Fosamprenavir: Drug development for adherence

Annals of Pharmacotherapy

Volumn 40, Issue 7-8, 2006, Pages 1301-1310

  Hester, E Kelly ^a   Chandler, Haley V ^a   Sims, Kelli M ^a  

^a AUBURN UNIVERSITY   (United States)

Author keywords

Fosamprenavir; GW433908; Lexiva

Indexed keywords

ABACAVIR; AMPRENAVIR; AMPRENAVIR PHOSPHATE; ANTIARRHYTHMIC AGENT; ANTICOAGULANT AGENT; ANTICONVULSIVE AGENT; ANTIFUNGAL AGENT; ANTILIPEMIC AGENT; ANTIMYCOBACTERIAL AGENT; BENZODIAZEPINE DERIVATIVE; CALCIUM CHANNEL BLOCKING AGENT; CYTOCHROME P450 1A2; CYTOCHROME P450 2C9; CYTOCHROME P450 3A; CYTOCHROME P450 3A4; HYPERICUM PERFORATUM EXTRACT; IMMUNOSUPPRESSIVE AGENT; INDINAVIR; LAMIVUDINE; LOPINAVIR; METHADONE; NELFINAVIR; ORAL CONTRACEPTIVE AGENT; PHENYTOIN; PROTEINASE INHIBITOR; RIFAMPICIN; RITONAVIR; TRICYCLIC ANTIDEPRESSANT AGENT; UNINDEXED DRUG; VALPROATE SEMISODIUM;

ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; BODY FAT DISTRIBUTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSS RESISTANCE; CROSSOVER PROCEDURE; DIARRHEA; DISEASE ASSOCIATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DYSLIPIDEMIA; HEADACHE; HEART ARRHYTHMIA; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERGLYCEMIA; LEG ISCHEMIA; LIPODYSTROPHY; NAUSEA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINASE INHIBITION; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATION DEPRESSION; REVIEW; RHABDOMYOLYSIS; SEDATION; STEADY STATE; VASOSPASM; VIRUS RESISTANCE; VOMITING;

CARBAMATES; CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; DRUG INTERACTIONS; DRUG RESISTANCE, VIRAL; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; PATIENT COMPLIANCE; PHOSPHORIC ACID ESTERS; SULFONAMIDES;

EID: 33746955148     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1G034     Document Type: Review

References (42)

1. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998;338:853-60.
2. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents, October 6, 2005. Panel on Clinical Practices for Treatment of HIV Infection, www.aidsinfo.nih.gov/guidelines (accessed 2005 Nov 16).
3. Bangsberg DR, Moss AR, Deeks SG. Paradoxes of adherence and drug resistance to HIV antiretroviral therapy. J Antimicrob Chemother 2004; 53:696-9.
4. Sethi AK, Celentano DD, Gange SJ, Moore RD, Gallant JE. Association between adherence and antiretroviral therapy and human immunodeficiency virus drug resistance. Clin Infect Dis 2003;37:1112-8.
5. Wood E, Hogg RS, Yip B, Harrigan PR, O'Shaughnessy MV, Montaner JS. Is there a baseline CD4 cell count that precludes a survival response to modern antiretroviral therapy? AIDS 2003;17:711-20.
6. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30.
7. Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS 2003;17:169-77.
8. Falcoz C, Jenkins JM, Bye C, et al. Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers. J Clin Pharmacol 2002;42:887-98.
9. Wood R, Arasteh K, Stellbrink H, 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;48:116-23.
10. Rodriguez-French A, Boghossian J, Gray GE, et al. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naïve HIV-1 infected patients. J Acquir Immune Defic Syndr 2004;35:22-32.
11. Gathe JC, Ive P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ritonavir versus twice-daily nelfinavir in naive HTV-1-infected patients. AIDS 2004;18:1529-37.
12. DeJesus E, LaMarca A, Sension M, Beltran C, Yeni P. The Context study: efficacy and safety of GW433908/RTV in protease inhibitor-experienced subjects with virological failure (24 week results) (abstract 178). In: Abstracts of the 10th Conference on Retroviruses and Opportunistic Infections. Boston, February 10-14, 2003.
13. Package insert. Lexiva (fosamprenavir). Research Triangle Park, NC: GlaxoSmithKline.http://us.gsk.com/products/assets/us_lexiva.pdf (accessed 2005 Nov 8).
14. Maguire M, Shortino D, Klein A, et al. Emergence of resistance to protease inhibitor amprenavir in human immunodeficiency virus type 1-infected patients: selection of four alternative viral protease genotypes and influence of viral susceptibility to coadministered reverse transcriptase nucleoside inhibitors. Antimicrob Agents Chemother 2002;46:731-8.
15. Tisdale M, Myers RE, Ai T-Khaled M, Snowden W. HIV drug resistance analysis during clinical studies with the protease inhibitor amprenavir (abstract 118). In: Abstracts of the 6th Conference on Retroviruses and Opportunistic Infections, Chicago, January 31-February 4, 1999.
16. Tisdale M, Myers RE, Maschera B, Parry NR, Oliver NM, Blair ED. Cross-resistance analysis of human immunodeficiency virus type 1 variants individually selected for resistance to five different protease inhibitors. Antimicrob Agents Chemother 1995;39:1704-10.
17. Partaledis JA, Yamaguchi K, Tisdale M, et al. In vitro selection and characterization of human immunodeficiency virus type 1 (HTV-1) isolates with reduced sensitivity to hydroxyethylamino sulfonamide inhibitors of HTV-1 aspartyl protease. J Virol 1995;69:5228-35.
18. Johnson VA, Brun-Vezinet F, Clotet B, et al. Update of the drug resistance mutations in HIV-1: 2004. Top HIV Med 2004;12:119-24.
19. MacManus S, Yates PJ, Elston RC, White S, Richards N, Snowden W. GW433908/ritonavir once daily in antiretroviral therapy-naïve HIV-infected patients: absence of protease resistance at 48 weeks. AIDS 2004; 18:651-5.
20. Quattek K, Kotsopoulos N, Garris C, Elston R. The low incidence of resistance mutations in naive patients receiving 908/RTV QD compared to NFV BID cannot be explained by adherence differences (abstract 10.1/18). Presented at: Ninth European AIDS Conference, Warsaw, October 25-29, 2003.
21. MacManus S, Yates P, White S, Richards N, Snowden W. GW433908 in ART-naïve subjects: absence of resistance at 48 weeks with boosted regimen and amprenavir-like resistance profile with unboosted regimen (abstract 598). In: Abstracts of the 10th Conference on Retroviruses and Opportunistic Infections, Boston, February 10-14, 2003.
22. Schmidt B, Korn K, Moschik B, Paatz C, Uberla K, Walter H. Low level of cross-resistance to amprenavir (141W94) in samples from patients pretreated with other protease inhibitors. Antimicrob Agents Chemother 2000;44:3213-6.
