Simplification strategies to reduce antiretroviral drug exposure: Progress and prospects

Antiviral Therapy

Volumn 14, Issue 1, 2009, Pages 1-12

  McKinnon, John E ^a   Mellors, John W ^a   Swindells, Susan ^b  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTIRETROVIRUS AGENT; ATAZANAVIR; ATAZANAVIR PLUS RITONAVIR; DARUNAVIR; DARUNAVIR PLUS RITONAVIR; DIDANOSINE; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; FOSAMPRENAVIR PLUS RITONAVIR; INDINAVIR; INDINAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; INDINAVIR PLUS RITONAVIR; INDINAVIR PLUS ZIDOVUDINE; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TENOFOVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ANTIVIRAL RESISTANCE; ANTIVIRAL THERAPY; CARDIOVASCULAR DISEASE; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; COST BENEFIT ANALYSIS; COST CONTROL; CREATININE BLOOD LEVEL; DOSAGE SCHEDULE COMPARISON; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG EXPOSURE; DRUG INTERMITTENT THERAPY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERLIPIDEMIA; KIDNEY DISEASE; LIVER DISEASE; MAINTENANCE THERAPY; MONOTHERAPY; NEPHROLITHIASIS; NEPHROTOXICITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; SIDE EFFECT;

ADMINISTRATION, ORAL; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRUG RESISTANCE, MULTIPLE, VIRAL; DRUG THERAPY, COMBINATION; FORECASTING; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MEDICATION ADHERENCE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR;

EID: 61849099349     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (70)

1. Negredo E, Bonjoch A, Clotet B. Benefits and concerns of simplification strategies in HIV-infected patients. J Antimicrob Chaemother 2006; 58:235-242.
2. Schechter M, Nunes EP. Monotherapy with lopinavir/ritonavir. Expert Opin Investig Drugs 2007; 16:735-741.
3. Rosenbach KA, Allison R, Nadler JR Daily dosing of highly active antiretroviral therapy. Clin Infect Dis 2002; 34:686-692.
4. Nilsson Schonnesson L, Williams ML, Ross MW, Bratt G, Keel B. Factors associated with suboptimal antiretroviral therapy adherence to dose, schedule, and dietary instructions. AIDS Behav 2007; 11:175-183.
5. Ammassari A, Trotta MP, Murri R, et al. Correlates and predictors of adherence to highly active antiretroviral therapy: overview of published litreature. J Acquir Immune Defic Syndr 2002; 31:S123-S127.
6. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Department of Health and Human Services. November 3, 2008. (Updated 3 November 2008. Accessed 4 November 2008.) Available at http://www.aidsinfo.nih.gov
7. A once-daily combination tablet (Atripla) for HIV. Med Lett Drugs Ther 2006; 48:78-79.
8. World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a 3ublic health approach. 2006 revision. (Updated 7 Au ust 006. Accessed 8 January 2008.) Available from http://www.who.int/hiv/pub/guidelines/ artadultguidelines.pdf
9. Henry K, Brundage R, Weller D, Akinsete O, Sher A. Comparison of generic zidovudine plus lamivudine (Cipla, Duovir) and the GlaxoSmithKline brand (Combivir) tablets. J Acquir Immune Defic Syndr 2004; 35:537.
10. Vezina HE, Henry K, Ravindran GD, et al. A randomized crossover study to determine bioequivalence of generic and brand name nevirapine, zidovudine, and lamivudine in HIV-negative women in India. J Acquir Immune Defic Syndr 2006; 41:131-136.
11. US Food and Drug Administration. Approved and tentatively approved antiretrovirals in association with the President's emergency plan. (Updated 23 December 2008. Accessed 22 September 2008.) Available from http://www.fda.gov/oia/pepfar.htm
12. Khanlou H, Yeh V, Guyer B, Farthing C. Early virologic failure in a pilot study evaluatt the efficacy of therapy containing once-daily abacavir, lamivudine, and tenofovir DF in treatment-naive HIV-infected patients. AIDS Patient Care STDS 2005; 19:135-140.
13. Gallant JE, Rodriguez AE, Weinberg WG, et al. Early virologic nonresponse to tenofovir, abacavir, and lamivudine in HIV-infected antiretroviral-naive subjects. J Infect Dis 2005; 192:1921-1930.
