CROI 2020 Abstract eBook
Conclusion: Among ART-experienced, virologically suppressed PLWH initiating DTG/RPV as a 2-DR or standard 3-DR, there was no observed difference in the risk of virological failure in a real-world setting.
respectively. Baseline characteristics are shown in Table. VF occurred in 3.8% (n=30) of DTG/RPV and 2.6% (n=15) of DTG/xTC subjects (p=NS), with a median delay to VF of 232 days [IQR 100-507] and 301 days [IQR 188-427], respectively. Among VF subjects, 9/30 (33%) had history of VF on NNRTI-based regimen in DTG/RPV group and 5/15 (30%) had history of VF on NRTI-based regimen in DTG/xTC group. At DTG/RPV VF, 17/30 genotypes were available: 2 genotypes harbored NNRTI RAMs already detected on historical genotypes (E138A ; E138A+L100I) ; 2 genotypes harbored new RAMs, 1 genotype with E138K on NNRTI and 1 genotype with E138K+K101E on NNRTI and N155H on INSTI. At DTG/xTC VF, 6/15 genotypes were available: no new RAM was detected and 1 genotype harbored M184V already detected on historical genotypes. The only predictive factor of VF on DTG/RPV was history of VF to NNRTI-based ART (HR 2.82, CI95% 1.04-7.6), while gender, age, duration of HIV RNA <50 c/mL prior to 2DR, nadir CD4, zenith HIV RNA and CDC stage C were not. No factor was associated with VF under DTG/xTC. Conclusion: In this large real-life cohort, DTG-2DR maintained sustain HIV RNA virologic suppression, and were associated with a low rate of VF. DTX/xTC was associated with slightly lower VF rate than DTG/RPV and the absence of RAM emergence at VF. ARV history are prior VF are key issues to consider before offering 2DR maintenance.
492 SHALL WE DANCE? EXTENDING TANGO’S RESULTS TO CLINICAL PRACTICE Gianmaria Baldin 1 , Alberto Borghetti 1 , Arturo Ciccullo 1 , Stefano Rusconi 2 , Amedeo Capetti 2 , Gaetana Sterrantino 3 , Manuela Colafigli 4 , Gabriella d'Ettorre 5 , Andrea Giacometti 6 , Maria V. Cossu 2 , William Gennari 7 , Cristina Mussini 7 , Vanni Borghi 7 , Simona Di Giambenedetto 8 1 Catholic University of the Sacred Heart, Rome, Italy, 2 Luigi Sacco University Hospital, Milan, Italy, 3 Azienda Ospedaliero– Universitaria Careggi, Firenze, Italy, 4 San Gallicano Dermatology Institute, Rome, Italy, 5 Sapienza University of Rome, Rome, Italy, 6 Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona, Ancona, Italy, 7 Azienda Ospedaliera Universitaria Policlinico di Modena, Modena, Italy, 8 Catholic University of Sacred Heart Rome, Rome, Italy Background: Results from the TANGO study highlight the high efficacy and tolerability of lamivudine (3TC) and dolutegravir (DTG) as a switch strategy. However, trials’ populations often differ from real-practice settings. We aimed to confirm the study’s findings in our multicenter cohort. Methods: This was an observational study enrolling HIV-infected, virologically suppressed patients switching to 3TC+DTG, divided into 2 groups based on their adherence to the TANGO inclusion criteria. We collected patients’ history, virological, immunological assessment at baseline, 48, 96 and 144 weeks. We performed Kaplan-Meier survival analysis to evaluate time to virological failure (VF, defined by 2 consecutive HIV-RNA determinations≥50 cps/mL or a single HIV-RNA≥1000 cps/mL) and treatment discontinuation (TD), Cox-regression to find predictors of VF or TD and linear mixed model for repeated measures to identify significant changes in immunological parameters. Results: We analyzed 557 patients: 145 (26.0%) met the TANGO inclusion criteria (TANGO group, TG). During 248 PYFU in the TG and 776 PYFU in the non-TG, 1 and 11 VF occurred in the 2 groups respectively. The estimated probability of maintaining virological suppression was 99.2% (SD±1.6) at 48, 96 and 144 weeks in the TG, and 98.5% (SD±1.4) at 48 weeks, 97.7 (SD±1.8) at 96 weeks and 95.7% (SD±2.6) at 144 weeks in the non-TG (log-rank p=0.189). Respecting TANGO’s criteria did not affect the risk of VF (aHR 0.35, 95%CI 0.04-2.84; p=0.327), even after adjusting for age, anti-HCV serostatus and HIV duration. Estimated probabilities of remaining on 3TC+DTG were 86.6% (SD±5.9) at week 48 and 79.5% (SD±7.5) at weeks 96 and 144 in the TG, and 85.8% (SD±3.5), 78.9% (SD±4.3) and 73.9% (SD±5.1) at weeks 48, 96 and 144 in the non-TG (log-rank p=0.654), with no significant increase in the hazard of TD for the TG after adjustment for age, gender, HIV risk factor, CD4 nadir, HIV duration and time on ARV. A significant increase in CD4 cell count (mean change at 96 weeks, +87 cell/µL in TG and +40 cell/µL in the non-TG) and CD4/CD8 ratio (mean change at 96 weeks, +0.05 in the TG and +0.07 in the other) was observed over time in both groups. Conclusion: Results from our multicenter study are in line with the results from the TANGO study and their applicability to everyday clinical practice.
