Single-agent tenofovir versus combination emtricitabine plus tenofovir for pre-exposure prophylaxis for HIV-1 acquisition: An update of data from a randomised, double-blind, phase 3 trial

The Lancet Infectious Diseases

Volumn 14, Issue 11, 2014, Pages 1055-1064

  Baeten, Jared M ^a,b   Donnell, Deborah ^a,c   Mugo, Nelly R ^a,d   Ndase, Patrick ^a   Thomas, Katherine K ^a   Campbell, James D ^e   Wangisi, Jonathan ^f   Tappero, Jordan W ^e   Bukusi, Elizabeth A ^a,d,g,h   Cohen, Craig R ^h   Katabira, Elly ⁱ   Ronald, Allan ^i,j   Tumwesigye, Elioda ^k   Were, Edwin ^l   Fife, Kenneth H ^m   Kiarie, James ^a,g   Farquhar, Carey ^a,b   John Stewart, Grace ^a,b   Kidoguchi, Lara ^a   Coombs, Robert W ^a,b   Hendrix, Craig ⁿ   Marzinke, Mark A ⁿ   Frenkel, Lisa ^a,b,o   Haberer, Jessica E ^p,q   Bangsberg, David ^p,q   Celum, Connie ^a,b   more..

^a UNIVERSITY OF WASHINGTON   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c USA   (United States)

^d KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^e CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^f THE AIDS SUPPORT ORGANIZATION   (Uganda)

^g UNIVERSITY OF NAIROBI   (Kenya)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ MAKERERE UNIVERSITY   (Uganda)

^j UNIVERSITY OF MANITOBA   (Canada)

^k Kabwohe Clinical Research Centre   (Uganda)

^l MOI UNIVERSITY   (Kenya)

^m INDIANA UNIVERSITY   (United States)

ⁿ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

^p MASSACHUSETTS GENERAL HOSPITAL   (United States)

^q HARVARD MEDICAL SCHOOL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CREATININE; EMTRICITABINE; PHOSPHORUS; TENOFOVIR DISOPROXIL; VIRUS RNA; ADENINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DEOXYCYTIDINE; PHOSPHONIC ACID DERIVATIVE; PLACEBO; TENOFOVIR;

ABNORMALLY LOW SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ANTIVIRAL RESISTANCE; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; FEMALE; FOLLOW UP; GENE MUTATION; HETEROSEXUALITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INCIDENCE; INFECTION PREVENTION; INTENTION TO TREAT ANALYSIS; K65R GENE; K70E GENE; KENYA; M184I GENE; M184V GENE; MALE; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRE EXPOSURE PROPHYLAXIS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SENSITIVITY ANALYSIS; SEROCONVERSION; UGANDA; UNSPECIFIED SIDE EFFECT; VIRUS GENE; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DRUG COMBINATION; DRUG EFFECTS; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; PRE-EXPOSURE PROPHYLAXIS; PROCEDURES; TREATMENT OUTCOME; VIROLOGY;

ADENINE; ADULT; ANTI-HIV AGENTS; DEOXYCYTIDINE; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; EMTRICITABINE; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; KENYA; MALE; ORGANOPHOSPHONATES; PLACEBOS; PRE-EXPOSURE PROPHYLAXIS; TENOFOVIR; TREATMENT OUTCOME; UGANDA;

EID: 84908293477     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(14)70937-5     Document Type: Article

References (30)

1. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011, 365:493-505.
2. Donnell D, Baeten JM, Kiarie J, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 2010, 375:2092-2098. for the Partners in Prevention HSV/HIV Transmission Study Team.
3. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012, 367:399-410.
4. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010, 363:2587-2599.
5. Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012, 367:423-434.
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, 329:1168-1174.
7. Choopanya K, Martin M, Suntharasamai P, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2013, 381:2083-2090. for the Bangkok Tenofovir Study Group.
8. Tsai CC, Follis KE, Sabo A, et al. Prevention of SIV infection in macaques by (R)-9-(2-phosphonylmethoxypropyl)adenine. Science 1995, 270:1197-1199.
9. Garcia-Lerma JG, Otten RA, Qari SH, et al. Prevention of rectal SHIV transmission in macaques by daily or intermittent prophylaxis with emtricitabine and tenofovir. PLoS Med 2008, 5:e28.
10. Parikh UM, Dobard C, Sharma S, et al. Complete protection from repeated vaginal simian-human immunodeficiency virus exposures in macaques by a topical gel containing tenofovir alone or with emtricitabine. J Virol 2009, 83:10358-10365.
11. Garcia-Lerma JG, Cong ME, Mitchell J, et al. Intermittent prophylaxis with oral truvada protects macaques from rectal SHIV infection. Sci Transl Med 2010, 2:14ra4.
12. Mujugira A, Baeten JM, Donnell D, et al. Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention. PLoS One 2011, 6:e25828.
13. Joint United National Programme on HIV/AIDS (UNAIDS), AVAC. Good participatory practice: guidelines for biomedical HIV prevention trials 2011. Geneva, Switzerland, 2011.
14. Ethical considerations in biomedical HIV prevention trials 2007, UNAIDS/WHO, Joint UN Programme on HIV/AIDS, Geneva.
15. Ndase P, Celum C, Campbell J, et al. Successful discontinuation of the placebo arm and provision of an effective HIV prevention product after a positive interim efficacy result: the partners PrEP study experience. J Acquir Immune Defic Syndr 2014, 66:206-212.
16. Beck IA, Crowell C, Kittoe R, et al. Optimization of the oligonucleotide ligation assay, a rapid and inexpensive test for detection of HIV-1 drug resistance mutations, for non-North American variants. J Acquir Immune Defic Syndr 2008, 48:418-427.
17. Haberer JE, Baeten JM, Campbell J, et al. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med 2013, 10:e1001511.
18. Breslow NE, Lumley T, Ballantyne CM, Chambless LE, Kulich M Improved Horvitz-Thompson estimation of model parameters from two-phase stratified samples: applications in epidemiology. Stat Biosci 2009, 1:32.
19. Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012, 367:411-422.
20. Marrazzo J, Ramjee G, Nair G, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the VOICE (MTN 003). 20th Conference on Retroviruses and Opportunistic Infections; Atlanta, USA; March 3-6, 2013: 26LB (abstr).
21. Katz MH, Gerberding JL Postexposure treatment of people exposed to the human immunodeficiency virus through sexual contact or injection-drug use. N Engl J Med 1997, 336:1097-1100.
22. Smith DK, Grohskopf LA, Black RJ, et al. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep 2005, 54(RR-2):1-20.
23. Guidance on pre-exposure oral prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: recommendation for use in the context of demonstration projects 2012, WHO, World Health Organization, Geneva.
24. Programmatic Update: Use of Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants 2012, WHO, World Health Organization, Geneva.
25. Preexposure prophylaxis for the prevention of HIV infection in the United States-2014: a clinical practice guideline 2014, CDC, Centers for Disease Control and Prevention.
26. FDA approves first drug for reducing the risk of sexually acquired HIV infection US Food and Drug Administration, (accessed Sept 25, 2014). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm.
27. Mujugira A, Celum C, Thomas KK, et al. Delay of antiretroviral therapy initiation is common in East African HIV-infected individuals in serodiscordant partnerships. J Acquir Immune Defic Syndr 2014, 66:436-442.
28. Baeten J, Celum C Systemic and topical drugs for the prevention of HIV infection: antiretroviral pre-exposure prophylaxis. Annu Rev Med 2013, 64:219-232.
29. Baeten JM, Haberer JE, Liu AY, Sista N Preexposure prophylaxis for HIV prevention: where have we been and where are we going?. J Acquir Immune Defic Syndr 2013, 63(suppl 2):S122-S129.
30. Celum C, Baeten JM, Hughes JP, et al. Integrated strategies for combination HIV prevention: principles and examples for men who have sex with men in the Americas and heterosexual African populations. J Acquir Immune Defic Syndr 2013, 63(suppl 2):S213-S220.