Defining success with HIV pre-exposure prophylaxis: A prevention-effective adherence paradigm

AIDS

Volumn 29, Issue 11, 2015, Pages 1277-1285

  Haberera, Jessica E ^a,b   Bangsberga, David R ^a,b   Baetenc, Jared M ^c   Currane, Kathryn ^d   Koechline, Florence ^d   Amicof, K Rivet ^e   Andersong, Peter ^f   Mugoc, Nelly ^c,g   Venteri, Francois ^h   Goicocheaj, Pedro ^i,j   Caceresk, Carlos ^j,k   O'Reillye, Kevin ^d  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

^e UNIVERSITY OF MICHIGAN   (United States)

^f UNIVERSITY OF COLORADO   (United States)

^g KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^h UNIVERSITY OF THE WITWATERSRAND   (South Africa)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j Network for Multidisciplinary Studies in ARV Based HIV Prevention (NEMUS)   (Peru)

^k UNIVERSIDAD PERUANA CAYETANO HEREDIA   (Peru)

more..

Author keywords

adherence; pre exposure prophylaxis

Indexed keywords

EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; TENOFOVIR; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT;

BEHAVIOR MODIFICATION; CLINICAL TRIAL (TOPIC); CONDOM USE; COUNSELING; DRUG BLOOD LEVEL; DRUG EFFICACY; FAMILY PLANNING; HEALTH PROGRAM; HIV TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RISK; MEDICATION COMPLIANCE; NOTE; PRACTICE GUIDELINE; PRE-EXPOSURE PROPHYLAXIS; PRIORITY JOURNAL; HIV INFECTIONS; MALE; PROCEDURES; PUBLIC HEALTH; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANTI-HIV AGENTS; HIV INFECTIONS; HUMANS; MALE; MEDICATION ADHERENCE; PRE-EXPOSURE PROPHYLAXIS; PUBLIC HEALTH; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84941588211     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000647     Document Type: Note

References (49)

