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Clinical Studies

TRIUMEQ* Was Generally Better Tolerated vs Atripla® up to 144 Weeks With Fewer Discontinuations2
Discontinuations due to adverse events

SINGLE—Proportion of patients with adverse events leading to discontinuation at 48, 96, and 144 weeks2,3

  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
Primary endpoint: Proportion with HIV-1 RNA <50 c/mL at Week 48, FDA snapshot analysis
(-10% non-inferiority margin with pre-specified tests for superiority)
  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count

DTG + ABC/3TC had statistically superior efficacy vs EFV/TDF/FTC

88% vs 81% were undetectable at 48 weeks (P=0.003)

80% vs 72%  remained subsequently undetectable at 96 weeks (P=0.006)

71% vs 63% remained subsequently undetectable at 144 weeks (P=0.010)

DTG + ABC/3TC is effective regardless of baseline viral load

83% of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at 48 weeks

DTG + ABC/3TC was still as effective as EFV/TDF/FTC in patients with high baseline viral loads at 96 weeks

69% of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at 144 weeks

DTG + ABC/3TC was generally better tolerated vs EFV/TDF/FTC with fewer discontinuations

2% vs 10% discontinued due to AEs at 48 weeks

3% vs 11% discontinued due to AEs at 96 weeks

4% vs 14% discontinued due to AEs at 144 weeks

No INI or NRTI resistance up to 144 weeks with DTG + ABC/3TC

Fewer treatment-naïve patients taking TRIUMEQ discontinued treatment due to adverse events up to 144 weeks compared with Atripla®2,3

Adverse Events ≥5%

SINGLE—Most common treatment-related adverse events ≥5% in either arm up to 144 weeks (N=833)2

  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
Primary endpoint: Proportion with HIV-1 RNA <50 c/mL at Week 48, FDA snapshot analysis
(-10% non-inferiority margin with pre-specified tests for superiority)
  • DTG + ABC/3TC had statistically superior efficacy vs EFV/TDF/FTC88% vs 81% were undetectable at 48 weeks (P=0.003)80% vs 72%  remained subsequently undetectable at 96 weeks (P=0.006)71% vs 63% remained subsequently undetectable at 144 weeks (P=0.010)

    DTG + ABC/3TC is effective regardless of baseline viral load

    83% of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at 48 weeks

    DTG + ABC/3TC was still as effective as EFV/TDF/FTC in patients with high baseline viral loads at 96 weeks

    69% of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at 144 weeks

    DTG + ABC/3TC was generally better tolerated vs EFV/TDF/FTC with fewer discontinuations

    2% vs 10% discontinued due to AEs at 48 weeks

    3% vs 11% discontinued due to AEs at 96 weeks

    4% vs 14% discontinued due to AEs at 144 weeks

    No INI or NRTI resistance up to 144 weeks with DTG + ABC/3TC

  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count
  • Treatment-naïve, HIV-1 positive
  • HLA-B*5701 negative
  • HIV-1 RNA 1000 c/mL
  • Creatinine clearance
    >50 mL/min
  • Stratified by baseline viral load and CD4 cell count

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