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AIDS. 2010 Sep 24;24(15):2375-80. doi: 10.1097/QAD.0b013e32833dfad1.

Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation.

Author information

1
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

Abstract

OBJECTIVE:

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

DESIGN:

Multicentric observational prospective study.

METHOD:

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.

CONCLUSION:

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.

PMID:
20729709
DOI:
10.1097/QAD.0b013e32833dfad1
[Indexed for MEDLINE]

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