N, transgender identity, alcohol use, or sexual behaviors.FTC/TDF and ulcer occurrenceA total of 1,019 participants tested seropositive for HSV-2 at baseline or during follow-up; of those, 22 (2.2 ) tested seropositive for HSV-2 after HIV seroconversion. Among the remaining 997,Daily Oral FTC/TDF PrEP and HSV-2 among MSMTable 1. Characteristics of participants testing HSV-2 seronegative at baselin
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
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
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
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
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
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