World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd edn. 2016. http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf?ua=1. Accessed 28 Apr 2017.
World Health Organization. Guidance on pre-exposure oral prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: recommendations for use in the context of demonstration projects. 2012. http://www.who.int/hiv/pub/guidance_prep/en/. Accessed 25 Feb 2017.
US Public Health Service pre-exposure prophylaxis for the prevention of HIV infection in the United States—2014. A clinical practice guideline. 2014. https://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf. Accessed 25 Feb 2017.
AVAC. PrEPWatch: Country Updates. http://www.prepwatch.org/scaling-up/country-updates/. Accessed 8 Mar 2017.
UNAIDS Global summary of the AIDS epidemic. 2015. http://www.who.int/mediacentre/factsheets/fs334/en/. Accessed 8 Mar 2017.
World Health Organization Media Centre. Women’s health factsheet. 2013. http://www.who.int/mediacentre/factsheets/fs334/en/. Accessed 8 Mar 2017.
Parker RG, Easton D, Klein CH. Structural barriers and facilitators in HIV prevention: a review of international research. AIDS. 2000;14(Suppl 1):S22–32.
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587–99.
Grohskopf LA, Chillag KL, Gvetadze R, Liu AY, Thompson M, Mayer KH, et al. Randomized trial of clinical safety of daily oral tenofovir disoproxil fumarate among HIV-uninfected men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2013;64(1):79–86.
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399–410.
Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423–34.
Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411–22.
Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18.
Murnane PM, Celum C, Mugo N, Campbell JD, Donnell D, Bukusi E, et al. Efficacy of preexposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial. AIDS. 2013;27(13):2155–60.
Kahle EM, Hughes JP, Lingappa JR, John-Stewart G, Celum C, Nakku-Joloba E, et al. An empiric risk scoring tool for identifying high-risk heterosexual HIV-1 serodiscordant couples for targeted HIV-1 prevention. J Acquir Immune Defic Syndr. 2012;62:339–47.
Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, 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(9883):2083–90.
Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Chaipung B, et al. Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir Study. Lancet HIV. 2017;4(2):e59–66.
Fonner VA, Dalglish SL, Kennedy CE, Baggaley R, O’Reilly KR, Koechlin FM, et al. Effectiveness and safety of oral HIV preexposure prophylaxis for all populations. AIDS. 2016;30(12):1973–83.
Geary CW, Bukusi EA. Women and ARV-based HIV prevention—challenges and opportunities. J Int AIDS Soc. 2014;17(3 Suppl 2):19356.
Kwakwa HA, Bessias S, Sturgis D, Mvula N, Wahome R, Coyle C, et al. Attitudes toward HIV pre-exposure prophylaxis in a United States urban clinic population. AIDS Behav. 2016;20(7):1443–50.
Mack N, Evens EM, Tolley EE, Brelsford K, Mackenzie C, Milford C, et al. The importance of choice in the rollout of ARV-based prevention to user groups in Kenya and South Africa: a qualitative study. J Int AIDS Soc. 2014;17(3 Suppl 2):19157.
Luecke EH, Cheng H, Woeber K, Nakyanzi T, Mudekunye-Mahaka IC, van der Straten A, et al. Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study. J Int AIDS Soc. 2016;19(1):20875.
Corneli A, Perry B, McKenna K, Agot K, Ahmed K, Taylor J, et al. Participants’ explanations for nonadherence in the FEM-PrEP clinical trial. J Acquir Immune Defic Syndr. 2016;71(4):452–61.
Koechlin FM, Fonner VA, Dalglish SL, O’Reilly KR, Baggaley R, Grant RM, et al. Values and preferences on the use of oral pre-exposure prophylaxis (PrEP) for HIV prevention among multiple populations: a systematic review of the literature. AIDS Behav. 2017;21(5):1325–35.
Auerbach JD, Kinsky S, Brown G, Charles V. Knowledge, attitudes, and likelihood of pre-exposure prophylaxis (PrEP) use among US women at risk of acquiring HIV. AIDS Patient Care STDS. 2015;29(2):102–10.
