PMID- 33364747
OWN - NLM
STAT- MEDLINE
DCOM- 20210921
LR  - 20220419
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 14
DP  - 2020
TI  - The Effect of Switching from Tenofovir Disoproxil Fumarate (TDF) to Tenofovir 
      Alafenamide (TAF) on Liver Enzymes, Glucose, and Lipid Profile.
PG  - 5515-5520
LID - 10.2147/DDDT.S274307 [doi]
AB  - OBJECTIVE: We aimed to investigate the effect of switching from tenofovir 
      disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on the hepatic safety 
      and metabolic profile. METHODS: Consecutive HIV patients, enrolled in the 
      Surveillance Cohort Long-term Toxicity Antiretrovirals/Antivirals (SCOLTA) 
      project, switching from TDF to TAF were included. Changes from baseline (T0) to 
      6-month follow-up (T1) were evaluated using paired t-test and signed rank test. 
      RESULTS: A total of 190 patients switched from TDF to TAF and had one 6-month 
      follow-up visit. They were 80% male, 74.2% at CDC stage A-B, 93.7% with 
      undetectable HIV-viral load. Mean age was 46.7+/-10.7 years, body mass index was 
      25.0+/-3.9 kg/m(2), median CD4 cell count was 634 cell/microL (interquartile range 
      [IQR]=439-900), aspartate aminotransferase (AST) was 23 (IQR=19-30) IU/L, and 
      alanine aminotransferase (ALT) was 24 (IQR=17-34) IU/L. At T1, both AST 
      (median=-1, IQR=-5-2 IU/L, P=0.004) and ALT (median=-2, IQR=-7-3 IU/L, P=0.0004) 
      showed a significant decrease. Among 28 patients with ALT >40 at baseline, 
      reduction was significant both clinically (-17, IQR=-32--1) and statistically 
      (P=0.0003). Total cholesterol levels (TC) increased (+13.4+/-3.8 mg/dL, P=0.0006), 
      as well as HDL-cholesterol (HDL-C) (+3.8+/-1.2 mg/dL, P=0.02), LDL Cholesterol 
      (LDL-C) (+7.6+/-3.4, P=0.03) and glucose (+4.0+/-1.8 mg/dL, P=0.02). D:A:D: and 
      Framingham risk score did not change at 6 months after switch. CONCLUSION: A 
      significant reduction of liver enzymes was observed after switching from TDF to 
      TAF, especially in subjects with initial level of ALT >40 IU/L. Glucose, TC, 
      HDL-C, and LDL-C increased, with no effect on cardiovascular risk scores.
CI  - (c) 2020 Squillace et al.
FAU - Squillace, Nicola
AU  - Squillace N
AUID- ORCID: 0000-0002-7608-6045
AD  - Infectious Diseases Unit ASST-MONZA, San Gerardo Hospital-University of 
      Milano-Bicocca, Monza, Italy.
FAU - Ricci, Elena
AU  - Ricci E
AUID- ORCID: 0000-0001-5279-0444
AD  - "ASIA" Foundation ONLUS, Milan, Italy.
FAU - Menzaghi, Barbara
AU  - Menzaghi B
AUID- ORCID: 0000-0002-5073-6521
AD  - Unit of Infectious Diseases, ASST della Valle Olona, Busto Arsizio, Italy.
FAU - De Socio, Giuseppe Vittorio
AU  - De Socio GV
AUID- ORCID: 0000-0001-8774-4843
AD  - Department of Internal Medicine 2, Infectious Diseases Unit, "Santa Maria della 
      Misericordia" General Hospital, Perugia, Italy.
FAU - Passerini, Simone
AU  - Passerini S
AD  - 1st Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
FAU - Martinelli, Canio
AU  - Martinelli C
AD  - Infectious Diseases Unit, Careggi Hospital, Florence, Italy.
FAU - Mameli, Maria Sabrina
AU  - Mameli MS
AD  - Unit of Infectious Diseases, Department of Medical, Surgical and Experimental 
      Sciences, University of Sassari, Sassari, Italy.
