CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

502 96 WEEK EFFICACY AND SAFETY OF B/F/TAF IN TREATMENT-NAÏVE ADULTS AND ADULTS ≥50 YRS Samir K. Gupta 1 , Anthony Mills 2 , Cynthia Brinson 3 , Kimberly Workowski 4 , Amanda Clarke 5 , Andrea Antinori 6 , Jeffrey L. Stephens 7 , Ellen Koenig 8 , Jose R. Arribas 9 , David M. Asmuth 10 , Douglas Ward 11 , Jürgen K. Rockstroh 12 , Mingjin Yan 13 , Diana Brainard 13 , Hal Martin 13 1 Indiana University, Indianapolis, IN, USA, 2 Men’s Health Foundation, Los Angeles, CA, USA, 3 Central Texas Clinical Research, Austin, TX, USA, 4 Emory University, Atlanta, GA, USA, 5 Brighton & Sussex University Hospitals NHS Trust, Brighton, UK, 6 Lazzaro Spallanzani National Institute for Infectious Diseases, Rome, Italy, 7 Mercer University, Macon, GA, USA, 8 Instituto Dominicano de Estudios Virológicos, Santo Domingo, Dominican Republic, 9 La Paz University Hospital, Madrid, Spain, 10 University of California Davis, Davis, CA, USA, 11 Dupont Circle Physicians Group, Washington, DC, USA, 12 Bonn University Hospital, Bonn, Germany, 13 Gilead Sciences, Inc, Foster City, CA, USA Background: As the population living with HIV ages, identifying effective and safe regimens for older patients is of heightened importance. The single-tablet bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) is a guidelines- recommended regimen that may benefit older patients due to its favorable adverse event (AE) profile and few drug interactions. Methods: We conducted two randomized, double blind, phase 3 studies of B/F/ TAF in treatment-naïve adults, Study 1489: B/F/TAF vs dolutegravir, abacavir, and lamivudine (DTG/ABC/3TC) and Study 1490: B/F/TAF vs DTG + F/TAF. A pre-specified pooled analysis assessed efficacy as the proportion with HIV-1 RNA <50 c/mL (FDA Snapshot) and safety at Week (W) 96. Proteinuria and bone mineral density (BMD) were measured in Study 1489 only. We performed a post-hoc analysis in adults ≥50 yrs. Results: 1274 were randomized and treated (634 B/F/TAF, 315 DTG/ABC/3TC, 325 DTG + F/TAF); 196 were age ≥50 yrs (96 B/F/TAF, 41 DTG/ABC/3TC, 59 DTG + F/TAF). Efficacy was high for all treatments and for age ≥50 subgroup (Table). Overall, the most common AEs were nausea (10% B/F/TAF, 24% DTG/ABC/3TC , 11% DTG + F/TAF [p<0.001 B/F/TAF vs DTG/ABC/3TC]), diarrhea (17% B/F/TAF, 16% DTG/ABC/3TC, 16% DTG + F/TAF), and headache (15% B/F/TAF, 16% DTG/ ABC/3TC, 15% DTG + F/TAF). Treatment-related AEs occurred in 24% B/F/TAF, 40% DTG/ABC/3TC (p<0.001 B/F/TAF vs DTG/ABC/3TC), and 28% DTG + F/TAF. The most common treatment-related AE was nausea: 4% B/F/TAF, 17% DTG/ ABC/3TC (p<0.001 B/F/TAF vs DTG/ABC/3TC), and 5% DTG + F/TAF. Treatment related AEs in those age ≥50 yrs were similar to the full population: 23% B/F/ TAF, 37% DTG/ABC/3TC, 29% DTG + F/TAF. Overall, AEs leading to study drug discontinuation were reported for 1% on B/F/TAF, 2% on DTG/ABC/3TC and 2% on DTG + F/TAF, and in age ≥50 yrs: 2% B/F/TAF, 5% DTG/ABC/3TC and 7% DTG + F/TAF. In Study 1489 mean % changes in hip and spine BMD, proteinuria, and renal biomarkers were similar. There were small changes from baseline in fasting lipids at W96 overall and no significant differences between treatments in participants ≥50 yrs. Conclusion: Through two years of treatment B/F/TAF resulted in high rates of virologic suppression, was safe and well tolerated with fewer treatment-related AEs compared to other guidelines-recommended regimens; similar results were found in adults ≥50 yrs. There were no clinically significant impacts on bone and renal safety or on fasting lipids.

Poster Abstracts

503 CD4+ RECOVERY AFTER ART INITIATION: A COMPARISON BETWEEN DOLUTEGRAVIR AND EFAVIRENZ Mariana V. Meireles, Ana R. Pati Pascom , Adele Benzaken Ministry of Health of Brazil, Brasilia, Brazil Background: CD4 cell count recovery is an important predictor of AIDS-related morbidity and mortality, especially among those who start antiretroviral therapy (ART) with lower counts. In this study, we aimed to compare CD4 count recovery in patients starting ART in Brazil with TLE (tenofovir+lamivudine+efavirenz) vs TLD (tenofovir-lamivudine-dolutegravir). These were the regimens recommended as preferred 1st-line in the most recent treatment guidelines in the country, released in Dec 2013 (TLE) and in Jan 2017 (TLD). Methods: Data was extracted from two information systems from the Brazilian Ministry of Health, which record every viral load (VL) and CD4 counts performed within the country’s public health system, and every ART prescription. We included patients aged 15 and over, starting ART from Jan 2014 to Jul 2017 on either TLE or TLD and who had a CD4 count at baseline (-180 to 30 days) and after a year (365±90 days) from treatment initiation. CD4 count recovery was calculated as the difference between these values, adjusted by the time interval between ART initiation and the follow up measurement to report a standardized 365-day change. We present median absolute yearly CD4 changes and proportions which achieved 50, 100 and 200-cell/mm³ increases, with respective p-values for the Mann-Whitney U and χ2-tests. We also performed a logistic regression model adjusting for sex, age, baseline VL and presence of viral suppression (at 365±90 days), with a 200-cell increase as the outcome, and report the aOR and 95%CI. All analyses are stratified by baseline CD4 count. Results: 61,297 individuals were included in the analysis, of whom 7,509 (12.3%) were on TLD. Median age was 34yo, median baseline CD4 was 351 cells/ mm³, and 71.2%were male. Median increase in CD4 count was higher with TLD than with TLE in all baseline CD4 strata (all p-values <0.001). A higher absolute difference was observed in the 350+ cells/mm³ group (36 cells/mm³) and a lower in the 100-199 cells/mm³ group (24 cells/mm³). In the multivariable analysis patients on TLD remained significantly more likely to present a 200-cell/mm³ increase than those on TLE in all strata. Conclusion: In this study, dolutegravir led to a higher CD4 cell recovery after the 1st year of ART than did efavirenz, in all strata of CD4 analyzed, both in the unadjusted analyses and after controlling for other factors. These findings should be taken into account when choosing initial ART, especially in patients for whom immunologic recovery is a priority.

CROI 2019 187

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