Patterson KB, Prince HA, Kraft E, Jenkins AJ, Shaheen NJ, Rooney JF, et al. Penetration of tenofovir and emtricitabine in mucosal tissues: implications for prevention of HIV-1 transmission. Sci Transl Med. 2011;3(112):112re4.
Louissaint NA, Cao Y-J, Skipper PL, Liberman RG, Tannenbaum SR, Nimmagadda S, et al. Single dose pharmacokinetics of oral tenofovir in plasma, peripheral blood mononuclear cells, colonic tissue, and vaginal tissue. AIDS Res Hum Retrovir. 2013;29(11):1443–50.
Dumond JB, Yeh RF, Patterson KB, Corbett AH, Jung BH, Rezk NL, et al. Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxis. AIDS. 2007;21(14):1899–907.
Seifert SM, Chen X, Meditz AL, Castillo-Mancilla JR, Gardner EM, Predhomme JA, et al. Intracellular tenofovir and emtricitabine anabolites in genital, rectal, and blood compartments from first dose to steady state. AIDS Res Hum Retrovir. 2016;32(10–11):981–91.
Cottrell ML, Yang KH, Prince HMA, Sykes C, White N, Malone S, et al. A translational pharmacology approach to predicting outcomes of preexposure prophylaxis against HIV in men and women using tenofovir disoproxil fumarate with or without emtricitabine. J Infect Dis. 2016;214(1):55–64.
Thompson CG, Cohen MS, Kashuba ADM. Antiretroviral pharmacology in mucosal tissues. J Acquir Immune Defic Syndr. 2013;63(Suppl 2):S240–7.
Mugwanya KK, Wyatt C, Celum C, Donnell D, Mugo NR, Tappero J, et al. Changes in glomerular kidney function among HIV-1-uninfected men and women receiving emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis: a randomized clinical trial. JAMA Intern Med. 2015;175(2):246–54.
Mandala J, Nanda K, Wang M, De Baetselier I, Deese J, Lombaard J, et al. Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial. BMC Pharmacol Toxicol. 2014;24(15):77.
Liu AY, Vittinghoff E, Sellmeyer DE, Irvin R, Mulligan K, Mayer K, et al. Bone mineral density in HIV-negative men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial in San Francisco. PLoS One. 2011;6(8):e23688.
Hoornenborh E, de Bree GJ. Acute infection with a wild-type HIV virus in PrEP use with high TDF levels. 2017 CROI Conference February 13–17, Seattle, WA, Abstract #953. http://www.croiconference.org/sessions/acute-infection-wild-type-hiv-1-virus-prep-user-high-tdf-levels. Accessed 17 May 2017.
Hanson BM, Dorais JA. Reproductive considerations in the setting of chronic viral illness. Am J Obstet Gynecol. 2017. doi:10.1016/j.ajog.2017.02.012.
Mofenson LM, Baggaley RC, Mameletzis I. Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding. AIDS. 2017;31(2):213–32.
Benaboud S, Pruvost A, Coffie PA, Ekouévi DK, Urien S, Arrivé E, et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d’Ivoire, in the ANRS 12109 TEmAA Study, Step 2. Antimicrob Agents Chemother. 2011;55(3):1315–7.
Mugwanya KK, Hendrix CW, Mugo NR, Marzinke M, Katabira ET, Ngure K, et al. Pre-exposure prophylaxis use by breastfeeding HIV-uninfected women: a prospective short-term study of antiretroviral excretion in breast milk and infant absorption. PLoS Med. 2016;13(9):e1002132.
Abraham BK, Gulick R. Next-generation oral preexposure prophylaxis: beyond tenofovir. Curr Opin HIV AIDS. 2012;7(6):600–6.
Horn T and Jeffreys R. Preventative technologies: antiretroviral and vaccine development. http://www.pipelinereport.org/sites/default/files/201607/HIV%20Prevention.pdf. Accessed 14 Apr 2017.
