Tolerability of HIV postexposure prophylaxis

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

Tosini W, Muller P, Prazuck T, Benabdelmoumen G, Peyrouse E, Christian B, Quertainmont Y, Bouvet E, Rabaud C. AIDS. 2010; 24:2375-80

The objective of the study was to evaluate the tolerability of HIV postexposure prophylaxis (PEP) with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation (TDF/FTC+LPV/r) in a multicentric observational prospective study. 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. Between November 2006 and June 2008, 249 participants were included in 10 French hospitals. The mean age of participants was 31.5 +/- 10 years and the male/female sex ratio 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 diarrhoea, 78% asthenia, and 59% nausea and/or vomiting. 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 <>should be considered as standard of care concerning HIV PEP.

Editors’ note: This team has been evaluating the tolerability of post-exposure prophylaxis (PEP) antiretroviral drug regimens for over ten years. Although people who have been exposed to HIV through occupational or sexual exposure only have to take the drugs for 28 days, treatment interruptions and dropouts can be high due to adverse events. Compared with historical controls receiving other protease-inhibitor-based regimens, of whom 21% to 35% discontinued, this combination of TDF/FTC (tenofovir/emtricitabine) and LPV/r (ritonavir-boosted lopinavir) was well tolerated with only 12% of participants stopping PEP due to adverse events. Sex differences were seen though with female sex an independent predictor of poorer PEP tolerability and high discontinuation rate. Women were significantly more likely than men to experience gastric adverse events such as nausea and vomiting and had more frequent insomnia.