Translating efficacy into effectiveness in antiretroviral therapy: Beyond the pill count

Drugs

Volumn 67, Issue 14, 2007, Pages 1969-1979

  Fletcher, Courtney V ^a  

^a UNIVERSITY OF COLORADO   (United States)

Author keywords

Antiretrovirals, therapeutic use; HIV infections, treatment; Lopinavir ritonavir, therapeutic use

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; AMPRENAVIR; AMPRENAVIR PHOSPHATE; ANTIRETROVIRUS AGENT; ATAZANAVIR; ATAZANAVIR PLUS RITONAVIR; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ESOMEPRAZOLE; FAMOTIDINE; FOSAMPRENAVIR PLUS RITONAVIR; HYPERICUM PERFORATUM EXTRACT; INDINAVIR; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; METHADONE; MEVINOLIN; NELFINAVIR; OMEPRAZOLE; ORAL CONTRACEPTIVE AGENT; PROTEINASE INHIBITOR; RANITIDINE; RIFAMPICIN; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; SIMVASTATIN; STAVUDINE; TIPRANAVIR PLUS RITONAVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; ZIDOVUDINE;

BLOOD TOXICITY; BODY FAT DISTRIBUTION; CALCULATION; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; CLINICAL TRIAL; DIABETES MELLITUS; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DYSLIPIDEMIA; ENDOCRINE DISEASE; FOOD DRUG INTERACTION; GENE MUTATION; GENOTYPE; HEPATITIS; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERLACTATEMIA; HYPERSENSITIVITY REACTION; IC 50; LACTIC ACIDOSIS; LIVER TOXICITY; MYOPATHY; NAUSEA AND VOMITING; NEPHROTOXICITY; NEUROTOXICITY; PANCREAS DISEASE; PATIENT COMPLIANCE; PHENOTYPE; REVIEW; SIDE EFFECT; TREATMENT INDICATION; VIRUS REPLICATION; VIRUS STRAIN; WELLBEING;

EID: 34948875339     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200767140-00001     Document Type: Review

References (60)