23. Elston RC, Yates P, Tisdale M, Richards N, White S, DeJesus E. GW433908 (908)/ritonavir: 48 week results in PI-experienced subjects: a retrospective analysis of virological response based on baseline genotype and phenotype (abstract MoOrB1055). In: Program and abstracts of the XV International AIDS Conference, Bangkok, Thailand, July 11-16, 2004.
24. Package insert. Agenerase (amprenavir). Research Triangle Park, NC: GlaxoSmithKline. http://us.gsk.com/products/assets/us_agenerase_ capsules.pdf (accessed 2004 Dec 21).
25. Sohma Y, Hayashi Y, Ito T, Matsumoto H, Kimura T, Kiso Y. Development of water-soluble prodrugs of the HIV-1 protease inhibitor KNI-727: importance of the conversion time for higher gastrointestinal absorption of prodrugs based on spontaneous chemical cleavage. J Med Chem 2003;46:4124-35.
26. Wire MB, Ballow C, Preston SL, et al. Pharmacokinetics and safety of GW433908 and ritonavir, with and without efavirenz, in healthy volunteers. AIDS 2004;18:897-907.
27. Ruane P, Wire M, Shelton M, Lou Y, Lancaster C, Pappa K. Plasma amprenavir pharmacokinetics and safety following coadministration of fosamprenavir with a reduced ritonavir dose once daily (COL10053) (abstract A-449). In: Program and abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, October 30-November 2, 2004.
28. Carr A, Samaras K, Burton S, et al. A syndrome of peripheral lipodystrophy, hyperlipidemia, and insulin resistance in patients receiving HIV protease inhibitors. AIDS 1998;12:F51-8.
29. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285:2486-97.
30. Horban A, Staszewski S, Walmsley S, et al. Favourable increase in high density lipo-protein cholesterol (HDL-C) concentrations in chronic HIV-infected therapy naïve subjects receiving 908/r QD in the Solo study (abstract F8/3). Ninth European AIDS Conference, Warsaw, October 2003.
31. Nadler J, Rodriguez-French A, Wannamaker P. Favorable increases in HDL-cholesterol in HIV-infected antiretroviral therapy-naive subjects receiving GW433908 in the NEAT study (abstract H-156). In: Program and abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, October 30-November 2, 2004.
32. Chen D, Misra A, Garg A. Lipodystrophy in human immunodeficiency virus-infected patients. J Clin Endocrinol Metab 2002;87:4845-56.
33. Wanke CA, Falutz JM, Shevitz A, Phair JP, Ketler DP. Clinical evaluation and management of metabolic and morphologic abnormalities associated with human immunodeficiency virus. Clin Infect Dis 2002;34:248-59.
34. Dube MP, Stein JH, Aberg JA, et al., for the Adults AIDS Clinical Trials Group Cardiovascular Subcommittee. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis 2003;37:613-27.
35. Shelton MJ, Ford SL, Wire MB. Coadministration of esomeprazole with fosamprenavir has no impact on steady-state plasma amprenavir pharmacokinetics (APV10031) (abstract 24). In: Program and abstracts of the 6th International Workshop on Clinical Pharmacology of HIV Therapy, Quebec City, Canada, April 28-30, 2005.
36. DeJesus E. Evaluation of the pharmacokinetic drug interaction between fosamprenavir, fosamprenavir plus ritonavir, and nevirapine in HIV-infected patients (APV10014) (abstract A-447). In: Program and abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; Washington, DC, October 30-November 2, 2004.
37. Boffito M, Dickinson L, Hill A, et al. Steady-state pharmacokinetics of saquinavir hard-gel/ritonavir/fosamprenavir in HIV-1-infected patients. J Acquir Immune Defic Syndr 2004;37:1376-84.
38. Church J, Rathore M, Rubio T, et al. Phase III study of amprenavir in protease-inhibitor naïve and experienced HIV-infected children and adolescents (abstract 693). In: Program and abstracts of the Seventh Conference on Retro viruses and Opportunistic Infections, San Francisco, January 30-February 2, 2000.
39. Blanche S, Fetter A, Cox H, Yeo J, Randall S, Snowden W. A phase II study of amprenavir in antiretroviral-experienced children with HIV infection (abstract 695). In: Program and abstracts of the Seventh Conference on Retroviruses and Opportunistic Infections, San Francisco, January 30-February 2, 2000.
40. Mannheimer S, Friedland G, Matts J, Child C, Chesney M. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clin Infect Dis 2002;34:115-21.
41. Mannheimer SB, Matts J, Telzak E, et al. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care 2005;17:10-22.
42. Drug topics redbook. 2005. Montvale, NJ: Medical Economics, 2005.