Cost effectiveness of darunavir/ritonavir 600/100mg bid in treatment-experienced, lopinavir-naive, protease inhibitor-resistant, HIV-infected adults in Belgium, Italy, Sweden and the UK

PharmacoEconomics

Volumn 28, Issue SUPPL. 1, 2010, Pages 147-167

  Moeremans, Karen ^a   Hemmett, Lindsay ^b   Hjelmgren, Jonas ^c   Allegri, Gabriele ^d   Smets, Erik ^e  

^a IQVIA   (United States)

^b Tibotec a division of Janssen Cilag Ltd   (United Kingdom)

^c Janssen Cilag AB   (Sweden)

^d Janssen Cilag SpA Italia   (Italy)

^e JOHNSON AND JOHNSON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DARUNAVIR PLUS RITONAVIR; LOPINAVIR PLUS RITONAVIR; PROTEINASE INHIBITOR; RITONAVIR PLUS TIPRANAVIR;

ADULT; AGED; ARTICLE; BELGIUM; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DEMOGRAPHY; DRUG SUBSTITUTION; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; GENE MUTATION; HEALTH STATUS; HIDDEN MARKOV MODEL; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; IMMUNE RESPONSE; ITALY; MALE; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; PROBABILITY; QUALITY ADJUSTED LIFE YEAR; REIMBURSEMENT; SWEDEN; UNITED KINGDOM; UNITED STATES;

ADULT; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; BELGIUM; CD4 LYMPHOCYTE COUNT; CLINICAL TRIALS, PHASE II AS TOPIC; COST-BENEFIT ANALYSIS; DRUG RESISTANCE, VIRAL; FEMALE; GREAT BRITAIN; HEALTH CARE COSTS; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; ITALY; MALE; MARKOV CHAINS; MULTICENTER STUDIES AS TOPIC; PYRIMIDINONES; QUALITY-ADJUSTED LIFE YEARS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RITONAVIR; RNA, VIRAL; SULFONAMIDES; SWEDEN; VIRAL LOAD;

EID: 78650725928     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.2165/11587500-000000000-00000     Document Type: Article

References (81)

