CROI 2018 Abstract eBook

Abstract eBook

Poster Abstracts

updated (ART experience, CD4, viral load, AIDS, protease inhibitor (PI)/tenofovir (TDF) exposure) factors. Results: The mean age at baseline of the 8334 participants was 36 years; most were female with median CD4 count 320 cells/mm 3 (Table). Median eGFR was 113 mL/min/1.73m 2 ; eGFR <60 was present in 1.2%, 2.4%, 2.9% and 4.7% of those from East Africa, Southern Africa, the Caribbean and West Africa, respectively (p <0.001). During >68000 person-years, 258, 97 and 71 persons, respectively, developed CKD stage ≥3, ≥4 and 5, with the highest incidence observed in West Africans (Table). Using East Africans as the reference group, the adjusted incidence rate ratio of CKD 5 was 5.38 (2.26, 12.82) among those fromWest Africa, 3.05 (1.31, 7.08) for those from Southern Africa, and 2.64 (0.98, 7.07) among Caribbeans. Participants fromWest Africa were also at significantly higher risk of CKD ≥3 (2.71 [1.82, 4.03]) and CKD ≥4 (2.83 [1.41, 5.67]). Conclusion: The risk of CKD and kidney disease progression varied significantly among HIV positive black populations, with the highest rates observed in West Africans, suggesting that APOL1 risk alleles is likely an important determinant of CKD in this population.

reasons not related to efficacy (n=4). EVG, COBI, and TAF PK were consistent with exposures in normal renal function. As expected, exposures of FTC and TFV (metabolite of TAF), which are renally eliminated, were higher v. historical data in normal renal function (Table). 16 (29%) participants had Grade (G) 3 or 4 AEs unrelated to study drug; 6 (11%) participants experienced study drug related AEs (all were G1-2, including nausea in 4). Two participants discontinued E/C/F/ TAF due to AEs (allergic pruritis, related; staphylococcal endocarditis, unrelated). The participant with endocarditis died from heart failure after entering hospice. 24 (44%) participants had G3-4 laboratory abnormalities, all of which were present at baseline. 79% of participants felt “much more satisfied” with the STR convenience compared to baseline. Conclusion: Switching to E/C/F/TAF STR maintained virologic suppression at W24, was well tolerated, and more convenient for adults with ESRD on HD.

Poster Abstracts

733 CHANGE IN FAT/LEAN MASS IN HIV-POSITIVE AND -NEGATIVE SUBJECTS; DATA FROM HIV UPBEAT Aoife G. Cotter 1 , Alan Macken 1 , Willard Tinago 1 , Eoin Kavanagh 2 , Geraldine McCarthy 1 , Juliet Compston 3 , Caroline Sabin 4 , Patrick W. Mallon 1 1 University College Dublin, Dublin, Ireland, 2 Mater Misericordiae University Hospital, Dublin, Ireland, 3 Cambridge University, Cambridge, UK, 4 University College London, London, UK Background: Changes in body composition with antiretroviral therapy (ART) initiation have been well defined but long-term body composition changes in people living with HIV on stable ART compared to people without HIV remains unclear. With concerns regarding fat gain and sarcopenia in older PLWH, we aimed to compare changes in fat and lean mass in a large cohort of HIV+ and HIV- individuals. Methods: In HIV UPBEAT, a prospective cohort of HIV+ and HIV- subjects from similar demographic backgrounds, subjects had annual dual energy Xray absorptiometry (DXA) to measure total and regional (arms, legs, trunk) fat and lean mass and provided clinical, demographic and laboratory data. We determined the absolute change in log-transformed body composition variables with longitudinal mixed effects models. Time-updated variables were included in models and removed if no difference in slope was determined. Data are presented as median(interquartile range) or %change(95% C.I.) unless otherwise specified. Results: From February 2011-June 2014, 462, 367 and 262 subjects provided DXA data at 3 annual visits respectively. Compared to the HIV- group, the HIV+ group were younger (38.5 (33.3, 46.1) vs 41.7 (34.6, 48.4) years, P=0.03; 13.7% and 20.0% aged >50 respectively, P=0.07), more likely male (58.0% vs 43.4%, P=0.002) and of African ethnicity (39.2% vs 24.9%, P=0.001). While arm fat increased by +4.95(+3.51,+6.41)% per year (P<0.0001), there were no significant changes in leg, trunk or total fat (fig) and no significant between- group differences in annual %change in arm (+0.92(-1.86,+3.75)%), leg (-0.46(- 2.57,+1.86)%), trunk (-0.69(-3.75,+2.09)%) or total fat (-0.09(-0.03,+2.33)%) between HIV+ and HIV- groups. Arm lean mass increased by +1.62(+0.93, +2.10)% per year (P<0.0001) but there was no significant change in leg, trunk or total lean mass (fig). There was no significant between-group difference in annual %change in arm (+0.23(-0.93,+1.39)%), leg (+0.46(-0.23,+0.93)%), trunk (-0.69 (-2.09,+0.93)%) or total lean mass (+0.23(-0.23,+0.69)%) between HIV+ and HIV- groups. Conclusions were unchanged after adjustment for age, gender or ethnicity. Conclusion: While we observed increases in arm fat and lean mass, these did not differ between HIV+ and HIV- groups. We observed no significant change in other parameters of fat or lean mass either in the entire cohort or between groups. These data are reassuring; alterations in body composition in this cohort of PLWH reflect those observed in a relevant HIV- control group.