1. 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.
2. 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; 381:2083-2090.
3. 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; 363:2587-2599.
4. Marazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito Taljaard M, et al. Preexposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the VOICE study (MTN 003). In 20th Conference on Retroviruses and Opportunistic Infections. Oral Abstract 26LB. Atlanta, Georgia; March 2013.
5. 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; 367:423-434.
6. 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; 367:411-422.
7. Amico KR, Stirratt MJ. Adherence to preexposure prophylaxis: current, emerging, and anticipated bases of evidence. Clin Infect Dis 2014; 59 (Suppl 1):S55-S60.
8. van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of preexposure prophylaxis trials for HIV prevention. AIDS 2012; 26:F13-19.
9. Grant R, Anderson P, McMahan V, Liu A, Amico KR, Mehrotra M, et al. Results of the iPrEx open-label extension (iPrEx OLE) in men and transgender women who have sex with men: PrEP uptake, sexual practices, and HIV incidence. Lancet Infect Dis 2014; 14:820-829.
10. Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, 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.
11. Volberding PA, Deeks SG. Antiretroviral therapy and management of HIV infection. Lancet 2010; 376:49-62.
12. Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000; 133:21-30.
13. Shuter J, Sarlo JA, Kanmaz TJ, Rode RA, Zingman BS. HIVinfected patients receiving lopinavir/ritonavir-based antiretroviral therapy achieve high rates of virologic suppression despite adherence rates less than 95%. J Acquir Immune Defic Syndr 2007; 45:4-8.
14. Bangsberg DR. Less than 95% adherence to nonnucleoside reverse-transcriptase inhibitor therapy can lead to viral suppression. Clin Infect Dis 2006; 43:939-941.
15. Lima VD, Bangsberg DR, Harrigan PR, Deeks SG, Yip B, Hogg RS, et al. Risk of viral failure declines with duration of suppression on highly active antiretroviral therapy irrespective of adherence level. J Acquir Immune Defic Syndr 2010; 55: 460-465.
16. Rosenblum M, Deeks SG, van der Laan M, Bangsberg DR. The risk of virologic failure decreases with duration of HIV suppression, at greater than 50% adherence to antiretroviral therapy. PLoS One 2009; 4:e7196.
17. Hogg RS, Heath K, Bangsberg D, Yip B, Press N, O'Shaughnessy MV, et al. Intermittent use of triple-combination therapy is predictive of mortality at baseline and after 1 year of follow-up. AIDS 2002; 16:1051-1058.
18. Dybul M, Nies-Kraske E, Daucher M, Hertogs K, Hallahan CW, Csako G, et al. Long-cycle structured intermittent versus continuous highly active antiretroviral therapy for the treatment of chronic infection with human immunodeficiency virus: effects on drug toxicity and on immunologic and virologic parameters. J Infect Dis 2003; 188:388-396.
19. World Health Organization. Guidance on oral preexposure prophylaxis (PrEP) for serodiscordant couples, men and transgender womenwho have sex withmen at high risk of HIV: recommendations for use in the context of demonstration projects. July 2012.http://www.who.int/hiv/pub/guidance-prep/en/.
20. U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States: 2014, a clinical practice guideline. May 2014. www.cdc.gov/hiv/pdf/prepgui delines2014.pdf.
21. Gomez GB, Borquez A, Case KK, Wheelock A, Vassall A, Hankins C. The cost and impact of scaling up preexposure prophylaxis for HIV prevention: a systematic review of cost-effectiveness modelling studies. PLoS Med 2013; 10: e1001401.
22. Corneli AL, McKenna K, Headley J, Ahmed K, Odhiambo J, Skhosana J, et al. A descriptive analysis of perceptions of HIV risk and worry about acquiring HIV among FEM-PrEP participants who seroconverted in Bondo, Kenya, and Pretoria, South Africa. J Int AIDS Soc 2014; 17:19152.
23. Wilson IB, Carter AE, Berg KM. Improving the self-report of HIV antiretroviral medication adherence: is the glass half full or half empty? Curr HIV/AIDS Rep 2009; 6:177-186.
24. Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, et al. Optimal recall period and response task for selfreported HIV medication adherence. AIDS Behav 2008; 12:86-94.
25. Haberer JE, Baeten J, Heffron R, Mugo N, Katabira E, Ngure K, et al. Self-reported adherence to pre-exposure prophylaxis (PrEP) and sexual behavior by text messaging: preliminary findings from the partners mobile adherence to PrEP study. In 9th International Conference on HIV Treatment and Prevention Adherence. Poster 316. Miami, Florida; June 2014.
26. Minnis AM, Steiner MJ, Gallo MF, Warner L, Hobbs MM, van der Straten A, et al. Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe. Am J Epidemiol 2009; 170:918-924.
