Abstract
Since July 2010, there have been five clinical trials demonstrating the efficacy of antiretrovirals as treatment or oral/topical prophylaxis, in preventing HIV. One of the biggest challenges facing HIV prevention is how to translate these biomedical HIV prevention technologies with high adherence to achieve public health impact to turn the tide of the epidemic. The rapidly evolving field of HIV prevention is about to embark on the challenge of translating efficacy observed in clinical trial conditions into effectiveness in the real world. This task, looming large, presents a particular challenge because it requires multiple biomedical, behavioral, and social interventions in combination to maximize their synergy as appropriate for each unique epidemic setting. In real-world settings, particular efforts will be needed to ensure high adherence, as two trials of pre-exposure prophylaxis did not show efficacy principally due to poor adherence to daily regimens. Despite the numerous challenges in implementing antiretroviral treatment for prevention, it has, in conjunction with pre-exposure prophylaxis, created newfound optimism in HIV prevention. Most importantly, antiretroviral implementation is gaining momentum despite obstacles and its impact on the HIV epidemic is becoming evident.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005;2:e298.
Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369:643–56.
Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–66.
Grosskurth H, Mosha F, Todd J, Mwijarubi E, Klokke A, Senkoro K, Mayaud P, Changalucha J, Nicoll A, ka-Gina G, et al. Impact of improved treatment of sexually transmitted diseases on HIV infection in rural Tanzania: randomised controlled trial. Lancet. 1995;346:530–6.
Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009;361:2209–20.
Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany ABM, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D, on behalf of the CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74.
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587–99.
Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410.
Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367:423–34.
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493–505.
U.S. Food and Drug Administration. FDA approves first drug for reducing the risk of sexually acquired HIV infection. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.html. In: Silver Spring, MD 2012. Accessed 19 July 2012.
Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009;373:48–57.
Tanser F, Barnighausen T, Grapsa E, Zaidi J, Newell ML. High coverage of ART associated with decline in risk of HIV acquisition in rural KwaZulu-Natal, South Africa. Science. 2013;339:966–71.
Abbas UL, Anderson RM, Mellors JW. Potential impact of antiretroviral chemoprophylaxis on HIV-1 transmission in resource-limited settings. PLoS ONE. 2007;2:e875.
Williams BG, Abdool Karim SS, Gouws E, Abdool Karim Q. Epidemiological impact of tenofovir gel on the HIV epidemic in South Africa. J Acquir Immune Defic Syndr. 2011;58:207–10.
Pretorius C, Stover J, Bollinger L, Bacaer N, Williams B. Evaluating the cost-effectiveness of pre-exposure prophylaxis (PrEP) and its impact on HIV-1 transmission in South Africa. PLoS ONE. 2010;5:e13646.
Walensky RP, Park JE, Wood R, Freedberg KA, Scott CA, Bekker LG, Losina E, Mayer KH, Seage GR 3rd, Paltiel AD. The cost-effectiveness of pre-exposure prophylaxis for HIV infection in South African women. Clin Infect Dis. 2012;54:1504–13.
Auvert B, Taljaard D, Rech D, Lissouba P, Singh B, Shabangu D, Nhlapo C, Otchere-Darko J, Mashigo T, Phatedi G, Taljaard R, Tsepe M, Chakela M, Mkhwanazi A, Ntshangase P, Billy S, Lewis D. Effect of the Orange Farm (South Africa) male circumcision roll-out (ANRS-12126) on the spread of HIV [abstract WELBC02]. In: Sixth International AIDS Society Conference. Rome; 2011.
Centers for Disease Control and Prevention. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep. 2011;60:65–8.
Centers for Disease Control and Prevention. Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep. 2012;61:586–9.
Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak’Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D, for the FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411–22.
Microbicide Trials Network. Press release: daily HIV prevention approaches didn’t work for African women in the VOICE Study. 2013.
Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Grant R, Kashuba A, Taylor D, FEM-PrEPS Study Group. The FEM-PrEP Trial of Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) among African Women [Abstract 32LB]. In: Conference of Retroviruses and Opportunistic Infections. Seattle; 2012.
van Oosterhout JJ, Bodasing N, Kumwenda JJ, Nyirenda C, Mallewa J, Cleary PR, de Baar MP, Schuurman R, Burger DM, Zijlstra EE. Evaluation of antiretroviral therapy results in a resource-poor setting in Blantyre, Malawi. Trop Med Int Health 2005;10:464–70.