1. Palella Jr 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. Mocroft A, Ledergerber B, Katlama C, et al. Decline in the AIDS and death rates in the EuroSIDA study: An observational study. Lancet 2003; 362: 22-9
3. Hamers FF, Downs AA. The changing face of the HIV epidemic in western Europe: What are the implications for public health policies? Lancet 2004; 364: 83-94
4. Walensky RP, Paltiel AD, Losina E, et al. The survival benefits of AIDS treatment in the United States. J Infect Dis 2006; 194: 11-9
5. Gallant JE. Approach to the treatment-experienced patient. Infect Dis Clin North Am 2007; 21: 85-102, viii-ix
6. Gazzard B, Bernard AJ, Boffito M, et al. British HIV Association (BHIVA) guidelines for the treatment of HIVinfected adults with antiretroviral therapy (2006). HIV Med 2006; 7: 487-503
7. European AIDS Clinical Society (EACS). Guidelines for the clinical management and treatment of HIV infected adults in Europe. 2009 Nov [online]. Available from URL: Http://www.europeanaidsclinicalsociety.org/guidelines.asp [Accessed 2009 Dec 10]
8. 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; 2009 Dec 1 [online]. Available from URL: Http://www.aidsinfo.nih.gov/ContentFiles/Adult andAdolescentGL.pdf [Accessed 2009 Dec 10]
9. Clotet B, Bellos N, Molina JM, et al. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: A pooled subgroup analysis of data from two randomised trials. Lancet 2007; 369: 1169-78
10. Madruga JV, Berger D, McMurchie M, et al. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: A randomised controlled phase III trial. Lancet 2007; 370: 49-58
11. Walmsley S, Bernstein B, King M, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med 2002; 346: 2039-46
12. DeJesus E, LaMarca A, SensionM, et al. The Context study: Efficacy and safety of GW433908/RTV in PI-experienced subjects with virological failure (24 week results) [abstract 178]. 10th Conference on Retroviruses and Opportunistic Infections; 2003 Feb 10-14; Boston, MA, USA
13. Johnson M, Grinsztejn B, Rodriguez C, et al. Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS 2005; 19: 685-94
14. Dragsted UB, Gerstoft J, YouleM, et al. A randomized trial to evaluate lopinavir/ritonavir versus saquinavir/ritonavir in HIV-1-infected patients: The MaxCmin2 trial. Antiviral Ther 2005; 10: 735-43
15. Eron Jr J, Yeni P, Gathe Jr J, 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 randomised noninferiority trial. Lancet 2006; 368: 476-82
16. Hammer SM, Saag MS, Schechter M, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society - USA panel. JAMA 2006; 296: 827-43
17. Berger DS, Northland R, Scribner A, et al. Effect of baseline factors on virological response to darunavir/r and lopinavir/r at week 48 in TITAN [abstract P7.3/27] 11th European AIDS Conference; 2007 Oct 24-27; Madrid, Spain
18. Tibotec Pharmaceuticals. Results of TITAN phase III clinical trial for darunavir/r. Mechelen, Belgium: Tibotec Pharmaceuticals. Data on file, 2007
19. Clavel F, Hance AJ. HIV drug resistance. N Engl J Med 2004; 350: 1023-35
20. Mauskopf J, Brogan A, Smets E, et al. Cost-effectiveness of TMC114 (darunavir)/ritonavir compared with currently available protease inhibitors in treatment-experienced HIV patients [abstract P51]. 8th International Congress on Drug Therapy in HIV Infection; 2006 Nov 12-16; Glasgow, UK
21. Mauskopf J, Brogan A, Martin S, et al. Cost effectiveness of darunavir/ritonavir in highly treatment-experienced, HIV- 1-infected adults in the USA. PharmacoEconomics 2010; 28 Suppl. 1: 83-105
22. Phillips AN, Lundgren JD. The CD4 lymphocyte count and risk of clinical progression. Curr Opin HIV AIDS 2006; 1: 43-9
23. Simpson KN, Luo MP, Chumney E, et al. Cost-effectiveness of lopinavir/ritonavir versus nelfinavir as the first-line highly active antiretroviral therapy regimen for HIV infection. HIV Clin Trials 2004; 5: 294-304
24. Jensen-Fangel S, Pedersen L, Pedersen C, et al. Lowmortality in HIV-infected patients starting highly active antiretroviral therapy: A comparison with the general population. AIDS 2004; 18: 89-97
25. Deeks SG, Barbour JD, Grant RM, et al. Duration and predictors of CD4 T-cell gains in patients who continue combination therapy despite detectable plasma viremia. AIDS 2002; 16: 201-7
