Pre-exposure prophylaxis for HIV infection: how antiretroviral pharmacology helps to monitor and improve adherence

Bibliography

• FDA. 2012. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm [Accessed 12 March 2013]
   Google Scholar
• 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(5996):1168-74
   PubMed Web of Science ®Google Scholar
• 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(27):2587-99
   PubMed Web of Science ®Google Scholar
• Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012;367(5):399-410
   PubMed Web of Science ®Google Scholar
• Thigpen MC, Kebaabetswe PM, Paxton LA, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012;367(5):423-34
   PubMed Web of Science ®Google Scholar
• Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med 2012;367(5):411-22
   PubMed Web of Science ®Google Scholar
• 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 study (MTN 003) [Paper#26LB]. Paper presented at: 20th Conference on Retroviruses and Opportunistic Infections; Atlanta, GA; 2013
   Google Scholar
• Robbins BL, Srinivas RV, Kim C, et al. Anti-human immunodeficiency virus activity and cellular metabolism of a potential prodrug of the acyclic nucleoside phosphonate 9-R-(2-phosphonomethoxypropyl)adenine (PMPA), Bis(isopropyloxymethylcarbonyl)PMPA. Antimicrob Agents Chemother 1998;42(3):612-17
   PubMed Web of Science ®Google Scholar
• Wang LH, Begley J, St Claire RL, et al. Pharmacokinetic and pharmacodynamic characteristics of emtricitabine support its once daily dosing for the treatment of HIV infection. AIDS Res Hum Retroviruses 2004;20(11):1173-82
   PubMed Web of Science ®Google Scholar
• Taburet AM, Paci-Bonaventure S, Peytavin G, Molina JM. Once-daily administration of antiretrovirals: pharmacokinetics of emerging therapies. Clin Pharmacokinet 2003;42(14):1179-91
   Google Scholar
• Gallant JE, Staszewski S, Pozniak AL, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA 2004;292(2):191-201
   PubMed Web of Science ®Google Scholar
• Saag MS, Cahn P, Raffi F, et al. Efficacy and safety of emtricitabine vs stavudine in combination therapy in antiretroviral-naive patients: a randomized trial. JAMA 2004;292(2):180-9
   PubMed Web of Science ®Google Scholar
• Hawkins T, Veikley W, St Claire RL, et al. Intracellular pharmacokinetics of tenofovir diphosphate, carbovir triphosphate, and lamivudine triphosphate in patients receiving triple-nucleoside regimens. J Acquir Immune Defic Syndr (1999) 2005;39(4):406-11
   PubMed Web of Science ®Google Scholar
• 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(2):e28
   PubMed Web of Science ®Google Scholar
• Van Rompay KK, Berardi CJ, Aguirre NL, et al. Two doses of PMPA protect newborn macaques against oral simian immunodeficiency virus infection. AIDS (London, England) 1998;12(9):F79-83
   PubMed Web of Science ®Google Scholar
• Louissaint NA, Nimmagadda S, Fuchs EJ, et al. Distribution of cell-free and cell-associated HIV surrogates in the colon after simulated receptive anal intercourse in men who have sex with men. J Acquir Immune Defic Syndr (1999) 2012;59(1):10-17
   PubMed Web of Science ®Google Scholar
• Louissaint NA, Fuchs EJ, Bakshi RP, et al. Distribution of cell-free and cell-associated HIV surrogates in the female genital tract after simulated vaginal intercourse. J Infect Dis 2012;205(5):725-32
   Google Scholar
• Hendrix CW, Chen BA, Guddera V, et al. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PloS One 2013;8(1):e55013
   PubMed Web of Science ®Google Scholar
• Karim SS, Kashuba AD, Werner L, Karim QA. Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women. Lancet 2011;378(9787):279-81
   PubMed Web of Science ®Google Scholar
• Anton P, Cranston R, Carballo-Dieguez A, et al. RMP-02/MTN-006: a phase 1 placebo-controlled trial of rectally applied 1% vaginal TFV gel with comparison to oral TDF [Paper #34LB]. Paper presented at: 18th Conference on Retroviruses and Opportunistic Infections; Boston, MA; 2011
   Google Scholar
• Patterson KB, Prince HA, Kraft E, et al. Penetration of tenofovir and emtricitabine in mucosal tissues: implications for prevention of HIV-1 transmission. Sci Transl Med 2011;3(112):112re114
   Web of Science ®Google Scholar
• Anderson PL, Kiser JJ, Gardner EM, et al. Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection. J Antimicrob Chemother 2011;66(2):240-50
   PubMed Web of Science ®Google Scholar
