Safety of fosamprenavir in a cohort of HIV-1-infected patients with co-morbidities

In Vivo

Volumn 25, Issue 5, 2011, Pages 813-820

  Esposito, Vincenzo ^a   Chiodini, Paolo ^b   Viglietti, Rosaria ^a   Parrella, Roberto ^a   Parrella, Giovanni ^a   Maddaloni, Adelaide ^a   Sangiovanni, Vincenzo ^a   Gargiulo, Miriam ^a   Abrescia, Nicola ^a   Chirianni, Antonio ^a  

^a AO Dei Colli Hospital for Infectious Diseases D Cotugno   (Italy)

^b SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

Comorbidities; Fosamprenavir; HAART; HIV; Liver; Toxicity

Indexed keywords

ABACAVIR; ALANINE AMINOTRANSFERASE; ANTIRETROVIRUS AGENT; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; FOSAMPRENAVIR; GLUCOSE; LAMIVUDINE; TRIACYLGLYCEROL; ZIDOVUDINE;

ADULT; AGED; ARTICLE; CHOLESTEROL BLOOD LEVEL; COMORBIDITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GLUCOSE BLOOD LEVEL; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HYPERTENSION; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; METABOLIC DISORDER; RISK FACTOR; SIDE EFFECT; TRIACYLGLYCEROL BLOOD LEVEL; VIRUS LOAD;

