References related to the application for Inclusion of Emtricitabine and Tenofovir Disoproxil Fumarate Fixed Dose Combination Tablet

 

1. Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.  May 4, 2006 [AIDSInfo Web site. Available at:]. Available at: http://AIDSinfo.nih.gov. Accessed May 9, 2006.

 

2. Yeni PG, Hammer SM, Hirsch MS, et al. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA. 2004;292(2):251-265.

 

3. 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. Jul 14 2004;292(2):191-201.

 

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

 

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

 

6. 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.

 

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

 

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

 

9. 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.

 

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: Available at: www.kff.org. Accessed May 15, 2006.

 

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

 

23. 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.

 

24. Blum MR, Begley J, Zong J, Hill D, Adda N, Chittick G. Lack of a pharmacokinetic interaction between emtricitabine and tenofovir DF when co-administered to steady state in healthy volunteers [poster]. Paper presented at: 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 14-17, 2003; Chicago, Ill, USA.

 

25. Kearney BP, Zong J, Begley J, Shah J. Bioequivalence of combination tenofovir DF/emtricitabine tablets for one-pill once daily administration [poster]. Paper presented at: 5th International Workshop on Clinical Pharmacology of HIV Therapy; April 1-3, 2004; Rome, Italy.

 

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

 

27. Miller MD, Margot N, Lu B, et al. Genotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate in antiretroviral-experienced patients. J Infect Dis. 2004;189(5):837-846.

 

28. Miller MD, McColl DJ, White KL, Tran S, Coakley DF, Cheng AK. Genotypic and Phenotypic Characterization of Virologic Failure Through 48 Weeks Among Treatment-naive Patients Taking Tenofovir DF or Stavudine (d4T) in Combination with Lamivudine (3TC) and Efavirenz (EFV) [poster]. Paper presented at: Sixth International Congress on Drug Therapy in HIV Infection; November 17-21, 2002; Glasgow, UK.

 

29. Miller MD, Margot NA, McColl DJ, Wrin T, Coakley DF, Cheng AK. Characterization of resistance mutation patterns emerging over two years during first line antiretroviral treatment with tenofovir DF or stavudine in combination with lamivudine and efavirenz [poster presentation]. Paper presented at: XII International HIV Drug Resistance Workshop; June 10-14, 2003; Los Cabos, Mexico.

 

30. White KL, Margot NA, Wrin T, Petropoulos CJ, Miller MD, Naeger LK. Molecular mechanisms of resistance to human immunodeficiency virus type 1 with reverse transcriptase mutations K65R and K65R+M184V and their effects on enzyme function and viral replication capacity. Antimicrob Agents Chemother. 2002;46(11):3437-3446.

 

31. Bloor S, Kemp SD, Hertogs K, Alcorn T, Larder BA. Patterns of HIV drug resistance in routine clinical practice:  a survey of almost 12000 samples from the USA in 1999. Antivir Ther. 2000;5(Suppl 3):132.

 

32. Winston A, Mandalia S, Pillay D, Gazzard B, Pozniak A. The prevalence and determinants of the K65R mutation in HIV-1 reverse transcriptase in tenofovir-naive patients. AIDS. 2002;16(15):2087-2089.

 

33. Cassetti I, Madruga JVR, Suleiman JMAH, Zhong J, Enejosa J, Cheng A. Tenofovir DF (TDF) in combination with lamivudine (3TC) and efavirenz (EFV) in antiretroviral-na´ve HIV-infected patients: a 4-year follow-up [poster WePe6.3C05]. Paper presented at: 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro, Brazil.

 

34. Madruga JVR, Cassetti I, Suleiman JMAH, Zhong L, Enejosa J, Cheng A. Improvement in lipoatrophy and lipid abnormalities following switch from stavudine (d4T) to tenofovir DF (TDF) in combination with lamivudine (3TC) and efavirenz (EFV) in HIV-infected patients: a 48-week follow-up from study 903E [poster TuPe2.2B12]. Paper presented at: 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro, Brazil.

 

35. 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.

 

36. 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.

 

37. 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.

 

38. 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.

 

39. 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.

 

40. KaletraĎ (lopinavir/ritonavir) capsules (lopinavir/ritonavir) oral solution. US Prescribing Information.  Abbott Laboratories.  North Chicago, IL, USA. April 20, 2005.

 

41. 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.

 

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

 

43. 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.

 

44. 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.

 

45. 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.

 

46. Gilead Sciences, Inc.

 

47. Gallant JE, Staszewski S, Pozniak A, et al. Long-term efficacy and safety of tenofovir DF (TDF): a 144 week comparison versus stavudine (d4T) in antiretroviral-Na´ve patients [poster]. Paper presented at: XV International AIDS Conference; July 11-16, 2004; Bangkok, Thailand.

 

48. de Ruiter A, Pozniak AL, Staszewski S, et al. Long-term safety and efficacy of tenofovir DF (TDF) versus stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) in antiretroviral-na´ve women: 144 week results [oral presentation]. Paper presented at: Presented at the XV International AIDS Conference; July 11-16, 2004; Bangkok, Thailand.

 

49. 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.

 

50. 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.

 

51. O'Brien ME, Kupka R, Msamanga GI, Saathoff E, Hunter DJ, Fawzi WW. Anemia is an independent predictor of mortality and immunologic progression of disease among women with HIV in Tanzania. JAIDS. Oct 1 2005;40(2):219-225.

 

52. Diallo DA, Baby M, Dembele M, et al. [Frequency, risk factors and prognostic value of anemia associated with HIV/AIDS in the adult in Mali]. Bull Soc Pathol Exot. May 2003;96(2):123-127.

 

53. Campaign for Access to Essential Medicines. MÚdecins Sans FrontiŔres. Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries. 8th Edition. Available at: Available at: www.accessmed-msf.org. Accessed 09 May, 2006.