PRESCRIBE A REGIMEN AROUND

WHEN TREATING HIV-1, PUT DOLUTEGRAVIR AT THE CORE OF THERAPY

PROVEN VIROLOGIC
EFFICACY1-4

For HIV-1–infected adults taking dolutegravir-based regimens through 144 weeks in SINGLE, 96 weeks in SPRING-2 and FLAMINGO, and 48 weeks in SAILING*

Explore the treatment-naïve and treatment-experienced adult trials*

A HIGH BARRIER TO RESISTANCE1,5†

Treatment-naïve trial results support a high barrier to resistance with dolutegravir at the core

See long-term data through 144 weeks in the SINGLE trial

BOOSTER-FREE
DOSING6

Regimens with dolutegravir are booster free and can be taken with or without food

Learn about additional dosing characteristics

*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 adults with HIV-1. 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 SPRING-2 trial, a randomized, double-blind, active-control, noninferiority trial comparing dolutegravir 50 mg once daily + ABC/3TC or TDF/FTC (n=411) vs raltegravir 400 mg twice daily + ABC/3TC or TDF/FTC (n=411) in treatment-naïve adults with HIV-1. At baseline, median age was 36 years, 87% of patients were male, 28% had HIV-1 RNA >100,000 copies/mL, 48% had CD4+ T-cell counts <350 cells/mm3, 11% had hepatitis B and/or C virus co-infection, and 2% were CDC Class C (AIDS).2 Based on data from the SAILING trial, a randomized, double-blind, active-control, noninferiority trial comparing dolutegravir 50 mg once daily + BR (n=357) vs raltegravir 400 mg twice daily + BR (n=362) in treatment-experienced, INSTI-naïve adults with HIV-1. BR was investigator selected and consisted of up to 2 agents including at least 1 fully active agent. At baseline, median age was 43 years, 68% of patients were male, 20% had HIV-1 RNA >100,000 copies/mL, 72% had CD4+ T-cell counts <350 cells/mm3, 16% had hepatitis B and/or C virus co-infection, and 46% were CDC Class C (AIDS). All patients had resistance to 2 ART classes (not including INSTIs); 49% were resistant to 3 ART classes.4

No patients in the treatment arm receiving dolutegravir 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; BR=background regimen; CDC=Centers for Disease Control and Prevention; ART=antiretroviral therapy; INSTI=integrase strand transfer inhibitor; NRTIs=nucleoside reverse transcriptase inhibitors.


Please see full Prescribing Information for TIVICAY.

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. Raffi F, Jaeger H, Quiros-Roldan E, et al; on behalf of the SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13(11):927-935.
  3. Molina J-M, Clotet B, van Lunzen J, et al; on behalf of the FLAMINGO Study Team. Once daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomized, open-label, phase 3b study. Lancet HIV. 2015;2:e127-e136.
  4. Cahn P, Pozniak AL, Mingrone H, et al; on behalf of the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708.
  5. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.
  6. 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.