HIV-1 TREATMENT REGIMENS
POWERED BY DOLUTEGRAVIR AT THE CORE
When prescribing an HIV-1 treatment, choose a dolutegravir-based regimen
INDICATION
TIVICAY and TIVICAY PD are human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitors (INSTIs) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced, but INSTI-naïve) aged ≥4 weeks and weighing ≥3 kg
TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent
Proven high barrier to resistance*†
in treatment-naïve patients and
treatment-experienced
patients
with baseline resistance1-5
Resistance was a secondary endpoint for SINGLE, SPRING-2, FLAMINGO, and SAILING
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CLINICAL TRIALS
Explore treatment-naïve and
treatment-experienced clinical trials
that included DTG-based regimens
*Based on the SINGLE double-blind (to Week 96; open-label from Week 96 to Week 144) trial comparing DTG 50 mg once daily + ABC/3TC (n=414) vs EFV/TDF/FTC once daily (n=419). No patients in the treatment arm receiving DTG in the SINGLE trial had a detectable decrease in susceptibility to DTG 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.
†Based on data from SAILING, a 48-week, randomized, double-blind, active-control trial comparing DTG 50 mg once daily + BR (n=357) vs RAL 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. All patients had at least 2-class antiretroviral treatment resistance (not including INSTIs); 49% were resistant to ≥3 ART classes. No patients with treatment-emergent integrase substitutions in the arm receiving DTG (n=5) had reduced susceptibility (>2-fold change) to DTG. Substitutions with <2-fold decreased susceptibility: L74L/M/I, Q95Q/L, V151V/I (n=1 each), and R263K (n=2).
3TC=lamivudine; ABC=abacavir; ART=antiretroviral therapy; BR=background regimen; DTG=dolutegravir; EFV=efavirenz; FTC=emtricitabine; INSTI=integrase strand transfer inhibitor; NRTI=nucleoside reverse strand transfer inhibitor; RAL=raltegravir; TDF=tenofovir disoproxil fumarate.
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. 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(4):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. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372.
A DEEPER LOOK AT TIVICAY
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