Effectiveness of protease inhibitor monotherapy versus combination antiretroviral maintenance therapy: A meta-analysis

PLoS ONE

Volumn 6, Issue 7, 2011, Pages

  Mathis, Sandra ^a   Khanlari, Bettina ^b   Pulido, Federico ^c   Schechter, Mauro ^d   Negredo, Eugenia ^e   Nelson, Mark ^f   Vernazza, Pietro ^g   Cahn, Pedro ^h   Meynard, Jean Luc ⁱ   Arribas, Jose ^j   Bucher, Heiner C ^a  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

^c UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^d FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^e HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^f CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^g CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^h FUNDACIÓN HUÉSPED   (Argentina)

ⁱ HÔPITAL SAINT ANTOINE   (France)

^j UNIVERSIDAD AUTÓNOMA DE MADRID   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DARUNAVIR; HUMAN IMMUNODEFICIENCY VIRUS PROTEINASE INHIBITOR; LOPINAVIR; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANTIVIRAL THERAPY; ARTICLE; CD4 LYMPHOCYTE COUNT; CEREBROSPINAL FLUID; COMBINATION CHEMOTHERAPY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HEPATITIS C; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTENTION TO TREAT ANALYSIS; MAINTENANCE THERAPY; META ANALYSIS; MIXED INFECTION; MONOTHERAPY; MORTALITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; UNSPECIFIED SIDE EFFECT; VIREMIA; VIRUS LOAD; VIRUS MUTATION; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DRUG COMBINATION; FOLLOW UP; MAINTENANCE CHEMOTHERAPY; REVIEW; RISK FACTOR; TREATMENT OUTCOME; VIROLOGY;

CLINICAL TRIALS AS TOPIC; DRUG THERAPY, COMBINATION; FOLLOW-UP STUDIES; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; INTENTION TO TREAT ANALYSIS; MAINTENANCE CHEMOTHERAPY; RISK FACTORS; TREATMENT OUTCOME;

EID: 79960446259     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0022003     Document Type: Article

References (61)

