CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

696 TDF and Quantitative Ultrasound Bone Density in African Patients on Second-Line ART Firmin N. Kabore 1 ; Sabrina Eymard-Duvernay 2 ; Amandine Cournil 3 ; Jacques Zoungrana 4 ; Assane Diouf 5 ; Arsène Héma 4 ; Laura Ciaffi 6 ; Eric Delaporte 3 1 CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso; 2 INSERM, Montpellier, France; 3 UMI 233-IRD/U1175-INSERM/Montpellier Univ, Montpellier, France; 4 CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso; 5 Cheikh Anta Diop Univ, Dakar, Senegal; 6 IRD, Site ANRS Cameroun, Yaoundé, Cameroon

Background: Several reports indicated that HIV-1 infected people have lower bone mineral density (BMD) than general population, independently of traditional osteoporosis risk factors. TDF-including regimens have been associated with greater loss of BMD than other regimens. Objective : To identify low bone mineral density associated factors in African patients on a protease inhibitor (PI)- based second line antiretroviral treatment (ART). Methods: It is a sub-study (ANRS 12250) of a multicenter randomized phase 3 trial that compared efficacy and safety of three second line combinations in Africa (ANRS 12169). Patients from Bobo-Dioulasso (Burkina Faso), Yaounde (Cameroun) and Dakar (Senegal) were randomized to receive either TDF/FTC/LPVr, ABC/ddI/LPVr or TDF/ FTC/DRVr. The BMD was assessed by calcaneum quantitative ultrasound ( Achilles, GE Healthcare ) at baseline and every 6 months. Stiffness index was used to evaluate BMD and associated factors were determined by multiple linear regressions. Mixed models with random effects were used to determine associated factors during the follow-up. Results: Out of 228 patients, 158 (69%) were included in Yaounde and 168 (74%) were women. At baseline, mean age was 40 ± 10 years, mean T-CD4 counts was 218 ± 139 cells/µl and mean viral load, 4.5 ± 0.7 log/ml. The mean duration of the first line ART was 55 ± 24 months and the mean baseline stiffness index was 103 ± 22. Independent factors associated with baseline BMD were sex (β=-10.57 [-17.90,-3.23] for women), age (β=-0.87 [-1.24,-0.50] per year), body mass index (BMI) (β=+0.80 [-0.07,1.52] per unit of BMI) and study site (β=+12.81 [6.48,19.14] for Yaounde). After 24 months of second line therapy, a reduction of 7.3% of mean stiffness index was observed, compared to baseline. The factors associated with BMD during the follow-up were similar to those found at baseline (table). Exposure to TDF or to LPV was not associated with greater loss of BMD over time. Conclusions: BMD decreases after second line ART initiation in African patients independently of TDF or LPV exposition. Factors associated with BMD were age, sex, baseline BMI, study site and time of follow up.

Poster Abstracts

697 Bone-Mineral Density After Switching to ATV/r+3TC: A Substudy of the AtLaS-M Trial Alessandro D’Avino 1 ; Andrea De Luca 2 ; Anna Pia Lassandro 1 ; Nicoletta Ciccarelli 3 ; Francesca Lombardi 4 ; Massimo Giuliani 5 ; Adriano Lazzarin 6 ; Massimiliano Fabbiani 4 ; Simona Di Giambenedetto 4 ; Roberto Cauda 4 1 Inst of Clinical Infectious Diseases -Università Cattolica del Sacro Cuore, Rome, Italy; 2 Univ of Siena, Siena, Italy; 3 Catholic Univ, Rome, Italy; 4 Inst of Clinical Infectious Diseases, Catholic Univ of Sacred Heart, Rome, Italy; 5 San Gallicano Dermatological Inst, IRCCS, Rome, Italy; 6 Vita-Salute Univ, San Raffaele Scientific Inst, Milan, Italy Background: AtLaS-M is a randomized multi-center trial showing superior efficacy and safety of treatment simplification to a dual regimen with ATV/r+3TC (dual therapy, DT) as compared to continuing ATV/r+2NRTI (triple therapy, TT) in virologically suppressed HIV+ patients. Here, we report data of Bone Mineral Density (BMD) and Body Fat Distribution at 48 Weeks. Methods: BMD at femoral neck and lumbar spine and body fat distribution as measured by DEXA and bio-markers of bone turnover were measured at baseline and 48w. Student t-test was used to compare means and multivariate regression to assess predictors of mean changes at 48 weeks Results: 106 randomized patients were included in this sub-study, 60 from the DT and 46 from the TT arm. 82.1%were male, the most frequent risk factor was MSM contacts (50%), median age was 47 y (IQR 38-51), median BMI 24.1 kg/cm 2 (22.2-26), 49.1%were smokers, 88.9%were on a tenofovir-containing NRTI backbone with a median time of HAART exposure of 1.99 years (1.32-4.93). At BL, 62.3% of pts had a low BMD in any district and 68.8% a pathological Vitamin D level. No baseline difference was found between arms. At 48w, in the DT arm, BMD of the femoral neck showed a significant increase (mean change +1.93% p=0.002), while in the TT arm no significant modification was observed (mean change -1.13%; mean difference in change 3,06% p=0.01). DT arm also improved lumbar spine BMD at 48W (+0.53% p=0.21) while TT armworsened (-1.3% p=0.14). Pts randomized to DT, showed a significant reduction of PTH (-9.3 vs +1.9 ng/L in TT, mean difference in change -5.9 ng/L p=0.002) and osteocalcin levels (-7.2 vs -1.3 ng/ml in TT; mean difference in change -5.92 ng/ml p<0.001) at 48w. Body fat distribution did not show changes within and between groups. At multivariate logistic regression, pts losing BMI had a lower probability to gain lumbar spine BMD at 48w (OR 0.72 95%CI 0.54-0.97, p=0.03), while pts with osteopenia at BL as compared to those with osteoporosis were more likely to improve (OR 2.96 95%CI 1.18-7.44 p=0.02). Remarkably, BMD gain at femoral neck observed in pts receiving DT was independent from their baseline NRTI backbone type. Conclusions: In virologically controlled pts on ATV/r+2NRTI, a switch to DT with ATV/r+3TC was associated with significant improvements in BMD and markers of bone turnover after one year. Early diagnosis of BMD loss seems crucial since pts with osteoporosis benefit less from switch to DT as compared to those with a less advanced condition.

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CROI 2016