Promising prevention approaches: Tenofovir gel and prophylactic use of antiretroviral medications

Current HIV/AIDS Reports

Volumn 8, Issue 4, 2011, Pages 241-248

  Krakower, Douglas ^a   Mayer, Kenneth H ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Anti HIV agents; Chemoprevention; Clinical trial; Gels; HIV; HIV infections prevention and control; Primary prevention; Reverse transcriptase inhibitors; Unsafe sex

Indexed keywords

ABACAVIR; ANTIRETROVIRUS AGENT; EMTRICITABINE; LAMIVUDINE; MARAVIROC; NEVIRAPINE; PLACEBO; TENOFOVIR; ZIDOVUDINE;

ARTICLE; BONE METABOLISM; CLINICAL TRIAL (TOPIC); DIARRHEA; DRUG DOSAGE FORM COMPARISON; GASTROINTESTINAL INFECTION; GEL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KIDNEY DISEASE; SIDE EFFECT; SINGLE DRUG DOSE;

ADENINE; ANTI-HIV AGENTS; FEMALE; GELS; HIV INFECTIONS; HUMANS; MALE; PHOSPHONIC ACIDS; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 81355146472     PISSN: 15483568     EISSN: 15483576     Source Type: Journal    
DOI: 10.1007/s11904-011-0094-4     Document Type: Article

References (55)