Massud I, Mitchell J, Babusis D, Deyounks F, Ray AS, Rooney JF, et al. Chemoprophylaxis with oral emtricitabine and tenofovir alafenamide combination protects macaques from rectal simian/human immunodeficiency virus infection. J Infect Dis. 2016;214(7):1058–62.
Gunawardana M, Remedios-Chan M, Miller CS, Fanter R, Yang F, Marzinke MA, et al. Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis. Antimicrob Agents Chemother. 2015;59(7):3913–9.
Schlesinger E, Johengen D, Luecke E, et al. A tubable, biodegradable, thin-film polymer device as a long-acting implant delivering tenofovir alafenamide fumarate for HIV pre-exposure prophylaxis. Pharm Res. 2016;33(7):1649–56.
Garrett KL, Cottrell ML, Prince HM, Sykes C, Schauer A, Peery A, et al. Concentrations of TFV and TFVdp in female mucosal tissues after a single dose of TAF. 2016 CROI Conference February 22–25, Boston, MA, Poster #102LB. http://www.croiconference.org/sessions/concentrations-tfv-and-tfvdp-female-mucosal-tissues-after-single-dose-taf. Accessed 3 Apr 2017.
National Institutes of Health Clinicaltrials.gov. Safety and efficacy of emtricitabine and tenofovir alafenamide (F/TAF) fixed-dose combination once daily for pre-exposure prophylaxis in men and transgender women who have sex with men and are at risk for HIV-1 infection (DISCOVER). https://clinicaltrials.gov/ct2/show/NCT02842086. Accessed 20 May 2017.
Ohrui H, Kohgo S, Hayakawa H, Kodama E, Matsuoka M, Nakata T, Mitsuya H. 2′-deoxy-4′-C-ethynyl-2-fluoroadenosine: a nucleoside reverse transcriptase inhibitor with highly potent activity against wide spectrum of HIV-1 strains, favorable toxic profiles, and stability in plasma. Nucleos Nucleot Nucl. 2007;26:1543–6.
Kovarova M, Shanmugasundaram U, Baker CE, et al. HIV pre-exposure prophylaxis for women and infants prevents vaginal and oral HIV transmission in a preclinical model of HIV infection. J Antimicrob Chemother. 2016;71:3185–94.
Dumond JB, Patterson KB, Pecha AL, Werner RE, Andrews E, Damle B, et al. Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women. J Acquir Immune Defic Syndr. 2009;51(5):546–53.
Neff CP, Ndolo T, Tandon A, Habu Y, Akkina R. Oral pre-exposure prophylaxis by anti-retrovirals raltegravir and maraviroc protects against HIV-1 vaginal transmission in a humanized mouse model. PLoS One. 2010;5(12):e15257.
Massud I, Aung W, Martin A, Bachman S, Mitchell J, Aubert R, et al. Lack of prophylactic efficacy of oral maraviroc in macaques despite high drug concentrations in rectal tissues. J Virol. 2013;87(16):8952–61.
Coll J, Moltó J, Boix J, Gómez-Mora E, Else L, García E, Paredes R, Ouchi D, Carillo A, Escrig R, Back D, Clotet B, Cabrera C. Single oral dose of maraviroc does not prevent ex vivo HIV infection of rectal mucosa in HIV-1 negative human volunteers. AIDS. 2015;29(16):2149–54.
Moss JA, Butkyavichene I, Churchman SA, et al. Combination pod-intravaginal ring delivers antiretroviral agents for HIV prophylaxis: pharmacokinetic evaluation in an ovine model. Antimicrob Agents Chemother. 2016;60(6):3759–66.
Gulick RM, Wilkin TJ, Chen YQ, et al. Phase 2 Study of the safety and tolerability of maraviroc-containing regimens to prevent HIV infection in men who have sex with men (HPTN 069/ACTG A5305). J Infect Dis. 2017;215(2):238–46.
Gulick RM et al. HPTN 069/ACTG A5305: maraviroc-containing PrEP regimens safe, tolerable in cohort of US women. 21st International AIDS Conference 2016, Durban, South Africa. http://www.natap.org/2016/IAC/IAC_15.htm. Accessed 14 Apr 2017.
