PROSPECTS FOR THE LONG-TERM EFFICACY OF FOSAMPRENAVIR (TELZIR) USED AS PART OF ANTIRETROVIRAL THERAPY IN HIV-INFECTED PATIENTS


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Abstract

Fosamprenavir (Telzir) is an oral prodrug of the protease inhibitor (PI) amprenavir, with an optimum dosage regimen. Fosamprenavir in combination with other antiretroviral agents is indicated for the treatment of HIV-infected patients, particularly those who have not previously received antiretroviral therapy. The objective of this paper is to analyze the use of Fosamprenavir in view of its antiviral efficacy and safety as compared with other PI inhibitors in HIV-infected patients and to evaluate the long-term efficacy of fosamprenavir as antiretroviral therapy regimens.

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About the authors

Yuliya Sh. GUSHCHINA

Peoples' Friendship University of Russia

Email: gushchina@mail.ru
Moscow

M. B KUVAEVA

Peoples' Friendship University of Russia

Email: kubaevamariyam@mail.ru
Moscow

References

  1. Panel on clinical practices for treatment of HIV-infection convened by the US Department of Health and Human Ser-vices (DHHS). Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. 23 March 2004 [online]. Available from URL: http://aidsinfo.nih.gov/ guidelines/adult/ AA_071403.pdf [Accessed 2004 Apr 22].
  2. British HIV Association Writing Committee. British HIV Asso-ciation (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. HIV Med. 2001; 2 (4): 276—313.
  3. EACS 2013: New European Treatment Guidelines Strike Balance Between Individual Choice and Public Health. EACS Guidelines are available online at www.eacsociety.org and in the EACS Guidelines App.
  4. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. 30 June 2013. ISBN: 978 92 4 150572 7.
  5. Palella F.J.Jr., Delaney K.M., Moorman A.C. et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N. Engl. J. Med. 1998; 338 (13): 853—860.
  6. Noble S., Goa K.L. Amprenavir: a review of its clinical potential in patients with HIV infection. Drugs 2000; 60 (6): 1383—1410.
  7. Baker C., Chaturvedi P.R., Hale M.R. et al. Discovery of VX-175/ GW433908, a novel, water-soluble prodrug of amprenavir. 39th Interscience conference on anti-microbial agents and chemotherapy. 26—29 Sep. 1999, San Francisco. Аbstract 916.
  8. Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS 2003; 17 (4): 169—177.
  9. Roche Laboratories Inc. Invirase (saquinavir mesylate): U.S. FDA approves Invirase boosted with ritonavir use in treatment of HIV/AIDS [online]. Available from URL: http:// www.fortovase.com [Accessed 2004 Apr 20]
  10. Gathe J.D.S., Loutfy B., Podzamczer M. et al. Study M05—730 primary efficacy results at week 48: Phase 3, randomized, open-label study of lopinavir/ritonavir tablets once daily vs twice daily, co-administered with tenofovir df + emtricitabine in ARV-naïve HIV-1-infected subjects. 15th Conference on retroviruses and opportunistic infections. Boston, MA, USA, 2008.
  11. Wood R., Arasteh K., Stellbrink H.J. et al. Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients. Antimicrob. Agents Chemother. 2004; 48: 116—123.
  12. Sadler B.M., Hanson C.D., Chittick G.E. et а! NS Safety and pharmacokinetics of amprenavir (141W94), a human immunodeficiency virus (HIV) type 1 protease inhibitor, following oral administration of single doses to HIV-infected adults. Antimicrob. Agents Chemother. 1999; 43(7): 1686—1692.
  13. Sadler B.M., Hanson C.D., Chittick G.E. et al. Pharmacokinetics and safety of amprenavir and ritonavir following multiple-dose, co-administration to healthy volunteers. AIDS 2001; 15(8): 1009—1018.
  14. GlaxoSmithKline. Agenerase (amprenavir) capsules: prescrib-ing information (US) [online]. Available from URL: http:// us.gsk.com/products/assets/us_agenerase_ capsules.pdf
  15. GlaxoSmithKline. Lexiva (fosamprenavir calcium) tablets: prescribing information (US) [online]. Available from URL: http://us.gsk.com/products/assets/us_lexiva.pdf
