Inner Strength

For your HLA-B*5701–negative adult patients with HIV-1...
TRIUMEQ—the only single-pill coformulation with DOLUTEGRAVIR AT THE CORE

Not an actual patient.

*Based on data from the SINGLE trial, a randomized, double-blind (to Week 96; open-label from Week 96 to Week 144), active-control, noninferiority trial comparing dolutegravir 50 mg once daily + ABC/3TC (n=414) vs efavirenz/TDF/FTC once daily (n=419) in treatment-naïve, HLA-B*5701–negative adults with HIV-1. One dolutegravir 50-mg tablet + fixed-dose ABC/3TC is bioequivalent to 1 TRIUMEQ tablet under fasted conditions. At baseline, median age was 35 years, 84% of patients were male, 32% had HIV-1 RNA >100,000 copies/mL, 53% had CD4+ T-cell counts <350 cells/mm3, 7% had hepatitis C virus co-infection (hepatitis B co-infection was an exclusion criterion), and 4% were CDC Class C (AIDS).1

Based on data from the ARIA trial, a randomized, open-label, active-control, noninferiority trial comparing TRIUMEQ once daily (n=248) vs atazanavir/ritonavir once daily + TDF/FTC (n=247) in treatment-naïve, HLA-B*5701–negative adult female patients with HIV-1. At baseline, median age was 37 years, 100% of patients were female, 7% had hepatitis C virus co-infection (hepatitis B co-infection was an exclusion criterion), 4% were CDC Class C (AIDS), 27% had HIV-1 RNA >100,000 copies/mL, and 51% had CD4+ T-cell counts <350 cells/mm3.2

No patients in the treatment arm receiving TRIUMEQ in the SINGLE trial had a detectable decrease in susceptibility to dolutegravir or background NRTIs (ABC/3TC) in the resistance analysis data set (n=11 with HIV-1 RNA >400 copies/mL at failure or last visit and having resistance data). Two patients with virologic failure in the SINGLE trial had treatment-emergent G/D/E193D and G193G/E integrase substitutions at Week 84 and Week 108, respectively, and 1 patient with 275 copies/mL HIV-1 RNA had a treatment-emergent Q157Q/P integrase substitution detected at Week 24.


ABC/3TC=abacavir/lamivudine; TDF/FTC=tenofovir/emtricitabine; NRTIs=nucleoside reverse transcriptase inhibitors.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.

References

  1. Walmsley S, Baumgarten A, Berenguer J, et al. Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in antiretroviral therapy-naive patients: week 96 and week 144 results from the SINGLE randomized clinical trial. J Acquir Immune Defic Syndr. 2015;70(5):515-519.
  2. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.
  3. Min S, Song I, Borland J, et al. Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2010;54(1):254-258.