491 2-DRUG REGIMEN COMPARABLE TO 3-DRUG REGIMENS UP TO 18 MONTHS IN A REAL WORLD SETTING Gerald Pierone 1 , Kathy L. Schulman 2 , Jennifer S. Fusco 2 , Vani Vannappagari 3 , Michael Aboud 4 , Leigh Ragone 3 , Gregory Fusco 2 1 Whole Family Health Center, Vero Beach, FL, USA, 2 Epividian, Durham, NC, USA, 3 ViiV Healthcare, Research Triangle Park, NC, USA, 4 ViiV Healthcare, London, UK Background: Dolutegravir/rilpivirine (DTG/RPV) was the first single tablet, once daily regimen, containing only two antiretrovirals to be approved. Our objective was to compare the effectiveness and durability of DTG/RPV to standard three-drug regimens (3-DR) in a real-world setting. Methods: People living with HIV-1 (PLWH) who initiated a two drug regimen (2-DR) comprised of DTG/RPV or 3-DR, defined as one core agent and two NRTIs, were identified in the OPERA Database. Those who initiated therapy between 1/1/2018–12/31/2018, were ART experienced, age ≥13 years, and suppressed (<50 copies/mL) at start were analyzed. Discontinuation (d/c) was defined as cessation of 2- or 3-DR. Sustained suppression was defined as last viral load (VL) <200 copies. Virologic failure (VF) was defined as either 2 consecutive VL ≥ 200 copies/mL or 1 VL ≥ 200 copies/mL + d/c. The population was observed through 06/30/2019. Baseline characteristics were described using Pearson’s chi-square, Fisher exact, or Wilcoxon rank-sum tests. Kaplan-Meier methods were used to describe d/c and VF. Cox Proportional Hazards modeling was used to assess the risk of VF adjusting for age, sex, race, ethnicity, risk of infection, region, baseline CD4 cell count, history of substance abuse, history of syphilis and VACS score at baseline. Results: Among 545 PLWH who initiated DTG/RPV as a 2-DR and 5,524 PLWH who initiated 3-DR, DTG/RPV 2-DR users were significantly (p<.0001) older, more likely to be Hispanic, MSM, to have comorbidities and to receive care in the southern and western United States. They were less likely to be African American or to receive care in the Northeast or Midwest. PLWH initiating 3-DR were more likely to have a history of syphilis. Median (IQR) follow-up was similar between 2-DR and 3-DR initiators at 10.7 (6.8-14.6) months. DTG/RPV 2-DR users experienced fewer discontinuations compared to 3-DR users (15.0% vs. 28.0%, <.0001) and were more likely to sustain suppression (97.7% vs 95.5%, p=.02) compared to 3-DR users. VF rates per 100 person-years (95% CI) did not differ (DTG/RPV: 1.45 (0.69, 3.03) vs. 3-DR: 2.63 (2.21, 3.14 )). Differences in the risk of VF between 3-DR, DTG/RPV initiators in adjusted Cox models were not significant (aHR 1.32, 95% CI 0.61,2.89) (Fig. 1).
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