title: Tenofovir Gel for the Prevention of Herpes Simplex Virus Type 2 Infection.
abstract: BACKGROUND
  Globally, herpes simplex virus type 2 (HSV-2) infection is the most common cause of genital ulcer disease. Effective prevention strategies for HSV-2 infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections.
  
  
  METHODS
  We assessed the effectiveness of pericoital tenofovir gel, an antiviral microbicide, in preventing HSV-2 acquisition in a subgroup of 422 HSV-2-negative women enrolled in the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 study, a double-blind, randomized, placebo-controlled trial. Incident HSV-2 cases were identified by evidence of seroconversion on an HSV-2 IgG enzyme-linked immunosorbent assay between study enrollment and exit. A confirmatory analysis was performed by Western blot testing.
  
  
  RESULTS
  The HSV-2 incidence rate was 10.2 cases per 100 person-years (95% confidence interval [CI], 6.8 to 14.7) among 202 women assigned to tenofovir gel, as compared with 21.0 cases per 100 person-years (95% CI, 16.0 to 27.2) among 222 women assigned to placebo gel (incidence rate ratio, 0.49; 95% CI, 0.30 to 0.77; P=0.003). The HSV-2 incidence rate among the 25 women with vaginal tenofovir concentrations of 10,000 ng per milliliter or more was 5.7 cases per 100 person-years, as compared with 15.5 cases per 100 person-years among the 103 women with no detectable vaginal tenofovir (incidence rate ratio, 0.37; 95% CI, 0.04 to 1.51; P=0.14). As confirmed by Western blot testing, there were 16 HSV-2 seroconversions among women assigned to tenofovir gel as compared with 36 among those assigned to the placebo gel (incidence rate ratio, 0.45; 95% CI, 0.23 to 0.82; P=0.005).
  
  
  CONCLUSIONS
  In this study in South Africa, pericoital application of tenofovir gel reduced HSV-2 acquisition in women. (Funded by the U.S. Agency for International Development and others; ClinicalTrials.gov number, NCT00441298.).
authors.affiliation: From the Centre for the AIDS Programme of Research in South Africa (CAPRISA) (S.S.A.K., Q.A.K., A.B.M.K., C.B., A.C.G., L.W., L.E.M., N.S., A.M., T.N.G.) and the University of KwaZulu-Natal (S.S.A.K.) - both in Durban, South Africa; the Department of Epidemiology, Mailman School of Public Health, Columbia University, New York (S.S.A.K., Q.A.K.); and the Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill (A.K.).
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
authors.forename: Quarraisha
authors.initials: Q
authors.lastname: Abdool Karim
authors.forename: Ayesha B M
authors.initials: AB
authors.lastname: Kharsany
authors.forename: Cheryl
authors.initials: C
authors.lastname: Baxter
authors.forename: Anneke C
authors.initials: AC
authors.lastname: Grobler
authors.forename: Lise
authors.initials: L
authors.lastname: Werner
authors.forename: Angela
authors.initials: A
authors.lastname: Kashuba
authors.forename: Leila E
authors.initials: LE
authors.lastname: Mansoor
authors.forename: Natasha
authors.initials: N
authors.lastname: Samsunder
authors.forename: Adrian
authors.initials: A
authors.lastname: Mindel
authors.forename: Tanuja N
authors.initials: TN
authors.lastname: Gengiah
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000282:Administration, Intravaginal; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control; D018023:HIV Seronegativity; D006558:Herpes Genitalis / Q000453:epidemiology / Q000517:prevention & control*; D018258:Herpesvirus 2, Human; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000068698:Tenofovir; D055815:Young Adult
chemical_list: D005782:Gels; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D000068698:Tenofovir; D000225:Adenine