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  ID Week
Oct 8-12 2014
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Raltegravir Containing regimen, for Post Exposure Prophylaxis (PEP) well tolerated in Health Care Workers (HCW)
  Reported by Jules Levin
IDSA 2014 Oct 8-12 Philadelphia, PA
Kassem Bourgi1, Daniella Thompson2, Dwayne Baxa1 3, Indira Brar1
1Henry Ford Hospital/Wayne State University
2 University of Texas Southwestern 3Oakland University William Beaumont School of Medicine


Program abstract:
HCW with occupational exposure to blood are at risk for HIV infection. To decrease the risk of HIV acquisition, antiretroviral drugs are used as PEP. Studies evaluating PEP after high-risk sexual activity demonstrate Truvada + Raltegravir (R) to be extremely well tolerated. Since 2005, the PEP regimen used for occupational exposure at our insititious (Henry Ford Health System) has been Truvada + Kaletra (K). The aim of this study was to demonstrate that a HCW PEP regimen of Raltegravir + Truvada has a high rate of completion and is well tolerated.
Eligible subjects were randomized in this prospective, open label, controlled study at a 1:1 ratio to either the R or K arms. Data collected at baseline, 2, 4, 6, 12 and 24 weeks post-exposure included laboratory chemistries, symptoms and side-effects. Symptoms reported in >10% of subjects were evaluated. Fishers exact test and student T test were applied to determine statistical significance.
A total of 16 subjects (8 per study arm) were enrolled from Feb. 2011 to Feb. 2013.
One from each arm discontinued after finding the source patient to be HIV negative. There were 17 reports of side-effects in the K arm and 6 in R arm. At week 2, 8 subjects reported nausea, abdominal pain, diarrhea, flatulence, tiredness, anxiety/depression. Abdominal pain and diarrhea tended to be greater in the K arm vs R arm (p=0.096 and p=0.035 respectively). Symptoms at week 4 were not significantly different between the arms. There was no difference between the two arms regarding incomplete dosage at either week 2 or week 4 of therapy (p=0.441). One Kaletra patient discontinued therapy after 19 days due to tolerance issues. The creatinine level was changed for the R arm, showing an average increase from 0.69 at baseline to 0.79 at week 4 (p=0.053). There were no HIV seroconversions at week 24 post-exposure.
A Raltegravir containing regimen as occupational PEP is well tolerated with high completion rates by HCW.