CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

563 EFFECTIVENESS OF HEPATITIS C TREATMENT IN HIV/HCV COINFECTED PATIENTS IN MYANMAR Derek Johnson 1 , Htay Thet Mar 2 , Phone Thit 2 , Tobias Homan 2 , Phyu Ei Mon 1 , Kyi Pyar Soe 1 , Win Le Shwe Sin Ei 1 , Khin Sanda Aung 3 , Thin Thin Thwe 2 , Nyan Lynn Tun 2 , Kyaw Zay Lwin 2 , Aude Nguyen 1 , Anne Loarec 2 1 MSF, Geneva, Switzerland, 2 MSF Epicentre, Paris, France, 3 Ministry of Health and Sports, Yangon, Myanmar Background: Approximately 5 million people are estimated to be co-infected with HIV and HCV, the majority of which live in low and middle income countries. The safety and success of new direct-acting antiviral (DAA) therapy based regimens has considerably improved. However, there is little data on the effectiveness of HCV treatment in populations of people living with HIV. The purpose of this study was to assess the effectiveness and feasibility of DAA treatment of HCV in HIV co-infected patients in a low resource setting. Methods: This study used a prospective longitudinal design. Liver fibrosis stage was evaluated by transient elastography using FibroScan. HCV viral load was determined using GeneXpert. Dried blood samples were genotyped at Geneva University Hospital. HCV treatment included sofosbuvir + daclatasvir, with or without ribavirin depending on genotype and cirrhotic stage. Individuals were eligible for treatment if they met the following criteria: 1) were 18 years old or older, 2) On ART and HIV viral load undetectable or asymptomatic with CD4 >500 µL, 3) confirmed chronic HCV infection 4) Liver fibrosis ≥F3 or ≥F2 if treatment is available. The primary endpoint was sustained virologic response (SVR) at the end of 12 weeks of treatment, defined as HCV-RNA response either undetectable or below a concentration of 12UI/mL. Results: Of the 320 individuals treated, 307 (95.9%) achieved SVR while 7 individuals failed treatment (2.1%) and 6 either died or were lost to follow-up (1.8%) (Figure 1). Between January 2014 and November 6th 2017 4,730 HIV positive individuals attending Myintta Yeik clinic in Dawei, Myanmar and 17,047 HIV positive individuals attending either Thaketa or Insein clinic in Yangon, Myanmar were screened for HCV antibodies. Of the 21,777 individuals screened, 1,371 (6.3%) tested positive. 320 individuals initiated treatment between November 7th, 2016 and November 6th, 2017, the time fromwhich the Myanmar Ministry of Health and Sports gave permission to initiate HCV treatment for this study. The average age of the combined cohorts was 44.7 (SD 6.3).The majority were male (78.2%). More than half (53.3%) of participants reported previous substance abuse. Previous time in prison was reported by 29.2% of participants. Conclusion: Our study demonstrates that treatment for HIV/HCV co-infected patients is feasible and highly successful in a resource limited setting. Our study suggest that clinicians can be trained to integrate treatment of hepatitis C into existing HIV services.