732 SAFETY AND EFFICACY OF E/C/F/TAF IN HIV-INFECTED ADULTS ON CHRONIC HEMODIALYSIS Joseph J. Eron 1 , Jean-Daniel Lelievre 2 , Robert Kalayjian 3 , Jihad Slim 4 , Anson K. Wurapa 5 , Jeffrey L. Stephens 6 , Cheryl McDonald 7 , Eric Cua 8 , Aimee Wilkin 9 , Brigitte Schmied 10 , Mehri McKellar 11 , Joseph M. Custodio 12 , Shuping Jiang 12 , Devi SenGupta 12 , Moupali Das 12 1 University of North Carolina Chapel Hill, Chapel Hill, NC, USA, 2 Hôpital Henri Mondor, Créteil, France, 3 MetroHealth Medical Center, Cleveland, OH, USA, 4 Saint Michael’s Medical Center, Newark, NJ, USA, 5 Infectious Disease Specialists of Atlanta, Atlanta, GA, USA, 6 Mercer University, Macon, GA, USA, 7 Tarrant County Infectious Disease Associates, Fort Worth, TX, USA, 8 Nice University Hospital, Nice, France, 9 Wake Forest University, Winston-Salem, NC, USA, 10 Otto-Wagner Hospital, Vienna, Austria, 11 Duke University, Durham, NC, USA, 12 Gilead Sciences, Inc, Foster City, CA, USA Background: Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir alafenamide (E/C/F/TAF) is approved for use in HIV-1 infected individuals with mild to moderate chronic kidney disease (estimated glomerular filtration [eGFR] 30-69 mL/min). Current HIV treatment for individuals with renal failure on hemodialysis (HD) requires complex regimens with multiple pills. This is the first study to evaluate safety, efficacy, and pharmacokinetics (PK) of a daily single-tablet regimen (STR) in HIV-infected adults with end stage renal disease (ESRD) on chronic HD. Methods: HIV1 infected, virologically suppressed adults with ESRD (eGFR <15mL/min) on chronic HD for ≥6 months were switched to open-label E/C/F/ TAF 150/150/200/10 mg once daily for 48 weeks (W). Efficacy was assessed as the proportion of participants with HIV1 RNA <50 copies (c)/mL (Snapshot algorithm). Maintenance of virologic suppression (<50 c/mL), safety, and patient satisfaction (Treatment Satisfaction Questionnaire) were assessed throughout the study. A PK substudy was done at or between W2 and 4. W24 data are presented here and W48 data will be available for the conference. Results: We enrolled 55 participants; median age 51yrs (range 23-64), 24% female, 82% Black, median time on HD 6yrs (range 1-17), median CD4 count 515 cells/mL (IQR 387, 672), and 22% Hepatitis C Ab positive, and 27% history of diabetes. At W24, 87% (48/55) had HIV-1 RNA <50 c/mL. The other 7 participants discontinued due to lack of efficacy (n=1), AE (n=2), or other

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