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• W3015440894 abstract "We read with interest the work by Vizcarra et al.[1], showing significant increases in weight gain and body fat mass in patients switched to a two-drug regimen of dolutegravir (DTG) with rilpivirine. In their cohort, the authors found similar increases, although less significant, in patients on lamivudine (3TC) with boosted darunavir. The issue of weight gain in patients treated with integrase inhibitors has become of major concern for clinicians following recent reports [2]; the mechanism underlying such effect is still unknown and data in literature on the effect of a two-drug regimen with DTG+3TC on body mass are still lacking. We aimed to assess changes in body fat mass and bone mineral density in patients switched to lamivudine with dolutegravir (DTG group) in a real-life scenario and compare them with a ‘control’ cohort of patients switched to lamivudine with boosted-atazanavir (ATV group). Enrolled patients performed a whole-body dual-energy X-ray absorptiometry as well as bone mineral density (BMD) (g/cm2) determinations at the lumbar spine (L2–L4) and at the femoral neck up to 6 months before the switch and after 12 months; all measurements were performed by the same operator, through a Hologic device (QDR 4500A, Hologic Inc., Bedford, Massachusetts, USA). We also collected patients’ clinical history, viroimmunological parameters and comedications. All patients provided written informed consent to data collection. Differences were assessed using parametric or nonparametric tests, as appropriate; predictors of changes were assessed via linear regression. Overall, we analyzed 39 patients: 16 in the ATV group and 23 in the DTG group. Twenty-seven patients (69%) were men, with a median age of 50 years [interquartile range (IQR) 43–56], a median time from HIV diagnosis of 10 years (IQR 5–18) and a median time from ARV initiation of 8.5 years (IQR 3.1–16.3). Eleven patients (28%) had a previous AIDS-defining event whereas two (5%) were HCV-coinfected. Patients in the DTG group were significantly younger (52 vs. 46 years, P = 0.001), with lower time from HIV diagnosis (15.6 vs. 5.8 years, P = 0.003) and from ARV initiation (12 vs. 4.2 years, P = 0.001) compared with patients in the ATV group. Full patient characteristics are available in Table 1.Table 1: Patients’ characteristics at baseline.After 12 months, in both groups, we observed an increase in total fat mass, but not statistically significant; in particular, we registered a median increase of 1.0 kg in the DTG group (P = 0.114) and 0.6 kg in the ATV group (P = 0.507). Similarly, body fat percentage increased in the DTG group (+1.5%) and in the ATV group (+1.0%). At a multivariate analysis, no predictors were found after adjusting for age, sex, HIV risk factor, years of ARV exposure, CD4+ nadir cell count. Regarding bone density, in the DTG group, after 1 year of follow-up, we found a significant improvement both in spine BMD (median, +0.02 g/cm2, P = 0.010) and in femur BMD (+0.03 g/cm2, P = 0.006); meanwhile, in the ATV group, we found a significant improvement only in femur BMD (+0.01 g/cm2, P = 0.023). In both groups, the observed improvement was independent from the use of diphosphonates or vitamin D supplementation. In our cohort, we did not observe a significant increase in either total fat mass or weight gain in experienced HIV-positive patients switching to DTG+3TC. This strategy has already been described in large cohorts and clinical trials [3,4] as well tolerated and highly tolerable in terms of metabolic profile; our work shows evidence of a neutral effect on body fat mass. To the best of our knowledge, this is one of the first studies describing fat mass changes in patients on DTG+3TC. Moreover, confirming our previous report [5], we observed a significant improvement in bone mineral density on both spine and femural neck with this strategy after 12 months. The main limitations of this study are represented by its retrospective nature, the small sample size and the limited follow-up time. In conclusion, in our clinical practice setting, we did not observe, in patients switched to DTG+3TC, a significant increase in body fat, while, at the same time, there was an improvement in bone mineral density. Both these findings further confirm the excellent tolerability of this strategy, making it even more attractive for an aging HIV population with an increasing number of comorbidities. Acknowledgements Funding: This study was performed as part of our routine work. Conflicts of interest Transparency declarations: A.B. has received nonfinancial support from Bristol-Myers Squibb and ViiV Healthcare, and personal fees from Gilead Sciences. S.D.G. was a paid consultant or member of advisory boards for Gilead, ViiV Healthcare, Janssen-Cilag, Merck Sharp & Dohme and Bristol-Myers Squibb. All other authors: none to declare." @default.
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• W3015440894 date "2020-05-01" @default.
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• W3015440894 title "No significant changes in body fat mass in virologically suppressed, HIV-positive patients switched to lamivudine--dolutegravir" @default.
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• W3015440894 doi "https://doi.org/10.1097/qad.0000000000002495" @default.
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