References related to the application for Inclusion of Emtricitabine

 

1. UNAIDS/World Health Organization. AIDS epidemic update: December 2005 December 2005.

 

2. Joint United Nations Programme on HIV/AIDS (UNAIDS). Global summary of the HIV and AIDS epidemic, December 2005. PowerPoint Presentation] http://www.unaids.org/en/HIV_data/Epidemiology/epi_slides.asp. Accessed May 11, 2006.

 

3. UNAIDS/World Health Organization. HIV infection rates decreasing in several countries but global number of people living with HIV continues to rise [press release] November 21 2005.

 

4. Joint United Nations Programme on HIV/AIDS (UNAIDS). Executive Summary. 2004 Report on the global AIDS epidemic. Switzerland: UNAIDS; June 2004.

 

5. UNAIDS/World Health Organization. AIDS epidemic update: December 2003 December 2003.

 

6. Palella FJ, Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med. 1998;338(13):853-860.

 

7. World Health Organization. Antiretroviral Therapy for HIV Infection in Adults and Adolescents in Resource-Limited Settings: Towards Universal Access. Recommendations for a public health approach. 2006 revision 2006.

 

8. Hammer SM, Saag MS, Schechter M, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel. JAMA. Aug 16 2006;296(7):827-843.

 

9. (DHHS) DoHaHS. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. October 10, 2006. AIDSinfo Web site.  Available at:] http://AIDSinfo.nih.gov. Accessed October 10, 2006.

 

10. Richman DD, Morton SC, Wrin T, et al. The prevalence of antiretroviral drug resistance in the United States. AIDS. Jul 2 2004;18(10):1393-1401.

 

11. Lanier ER, Scott J, Ait-Khaled M, et al. Prevalence of mutations associated with resistance to antiretroviral therapy from 1999-2002 [poster]. Paper presented at: 10th Conference on Retroviruses and Opportunistic Infections; Feb 10-14, 2003; Boston, Mass, USA.

 

12. McColl DJ, Parkin NT, Miller MD. Characterization of Patient-derived HIV-1 Isolates Containing the L74V or K65R Mutations in Reverse Transcriptase (RT) [poster]. Paper presented at: 7th International Congress on Drug Therapy in HIV Infection; November 14-18, 2004; Glasgow, UK.

 

13. Daar ES, Richman DD. Confronting the emergence of drug-resistant HIV type 1: impact of antiretroviral therapy on individual and population resistance. AIDS Res Hum Retroviruses. May 2005;21(5):343-357.

 

14. Weinstock HS, Zaidi I, Heneine W, et al. The epidemiology of antiretroviral drug resistance among drug-naive HIV-1-infected persons in 10 US cities. J Infect Dis. Jun 15 2004;189(12):2174-2180.

 

15. Wensing AMJ, van de Vijver DAMC, Asjo B, et al. Analysis for more than 1600 newly diagnosed patients with HIV from 17 European countries shows that 10% of the patients carry primary drug resistance: the CATCH-Study [abstract]. Paper presented at: 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 13-16, 2003; Paris, France.

 

16. Masquelier B, Bhaskaran K, Pillay D, et al. Prevalence of transmitted HIV-1 drug resistance and the role of resistance algorithms: data from seroconverters in the CASCADE collaboration from 1987 to 2003. J Acquir Immune Defic Syndr Hum Retrovirol. Dec 15 2005;40(5):505-511.

 

17. Little SJ, Holte S, Routy J-P, et al. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med. 2002;347(6):385-394.

 

18. McColl DJ, Margot NA, Lu B, Cheng AK, Miller MD. Lack of resistance to tenofovir DF at week 48 and impact of baseline resistance mutations on treatment response in study 934 [poster TuPp0305]. Paper presented at: 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro, Brazil.

 

19. Loveday C. International perspectives on antiretroviral resistance. Nucleoside reverse transcriptase inhibitor resistance. J Acquir Immune Defic Syndr Hum Retrovirol. 2001;26(Suppl 1):S10-S24.

 

20. World Health Organization (WHO). Progress on global access to HIV antiretroviral therapy: an update on "3 by 5". Geneva, Switzerland: World Health Organization; June 2005.

 

21. Kates J, Leggoe AW. The Henry J. Kaiser Family Foundation HIV/AIDS Policy Fact Sheet:  The HIV/AIDS Epidemic in the United States. September 2005.  Available at: www.kff.org. Accessed May 15, 2006.

