Tenofovir gel for the prevention of herpes simplex virus type 2 infection

New England Journal of Medicine

Volumn 373, Issue 6, 2015, Pages 530-539

  Karim, Salim S Abdool ^a,b,c   Karim, Quarraisha Abdool ^a,c   Kharsany, Ayesha B M ^a   Baxter, Cheryl ^a   Grobler, Anneke C ^a   Werner, Lise ^a   Kashuba, Angela ^d   Mansoor, Leila E ^a   Samsunder, Natasha ^a   Mindel, Adrian ^a   Gengiah, Tanuja N ^a  

^a UNIVERSITY OF KWAZULU NATAL   (South Africa)

^b UNIVERSITY OF KWAZULU NATAL   (South Africa)

^c Mailman School of Public Health   (United States)

^d University of North Carolina at Chapel Hill   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TENOFOVIR; ADENINE; GEL; PHOSPHONIC ACID DERIVATIVE; RNA DIRECTED DNA POLYMERASE INHIBITOR;

ADULT; CLINICAL EFFECTIVENESS; CONFERENCE PAPER; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG FORMULATION; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; HERPES SIMPLEX; HERPES SIMPLEX VIRUS 2; HERPES SIMPLEX VIRUS 2 INFECTION; HUMAN; INCIDENCE; INFECTION RISK; MAJOR CLINICAL STUDY; NONHUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SEXUAL BEHAVIOR; SOCIAL ASPECT; WESTERN BLOTTING; ANALOGS AND DERIVATIVES; GEL; HERPES GENITALIS; HIV INFECTIONS; INTRAVAGINAL DRUG ADMINISTRATION; KAPLAN MEIER METHOD; SERODIAGNOSIS; YOUNG ADULT;

ADENINE; ADMINISTRATION, INTRAVAGINAL; ADULT; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; GELS; HERPES GENITALIS; HERPESVIRUS 2, HUMAN; HIV INFECTIONS; HIV SERONEGATIVITY; HUMANS; INCIDENCE; KAPLAN-MEIER ESTIMATE; ORGANOPHOSPHONATES; REVERSE TRANSCRIPTASE INHIBITORS; YOUNG ADULT;

EID: 84938895020     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1410649     Document Type: Conference Paper

References (25)

1. Looker KJ, Magaret AS, Turner KM, Vickerman P, Gottlieb SL, Newman LM. Global estimates of prevalent and incident herpes simplex virus type 2 infections in 2012. PLoS One 2015; 10(1): e114989.
2. Bradley H, Markowitz LE, Gibson T, McQuillan GM. Seroprevalence of herpes simplex virus types 1 and 2 - United States, 1999-2010. J Infect Dis 2014; 209: 325-33.
3. Looker KJ, Garnett GP, Schmid GP. An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection. Bull World Health Organ 2008; 86: 805-12.
4. Smith JS, Robinson NJ. Age-specific prevalence of infection with herpes simplex virus types 2 and 1: a global review. J Infect Dis 2002; 186: Suppl 1: S3-S28.
5. Global strategy for the prevention and control of sexually transmitted infections: 2006-2015: breaking the chain of transmission. Geneva: World Health Organization, 2007.
6. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 329: 1168-74.
7. Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 2015; 372: 509-18.
8. Rees H, Delany-Moretlwe SA, Lombard C, et al. FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, February 23-26, 2015. abstract.
9. Schwartz JL, Rountree W, Kashuba AD, et al. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel. PLoS One 2011; 6(10): e25974.
10. Dumond JB, Yeh RF, Patterson KB, et al. Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxis. AIDS 2007; 21: 1899-907.
11. Andrei G, Lisco A, Vanpouille C, et al. Topical tenofovir, a microbicide effective against HIV, inhibits herpes simplex virus-2 replication. Cell Host Microbe 2011; 10: 379-89.
12. Tien D, Schnaare RL, Kang F, et al. In vitro and in vivo characterization of a potential universal placebo designed for use in vaginal microbicide clinical trials. AIDS Res Hum Retroviruses 2005; 21: 845-53.
13. Mansoor LE, Abdool Karim Q, Yende-Zuma N, et al. Adherence in the CAPRISA 004 tenofovir gel microbicide trial. AIDS Behav 2014; 18: 811-9.
14. Karim QA, Kharsany AB, Frohlich JA, et al. Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial. Trials 2011; 12: 67.
15. Karim SS, Kashuba AD, Werner L, Karim QA. Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women. Lancet 2011; 378: 279-81.
16. Delany-Moretlwe S, Jentsch U, Weiss H, et al. Comparison of focus HerpesSelect and Kalon HSV-2 gG2 ELISA serological assays to detect herpes simplex virus type 2 antibodies in a South African population. Sex Transm Infect 2010; 86: 46-50.
17. Ashley RL, Militoni J, Lee F, Nahmias A, Corey L. Comparison of Western blot (immunoblot) and glycoprotein G-specific immunodot enzyme assay for detecting antibodies to herpes simplex virus types 1 and 2 in human sera. J Clin Microbiol 1988; 26: 662-7.
18. Martin ET, Krantz E, Gottlieb SL, et al. A pooled analysis of the effect of condoms in preventing HSV-2 acquisition. Arch Intern Med 2009; 169: 1233-40.
19. Tobian AA, Serwadda D, Quinn TC, et al. Male circumcision for the prevention of HSV-2 and HPV infections and syphilis. N Engl J Med 2009; 360: 1298-309.
20. Tan DH, Kaul R, Raboud JM, Walmsley SL. No impact of oral tenofovir disoproxil fumarate on herpes simplex virus shedding in HIV-infected adults. AIDS 2011; 25: 207-10.
21. Marcus JL, Glidden DV, McMahan V, et al. Daily oral emtricitabine/tenofovir preexposure prophylaxis and herpes simplex virus type 2 among men who have sex with men. PLoS One 2014; 9(3): e91513.
22. Celum C, Morrow RA, Donnell D, et al. Daily oral tenofovir and emtricitabinetenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial. Ann Intern Med 2014; 161: 11-9.
23. Van de Perre P, Segondy M, Foulongne V, et al. Herpes simplex virus and HIV-1: deciphering viral synergy. Lancet Infect Dis 2008; 8: 490-7.
24. Glynn JR, Biraro S, Weiss HA. Herpes simplex virus type 2: a key role in HIV incidence. AIDS 2009; 23: 1595-8.
25. Ashley RL, Wu L, Pickering JW, Tu MC, Schnorenberg L. Premarket evaluation of a commercial glycoprotein G-based enzyme immunoassay for herpes simplex virus type-specific antibodies. J Clin Microbiol 1998; 36: 294-5.