FAU - Maggi, Paolo
AU  - Maggi P
AUID- ORCID: 0000-0002-8772-0136
AD  - University of Campania "Luigi Vanvitelli", Napoli, Italy.
FAU - Falasca, Katia
AU  - Falasca K
AUID- ORCID: 0000-0002-8795-5410
AD  - Clinic of Infectious Diseases, Department of Medicine and Science of Aging, 
      University "G. d'Annunzio" Chieti-Pescara, Chieti, Italy.
FAU - Cordier, Laura
AU  - Cordier L
AD  - 1st Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
FAU - Celesia, Benedetto Maurizio
AU  - Celesia BM
AUID- ORCID: 0000-0002-6919-1955
AD  - Unit of Infectious Diseases, University of Catania, ARNAS Garibaldi, Catania, 
      Italy.
FAU - Salomoni, Elena
AU  - Salomoni E
AUID- ORCID: 0000-0001-6094-2102
AD  - Infectious Diseases Unit, Santa Maria Annunziata Hospital, Usl centro, Florence, 
      Italy.
FAU - Di Biagio, Antonio
AU  - Di Biagio A
AUID- ORCID: 0000-0003-1436-5089
AD  - Infectious Diseases, San Martino Hospital Genoa, Genoa, Italy.
FAU - Pellicano, Giovanni Francesco
AU  - Pellicano GF
AUID- ORCID: 0000-0002-9640-8742
AD  - Department of Human Pathology of the Adult and the Developmental Age "G. 
      Barresi", Unit of Infectious Diseases, University of Messina, Messina, Italy.
FAU - Bonfanti, Paolo
AU  - Bonfanti P
AUID- ORCID: 0000-0001-7289-8823
AD  - Infectious Diseases Unit ASST-MONZA, San Gerardo Hospital-University of 
      Milano-Bicocca, Monza, Italy.
CN  - CISAI Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20201215
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Enzyme Inhibitors)
RN  - 0 (Lipids)
RN  - 99YXE507IL (Tenofovir)
RN  - EC 2.6.1.1 (Aspartate Aminotransferases)
RN  - EC 2.6.1.2 (Alanine Transaminase)
RN  - EL9943AG5J (tenofovir alafenamide)
RN  - IY9XDZ35W2 (Glucose)
RN  - OF5P57N2ZX (Alanine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Alanine/*pharmacology
MH  - Alanine Transaminase/*antagonists & inhibitors/metabolism
MH  - Aspartate Aminotransferases/*antagonists & inhibitors/metabolism
MH  - Enzyme Inhibitors/*pharmacology
MH  - Female
MH  - Glucose/analysis
MH  - Humans
MH  - Lipids/analysis
MH  - Male
MH  - Middle Aged
MH  - Tenofovir/*analogs & derivatives/pharmacology
PMC - PMC7751319
OTO - NOTNLM
OT  - HIV
OT  - TAF
OT  - TDF
OT  - liver enzymes
COIS- Nicola Squillace reports personal fees from ViiV Healthcare and grants from 
      Gilead science, outside the submitted work. Benedetto Maurizio Celesia reports 
      personal fees and non-financial support from MSD, Janssen cilag grants, personal 
      fees, non-financial support, consultancy from Gilead sciences, grants, personal 
      fees, non-financial support, consultancy from ViiV healthcare, outside the 
      submitted work. Paolo Bonfanti reports personal fees from ViiV, Gilead, Jannsen, 
      and Merck, outside the submitted work. The authors report no other potential 
      conflicts of interest for this work.
EDAT- 2020/12/29 06:00
MHDA- 2021/09/22 06:00
PMCR- 2020/12/15
CRDT- 2020/12/28 12:04
PHST- 2020/07/29 00:00 [received]
PHST- 2020/11/10 00:00 [accepted]
PHST- 2020/12/28 12:04 [entrez]
PHST- 2020/12/29 06:00 [pubmed]
PHST- 2021/09/22 06:00 [medline]
PHST- 2020/12/15 00:00 [pmc-release]
AID - 274307 [pii]
AID - 10.2147/DDDT.S274307 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2020 Dec 15;14:5515-5520. doi: 10.2147/DDDT.S274307. 
      eCollection 2020.