Nachega JB, Stein DM, Lehman DA, Hlatshwayo D, Mothopeng R, Chaisson RE, Karstaedt AS. Adherence to antiretroviral therapy in HIV-infected adults in Soweto, South Africa. AIDS Res Hum Retroviruses. 2004;20:1053–6.
Byakika-Tusiime J, Oyugi JH, Tumwikirize WA, Katabira ET, Mugyenyi PN, B DR. Adherence to HIV antiretroviral therapy in HIV+ Ugandan patients purchasing therapy. Int J STD AIDS. 2005;16:38–41.
Anderson PL, Lama JR, Buchbinder S, Guanira J, Montoya O, Casapia M, Liu A, Bushman LR, McMahan V, Amico KR, Glidden DV, Grant RM, iPrEx Study Team. Expanded case-control analysis of drug detection in the global iPrEx trial [abstractMOLBPE034]. In: 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Rome, Italy; 2011.
Aurigemma M, Goicochea P. iPrEx Fact Sheet: Drug Resistance. In: Global iPrEX; 2011.
Abbas U, Glaubius R, Mubayi A, Hood G, Mellors J. Predicting the Impact of ART and PrEP with Overlapping Regimens on HIV Transmission and Drug Resistance in South Africa [abstract no 98LB]. In: 18th Conference on Retroviruses and Opportunistic Infections. Boston, Massachusetts; 2011.
Cassell MM, Halperin DT, Shelton JD, Stanton D. Risk compensation: the Achilles’ heel of innovations in HIV prevention? Br Med J. 2006;332:605–7.
Vissers DC, Voeten HA, Nagelkerke NJ, Habbema JD, de Vlas SJ. The impact of pre-exposure prophylaxis (PrEP) on HIV epidemics in Africa and India: a simulation study. PLoS ONE. 2008;3:e2077.
Macklin R, Cowan E, Rutherford G. Given financial constraints, it would be unethical to divert antiretroviral drugs from treatment to prevention. Health Aff. 2012;31:1537–44.
World Health Organisation. The strategic use of antiretrovirals to help end the HIV epidemic. Geneva, Switzerland: World Health Organisation; 2012.
WHO, UNAIDS, UNICEF. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector. Geneva, Switzerland: World Health Organisation; 2010.
Shisana O, Rehle T, Simbayi LC, Zuma K, Jooste S, Pillay-van-Wyk V, Mbelle N, Van Zyl J, Parker W,., Zungu NP, Pezi S, the SABSSM III Implementation Team. South African national HIV prevalence, incidence, behaviour and communication survey 2008: a turning tide among teenagers? Cape Town: HSRC Press; 2009.
Abdool Karim SS. Stigma impedes AIDS prevention. Nature. 2011;474:29–31.
Gilead Sciences Inc. Investigators Brochure: Tenofovir Gel (GS-1278). In: Foster City, California Gilead Sciences, Inc; Second Edition, 31 March 2005.
Nuesch R, Ananworanich J, Srasuebkul P, Chetchotisakd P, Prasithsirikul W, Klinbuayam W, Mahanontharit A, Jupimai T, Ruxrungtham K, Hirschel B. Interruptions of tenofovir/emtricitabine-based antiretroviral therapy in patients with HIV/hepatitis B virus co-infection. AIDS. 2008;22:152–4.
Gilead Sciences Inc. Emtriva package insert. July 2003.
Msellati P, Hingst G, Kaba F, Viho I, Welffens-Ekra C, Dabis F. Operational issues in preventing mother-to-child transmission of HIV-1 in Abidjan, Cote d’Ivoire, 1998–99. Bull World Health Organ. 2001;79:641–7.
World Health Organisation. Coverage of selected health services for HIV/AIDS prevention and care in less developed countries in 2001. http://whqlibdoc.who.int/publications/9241590319.pdf. In: Geneva, Switzerland: World Health Organisation; 2002.
Amico P, Aran C, Avila C. HIV spending as a share of total health expenditure: an analysis of regional variation in a multi-country study. PLoS ONE. 2010;5:e12997. doi:12910.11371/journal.pone.0012997.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Science+Business Media New York
About this chapter
Cite this chapter
Abdool Karim, S., Baxter, C. (2014). Translating Pre-Exposure Prophylaxis Evidence into Practice and Public Health Impact. In: Eaton, L., Kalichman, S. (eds) Biomedical Advances in HIV Prevention. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8845-3_2
Download citation
DOI: https://doi.org/10.1007/978-1-4614-8845-3_2
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-8844-6
Online ISBN: 978-1-4614-8845-3
eBook Packages: MedicineMedicine (R0)