1. UNAIDS: Report on the Global AIDS Epidemic. Available at http://www.unaids.org/GlobalReport/default.htm. Accessed June 2011.
2. CW Dieffenbach AS Fauci 2011 Thirty years of HIV and AIDS: future challenges and opportunities Ann Intern Med 154 11 766 771 21628350
3. Q Abdool Karim SS Abdool Karim JA Frohlich, et al. 2010 Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women Science 329 5996 1168 1174 20643915 10.1126/science. 1193748 1:CAS:528:DC%2BC3cXhtV2hsr%2FI This reference reports the results of CAPRISA-004, a community-based, randomized controlled trial that demonstrated the efficacy of topical tenofovir gel in reducing the risk of HIV acquisition by 39% among at-risk heterosexual women in South Africa
4. RM Grant JR Lama PL Anderson, et al. 2010 Preexposure chemoprophylaxis for HIV prevention in men who have sex with men N Engl J Med 363 27 2587 2599 21091279 10.1056/NEJMoa1011205 1:CAS:528:DC%2BC3MXit1ansg%3D%3D This reference reports the results of iPrEx, a multinational, randomized controlled trial in which daily administration of oral FTC-TDF decreased the risk of HIV acquisition among high-risk MSM and transgender women by 44%
5. DM Cardo DH Culver CA Ciesielski, et al. 1997 A case-control study of HIV seroconversion in health care workers after percutaneous exposure N Engl J Med 337 21 1485 1490 9366579 10.1056/NEJM199711203372101 1:STN:280: DyaK1c%2Fis1Oltg%3D%3D (Pubitemid 27495773)
6. M Schechter RF do Lago AB Mendelsohn, et al. 2004 Behavioral impact, acceptability, and HIV incidence among homosexual men with access to postexposure chemoprophylaxis for HIV J Acquir Immune Defic Syndr 35 5 519 525 15021317 10.1097/00126334-200404150-00010 (Pubitemid 38420661)
7. JG Garcia-Lerma ME Cong J Mitchell, et al. 2010 Intermittent prophylaxis with oral truvada protects macaques from rectal SHIV infection Sci Transl Med 2 14 14ra14 10.1126/scitranslmed.3000391
8. L Peterson D Taylor R Roddy, et al. 2007 Tenofovir disoproxil fumarate for prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial PLoS Clin Trials 2 5 e27 17525796 10.1371/journal.pctr. 0020027 (Pubitemid 46851988)
9. KH Mayer LA Maslankowski F Gai, et al. 2006 Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women AIDS 20 4 543 551 16470118 10.1097/01.aids.0000210608.70762.c3 1:CAS:528:DC%2BD28Xht1Cmtb8%3D (Pubitemid 43731598)
10. Hendrix C, Minnis A, Guddera V, et al. MTN-001: a phase 2 cross-over study of daily oral and vaginal TFV in healthy, sexually active women results in significantly different product acceptability and vaginal tissue drug concentrations. [abstract 35LB]. Presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston; February 27-March 2, 2011.
11. Hillier S. Safety and acceptability of coitally dependant use of 1% tenofovir over six months of use. [abstract BO12-655]. Presented at the Microbicides 2008 Conference. New Delhi, India; February 24-27, 2008.
12. AIDS Vaccine Advocacy Coalition (AVAC): Global Advocacy for HIV Prevention website. Available at http://www.avac.org. Accessed June 2011.
13. CONRAD: Press Release: FDA and CONRAD Chart U.S. Regulatory Path for 1% Tenofovir Gel for HIV Prevention. Available at http://www.conrad.org/news- pressreleases-56.html. Accessed June 2010.
14. 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. [abstract 34LB]. Presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston; February 27-March 2, 2011.
15. Baeten J, Celum C. Antiretroviral pre-exposure prophylaxis for HIV-1 prevention among heterosexual African men and women: the partners PrEP study [abstract MOAX0106]. Presented at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Rome, Italy; July 17-20, 2011.
16. Thigpen MC, Kebaabetswe PM, Smith DK, et al. Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: results from the TDF2 Study. [abstract WELBC01]. Presented at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Rome, Italy; July 17-20, 2011.
17. Family Health International: FHI to Initiate Orderly Closure of FEM-PrEP. Available at http://www.fhi.org/en/Research/Projects/FEM-PrEP.htm. Accessed June 2011.
18. AE Zimmermann T Pizzoferrato J Bedford, et al. 2006 Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions Clin Infect Dis 42 2 283 290 16355343 10.1086/499048 1:CAS:528:DC%2BD28XovVGqsg%3D%3D (Pubitemid 43054205)