14. Gulick RM, Ribaudo HJ, Shikuma CM, et al. Triple-nucleoside regimens versus efavirenz-contianing regimens for the initial treatment of HIV-1 infection. N Engl J Med 2004; 350:1850-1861.
15. Perez-Elias MJ, Moreno A, Moreno S, et al. Higher virological effectiveness of NNRTI-based antiretroviral regimens containing nevirapine or efavirenz compared to a triple NRTI regimen as initial therapy in HIV-1-infected adults. HIV Clin Trials 2005; 6:312-319.
16. Gulick RM, Ribaudo HJ, Shikuma CM, et al. Three- vs four-drug antreroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial. JAMA 2006; 296:769-781.
17. Hammer SM, Saag MS, Schechter M, et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel. Top HIV Med 2006; 14:827-843. [Republished from JAMA 2006; 296:827-843
18. Wohl DA, McComsey G, Tebas P et al. Current concepts in the diagnosis and management of metabolic complications of HIV infection and its therapy. Clin Infect Dis 2006; 43:645-653.
19. Opravil M, Hirschel B, Lazzarin A, et al. A randomized trial of simplified maintenance therapy with abacavir, 1amivudine, and zidovudine in human immunodeficiency virus infection. J Infect Dis 2002; 185:1251-1260.
20. Katlama C, Fenske S, Gazzard B, et al. TRIZAL study: switching iron successful HAART to Trizivir™ (abacavir-lamivudine-zidovudine combination tablet): 48 weeks efficacy, safety and adherence results. HIV Med 2003; 4:79-86.
21. Markowitz M, Hill-Zabala C, Lang J, et al. Induction with abacavir/lamivudine/zidovudine plus efavirenz for 48 weeks followed by 48-week maintenance with abacavir/lamivudine/zidovudine alone in antiretroviral-naive HIV-1-infected patients. J Acquir Immune Defic Syndr 2005; 39:257-264.
22. Mallolas J, Pich J, Penaranda M, et al. Induction therapy with trizivir plus efavirenz or lopinavir/ritonavir followed by trizivir alone in naive HIV-1-infected adults. AIDS 2008; 22:377-384.
23. Robbins GK, De Gruttola V, Shafer RW, et al. Comparison of sequential three-drug regimens as initial thera or HIV-1 infection. N Engl J Med 2003; 349:2293-2303.
24. Staszewski S, Morales-Ramirez J, Tashima KT, et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. N Engl J Med 1999; 341:1865-1873.
25. Riddler SA, Haubrich R, DiRienzo AG, et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 2008; 358:2095-2106.
26. Delaugerre C, Rohban R. Simon A, et al. Resistance profile and cross-resistance of HIV-1 among patients failing a non-nucleoside reverse transcriptase inhibitor-containing regimen. J Med Virol 2001; 65:445-448.
27. Madruga JV, Cahn P, Grinsztejn B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised double-blind, placebo-controlled trial. Lancet 2007; 370:29-38.
28. Lazzarin A, Campbell T, Clotet B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial, Lancet 2007; 370:39-48.
29. Goebel F, Yokovelev A, Pozniak AI, et al. Short-term antiviral activity of TMC278 - a novel NNRTI - in treatment-naive HIV-1-infected subjects. AIDS 2006; 20:1721-1726.
30. + ARV naive patients. Interim analysis of subjects completing at least 24 weeks of a 48 week study. 43rd Annua Interscience Conference on Antimicrobial Agents and Chemotherapy 14-17 September 2003, Chicago, IL, USA. Abstract 2608.
31. Delfraissy JF, Flandre P, Delaugerre C, et al. Lopinavir/ ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS 2008;4 22:385-393
32. Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five days-on, two-days-off (FOTO) study. HIV Clin Trials 2007; 8:19-23.
33. Dybul M, Nies-Kraske E, Dewar R, et al. A proo f-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine lamivudine, and efavirenz for the treatment of chronic HIV infection. J Infect Dis 2004; 189:1974-1982.
34. Dybul M, Chun TW Yoder C, et al. Short-cycle structured intermittent treatment of chronic HIV infection highly active antiretroviral therapy: effects on virologic immunologic, and toxicity parameters. Proc Nad Acad Sci U S A 2001; 98:15161-15166
35. Danel C, Moh R, Minga A, et al. CD4-guided antiretroviral treatment interruption strategy in HIV infected adults in west Africa (Trivacan ANRS 1269 trial): a randomized trial. Lancet 2006; 367:1981-1989.
