PMID- 25433663
OWN - NLM
STAT- MEDLINE
DCOM- 20150129
LR  - 20220316
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 15
IP  - 6
DP  - 2014 Nov-Dec
TI  - Discontinuation of tenofovir disoproxil fumarate for presumed renal adverse 
      events in treatment-naive HIV-1 patients: meta-analysis of randomized clinical 
      studies.
PG  - 231-45
LID - 10.1310/hct1506-231 [doi]
AB  - BACKGROUND: Safety and efficacy of tenofovir disoproxil fumarate (TDF) as a 
      component of antiretroviral therapy (ART) have been demonstrated in clinical 
      trials. TDF nephrotoxicity has been reported in both HIV-infected and noninfected 
      patients. This meta-analysis explored the frequency of discontinuation attributed 
      to renal adverse events (AEs) in randomized, controlled clinical studies that 
      used TDF-containing regimens for ART-naive, HIV-infected patients. METHODS: A 
      literature search of 4 electronic databases through October 31, 2013 was 
      utilized. RCTs included were limited to randomized, prospective, comparative 
      design in ART treatment-naive adults with HIV-1 infections receiving ART. Studies 
      included trials containing TDF treatment regimens, with or without a non-TDF 
      control group. Study design, follow-up, size of study population, treatment 
      group, patient demographics, number of patients exposed to TDF or non-TDF 
      control, baseline characteristics, investigator-defined criteria for renal AEs, 
      and number of discontinuations due to a presumed renal AEs were extracted. 
      RESULTS: Twenty-one clinical studies met the selection criteria. Treatment 
      duration ranged from 48 to 288 weeks. Renal AEs led to study drug discontinuation 
      in 44 of 10,129 patients exposed to TDF (0.43%; 95% CI, 0.32%-0.58%) and 2 of 
      2,013 patients exposed to non-TDF-containing regimens (0.10%; 95% CI, 
      0.01%-0.36%). In 5 randomized, controlled studies that included a non-TDF 
      comparator, the estimated risk difference between the treatment groups (TDF vs 
      non-TDF) was 0.50% (95% CI, 0.13%-0.86%; P = .007). CONCLUSIONS: In clinical 
      studies using TDF-containing regimens, the rate of discontinuations due to renal 
      AEs was low, but was slightly higher than in studies using non-TDF comparators.
FAU - Winston, Jonathan
AU  - Winston J
AD  - Icahn School of Medicine at Mount Sinai, New York, New York.
FAU - Chonchol, Michel
AU  - Chonchol M
AD  - Division of Renal Diseases and Hypertension, University of Colorado Hospital, 
      Aurora, Colorado.
FAU - Gallant, Joel
AU  - Gallant J
AD  - Southwest CARE Center, Santa Fe, New Mexico.
FAU - Durr, Jacques
AU  - Durr J
AD  - University of South Florida Morsani College of Medicine, Tampa, Florida.
FAU - Canada, Robert B
AU  - Canada RB
AD  - The University of Tennessee Health Science Center, Memphis, Tennessee.
FAU - Liu, Hui
AU  - Liu H
AD  - Gilead Sciences, Foster City, California.
FAU - Martin, Patty
AU  - Martin P
AD  - Gilead Sciences, Foster City, California.
FAU - Patel, Kiran
AU  - Patel K
AD  - Gilead Sciences, Foster City, California.
FAU - Hindman, Jason
AU  - Hindman J
AD  - Gilead Sciences, Foster City, California.
FAU - Piontkowsky, David
AU  - Piontkowsky D
AD  - Gilead Sciences, Foster City, California.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Organophosphonates)
RN  - 99YXE507IL (Tenofovir)
RN  - JAC85A2161 (Adenine)
SB  - IM
MH  - Adenine/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Adult
MH  - Drug Administration Schedule
MH  - HIV Infections/*drug therapy
MH  - Humans
MH  - Kidney Diseases/*chemically induced
MH  - Organophosphonates/administration & dosage/*adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Risk Factors
MH  - Tenofovir
OTO - NOTNLM
OT  - adverse events
OT  - discontinuation
OT  - human immunodeficiency virus
OT  - renal toxicity
OT  - tenofovir disoproxil fumarate
EDAT- 2014/12/01 06:00
MHDA- 2015/01/30 06:00
CRDT- 2014/12/01 06:00
PHST- 2014/12/01 06:00 [entrez]
PHST- 2014/12/01 06:00 [pubmed]
PHST- 2015/01/30 06:00 [medline]
AID - PN07R17M36V55602 [pii]
AID - 10.1310/hct1506-231 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2014 Nov-Dec;15(6):231-45. doi: 10.1310/hct1506-231.