Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study

• Published in: Journal of acquired immune deficiency syndromes (1999) Vol. 55; no. 1; p. 49
• Main Authors: Post, Frank A, Moyle, Graeme J, Stellbrink, Hans Jürgen, Domingo, Pere, Podzamczer, Daniel, Fisher, Martin, Norden, Anthony G, Cavassini, Matthias, Rieger, Armin, Khuong-Josses, Marie-Aude, Branco, Teresa, Pearce, Helen C, Givens, Naomi, Vavro, Cindy, Lim, Michael L
• Format: Journal Article
• Language: English
• Published: United States 01.09.2010
• Subjects: Adenine - administration & dosage; Adenine - adverse effects; Adenine - analogs & derivatives; Adolescent; Adult; Aged; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Benzoxazines - administration & dosage; Benzoxazines - adverse effects; beta 2-Microglobulin - urine; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Dideoxynucleosides - administration & dosage; Dideoxynucleosides - adverse effects; Drug Combinations; Emtricitabine; Female; Glomerular Filtration Rate - drug effects; HIV Infections - drug therapy; HIV-1 - isolation & purification; Humans; Kidney - drug effects; Lamivudine - administration & dosage; Lamivudine - adverse effects; Male; Middle Aged; Organophosphonates - administration & dosage; Organophosphonates - adverse effects; Retinol-Binding Proteins - urine; Tenofovir; Treatment Outcome; Viral Load; Young Adult
• ISSN: 1944-7884
• DOI: 10.1097/QAI.0b013e3181dd911e

Abacavir/lamivudine and tenofovir/emtricitabine fixed-dose combinations are commonly used first-line antiretroviral therapies, yet few studies have comprehensively compared their safety profiles. Forty-eight-week data are presented from this multicenter, randomized, open-label study comparing the safety profiles of abacavir/lamivudine and tenofovir/emtricitabine, both administered with efavirenz, in HLA-B*5701-negative HIV-1-infected adults. Three hundred eighty-five subjects were enrolled in the study. The overall rate of withdrawal was high (28%). Changes in estimated glomerular filtration rate from baseline were similar between arms [difference 0.953 mL.min.1.73 m (95% confidence interval: -1.445 to 3.351), P = 0.435]. Urinary excretion of retinol-binding protein and beta-2 microglobulin increased significantly more in the tenofovir/emtricitabine arm (+50%; +24%) compared with the abacavir/lamivudine arm (no change; -47%) (P < 0.0001). A lower proportion achieved viral load <50 copies per milliliter in the abacavir/lamivudine arm (114 of 192, 59%) compared with the tenofovir/emtricitabine arm (137 of 193, 71%) [difference 11.6% (95% confidence interval: 2.2 to 21.1)]. The overall virological failure rate was low. The adverse event rate was similar between arms (except drug hypersensitivity, reported more in the abacavir/lamivudine arm). The study showed no difference in estimated glomerular filtration rate between the arms, however, increases in markers of tubular dysfunction were observed in the tenofovir/emtricitabine arm, the long-term consequence of which is unclear. A significant difference in efficacy favoring tenofovir/emtricitabine was observed.