36. Ananworanich J, Gayet-Ageron A, Le Braz M, et al. guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomized trial. Lancet 2006; 368:459-465.
37. + count-guided interruption of antiretroviral treatment. N Engl J Med 2006; 355:2283-2296.
38. Opravil M, Baumann D, Chave JP, et al. Long-term efficacy after switch from protease inhibitor-containing highly active antiretroviral therapy to abacavir, lamivudine, and zidovudine. AIDS 2004; 18:2213-2215
39. Havlir DV, Marschner IA, Hirsch MS, et al. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. N Engl J Med 1998; 339:1261-1268
40. Pialoux G, Raffi F, Brun-Vezinet F, et al. A randomized trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and t indinavir in previously untreated HIV-1-infected patients. N Engl J Med 1998; 339:1269-1276.
41. Kahlert C, Hupfer M, Wagels T, et al. Ritonavir boosted indinavir treatment as a simplified maintenance "mono"- therapy for HIV infection. AIDS 2004; 18:955-957.
42. Arribas JR, Pulido F, Delgado R, et al. Lopinavir/ritonavir as single-drug therapy for maintenance of HIV-1 viral suppression: 48-week results of a randomized, controlled, open-label, proof-of-concept pilot clinical trial (OK Study). J Acquir Immune Defic Syndr 2005; 40: 280-287.
43. McKinnon JE, Arribas JR, Pulido F, Delgado R, mellors JW. The level of persistent HIV viremia does not increase after successful simplication of maintenance therapy to lopinavir/ritonavir alone. AIDS 2006; 20:2331-2335.
44. Pulido F, Delgado R, Perez-Valero I, et al. Long-term 94 years) efficacy of lopinavir/ritonavir monotherapy for maintenance of HIV suppression. J Antimicrob Chemother 2008; 61:1359-1361.
45. Pulido F, Arribas JR, Delgado R, et al. Lopinavir-ritnovir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS 2008; 22:F1-F9.
46. Arribas JR, Pulido F, Delgado R, et al. Lopinavir/ritonavir monotherapy versus lopinavir/ritonavir and two nucleosides fro maintenance therapy of HIV. Ninety-six week results of a randomized, controlled, open-label clinical trial (OK04 Study). 11th European AIDS Conference/EACS. 24-27 October 2007, Madrid, Spain. Abstract PS3/1.
47. Pulido F, Arribas J, Gonzalez-Garcia J, et al. Risk factors for loss of virological suppression at 48 weeks in patients receiving lopinavir/ritonavir monotherapy vs triple therapy with LPV/r (OK and OK04 Trials). 14th Conference on Retroviruses and Opportunistic Infections. 25-28 February 2007, Los Angeles, CA, USA. Abstract 513.
48. Cameron W, de Silva B, Arribas J, et al. A two-year randomized controlled clinical trial in antiretroviral-naive subjects using lopinavir/ritonavir (LPV/r) monotherapy after initial induction treatment compared to an efavirenz (EFV) 3-drug regimen (Study M03-613). XVI International AIDS Conference 13-18 August 2006, Toronto, ON Canada. Abstract THLB0201.
49. Campo R, da Silva BA, Cotte I, et al.. Predictors of loss of virologic response in subjects who deintensified to lopinavir/ritonavir monotherapy after achieving plasma HIV-1 RNA,50 copies/ml on lopinavir/ ritonavir plus zidovudine/lamivudine. 14th Conference on Retroviruses and Opportunistic Infections. 25-28 February 2007, Los Angeles, CA, USA. abstract 514.
50. Cameron W, da Silva B, Arribas J, et al. Significant sparing of peripheral lipotrophy by HIV treatment with LPV/r + ZDV/#TC induction followed by LPV/r monotherapy compared with EFV + ZDV/3TC. 14th Conference on Retroviruses and Opportunistic Infections. 25-28 February 2007, Los Angeles, CA, USA. Abstract 44LB.
51. Nunes EP, Oliviera MS, Almeida MMTB, et al. 48-week efficacy and safety results of simplication to single agent lopinavir/ritonavir (LPV/ r) regimen in patients suppressed below 80 copies/ml on HAART- the KalMO Study. XVI International AIDS Confernce 13-18 August 2006, Toronto, ON Canada. Abstract TUAB0103.