Next PrEP. HPTN 069/ACTG 5305. http://www.nextprepstudy.org/about.html. Accessed 6 Apr 2017.
Jackson AGA, Else LJ, Mesquita PMM, Egan D, Back DJ, Karolia Z, et al. A compartmental pharmacokinetic evaluation of long-acting rilpivirine in HIV-negative volunteers for pre-exposure prophylaxis. Clin Pharmacol Ther. 2014;96(3):314–23.
Verloes R, Deleu S, Niemeijer N, Crauwels H, Meyvisch P, Williams P. Safety, tolerability and pharmacokinetics of rilpivirine following administration of a long-acting formulation in healthy volunteers. HIV Med. 2015;16(8):477–84.
McGowan I, Dezzutti CS, Siegel A, Engstrom J, Nikiforov A, Duffill K, et al. Long-acting rilpivirine as potential pre-exposure prophylaxis for HIV-1 prevention (the MWRI-01 study): an open-label, phase 1, compartmental, pharmacokinetic and pharmacodynamic assessment. Lancet HIV. 2016;3(12):e569–78.
Bekker LG, Li S, Tolley E, et al. HPTN 076: TMC278 LA safe, tolerable and acceptable for HIV pre-exposure prophylaxis. 2017 CROI Conference February 13-17, Seattle, WA, Poster #2429. http://www.croiconference.org/sessions/hptn-076-tmc278-la-safe-tolerable-and-acceptable-hiv-preexposure-prophylaxis. Accessed 14 Apr 2017.
National Institutes of Health Clinicaltrials.gov. Phase II safety and acceptability of an investigation injectable product, TMC278LA, for pre-exposure prophlyaxis (TMC278LA). https://clinicaltrials.gov/ct2/show/NCT02165202 (Identification No. NCT02165202). Accessed 14 Apr 2017.
McGowan I. The promise and challenges of sustained delivery of PrEP. 2016 CROI Conference February 22–25, Boston, MA, Abstract #71. http://www.croiconference.org/sessions/promise-and-challenges-sustained-delivery-prep. Accessed 14 Apr 2017.
das Neves J, Martins JP, Sarmento B. Will dapivirine redeem the promises of anti-HIV microbicides? Overview of product design and clinical testing. Adv Drug Deliv Rev. 2016;103:20–32.
Rees H, Delany-Moretlwe SA, Lombard C, Baron D, Panchia R, Myer L, et al. FACTS 001 phase III trial of pericoital tenofovir 1% gel for preventionin women. 2015 CROI Conference February 23–26, Seattle, WA, Abstract #26LB. http://www.croiconference.org/sessions/facts-001-phase-iii-trial-pericoital-tenofovir-1-gel-hiv-prevention-women. Accessed 14 Apr 2017.
International Partnerships for Microbicides. Sister studies: the ring study and ASPIRE. February 2016. http://www.ipmglobal.org/publications/sister-studies-ring-study-and-aspire. Accessed 2 Apr 2017.
Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016;375(22):2121–32.
Nel A, van Niekerk N, Kapiga S, Bekker L-G, Gama C, Gill K, et al. Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women. N Engl J Med. 2016;375(22):2133–43.
Balkus J, Palanee-Phillips T, Siva S, Nakabiito C, Nair G, Kabwigu S, et al. Dapivirine ring use does not diminish the effectiveness of hormonal contraception. 2017 CROI Conference February 13–17, Seattle, WA, Abstract #88. http://www.croiconference.org/sessions/dapivirine-ring-use-does-not-diminish-effectiveness-hormonal-contraception. Accessed 14 Apr 2017.
Makanani B, Balkus J, Palanee-Phillips T, Mbilizi Y, Piper J, Kintu K, et al. Pregnancy incidence and outcome samong women using the dapivirine vaginal ring. 2017 CROI Conference February 13-17, Seattle, WA, Abstract #935. http://www.croiconference.org/sessions/pregnancy-incidence-and-outcomes-among-women-using-dapivirine-vaginal-ring. Accessed 14 Apr 2017.
