CROI 2018 Abstract eBook

Abstract eBook

Poster Abstracts

Conclusion: In our cohort of patients in HIV care, initial INSTI-based ART regimens had longer durations than non-INSTI regimens. They were also associated with improved rates of virologic suppression. Results support the use of INSTI regimens as the initial therapy in U.S. treatment guidelines.

Conclusion: M184V did not seem to be associated to higher risk of VF with 3TC+PI/r or DTG, but with a higher probability of VB. The shorter time of viral suppression appears to increase the risk of VF and of VB in those with M184V.

498 IMPACT OF PREVIOUS M184V ON VIROLOGICAL OUTCOME OF SWITCH TO 3TC-BASED DUAL THERAPIES Roberta Gagliardini 1 , Arturo Ciccullo 1 , Alberto Borghetti 1 , Franco Maggiolo 2 , Dario Bartolozzi 3 , Vanni Borghi 4 , Monica Pecorari 4 , Antonio Di Biagio 5 , Anna Paola Callegaro 2 , Bianca Bruzzone 5 , Francesco Saladini 6 , Stefania Paolucci 7 , Lara Bellazzi 7 , Simona Di Giambenedetto 1 , Andrea De Luca 8 1 Catholic University of the Sacred Heart, Rome, Italy, 2 Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy, 3 Azienda Ospedaliero– Universitaria Careggi, Firenze, Italy, 4 University of Modena and Reggio Emilia, Modena, Italy, 5 IRCCS AOU San Martino-IST, Genoa, Italy, 6 University of Siena, Siena, Italy, 7 IRCCS Policlinico San Matteo Foundation, Pavia, Italy, 8 Siena University Hospital, Siena, Italy Background: A randomized study showed higher efficacy of maintenance dual therapy (DT) with protease inhibitors(PI)/ritonavir(r) + 3TC despite the presence of M184V. Aim of this study was to compare virological efficacy of DT in pts with a history of M184V detection (M184V+) and without (M184V-). Methods: We retrospectively analyzed HIV+ pts with HIV-RNA50 copies/ ml switching to DT and with at least one previous genotype in the Italian ARCA database. Pts were followed from baseline (BL, starting of DT) until discontinuation or virological failure (VF). The primary endpoints were: VF [viral load (VL)>50 cps/mL in 2 consecutive determinations or one 200 cps/mL] and virological blips (VB) (VL 51-199 cp/mL not confirmed). M184V was assessed in the historical genotypic resistance tests (hGRT). Results: 436 pts were included, 45(10%) switched to 3TC with lopinavir/r, 106(24%) with atazanavir/r, 155 (36%) with darunavir/r, 126(29%) with dolutegravir,4(1%) with raltegravir. 87/436 pts were M184V+ according to hGRT, 85/436 according to last GRT. The M184V+ group more frequently included females, IDU, had older age, lower CD4+ at nadir, longer duration of ART and of viral suppression. Median follow-up was 1.2 years (ys) (IQR 0.6;2.4). VF occurred in 17/369 M184V- pts and in 7/87 M184V+ pts. The 3-year probability of remaining free from VF was 91.9% (95% CI 86.6;97.2) in M184V- and 87.8% (78.4;97.2) in M184V+ (log rank p=0.323). In a multivariate model adjusting for M184V, class of 2nd drug and duration of viral suppression only zenith VL (aHR 2.07 per 1-log higher, p=0.034) was independently associated with VF. In pts without VF, VB occurred in 18/332 (5%) M184V- and 10/80 (13%) M184V+ pts. The 3-y probability of not having VB was 90.1% (84;96.2) in M184V- and 79.8% (67.8;91.8) in M184V+ (p=0.016). At multivariate analysis, only M184V resulted to be predictor of VB (aHR 2.84, p=0.040). Similar results were found with different definitions of VF and VB. Selecting pts with viral suppression 6.6ys (median of M184V+ group) (n=308), the 3-y probability of remaining free from VF was 92.5% in M184V- and 82.9% in M184V+ (p=0.080): zenith VL was the only predictor of VF; VB were 13/239 and 8/37, respectively, and the probability of remaining free of VB was 91.1% - and 69.4% (p<0.001).

Poster Abstracts

499 HIV TREATMENT EXPERIENCED PATIENTS SWITCHED TO D/C/F/TAF: AGE, GENDER, RACE ANALYSES Gregory D. Huhn 1 , Edwin DeJesus 2 , Pierre-Marie Girard 3 , Romana Petrovic 4 , Eric Y. Wong 5 , Kimberley Brown 5 1 Ruth M. Rothstein CORE Center, Chicago, IL, USA, 2 Orlando Immunology Center, Orlando, FL, USA, 3 University Pierre & Marie Curie, Paris, France, 4 Janssen, Beerse, Belgium, 5 Janssen Scientific Affairs, LLC, Titusville, NJ, USA Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is the only darunavir and F/TAF-containing single-tablet regimen in development for the treatment of patients with HIV-1 infection. EMERALD evaluated the efficacy and safety of switching to D/C/F/TAF 800/150/200/10 mg versus continuing use of a boosted protease inhibitor+emtricitabine/tenofovir disoproxil fumarate (control). We report Week 48 results in subgroups based on age, gender, and race. Methods: EMERALD is a phase 3, randomized (2:1), non-inferiority trial of treatment experienced, virologically suppressed HIV-1–infected adults (viral load [VL] <50 copies [c]/mL for ≥2 months; 1 VL ≥50 and <200 c/mL allowed in 12 months before screening; previous non-darunavir virologic failure [VF] allowed). The primary endpoint was proportion of patients with virologic rebound (confirmed VL ≥50 c/mL or premature discontinuation with last VL ≥50 c/mL) cumulative through Week 48. Virologic response was defined as VL <50 c/mL (FDA snapshot). Safety was assessed by adverse events (AEs) and changes in bone mineral density and eGFR from baseline to Week 48. Results were evaluated in subgroups by age (≤50 vs >50 y), gender, and race (non- black/African American [AA] vs black/AA). Results: Of the 1141 patients randomized and treated, 382 (33.5%) were >50 y, 205 (18.0%) women, and 237 (20.8%) black/AA. Overall, virologic rebound rates were similar in the D/C/F/TAF and control arms (2.5% vs 2.1%); results were consistent across age, gender, and race subgroups (Table). Virologic response rates were similar for D/C/F/TAF (94.9%) and control (93.7%) in the total population and consistent across subgroups. No resistance to study drugs was observed. Overall rates of adverse events (AEs) and discontinuations due to an AE were generally similar for D/C/F/TAF and control, with no significant differences across subgroups. Consistent with the total population, improved bone safety (bone loss/atrophy AEs related to study drug; bone mineral density) and renal function (eGFR [serum cystatin C]) were seen with D/C/F/TAF versus control across subgroups.

CROI 2018 180