1. Thompson MA, Aberg JA, Cahn P, Montaner JS, Rizzardini G, et al. (2010) Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA 304: 321-33.
2. Sterne JA, Hernan MA, Ledergerber B, Tilling K, Weber R, et al. (2005) Long-term effectiveness of potent antiretroviral therapy in preventing AIDS and death: a prospective cohort study. Lancet 366: 378-84.
3. Gallant JE, DeJesus E, Arribas JR, Pozniak AL, Gazzard B, et al. (2006) Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med 354: 251-60.
4. Arribas JR, Pulido F, Delgado R, Lorenzo A, Miralles P, et al. (2005) 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 40: 280-87.
5. Pierone G Jr, Mieras J, Bulgin-Coleman D, Kantor C, Shearer J, et al. (2006) A pilot study of switch to lopinavir/ritonavir (LPV/r) monotherapy from nonnucleoside reverse transcriptase inhibitor-based therapy. HIV Clin Trials 7: 237-45.
6. Battegay M, Bucher HC, (2010) Antiretroviral monotherapy: should we abandon the principles of successful antiretroviral therapy? AIDS 24: 1057-59.
7. Panel on Antiretroviral Guidelines for Adults and Adolescents (2009) Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services.
8. European AIDS Clinical Society (2009) Clinical Management and Treatment of HIV Infected Adults in Europe. http://www.europeanaidsclinicalsociety.org/guidelines.asp. Accessed 2011 June 16.
9. DerSimonian R, Laird N, (1986) Meta-analysis in clinical trials. Contr Clin Trials 7: 177-88.
10. Higgins JP, Thompson SG, Deeks JJ, Altman DG, (2003) Measuring inconsistency in meta-analyses. BMJ 327: 557-60.
11. Higgins JP, Thompson SG, (2002) Quantifying heterogeneity in a meta-analysis. Stat Med 21: 1539-58.
12. Sterne JA, Egger M, (2001) Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. J Clin Epidemiol 54: 1046-55.
13. Soonawala D, Middelburg RA, Egger M, Vandenbroucke JP, Dekkers OM, (2010) Efficacy of experimental treatments compared with standard treatments in non-inferiority trials: a meta-analysis of randomized controlled trials. Int J Epidemiol 39: 1567-81.
14. Le HA, Giraudeau B, Baron G, Ravaud P, (2006) Quality of reporting of noninferiority and equivalence randomized trials. JAMA 295: 1147-51.
15. Gisolf EH, Jurriaans S, Pelgrom J, van Wanzeele F, van der Ende ME, et al. (2000) The effect of treatment intensification in HIV-infection: a study comparing treatment with ritonavir/saquinavir and ritonavir/saquinavir/stavudine. Prometheus Study Group. AIDS 14: 405-13.
16. Eron JJ, Haubrich R, Lang W, Pagano G, Millard J, et al. (2001) A phase II trial of dual protease inhibitor therapy: amprenavir in combination with indinavir, nelfinavir, or saquinavir. J Acquir Immune Defic Syndr 26: 458-61.
17. Gisolf EH, Dreezen C, Danner SA, Weel JL, Weverling GJ, (2000) Risk factors for hepatotoxicity in HIV-1-infected patients receiving ritonavir and saquinavir with or without stavudine. Prometheus Study Group. Clin Infect Dis 31: 1234-39.
18. Delfraissy JF, Flandre P, Delaugerre C, Ghosn J, Horban A, et al. (2008) Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS 22: 385-93.
19. Cameron DW, da Silva BA, Arribas JR, Myers RA, Bellos NC, et al. (2008) A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis 198: 234-40.
20. Havlir DV, Marschner IC, Hirsch MS, Collier AC, Tebas P, et al. (1998) Maintenance antiretroviral therapies in HIV infected patients with undetectable plasma HIV RNA after triple-drug therapy. AIDS Clinical Trials Group Study 343 Team. N Engl J Med 339: 1261-68.
21. Lewi DS, Suleiman JM, Uip DE, Pedro RJ, Souza RA, et al. (2000) Randomized, double-blind trial comparing indinavir alone, zidovudine alone and indinavir plus zidovudine in antiretroviral therapy-naive HIV-infected individuals with CD4 cell counts between 50 and 250/mm3. Rev Inst Med Trop Sao Paulo 42: 27-36.
22. Hirsch M, Steigbigel R, Staszewski S, Mellors J, Scerpella E, et al. (1999) A randomized, controlled trial of indinavir, zidovudine, and lamivudine in adults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy. J Infect Dis 180: 659-665.
23. Murphy RL, Gulick RM, DeGruttola V, D'Aquila RT, Eron JJ, et al. (1999) Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection. AIDS Clinical Trials Group 347 Study Team. J Infect Dis 179: 808-16.
24. Gilks CF, Walker AS, Munderi P, Reid A, Ssali F, et al. (2010) Boosted protease inhbitor monotherapy as maintenance second-line-retroviral therapy in Africa. XVIII Internationa AIDS Conference July 18-23, 2010 Vienna Abstract LPBE16.
25. The HIV Netherlands Australia Thailand Research Collaboration, (2010) Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)- Based Regimens NCT00627055.
26. Medical Research Council, (2010) Europe-Africa Research Network for Evaluation of Second-line Therapy (EARNEST) NCT00988039.
27. Fundacion SEIMC-GESIDA, (2010) Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy (KRETA) NCT00865007.
28. French National Agency for Research on AIDS and Viral Hepatitis (2010) Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-Partum Phase. ANRS 135 Primeva, NCT00424814.
29. Bamrasnaradura Infectious Diseases Institute (2010) Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure (BIDI-MONO) NCT01189695.
30. French National Agency for Research on AIDS and Viral Hepatitis (2010) Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients (ANRS 140 DREAM) NCT00946595.
31. Fundacion SEIMC-GESIDA (2010) Prevention of Lipoatrophy in Patients Treated With Lopinavir/Ritonavir in Monotherapy Versus ZDV +3TC + ABC (KALIPO) NCT00865475.
32. Sociedad Andaluza de Enfermedades Infecciosas (2010) Clinical Trial, Open-label, Randomised, in Order to Compare the Quality of Life for Those VIH+ Patients That Start With Monotherapy on LPV/r Tablets Vs.Triple Therapy With a Boosted Protease Inhibitor (QoLKAMON) NCT01166477.
33. IRCCS San Raffaele (2010) Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy NCT00437476.
