PMID- 26176344
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20220409
IS  - 1468-1293 (Electronic)
IS  - 1464-2662 (Print)
IS  - 1464-2662 (Linking)
VI  - 17
IP  - 2
DP  - 2016 Feb
TI  - The ASSURE study: HIV-1 suppression is maintained with bone and renal biomarker 
      improvement 48 weeks after ritonavir discontinuation and randomized switch to 
      abacavir/lamivudine + atazanavir.
PG  - 106-17
LID - 10.1111/hiv.12281 [doi]
AB  - OBJECTIVES: HIV treatment guidelines endorse switching or simplification of 
      antiretroviral therapy in therapy-experienced patients with suppressed viraemia; 
      ritonavir discontinuation may also enhance tolerability and reduce long-term 
      adverse events (AEs). This open-label, multicentre, noninferiority study enrolled 
      HIV-1-infected, treatment-experienced adults with confirmed HIV-1 RNA </= 75 HIV-1 
      RNA copies/mL currently receiving tenofovir/emtricitabine + atazanavir/ritonavir 
      (TDF/FTC + ATV/r) for >/= 6 months with no reported history of virological failure. 
      METHODS: Participants were randomized 1:2 to continue current treatment or switch 
      to abacavir/lamivudine + atazanavir (ABC/3TC + ATV). Endpoints included the 
      proportion of participants with HIV-1 RNA < 50 copies/mL by time to loss of 
      virological response (TLOVR), AEs, fasting lipids, and inflammatory, coagulation, 
      bone and renal biomarkers. RESULTS: After 48 weeks, 76% (152 of 199) of 
      ABC/3TC + ATV-treated and 79% (77 of 97) of TDF/FTC + ATV/r-treated participants 
      had HIV-1 RNA < 50 copies/mL (TLOVR; P = 0.564). Other efficacy analyses yielded 
      similar results. Rates of new grade 2-4 AEs were 45% in both groups, but an 
      excess of hyperbilirubinaemia made the rate of treatment-emergent grade 3-4 
      laboratory abnormalities higher with TDF/FTC + ATV/r (36%) compared with 
      ABC/3TC + ATV (19%). Most fasting lipid levels remained stable over time; 
      high-density lipoprotein (HDL) cholesterol increased modestly in 
      ABC/3TC + ATV-treated participants. Bone and renal biomarkers improved 
      significantly between baseline and week 48 in participants taking ABC/3TC + ATV 
      and were stable in participants taking TDF/FTC + ATV/r. No significant changes 
      occurred in any inflammatory or coagulation biomarker within or between treatment 
      groups. CONCLUSIONS: The ABC/3TC + ATV treatment-switch group had similar viral 
      suppression rates up to 48 weeks to the TDF/FTC + ATV/r comparator group, with 
      lower rates of moderate- to high-grade hyperbilirubinaemia and improvements in 
      bone and renal biomarkers.
CI  - (c) 2015 ViiV Healthcare. HIV Medicine published by John Wiley & Sons Ltd on behalf 
      of British HIV Association.
FAU - Wohl, D A
AU  - Wohl DA
AD  - AIDS Clinical Trials Unit, University of North Carolina, Chapel Hill, NC, USA.
FAU - Bhatti, L
AU  - Bhatti L
AD  - AIDS Healthcare Foundation, Beverly Hills, CA, USA.
FAU - Small, C B
AU  - Small CB
AD  - New York Medical College, Valhalla, NY, USA.
FAU - Edelstein, H
AU  - Edelstein H
AD  - Alameda County Medical Center, Oakland, CA, USA.
FAU - Zhao, H H
AU  - Zhao HH
AD  - GlaxoSmithKline, Research Triangle Park, Research Triangle Park, NC, USA.
FAU - Margolis, D A
AU  - Margolis DA
AD  - GlaxoSmithKline, Research Triangle Park, Research Triangle Park, NC, USA.
FAU - DeJesus, E
AU  - DeJesus E
AD  - Orlando Immunology Center, Orlando, FL, USA.
FAU - Weinberg, W G
AU  - Weinberg WG
AD  - Kaiser Foundation Health Plan of Georgia, Inc., Atlanta, GA, USA.
FAU - Ross, L L
AU  - Ross LL
AD  - ViiV Healthcare, Research Triangle Park, NC, USA.
FAU - Shaefer, M S
AU  - Shaefer MS
AD  - ViiV Healthcare, Research Triangle Park, NC, USA.
LA  - eng
GR  - P30 AI050410/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150714
PL  - England
TA  - HIV Med
JT  - HIV medicine
JID - 100897392
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Dideoxynucleosides)
RN  - 0 (Drug Combinations)
RN  - 0 (Lipids)
RN  - 0 (RNA, Viral)
RN  - 0 (abacavir, lamivudine drug combination)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 4MT4VIE29P (Atazanavir Sulfate)
RN  - O3J8G9O825 (Ritonavir)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/*therapeutic use
MH  - Antiretroviral Therapy, Highly Active
MH  - Atazanavir Sulfate/*therapeutic use
MH  - Biomarkers/blood
MH  - Bone Density/*drug effects
MH  - CD4 Lymphocyte Count
MH  - Dideoxynucleosides/*therapeutic use
MH  - Drug Combinations
MH  - Drug Substitution/methods
MH  - Female
MH  - HIV Infections/blood/*drug therapy/physiopathology
MH  - Humans
MH  - Kidney/*drug effects
MH  - Lamivudine/*therapeutic use
MH  - Lipids/*blood
MH  - Male
MH  - Middle Aged
MH  - RNA, Viral/*blood
MH  - Ritonavir/*adverse effects
MH  - Treatment Outcome
MH  - Viral Load
PMC - PMC5034844
OTO - NOTNLM
OT  - HIV
OT  - abacavir
OT  - bone biomarkers
OT  - renal biomarker
OT  - tenofovir
EDAT- 2015/07/16 06:00
MHDA- 2016/12/15 06:00
PMCR- 2016/09/23
CRDT- 2015/07/16 06:00
PHST- 2014/04/14 00:00 [accepted]
PHST- 2015/07/16 06:00 [entrez]
PHST- 2015/07/16 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2016/09/23 00:00 [pmc-release]
AID - HIV12281 [pii]
AID - 10.1111/hiv.12281 [doi]
PST - ppublish
SO  - HIV Med. 2016 Feb;17(2):106-17. doi: 10.1111/hiv.12281. Epub 2015 Jul 14.