EID: 79960637777     PISSN: 0258851X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (55)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents: Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services, pp. 1-166, 2011.
2. Tsiodras S, Perelas A, Wanke C and Mantzoros CS: The HIV-1/HAART associated metabolic syndrome - novel adipokines, molecular associations and therapeutic implications. J Infect 61: 101-113, 2010.
3. Carosi G, Puoti M, Antonucci G, De Luca A, Maserati R, Torti C, Bonfanti P, Bonora S, Bruno R, Gaeta GB, Antinori A, Monforte A, Orani A, Sagnelli E, Cargnel A, Cauda R, Mazzotta F, Pastore G, Suter F and Vullo V: Antiretroviral therapy in chronic liver disease: Focus on HIV/HCV coinfection - statements of the first Italian consensus workshop. AIDS Rev 7: 161-167, 2005. (Pubitemid 41671916)
4. Greub G, Ledergerber B, Battegay M, Grob P, Perrin L, Furrer H, Burgisser P, Erb P, Boggian K, Piffaretti JC, Hirschel B, Janin P, Francioli P, Flepp M and Telenti A: Clinical progression, survival, and immune recovery during antiretroviral therapy in patients with HIV-1 and hepatitis C virus coinfection: the Swiss HIV Cohort Study. Lancet 356: 1800-1805, 2000.
5. Thio CL, Seaberg EC, Skolasky R Jr., Phair J, Visscher B, Muñoz A and Thomas DL; Multicenter AIDS Cohort Study: HIV-1, hepatitis B virus, and risk of mortality in the Multicenter Cohort Study (MACS). Lancet 360: 1921-1926, 2002.
6. Ogedegbe AO and Sulkowski MS: Antiretroviral-associated liver injury. Clin Liver Dis 7: 475-499, 2003.
7. Birkus G, Hitchcock MJ and Cihlar T: Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemother 46: 716-723, 2002. (Pubitemid 34157656)
8. Ritchie MD, Haas DW, Motsinger AA, Donahue JP, Erdem H, Raffanti S, Rebeiro P, George AL, Kim RB, Haines JL and Sterling TR: Drug transporter and metabolizing enzyme gene variants and NNRTI hepatotoxicity. Clin Infect Dis 43: 779-782, 2006. (Pubitemid 44330745)
9. Stern J, Robinson PA, Love J, Lanes S, Imperiale MS and Mayers DL: A comprehensive hepatic safety analysis of nevirapine in different populations of HIV-infected patients. J Acquir Immune Defic Syndr 34(S1): 21-33, 2003.
10. Manfredi R and Calza L: Nevirapine versus efavirenz in 742 patients: no link of liver toxicity with female sex, and a baseline CD4 cell count greater than 250 cells/microliter. AIDS 20: 2233-2236, 2006.
11. Sulkowski MS, Thomas DL, Chaisson RE and Moore RD: Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA 283: 74-80, 2000. (Pubitemid 30038386)
12. Bonfanti P, Landonio S, Ricci E, Martinelli C, Fortuna P, Faggion I and Quirino T; CISAI study group: Risk factors for hepatotoxicity in patients treated with highly active antiretroviral therapy. J Acquir Immune Def Syndr 27: 316-318, 2001. (Pubitemid 32661977)
13. Wit F, Weverling GJ, Weel J, Jurriaans S and Lange JM: Incidence and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. J Infect Dis 186: 23-31, 2002. (Pubitemid 34666910)
14. Kandula VR, Khanlou H and Farthing C: Tipranavir: a novel second-generation nonpeptidic protease inhibitor. Expert Rev Anti Infect Ther 3: 9-21, 2005. (Pubitemid 40277835)
15. Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D and, Valdez H; RESIST investigator group: Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multidrug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet 368: 466-475, 2006.
16. Den Brinker M, Wit FW, Wertheim-van Dillen PM, Jurriaans S, Weel J, Van Leeuwen R, Pakker NG, Reiss P, Danner SA, Weverling GJ and Lange JM: Hepatitis B and C co-infection and the risk for hepatotoxicity of highly active antiretroviral in HIV-1 infection. AIDS 14: 2895-2902, 2000. (Pubitemid 32042753)
17. Konopnicki D, Mocroft A, De Wit S, Antunes F, Ledergerber B, Katlama C, Zilmer K, Vella S, Kirk O and Lundgren JD; EuroSIDA Group: Hepatitis B and HIV: prevalence, AIDS progression, response to highly active antiretroviral therapy and increased mortality in the EuroSIDA cohort. AIDS 19: 593-601, 2005. (Pubitemid 40543982)
18. Furfine ES, Baker CT, Hale MR, Reynolds DJ, Salisbury JA, Searle AD, Studenberg SD, Todd D, Tung RD and Spaltenstein A: Preclinical pharmacology and pharmacokinetics of GW433908, a water-soluble prodrug plasma of human immunodeficiency virus protease inhibitor amprenavir. Antimicrob Agents Chemother 48: 791-798, 2004. (Pubitemid 38280326)
19. Studenberg SD, Furfine ES, Boehlert CC, Delozier CR, Smith CD and Woolley JL: Mechanism of absorption of GW433908, the phosphate prodrug of the HIV protease inhibitor amprenavir. Abstr Front Drug Dev Antiretrovir Ther: abstract no. 069, 2000.
