title: Daily oral tenofovir and emtricitabine-tenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial.
abstract: Daily oral preexposure prophylaxis (PrEP) using the antiretroviral tenofovir disoproxil fumarate (TDF) alone or in combination with emtricitabine (FTC-TDF) reduces the risk for HIV-1 acquisition. Tenofovir has in vitro activity against herpes simplex virus type 2 (HSV-2).
  
  
  
  To assess the efficacy of daily oral PrEP with tenofovir and FTC-TDF in the prevention of HSV-2 acquisition.
  
  
  
  Subgroup analysis of data from a randomized, placebo-controlled trial with concealed allocation. (ClinicalTrials.gov: NCT00557245).
  
  
  
  Multiple sites in Kenya and Uganda.
  
  
  
  Heterosexual men and women who were seronegative for HIV-1 and HSV-2 and at high risk for HIV-1 acquisition due to having an HIV-1-infected partner.
  
  
  
  Once-daily oral tenofovir disoproxil fumarate (TDF), alone or combined with emtricitabine (FTC-TDF), compared with placebo.
  
  
  
  HSV-2 seroconversion.
  
  
  
  A total of 131 participants seroconverted to HSV-2 (79 of 1041 assigned to tenofovir or FTC-TDF PrEP [HSV-2 incidence, 5.6 per 100 person-years] and 52 of 481 assigned to placebo [HSV-2 incidence, 7.7 per 100 person-years]). The hazard ratio (HR) for HSV-2 acquisition with daily oral PrEP was 0.70 (95% CI, 0.49 to 0.99; P = 0.047) compared with placebo, and the absolute risk reduction was 2.1 per 100 person-years. Among the 1044 participants with HSV-2-infected partners, the HR for PrEP was 0.67 (CI, 0.46 to 0.98; P = 0.038) compared with placebo, and the absolute risk reduction was 3.1 per 100 person-years.
  
  
  
  Randomization was not stratified by HSV-2 status, and diagnostic tests to exclude participants with acute HSV-2 at baseline are not available.
  
  
  
  Daily oral tenofovir-based PrEP significantly reduced the risk for HSV-2 acquisition among heterosexual men and women. Modest protection against HSV-2 is an added benefit of HIV-1 prevention with oral tenofovir-based PrEP.
  
  
  
  Bill & Melinda Gates Foundation.
authors: Connie
authors: C
authors: Celum
authors: Rhoda A
authors: RA
authors: Morrow
authors: Deborah
authors: D
authors: Donnell
authors: Ting
authors: T
authors: Hong
authors: Craig W
authors: CW
authors: Hendrix
authors: Katherine K
authors: KK
authors: Thomas
authors: Kenneth H
authors: KH
authors: Fife
authors: Edith
authors: E
authors: Nakku-Joloba
authors: Andrew
authors: A
authors: Mujugira
authors: Jared M
authors: JM
authors: Baeten
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D000284:Administration, Oral; D000328:Adult; D044966:Anti-Retroviral Agents / Q000097:blood / Q000627:therapeutic use; D000998:Antiviral Agents / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D018023:HIV Seronegativity; D015497:HIV-1 / Q000235:genetics; D006558:Herpes Genitalis / Q000517:prevention & control*; D018258:Herpesvirus 2, Human; D020010:Heterosexuality; D006801:Humans; D015994:Incidence; D008297:Male; D055118:Medication Adherence; D063065:Organophosphonates / Q000097:blood / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068698:Tenofovir
chemical_list: D044966:Anti-Retroviral Agents; D000998:Antiviral Agents; D063065:Organophosphonates; D012367:RNA, Viral; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine