54
Views
4
CrossRef citations to date
0
Altmetric
Original Articles

A Pilot, Prospective, Open-Label Simplification Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Once-Daily Lopinavir-Ritonavir Monotherapy in HIV-HCV Coinfected Patients: The MONOCO Study

, , , , &
Pages 179-188 | Published online: 06 Jan 2015

REFERENCES

  • Macias J, Melguizo I, Fernandez-Rivera FJ, et al. Mortality due to liver failure and impact on survival of hepatitis virus infections in HIV-infected patients receiving potent antiretroviral therapy. Eur J Clin Microbiol Infect Dis. 2002 ;21(11): 775–781.
  • Aceti A, Pasquazzi C, Zechini B, De Bac C. Hepatotoxic-ity development during antiretroviral therapy containing protease inhibitors in patients with HIV: the role of hepatitis B and C virus infection. J Acquir Immune Defic Syndr. 2002;29(1):41–48.
  • den Brinker M, Wit FW, Wertheim-van DiIlen PM, et al. Hepatitis B and C virus co-infection and the risk for hepa-totoxicity of highly active antiretroviral therapy in HIV-1 infection. AIDS. 2000;14(18):2895–2902.
  • Martinez E, Blanco JL, Arnaiz JA, et al. Hepatotoxicity in HIV-1-infected patients receiving nevirapine-containing antiretroviral therapy. AIDS. 200115(10):1261–1268.
  • Monforte Ade A, Bugarini R, Pezzotti P, et al. Low fre-quency of severe hepatotoxicity and association with HCV coinfection in HIV-positive patients treated with HAART. J Acquir Immune Defic Syndr 2001;28(2):114–123.
  • Rodriguez-Rosado R, Garcia-Samaniego J, Soriano V. Hepatotoxicity after introduction of highly active antiretro-viral therapy. AIDS. 1998;12(10):1256.
  • Sulkowski MS, Thomas DL, Chaisson RE, Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA. 2000;283(1): 74–80.
  • Wit FW, Weyerling GJ, Weel J, Jurriaans S, Lange JM. Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. J Infect Dis. 2002;186(1):23–31.
  • Bani-Sadr F, Lapidus N, Bedossa P, et al. Progression of fibrosis in HIV and hepatitis C virus-coinfected patients treated with interferon plus ribavirin-based therapy: analy-sis of risk factors. Clin Infect Dis. 2008;46(5):768–774.
  • Fortgang IS, Belitsos PC, Chaisson RE, Moore RD. Hepa-tomegaly and steatosis in HIV-infected patients receiving nucleoside analog antiretroviral therapy. Am J Gastroen-terol. 1995;90(9):1433–1436.
  • Labarga P, Soriano V, Vispo ME, et al. Hepatotoxicity of antiretroviral drugs is reduced after successful treatment of chronic hepatitis C in HIV-infected patients. J Infect Dis. 2007;196(5):670–676.
  • Sulkowski M, Mehta S, Moore R, et al. Population preva-lence of hepatic steatosis among antiretroviral-expe-rienced HCV/HIV co-infected adults with and without stavudine exposure. Paper presented at: 11th Conference on Retroviruses and Opportunistic Infections; 2004; San Francisco, California.
  • Perronne C. Antiviral hepatitis and antiretroviral drug interactions. J HepatoL 2006;44(1 suppl):S119–125.
  • Lafeuillade A, Hittinger G, Chadapaud S. Increased mitochondrial toxicity with ribavirin in HIV/HCV coinfec-tion. Lancet. 2001;357(9252):280–281.
  • Sulkowski MS, Benhamou Y. Therapeutic issues in HIV/ HCV-coinfected patients. J Viral Hepat. 2007;14(6): 371–386.
  • Arribas JR, Pulido F, Delgado R, et al. Lopinavir/ritonavir as single-drug therapy for maintenance of HIV-1 viral sup-pression: 48-week results of a randomized, controlled, open-label, proof-of-concept pilot clinical trial (OK Study). J Acquir Immune Defic Syndr 2005;40(3):280–287.
  • Bierman WF, van Agtmael MA, Nijhuis M, Danner SA, Boucher CA. HIV monotherapy with ritonavir-boosted protease inhibitors: a systematic review. AIDS. 2009;23(3): 279–291.
  • Cameron D, da Silva B, Arribas J, et al. A two-year ran-domized controlled clinical trial in antiretroviral-näfve sub-jects using lopinavir/ritonavir (LPV/r) monotherapy after initial induction treatment compared to an efavirenz (EFV) 3-drug regimen (Study M03-613). Paper presented at: XVI International AIDS Conference; August 13–18, 2006; Toronto, Canada.
  • Ghosn J, Flandre P, Cohen-Codar I, et al. Long-term (96-week) follow-up of antiretroviral-naive HIV-infected patients treated with first-line lopinavir/ritonavir monother-apy in the MONARK trial. HIV Med. 2010;11(2):137–142.
  • Loutfy M, Ackad N, Antoniou T, et al. Randomized con-trolled trial of once-daily tenofovir, lamivudine, and lopi-navir/ritonavir versus remaining on the same regimen in virologically suppressed HIV-infected patients on their first P1-containing HAART regimen. HIV Clin Trials. 2007;8(5):259–268.
  • Nunes E, Oliveira M, Almeida M, et al. 48 week efficacy and safety results of simplification to single agent lopina-vir/ritonavir (LVR/r) regimen in patients suppressed below 80 copies/mL on HAART - the KalMo Study. Paper pre-sented at: International AIDS Conference; August 13–18, 2006; Toronto, Canada.