20. Okusanya O, Forrest A, Di Francesco R, Bilic S, Rosenkranz S, Para MF, Adams E, Yarasheski KE, Reichman RC and Morse GD; ACTG 5043 Protocol Team: Compartmental pharmacokinetic analysis of oral amprenavir with secondary peaks. Antimicrob Agents Chemother 51: 1822-1826, 2007.
21. Gathe JC Jr., Ive P, Wood R, Schürmann D, Bellos NC, DeJesus E, Gladysz A, Garris C and Yeo J: SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS 18: 1529-1537, 2004. (Pubitemid 39037477)
22. Elston RC, Yates P, Tisdale M, Richards N, White S and De Jesus E: GW433908 (908)/ritonavir (r): 48-week results in PI-experienced subjects: a retrospective analysis of virologic response based on baseline genotype and phenotype. Int Conf AIDS 15: abstract no. MoOrB1055, 2004.
23. Pulido F, Katlama C, Marquez M, Thomas R, Clumeck N, Pedro Rde J, Cattelan AM, Zhu C and Tymkewycz P: A randomised study investigating the efficacy and safety of amprenavir in combination with low-dose ritonavir in protease inhibitor-experienced HIV-infected adults. HIV Med 5: 296-302, 2004.
24. Pulido F, Estrada V, Baril JG, Logue K, Schewe K, Plettenberg A, Duiculescu D, Yau L, Vavro C, Lim ML and Pharo C: Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks. HIV Clinical Trials 10(2): 76-87, 2009.
25. Kashuba AD, Tierney C, Downey GF, Acosta EP, Vergis EN, Klingman K, Mellors JW, Eshleman SH, Scott TR and Collier AC: Combining fosamprenavir with lopinavir/ritonavir substantially reduces amprenavir and lopinavir exposure: ACTG protocol A5143 results. AIDS 19: 145-152, 2005. (Pubitemid 40409533)
26. Taburet AM, Raguin G, Le Tiec C, Droz C, Barrail A, Vincent I, Morand-Joubert L, Chêne G, Clavet F and Girard PM: Interactions between amprenavir and the lopinavir-ritonavir combination in heavily pretreated patients infected with human immunodeficiency virus. Clin Pharmacol Ther 75: 310-323, 2004. (Pubitemid 38471556)
27. Wire MB, Shelton MJ and Studenberg S: Fosamprenavir: clinical pharmacokinetics and drug interaction of the amprenavir prodrug. Clin Pharmacokinet 45(2): 137-168, 2006. (Pubitemid 43290828)
28. Arvieux C and Tribut O: Amprenavir or fosamprenavir plus ritonavir in HIV infection: pharmacology, efficacy and tolerability profile. Drugs 65(5): 633-659, 2005. (Pubitemid 40477784)
29. Wire MB, Baker KL, Jones LS, Shelton MJ, Lou Y, Thomas GJ and Berrey MM: Ritonavir increases plasma amprenavir (APV) exposure to a similar extent when coadministered with either fosamprenavir or APV Antimicrob Agents Chemother 50(4): 1578-1580, 2006.
30. Wire MB, Shelton MJ, Lou Y, Agarwala S, Child M and Min SS: The pharmacokinetic interaction between fosamprenavir/ ritonavir and atazanavir in healthy adult subjects (APV10018). EACS 10: abstract no. PE4.3/9, 2005.
31. Shelton MJ, Ford SL, Borland J, Lou Y, Wire MB, Min SS, Xue ZG and Yuen G: Co-administration of esomeprazole with fosamprenavir has no impact on steady-state plasma amprenavir pharmacokinetics. J Acquir Immune Defic Syndr 42(1): 61-67, 2006. (Pubitemid 43947947)
32. Shelton MJ, Wire MB, Lou Y, Adamkiewicz B and Min SS: Pharmacokinetic and safety evaluation of high dose combinations of fosamprenavir and ritonavir. Antimicrob Agents Chemother 50(3): 928-934, 2006. (Pubitemid 43327796)
33. Kim Y, Hu C and Wire MB: Steady-state amprenavir pharmacokinetics are similar between healthy and HIV-infected subjects following GW433908 +/- ritonavir using population pharmacokinetic analysis (abstract n. 7.5). International Workshop on Clinical Pharmacology of HIV Therapy 5: abstract no. 7.5, 2004.
34. Gathe JC Jr, Wood R, Sanne I, Dejesus E, Shürmann D, Gladysz A, Garris C, Givens N, Elston R and Yeo J: Long-term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ ritonavir once daily in therapy-naive patients with HIV-1 infection: an uncontrolled, open-label, single-arm follow-on study. Clin Therapeut 28(5): 745-754, 2005. (Pubitemid 44173054)
35. Ruane PJ, Luber AD, Wire MB, Lou Y, Shelton MJ, Lancaster C and Pappa K; COL 10053 Study Team: Plasma amprenavir pharmacokinetics and tolerability following administration of 1400 milligrams of fosamprenavir once daily in combination with either 100 or 200 milligrams of ritonavir in healthy volunteers. Antimicrob Agents Chemother 51(2): 560-565, 2007. (Pubitemid 46185273)
36. Boffito M, Dickinson L, Hill A, Back D, Moyle G, Nelson M, Higgs C, Fletcher C, Gazzard B and Pozniak A: Steady-state pharmacokinetics of saquinavir hard-gel/ritonavir/fosamprenavir in HIV-1-infected patients. J Acquir Immune Defic Syndr 37: 1376-1384, 2004. (Pubitemid 39435052)