  16. Wire M.B., Ballow C., Preston S.L. et al. An assessment of plasma amprenavir (APV) pharmacokinetics (PK) following adminis-tration of two GW433908 (908) and ritonavir (RTV) BID regimens in combination with efavirenz (EFV) in healthy adult subjects (APV10010) [poster 431W]. 9th Conference on retroviruses and opportunistic infections. 24—28 Feb 2002, Seattle.
  17. Gathe Jr.J.C., Ive P., Wood R. et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ ritonavir ver-sus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS 2004; 18: 1529—1537.
  18. Rodriguez-French A., Boghossian J., Gray G.E. et al. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antire-troviral therapy-naive HIV-1-infected patients. J. Acquir. Immune Defic. Syndr. 2004; 35 (1): 22—32.
  19. Caron M., Auclair M., Sterlingot H. et al. Some HIV protease inhibitors alter lamin A/C maturation and stability, SREBP-1 nuclear localization and adipocyte differentiation. AIDS 2003; 17: 2437—2444.
  20. Chapman TM, Plosker GL, Perry CM. Fosamprenavir: a review of its use in the management of antiretroviral therapy-naive patients with HIV infection. Drugs 2004; 64(18): 2101—2124.
  21. Ruane P.J., Luber A.D., Wire M.B. et al. Plasma amprenavir pharmacokinetics and tolerability following administration of 1,400 milligrams of fosamprenavir once daily in combination with either 100 or 200 milligrams of ritonavir in healthy volunteers. Antimicrob. Agents Chemother. 2007; 51(2): 560—565.
  22. Eron J.Jr., Yeni P., Gathe J.Jr. et al. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomized non-inferiority trial. Lancet 2006; 368: 476—482.
  23. Calza L., Manfredi R., Pocaterra D., Chiodo F. Efficacy and tolerability of a fosamprenavir-ritonavir-based versus a lopinavir-ritonavir-based antiretroviral treatment in 82 therapy-naïve patients with HIV-1 infection. Int. J. STD AIDS 2008; 19(8): 541—544.
  24. Murphy R.L., da Silva B.A., Hicks C.B. et al. Seven-year efficacy of a lopinavir/ritonavir-based regimen in antiretroviralnaïve HIV-1-infected patients. HIV Clin. Trials 2008; 9: 1—10.
  25. Hicks C., King M.S., Gulick R.M. et al. Long-term safety and durable antiretroviral activity of lopinavir/ritonavir in treatment-naive patients: 4 year follow-up study. AIDS 2004; 18: 775—779.
  26. Weeks F., Pulido V., Estrada J.G. et al. Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ ritonavir in combination with abacavir/lamivudine over 144weeks. HIV Clin. Trials 2009; 10(2): 76—87.
  27. Cooper D., Bloch M., Humphries A. et al. for the STEAL Study Investigators. Simplification with fixed-dose tenofovir/emtricitabine or abacavir/lamivudine in adults with suppressed HIV replication: The STEAL Study, a randomised, open-label, 96 week non-inferiority trial. Poster presentation at the 16th Conference on retroviruses and opportunistic infections. 8—11 February 2009. Montreal, Canada. Poster 576.
  28. Wood R., Gathe J.C., Givens N. et al. Long-term safety study of fosamprenavir-containing regimens in HIV-1-infected patients. HIV Clin. Trials 2013; 14(5): 183—191.
  29. Division of AIDS, National Institute of Allergy and Infectious Diseases. Table for Grading Severity of Adult Adverse Experiences. Rockville, MD: NIAID; 2004.
  30. Wire M.B., Shelton M.J., Studenberg S. Fosamprenavir. Clinical pharmacokinetics and drug interactions of the amprenavir prodrug. Clin. Pharmacokinet. 2006, 45: 137—168.
  31. Orrick J.J., Steinhart C.R. Atazanavir. Ann. Pharmacother. 2004; 38: 1664—1674.
  32. Smith K.Y., Weinberg W.G., DeJesus E. et al. Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT. AIDS Research and Therapy 2008, 5: 5. doi: 10.1186/1742-6405-5-5
  33. Carosi G., Lazzarin A., Stellbrink H. et al. Study of once-daily versus twice-daily fosamprenavir plus ritonavir/ administered with abacavir/lamivudine once daily in antiretroviral-naïve HIV-1-infected adult subjects. HIV Clin. Trials 2009; 10(6): 356—367.
  34. D:A:D Study Group. Class of antiretoviral drugs and the risk of myocardial infarction. N. Engl. J. Med. 2007; 356: 1723—1735.
  35. Pineda J.A., Pérez-Elias M.-J., Pena J.M. et al. Low rate of adverse hepatic events associated with fosamprenavir/ ritonavir-based antiretroviral regimens. HIV Clin. Trials 2008; 9(5): 309—313.

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