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Review

Combining biomedical preventions for HIV: Vaccines with pre-exposure prophylaxis, microbicides or other HIV preventions

Pages 3202-3211 | Received 23 Mar 2016, Accepted 28 Aug 2016, Published online: 28 Sep 2016

References

  • UNAIDS fact sheet. http://www.unaids.org/sites/default/files/media_asset/20150901_FactSheet_2015_en.pdf
  • CDC HIV/AIDS statistics. http://www.cdc.gov/hiv/statistics/overview/ataglance.html
  • CDC news release. http://www.cdc.gov/nchhstp/newsroom/2016/croi-2016.html
  • Gray GE, Laher F, Doherty T, Abdool Karim S, Hammer S, Mascola J, Beyrer C, Corey L. Which new health technologies do we need to achieve an end to HIV/AIDS? PLoS Biol 2016; 14:e1002372; PMID:26933962; http://dx.doi.org/10.1371/journal.pbio.1002372
  • Grant R, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapía M, Guanira-Carranza JV, Ramirez-Cardich ME, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010; 363:2587-99; PMID:21091279; http://dx.doi.org/10.1056/NEJMoa1011205
  • Thigpen M, Kebaabetswe P, Paxton L, Smith D, Rose C, Segolodi T, Henderson F, Pathak S, Soud F, Chillag K, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012; 367:423-34; PMID:22784038; http://dx.doi.org/10.1056/NEJMoa1110711
  • Baeten J, Donnell D, Ndase P, Mugo N, Campbell J, Wangisi J, Tappero J, Bukusi E, Cohen C, Katabira E, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 367:399-410; PMID:22784037; http://dx.doi.org/10.1056/NEJMoa1108524
  • Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, 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; 381:2083-90; PMID:23769234; http://dx.doi.org/10.1016/S0140-6736(13)61127-7
  • McCormack S, Dunn D, Desai M, Dolling D, Gafos M, Gilson R, Sullivan A, Clarke A, Reeves I, Schembri G, 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 randomised trial. Lancet 2015; 387:53-60; PMID:26364263; http://dx.doi.org/10.1016/S0140-6736(15)00056-2
  • Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A and the ANRS IPERGAY Study Group. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med 2015; 373:2237-46; PMID:26624850; http://dx.doi.org/10.1056/NEJMoa1506273
  • Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012; 367:411-22; PMID:22784040; http://dx.doi.org/10.1056/NEJMoa1202614
  • Marrazzo J, Ramjee G, Richardson B, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van der Straten A, Noguchi L, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 2015; 372:509-18; PMID:25651245; http://dx.doi.org/10.1056/NEJMoa1402269
  • FDA. FDA approves first drug for reducing the risk of sexually acquired HIV infection. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm
  • CDC PrEP guidelines. http://www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf
  • WHO HIV guidelines. http://www.who.int/hiv/pub/guidelines/keypopulations/en/
  • CDC media release. http://www.cdc.gov/nchhstp/newsroom/2016/croi-2016.html
  • Abdool Karim Q, Abdool Karim S, Frohlich J, Grobler A, Baxter C, Mansoor L, Kharsany A, Sibeko S, Mlisana K, Omar Z, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 329:1168-74.; http://dx.doi.org/10.1126/science.1193748
  • Rees H, Delany-Moretlwe S, Lombard C, Baron D, Panchia R, Myer L, Schwartz J, Doncel GF, Gray G. FACTS 001 Phase III trial of periocoital tenofovir 1% gel for HIV prevention in women. Conference on Retroviruses and Opportunistic infections 2015, Seattle, WA.
  • Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM, Matovu Kiweewa F, Nair G, Mhlanga F, et al. and MTN-020–ASPIRE Study Team. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med 2016; [epub ahead of print]; http://dx.doi.org/10.1056/NEJMoa1506110
  • Nel A, Kapiga S, Bekker LG, Devlin B, Borremans M, Rosenberg Z, for the IPM 027/Ring Study Research Center Teams. Safety and efficacy of dapivirine vaginal ring for HIV-1 prevention in African women. Conference on Retroviruses and Opportunistic infections 2016, Boston. LB 110
  • Harmon T, Fisher K, McGlynn M, Stover J, Warren M, Teng Y, Näveke A. Exploring the potential health impact and cost-effectiveness of AIDS vaccine within a comprehensive HIV/AIDS response in low- and middle-income countries. PLos One 2016; 11:e0146387; PMID:26731116; http://dx.doi.org/10.1371/journal.pone.0146387
  • Barouch DH, Michael NL. Accelerating HIV-1 vaccine efficacy trials. Cell 2014; 159:969-72; PMID:25416935; http://dx.doi.org/10.1016/j.cell.2014.10.046
  • Excler JL, Robb ML, Kim JH. Prospects for a globally effective HIV-1 vaccine. Am J Prev Med 2015; 49:S307-18; PMID:26590431; http://dx.doi.org/10.1016/j.amepre.2015.09.004
  • Sheets R, Zhou T, I K. Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: A review from a regulatory perspective. Biologicals 2015; 44:73-89; PMID:26776940; http://dx.doi.org/10.1016/j.biologicals.2015.10.004
  • Pitisuttithum P, Gilbert P, Gurwith M, Heyward W, Martin M, van Griensven F, Hu D, Tappero JW, Choopanya K. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. Infect Dis 2006; 194:1661-71; http://dx.doi.org/10.1086/508748
  • Flynn NM, Forthal DN, Harro CD, Judson FN, Mayer KH, Para MF. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis 2005; 191:654-65; PMID:15688278; http://dx.doi.org/10.1086/428404
  • Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 2008; 372:1881-93; PMID:19012954; http://dx.doi.org/10.1016/S0140-6736(08)61591-3
  • Gray GE, Allen M, Moodie Z, Churchyard G, Bekker LG, Nchabeleng M, Mlisana K, Metch B, de Bruyn G, Latka MH, et al. Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study. Lancet Infect Dis 2011; 11:507-15; PMID:21570355; http://dx.doi.org/10.1016/S1473-3099(11)70098-6
  • Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, et al. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med 2013; 369:2083-92; PMID:24099601; http://dx.doi.org/10.1056/NEJMoa1310566
  • Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med 2009; 361:2209-20; PMID:19843557; http://dx.doi.org/10.1056/NEJMoa0908492
  • Gilbert PB, Berger JO, Stablein B, Becker S, Essex M, Hammer SM, Kim JM, DeGruttola VG. Statistical interpretation of the RV144 HIV vaccine efficacy trial in Thailand: A case study for statistical issues in efficacy trials. J Infect Dis 2011; 203:969-75; PMID:21402548; http://dx.doi.org/10.1093/infdis/jiq152
  • Kim JH, Excler JL, Michael NL. Lessons from the RV144 Thai phase III HIV-1 vaccine trial. Ann Rev Med 2015; 66:1275-1286.
  • Haynes BF, Gilbert PB, McElrath MJ, Zolla-Pazner S, Tomaras GD, Alam SM, Evans DT, Montefiori DC, Karnasuta C, Sutthent R, et al. Immune-correlates analysis of an HIV-1 vaccine efficacy trial. N Engl J Med 2012; 366:1275-86; PMID:22475592; http://dx.doi.org/10.1056/NEJMoa1113425
  • Corey L, Gilbert PB, Tomaras GD, Haynes BF, Pantaleo G, Fauci AS. Immune correlates of vaccine protection against HIV-1 acquisition. Sci Transl Med 2015; 310rv7:1-10
  • Sheets R, Zhou T, Knezevic I. Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective. Biologicals 2015; 44:90-110; PMID:26732973; http://dx.doi.org/10.1016/j.biologicals.2015.11.003
  • AIDS Vaccine Advocacy Coalition. http://www.avac.org/trial/hvtn-702
  • HIV Prevention Trial Network. http://www.hptn.org/research_studies
  • Huang Y, DiazGranados C, Janes H, Huang Y, deCamp AC, Metch B, Grant S, Sanchez B, Phogat S, Koutsoukos M, et al. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial. Curr Opin Virol 2016; 17:57-65; PMID:26827165; http://dx.doi.org/10.1016/j.coviro.2016.01.007