19. LA Szczech 2008 Renal dysfunction and tenofovir toxicity in HIV-infected patients Top HIV Med 16 4 122 126 18838746
20. P Labarga P Barreiro L Martin-Carbonero, et al. 2009 Kidney tubular abnormalities in the absence of impaired glomerular function in HIV patients treated with tenofovir AIDS 23 6 689 696 19262355 10.1097/QAD.0b013e3283262a64 1:CAS:528:DC%2BD1MXivFeqtr8%3D
21. D Cooper Ryan N Wiebe N Smith, et al. 2010 Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients Clin Infect Dis 51 5 496 505 20673002 10.1086/655681 1:STN:280:DC%2BC3cjisFyisg%3D%3D
22. DL Jacobson D Spiegelman TK Knox IB Wilson 2008 Evolution and predictors of change in total bone mineral density over time in HIV-infected men and women in the nutrition for healthy living study J Acquir Immune Defic Syndr 49 3 298 308 18845956 10.1097/QAI.0b013e3181893e8e 1:CAS:528:DC%2BD1cXhtlWrsLjE
23. Liu A, Vittinghoff E, Irby R, et al. BMD loss in HIV-men participating in a TDF PrEP clinical trial in San Francisco. [abstract 93]. Presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston; February 27-March 2, 2011.
24. • Interim Guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep. 2011;60(3):65-8. This reference is a summary of interim guidance from the CDC on the use of daily oral chemoprophylaxis with FTC-TDF in high-risk MSM. The authors outline current recommendations around laboratory and clinical monitoring associated with PrEP use in this population.
25. Liegler T, Abdel-Mohsen M, Atchison R, et al. Drug resistance and minor drug resistant variants in iPrEx. [abstract 97LB]. Presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston; February 27-March 2, 2011.
26. A Kwara A DeLong N Rezk, et al. 2008 Antiretroviral drug concentrations and HIV RNA in the genital tract of HIV-infected women receiving long-term highly active antiretroviral therapy Clin Infect Dis 46 5 719 725 18220480 10.1086/527387 1:CAS:528:DC%2BD1cXjslWgtr8%3D (Pubitemid 351321556)
27. HIV Prevention Trials Network: HPTN Studies. Available at http://www.hptn.org/research-studies.asp. Accessed June 2011.
28. JB Dumond RF Yeh KB Patterson, et al. 2007 Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxis AIDS 21 14 1899 1907 17721097 10.1097/QAD.0b013e328270385a 1:CAS:528:DC%2BD2sXpsFahsLg%3D (Pubitemid 47329766)
29. KK Van Rompay TB Matthews J Higgins, et al. 2002 Virulence and reduced fitness of simian immunodeficiency virus with the M184V mutation in reverse transcriptase J Virol 76 12 6083 6092 12021341 10.1128/JVI.76.12.6083-6092.2002 (Pubitemid 34556303)
30. JB Dumond KB Patterson AL Pecha, et al. 2009 Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women J Acquir Immune Defic Syndr 51 5 546 553 19546811 10.1097/QAI.0b013e3181ae69c5
31. A Nel S Smythe K Young K Malcolm, et al. 2009 Safety and pharmacokinetics of dapivirine delivery from matrix and reservoir intravaginal rings to HIV-negative women J Acquir Immune Defic Syndr 51 4 416 423 19623693 10.1097/QAI.0b013e3181acb536 1:CAS:528:DC%2BD1MXotlehuro%3D
32. DL Patton YT Sweeney JE Balkus, et al. 2007 Preclinical safety assessments of UC781 anti-human immunodeficiency virus topical microbicide formulations Antimicrob Agents Chemother 51 5 1608 1615 17353240 10.1128/AAC.00984-06 1:CAS:528:DC%2BD2sXlt1yjsrs%3D (Pubitemid 46744134)
33. J Ghosn ML Chaix G Peytavin, et al. 2004 Penetration of enfuvirtide, tenofovir, efavirenz, and protease inhibitors in the genital tract of HIV-1-infected men AIDS 18 14 1958 1961 15353984 10.1097/00002030-200409240- 00014 (Pubitemid 39313214)
34. SM Patel S Johnson SM Belknap, et al. 2004 Serious adverse cutaneous and hepatic toxicities associated with nevirapine use by non-HIV-infected individuals J Acquir Immune Defic Syndr 35 2 120 125 14722442 10.1097/00126334-200402010-00003 1:CAS:528:DC%2BD2cXjsl2gug%3D%3D (Pubitemid 38133733)
35. S Mallal D Nolan C Witt, et al. 2002 Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir Lancet 359 9308 727 732 11888582 10.1016/S0140-6736(02)07873-X 1:CAS:528:DC%2BD38XhvVWhsbY%3D (Pubitemid 34215071)
36. Amico KR, Liu A, McMahan V, et al. Adherence indicators and PrEP drug levels in the iPrEx study. [abstract 95LB]. Presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston; February 27-March 2, 2011.