Giacobbi NS, Sluis-Cremer. Cross-resistance profiles of the NNRTIs in development to prevent HIV-1 infection. 2017 CROI Conference February 13-17, Seattle, WA, Abstract #501. http://www.croiconference.org/sessions/cross-resistance-profiles-nnrtis-development-prevent-hiv-1-infection. Accessed 14 Apr 2017.
Whitfield T, Torkington A, van Halsema C. Profile of cabotegravir and its potential in the treatment and prevention of HIV-1 infection: evidence to date. HIV AIDS (Auckl). 2016;8:157–64.
Spreen W, Ford SL, Chen S, Wilfret D, Margolis D, Gould E, et al. GSK1265744 pharmacokinetics in plasma and tissue after single-dose long-acting injectable administration in healthy subjects. J Acquir Immune Defic Syndr. 2014;67(5):481–6.
Spreen W, Williams P, Margolis D, Ford SL, Crauwels H, Lou Y, et al. Pharmacokinetics, safety, and tolerability with repeat doses of GSK1265744 and rilpivirine (TMC278) long-acting nanosuspensions in healthy adults. J Acquir Immune Defic Syndr. 2014;67(5):487–92.
HIV Prevention Trials Network. HPTN 077: A phase IIa study to evaluate the safety, tolerability and pharmacokinetics of the investigational injectable HIV integrase inhibitor, GSK1265744, in HIV-uninfected men and women. https://www.hptn.org/sites/default/files/2016-05/077V1_01May14.pdf. Accessed 6 Apr 2017.
National Institutes of Health Clinicaltrials.gov. Safety and efficacy study of injectable cabotegravir compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), for pre-exposure prophylaxis in HIV-uninfected cisgender men and transgender women who have sex with men. from: https://clinicaltrials.gov/show/NCT02720094. Accessed 14 Apr 2017.
Margolis DA, Brinson CC, Smith GHR, de Vente J, Hagins DP, Eron JJ, et al. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial. Lancet Infect Dis. 2015;15(10):1145–55.
Molina J-M, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. 2015;373(23):2237–46.
McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomized trial. Lancet. 2016;387(10013):53–60.
Volk JE, Marcus JL, Phengrasamy T, Blechinger D, Nguyen DP, FOllansbee S, Hare CB. No new HIV infections with increasing use of HIV preexposure prophylaxis in a clinical practice setting. Clin Infect Dis. 2015;61:1601–3.
Smith DK, Van Handel M, Wolitski RJ, Stryker JE, Hall HI, Prejean J, et al. Vital signs: estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition—United States, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291–5.
Wu H, Mendoza MCB, Huang Y-LA, Hayes T, Smith DK, Hoover KW. Uptake of HIV preexposure prophylaxis among commercially insured persons-United States, 2010-2014. Clin Infect Dis. 2017;64(2):144–9.
Bush S, Magnuson D, Rawlings MK, Hawkins T, McCallister S, Giler M, et al. Racial Characteristics of FTC/TDF for Pre-exposure Prophylaxis (PrEP) Users in the US. 2016 ASM Microbe/ICAAC, Boston, MA. http://www.natap.org/2016/HIV/062216_02.htm. Accessed 14 Apr 2017.
Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014;14(9):820–9.
Cowan FM, Delany-Moretlwe S, Sanders EJ, Mugo NR, Guedou FA, Alary M, et al. PrEP implementation research in Africa: what is new? J Int AIDS Soc. 2016;19(7(Suppl 6)):21101.
European AIDS Clinical Society. Guidelines Version 8.2. http://www.eacsociety.org/files/guidelines_8.2-english.pdf. Published January 2017. Accessed 17 May 2017.
Hattori S, Ide K, Nakata H, Harada H, Suzu S, Ashida N, et al. Potent activity of a nucleoside reverse transcriptase inhibitor, 4′-ethynyl-2-fluoro-2′-deoxyadenosine, against human immunodeficiency virus type 1 infection in a model using human peripheral blood mononuclear cell-transplanted NOD/SCID Janus kinase 3 knockout mice. Antimicrob Agents Chemother. 2009;53(9):3887–93.