Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation.
OBJECTIVE
To evaluate the tolerability of HIV postexposure prophylaxis (PEP) with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation (TDF/FTC+LPV/r).


METHODS
Multicentric observational prospective study.


METHODS
Adults with an HIV transmission risk in the past 48 h were eligible. Baseline sociodemographic characteristics, description of exposure event, and HIV serostatus of the source patient were collected. Laboratory monitoring for toxicity and a clinical evaluation were performed; adherence and side effects were recorded using a standardized form on day 0, 15, and 28.


RESULTS
Between November 2006 and June 2008, 249 participants were included in 10 French hospitals. Mean age was 31.5 +/- years. Sex ratio male/female was 1.96. Exposure events are as follows: occupational exposure, 40 (16%); sexual intercourse, 204 (82%); and other, 5 (2%). Tolerability could be evaluated in 188 cases. In 22 cases, PEP was discontinued for adverse effects before day 28, including two cases of skin rash related to TDF/FTC prescription, one renal lithiasis related to LPV/r prescription, and one rhabdomyolysis. One hundred and sixty-six persons completed the 28 days of PEP with tolerability judged as good in 96 (58%) individuals. Among everyone who experienced at least one side effect, 78% reported diarrhea, 78% asthenia, and 59% nausea and/or vomiting.


CONCLUSIONS
Considering data of previous studies performed using similar methodology, the dropout rate due to adverse events appeared significantly lower in TDF/FTC+LPV/r tablet formulation than those in zidovudine/lamivudine (ZDV/3TC)+nelfinavir (P < 0.0001), ZDV/3TC+lopinavir/ritonavir soft gel capsules (P < 0.01), and 3TC+TDF+atazanavir boosted by ritonavir (P < 0.05) and should be considered as standard of care concerning HIV PEP.
Tosini
William
W
Groupe d'Etude sur le Risque d'exposition des Soignants aux Agents Infectieux (GERES), Université aris Diderot Paris 7, UFR de Médecine site Bichat, Paris Cedex 18 France. wilto@libero.it
Muller
Philippe
P
Prazuck
Thierry
T
Benabdelmoumen
Ghania
G
Peyrouse
Eric
E
Christian
Bernard
B
Quertainmont
Yann
Y
Bouvet
Elisabeth
E
Rabaud
Christian
C
D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage; D018791:CD4 Lymphocyte Count; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000517:prevention & control; D017320:HIV Protease Inhibitors / Q000008:administration & dosage*; D015497:HIV-1 / Q000187:drug effects* / Q000472:pathogenicity; D006801:Humans; D061466:Lopinavir; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D017410:Practice Guidelines as Topic; D011744:Pyrimidinones / Q000008:administration & dosage; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000008:administration & dosage; D000068698:Tenofovir; D016896:Treatment Outcome; D055815:Young Adult
D000998:Antiviral Agents; D017320:HIV Protease Inhibitors; D063065:Organophosphonates; D011744:Pyrimidinones; D012367:RNA, Viral; D003841:Deoxycytidine; D061466:Lopinavir; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; D019438:Ritonavir