26. Kaufmann GR, Furrer H, Ledergerber B, et al. Characteristics, determinants, and clinical relevance of CD4 T cell recovery to <500 cells/microl in HIV type 1-infected individuals receiving potent antiretroviral therapy. Clin Infect Dis 2005; 41: 361-72
27. Ledergerber B, Lundgren JD,Walker AS, et al. Predictors of trend in CD4-positive T-cell count and mortality among HIV-1-infected individuals with virological failure to all three antiretroviral-drug classes. Lancet 2004; 364: 51-62
28. Benzie AA, Bansi LK, Sabin C, et al. Viral rebound in patients on antiretroviral therapy with viral suppression: Association with extent of previous virological failure and time with viral suppression. HIV Med 2006; 7 Suppl. 1: 3. Abstract O9
29. Cahn P; RESIST 2 Study Team. 24-Week data from RESIST 2: Phase 3 study of the efficacy and safety of background therapy plus tipranavir/ritonavir (TPV/r) or optimized ritonavir-boosted standard-of-care (SOC) comparator PI (CPI) in a large randomized multicenter trial in treatmentexperienced HIV+ patients [abstract PL14.3]. 7th International Congress on Drug Therapy in HIV Infection; 2004 Nov 14-18; Glasgow, UK
30. Hicks C, Cahn P, Cooper DA, et al. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatmentexperienced 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 openlabel trials. Lancet 2006; 368: 466-75
31. Hicks C; RESIST 1 Study Team. A phase 3 randomized, controlled, open-label multicenter trial comparing tipranavir/ritonavir (TPV/r) to an optimized comparator protease inhibitor/r (CPI/r) regimen in antiretroviral (ARV) experienced patients: 24-week data [abstract 3726]. 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2004 Oct 31-Nov 2;Washington, DC, USA
32. Cooper D, Hicks C, Cahn P, et al. 24-Week RESIST study analyses: The efficacy of tipranavir/ritonavir is superior to lopinavir/ritonavir, and the TPV/r treatment is enhanced by inclusion of genotypically active antiretrovirals in the optimized background regimen (OBR) [abstract 560]. 12th Conference on Retroviruses and Opportunistic Infections; 2005 Feb 22-25; Boston, MA, USA
33. Tarwater PM, Margolick JB, Jin J, et al. Increase and plateau of CD4 T-cell counts in the 3(1/2) years after initiation of potent antiretroviral therapy. J Acquir Immune Defic Syndr 2001; 27: 168-75
34. Kaufmann GR, Perrin L, Pantaleo G, et al. CD4 Tlymphocyte recovery in individuals with advanced HIV-1 infection receiving potent antiretroviral therapy for 4 years: The Swiss HIV Cohort Study. Arch Intern Med 2003; 163: 2187-95
35. Hunt PW, Deeks SG, Rodriguez B, et al. Continued CD4 cell count increases in HIV-infected adults experiencing 4 years of viral suppression on antiretroviral therapy. AIDS 2003; 17: 1907-15
36. Smith CJ, Sabin CA, Lampe FC, et al. The potential for CD4 cell increases in HIV-positive individuals who control viraemia with highly active antiretroviral therapy. AIDS 2003; 17: 963-9
37. Garcia F, de Lazzari E, Plana M, et al. Long-term CD4+ T-cell response to highly active antiretroviral therapy according to baseline CD4+ T-cell count. J Acquir Immune Defic Syndr 2004; 36: 702-13
38. Moeremans K, Annemans L, Löthgren M, et al. Cost effectiveness of darunavir/ritonavir 600/100 mg bid in protease inhibitor-experienced, HIV-1-infected adults in Belgium, Italy, Sweden and the UK. PharmacoEconomics 2010; 28 Suppl. 1: 107-28
39. Petrou S,Dooley M, Whitaker L, et al. The economic cost of caring for people with HIV infection and AIDS in England and Wales. PharmacoEconomics 1996; 9: 332-40
40. Maggiolo F, Migliorino M, Pirali A, et al. Duration of viral suppression in patients on stable therapy for HIV-1 infection is predicted by plasma HIV RNA level after 1 month of treatment. J Acquir Immune Defic Syndr 2000; 25: 36-43
41. Yamashita TE, Phair JP, Muñoz A, et al. Immunologic and virologic response to highly active antiretroviral therapy in the Multicenter AIDS Cohort Study.AIDS 2001; 15: 735-46
42. Hill A, Moyle G. Relative antiviral efficacy of ritonavirboosted darunavir and ritonavir-boosted tipranavir vs. control protease inhibitor in the POWER and RESIST trials. HIV Med 2007; 8: 259-64