37. MJ Stirratt CM Gordon 2008 Adherence to biomedical HIV prevention methods: considerations drawn from HIV treatment adherence research Curr HIV/AIDS Rep 5 4 186 192 18838058 10.1007/s11904-008-0027-z
38. G Guest D Shattuck L Johnson, et al. 2008 Changes in sexual risk behavior among participants in a PrEP HIV prevention trial Sex Transm Dis 35 12 1002 1008 19051397
39. SA Golub W Kowalczyk CL Weinberger JT Parsons 2010 Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men J Acquir Immune Defic Syndr 54 5 548 555 20512046 10.1097/QAI.0b013e3181e19a54
40. Mayer KH, Krakower D, Novak DS, et al. On-line assessment of Pre-Exposure Prophylaxis (PrEP) knowledge, attitudes and experience among at risk American Men who have Sex with Men (MSM) before and after the publication of the iPrEx trial results. [abstract TUPE360]. Accepted to the 6th IAS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Rome, Italy; July 17-20, 2011.
41. MJ Mugavero WE Norton MS Saag 2010 Health care system and policy factors influencing engagement in HIV medical care: piecing together the fragments of a fractured health care delivery system Clin Infect Dis 52 Supplement 2 S238 S246 10.1093/cid/ciq048
42. KS Yarnall KI Pollak T Ostbye KM Krause JL Michener 2003 Primary care: is there enough time for prevention? Am J Public Health 93 4 635 641 12660210 10.2105/AJPH.93.4.635 (Pubitemid 36790885)
43. K Desai SL Sansom ML Ackers, et al. 2008 Modeling the impact of HIV chemoprophylaxis strategies among men who have sex with men in the United States: HIV infections prevented and cost-effectiveness AIDS 22 14 1829 1839 18753932 10.1097/QAD.0b013e32830e00f5
44. AD Paltiel KA Freedberg CA Scott, et al. 2009 HIV preexposure prophylaxis in the United States: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness Clin Infect Dis 48 6 806 815 19193111 10.1086/597095
45. Walensky R, Park J-E, Wood R, Freedberg K, Scott C, Bekker LG, et al. Cost effectiveness of PrEP for HIV infection in South Africa. [abstract 37LB]. Presented at the 18th Conference on Retroviruses and Opportunistic Infections. Boston; February 27-March 2, 2011.
46. The Wall Street Journal: New Gel Cuts Risk of HIV Infection. Available at http://online.wsj.com/article/SB10001424052748704720004575377140651050822.html. Accessed August 2011.
47. DE Montano WR Phillips D Kasprzyk A Greek 2008 STD/HIV prevention practices among primary care clinicians: risk assessment, prevention counseling, and testing Sex Transm Dis 35 2 154 166 18007273 10.1097/OLQ.0b013e3181574d97 (Pubitemid 351158694)
48. RM Epstein DS Morse RM Frankel, et al. 1998 Awkward moments in patient-physician communication about HIV risk Ann Intern Med 128 6 435 442 9499326 1:STN:280:DyaK1c7ls1CjtQ%3D%3D (Pubitemid 28128703)
49. TA Peterman LS Lin DR Newman, et al. 2000 Does measured behavior reflect STD risk? An analysis of data from a randomized controlled behavioral intervention study. Project RESPECT Study Group Sex Transm Dis 27 8 446 451 10987449 10.1097/00007435-200009000-00004 1:STN:280:DC%2BD3MrisF2ruw%3D%3D (Pubitemid 30666946)
50. SP Buchbinder A Liu 2011 Pre-exposure prophylaxis and the promise of combination prevention approaches AIDS Behav 15 Suppl 1 S72 S79 21331801 10.1007/s10461-011-9894-1
51. Siegfried N, Muller M, Deeks JJ, Volmink J. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev. 2009(2):CD003362.
52. P Chigwedere GR Seage T-H Lee M Essex 2008 Efficacy of antiretroviral drugs in reducing mother-to-child transmission of HIV in Africa: a meta-analysis of published clinical trials AIDS Res Hum Retrovir 24 6 827 837 18544018 10.1089/aid.2007.0291 1:CAS:528:DC%2BD1cXns1Onurs%3D (Pubitemid 351871673)
53. S Cohen Myron L Gay Cynthia 2010 Treatment to prevent transmission of HIV-1 Clin Inf Dis 50 3 S85 S95 10.1086/651478
54. D Donnell JM Baeten J Kiarie, et al. 2010 Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis Lancet 375 9731 2092 2098 20537376 10.1016/S0140-6736(10)60705-2
55. HIV Prevention Trials Network: Press Release: initiation of antiretroviral treatment protects uninfected sexual partners from HIV infection (HPTN Study 052). Available at http://www.hptn.org/web%20documents/ PressReleases/HPTN052PressReleaseFINAL5-12-118am.pdf. Accessed June 2011.