Simplification to dual antiretroviral therapy including a ritonavir-boosted protease inhibitor in treatment-experienced HIV-1-infected patients

Journal of Antimicrobial Chemotherapy

Volumn 67, Issue 10, 2012, Pages 2479-2486

  Burgos, Joaquin ^a   Crespo, Manuel ^a   Falć, Vicenç ^a   Curran, Adria ^a   Navarro, Jordi ^a   Imaz, Arkaitz ^b   Domingo, Pere ^c   Podzamczer, Daniel ^b   Mateo, Ma Gracia ^c   Villar, Sara ^a   Van den eynde, Eva ^a   Ribera, Esteve ^a   Pahissa, Albert ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^c UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

Author keywords

Antiretroviral treatments; NRTI sparing regimens; Switching strategies

Indexed keywords

ABACAVIR; ATAZANAVIR; DARUNAVIR; DIDANOSINE; EFAVIRENZ; EMTRICITABINE; ENFUVIRTIDE; ETRAVIRINE; FOSAMPRENAVIR; INDINAVIR; LAMIVUDINE; LOPINAVIR; MARAVIROC; NELFINAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; RALTEGRAVIR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; STAVUDINE; TENOFOVIR; THYMIDINE DERIVATIVE; TIPRANAVIR; VIRUS RNA; ZIDOVUDINE;

ADULT; AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; CD4+ T LYMPHOCYTE; CLINICAL EFFECTIVENESS; DIARRHEA; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPOPHOSPHATEMIA; INTENTION TO TREAT ANALYSIS; KIDNEY FAILURE; LIPOATROPHY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OBSERVATIONAL STUDY; RETROSPECTIVE STUDY; SIDE EFFECT; STONE FORMATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RITONAVIR; SPAIN; TREATMENT OUTCOME;

EID: 84866629180     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dks227     Document Type: Article

References (47)

