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
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
D if the HSV-2 diagnosis occurred at or after HIV seroconversion, and ulcers were excluded if they occurred at or after HIV seroconversion. We estimated the proportion of participants with 1 ulcer AE classified as Gradeor above (i.e., moderate, severe, or potentially life-threatening), 1 STI examination during which a perianal ulcer was detected, and 1 STI examination during which a groin ulcer
O predict the probability of having detectable drug and the probability that the level of tenofovir diphosphate (TFV-DP) in PBMCs was .16 fmol per million viable cells, the concentration associated with an estimated 90 reduction in HIV acquisition. [15] Drug levels were multiply imputed [16] for visits at which drug level testing was not conducted but the participant was still taking study drug,
Nversion to determine whether there were differences in ulcer occurrence by randomization group in the absence of study drug. All analyses were conducted in SAS 9.3 or Stata 12.Results Study participantsCharacteristics of the 2,499 iPrEx participants have been described previously. [13] Briefly, all participants were born male and 313 (13.0 ) identified as transgender or as women. The mean age at
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
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