• Dumond JB, Patterson KB, Pecha AL, et al. Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women. J Acquir Immune Defic Syndr (1999) 2009;51(5):546-53
   PubMed Web of Science ®Google Scholar
• Brown KC, Patterson KB, Malone SA, et al. Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men. J Infect Dis 2011;203(10):1484-90
   PubMed Web of Science ®Google Scholar
• Roche M, Jakobsen MR, Sterjovski J, et al. HIV-1 escape from the CCR5 antagonist maraviroc associated with an altered and less-efficient mechanism of gp120-CCR5 engagement that attenuates macrophage tropism. J Virol 2011;85(9):4330-42
   Google Scholar
• HIV Prevention Trials Network (HPTN). HPTN 069: Phase II randomized, double-blind, study of safety and tolerability of maraviroc, maraviroc + emtricitabine, maraviroc + tenofovir or tenofovir + emtricitabine for preexposure prophylaxis to prevent HIV transmission in at-risk men who have sex with men. Available at: http://www.hptn.org/research_studies/hptn069.asp. [Accessed 15 May 2013]
   Google Scholar
• Baert L, van 't Klooster G, Dries W, et al. Development of a long-acting injectable formulation with nanoparticles of rilpivirine (TMC278) for HIV treatment. Eur J Pharm Biopharm 2009;72(3):502-8
   PubMed Web of Science ®Google Scholar
• Else L, Jackson A, Tjia J, et al. Pharmacokinetics of long-acting rilpivirine in plasma, genital tract and rectum of HIV-negative females and males administered a single 600 mg dose. Paper presented at: 13th International Workshop on Clinical Pharmacology of HIV Therapy; Barcelona, Spain; 2012; O_12
   Google Scholar
• GlaxoSmithKline. A single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects. Available from: http://clinicaltrials.gov/ct2/show/NCT01215006 [Accessed 26 March 2013]
   Google Scholar
• Min S, DeJesus E, McCurdy L, et al. Pharmacokinetics (PK) and safety in healthy and HIV-infected subjects and short-term antiviral efficacy of S/GSK1265744, a next generation once daily HIV integrase inhibitor. 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; San Francisco; 2009. p. CA H-1228
   Google Scholar
• Spreen E, Ford S, Chen S, et al. Pharmacokinetics, safety, tolerability of the HIV integrase inhibitor S/GSK1265744 long acting parenteral nanosuspension following single dose administration to healthy adults XIX. International AIDS Conference; Washington, DC; 2012. p. TUPE040
   Google Scholar
• Andrews C, Gettie A, Russell-Lodrigues K. Long-acting parenteral formulation of GSK1265744 protects macaques against repeated intrarectal challenges with SHIV [abstract 24LB]. Paper presented at: 20th Conference on Retroviruses and Opportunistic Infections; Atlanta, GA; 2013
   Google Scholar
• Jacobson JM, Kuritzkes DR, Godofsky E, et al. Safety, pharmacokinetics, and antiretroviral activity of multiple doses of ibalizumab (formerly TNX-355), an anti-CD4 monoclonal antibody, in human immunodeficiency virus type 1-infected adults. Antimicrob Agents Chemother 2009;53(2):450-7
   PubMed Web of Science ®Google Scholar
• International Partnership for Microbicides, Inc. Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women (ASPIRE). Available from: http:/http://clinicaltrials.gov/show/NCT01617096 [Accessed 8 April 2013]
   Google Scholar
• Smith J, Rastogi R, Teller R, et al. A tenofovir disoproxil fumarate intravaginal ring completely protects against repeated SHIV vaginal challenge in nonhuman primates [abstract 25LB]. Paper presented at: 20th Conference on Retrovirals and Opportunistic Infections; Atlanta, GA; 2013
   Google Scholar
• Lucas GM, Mullen BA, Weidle PJ, et al. Directly administered antiretroviral therapy in methadone clinics is associated with improved HIV treatment outcomes, compared with outcomes among concurrent comparison groups. Clin Infect Dis 2006;42(11):1628-35
   PubMed Web of Science ®Google Scholar
• Altice FL, Maru DS, Bruce RD, et al. Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial. Clin Infect Dis 2007;45(6):770-8
   PubMed Web of Science ®Google Scholar
• Kirkland LR, Fischl MA, Tashima KT, et al. Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment. Clin Infect Dis 2002;34(4):511-18
   PubMed Web of Science ®Google Scholar
• Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care 2000;12(3):255-66
   PubMed Web of Science ®Google Scholar