1. Thompson MA, Aberg JA, Cahn P et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA Panel. JAMA 2010; 304: 321-33.
2. Panel de expertos de Gesida y plan nacional sobre el Sida. National Consensus Document by GESIDA/National Aids Plan on Antiretroviral Treatment in Adults Infected by the Human Immunodeficiency Virus (January 2012 Update). http://www.gesida.seimc.org (30 March 2012, date last accessed).
3. Mocroft A, Vella S, Benfield TL et al. Changing patterns of mortality across Europe in patients infected with HIV. Lancet 1998; 352: 1725-30.
4. Sterne JA, Hernán MA, Ledergerber B et al. Long-term effectiveness of potent antiretroviral therapy in preventing AIDS and death: a prospective cohort study. Lancet 2005; 366: 378-84.
5. Becker S, Rachlis A, Gill J et al. Successful substitution of protease inhibitors with efavirenz (EFV) in patients with undetectable viral loads-a prospective, randomized, multicenter, open-label study (DMP 049). In: Abstracts of the Eighth Conference on Retroviruses and Opportunistic Infections, Chicago, IL, 2001. Abstract 20, p. 49. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
6. Raffi F, Bonnet B, Ferre V et al. Substitution of a nonnucleoside reverse transcriptase inhibitor for a protease inhibitor in the treatment of patients with undetectable plasma human immunodeficiency virus type 1 RNA. Clin Infect Dis 2000; 31: 1274-8.
7. Ruiz L, Negredo E, Domingo P et al. Antiretroviral treatment simplification with nevirapine in protease inhibitor-experienced patients with HIV-associated lipodystrophy: 1-year prospective follow-up of a multicenter, randomized, controlled study. J Acquir Immune Defic Syndr 2001; 27: 229-36.
8. Negredo E, Cruz L, Paredes R et al. Virological, immunological, and clinical impact of switching from protease inhibitors to nevirapine or to efavirenz in patients with human immunodeficiency virus infection and long-lasting viral suppression. Clin Infect Dis 2002; 34: 504-10.
9. Molina JM, Journot V, Morand-Joubert L et al. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized study. J Infect Dis 2005; 191: 830-9.
10. Gatell J, Salmon-Ceron D, Lazzarin A 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: 1484-92.
11. Negredo E, Molto J, Munoz-Moreno JA et al. Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antivir Ther 2004; 9: 335-42.
12. Fisher M, Moyle GJ, Shahmanesh M et al. A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr 2009; 51: 562-8.
13. Martínez E, Arranz JA, Podzamczer D et al. A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in HIV-1-infected patients with virological suppression. J Acquir Immune Defic Syndr 2009; 5: 290-7.
14. Martin A, Bloch M, Amin J et al. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-lamivudine: a randomized, 96-week trial. Clin Infect Dis 2009; 49: 1591-601.
15. De Jesus E, Young B, Morales-Ramirez JO et al. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr 2009; 51: 163-74.
16. Hodder SL, Mounzer K, DeJesus E et al. Patient-reported outcomes in virologically suppressed, HIV-1-infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDs 2010; 24: 87-96.
17. Havlir D, Marschner I, Hirsch M et al. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. N Engl J Med 1998; 339: 1261-8.
18. Pialoux G, Raffi F, Brun-Vezinet F et al. A randomised trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and indinavir in previously untreated HIV-1-infected patients. N Engl J Med 1998; 339: 1269-76.
19. Reijers M, Weverling G, Jurriaans S et al. Maintenance therapy after quadruple induction therapy in HIV-1 infected individuals: Amsterdam Duration of Antiretroviral Medication (ADAM) study. Lancet 1998; 352: 185-7.
20. Arribas J, Delgado R, Arranz A et al. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr 2009; 51: 147-52.
21. Pulido F, Arribas JR, Delgado R et al. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS 2008; 11: F1-9.
22. Arribas J, Horban A, Gerstolf J et al. The MONET trial: darunavir/ ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/mL. AIDS 2010; 24: 223-30.
23. Gutmann C, Cusini A, Gunthard H et al. Randomized controlled study demonstrating failure of LPV/r monotherapy in HIV: the role of compartment and CD4-nadir. AIDS 2010; 24: 2347-54.
24. Mathis S, Khanlari B, Pulido F et al. Effectiveness of protease inhibitor monotherapy versus combination antiretroviral maintenance therapy: a meta-analysis. PLoS One 2011; 6: e22003.
25. Reynes J, Lawal A, Pulido F et al. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/emtricitabine in antiretroviral-naïve subjects: the PROGRESS study, 48-week results. HIV Clin Trials 2011; 12: 255-67.
26. Riddler S, Haubrich R, diRienzo A et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 2008; 358: 2095-106.
27. Johnson VA, Brun-Vézinet F, Clotet B et al. Update of the drug resistance mutations in HIV-1: December 2010. Top HIV Med 2010; 18: 156-63.
28. Stanford University. Genotypic Resistance Interpretation Algorithm, Version 6.0.5. http://hivdb.stanford.edu/pages/algs/HIVdb.html (30 March 2012, date last accessed).
29. Center for Drug Evaluation and Research (CDER). Guidance for Industry, Antiretroviral Drugs Using Plasma HIV RNA Measurements- Clinical Considerations for Accelerated and Traditional Approval, Appendix B, October 2002. http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM070968.pdf (30 March 2012, date last accessed).
30. Brundage MD, Pater JL, Zee B. Assessing the reliability of two toxicity scales: implications for interpreting toxicity data. J Natl Cancer Inst 1993; 85: 1138-48.
31. Tebas P, Zhang J, Hafner R et al. Peripheral and visceral fat changes following a treatment switch to a non-thymidine analogue or a nucleoside-sparing regimen in HIV-infected subjects with peripheral lipoatrophy: results of ACTG A5110. J Antimicrob Chemother 2009; 63: 998-1005.
32. Negredo E, Miró O, Rodriguez-Santiago B et al. Improvement of mitochondrial toxicity in patients receiving a nucleoside reversetranscriptase inhibitor-sparing strategy: results from the Multicenter Study with Nevirapine and Kaletra (MULTINEKA). Clin Infect Dis 2009; 49: 892-900.
33. Tyrer M, Swaden L, Marshall NJ et al. Switching to dual therapy with darunavir/ritonavir and etravirine: a simplification strategy. J Int AIDS Soc 2010; 13: 51.
34. Bernardino JI, Vergas J, Tellez MJ et al. Dual therapy with darunavir/ ritonavir and etravirine in clinical practice: an NRTI-sparing strategy in ART experienced patients. In: Sixth IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, 2011. Poster CDB356.
35. Ruane P, Alas B, Ryan R et al. A 48-week pilot study switching suppressed patients to darunavir/ritonavir and etravirine from enfuvirtide, protease inhibitor(s), and non-nucleoside reverse transcriptase inhibitor(s). AIDS Res Hum Retrovir 2010; 26: 1215-9.
36. Allavena C, Mounoury O, Rodallec A et al. Efficacy and safety of an NRTI-sparing dual regimen of raltegravir and ritonavir-boosted protease inhibitor in a triple antiretroviral class-experienced population. HIV Clin Trials 2009; 10: 337-40.
37. Cordery D, Hesse K, Amin J et al. Raltegravir and unboosted atazanavir dual therapy in virologically suppressed antiretroviral treatment-experienced HIV patients. Antivir Ther 2010; 15: 1035-8.
38. Eron JJ, Young B, Cooper DA et al. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet 2010; 30: 396-407.
39. Kilby JM. Switching HIV therapies: competing host and viral factors. Lancet 2010; 375: 352-4.
40. Martinez E, Arnaiz JA, Podzamczer D et al. Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med 2003; 349: 1036-46.
41. Martínez E, Larrousse M, Llibre JM et al. Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS 2010; 24: 1697-707.
42. Pulido F, Pérez-Valero I, Delgado R et al. Risk factors for loss of virological suppression in patients receiving lopinavir/ritonavir monotherapy for maintenance of HIV suppression. Antivir Ther 2009; 14: 195-201.
43. Taiwo B, Zheng L, Gallien S et al. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS 2011; 25: 2113-22.
44. Kozal MJ, Lupo S, DeJesus E et al. The SPARTAN study: a pilot study to assess the safety and efficacy of an investigational NRTI- and RTV-sparing regimen of atazanavir (ATV) experimental dose of 300 mg BID plus raltegravir (RAL) 400 mg BID (ATV+RAL) in treatment-naive HIV-infected subjects. In: Abstracts of the Seventeenth International AIDS Conference, Vienna, 2010. Abstract THLBB2.
45. Imaz A, Llibre JM, Mora M et al. Efficacy and safety of nucleoside reverse transcriptase inhibitor-sparing salvage therapy for multidrug-resistant HIV-1 infection based on new-class and new-generation antiretrovirals. J Antimicrob Chemother 2011; 66: 358-62.
46. Yazdanpanah Y, Fagard C, Descamps D et al. High rate of virologic suppression with raltegravir plus etravirine and darunavir/ritonavir among treatment-experienced patients infected with multidrug-resistant HIV: results of the ANRS 139 TRIO trial. Clin Infect Dis 2009; 49: 1441-9.
47. Mallolas J, Podzamczer D, Milinkovic A et al. Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study. J Acquir Immune Defic Syndr 2009; 51: 29-36.