27. Gallo MF, Behets FM, Steiner MJ, Hobbs MM, Hoke TH, Van Damme K, et al. Prostate-specific antigen to ascertain reliability of self-reported coital exposure to semen. Sex Transm Dis 2006; 33:476-479.
28. Williams AB, Amico KR, Bova C, Womack JA. A proposal for quality standards for measuring medication adherence in research. AIDS Behav 2013; 17:284-297.
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. Amico KR, Marcus JL, McMahan V, Liu A, Koester KA, Goicochea P, et al. Study product adherence measurement in the iPrEx placebo-controlled trial: concordance with drug detection. J Acquir Immune Defic Syndr 2014; 66:530-537.
31. Bisson GP, Gross R, Bellamy S, Chittams J, Hislop M, Regensberg L, et al. Pharmacy refill adherence compared with CD4 count changes for monitoring HIV-infected adults on antiretroviral therapy. PLoS Med 2008; 5:e109.
32. Haberer JE, Kahane J, Kigozi I, Emenyonu N, Hunt P, Martin J, et al. Real-time adherence monitoring for HIV antiretroviral therapy. AIDS Behav 2010; 14:1340-1346.
33. Haberer JE, Kiwanuka J, Nansera D, Muzoora C, Hunt PW, So J, et al. Realtime adherence monitoring of antiretroviral therapy among HIV-infected adults and children in rural Uganda. AIDS 2013; 27:2166-2168.
34. Matthews LT, Baeten JM, Celum C, Bangsberg DR. Periconception preexposure prophylaxis to prevent HIV transmission: benefits, risks, and challenges to implementation. AIDS 2010; 24:1975-1982.
35. Kibengo FM, Ruzagira E, Katende D, Bwanika AN, Bahemuka U, Haberer JE, et al. Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV preexposure prophylaxis (PrEP) among HIVuninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial. PLoS One 2013; 8:e74314.
36. Mutua G, Sanders E, Mugo P, Anzala O, Haberer JE, Bangsberg D, et al. Safety and adherence to intermittent preexposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers. PLoS One 2012; 7:e33103.
37. ANRS Press Release. A drug taken at the time of sexual intercourse effectively reduces the risk of infection. October 2014. http://www.ipergay.fr.
38. Ngure KHR, Mugo N, Irungu E, Njambi Njuguna N, Mwaniki L, Thompson K, et al. Uptake of HIV self-testing among people receiving PrEP in Kenya. In HIV Research for Prevention. Oral abstract OA27.02. Cape Town, South Africa; October 2014.
39. Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, et al. Emtricitabine-tenofovir concentrations and preexposure prophylaxis efficacy in men who have sex with men. Sci Transl Med 2012; 4:151-125.
40. Hendrix CW, Andrade A, Kashuba AD, Marzinke M, Anderson PL, Moore A, et al. Tenofovir-emtricitabine directly observed dosing: 100% adherence concentrations (HPTN 066). In Conference on Retorviruses and Opportunistic Infections. Abstract 014. Boston, Massachusetts; March 2014.
41. Louissaint NA, Cao YJ, 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 Retroviruses 2013; 29:1443-1450.
42. Anderson PL, Meditz A, Zheng JH, Predhomme J, Klein B, Guida LA, et al. Cellular pharmacology of tenofovir and emtricitabine in blood, rectal, and cervical cells from HIV-negative volunteers. In Abstracts of the Nineteenth Conference on Retroviruses and Opportunistic Infections, Seattle, WA, 2012. Abstract 587. Foundation for Retrovirology and Human Health, Alexandria, Virginia, USA.
43. 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; 3:112-114.
44. U.S. Public Health Service Working Group: Kuhar DT, Henderson DK, Struble KA, Heneine W, Thomas V, Cheever LW, et al. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. InUSPublicHealth ServiceGuidelines for the Management of Occupational Exposures to HIV. September 2013. http://stacks.cdc.gov/view/cdc/20711.
45. Myers JE, Sepkowitz KA. A pill for HIV prevention: deja vu all over again? Clin Infect Dis 2013; 56:1604-1612.
46. Matteson PS, Hawkins JW. Women's patterns of contraceptive use. Healthcare Women Int 1997; 18:455-466.
47. Amico KR, McMahan V, Marcus J, Goicochea P, Vargas L, Grant R, et al. Integrated next step counseling (iNSC): a discussion based sexual health promotion conversation to support men who have sex with men using PrEP in the iPrEx open label extension. In 7th Annual HIV Treatment and Prevention Adherence Conference of the International Association of Providers in AIDS Care. Abstract 80467. Miami, Florida; June 2012.
48. Katz IT, Ware NC, Gray G, Haberer JE, Mellins CA, Bangsberg DR. Scaling up human papillomavirus vaccination: a conceptual framework of vaccine adherence. Sex Health 2010; 7:279-286.
49. Buchbinder SP, Glidden DV, Liu AY, McMahan V, Guanira JV, Mayer KH, et al. HIV preexposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial. Lancet Infect Dis 2014; 14:468-475.