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Used acyclovir or valacyclovir during study follow-up.HSV-2 prevalenceOf the 2,499 participants, 1383 (55.3 ) tested negative for HSV-2 at baseline, 892 (35.7 ) tested positive, 223 (8.9 ) had indeterminate tests, and one test was not done. Of the 223 with indeterminate tests at baseline, 114 (51.1 ) tested positive for HSV-2 infection at some point during follow-up. Factors associated with testin
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Used acyclovir or valacyclovir during study follow-up.HSV-2 prevalenceOf the 2,499 participants, 1383 (55.3 ) tested negative for HSV-2 at baseline, 892 (35.7 ) tested positive, 223 (8.9 ) had indeterminate tests, and one test was not done. Of the 223 with indeterminate tests at baseline, 114 (51.1 ) tested positive for HSV-2 infection at some point during follow-up. Factors associated with testin
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O column totals due to missing data. doi:10.1371/journal.pone.0091513.tparticipants reported taking over 90 of study drug doses, drug was detectable in the blood specimens of only 50 of participants tested in a random subsample.[13] Although we did not observe an effect of FTC/TDF even after accounting for drug levels, it may be that oral FTC/TDF will be shown to have an impact on HSV-2 incidenc
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Lcer was identified, and 5.6 had 1 STI examination during which a groin ulcer was identified after HIV seroconversion, and thus after stopping study drug. The proportions with each type of ulcer did not differ between participants in the FTC/TDF arm and participants in the placebo arm. Finally, the iPrEx protocol did not use the HSV-2 test manufacturer's suggested cutoffs for indeterminate (IR
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Lcer was identified, and 5.6 had 1 STI examination during which a groin ulcer was identified after HIV seroconversion, and thus after stopping study drug. The proportions with each type of ulcer did not differ between participants in the FTC/TDF arm and participants in the placebo arm. Finally, the iPrEx protocol did not use the HSV-2 test manufacturer's suggested cutoffs for indeterminate (IR
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No differences by randomization group in the proportion of participants with 1 STI examination during which a perianal ulcer (FTC/TDF 3.5 vs. placebo 4.7 , P = 0.37) or groin ulcer (FTC/TDF 2.5 vs. placebo 1.9 , P = 0.51) was identified; results were similar after excluding participants with a positive syphilis rapid plasma reagin test at the same visit. However, symptoms that prompted STI exam
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D ,25 years (7.1 per 100 person-years) and the lowest rate among participants aged 40 years (1.6 per 100 person-years; P trend = 0.001). Country of residence was also associated with HSV-2 incidence, with theDaily Oral FTC/TDF PrEP and HSV-2 among MSMthere were 72 ulcer AEs classified as Grade 2 or above, with 43 participants (4.3 ) having 1 ulcer AE. Among the 72 ulcer AEs, 23 (31.9 ) were conf
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D ,25 years (7.1 per 100 person-years) and the lowest rate among participants aged 40 years (1.6 per 100 person-years; P trend = 0.001). Country of residence was also associated with HSV-2 incidence, with theDaily Oral FTC/TDF PrEP and HSV-2 among MSMthere were 72 ulcer AEs classified as Grade 2 or above, with 43 participants (4.3 ) having 1 ulcer AE. Among the 72 ulcer AEs, 23 (31.9 ) were conf