CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

1 University Hospital Frankfurt, Frankfurt, Germany, 2 Fundacion Jimenez Diaz, Madrid, Spain, 3 Mater Misericordiae University Hospital, Dublin, Ireland, 4 King’s College Hospital, London, UK, 5 University Hospital of La Coruña, La Coruña, Spain, 6 University College London, London, UK Background: Active opportunistic infections and/or low CD4+T-cell (CD4+) counts are exclusion criteria in most clinical trials. Late presenters (LP) are therefore inadequately represented in studies comparing efficacy of antiretroviral regimens, leading to a lack of data on optimal treatment options. Our study aimed to investigate the efficacy and safety of first line ART with integrase-inhibitor (INSTI) or protease-inhibitor (PI) based regimens in patients with low CD4+ counts and/or an AIDS-defining disease. Methods: We conducted a retrospective, multicenter analysis to investigate discontinuation rates and clinical outcome in patients with a CD4 cell count <200/µL and/or an AIDS defining disease after starting first line ART. Data were collected in three European HIV clinics: Universityhospital Frankfurt, Kings College London and Hospital Fundación Jiménez Díaz Madrid. All patients with CD4<200/µL and/or an AIDS defining disease who started INSTI or PI-based first line ART between January 2014 and December 2016 were included in this study. Proportions of those discontinuing ART and with adverse events were compared using univariate analysis. Virologic response was analyzed by using FDA snapshot analysis (HIV-1 RNA <50 copies/mL at week 48). Results: A total of 218 LP were included in the study, 13.8%women, 23.8% non-European ethnicity with a mean (SD) baseline CD4 91/µL (112) and CD4/ CD8 ratio of 0.11 (0.19). 131 LP were started on INSTI-based regimen and 87 on PI`s. Between-group differences are presented in table 1. Those commenced on PI were more likely to be older; 91.8% of the INSTI and 92.4% of PI treated patients had a viral load <50 copies/mL at week 48, discontinuation rates due to adverse events were 3.4% in the INSTI and 8.1% in the PI group respectively. No significant differences in discontinuation rates were observed at week 12 or 48 between INSTI and PI-based regimens (p=0.78 and 0.47 respectively). Virologic response was equally good in those receiving integrase or protease inhibitors (91.8% vs. 92.4%; p = 0.88; odds ratio (95% CI) 1.05 (0.38– 2.82). Conclusion: In a European cohort of LP starting first line INSTI or PI based ART regimens, there were no significant differences in discontinuation rates or virologic response at week 48. Our results indicate that the choice between INSTI and PI can be made on an individual basis of the patient presenting late for first line ART. Future research will focus on the identifying factors associated with regimen selection in this cohort.

1 Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro. Brazil, 2 Harvard University, Boston, MA, USA, 3 Asociacion Civil Impacta Salud y Educacion, Lima, Peru, 4 University of Washington, Seattle, WA, USA Background: Poor adherence to antiretroviral therapy (ART) predicts virologic failure (VF). Self-reported adherence and health-related quality of life (QoL) have been associated with 1st-line ART failure in resource-limited settings (RLS). Our objective was to assess whether QoL metrics add to self-reported adherence data at 4 weeks after starting 2nd-line ART in predicting early VF. Methods: ACTG A5273 was a randomized clinical trial conducted between 2012 and 2014, which showed non inferior virologic efficacy of lopinavir/ritonavir (LPV/r) + raltegravir compared to LPV/r + nucleos(t)ide reverse transcriptase inhibitors as 2nd-line ART in participants failing non-nucleoside reverse transcriptase inhibitor ART at 15 sites in 9 RLS. Early 2nd-line VF was defined as HIV-1 RNA >400 c/mL at week 24 with subsequent confirmation. At baseline and week 4, participants completed the ACTG SF-21, which has 8 QoL domains each scored between 0 (worst) and 100 (best). Adherence was dichotomized as incomplete (self-report of any dose missed in the first 4 weeks of 2nd-line ART) and complete (no missed dose). Logistic regression was used to assess whether QoL at week 4, categorized in each domain as high (score 100), medium (75-<100) and low (<75), enhanced prediction of early 2nd-line VF in addition to adherence. Results: 512 eligible adults (49%male, median age 39 years) were included including 500 with assessments for QoL and adherence at week 4 and for early VF; 7.4% (n=37/500) had early VF and 20.6% (103/500) reported incomplete adherence at week 4. Mean QoL improved (p<0.04) from baseline to week 4 in all domains: from 67 to 72 (general health perceptions), 91 to 93 (physical functioning), 80 to 83 (role functioning), 91 to 93 (social functioning), 91 to 94 (cognitive functioning, CF), 83 to 84 (pain, 85 to 89 (mental health), and 80 to 83 (energy/fatigue, E/F). Early VF was more common among participants who self- reported incomplete (14/103, 13.6%) versus complete adherence (23/397, 5.8%) at week 4 (OR: 2.56; 95%CI: 1.27-5.17; p=0.009). In analyses (both unadjusted and adjusted for adherence), lower QoL in CF and E/F categories at week 4 were associated with significantly higher odds of early 2nd-line VF (overall p<0.04) (Table). Conclusion: Poorer QoL, particularly CF and E/F, adds to self-reported incomplete adherence after 4 weeks of 2nd-line ART in predicting VF at week 24. Evaluation is needed to assess whether patients with poorer QoL might be targeted for greater support to reduce risk of VF. 497 LOW LEVEL VIREMIA AND VIROLOGIC FAILURE IN PERSONS WITH HIV TREATED WITH ART Julia Fleming 1 , Kelly Gebo 1 , Richard Rutstein 2 , W. C. Mathews 3 , Judith Aberg 4 , Charurut Somboonwit 5 , Laura W. Cheever 6 , Richard D. Moore 1 , for the HIV Research Network 1 Johns Hopkins University School of Medicine, Baltimore, MD, USA, 2 Children’s Hospital of Philadelphia, Philadelphia, PA, USA, 3 University of California San Diego, San Diego, CA, USA, 4 Icahn School of Medicine at Mt Sinai, New York, NY, USA, 5 University of South Florida, Tampa, FL, USA, 6 HRSA HIV/AIDS Bureau, Rockville, MD, USA Background: The clinical management of low level viremia remains unclear. The objective of this study was to investigate the association of blips and low level viremia with virologic failure. Methods: We included patients who enrolled into the HIV Research Network between 2005-2015 at one of 17 geographically diverse sites. Patients were included who achieved virologic suppression (HIV-1 RNA ≤ 50 c/ml on two consecutive viral loads) and had 2 viral loads following suppression. Blips and low level viremia (≥ 2 consecutive viral loads) were categorized separately: no blips/LLV, 51-200, 201-500 copies/mL. Cox proportional hazards regression was used to assess association between rates of blips/low level viremia and virologic failure (two consecutive viral loads > 500 c/ml).

Poster Abstracts

496 QUALITY OF LIFE AND ADHERENCE AS PREDICTORS OF SECOND-LINE ART VIROLOGICAL FAILURE Thiago S. Torres 1 , Linda J. Harrison 2 , Alberto M. La Rosa 3 , Lu Zheng 2 , Ann Collier 4 , Michael D. Hughes 2 , for the AIDS Clinical Trials Group (ACTG) A5273 Study Group

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