34. Fundacion SEIMC-GESIDA (2010) Treatment of HIV/HCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy With Lopinavir/r (PEKARI) NCT00866021.
35. Medical Research Council Clinical Trials Unit LU (2010) A randomised controlled trial of a strategy of switching to boosted protease inhibitor monotherapy versus continuing combination antiretroviral therapy for the long-term management of HIV-1 infected patients who have achieved sustained virological suppression on highly-active antiretroviral therapy ISRCTN04857074.
36. Guy's & St.Thomas' NHS Foundation Trust (UK) (2010) The metabolic impact of Darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1 infected patients: An unblinded, multicentre, randomised controlled trial ISRCTN04857074.
37. IRCCS San Raffaele (2010) Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy NCT00437684.
38. Vrije University Medical Centre (VUMC) (The Netherlands) (2010) HAART followed by maintenance with monotherapy- Kaletra (MAIMOKA) ISRCTN45284754.
39. Waters L, Jackson A, Singh K, Higgs C, Mandalia S, et al. (2008) Lopinavir Monotherapy get title. XVII International AIDS Conference August 3-8, 2008, Mexico City, Mexico Abstract CDB0193.
40. Pulido F, Arribas JR, Delgado R, Cabrero E, Gonzalez-Garcia J, et al. (2008) Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS 22: F1-F9.
41. Gutmann C, Cusini A, Gunthard HF, Fux C, Hirschel B, et al. (2010) Randomized controlled study demonstrating failure of LPV/r monotherapy in HIV: the role of compartment and CD4-nadir. AIDS 24: 2347-54.
42. Nunes EP, Santini de OM, Mercon M, Zajdenverg R, Faulhaber JC, et al. (2009) Monotherapy with Lopinavir/Ritonavir as maintenance after HIV-1 viral suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). HIV Clin Trials 10: 368-74.
43. Cahn P, Andrade-Villanueva J, Sierra-Madero J, Casetti I, Junod P, et al. (2010) Efficacy and safety of lopinavir/ritonavir monotherapy vs. standard of care consisting of a protease inhibitor and two NRTIs in adults with HIV-1. 12th European AIDS Conference (EACS) November 11-14, 2009 Cologne, Germany Abstract P/S4 3.
44. Meynard JL, Bouteloup V, Landman R, Bonnard P, Baillat V, et al. (2010) Lopinavir/ritonavir monotherapy versus current treatment continuation for maintenance therapy of HIV-1 infection: hte KALESOLO trial. J Antimicrob Chemother 65: 2436-44.
45. Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, et al. (2010) Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS 24: 2365-74.
46. Arribas JR, Horban A, Gerstoft J, Fatkenheuer G, Nelson M, et al. (2010) The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS 24: 223-30.
47. Echeverria P, Domingo P, Gutierrez M, Mateo G, Fuster M, et al. (2010) Saqinavir/ritonavir monotherapy as a new nucleoside sparing maintenance strategy in long-term virologically suppressed HIV-infected patients. Curr HIV Res 8: 467-70.
48. Pulido F, Arribas J, Delgado R, Pano JR, Lorenzo A, et al. (2010) Lopinavir/ritonavir as single-drug for maintenance of HIV-1 viral suppression. A randomized, controlled, open label, pilot, clinical trial (OK Study): 72 weeks analysis. 10th European AIDS Conference/EACS, November 17-20, 2005 Dublin, Irleand Abstract PE7 5/5.
49. Arribas JR, Delgado R, Arranz A, Munoz R, Portilla J, et al. (2009) Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr 51: 147-52.
50. Rieger A, Banhegyi D, Schmidt W, Arribas J, Hill A, et al. (2010) The MONET trial 96 week analysis: darunavir/r monotherapy versus darunavir/r +2NRTIs, for patients with HIV RNA <50 copies/mL at baseline. XVIII Internationa AIDS Conference, July 18-23, 2010 Vienna, Austria Abstract TBLBB209.
51. Jones B, Jarvis P, Lewis JA, Ebbutt AF, (1996) Trials to assess equivalence: the importance of rigorous methods. BMJ 313: 36-39.
52. Fleming TR, (2008) Current issues in non-inferiority trials. Stat Med 27: 317-32.
53. U.S.Department of Health and Human Services Food and Drug Administration (2010) Guidance for Industry, Non-inferiority Clinical Trials. http://www.fda.gov/../GuidanceComplianceRegulatoryInformation/Guidances/ucm202140.pdf. Accessed 2011 June 16.
54. Hill A, Sabin C, (2008) Designing and interpreting HIV noninferiority trials in naive and experienced patients. AIDS 22: 913-21.
55. Canestri A, Lescure FX, Jaureguiberry S, Moulignier A, Amiel C, et al. (2010) Discordance between cerebral spinal fluid and plasma HIV replication in patients with neurological symptoms who are receiving suppressive antiretroviral therapy. Clin Infect Dis 50: 773-78.
56. Cameron DW, da Silva BA, Arribas JR, Myers RA, Bellos NC, et al. (2008) A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis 198: 234-40.
57. Valantin MA, Flandre P, Kolta S, Duvivier C, Algarte-Genin M, et al. (2010) Fat tissue distribution changes in HIV-infected patients with viral suppression treated with DRV/r monotherapy vs 2 NRTI + DRV/r in the MONO-ANRS 136 randomized trial: Results at 48 weeks. 17th Conerence on Retroviruses and Opportunistic Infections, February 16-19,2010, San Franciso, USA Abstract 721.
58. van Vonderen MG, Lips P, van Agtmael MA, Hassink EA, Brinkman K, et al. (2009) First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/lopinavir/ritonavir. AIDS 23: 1367-76.
59. Hansen A, Obel N, Nielsen H, Pedersen C, Gerstoft J, (2010) Bone mineral density changes in protease inhibitor-sparing vs. nucleoside reverse transcriptase inhibitor-sparing highly active antiretroviral therapy: data from a randomized trial. HIV Med 12: 157-65.
60. Schackman BR, Scott CA, Sax PE, Losina E, Wilkin TJ, et al. (2007) Potential risks and benefits of HIV treatment simplification: a simulation model of a proposed clinical trial. Clin Infect Dis 45: 1062-70.
61. Simpson KN, Dietz B, Rahim B, S.Rayagopalan R, (2009) Cost effectiveness of switching to second line therapy with lopinavir/ritonavir (LPV/r) in Kenya and Uganda. 5th International AIDS Society Conference on Pathogenesis, Treatment and Prevention, July 19-22, 2009, Cape Town, South Africa Abstract MOPED012.