• Amico KR, Fisher WA, Cornman DH, et al. Visual analog scale of ART adherence: association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr 2006;42(4):455-9
   PubMed Web of Science ®Google Scholar
• Oyugi JH, Byakika-Tusiime J, Charlebois ED, et al. Multiple validated measures of adherence indicate high levels of adherence to generic HIV antiretroviral therapy in a resource-limited setting. J Acquir Immune Defic Syndr 2004;36(5):1100-2
   PubMed Web of Science ®Google Scholar
• Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS (London, England) 2002;16(2):269-77
   PubMed Web of Science ®Google Scholar
• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24(1):67-74
   PubMed Web of Science ®Google Scholar
• Berg KM, Wilson IB, Li X, Arnsten JH. Comparison of antiretroviral adherence questions. AIDS Behav 2012;16(2):461-8
   PubMed Web of Science ®Google Scholar
• Vanhove GF, Schapiro JM, Winters MA, et al. Patient compliance and drug failure in protease inhibitor monotherapy. JAMA 1996;276(24):1955-6
   PubMed Web of Science ®Google Scholar
• Belknap R, Weis S, Brookens A, et al. Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy. PLoS One 2013;8(1):e53373
   PubMed Web of Science ®Google Scholar
• Emtriva R [Package insert]. Gilead Sciences, Inc., Foster City, CA: 2012
   Google Scholar
• Viread R [Package insert]. Gilead Sciences, Inc., Foster City, CA: 2012
   Google Scholar
• Back DJ, Burger DM, Flexner CW, Gerber JG. The pharmacology of antiretroviral nucleoside and nucleotide reverse transcriptase inhibitors: implications for once-daily dosing. J Acquir Immune Defic Syndr 2005;39(Suppl 1):S1-23; quiz S24-25
   PubMed Web of Science ®Google Scholar
• Mannheimer S, Friedland G, Matts J, et al. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clin Infect Dis 2002;34(8):1115-21
   PubMed Web of Science ®Google Scholar
• Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther Drug Monit 2009;31(3):327-36
   PubMed Web of Science ®Google Scholar
• Koal T, Burhenne H, Romling R, et al. Quantification of antiretroviral drugs in dried blood spot samples by means of liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom 2005;19(21):2995-3001
   PubMed Web of Science ®Google Scholar
• Meesters RJ, van Kampen JJ, Reedijk ML, et al. Ultrafast and high-throughput mass spectrometric assay for therapeutic drug monitoring of antiretroviral drugs in pediatric HIV-1 infection applying dried blood spots. Anal Bioanal Chem 2010;398(1):319-28
   PubMed Web of Science ®Google Scholar
• Kromdijk W, Mulder JW, Rosing H, et al. Use of dried blood spots for the determination of plasma concentrations of nevirapine and efavirenz. J Antimicrob Chemother 2012;67(5):1211-16
   PubMed Web of Science ®Google Scholar
• Anderson P, Liu A, Buchbinder S, et al. Intracellular tenofovir-DP concentrations associated with PrEP efficacy in MSM from iPrEx. Paper presented at: Nineteenth Conference on Retroviruses and Opportunistic Infections; Seattle, WA; 2012; #31:B
   Google Scholar
• California Collaborative Treatment, Group. CCTG 595: text messaging intervention to improve adherence to PrEP in high-risk MSM. 2013. Available from: http://clinicaltrials.gov/show/NCT01761643 [Accessed 8 April 2013]
   Google Scholar
• Castillo-Mancilla JR, Zheng JH, Rower JE, et al. Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure. AIDS Res Hum Retroviruses 2013;29(2):384-90
   PubMed Web of Science ®Google Scholar
• Liu A, Gandhi M, Bacchetti P, et al. Validating hair as a biological marker of TFV drug exposure in HIV PrEP [Paper # 995]. Paper presented at: 18th Conference on Retroviruses and Opportunistic Infections; Boston, MA; 2011
   Google Scholar
• Adams JL, Sykes C, Menezes P, et al. Tenofovir diphosphate and emtricitabine triphosphate concentrations in blood cells compared with isolated peripheral blood mononuclear cells: a new measure of antiretroviral adherence? J Acquir Immune Defic Syndr 2013; Epub ahead of print
   Google Scholar
• Morey TE, Wasdo S, Wishin J, et al. Feasibility of a breath test for monitoring adherence to vaginal administration of antiretroviral microbicide gels. J Clin Pharmacol 2013;53(1):103-11
   PubMed Web of Science ®Google Scholar
• Van Damme L CA, Ahmed K, et al. The FEM-PrEP trial of emtricitabine/tenofovir disoproxil fumarate (Truvada) among African women. 19th Conference on Retroviruses and Opportunistic Infections; Seattle, WA; 2012
   Google Scholar