1. Tapper ML, Daar ES, Piliero PJ, et al. Strategies for initiating combination antiretroviral therapy. AIDS Patient Care STDS 2005; 19 (4): 224-38
2. Sax PE, Gathe Jr JC. Beyond efficacy: the impact of combination antiretroviral therapy on quality of life. AIDS Patient Care STDS 2005; 19 (9): 563-76
3. 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
4. Phillips AN, Miller V, Sabin C, et al. Durability of HIV-1 viral suppression over 3.3 years with multi-drug antiretroviral therapy in previously drug-naive individuals. AIDS 2001; 15: 2379-84
5. Munoz A, Hoover DR. Use of cohort studies for evaluating AIDS therapies. In: Finkelstein DM, Schoenfeld DA, editors. AIDS clinical trials. New York: Wiley-Liss Inc., 1995: 423-46
6. Munoz A, Gange SJ, Jacobson LP. Distinguishing efficacy, individual effectiveness and population effectiveness of therapies. AIDS 2000; 14: 754-6
7. Bartlett JA, Fath MJ, Demasi R, et al. An updated systematic overview of triple combination therapy in antiretroviral-naive HIV-infected adults. AIDS 2006; 20: 2051-64
8. Riddler SA, Haubrich R, DiRienzo G, et al. A prospective, randomized, phase III trial of NRTI-, PI-, and NNRTI-sparing regimens for initial treatment of HIV-1 infection: ACTG 5142 [abstract no. ThLB0204]. 16th International AIDS Conference; 2006 Aug 13-18; Toronto (ON)
9. Moore RD, Keruly JC, Gebo KA, et al. An improvement in virologic response to highly active antiretroviral therapy in clinical practice from 1996 through 2002. J Acquir Immune Defic Syndrome 2005; 39: 195-8
10. Lampe FC, Gatell JM, Staszewski S, et al. Changes over time in risk of initial virological failure of combination antiretroviral therapy: a multicohort analysis, 1996 to 2002. Arch Intern Med 2006; 166: 521-8
11. Gail MH. Use of observational data for evaluating AIDS therapies. In: Finkelstein DM, Schoenfeld DA, editors. AIDS clinical trials. New York: Wiley-Liss Inc., 1995: 403-22
12. Miller LG, Huffman HB, Weidmer BA, et al. Patient preferences regarding antiretroviral therapy. Int J STD AIDS 2002; 13: 593-601
13. Sherer Jr RD, Fath MJ, Da Silva BA, et al. The importance of potency and durability in HIV patient antiretroviral therapy preferences: a telephone survey. AIDS Patient Care STDS 2005; 19: 794-802
14. Winston A, Patel N, Back D, et al. Different methods to calculate the inhibitory quotient of boosted single protease inhibitors and their association with virological response. J Acquir Immune Defic Syndrome 2006; 41: 675-6
15. Motwani B, Khayr W. Pharmacoenhancement of protease inhibitors. Am J Ther 2006; 13: 57-63
16. 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 non-inferiority trial. Lancet 2006; 368: 476-82
17. Qazi NA, Morlese JF, Pozniak AL. Lopinavir/ritonavir (ABT-378/r). Expert Opin Pharmacother 2002; 3: 315-27
18. 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
19. Acosta EP, King JR. Methods for integration of pharmacokinetic and phenotypic information in the treatment of infection with human immunodeficiency virus. Clin Infect Dis 2003; 36: 373-7
20. Mocroft A, Phillips AN, Soriano V, et al. Reasons for stopping antiretrovirals used in an initial highly active antiretroviral regimen: increased incidence of stopping due to toxicity or patient/physician choice in patients with hepatitis C coinfection. AIDS Res Hum Retroviruses 2005; 21: 527-36
21. Murphy R, Da Silva BA, McMillan F, et al. Seven year follow-up of a lopinavir/ritonovir (LPV/r)-based regimen in antiretroviral (ARV)-naive subjects [poster no. PE7.9/3]. 10th European AIDS Conference; 2005 Nov 17-20; Dublin
22. Pozniak A, Gazzard B, Anderson J, et al. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. HIV Med 2003; 4 Suppl. 1: 1-41
23. Ruane P. Simplified antiretroviral regimens to improve quality of life. Simplification of antiretroviral therapy: optimizing quality-of-life concerns, volume 1 [online]. Available from URL: http://www.medscape.com/viewarticle/ 524241 [Accessed 2006 Jun 15]
24. O'Brien ME, Clark RA, Besch CL, et al. Patterns and correlates of discontinuation of the initial HAART regimen in an urban outpatient cohort. J Acquir Immune Defic Syndr 2003; 34: 407-14
25. Schrader S, Chuck SK, Rahn LW, et al. Switching to lopinavir/ritonavir (LPV/r) tablets once daily (TAB-QD) from soft-gelatin capsule dosed BID/QD (SGC-BID/SGC-QD) led to significant improvements in tolerability, diarrhea, antidiarrheal medication use, and satisfaction [poster no. 83]. 8th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV; 2006 Sep 24-26; San Francisco (CA)
26. Johnson MA, Gathe Jr JC, Podzamczer D, et al. A once-daily lopinavir/ritonavir-based regimen provides noninferior antiviral activity compared with a twice-daily regimen. J Acquir Immune Defic Syndr 2006; 43: 153-60
27. Louie M, Markowitz M. Goals and milestones during treatment of HIV-1 infection with antiretroviral therapy: a pathogenesis-based perspective. Antiviral Res 2002; 55: 15-25
28. Stone VE, Jordan J, Tolson J, et al. Perspectives on adherence and simplicity for HIV-infected patients on antiretroviral therapy: self-report of the relative importance of multiple attributes of highly active antiretroviral therapy (HAART) regimens in predicting adherence. J Acquir Immune Defic Syndr 2004; 36: 808-16
29. Duran S, Spire B, Raffi F, et al. Self-reported symptoms after initiation of a protease inhibitor in HIV-infected patients and their impact on adherence to HAART. HIV Clin Trials 2001; 2 (1): 38-45
