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Switch studies in virologically suppressed patients

Switch studies in virologically suppressed patients

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Switch studies in virologically suppressed patients

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  1. 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

  2. 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

  3. KalMo Study: Switch to LPV/r monotherapy Baseline characteristics and patient disposition Nunes EP, HIV Clin Trials 2009;10:368-74 KalMo

  4. 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