37. Marcelin AG, Flandre P, Molina JM, Katlama C, Yeni P, Raffi F, Antoun Z, Ait-Khaled M and Calvez V: Genotypic resistance analysis of the virological response to fosamprenavir-ritonavir in protease inhibitor-experienced patients in CONTEXT and TRIAD clinical trials. Antimicrob Agents Chemother 52(12): 4251-4257, 2008.
38. Rhame FS, Rawlins SL, Petruschke RA, Erb TA, Winchell GA, Wilson HM, Edelman JM and Abramson MA. Pharmacokinetics of indinavir and ritonavir administered at 667 and 100 milligrams, respectively, every 12 hours compared with indinavir administered at 800 milligrams every 8 hours in human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 48: 4200-4208, 2004. (Pubitemid 39434876)
39. Wire MB, Naderer OJ, Masterman AL, Lou Y and Stein DS: Dose separation does not overcome the pharmacokinetic interaction between fosamprenavir and lopinavir/ritonavir. Antimicrob Agents Chemother 50(8): 2756-2761, 2006.
40. Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM and Wannamaker PG: The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1 infected patients. J Acquir Immune Defic Syndr 35: 22-32, 2004. (Pubitemid 38044778)
41. DeJesus E, LaMarca A, Sension M, Beltran C and Yeni P; Conference on Retroviruses and Opportunistic Infections: The context study: efficacy and safety of GW433908/RTV in protease inhibitor-experienced subjects with virological failure (24 week results). CROI 10: abstract no. 178, 2003.
42. Hester EK, Chandler HV and Sims KM: Fosamprenavir: drug development for adherence. Ann Pharmacother 40: 1301-1310, 2006. (Pubitemid 44204960)
43. Seminari E, De Bona A, Gentilini G, Galli L, Schira G, Gianotti N, Uberti-Foppa C, Soldarini A, Dorigatti F, Lazzarin A and Castagna A: Amprenavir and ritonavir plasma concentrations in HIV-infected patients treated with fosamprenavir/ritonavir with various degrees of liver impairment. J Antimicrob Chemother 60: 831-836, 2007. (Pubitemid 47434263)
44. Pineda JA, Pérez-Elías MJ, Peña JM, Luque I and Rodríguez-Alcantara F; Fosamprenavir Expanded Access Program Group: Low rate of adverse hepatic events associated with fosamprenavir/ ritonavir-based antiretroviral regimens. HIV Clin Trials 9: 309-313, 2008.
45. Division of AIDS: Table for grading the severity of adult and pediatric adverse events (DAIDS AE Grading Table). DAIDS, pp. 1-21, 2009.
46. Del Romero J, Clavo P, Garcia S, Ballesteros J, Gomez R, Rodriguez C, Neila MA, Del Corral S and Castilla J: Prevalence of hepatitis C virus infection among two groups with HIV risk behaviors in Madrid (Spain). Int Conf AIDS 13: abstract no. WePeC4452, 2000.
47. De Luca A, Bugarini R, Lepri A, Puoti M, Girardi E, Antinori A, Poggio A, Pagano G, Tositti G, Cadeo G, Macor A, Toti M and D'Arminio Monforte A; Italian Cohort Naive Antiretrovirals Study Group: Coinfection with hepatitis viruses and outcome of initial antiretroviral regimens in previously naïve HIV-infected subjects. Arch Intern Med 16: 2125-2132, 2002. (Pubitemid 35168221)
48. Verucchi G, Calza L, Manfredi R and Chiodo F: Human immunodeficiency virus and hepatitis C virus coinfection: epidemiology, natural history, therapeutic options and clinical management. Infection 32: 33-46, 2004. (Pubitemid 38210511)
49. Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R and Snydman DR: Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infec Dis 32: 492-497, 2001. (Pubitemid 32173638)
50. Martin-Carbonero L, Soriano V, Valencia E, Garcia-Samaniego J, Lopez M and Gonzalez-Lahoz J: Increasing impact of chronic viral hepatitis on hospital admissions and mortality among HIV-infected patients. AIDS Res Hum Retroviruses 17: 1467-1471, 2001. (Pubitemid 33116749)
51. Rosenthal E, Poiree M, Pradier C, Perronne C, Salmon-Ceron D, Geffray L, Myers RP, Morlat P, Pialoux G, Pol S and Cacoub P; GERMIVIC Joint Study Group: Mortality due to hepatitis C-related liver disease in HIV-infected patients in France (Mortavic 2001 study). AIDS 17: 1803-1809, 2003.
52. Brau N: Chronic hepatitis C in patients with HIV/AIDS: a new challenge in antiviral therapy. J Antimicrob Chemother 56: 991-995, 2005.
53. El-Serag HB, Giordano TP, Kramer J, Richardson P and Souchek J: Survival in hepatitis C and HIV co-infection: a cohort study of hospitalized veterans. Clin Gastroenterol Hepatol 3: 175-183, 2005. (Pubitemid 40220313)
54. Giordano TP, Kramer JR, Souchek J, Richardson P and El-Serag HB: Cirrhosis and hepatocellular carcinoma in HIV-infected veterans with and without the hepatitis C virus: a cohort study, 1992-2001. Arch Intern Med 21: 2349-2354, 2004.
55. Kramer JR, Giordano TP, Souchek J and El-Serag HB: Hepatitis C coinfection increases the risk of fulminant hepatic failure in patients with HIV in the HAART era. J Hepatol 42: 309-314, 2005. (Pubitemid 40254243)