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Comparison of NRTI combinations. CBV versus TDF + FTC Study 934 ABC/3TC versus TDF/FTC HEAT Study ACTG 5202 Study ASSERT Study . ASSERT Study: ABC/3TC vs TDF/FTC. Design. Randomisation* 1 : 1 Open-label. W48. W96. N = 192. > 18 years ARV-naïve (no previous

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Comparison of nrti combinations
Comparison of NRTI combinations

  • CBV versus TDF + FTC

    • Study 934

  • ABC/3TC versus TDF/FTC

    • HEAT Study

    • ACTG 5202 Study

    • ASSERT Study


Assert study abc 3tc vs tdf ftc
ASSERT Study: ABC/3TC vs TDF/FTC

  • Design

Randomisation*

1 : 1

Open-label

W48

W96

N = 192

> 18 years

ARV-naïve (no previous

therapy with NNRTI and

< 14 days of other ARV)

HIV RNA > 1,000 c/mL

Any CD4 cell count

HLA-B*5701 negative

N = 193

*Randomisation was stratified by screening GFR (< or > 90 mL/min/1.73m2),

black race, body mass index (< or > 25 kg/m2)

  • Endpoints

    • Primary: change in GFR (MDRD) at W48 (90% power to detect a 10 mL/minute difference between arms)

    • Secondary: change in GFR (Cockroft-Gault), renal biomarkers, safety, virologic efficacy and immunologic response

Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72

ASSERT


Assert study abc 3tc vs tdf ftc1
ASSERT Study: ABC/3TC vs TDF/FTC

Baseline characteristics and patient disposition

* Includes 12 cases of suspected ABC HSR

Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72

ASSERT


Assert study abc 3tc vs tdf ftc2

Primary endpoint

Adjusted mean change from baseline in eGFR (MDRD) (mL/min/1.73 m2), ITT-exposed:

ABC/3TC = + 0.22 vs TDF/FTC = + 1.18 [95% CI for difference: -1.45; 3.35 (p = 0.44)

No difference between treatment arms using the Cockroft-Gault formula or in Per Protocol

ASSERT Study: ABC/3TC vs TDF/FTC

Outcome at week 48

ABC/3TC

TDF/FTC

HIV RNA < 50 c/mL

%

71

75

Virologic failure and resistance

59

50

25

* Less than 1 log10 c/mL decrease in HIV RNA at W4 or

confirmed HIV RNA > 400 c/mL, having previously been

< 400 c/mL at or after W4, or > 400 c/mL at or after W24

ITT, TLOVR

95% CI for the difference

= 2.2; 21.1

Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72

ASSERT


Assert study abc 3tc vs tdf ftc3
ASSERT Study: ABC/3TC vs TDF/FTC

Safety at W48

Drug-related grade 2-4 adverse events: 29% in ABC/3TC group vs 20% in TDF/FTC

No subjects met the protocol-defined decline in renal function or proximal renal tubule dysfunction criteria

Some markers of renal tubular dysfunction were elevated with TDF/FTC

Urinary excretion of retinol-binding protein and b-2 microglobulin increased significantly more in the TDF/FTC arm (+50%; +24%) compared with the ABC/3TC arm (no change; -47%) (P < 0.0001)

Increases from baseline in median total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol were greater in the ABC/3TC arm

Conclusion

No difference in primary outcome (GFR) at W48 between ABC/3TC and TDF/FTC

ABC/3TC was virologically inferior to TDF/FTC

Protocol-defined virologic failure occurred in 3% (ABC/3TC) vs 1% (TDF/FTC)

There were more discontinuations in ABC/3TC group

Post FA, JAIDS. 2010;55:49-57, Stellbrink HJ. CID 2010;51:963-72

ASSERT


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