly pruritus). Conclusion: The large MISTRAL study, conducted in a field-practice scenario, provides a still better prevalence, compared to registration trial, of SVR confirming the extraordinary efficacy and safety of Glecaprevir/Pibrentasvir association also for only 8 weeks treatment. Complete final results will be presented at the CROI meeting. 561 GRAZOPREVIR/ELBASVIR FOR HCV-INFECTED PWID IN REAL-WORLD SETTINGS: THE ZEPALIVE STUDY Juan Macías 1 , Luis Morano 2 , Francisco Téllez 3 , Maria J. Rios-Villegas 4 , Rafael Granados 5 , Antonio Collado 6 , Carlos Galera 7 , Francisco Vera 8 , Dolores Merino 9 , Ignacio Santos 10 , Oscar Rincón 11 , Juan A. Pineda 1 , for the HEPAVIR and GEHEP study groups. GEHEP-001 project 1 Hospital Universitario de Valme, Seville, Spain, 2 Hospital Universitario Alvaro Cunqueiro, Vigo, Spain, 3 Hospital Universitario de Puerto Real, Cadiz, Spain, 4 Hospital Universitario Virgen Macarena, Sevilla, Spain, 5 Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, 6 Hospital Universitario Torrecardenas, Almeria, Spain, 7 Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain, 8 Hospital General Universitario Santa Lucía, Cartagena, Spain, 9 Hospital Juan Ramón Jiménez, Huelva, Spain, 10 Hospital Universitario de La Princesa, Madrid, Spain, 11 Medical Department MSD, Madrid, Spain Background: Grazoprevir/elbasvir (GZR/EBR) has demonstrated high efficacy and tolerability in a wide range of settings. In the setting of drug use, GZR/EBR is supported by a specific clinical trial dedicated to drug users on opiate agonist therapy (OAT). In that trial, the rates of SVR were within those found in the rest of the GZR/EBR development. In real life conditions of use, there is a potential for a lower efficacy, particularly of a greater rate of reinfections, and more frequent drop-outs. Thus, we aimed at evaluating the SVR rates of GZR/EBR among PWID with and without OAT in real world conditions of use. Methods: The HEPAVIR-DAA cohort, recruiting HIV/HCV-coinfected patients (NCT02057003), and the GEHEP-MONO cohort (NCT02333292), including HCV-monoinfected individuals, are ongoing prospective multicenter cohorts of patients receiving treatment against HCV infection in clinical practice. Patients starting GZR/EBR included in the HEPAVIR-DAA or the GEHEP-MONO cohorts were analyzed. Overall SVR12 (ITT), discontinuations due to adverse effects and drop-outs were evaluated. The same analysis was carried out for PWID with and without OAT. Results: 272 patients have started GZR/EBR in the cohorts, and 171 have reached the SVR12 date of evaluation. 84 (49%) were PWID and 32/84 (38%) were on OAT. 49 (29%) individuals were coinfected by HIV. 112 (66%) were men and median (Q1-Q3) age was 48 (37-55) years. HCV genotype distribution was: 1a, 21%; 1b, 46%; 1 other subtype 5%; 4, 28%. 30 (18%) patients presented cirrhosis. All treatments were scheduled for 12 weeks without ribavirin (RBV), but for 5 patients (2.9%) (4 cirrhosis, 1 dialysis) planned for 16 weeks with RBV. One (0.6%) non-PWID dropped-out. Overall, 163/171 (95%) patients have reached SVR12. SVR12 by groups were: non-PWID, 95%; PWID not on OAT, 94%;

Poster Abstracts

560 A REAL-WORLD STUDY OF EFFICACY AND SAFETY OF GLECAPREVIR/ PIBRENTASVIR IN HCV PATIENTS Marcello Persico 1 , Andrea Aglitti 1 , Michele Milella 2 , Carmine Coppola 3 , Vincenzo Messina 4 , Ernesto Claar 5 , Ivan Gentile 6 , Paola Pierri 7 , Lorenzo Antonio Surace 8 , Filomena Morisco 6 , Paolo Tundo 9 , Giuseppina Brancaccio 10 , Nicola Coppola 10 , Annamaria Longo 11 , Mario Masarone 1 1 University of Salerno, Salerno, Italy, 2 University of Bari, Bari, Italy, 3 ASL Naples, Naples, Italy, 4 Azienda Ospedaliera Sant’Anna e San Sebastiano di Caserta, Caserta, Italy, 5 Evangelical Hospital Villa Betania Naples, Naples, Italy, 6 University of Naples Federico II, Naples, Italy, 7 AORN dei Colli, Naples, Italy, 8 Centro Medicina del Viaggiatore e delle Migrazioni, Lamezia Terme, Italy, 9 Hospital Santa Caterina Novella, Galatina, Italy, 10 Second University of Naples, Caserta, Italy, 11 Perrino Hospital, Brindisi, Italy Background: Data on the effectiveness and safety of Glecaprevir/Pibrentasvir for the treatment of HCV infection in a ‘field-practice’ scenario are still scant. This study (MISTRAL: MavIret SouTh italy ReAl Life), currently ongoing, evaluates this therapy in a large cohort of HCV-infected patients from Southern Italy. Methods: All HCV-infected patients, consecutively treated with Glecaprevir/ Pibrentasvir at 22 Centers all over Southern Italy were considered. Fibrosis

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