Switch studies in virologically suppressed patients
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Switch studies in virologically suppressed patients. Switch to TDF/FTC/EFV AI266-073 Switch to FTC + ddI + EFV ALIZE Switch to ATV/r-containing regimen ATAZIP Switch to ATV ± r-containing regimen SWAN SLOAT Switch to ATV-containing regimen ARIES INDUMA Switch to ATV/r monotherapy

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Switch studies in virologically suppressed patients

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Switch studies in virologically suppressed patients

Switch studies in virologically suppressed patients

Switch to TDF/FTC/EFV

AI266-073

Switch to FTC + ddI + EFV

ALIZE

Switch to ATV/r-containing regimen

ATAZIP

Switch to ATV±r-containing regimen

SWAN

SLOAT

Switch to ATV-containing regimen

ARIES

INDUMA

Switch to ATV/r monotherapy

ATARITMO

Swedish Study

ACTG A5201

OREY

Synopsis

  • Switch to LPV/r monotherapy

    • Pilot LPV/r

    • M03-613

    • American Study

    • KalMo

    • OK

    • OK04

    • KALESOLO

    • MOST

    • HIV-NAT 077

  • Switch to DRV/r monotherapy

    • MONOI

    • MONET

  • Switch to RAL-containing regimen

    • Canadian Study

    • CHEER

    • Montreal Study

    • EASIER

    • SWITCHMRK

    • SPIRAL


Kalmo study switch to lpv r monotherapy

KalMo Study: Switch to LPV/r monotherapy

  • Design

Randomisation

1 : 1

Open-label

W96

N = 30

60 HIV+ ≥ 18 years

On 2 NRTIs + (NNRTI or PI)> 6 months

HIV-1 RNA < 80 c/mL > 6 months

CD4 cell count > 200/mm3

N = 30

* 533/133 mg bid for the first 2 weeks if on NNRTI at screening

  • Endpoints

    • Primary endpoint: proportion of patients with HIV-1 RNA < 80 c/mLat W96 (ITT, missing equals failure analysis)

    • Secondary endpoints: virologic failure (2 consecutive HIV-1 RNA> 500 c/mL), AIDS-defining illnesses, CD4, safety, adverse events

Nunes EP, HIV Clin Trials 2009;10:368-74

KalMo


Kalmo study switch to lpv r monotherapy1

KalMo Study: Switch to LPV/r monotherapy

Baseline characteristics and patient disposition

Nunes EP, HIV Clin Trials 2009;10:368-74

KalMo


Kalmo study switch to lpv r monotherapy2

KalMo Study: Switch to LPV/r monotherapy

Virologic outcome

Other outcomes

  • 1 virologic failure (confirmed HIV-1 RNA > 500 c/mL) in each group. No resistance mutation on genotype

  • No difference in CD4 changes between groups

  • GI adverse events more frequent in the monotherapy group: 24 vs 10(p = 0.001)

  • 5 patients in the triple therapy group underwent regimen changes due to drug-related toxicities

  • Conclusion: switching to LPV/r monotherapy is effective, safe and well tolerated through 96 weeks

ITT analysis

HIV-1 RNA < 80 c/mL

On-treatment

analysis*

%

96

96

86.7

100

80

75

50

25

0

Triple therapy

LPV/r mono

* Includes only patients who completed

96 weeks of follow-up without discontinuation

for other reasons than virologic failure

Nunes EP, HIV Clin Trials 2009;10:368-74

KalMo


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