PWID on OAT, 97%. There were three relapses, two among PWID not on OAT and one in PWID on OAT. There were three breakthroughs in two non-PWID and one in PWID not on OAT. The SVR12 rates by genotype were: 1a, 92%; 1b, 96; 4, 96%. Conclusion: SVR rates achieved with GZR/EBR were high in real-world conditions of use. This drug combination is a safe and effective option for PWID with and without OAT managed outside the clinical trial setting. 562 REAL-WORLD DATA ON ELBASVIR/GRAZOPREVIR FOR HCV INFECTION IN HIV/NON-HIV PATIENTS Maria Luisa Montes 1 , Juan Berenguer 2 , Ángela Gil-Martín 3 , Adriana Ahumada 2 , Teresa Aldámiz-Echevarría 2 , José L. Calleja 4 , Agustín Albillos 5 , Antonio Olveira 1 , Maria Jesus Tellez Molina 6 , Lourdes Domínguez-Domínguez 7 , Conrado Fernández Rodríguez 8 , José Sanz 9 , Inma Jarrin 10 , María J. Calvo 3 , Juan González- García 1 1 La Paz University Hospital, Madrid, Spain, 2 Hospital General Universitario Gregorio Marañón, Madrid, Spain, 3 Subdireccion General de Farmacia, Madrid, Spain, 4 Hospital Puerta de Hierro, Madrid, Spain, 5 Hospital Ramón y Cajal, Madrid, Spain, 6 Hospital Universitario Clínico San Carlos, Madrid, Spain, 7 Hospital Universitario 12 de Octubre, Madrid, Spain, 8 Hospital Universitario Fundación Alcorcón, Alcorcón, Spain, 9 Hospital Universitario Príncipe de Asturias, Madrid, Spain, 10 Institute of Health Carlos III, Madrid, Spain Background: There are few real-world data on the effectiveness of elbasvir/ grazoprevir (EBV/GZR) for treatment (Rx) of chronic hepatitis C (CHC). We assessed the effectiveness and safety of EBV/GZR in a large prospective registry of individuals receiving DAAs for HCV. Methods: RUA-VHC (Madrid Registry of Use of DAA for HCV) is a prospective registry of HCV-monoinfected (MoP) and HIV/HCV-coinfected (CoP) individuals receiving all-oral direct-acting antivirals (DAAs) in hospitals of the Madrid Regional Health Service. RUA-VHC was created in November 2014 (Hepatology 2017; 66:344). We selected patients with CHC who had received EBV/GZR and were scheduled to finish Rx on or before 01/03/2018. Retreatment after all-oral DAA was excluded. We assessed sustained virologic response (SVR) at 12 wk by intention-to-treat (ITT) and by a modified intention-to-treat approach (m-ITT), in which non-virological failures for reasons other than discontinuation of Rx after adverse events or death were not analyzed. Results: A total of 1620 patients (1486 MoP/134 CoP) met the inclusion criteria. Duration of Rx was 12 wk in 1459 patients (1351 MoP/108 CoP), 16 wk in 159 patients (133 MoP/26 CoP), and 8 wk in 2 MoP. Ribavirin (RBV) was used in 8.1% of patients. Median age was 58 y. Men accounted for 52.5% of patients, 23.5% were previously treated, and 15.2% had cirrhosis. Genotype distribution was as follows: G1b, 69.9%; G1a, 16.9%; G4, 12.2%; G1 not subtyped, 1.0%. HCV-RNA was ≥800K IU/mL in 66.5%. Statistically significant differences between MoP and CoP were observed for age, gender, genotype distribution, Rx duration, and use of RBV. Rx outcomes by duration and patient group are shown in the table. SVR rates were 93.8% (95% CI, 92.5%-94.9%) by ITT and 96.9% (95% CI, 96.0%- 97.7%) by m-ITT analysis. HIV infection was not associated with Rx failure in the adjusted multivariable analysis including age, sex, liver stiffness, HCV genotype, HCV RNA, HIV, Rx duration, and RBV use (ITT and m-ITT). Factors independently associated with Rx failure by m-ITT included HCV G1a or G4, taking G1b as a reference (aOR 2.59 [95%CI, 1.32-5.08] and 2.96 [95%CI, 1.38-6.37], P=.003) and HCV RNA ≥800K IU/mL taking <800K IU/mL as a reference (aOR 2.16 [95%CI 1.06-4.42], P=.035). Conclusion: In this large prospective cohort, Rx outcomes for EBV/GZR against HCV were similar to those found in pivotal clinical trials. Factors associated with Rx included infection by HCV G1a or G4 and HCV RNA ≥800K IU/mL.

Poster Abstracts

564 HCV LATE RELAPSE IN PATIENTS WITH DIRECTLY ACTING ANTIVIRAL– RELATED SVR 12 Carmine Minichini 1 , Mariantonietta Pisaturo 1 , Mario Starace 1 , Caroprese Mara 2 , Margherita Macera 1 , Giuseppina Brancaccio 3 , Stefania De Pascalis 1 , Alfonso Galeota Lanza 4 , Rosa Zampino 1 , Evangelista Sagnelli 1 , Giovanni Battista Gaeta 1 , Nicola Coppola 1 , Antonella Santonicola 5

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