30. Max B, Sherer R. Management of the adverse effects of antiretroviral therapy and medication adherence. Clin Infect Dis 2000; 30 Suppl. 2: S96-116
31. Williams A, Friedland G. Adherence, compliance, and HAART. AIDS Clin Care 1997; 9: 51-54, 58
32. Piscitelli SC, Penzak SR, Flexner C. Practical therapeutics. In: Wormser GP, editor. AIDS and other manifestations of HIV infection. 4th ed. San Diego (CA): Elsevier Academic Press, 2004: 914-30
33. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, October 10, 2006 [online]. Available from URL: http://aidsinfo.nih. gov/ContentFiles/AdultandAdolescentGL.pdf [Accessed 2006 Oct 16]
34. Gourevitch MN, Friedland GH. Interactions between methadone and medications used to treat HIV infection: a review. Mt Sinai J Med 2000; 67: 429-36
35. Altice FL, Friedland GH, Cooney EL. Nevirapine induced opiate withdrawal among injection drug users with HIV infection receiving methadone. AIDS 1999; 13: 957-62
36. Abbott Laboratories. Kaletra® (lopinavir/ritonavir) tablets and oral solution. Prescribing information [online]. Abbott Laboratories, North Chicago (IL). Available from URL: http://ww-w.rxabbott.com/pdf/kaletratabpi.pdf [Accessed 2006 Jun 15]
37. Oldfield V, Plosker GL. Lopinavir/ritonavir: a review of its use in the management of HIV infection. Drugs 2006; 66: 1275-99
38. Adams C, Balkin A. Proton pump inhibitors (PPIs), antacids and histamine antagonists: what do HIV patients taking PIs know and do [poster no. 4.3/8]? 10th European AIDS Conference; 2005 Nov 17-20; Dublin
39. Klein CE, Chiu Y-L, Cai Y, et al. Lack of effect of acid reducing agents on the pharmacokinetics (PK) of lopinavir/ritonovir (LPV/r) tablet formulation [poster no. L-1003]. 13th Conference on Retroviruses and Opportunistic Infections; 2006 Feb 5-8; Denver (CO)
40. Winston A, Boffito M. The management of HIV-1 protease inhibitor pharmacokinetic interactions. J Antimicrob Chemother 2005; 56: 1-5
41. la Porte C, Cameron DW, Sabo JP, et al. The effect of omeprazole, food and formulation on the pharmacokinetics of tipranavir coadministered with ritonavir [abstract no. 59]. 8th International Workshop on Clinical Pharmacology of HIV Therapy; 2007 Apr 16-18; Budapest
42. Agarwala S, Eley TVC, Child M, et al. Pharmacokinetic effect of famotidine on atazanavir with and without ritonavir in healthy subjects [abstract no. 11]. 6th International Workshop on Clinical Pharmacology of HIV Therapy; 2005 Apr 28-30; Quebec (QC)
43. Highleyman L. Drug interactions and anti-HIV therapy. BETA 2005; 17: 20-9
44. Ouellet D, Hsu A, Qian J, et al. Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers. Br J Clin Pharmacol 1998; 46: 111-6
45. Chersich MF, Urban MF, Venter FW, et al. Efavirenz use during pregnancy and for women of child-bearing potential [online]. Available from URL: http://www.aidsrestherapy.com/content/3/1/11 [Accessed 2007 Aug 22]
46. Goicoechea M, Best B. Efavirenz/emtricitabine/tenofovir disoproxil fumarate fixed-dose combination: first-line therapy for all? Expert Opin Pharmacother 2007; 8: 371-82
47. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23: 1296-310
48. Portsmouth SD, Osorio J, McCormick K, et al. Better maintained adherence on switching from twice-daily to once-daily therapy for HIV: a 24-week randomized trial of treatment simplification using stavudine prolonged-release capsules. HIV Med 2005; 6: 185-90
49. Moyle G. The Assessing Patients' Preferred Treatments (APPT-1) study. Int J STD AIDS 2003; 14 Suppl. 1: S34-6
50. Rode R, Vrijens B, Niemi K, et al. Differenes in treatment compliance between lopinavir/ritonovir (LPV/r) given once (QD) versus twice (BID) daily do not affect virological or immunological [poster no. H-522]. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2005 Dec 16-19; Washington, DC
51. Vrouenraets SM, Wit FW, van Tongeren J, et al. Efavirenz: a review. Expert Opin Pharmacother 2007; 8: 851-71
52. Malan N, Krantz E, David N, et al. Efficacy and safety of atazanavir-based therapy in antiretroviral naive HIV-1 infected subjects, both with and without ritonavir, 48-week results from AI124-089 [abstract no. 107LB]. 13th Conference on Retro-viruses and Opportunistic Infections; 2006 Feb 5-8; Denver (CO)
53. Yeh KC, Deutsch PJ, Haddix H, et al. Single-dose pharmacokinetics of indinavir and the effect of food. Antimicrob Agents Chemother 1998; 42: 332-8
54. Electronic Medicines Compendium. Videx product information [online]. Available from URL: http://www.emc.medicines.-org.uk/ [Accessed 2006 Nov 27]
55. Electronic Medicines Compendium. Invirase product information [online]. Available from URL: http://www.emc.-medicines.org.uk/ [Accessed 2006 Nov 27]
56. Breitenbach J. Melt extrusion brings new benefits to HIV therapy. Am J Drug Deliv 2006; 4: 61-4
57. Klein CE, Chiu YL, Awni W, et al. The tablet formulation of lopinavir/ritonavir provides similar bioavailability to the soft-gelatin capsule formulation with less pharmacokinetic variability and diminished food effect. J Acquir Immune Defic Syndr 2007; 44: 401-10
58. Wagner GJ, Ryan GW. Relationship between routinization of daily behaviors and medication adherence in HIV-positive drug users. AIDS Patient Care STDS 2004; 18: 385-93
59. Catz SL, Kelly JA, Bogart LM, et al. Patterns, correlates, and barriers to medication adherence among persons prescribed new treatments for HIV disease. Health Psychol 2000; 19: 124-33
60. Johnson MO, Charlebois E, Morin SF, et al. Perceived adverse effects of antiretroviral therapy. J Pain Symptom Manage 2005; 29: 193-205