Article
Improvement in lipid profiles in antiretroviral-experienced HIV-positive patients with hyperlipidemia after a switch to unboosted atazanavir
Registro en:
SENSION, M. et al. Improvement in lipid profiles in antiretroviral-experienced HIV-positive patients with hyperlipidemia after a switch to unboosted atazanavir. Journal of Acquired Immune Deficiency Syndromes, v. 51, n. 2, p. 153-162, 2009.
1525-4135
10.1097/QAI.0b013e3181a5701c
Autor
Sension, Michael
Andrade Neto, Jose Luiz
Grinsztejn, Beatriz
Molina, Jean Michel
Zavala, Isidro
González-García, Juan
Donnelly, Alice
Phiri, Phillip
Ledesma, Emilio
McGrath, Donnie
067 Study Group
Resumen
The following members of the 067 Study Group participated in subject
recruitment, enrollment, medical management, and data collection: William
Powderly, MD, St. Louis, MO; Joseph Jemsek, MD, Huntersville, NC; Robert
Eng, MD, East Orange, NJ; Dorece Norris, MD and Daniel Seekins, MD,
Tampa, FL; Margaret Fischl, MD, Miami, FL; Chris Tsoukas, MD, Montreal,
Canada; Livette Johnson, MD, New York, NY; Sharon Walmsley, MD,
Toronto, Canada; Juan Sierra, MD, Mexico city, District Federal Mexico;
Stefan Esser, MD and Essen, Germany; Prof Reinhold Schmidt, Hannover,
Germany; Fernando Aiuti, MD, Rome, Italy; Alain Lafeuillade, MD, Toulon,
France; Prof Jacques Reynes, Montpellier, France; Prof Daniel Vittecoq,
Villejuif, France; Michele Bentata, MD, Bobigny, France; Prof Frederic Lucht,
Saint Etienne, France; Miguel Jimenez Gorgolas, MD, Madrid, Spain; Juan
Gonzalez Garcia, MD, Madrid, Spain; Juan Maria Gonzalez Lahoz, MD,
Madrid, Spain; Pere Domingo, MD, Barcelona, Spain; Giuliano Stagni, MD,
Perugia, Italy; Karam Mounzer, MD, Philadelphia, PA; Margaret Johnson,
MD, London, United Kingdom; Gary L. Simon, MD,Washington, DC; Gracy
McComsey, MD, Cleveland, OH; Mark Bloch, MD, Darlinghurst, Australia;
Cheryl K. MacDonald, MD, Fort Worth, TX; Javier O. Morales Ramirez, MD,
San Juan, Puerto Rico; Rohut Talwani, MD, Columbia, SC; Leonard Slater,
MD, Oklahoma City, OK; Isidro G. Zavala Trujillo, MD, Zapopan, Jal,
Mexico; Prof Jean-Michel Molina, Paris, France; Cecilia Shikuma, MD,
Honolulu, HI; Prof Francisco Antunes, Lisbon, Portugal; Beatriz Grinsztejn,
MD, Rio de Janeiro, Brazil; Jose Henrique Piloto, MD, Rio de Janeiro, Brazil;
Flavio Telles, MD, Curitiba, Brazil; Jose Luiz Andrade, MD, Curitiba, Brazil;
Waldo Belloso, MD, Buenos Aires, Argentina; Carlos Zala, MD, Buenos
Aires, Argentina; Claudia Rodriguez, MD, Buenos Aires, Argentina; Sergio
Lupo, MD, Santa Fe, Argentina; Elida Pallone, MD, Buenos Aires, Argentina;
Angel Minguez, MD, Cordoba, Argentina; Arnaldo Casiro, MD, Buenos
Aires, Argentina; Norma Luna, MD, Cordoba, Argentina; Jorge Corral, MD,
Buenos Aires, Argentina; Abel Jasovich, MD, Buenos Aires, Argentina; Isabel
Cassetti, MD, Buenos Aires, Argentina; Luis Noriega, MD, Santiago, Chile;
Carlos Perez, MD, Santiago, Chile; MarceloWolff, MD, Santiago, Chile; Juan
Echevarria, MD, Lima, Peru; Raul Salazar, MD, Lima, Peru; Andres Paredes,
MD, Lima, Peru; and Frederico Rangel, MD, Recife, Brazil. Objective: The primary objective was to compare the change in
fasting low-density lipoprotein (LDL) cholesterol from baseline to
week 12 between patients receiving an atazanavir-containing regimen
and those receiving comparator protease inhibitor (PI) regimens. Design: AI424-067 was a 48-week, open-label, randomized, prospective study of 246 patients on PI-based regimens with hyperlipidemia [fasting LDL cholesterol .130 mg/dL (.3.4 mmol/L)] and with HIV RNA ,50 copies per milliliter. Patients were randomized to switch to atazanavir (400 mg once daily) on day 1 (immediate switch) or maintain current PI regimen for the first 24 weeks, then switch to atazanavir (delayed switch). Methods: Plasma lipid levels were compared with baseline values at weeks 12, 24, and 48. Safety, viral load, and CD4 profiles were also evaluated. Results: At week 12, the mean percent changes in LDL cholesterol from baseline for the immediate-switch and delayed-switch groups were 215% and +1%, respectively (P , 0.0001). Favorable LDL cholesterol levels in the immediate-switch group were sustained through week 48. Both groups maintained comparable virologic control. Switching to atazanavir did not produce a significant change in safety or tolerability. Conclusions: A switch—either immediate or delayed—from a boosted or unboosted PI to unboosted atazanavir in patients with hyperlipidemia was associated with improvements in plasma lipid parameters without loss of virological suppression. 2028-08-30