43. De Meyer S, Lathouwers E, Dierynck I, et al. Characterization of virologic failures on darunavir/ritonavir in the randomized, controlled, phase III TITAN Trial in treatment- experienced patients [abstract 874]. 15th Conference on Retroviruses and Opportunistic Infections; 2008 Feb 3-6; Boston, MA, USA
44. Cook J, Dasbach E, Coplan P, et al. Modeling the long-term outcomes and costs of HIV antiretroviral therapy using HIV RNA levels: Application to a clinical trial. AIDS Res Hum Retroviruses 1999; 15: 499-508
45. Tibotec Pharmaceuticals.Results of POWER1 and POWER2 phase II clinical trials for darunavir/r. Mechelen, Belgium: Tibotec Pharmaceuticals. Data on file, 2005
46. Caekelbergh K, Moeremans K, Annemans L, et al. Cost of care for HIV/AIDS in Belgium according to disease stage [abstract P19.5/01]. 11th European AIDS Conference; 2007 Oct 24-27; Madrid, Spain
47. Ghatnekar O, Gisslén M, Hjortsberg C, et al. Medical resource use and cost of HIV-related care in the HAART-era at a university clinic in Sweden [abstract P19.10/01]. 11th European AIDS Conference; 2007 Oct 24-27; Madrid, Spain
48. Ghatnekar O, Hjortsberg C, Gisslén M, et al. Medical resource utilization and cost ofHIV-related care in the highly active antiretroviral therapy era at a university clinic in Sweden. PharmacoEconomics 2010; 28 Suppl. 1: 49-57
49. Tramarin A, Campostrini S, PostmaMJ, et al. Amulticentre study of patient survival, disability, quality of life and cost of care: Among patients with AIDS in northern Italy. PharmacoEconomics 2004; 22: 43-53
50. Personal Social Services Research Unit (PSSRU). Unit costs of health and social care 2008. Inflation indices; [online]. Available from URL: Http://www.pssru.ac.uk/uc/uc2008 contents.htm [Accessed 2009 Dec 10]
51. Statistics Belgium. Directorate-general statistics and economic information; [online]. Available from URL: Http://statbel.fgov.be [Accessed 2009 Dec 10]
52. Istituto Nazionale di Statistica. Indices of Consumer Prices; [online]. Available from URL: Http://www.istat.it [Accessed 2006 Dec 10]
53. Statistics Sweden. Consumer price index: Tables and charts; [online]. Available from URL: Http://www.scb.se/Pages/TableAndChart-33907.aspx [Accessed 2009 Dec 10]
54. Capri S, Ceci A, Terranova L, et al. Guidelines for economic evaluations in Italy: Recommendations from the Italian group of pharmacoeconomic studies. Drug Information J 2001; 35: 189-201
55. Tandvårds- och läkemedelsförmånsverket (TLV). General guidelines for economic evaluations from the Pharmaceutical Benefits Board (LFNAR 2003:2); 2003 Apr 24 [online]. Available from URL: Http://www.tlv.se/Upload/English/ENG-lfnar-2003-2.pdf [Accessed 2009 Dec 10]
56. National Institute for Health and Clinical Excellence; [online]. Our guidance 2007. Available from URL: Http://www. nice.org.uk/guidance/index.jsp [Accessed 2009 Dec 10]
57. Cleemput I, Crott R, Vrijens F, et al. Voorlopige richtlijnen voor farmaco-economisch onderzoek in België Brussel: Federaal Kenniscentrum voor de gezondheidszorg (KCE); Mei 2006. KCE Reports vol. 28A. Ref. D/2006/10.273/10; [online]. Available from URL: Www.kce.fgov.be/Down load.aspx?ID=494 [Accessed 2009 Dec 10]
58. Schackman BR, Goldie SJ, Freedberg KA, et al. Comparison of health state utilities using community and patient preference weights derived from a survey of patients with HIV/AIDS. Med Decis Making 2002; 22: 27-38
59. King Jr JT, Justice AC, Roberts MS, et al. Long-term HIV/AIDS survival estimation in the highly active antiretroviral therapy era. Med Decis Making 2003; 23: 9-20
60. World Health Organization (WHO). Table: Threshold values for intervention cost-effectiveness by region [online]. Available from URL: Http://www.who.int/ choice/costs/CER-levels/en/index.html [Accessed 2009 Dec 10]
61. Towse A. What is NICE's threshold? An external view. Chapter 2. In: Devlin N, TowseA, editors.Cost effectiveness thresholds: Economic and ethical issues. London: King's Fund/Office for Health Economics, 2002
