Dual-drug Regimen for Virally Suppressed HIV

TANGO was a phase 3, randomized, open-label, noninferiority study designed to determine whether HIV-infected adults with virological suppression on a ≥three-drug TAF remain suppressed after switching to a 2DR of dolutegravir 50 mg/lamivudine 300 mg given once daily (10 (link)). Participants were randomized 1:1 to the dolutegravir/lamivudine regimen or current TAF, and antiviral activity was monitored over 48 weeks. In an intensive PK substudy, serial PK samples were collected in fasted state in a subset of 30 participants receiving dolutegravir/lamivudine at week 4 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose). Sparse samples were obtained without regard to food from most dolutegravir/lamivudine-assigned participants at weeks 4 (pre-dose and 1 hour post-dose), 8 (1–4 hours or 4–12 hours post-dose), 12 (4–12 hours or 1–4 hours post-dose), and weeks 24, 36, and 48 (pre-dose). Plasma samples were analyzed for dolutegravir and lamivudine concentrations using validated analytical methods based on protein precipitation followed by UHPLC-MS/MS analysis with a TurboIonSpray interface and multiple reaction monitoring. The lower limit of quantification in plasma was 20 ng/mL for dolutegravir and 2.5 ng/mL for lamivudine (9 (link)).