  • Excler J, Rida W, Priddy F, Gilmour J, McDermott A, Kamali A, Anzala O, Mutua G, Sanders E, Koff W, et al. AIDS vaccines and preexposure prophylaxis: is synergy possible? AIDS Res Hum Retroviruses 2011; 27:669-80; PMID:21043994; http://dx.doi.org/10.1089/aid.2010.0206
  • Janes H, Gilbert P, Buchbinder S, et al. In pursuit of an HIV vaccine: designing efficacy trials in the context of partially effective non vaccine prevention modalities. AIDS Res Hum Retroviruses 2013; 11:1513-23; http://dx.doi.org/10.1089/aid.2012.0385
  • Veazey RS. Animal models for microbicide safety and efficacy testing. Curr Opin HIV AIDS 2013; 8:295-303; PMID:23698560
  • Pegu P, Vaccari M, Gordon S, Keele B, Doster M, Guan Y, Ferrari G, Pal R, Ferrari M, Whitney S, et al. Antibodies with high avidity to the gp120 envelope protein in protection from simian immunodeficiency virus SIV(mac251) acquisition in an immunization regimen that mimics the RV-144 Thai trial. J Virol 2013; 87:1708-19; PMID:23175374; http://dx.doi.org/10.1128/JVI.02544-12
  • Cheng-Mayer C, Huang Y, Gettie A, Tsai L, Ren W, Shakirzyanova M, Sina S, Trunova N, Blanchard J, Jenkins L, et al. Delay of simian human immunodeficiency virus infection and control of viral replication in vaccinated macaques challenged in the presence of a topical microbicide. AIDS 2011; 25:1833-41; PMID:21750420; http://dx.doi.org/10.1097/QAD.0b013e32834a1d94
  • Barouch DH, Klasse PJ, Dufour J, Veazey RS, Moore JP. Macaque studies of vaccine and microbicide combinations for preventing HIV-1 sexual transmission. Proc Natl Acad Sci U S A 2012; 109:8694-8; PMID:22586094; http://dx.doi.org/10.1073/pnas.1203183109
  • LeGrand R, Bosquet N, Dispinseri S, Hopewel N, Gosse L, Desjardins D, Shen X, Tolazzi M, Ochsenbauer C, Saidi H, et al. Microbicide-vaccine combination provides significant protection against vaginal SHIV 162P3 challenge in cynomolgous monkeys. HIV Research for Prevention Conference, Durban, SA, October 2014. Abstract A08.06 LB.
  • Baggaley R, Dimitrov D, Owen B, Pickles M, Butler A, Masse B, Boily M. Heterosexual anal intercourse: a neglected risk factor for HIV? Am J Reprod Immunol 2013; 69:95-105; PMID:23279040; http://dx.doi.org/10.1111/aji.12064
  • Ross TM, Pereira LE, Luckay A, McNicholl JM, García-Lerma JG, Heneine W, Eugene HS, Pierce-Paul BR, Zhang J, Hendry RM, Smith JM. A polyvalent clade B VLP HIV vaccine combined with partially protective Truvada pre-exposure prophylaxis prevents SHIV infection in macaques and primes for virus-amplified immunity. AIDS Res Hum Retroviruses 2014; 30:1072-81; PMID:24914761; http://dx.doi.org/10.1089/aid.2014.0030
  • McBurney S, Landucci G, Forthal D, Ross T. Evaluation of heterologous vaginal SHIV SF162p4 infection following vaccination with a polyvalent Clade B virus-like particle vaccine. AIDS Res Hum Retroviruses 2012; 28:1063-72; PMID:22214267
  • García-Lerma J, Cong M, Mitchell J, Youngpairoj A, Zheng Q, Masciotra S, Martin A, Kuklenyik Z, Holder A, Lipscomb J, et al. Intermittent prophylaxis with oral truvada protects macaques from rectal SHIV infection. Sci Transl Med 2010; 2:14ra4
  • HPTN 083 trial. http://www.hptn.org/research_studies/hptn083.asp
  • García-Lerma J, Aung W, Cong M, Zheng Q, Youngpairoj A, Mitchell J, Holder A, Martin A, Kuklenyik S, Luo W, et al. Natural substrate concentrations can modulate the prophylactic efficacy of nucleotide HIV reverse transcriptase inhibitors. J Virol 2011; 85:6610-7; http://dx.doi.org/10.1128/JVI.00311-11
  • Melchjorsen J, Risør MW, Søgaard OS, O'Loughlin KL, Chow S, Paludan SR, Ellermann-Eriksen S, Hedley DW, Minderman H, Østergaard L, Tolstrup M. Tenofovir selectively regulates production of inflammatory cytokines and shifts the IL-12/IL-10 balance in human primary cells. J Acquir Immune Defic Syndr 2011; 57:265-75; PMID:21471820; http://dx.doi.org/10.1097/QAI.0b013e3182185276
  • NIH news release. http://www.niaid.nih.gov/news/newsreleases/2016/Pages/HOPE-trial.aspx
  • Initiative for Multipurpose Prevention Technology. http://mpts101.org
  • Karim SSA. HIV pre-exposure prophylaxis in injecting drug users. Lancet 2013; 381(9883):2060–2062; http://dx.doi.org/10.1016/S0140-6736(13)61140-X