For HIV-1. See Full Indication.

EFFICACY AND RESISTANCE

SPRING-2: POWERFUL RESULTS IN
FIRST-LINE THERAPY1,2

A randomized, double-blind, active-control, noninferiority trial in 822* treatment-naïve adult (≥18 years) patients with HIV-1 and CrCl ≥50 mL/min

Baseline characteristics 
Median age was 36 years, 87% of patients were male, 11% were of African American/African heritage, 85% were white, 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 coinfection, 2% were CDC Class C (AIDS), and 39% received ABC/3TC 

Virologic Response

Proven virologic response for patients taking dolutegravir-based regimens
(FDA snapshot analysis: proportion of patients with HIV-1 RNA <50 copies/mL)2

Virologic response in patients
with high baseline viral load

Subgroup Analysis
Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load

Virologic response in patients
with low baseline viral load

Subgroup Analysis
Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load

Resistance Results

In SPRING-2, no patients receiving TIVICAY had detectable decreases in susceptibility to dolutegravir or background NRTIs (ABC/3TC or TDF/FTC) in the resistance analysis data set (n=1 with confirmed HIV-1 RNA >400 copies/mL at failure or last visit and having resistance data) 

Number of patients with treatment-emergent INSTI or NRTI substitutions with decreased susceptibility to ARVs studied based on the resistance analysis data set through 96 weeks2

*808 patients included in the efficacy and safety analyses.

Prespecified secondary endpoint; ITT–E population.

CrCl=creatinine clearance; ABC=abacavir; 3TC=lamivudine; TDF=tenofovir disoproxil fumarate; FTC=emtricitabine; FDA=Food and Drug Administration; CI=confidence interval; NRTI=nucleoside reverse transcriptase inhibitor; INSTI=integrase strand transfer inhibitor; NNRTI=nonnucleoside reverse transcriptase inhibitor; ARVs=antiretrovirals; ITT–E=intention-to-treat–exposed.

References: 1. 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. 2. Data on file, ViiV Healthcare.

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