52. Sprinz E, Bay MB, Lazzaretti RK, Jeffman MW, Mattevi VS. Lopinavir/ ritonavir monotherrapy as maintenance treatment in HIV-infected individuals with virological suppressrion: results from a pilot study in Brazil. HIV Med 2008; 9:270-276.
53. Sanne I, Piliero P, Squires K, et al. Results of a phase 2 clinical trial at 48 weeks (AI424-007): a dose-ranging, safety, and efficacy comparative of atazanavir at three doses in combination with didanosine and stavudine in antiretroviral-naive subjects. J Acquir Immune Defic Syndr 2003; 32:18-29.
54. Gatell J, Salmon-Ceron D, LazzarinA, et al. Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: the SWAN Study (AI424-097) 48-week results. Clin Infect Dis 2007; 44:1484-1491.
55. Gong YF, Robinson BS, Rose RE, et al. In vitro resistance profile of the human immunodefiency virus type 1 protease inhibitor MBS-232632. Antimicrob Agents Chemother 2008; 44:2319-2326.
56. Molina J-M, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and enitricitabine, for management of antiretroviral-naive HIV- 1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet 2008; 372:646-655.
57. Vernazza P, Daneel S, Schiffer V, et al. The role of compartment penetration in PI-monotherapy: the Atazanavir-Ritonavir Monomaintenance (ATARITMO) Trial. AIDS 2007; 21:1309-1315.
58. Swindells S, DiRienzo AG, Wilkin T, et al. Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy after sustained virologic suppression. JAMA 2006; 296:806-814.
59. McKinnon JE, Wilkin T, Swindells S, et al. Absence of protease resistance with virologic rebound by single genome sequencing on atazanavir/ritonavir as simplified maintenance therapy: ACTG 5201. 15th Conference on Retroviruses and Opportunistic Infections. 3-8 February 2008, Boston, MA, USA. Abstract 890.
60. Karlstrom O, Josephson F, Sonnerborg A. Early virologic rebound in a pilot trial of ritonavir-boosted atazanavir as maintenance monotherapy. J Acquir Immune Defic Syndr 2007; 44:417-422.
61. Shurtleff AC. TMC-1 14. Curr Opin Investig Drugs 2004; 5:879-886.
62. Wynn HE, Brundage RC, Fletcher CV. Clinical implications of CNS penetration of antiretroviral drugs. CNS Drugs 2002; 16:595-609.
63. Letendre SL, van den Brande G, Hermes A, et al. Lopinavir with ritonavir reduces the HIV RNA level in cerebrospinal fluid. Clin Infect Dis 2007; 45:1511-1517.
64. Yeh RF, Hammill HA, Fiscus SA, et al. Single agent therap (SAT) with lopinavir/ritonavir (LPV/r) controls HIV-1 viral replication in the female genital tract. 11th European AIDS Conference/EACS. 25-28 October 2007, Madrid, Spain. Abstract P7.7/02.
65. Schackman BR, Scott CA, Sax PE, et al. Potential risks and benefits of HIV regimen simplification: a simulation model of a proposed clinical trial. Clin Infect Dis 2007; 45:1062-1070.
66. Rey D, Hoen B, Chavanet P, et al. High rate of early virological failure with the once-daily tenofovir/lamivudine/nevirapine combination in naive HIV-1-infected patients. J Antimicrob Chemother 2009; 63:380-388.
67. Flandre P, Raffi F, Descamps D, et al. Final analysis of the Trilège induction-maintenance trial: results at 18 months. AIDS 2002; 16:561-568.
68. Reijers MH, Weverlin GJ, jurriaans S, et al. Maintenance therapy after quadrupfle induction therapy in HIV-1 infected individuals: Amsterdam Duration of Antiretroviral Medication (ADAM) study. Lancet 1998; 352:185-190.
69. Reijers MH, Weverling GJ, jurriaans S, et al. The ADAM study continued: maintenance therapy after 50 weeks of induction therapy. AIDS 2001; 15:129-131.
70. Pierone G, Jr., Mieras J, Bulgin-Coleman D, et al. A pilot study of switch to lopinavir/ritonavir (LPV/r) monotherapy from normucleoside reverse transcriptase inhibitor-based therapy. HIV Clin Trials 2006; 7:237-245.