Raltegravir Plus Tenofovir DF and Emtricitabine for Non-occupational Postexposure Prophylaxis (nPEP): African-Americans are at Higher Risk of Non-Completion of nPEP
Methods: Non-randomized, open label, prospective cohort pilot study. Volunteers were ≥18- years-old and had a potential sexual exposure to HIV (defined as vaginal, anal or other mucosal exposure to ejaculate rectal or cervicovaginal secretions from an HIV-infected or high risk individual of unknown HIV status) within 72 hours. A 28-day course of raltegravir, tenofovir DF and emtricitabine was given to subjects. Adherence and side effects were assessed. Statistical analysis was done using SPSS. Significance was set at 0.005 and CIs at 95%.
Results: 103 individuals were enrolled in a 2 year period. 89% of the participants were male, and 65% identified themselves as men who have sex with men. The mean age of participant was 32 years old. 68% of the patients were white, 24% were African-American, and 9% of other racial origin. 21% of the volunteers identified themselves as Hispanics. 41% of the participants reported that they had sex with a known HIV-1 infected individual, 53% reported not having used a condom and the remainder report that the condom broke.
None of the volunteers who completed all study visits had HIV-1 seroconversion at the 6-month follow-up. 11% of patients reported that they missed doses of medication. Only Grade 1 side effects were reported (headaches 5.8%, fatigue 4.8%, nausea 3.9%, dizziness, flushing, constipation, loose stools, and bloating 1.9%). 83% of the volunteers completed 28-day nPEP and 53% completed all study visits. African-American were the race with the lowest rate of 28-days nPEP completion (60% vs. 94%) (p=0.0016).
Conclusion: Tenofovir DF, emtricitabine and raltegravir was a very well tolerated regimen with a high rate of adherence and treatment completion. Efforts on prevention strategies need to continue to focus on high risk groups, such as African-Americans.
K. J. Vigil,
Merck: Received research grant for study, Research grant
Gilead: Received research support (medications) for the study, Research support
K. Luna, None
M. L. Martinez, None
R. Hasbun, None
R. Arduino, Merck: Speaker's Bureau, Speaker honorarium