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Treatment Naive Studies –

Treatment naive adults : Study 14901

Study Design

BIC/TAF/FTC vs DTG + TAF/FTC

  • 645 adults
  • HIV-1 RNA ≥ 500 copies/ml
  • eGFRcg ≥ 30 mL/min
  • Genotypic sensitivity to FTC, TFV

BIC 50 mg + TAF 25 mg + TFV 200 mg vs DTG 50 mg + TAF 25 mg + TFV 200 mg

eGFR: Estimated Glomerular Filtration Rate

CG: Cockcroft Gault

P E: Primary Endpoint

S E: Secondary Endpoint

1:1
n=320
n=325
 
0
PE
48
SE
96
Weeks
144

BIC/TAF/FTC QD

DTG + TAF/FTC placebo QD

DTG + TAF/FTC QD

BIC/TAF/FTC placebo QD

Powerful long-term efficacy in treatment-naive adults at week 96.

PARAMETER BIC/TAF/FTC (n=320) DTG/TAF/FTC (n=325)
HIV-1 RNA < 50 copies for mL 269 (84%) 281 (86%)

Proven Immunological Outcome

PARAMETER BIC/TAF/FTC (n=320) DTG/TAF/FTC (n=325)
CD4 cell count mean changes from baseline (%Change) 237 (10.7%) 281 (11%)

Lower incidence of drug related adverse events in BIC arm vs DTG arm, 20% vs 28%.

  • Better gastrointestinal tolerability profile (9% vs 14%).
  • There were no discontinuations due to renal adverse events and no causes of tubulopathy.

No patient on BIC/TAF/FTC had HIV-1 emergent drug resistance to BIC, TAF or FTC.

Treatment naive adults : Study 14892

Study Design

BIC/TAF/FTC vs DTG/ABC/3TC

  • 629 adults
  • HIV-1 RNA ≥ 500 copies/ml
  • eGFRcg ≥ 50 mL/min
  • HLA B*5701 negative
  • HBV negative
  • Genotypic sensitivity to FTC, TFV, ABC, 3TC

BIC 50 mg + TFV 25 mg + FTC 200 mg vs DTG 50 mg + ABC 600 mg + 3TC 300 mg

eGFR: Estimated Glomerular Filtration Rate

CG: Cockcroft Gault

P E: Primary Endpoint

S E: Secondary Endpoint

1:1
n=314
n=315
 
0
PE
48
SE
96
Weeks
144

BIC/TAF/FTC QD

DTG/ABC/3TC placebo QD

DTG/ABC/3TC QD

BIC/TAF/FTC placebo QD

Powerful long-term efficacy in treatment-naive adults at week 96.

PARAMETER BIC/TAF/FTC (n=314) DTG/ABC/3TC (n=315)
HIV-1 RNA < 50 copies for mL 276 (88%) 283 (90%)

Proven Immunological Outcome

PARAMETER BIC/TAF/FTC (n=314) DTG/ABC/3TC (n=315)
CD4 cell count mean changes from baseline 287 288

Improved safety profile of BIC vs DTG

  • Lower incidences of drug related adverse events 28% vs 40%.
  • Significantly lesser drug related nausea 6% vs 17%.
  • Two times lower frequency of dizziness & sleep disorder 3% vs 6% & 1% vs 4% respectively.

No patient on BIC/TAF/FTC had HIV-1 emergent drug resistance to BIC, TAF or FTC.

Treatment Experience Studies –

Treatment experienced patients : Study 18443

Study Design

  • Virologically Suppressed Adults (N = 563)
  • DTG + ABC/3TC or DTG/ABC/3TC
  • HIV-1 RNA < 50 copies/mL for ≥ 3 months
  • eGFRcg ≥ 50 mL/min

BIC 50 mg + TFV 25 mg + FTC 200 mg vs DTG 50 mg + ABC 600 mg + 3TC 300 mg

eGFR: Estimated Glomerular Filtration Rate

CG: Cockcroft Gault

1:1
n=282
n=281

Switched to
BIC/TAF/FTC QD

Continued on
DTG/ABC/3TC QD

Week 48 Primary endPoint

Maintained high rates of virological efficacy

PARAMETER BIC/TAF/FTC (n=282) DTG/ABC/3TC (n=281)
HIV-1 RNA < 50 copies for mL 264 (94%) 267 (95%)

Similar immunological outcome

PARAMETER BIC/TAF/FTC (n=282) DTG/ABC/3TC (n=281)
Mean CD4 cell count per μL (%Change) 724 (1%) 691 (0.5%)

Lower incidence of drug related adverse events in BIC arm vs DTG arm, 8% vs 16%.

  • Better gastrointestinal tolerability profile
  • Fewer neuropsychiatric adverse events such as abnormal dreams and insomnia

No virologically-suppressed patient who switched to BIC/TAF/FTC had HIV-1 emergent drug resistance to BIC, FTC, or TAF.

Treatment experienced patients : Study 18784

Study Design

  • Virologically Suppressed Adults (N=577)
  • Boosted# DRV or ATV regimen + 2 NRTIs (ABC/3TC or FTC/TDF)
  • HIV-1 RNA < 50 copies/mL for ≥ 6 months
  • eGFRCG ≥ 50 mL/min

BIC 50 mg, TFV 25 mg, TDF 300 mg, ABC 600 mg, 3TC 300 mg

eGFR: Estimated Glomerular Filtration Rate

CG: Cockcroft Gault

# Cobicistat or Ritonavir

1:1
n=290
n=287

Switched to
BIC/TAF/FTC QD

Continued on
Baseline Regimen

Week 48 Primary endPoint

Maintained high rates of virological efficacy.

PARAMETER BIC/TAF/FTC (n=290) bPI based regimen (n=287)
HIV-1 RNA < 50 copies for mL 267 (92%) 255 (89%)

Similar immunological outcome

PARAMETER BIC/TAF/FTC (n=290) bPI based regimen (n=287)
Mean change in CD4 cell count per μL (%Change) 25 (0.5%) 0 (0.5%)

Statistically significant improvements in lipid parameters#.

Potential for reduced drug interactions and regimen simplification.

  • unboosted regimen.
  • From a multi-tablet to a single-tablet regimen
  • One of the smallest tablet size among available single-tablet regimens

No virologically-suppressed patient who switched to BIC/TAF/FTC had HIV-1 emergent drug resistance to BIC, TAF or FTC.

# Observed in patients on ABC + 3TC based NRTI backbone regimen

References –

  1. Lancet HIV 2019 Published Online May 5, 2019, S2352-3018(19)30080-3
  2. Lancet HIV 2019 Published Online May 5, 2019,S2352-3018(19)30077-3
  3. Lancet HIV 2018; 5: e357–65 Published Online June 17, 2018, S2352-3018(18)30092-4
  4. Lancet HIV 2018; 5: e347–56 Published Online June 17, 2018, S2352-3018(18)30091-2

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