62. Weber R, Friis-Moller N, Sabin C, et al. HIV and non-HIVrelated deaths and their relationship to immunodeficiency: The D:A:D Study [abstract 595]. 12th Conference on Retroviruses and Opportunistic Infections; 2005 Feb 22-25; Boston, MA, USA
63. Mouton Y, Alfandari S, Valette M, et al. Impact of protease inhibitors on AIDS-defining events and hospitalizations in 10 French AIDS reference centres. Federation National desCentres de Lutte contre le SIDA.AIDS 1997; 11: F101-5
64. Stoll M, Claes C, Schulte E, et al. Direct costs for the treatment of HIV-infection in a German cohort after the introduction of HAART. Eur J Med Res 2002; 7: 463-71
65. Garattini L, Tediosi F, Di Cintio E, et al. Resource utilization and hospital cost ofHIV/AIDS care in Italy in the era of highly active antiretroviral therapy. AIDS Care 2001; 13: 733-41
66. Bozzette SA, Joyce G, McCaffrey DF, et al. Expenditures for the care of HIV-infected patients in the era of highly active antiretroviral therapy. N Engl J Med 2001; 344: 817-23
67. Levy A, Johnston K, Annemans L, et al. The impact of disease stage on direct medical costs of HIVmanagement: A review of the international literature. PharmacoEconomics 2010; 28 Suppl. 1: 35-47
68. Horne R, Clotet B, Cohen C, et al. Treatment-experienced patient perceptions of self-injectable therapy [abstract PE7.3/25]. 10th European AIDS Clinical Society Conference; 2005 Nov 11-14; Dublin, Ireland
69. U.S. Food and Drug Administration (FDA). FDA approves new HIV drug: Raltegravir tablets used in combination with other antiretroviral agents; 2007 Oct 16 [online]. Available fromURL: Http://www.fda.gov/NewsEvents/Newsroom/Press Announcements/2007/ucm109008.htm [Accessed 2009 Dec 10]
70. U.S. Food andDrug Administration (FDA). FDA approves new novel antiretroviral drug. 2007 Aug 6 [online]. Available from URL: Http://www.fda.gov/NewsEvents/News room/PressAnnouncements/2007/ucm108960.htm [Accessed 2009 Dec 10]
71. European Medicines Evaluation Agency (EMEA). Committee for Medicinal Products for Human Use (CHMP). European Public Assessment Report (EPAR): Isentress. Revision 8 - published 18/09/09. Isentress-H-C-860-II-10; [online]. Available from URL: Http://www.emea.europa. eu/humandocs/Humans/EPAR/isentress/ isentress.htm [Accessed 2009 Dec 10]
72. European Medicines Evaluation Agency (EMEA). Committee for Medicinal Products for Human Use (CHMP). European Public Assessment Report (EPAR): Celsentri. Revision 3 - published 12/08/09. Celsentri-H-C-811-II-07; [online]. Available from URL: Http://www.emea.europa.eu/humandocs/Humans/EPAR/celsentri/ celsentri.htm [Accessed 2009 Dec 10]
73. Simpson KN, Jones WJ, Rajagopalan R, et al. Cost effectiveness of lopinavir/ritonavir tablets compared with atazanavir plus ritonavir in antiretroviral-experienced patients in the UK, France, Italy and Spain. Clin Drug Investig 2007; 27: 807-17
74. Sherman DS, Fish DN. Management of protease inhibitorassociated diarrhea. Clin Infect Dis 2000; 30: 908-14
75. Loveday C, MacRae E. Susceptibility of a protease inhibitor (PI) treatment-experienced UK clinical cohort to TMC- 114 [abstract PL2.2]. 8th International Congress on Drug Therapy in HIV Infection; 2006 Nov 12-16; Glasgow, UK
76. Poveda E, de Mendoza C, Martin-Carbonero L, et al. Prevalence of darunavir resistance mutations in HIV-1- infected patients failing other protease inhibitors. J Antimicrob Chemother 2007; 60: 885-8
77. Mitsuya Y, Liu TF, Rhee SY, et al. Prevalence of darunavir resistance-associated mutations: Patterns of occurrence and association with past treatment. J Infect Dis 2007; 196: 1177-9
78. Ortiz R, Dejesus E, Khanlou H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS 2008; 22: 1389-97
79. Ammassari A, Trotta MP, Murri R, et al. Correlates and predictors of adherence to highly active antiretroviral therapy: Overview of published literature. J Acquir Immune Defic Syndr 2002 Dec 15; 31 Suppl. 3: S123-7
80. Maggiolo F, Ripamonti D, Gregis G, et al. Once-a-day therapy for HIV infection: A controlled, randomized study in antiretroviral-naive, HIV-1-infected patients. Antiviral Ther 2003; 8: 339-46
81. Negredo E, Bonjoch A, Clotet B. Benefits and concerns of simplification strategies in HIV-infected patients. J Antimicrob Chemother 2006; 58: 235-42