  • Bierman WF, Humphreys EH, Van Agtmael MA, Boucher CA, Rutherford GW. Ritonavir-boosted protease inhibi-tor monotherapy is 6% less effective than combination antiretroviral therapy in a meta-analysis J Int AIDS Soc. 2010;14\(suppl 4):018.
  • Mathis S, Khanlari B, Pulido F, et al. Effectiveness of pro-tease inhibitor monotherapy versus combination antiret-roviral maintenance therapy: a meta-analysis. PLoS One. 2011 ;6(7):e22003.
  • Lorello G, la Porte C, Pilon R, Zhang G, Karnauchow T, MacPherson P. Discordance in HIV-1 viral loads and antiretroviral drug concentrations comparing semen and blood plasma. HIV Med. 2009;10(9):548–554.
  • Arribas J, Pulido F, Delgado R, et al. Lopinavir/ritonavir as single-drug maintenance therapy in patients with HIV-1 viral suppression: forty-eight week results of a random-ized, controlled, open-label, clinical trial (0K04 Study). Paper presented at: XVI International AIDS Conference; August 13–18, 2006; Toronto, Ontario.
  • Delfraissy J, Flandre P, Delaugerre C, et al. MONARK Trial (MONotherapy AntiRetroviral Kaletra): 48-week anal-ysis of lopinavir/ritonavir (LPV/r) monotherapy compared to LPV/r + zidovudine/lamivudine (AZT/3TC) in antiret-roviral-nafve patients. Paper presented at: XVI Interna-tional AIDS Conference; August 13–18, 2006; Toronto, Canada.
  • 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(11):1036–1046.
  • Gathe J, Mayberry C, Miguel B, Norton M, Pasleyet M. Once-daily single-agent therapy with LPV(r) in subjects virologically suppressed on twice-daily LPV(r) single-agent therapy: LMANI III 48-week final results. Presented at: 12th European AIDS Conference; 2009; Cologne, Germany.
  • Caso A, Valencia E, Moreno V, Cervero M, Sanz J, Torres Perea R. Lopinavir/ritonavir monotherapy in clinical prac-tice. J Int AIDS Soc. 2010;13\(suppl 4):P50.
  • Clumeck N, Arribas J, Pulick P, et al. Low-level virae-mia during treatment with darunavir/r monotherapy ver-sus DRV/r+2NRTI5 in the MONET trial. J Int AIDS Soc. 2010;13\(suppl 4):019.
  • Pulido F, Arribas J, Hill A, van Delft Y, Moecklinghoff C. Analysis of major and minor IAS-USA PI mutations in the MONET trial of darunavir/ritonavir monotherapy versus DVR/r+2NRTI5. J Int AIDS Soc. 2010;13\(suppl 4):P131.
  • Eron JJ, Feinberg J, Kessler HA, et al. Once-daily versus twice-daily lopinavir/ritonavir in antiretroviral-naive HIV-positive patients: a 48-week randomized clinical trial. J Infect Dis. 2004;189(2):265–272.
  • la Porte CJ, Schippers EF, van der Ende ME, et al. Phar-macokinetics of once-daily lopinavir/ritonavir and the influence of dose modifications. AIDS. 2005;19(10): 1105–1107.
  • van Heeswijk RP, Bourbeau M, Seguin I, Giguere P, Garber GE, Cameron DW. Absence of circadian variation in the pharmacokinetics of lopinavir/ritonavir given as a once daily dosing regimen in HIV-1-infected patients. Br J Clin Pharmacol. 2005;59(4):398–404.
  • Molto J, Valle M, Blanco A, et al. Lopinavir/ritonavir phar-macokinetics in HIV and hepatitis C virus co-infected patients without liver function impairment: influence of liver fibrosis. Clin Pharmacokinet. 2007;46(1):85–92.
  • Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for pre-viously treated chronic HCV genotype 1 infection. N Engl J Med. 2011;364(13)1207–1217.
  • Jacobson IM, McHutchison JG, Dusheiko G, et al. Telapre-vir for previously untreated chronic hepatitis C virus infec-tion. N Engl J Med. 2011;364(25):2405–2416.
  • Alvarez D, Dieterich DT, Brau N, Moorehead L, Ball L, Sulkowski MS. Zidovudine use but not weight-based ribavirin dosing impacts anaemia during HCV treat-ment in HIV-infected persons. J Viral Hepat. 2006;13(10): 683–689.
  • Bani-Sadr F, Carrat F, Pol S, et al. Risk factors for symp-tomatic mitochondrial toxicity in HIV/hepatitis C virus-coinfected patients during interferon plus ribavirin-based therapy. J Acquir Immune Defic Syndr 2005;40(1):47–52.
  • Mira JA, Lopez-Cortes LF, Merino D, et al. Predictors of severe haematological toxicity secondary to pegylated interferon plus ribavirin treatment in HIV-HCV-coinfected patients. Antivir Ther 2007;12(8)1225–1235.
  • Amorosa VK, Slim J, Mounzer K, et al. The influence of abacavir and other antiretroviral agents on virological response to HCV therapy among antiretroviral-treated HIV-infected patients. Antivir Ther 2010;15(1):91–99.
  • Laufer N, Laguno M, Perez I, et al. Abacavir does not influence the rate of virological response in HIV-HCV-coinfected patients treated with pegylated interferon and weight-adjusted ribavirin. Antivir Ther. 2008;13(7): 953–957.
  • Mira JA, Lopez-Cortes LF, Barreiro P, et al. Efficacy of pegylated interferon plus ribavirin treatment in HIV/hepa-titis C virus co-infected patients receiving abacavir plus lamivudine or tenofovir plus either lamivudine or emtric-itabine as nucleoside analogue backbone. J Antimicrob Chemother 2008;62(6):1365–1373.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.