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Tenofovir DF/emtricitabine/raltegravir (TDF/FTC/RAL) appears safe and well-tolerated for non-occupational post-exposure prophylaxis (NPEP)
Presented by Kenneth Mayer (United States).
K. Mayer1,2, M. Mimiaga1,3, M. Gelman1, J. Trufant1, S. Maynard1, P. McMorrow1
1Fenway Health, The Fenway Institute, Boston, United States, 2Brown University, Infectious Disease Division, Providence, Virgin Islands, U.S., 3Harvard Medical School, Psychiatry, Boston, United States
Background: Although NPEP is routinely recommended after high risk HIV exposures, 3 drug regimens using NNRTIs and PIs have been poorly tolerated, leading to suboptimal completion rates. TDF/FTC/RAL has been well-tolerated and highly effective in the treatment of HIV-infected patients, making it a reasonable combination to consider for NPEP.
Methods: Boston's Fenway Community Health (FCH) has studied NPEP regimens since 1997. In 2008, FCH began a Phase IV study to evaluate the safety and tolerability of TDF/FTC/RAL, and data from the first 39 participants enrolled are presented here, and compared to historical controls who had received a standard AZT/3TC/PI regimen. Fishers' Exact Tests were used to compare global independence among the variables.
Results: All NPEP participants who used TDF/FTC/RAL were male, and 97.5% were homosexual or bisexual. Eight percent of the men were Black and 18% Latino; the mean age of the men was 33 (range 22-61 y.o.). Sixty seven percent reported unprotected receptive anal intercourse and 59% reported unprotected insertive anal intercourse as reasons for NPEP; 31% had sex with a known HIV-infected partner. The most common symptoms TDF/FTC/RAL users reported were: nausea (33.3%), diarrhea (20.5%), fatigue (12.8%), which were all significantly less frequent compared to reports from AZT/3TC/PI users (p< 0.01); however abdominal discomfort was more common in TDF/FTC/RAL users (18.0%, p< 0.01). Less common complaints in TDF/FTC/RAL users were: headache (15.4%), myalgias (7.6%) and dizziness (5.1%). All but one participant (97.4%) completed the 4 week regimen; 46.2% of the participants reported 100% adherence. One participant discontinued medication because of dizziness. No significant renal, hepatic or hematological abnormalities were associated with this regimen. None of the men who used TDF/FTC/RAL has become HIV-infected.
Conclusions: TDF/FTC/RAL was generally well-tolerated for NPEP, with a good safety profile, suggesting that expanded studies of this combination to evaluate this indication are warranted.
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