T among participants living in Peru (46.0 ), Brazil (37.8 ), and Ecuador (37.3 ), with lower prevalence among participants living in Thailand (6.4 ), South Africa (17.6 ), and the United States (27.1 ; P,0.001). Randomization group was not associated with HSV-2 prevalence at baseline (P = 0.44). In multivariable analysis, all factors remained significantly associated with HSV-2 prevalence with the
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
Idence of 6.1 per 100 person-years) and 60 were in the placebo group (incidence of 5.6 per 100 person-years). There was no significant difference in time to HSV-2 incidence among participants assigned to the FTC/TDF arm compared with those assigned to the placebo arm (HR 1.1, 95 CI: 0.8?.5; P = 0.64; Figure 2). Compared with participants in the placebo arm, there was also no difference in time to
Idence of 6.1 per 100 person-years) and 60 were in the placebo group (incidence of 5.6 per 100 person-years). There was no significant difference in time to HSV-2 incidence among participants assigned to the FTC/TDF arm compared with those assigned to the placebo arm (HR 1.1, 95 CI: 0.8?.5; P = 0.64; Figure 2). Compared with participants in the placebo arm, there was also no difference in time to
N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f
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
T among participants living in Peru (46.0 ), Brazil (37.8 ), and Ecuador (37.3 ), with lower prevalence among participants living in Thailand (6.4 ), South Africa (17.6 ), and the United States (27.1 ; P,0.001). Randomization group was not associated with HSV-2 prevalence at baseline (P = 0.44). In multivariable analysis, all factors remained significantly associated with HSV-2 prevalence with the
Aseline by age group at enrollment, while Figure 1b shows HSV-2 incidence during follow-up by age group at enrollment. HSV-2, herpes simplex virus type 2. doi:10.1371/journal.pone.0091513.gDiscussionIn this analysis of participants in the iPrEx trial of daily oral FTC/TDF PrEP, we found no association between FTC/TDF and incidence of HSV-2 infection, even after accounting for actual use of FTC/TDF