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Outcomes by Sex Following Treatment Initiation With Atazanavir Plus Ritonavir or Efavirenz With Abacavir/Lamivudine or Tenofovir/Emtricitabine

2013; Oxford University Press; Volume: 58; Issue: 4 Linguagem: Inglês

10.1093/cid/cit747

1537-6591

Kimberly Y. Smith, C. Tierney, Katie R. Mollan, Charles S. Venuto, Chakra Budhathoki, Qing Ma, Gene D. Morse, Paul E. Sax, David Katzenstein, Catherine Godfrey, Margaret A. Fischl, Eric S. Daar, Ann C. Collier, Héctor Hernando Villamil Bolívar, Sandi L. Navarro, Susan L. Koletar, Diane Gochnour, Edward Seefried, Julie Hoffman, Judith Feinberg, M. Saemann, Kristine B. Patterson, Donna Pittard, D. Currin, Kyle R. Upton, Michael S. Saag, G. Thomas Ray, Steven C. Johnson, Bartolo Santos, C. Funk, Mike Morgan, Beth E. Jackson, Pablo Tebas, Astrid Thomas, G.-Y. Kim, Michael K. Klebert, Jorge Santana, S. Marrero, J. Norris, Sandra Costa Valle, G. M. Cox, Martha Silberman, Sadia Shaik, Rosa María López, Matthew Vasquez, Demetre Daskalakis, Christina Megill, Jessica Shore, Babafemi Taiwo, M. Goldman, M Boston, Jeffrey L. Lennox, Carlos del Río, Timothy W. Lane, Kim Epperson, Anne F. Luetkemeyer, Miranda Payne, Barbara Gripshover, Danielle D. Antosh, Joel R. Reid, M. Jacob Adams, Sheryl Storey, Shelia B. Dunaway, Joel E. Gallant, Ilene Wiggins, Kimberly Y. Smith, J. A. Swiatek, J. Timpone, Priti Kumar, Andrew Moe, Miguel Ángel Seguí, Jon A Gothing, Joseph A. Delaney, Kim Whitely, Albert M. Anderson, Scott M. Hammer, Michael T. Yin, Mamta K. Jain, Tess Petersen, Roberto Corales, Christine Hurley, Keith Henry, B. Bordenave, Anne S. Youmans, Mary Albrecht, Richard B. Pollard, A A Olusanya, Paul R. Skolnik, Bianca N. Adams, Karen T. Tashima, Helen Patterson, M. Ukwu, Lisa R. Rogers, Henry H. Balfour, Kathy A. Fox, Susan Swindells, F. Van Meter, Gregory K. Robbins, Nicole Burgett-Yandow, Cynthia Davis, Catherine Boyce, William A. O’Brien, G. Casey, Gene D. Morse, C.-B. Hsaio, Julian Meier, Jack T. Stapleton, Donna Mildvan, M.P. Revuelta, D. Currin, Wafaa El‐Sadr, Avelino Loquere, Nayef El-Daher, Tamara Johnson, Robert Gross, K. Maffei, Valery Hughes, Glenn Sturge, Deborah McMahon, B. Rutecki, Michael Wulfsohn, Andrew Cheng, L. Dix, Qiming Liao,

HIV Research and Treatment

Background. We aimed to evaluate treatment responses to atazanavir plus ritonavir (ATV/r) or efavirenz (EFV) in initial antiretroviral regimens among women and men, and determine if treatment outcomes differ by sex. Methods. We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) in 1857 human immunodeficiency virus type 1–infected, treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico. Associations of sex with 3 primary study endpoints of time to virologic failure, safety, and tolerability events were analyzed using Cox proportional hazards models. Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling (NONMEM version VII). Results. Of 1857 participants, 322 were women. Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r. The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex. With ABC/3TC, women had a significantly higher (32%) safety risk compared to men; with TDF/FTC, the safety risk was 20% larger for women compared to men, but not statistically significant. Women had slower ATV clearance and higher predose levels of ATV compared to men. Self-reported adherence did not differ significantly by sex. Conclusions. This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV. This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential. Clinical Trials Registration NCT00118898.