Lopinavir/Ritonavir Combined with Raltegravir or Tenofovir/Emtricitabine in Antiretroviral-Naive Subjects: 96-Week Results of the PROGRESS Study. [artículo]
Por: Pulido Ortega, Federico [Unidad VIH]
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Colaborador(es): Servicio de Medicina Interna.
Editor: Aids Research and Human Retroviruses, 2013Descripción: 29(2):256-65.Recursos en línea: Solicitar documento Resumen: Alternative combinations of antiretrovirals (ARVs) are desired to increase treatment options for HIV-infected patients. PROGRESS was a randomized, open-label, 96-week pilot study comparing a regimen of lopinavir/ ritonavir (LPV/r) 400/100mg twice daily in combination with either raltegravir (RAL) 400mg twice daily or tenofovir/emtricitabine (TDF/FTC) 300/200mg once daily in ARV-naive adults. A total of 206 subjects were randomized and treated (LPV/r + RAL, N= 101; LPV/r + TDF/FTC, N= 105). Demographics and baseline characteristics were similar across treatment groups. At 96 weeks, 66.3% of subjects receiving LPV/r + RAL and 68.6% of subjects receiving LPV/r + TDF/FTC were responders (plasma HIV-1 RNA levels < 40 copies/ml) by the FDA time to loss of virologic response (FDA-TLOVR) algorithm (p = 0.767). Mean CD4(+) T cell increases through 96 weeks were similar between treatment groups (LPV/r + RAL = 281 cells/mm(3), LPV/r + TDF/ FTC = 296 cells/mm(3), p = 0.598). Safety and tolerability were generally similar between groups. The LPV/r + RAL regimen resulted in greater increases in peripheral fat, but not trunk fat, compared with LPV/r + TDF/FTC. There was a statistically significantly greater mean reduction in estimated glomerular filtration rate from baseline to week 96 in the LPV/r + TDF/FTC group compared with the LPV/r + RAL group (-7.33 ml/min vs. -1.43 ml/min; p = 0.035). The LPV/r + TDF/FTC group had a statistically significant (p < 0.001) mean percent decrease from baseline to week 96 in bone mineral density, which was significantly different from the mean percent change in the LPV/r + RAL group (-2.48% vs. + 0.68%, p < 0.001). These efficacy and safety observations support further evaluation of the LPV/r + RAL regimen.
| Tipo de ítem | Ubicación actual | Signatura | Estado | Fecha de vencimiento |
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Artículo
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PC6739 (Navegar estantería) | Disponible |
Formato Vancouver:
Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R et al. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week
results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65.
PMID: 22730929
Contiene 23 referencias
Alternative combinations of antiretrovirals (ARVs) are desired to increase treatment options for HIV-infected patients. PROGRESS was a randomized, open-label, 96-week pilot study comparing a regimen of lopinavir/ ritonavir (LPV/r) 400/100mg twice daily in combination with either raltegravir (RAL) 400mg twice daily or tenofovir/emtricitabine (TDF/FTC) 300/200mg once daily in ARV-naive adults. A total of 206 subjects were randomized and treated (LPV/r + RAL, N= 101; LPV/r + TDF/FTC, N= 105). Demographics and baseline characteristics were similar across treatment groups. At 96 weeks, 66.3% of subjects receiving LPV/r + RAL and 68.6% of subjects receiving LPV/r + TDF/FTC were responders (plasma HIV-1 RNA levels < 40 copies/ml) by the FDA time to loss of virologic response (FDA-TLOVR) algorithm (p = 0.767). Mean CD4(+) T cell increases through 96 weeks were similar between treatment groups (LPV/r + RAL = 281 cells/mm(3), LPV/r + TDF/ FTC = 296 cells/mm(3), p = 0.598). Safety and tolerability were generally similar between groups. The LPV/r + RAL regimen resulted in greater increases in peripheral fat, but not trunk fat, compared with LPV/r + TDF/FTC. There was a statistically significantly greater mean reduction in estimated glomerular filtration rate from baseline to week 96 in the LPV/r + TDF/FTC group compared with the LPV/r + RAL group (-7.33 ml/min vs. -1.43 ml/min; p = 0.035). The LPV/r + TDF/FTC group had a statistically significant (p < 0.001) mean percent decrease from baseline to week 96 in bone mineral density, which was significantly different from the mean percent change in the LPV/r + RAL group (-2.48% vs. + 0.68%, p < 0.001). These efficacy and safety observations support further evaluation of the LPV/r + RAL regimen.
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