Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables: Three-Year Results of the Randomized TANGO Study

作者：Ruolan Wang, Mark Underwood, Josep M. Llibre, Enrique Bernal, Cynthia Brinson, José Sanz Moreno, Stefan Scholten, Richard D. Moore, Parminder Saggu, J Oyee, Riya Moodley, Brian Wynne, Michelle Kisare, Bryn Jones, Mounir Ait‐Khaled · 发表于：Open Forum Infectious Diseases · 年份：2023 · DOI：10.1093/ofid/ofad626 · 被引用次数：7 · 研究领域：Hepatitis C virus research、HIV-related health complications and treatments、HIV/AIDS drug development and treatment

Abstract Background We compared proportions of participants with target detected, target not detected (TND), and elevated viral load (VL) and assessed baseline variables associated with week 144 inflammatory biomarker levels between dolutegravir-lamivudine (DTG/3TC) and tenofovir alafenamide–based regimens (TBRs) in the TANGO study (post hoc). Methods TANGO is an open-label, multicenter, phase 3 study that randomized adults with VL <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or continue TBR. At baseline and each study visit, the VL was measured. Elevated VL event frequencies were assessed, including “blips.” Interleukin 6, D-dimer, high-sensitivity C-reactive protein, soluble CD14, and soluble CD163 were measured at baseline and at week 144. Loge-transformed week 144 biomarker levels were compared between treatment groups using an analysis of covariance model adjusting for baseline variables. Results High, comparable proportions of participants had VL <40 copies/mL and TND at week 144 (DTG/3TC, 279 of 369 [76%]; TBR, 267 of 372 [72%], intention-to-treat exposed Snapshot analysis; adjusted difference, 3.9% [95% confidence interval, −2.5% to 10.2%]), with similar TND proportions at all postbaseline visits (123 of 369 [33%] vs 101 of 372 [27%], respectively). Similar proportions of DTG/3TC participants had ≥1 postbaseline VL ≥50 copies/mL (28 of 369 [8%] vs 42 of 372 [11%] for TBR), primarily blips (18 of 369 [5%] and 26 of 372 [7%], respectively). Wee...