Comparison of raltegravir vs efavirenz
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Comparison of raltegravir vs efavirenz. STARTMRK. STARTMRK Study: raltegravir vs efavirenz, in combination with TDF/FTC. Design. Randomisation* 1 : 1 Double-blind. W48. W96. > 18 years ARV-naïve HIV RNA > 5,000 c/mL Any CD4 cell count No resistance to EFV, TDF or FTC. N = 282.

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Comparison of raltegravir vs efavirenz

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Comparison of raltegravir vs efavirenz

Comparison of raltegravir vs efavirenz

  • STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

  • Design

Randomisation*

1 : 1

Double-blind

W48

W96

> 18 years

ARV-naïve

HIV RNA > 5,000 c/mL

Any CD4 cell count

No resistance to

EFV, TDF or FTC

N = 282

N = 284

*Randomisation was stratified by baseline HIV RNA (< or > 50,000 c/mL)

and viral hepatitis co-infection status

  • Objective

    • Non inferiority of RAL vs EFV: % HIV RNA < 50 c/mL by per protocol, non-completer = failure analysis (lower margin of the 2-sided 95% CI for the difference = - 12%, 90% power)

Lennox JL. Lancet 2009;374:796-806

STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc1

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

Baseline characteristics and patient disposition

RAL was administered with or without food, EFV on an empty stomach at bedtime,

TDF/FTC in the morning with food

Lennox JL. Lancet 2009;374:796-806

STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc2

RAL

EFV

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

Response to treatment at week 48

HIV RNA < 50 c/mL

HIV RNA < 50 c/mL at W48(observed-failure analysis)

by baseline factors

%

Primaryanalysis

Per protocol,

observed-failure *

91.6

100

89.1

86.1

81.9

75

50

25

Mean CD4/mm3 increase at W48 (observed-failure analysis):

189 (RAL) vs 163 (EFV)

(p = 0.0184)

N =

281

282

263

258

PP, NC = F

95% CI for the difference

= - 1.9; 10.3

95% CI for the difference

= - 2.6; 7.7

* Exclusion of discontinuations due to intolerability or reasons unrelated to treatment

Lennox JL. Lancet 2009;374:796-806

STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc3

Safety at W48

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

Lennox JL. Lancet 2009;374:796-806

STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc4

Safety: neuropsychiatric symptoms

At Week 8

CNS-related adverse events had occurred in 10% of RAL patients vs 18% of EFV patients (p = 0.0149)

Retrospective sensitivity analysis (additional symptoms): > 1 CNS-related adverse event: 20% vs 52% (p < 0.0001)

Most symptoms were self-limited

At Week 48

Cumulative incidence of CNS-related adverse event was significantly lower in patients on RAL: 14% vs 23% in the main analysis (p = 0.0044); 26% vs 59% in the sensitivity analysis (p < 0.0001)

These events were generally mild: 62% of RAL vs 79% of EFV

Only 1 patient, on EFV, discontinued the trial because of CNS-related adverse event

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

Lennox JL. Lancet 2009;374:796-806

STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc5

Virologic failure: definition

Non-response = HIV RNA > 50 c/mL at W24 or time of premature study discontinuation without achievement of HIV RNA < 50 c/mL

or Rebound = after an initial response, confirmed HIV RNA > 50 c/mL

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

* Genotyping was done only in patients with HIV RNA > 400 c/mL

** 4 additional patients genotyped when HIV RNA was > 400 c/mL but later achieved HIV RNA < 50 c/mL; 3 on RAL: resistance mutations to RAL evidenced in 1/1 (2 not amplified); 1 on EFV: no resistance mutation

Lennox JL. Lancet 2009;374:796-806

STARTMRK


Startmrk study raltegravir vs efavirenz in combination with tdf ftc6

Summary - Conclusion

At 48 weeks of treatment, RAL was non-inferior to EFV, in combination with TDF/FTC

RAL + TDF/FTC led to more rapid viral load decline (significantly more patients with HIV RNA < 50 c/mL for weeks 2 to 16)

Greater increase in CD4 was observed in the RAL group

Upon virologic failure, resistance mutations to RAL was found in half of the cases (for which genotyping was performed)

RAL was associated with significantly fewer overall and drug-related clinical adverse events, and CNS-related adverse events than was EFV

Mean changes in lipid parameters were smaller for RAL than for EFV

RAL + TDF/FTC is an alternative to EFV + TDF/FTC for first-line combination regimen in treatment-naïve HIV-infected patients

STARTMRK Study: raltegravir vs efavirenz,in combination with TDF/FTC

Lennox JL. Lancet 2009;374:796-806

STARTMRK


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