Journal Article

Simplification of Antiretroviral Therapy with Tenofovir-Emtricitabine or Abacavir-Lamivudine: A Randomized, 96-Week Trial

Allison Martin, Mark Bloch, Janaki Amin, David Baker, David A. Cooper, Sean Emery and Andrew Carr

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 49, issue 10, pages 1591-1601
Published in print November 2009 | ISSN: 1058-4838
Published online November 2009 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/644769
Simplification of Antiretroviral Therapy with Tenofovir-Emtricitabine or Abacavir-Lamivudine: A Randomized, 96-Week Trial

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

Background. There are 2 once-daily, fixed-dose-combination, dual-nucleoside analogue tablets: tenofovir 300 mg-emtricitabine 200 mg (TDF-FTC) and abacavir 600 mg-lamivudine 300 mg (ABC-3TC). Which fixed-dose-combination tablet is more effective and safe is uncertain.

Methods. We compared TDF-FTC and ABC-3TC in a randomized, open-label, 96-week trial in which either fixed-dose-combination was substituted for current nucleoside treatments in human leukocyte antigen-B*5701-negative adults with human immunodeficiency virus loads <50 copies/mL. The primary end point was virological failure (consecutive viral load measurements >400 copies/mL, by intention-to-treat). Secondary end points included death, AIDS, adverse events, serious non-AIDS events, metabolic parameters, and body composition. We used exact statistics for differences in proportions, T tests to compare means, and Cox regression for hazard ratios.

Results. Of 441 patients who were screened, 357 were treated; 98% were men, the mean age was 45 years, 30% were receiving TDF, 20% were receiving ABC, and 24% were receiving a protease inhibitor. Virological failure was uncommon (5.6% for ABC-3TC and 3.9% for TDF-FTC; difference, 1.7%; 95% confidence interval [CI], −2.8% to 6.1%; P=.62). No participant developed AIDS, whereas 18 (5%) participants developed a serious non-AIDS event (rate, 2.79 events per 100 person-years; 95% CI, 1.76–4.43), of which 4 were fatal. TDF-FTC was associated with significantly fewer serious non-AIDS events than ABC-3TC (1.2 vs 4.8 events per 100 patient-years; hazard ratio [HR], 0.24; 95% CI, 0.08–0.73; P=.012), influenced mostly by a lower rate of cardiovascular events (0.3 vs 2.2 events per 100 patient-years; HR, 0.12; 95% CI, 0.02–0.98; P=.048). TDF-FTC resulted in significantly lower bone mineral density (mean difference in hip t score, 0.16; 95% CI, 0.08–0.23; P<.001) but not in more fractures.

Conclusions. In this population, TDF-FTC and ABC-3TC had similar virological efficacy, but ABC-3TC was associated with more serious non-AIDS events, particularly cardiovascular events.

Clinical trials registration. NCT00192634.

Journal Article.  4741 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.