PMID- 27809711
OWN - NLM
STAT- MEDLINE
DCOM- 20170707
LR  - 20201209
IS  - 1945-5771 (Electronic)
IS  - 1528-4336 (Linking)
VI  - 17
IP  - 6
DP  - 2016 Nov
TI  - Systematic review of renal and bone safety of the antiretroviral regimen 
      efavirenz, emtricitabine, and tenofovir disoproxil fumarate in patients with HIV 
      infection.
PG  - 246-266
AB  - BACKGROUND: Tenofovir disoproxil fumarate (TDF) is a component of many 
      combinations of antiretroviral treatment (ART) regimens. Although potent and 
      generally well tolerated, TDF may cause renal and bone toxicity. The magnitude of 
      off-target side effects is proposed to be related to tenofovir plasma 
      concentrations, which are affected by food and drug-drug interactions with 
      concomitant antiretrovirals. OBJECTIVE: To perform a systematic literature review 
      and qualitatively report on renal and bone safety outcomes associated with 
      efavirenz (EFV), emtricitabine (FTC), and TDF (EFV+FTC+TDF) ART. METHODS: Embase 
      and PubMed databases were searched for randomized clinical trials and 
      observational cohort studies reporting on HIV treatment with EFV+FTC+TDF. 
      Relevant articles were hand-searched for renal (Grade 3-4 serum 
      creatinine/estimated glomerular filtration rate elevations, renal adverse events 
      [AEs], discontinuation due to renal AEs, and urinary biomarkers) and bone 
      outcomes (bone mineral density [BMD] reductions, bone turnover markers, and 
      fracture), and results compiled qualitatively. RESULTS: Of 337 retrieved 
      articles, 29 reporting renal and 11 reporting bone outcomes met the review 
      criteria. EFV+FTC+TDF was associated with a low frequency of renal AEs and 
      treatment discontinuations due to renal AEs. Renal AEs were more frequent when 
      TDF was taken with protease inhibitor (PI)- or cobicistat-containing ART. 
      EFV+FTC+TDF was associated with reduced BMD and increased bone turnover markers, 
      but BMD reductions were less than with PI-containing ART. No treatment-related 
      bone fractures were identified. CONCLUSIONS: EFV+FTC+TDF appeared to have a more 
      favorable renal safety profile than TDF administered with a PI or cobicistat. BMD 
      decreased with EFV+FTC+TDF, but no treatment-related fractures were identified.
FAU - Bedimo, Roger
AU  - Bedimo R
AD  - a Department of Medicine , VA North Texas Health Care System, University of Texas 
      Southwestern Medical Center , Dallas , TX , USA.
FAU - Rosenblatt, Lisa
AU  - Rosenblatt L
AD  - b Bristol-Myers Squibb , Plainsboro , NJ , USA.
FAU - Myers, Joel
AU  - Myers J
AD  - b Bristol-Myers Squibb , Plainsboro , NJ , USA.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20161104
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Alkynes)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 99YXE507IL (Tenofovir)
RN  - G70B4ETF4S (Emtricitabine)
RN  - JE6H2O27P8 (efavirenz)
SB  - IM
MH  - Alkynes
MH  - Antiretroviral Therapy, Highly Active/*adverse effects
MH  - Benzoxazines/administration & dosage
MH  - Bone Diseases/diagnosis/epidemiology/*etiology
MH  - Clinical Trials as Topic
MH  - Cyclopropanes
MH  - Drug Interactions
MH  - Emtricitabine/administration & dosage
MH  - HIV Infections/*complications/drug therapy
MH  - Humans
MH  - Incidence
MH  - Kidney Diseases/diagnosis/epidemiology/*etiology
MH  - Tenofovir/administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Atripla
OT  - Bone disease
OT  - Efavirenz
OT  - Emtricitabine
OT  - Protease inhibitor
OT  - Renal disease
OT  - Tenofovir
EDAT- 2016/11/05 06:00
MHDA- 2017/07/08 06:00
CRDT- 2016/11/05 06:00
PHST- 2016/11/05 06:00 [pubmed]
PHST- 2017/07/08 06:00 [medline]
PHST- 2016/11/05 06:00 [entrez]
AID - 10.1080/15284336.2016.1243363 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2016 Nov;17(6):246-266. doi: 10.1080/15284336.2016.1243363. Epub 
      2016 Nov 4.