CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

Results: The proportion of patients with pVL < 1 cp/mL did not evolve overtime: 72%, 63%, 72%, 68%, 57%, 47%, 68% and 69% at BL, W4, W8, W12, W16, W20, W24 and end of the study respectively. Median BL cell associated DNA in PBMC was similar in patients with BL pVL< 1 and > 1 cp/mL (2.77 and 2.96 log 10 copies/10 6 PBMCs, respectively). Among the 44 patients, 3 patients had minority X4-tropic viruses determined by UDS at BL and one of them presented VF. Some BL resistance mutations in integrase gene were detected by UDS at two positions: E138 and G140. None of studied factor was associated with VF. Conclusions: Overall, the proportion of patients with a VL < 1 cp/mL was similar during all the follow-up, suggesting that VF is not related to a lack of efficacy of the MVC/RAL combination. Neither UDS, nor ultrasensitive viremia were an added value to predict VF in this context of MVC/RAL switch. 565 D-dimer Doesn’t Return to Pre-HIV Levels After Therapy and Is LinkedWith HANA Events Matthew S. Freiberg 2 ; Ionut Bebu 4 ; RussellTracy 3 ; Jason F. Okulicz 1 ; Anuradha Ganesan 1 ; Adam Armstrong 5 ;Thomas O’Bryan 1 ; Brian K. Agan 1 IDCRP HIVWorking Group 1 Uniformed Services University of the Health Sciences, North Bethesda, MD, US; 2 Vanderbilt University Medical Center, Nashville, TN, US; 3 University of Vermont College of Medicine, Burlington, VT, US; 4 The George Washington University, Rockville, MD, US; 5 US Naval Medical Research Unit No. 6 Peru, Lima, Peru Background: Biomarkers of inflammation increase with HIV infection, and decline with therapy (ART). While it has been proposed that these markers fail to decline to levels that existed before HIV seroconversion (SC), this has never been directly demonstrated. Moreover, it is unknown whether this “residual” inflammation is associated with future HIV Associated Non AIDS (HANA) events. Methods: We analyzed data/specimens on 249 HIV+ participants from the US Military HIV Natural History Study, a prospective, multicenter observational cohort of ~5500 active duty military personnel and beneficiaries living with HIV, who had available (1) cryogenically stored blood specimens at three defined timepoints (TP): TP1) pre-HIV SC (closest specimen at or prior to last negative HIV test), TP2) >6 months post-HIV SC but prior to ART initiation, and TP3) >6 months post-ART with HIV-1 RNA levels<50 copies/mL on two successive evaluations; (2) detailed medical history data including incident HANA events and (3) were free of liver disease, CVD, cancer, or steroid use. We used cox proportional hazards models to investigate the association between the changes in biomarker values (TP3-TP1, “residual inflammation”) and HANA events while adjusting for confounders. Results: Median ages were 27 (TP1); 30 (TP2); and 31 (TP3). At TP2 the population was 98%male, had median BP of 126/80 mmHg; AST/ALT of 30/28 IU/L; hemoglobin of 15 g/ dL; total cholesterol, LDL, and triglyceride levels of 165, 107, and 139 mg/dL respectively; body mass index of 26. The median CD4 + and duration of HIV infection were 361 cells/uL and 392 days, respectively. At TP3 median time on ART was 354 days. There were 27 incident HANA events during 1133 PY of f/u (median 3.74 yr). All comparisons between median D-dimer biomarker levels, but not IL-6 levels, for TP1,2 and 1,3 and 2,3 (figure), were significant p<0.001. “Residual inflammation” for D-dimer, but not IL-6, was significantly associated with incident HANA events (hazard ratio (HR)=1.43, 95% confidence interval 1.04-1.97, p=0.03; and HR=1.29, 95% CI 0.73-2.27, p=0.38), respectively.

Poster Abstracts

Conclusions: After ART initiation and viral suppression, D-dimer remained elevated compared to pre-HIV SC levels in a cohort of healthy young adults. Residual D-dimer was also significantly associated with future HANA events. These data support the concept that successful ART alone does not eliminate inflammation associated with HIV infection, and may help explain the excess risk of non-AIDS diseases among those with HIV.

566 Virological Responses to Lamivudine and Emtricitabine in the Nationwide ATHENA Cohort Casper Rokx 1 ; Azzania Fibriani 1 ; David A. van deVijver 1 ; AnneliesVerbon 1 ; Martin Schutten 1 ; Luuk Gras 2 ; Bart J. Rijnders 1 On behalf of the Dutch HIV Monitoring Foundation 1 Erasmus University Medical Center, Rotterdam, Netherlands; 2 Academic Medical Center University of Amsterdam, Amsterdam, Netherlands

Background: Lamivudine (3TC) and emtricitabine (FTC) are considered interchangeable in recommended combination antiretroviral therapies (cART) including tenofovir (TDF) with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or boosted protease inhibitor (PI). The evidence for equivalent efficacy of 3TC and FTC in cART is inconsistent and data from randomized clinical trials that directly compare FTC and 3TC are lacking. The purpose of this study was to evaluate the virological responses to 3TC and FTC in combination with TDF and efavirenz (EFV), nevirapine (NVP) or boosted PI in a nationwide cohort. Methods: Observational cohort study on the AIDS Therapy Evaluation in the Netherlands (ATHENA) nationwide HIV cohort. Included were ART naive HIV-1 infected adults who initiated 3TC or FTC with TDF and either EFV or NVP or boosted PI between 2002 and 2012. Week 48 and week 240 virological failure to 3TC and FTC containing regimens were compared by multivariable adjusted logistic regression in on-treatment analysis. Time to 2 consecutive HIV-1 RNA <400 c/mL and time to virological failure after HIV-1 RNA <400 c/mL were compared by Cox proportional hazard models. Sensitivity analyses included intent to treat (ITT) analysis and propensity score adjusted models.

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CROI 2015