 

22. Schinazi RF, Lloyd RM, Jr, Nguyen M-HH, et al. Characterization of human immunodeficiency viruses resistant to oxathiolane-cytosine nucleosides. Antimicrob Agents Chemother. 1993;37(4):875-881.

 

23. Feng JY, Shi J, Schinazi RF, Anderson KS. Mechanistic studies show that (-)-FTC-TP is a better inhibitor of HIV-1 reverse transcriptase than 3TC-TP. FASEB J. 1999;13(12):1511-1517.

 

24. Wang LH, Begley J, Feng JY, Quinn J, Rousseau F. Pharmacokinetic and pharmacodynamic characteristics of emtricitabine support its once daily dosing. Paper presented at: XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain.

 

25. Emtriva« (emtricitabine) Capsules.  Emtriva« (emtricitabine) Oral Solution. US Prescribing Information.  Gilead Sciences, Inc. Foster City, CA.  September 2005.

 

26. Benson CA, van der Horst C, LaMarca A, et al. A randomized study of emtricitabine and lamivudine in stably suppressed patients with HIV. AIDS. 2004;18(17):2269-2276.

 

27. Wakeford C, Shen G, Hulett L, Quinn JB, Rousseau F. Long-term efficacy and safety of emtricitabine (FTC) in HIV+ adults switching from a lamivudine (3TC)-containing HAART regimen [poster]. Paper presented at: 10th Conference on Retroviruses and Opportunistic Infections; February 10-14, 2003, 2003; Boston, Mass, USA.

 

28. Saag M, Cahn P, Raffi F, et al. A randomized, double-blind, multicenter comparison of emtricitabine QD to stavudine BID [oral presentation]. Paper presented at: 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 27-30, 2002; San Diego, Calif, USA.

 

29. 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):180-190.

 

30. Cahn P, Raffi, F, et al. Virologic efficacy and patterns of resistance mutations in ART-naive patients receiving combination therapy with daily (QD) emtricitabine compared to twice-daily (BID) stavudine in a randomized, double blind, multicenter clinical trial [poster]. Paper presented at: 10th Conference on Retroviruses and Opportunistic Infections; February 10-14, 2003; Boston, Mass, USA.

 

31. Food and Drug Administration/CDER Web site.  Guidance for Industry: Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Considerations for Accelerated and Traditional Approval. October 2002.  Available at: http://www.fda.gov/cder/guidance/3647fnl.doc. Accessed September 29, 2003.

 

32. Raffi F, Saag M, Cahn P, et al. A randomized, double-blind, multicenter comparison of emtricitabine QD to stavudine BID in treatment-naive HIV-infected patients [oral presentation]. Paper presented at: 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 13-16, 2003; Paris, France.

 

33. Borroto-Esoda K, Harris J, Waters J, et al. Baseline Genotype as a Predictor of Virologic Failure in Patients Receiving Emtricitabine (FTC) Once Daily or Stavudine (d4T) Twice Daily in Combination with Didanosine (ddI) and Efavirenz (EFV) [Poster]. Paper presented at: 11th Conference on Retroviruses and Opportunistic Infections; February 8-11, 2004; San Francisco, Calif, USA.

 

34. Borroto-Esoda K, Waters J, Quinn JB, et al. Characterization of baseline and treatment-emergent resistance mutations following one year of therapy on an entirely once a day regimen including emtricitabine (FTC) [poster]. Paper presented at: XII International HIV Drug Resistance Workshop; June 10-14, 2003; Los Cabos, Mexico.

 

35. Sanne I, Mommeja-Marin H, Hinkle J, et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis. Mar 15 2005;191(6):825-829.

 

36. European Medicines Agency. Emtriva European Public Assement Report. Section 6: Scientific Discussion. July 31, 2006.  http://www.emea.eu.int/humandocs/Humans/EPAR/emtriva/emtriva.htm. Accessed October 23, 2006.

 

37. Pozniak AL, Gallant JE, DeJesus E, et al. Superior outcome for tenofovir DF, emtricitabine and efavirenz compared to fixed dose zidovudine/lamivudine and EFV in antiretroviral na´ve patients [oral presentation WeOa0202]. Paper presented at: 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro, Brazil.

 

38. Truvada« (emtricitabine and tenofovir disoproxil fumarate) Tablets. US Prescribing Information. Gilead Sciences, Inc. Foster City, CA. March 2006.

 

39. Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. Jan 19 2006;354(3):251-260.

 

40. VIREAD« (tenofovir disoproxil fumarate) Tablets.  US Prescribing Information.  Gilead Sciences, Inc. Foster City, CA. March 2006.

