PMID- 35643745
OWN - NLM
STAT- MEDLINE
DCOM- 20221215
LR  - 20221221
IS  - 1958-5578 (Electronic)
IS  - 0040-5957 (Linking)
VI  - 77
IP  - 6
DP  - 2022 Nov-Dec
TI  - [HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: 
      What about safety?].
PG  - 635-647
LID - S0040-5957(22)00067-1 [pii]
LID - 10.1016/j.therap.2022.03.008 [doi]
AB  - INTRODUCTION: Pre-exposure prophylaxis (PrEP) is a combination of antiretroviral 
      regimen, tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) that has been 
      shown to prevent HIV transmission. It had been regulated through a temporary 
      recommendation use since December 2015 and had marketing authorization in France 
      since March 2017. As, this product is proposed for adults and adolescents safe 
      from HIV but at high risk of infection, the question is to know if there is a 
      safety concern about this use. METHODS: A request has been made in the French 
      national pharmacovigilance database (ANPV) and VIGILYZE for an extraction of all 
      cases containing TDF/FTC as suspect drugs in PrEP use. In the second part, we did 
      a literature review in PubMED with MeSH terms and an analysis of the results of 
      the American, English and French initial clinical trials was performed. RESULTS: 
      In both database, 808 cases correspond to an indication of HIV prexposure 
      prophylaxis who represent 2058 adverse effects (AEs) mainly distributed in 
      gastro-intestinal disorders (38.5%), general disorders (16.8%) and 62 cases of 
      seroconversion. We identify 24% of unexpected AEs including 12% of serious AEs in 
      the French database. In literature review, there are no unexpected AEs published, 
      the AEs are mainly gastro-intestinal disorders. There was no significant 
      difference in the AE profile compared to the HIV-infected population treated with 
      TDF/FTC. CONCLUSION: Data from the ANPV, combined with data from the worldwide 
      pharmacovigilance database, show that the most commonly observed AEs are 
      gastrointestinal, mainly nausea, vomiting and diarrhea. A significant number of 
      asthenia and fatigue are also observed. These AEs are well described in the SMPc. 
      However, we have little data, which can be explained by a probable 
      under-reporting of AEs. We identify 24% of unexpected and potentially serious 
      adverse effects in France mainly among chemsex users. Based on these results, our 
      study confirms the safety of PrEP.
CI  - Copyright (c) 2022 Societe francaise de pharmacologie et de therapeutique. 
      Published by Elsevier Masson SAS. All rights reserved.
FAU - Jacomet, Carine
AU  - Jacomet C
AD  - Centre regional de pharmacovigilance de Franche-Comte, 3, boulevard 
      Alexandre-Fleming, 25000 Besancon, France.
FAU - Lebeller, Christine
AU  - Lebeller C
AD  - Centre regional de pharmacovigilance Paris HEGP, 75015 Paris, France.
FAU - Schiestel, Thomas
AU  - Schiestel T
AD  - Centre regional de pharmacovigilance Paris-Fernand-Widal, 75475 Paris, France.
FAU - Grandvuillemin, Aurelie
AU  - Grandvuillemin A
AD  - Centre regional de pharmacovigilance de Bourgogne, 21079 Dijon, France.
FAU - Davani, Siamak
AU  - Davani S
AD  - Centre regional de pharmacovigilance de Franche-Comte, 3, boulevard 
      Alexandre-Fleming, 25000 Besancon, France.
FAU - Valnet-Rabier, Marie-Blanche
AU  - Valnet-Rabier MB
AD  - Centre regional de pharmacovigilance de Franche-Comte, 3, boulevard 
      Alexandre-Fleming, 25000 Besancon, France. Electronic address: 
      mbrabier@chu-besancon.fr.
LA  - fre
PT  - English Abstract
PT  - Journal Article
PT  - Review
TT  - Utilisation de TRUVADA(R) en prophylaxie preexposition : analyse des bases de 
      vigilance et revue de la litterature.
DEP - 20220426
PL  - France
TA  - Therapie
JT  - Therapie
JID - 0420544
RN  - G70B4ETF4S (Emtricitabine)
RN  - 99YXE507IL (Tenofovir)
RN  - 0 (Anti-HIV Agents)
SB  - IM
MH  - Adult
MH  - Adolescent
MH  - Humans
MH  - United States
MH  - Emtricitabine/adverse effects
MH  - Tenofovir/adverse effects
MH  - *Pre-Exposure Prophylaxis/methods
MH  - *Anti-HIV Agents/adverse effects
MH  - *HIV Infections/prevention & control/drug therapy
OTO - NOTNLM
OT  - HIV
OT  - Pharmacovigilance
OT  - PrEP
OT  - Safety
OT  - TDF/emtricitabine
EDAT- 2022/06/02 06:00
MHDA- 2022/12/16 06:00
CRDT- 2022/06/01 09:41
PHST- 2021/11/10 00:00 [received]
PHST- 2022/02/01 00:00 [revised]
PHST- 2022/03/17 00:00 [accepted]
PHST- 2022/06/02 06:00 [pubmed]
PHST- 2022/12/16 06:00 [medline]
PHST- 2022/06/01 09:41 [entrez]
AID - S0040-5957(22)00067-1 [pii]
AID - 10.1016/j.therap.2022.03.008 [doi]
PST - ppublish
SO  - Therapie. 2022 Nov-Dec;77(6):635-647. doi: 10.1016/j.therap.2022.03.008. Epub 
      2022 Apr 26.