 

41. McColl DJ, Margot NA, Lu B, Cheng AK, Miller MD. Lack of resistance to tenofovir DF at week 48 and impact of baseline NNRTI resistance mutations on treatment response in study 934 [poster number PE7.3/16]. Paper presented at: 10th European AIDS Conference (EACS); November 17-20, 2005; Dublin, Ireland.

 

42. Gallant JE, Pozniak AL, DeJesus E, et al. Efficacy and safety of tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV through 96 weeks in antiretroviral treatment-naive patients [poster number TUPE0064]. Paper presented at: XVI International AIDS Conference; August 13-18, 2006; Toronto, Canada.

 

43. Molina JM, Wilkin A, Domingo P, et al. Once-daily vs. twice-daily lopinavir/ritonavir in antiretroviral-na´ve patients: 96-week results [poster WePe12.3C12]. Paper presented at: 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro, Brazil.

 

44. KALETRA« (lopinavir/ritonavir) tablets (lopinavir/ritonavir) oral solution US Prescribing Information. Abbott Laboratories. North Chicago, IL. Revised October, 2005.

 

45. Johnson MA, Gathe JC, Jr, Podzamczer D, et al. A once-daily lopinavir/ritonavir-based regimen provides noninferior antiviral activity compared with a twice-daily regimen. JAIDS. Aug 31 2006.

 

46. Landman R, Diallo M, Diakhate N, et al. Evaluation of TDF/FTC/EFV once daily first line regimen in West Africa. ANRS 1207/IMEA 025 trial [poster board 543]. Paper presented at: 13th Conference on Retroviruses and Opportunistic Infections; February 5-9, 2006; Denver, Colo, USA.

 

47. McColl DJ, Lu B, Miller MD, Borroto-Esoda K. Pooled analysis of recent emtricitabine and lamivudine clinical trials reveals differences in rates of development of the M184V/I mutation [poster number 139P]. Paper presented at: 15th Annual Canadian Conference on HIV/AIDS Research; May 25-28, 2006; Quebec City, Canada.

 

48. Sanne I, van der Horst C, Shaw A, et al. Two randomized, controlled, equivalence trials of emtricitabine (FTC) to lamivudine (3TC) [poster #4432]. Paper presented at: Presented at the XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain.

 

49. Borroto-Esoda K, Benson C, Quinn J, et al. Predictors of virologic failure in HIV-1 infected adults on a stable lamivudine HAART regimen [poster]. Paper presented at: XI International HIV Drug Resistance Workshop - Basic Principles & Clinical Implications; July 2-5, 2002, 2002; Seville, Spain.

 

50. Molina J-M, Journot V, Morand-Joubert L, et al. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. Mar 15 2005;191(6):830-839.

 

51. Molina JM, Journot V, Rozenbaum W, et al. Simplification therapy with once-daily efavirenz, emtricitabine and didanosine in patients virologically suppressed with a protease inhibitor-based regimen: three-year follow-up of the Alize-ANRS 099 trial [poster board 573]. Paper presented at: 12th Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2005; Boston, Mass, USA.

 

52. Molina JM, Bentata M, Garre M, et al. Hematological benefit of switching from regimens combining protease inhibitors and zidovudine plus lamivudine to once-daily emtricitabine, didanosine and effavirenz. A sub-study of the ANRS 099 ALIZE trial [poster number 830]. Paper presented at: 12th Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2005; Boston, Mass, USA.

 

53. DeJesus E, Ruane P, McDonald C, et al. Effects of switching from fixed dose zidovudine/lamivudine (CBV) to fixed dose tenofovir DF/emtricitabine (TVD): maintenance of virologic suppression and other benefits [oral presentation]. Paper presented at: 15th Annual Canadian Conference on HIV/AIDS Research; May 25-27, 2006; Quebec City, Canada.

 

54. Wang LH, Wiznia AA, Rathore MH, et al. Pharmacokinetics and Safety of Single Oral Doses of Emtricitabine in Human Immunodeficiency Virus-Infected Children. Antimicrob Agents Chemother. 2004;48(1):183-191.

 

55. Blum MR, Ndiweni D, Chittick G, Adda N, Kargl D, Josipovic D. Steady-State Pharmacokinetic Evaluation of Emtricitabine in Neonates Exposed to HIV In Utero [poster 568]. Paper presented at: 13th Conference on Retroviruses and Opportunistic Infections; February 5-9, 2006; Denver, CO.

 

56. Saez-Llorens X, Violari A, Ndiweni D, et al. Once Daily Emtricitabine (FTC) in HIV-Infected Pediatric Patients with Other Antiretroviral Agents [Poster 872]. Paper presented at: 10th Conference on Retroviruses and Opportunistic Infections; February 10-14, 2003; Boston, MA.

 

57. Violari A, Wiznia A, Ndiweni D, et al. Once daily (QD) emtricitabine (FTC) with other antiretroviral agents (ART) in HIV-infected pediatric patients at 48 weeks [poster]. Paper presented at: XV International AIDS Conference; July 11-16, 2004; Bangkok, Thailand.

 

58. Ndiweni D, Violari A, Saez-Llorens X, et al. Once daily (QD) emtrictabine (FTC) with other antiretroviral agents (ART) in HIV-infected pediatric patients [poster]. Paper presented at: 7th International Congress on Drug Therapy in HIV Infection; November 14-18, 2004; Glasgow, UK.

 

59. Harris J, Hinkle J, Makhuli K, Chappell B, Adda N, Rousseau F. Long-term virologic response and genotypic findings in HIV-1 infected pediatric patients receiving emtricitabine (FTC) once daily (QD) [poster number H-855]. Paper presented at: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; October 30-November 2, 2004; Washington, DC, USA.

 

60. Chittick G, Hinkle J, Harris J, Makhuli K, Adda N. Once daily (QD) emtricitabine (FTC) with other antiretroviral agents (ART) in HIV-infected pediatric patients [poster]. Paper presented at: Treatment and Management of HIV Infection in the United States Conference; September 15-18, 2005; Atlanta, Ga, USA.

 

61. McKinney R, Rodman J, Rathore MH, et al. PACTG 1021: Extended Followup and Pharmacokinetics for Once Daily Emtricitabine (FTC), Didanosine (ddI), and Efavirenz (EFV) for Antiretroviral Naive Children and Adolescents (Poster #936). Paper presented at: Conference on Retroviruses and Opportunistic Infections; February 8-11, 2004; San Francisco, California.

 

62. McKinney RE, Jr., Rathore M, Hu C, et al. Once-daily regimen of FTC, DDI, EFV in ARV therapy-naive children - PACTG 1021 [oral presentation]. Paper presented at: 13th Conference on Retroviruses and Opportunistic Infections (CROI); February 5-9, 2006; Denver, Colo, USA.

 

63. McKinney R, Rathore M, Hu C, et al. Phase I-II study of a once-daily regimen of emtricitabine, didanosine, and efavirenz in HIV-infected, therapy naive children and adolescents (PACTG Protocol 1021) [abstract]. Paper presented at: 13th Conference on Retroviruses and Opportunistic Infections (CROI); February 5-9, 2006; Denver, Colo, USA.

 

64. Gilead Sciences, Inc.

 

65. Mondou E, Hinkle J, Shaw A, Quinn J, Adda N, Rousseau F. Incidence of skin discoloration across phase 3 clinical trials of emtricitabine (FTC) in adults [poster 5916]. Paper presented at: XV International AIDS Conference; July 11-16, 2004; Bangkok, Thailand.

 

66. Gilead Announces Preliminary Results from 48-week Phase III Study of Emtricitabine in Patients with Chronic Hepatitis B [press release]. Foster City: Gilead Sciences, Inc. November 25, 2003.

 

67. Powderly W, Cahn P, Raffi F, et al. Lipid abnormalities and body habitus profile in a double-blind, randomized, controlled trial comparing emtrictabine (FTC) to stavudine (d4T) in HIV-1 ART-Na´ve patients [poster number 717]. Paper presented at: 11th Conference on Retroviruses and Opportunistic Infections; February 8-11, 2004; San Francisco, Calif, USA.

 

68. Arribas JR, Pozniak AL, Gallant JE, et al. Superior outcome for tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV in antiretroviral na´ve patients [oral presentation]. Paper presented at: 18th International Conference on Antiviral Research; April 10-14, 2005; Barcelona, Spain.

 

69. Gathe J, Podzamczer D, Johnson M, et al. Once-daily vs. twice-daily lopinavir/ritonavir in antiretroviral-na´ve patients: 48-week results [poster. Paper presented at: 11th Conference on Retroviruses and Opportunistic Infections; February 8-11, 2004; San Francisco, Calif, USA.

 

70. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 through 31 January 2006. Wilmington, NC: Registry Coordinating Center; 2006. Available from URL:] www.APRegistry.com. Accessed October 16, 2006.