Virologic response, early HIV-1 decay, and maraviroc pharmacokinetics with the nucleos(t)ide-free regimen of maraviroc plus darunavir/ritonavir in a pilot study

Journal of Acquired Immune Deficiency Syndromes

Volumn 64, Issue 2, 2013, Pages 167-173

  Taiwo, Babafemi ^a   Acosta, Edward P ^b   Ryscavage, Patrick ^c   Berzins, Baiba ^a   Lu, Darlene ^d   Lalezari, Jay ^e   Castro, Jose ^f   Adeyemi, Oluwatoyin ^g   Kuritzkes, Daniel R ^h   Eron, Joseph J ⁱ   Tsibris, Athe ^h   Swindells, Susan ^j  

^a NORTHWESTERN UNIVERSITY   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c UNIVERSITY OF MARYLAND   (United States)

^d HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^e Quest Clinical Research   (United States)

^f UNIVERSITY OF MIAMI   (United States)

^g The CORE Center   (United States)

^h BRIGHAM AND WOMEN S HOSPITAL   (United States)

ⁱ UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^j UNIVERSITY OF NEBRASKA AT OMAHA   (United States)

more..

Author keywords

Darunavir; Maraviroc; Nucleos(t)ide sparing; Pharmacokinetics; Viral dynamics

Indexed keywords

DARUNAVIR; EFAVIRENZ; LOPINAVIR PLUS RITONAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MARAVIROC; RITONAVIR;

ADULT; ANTIVIRAL RESISTANCE; AREA UNDER THE CURVE; CD4 LYMPHOCYTE COUNT; CLINICAL ARTICLE; CONFERENCE PAPER; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; FEMALE; FOLLOW UP; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MALE; MUTATION; OPEN STUDY; PILOT STUDY; PRIORITY JOURNAL; SIDE EFFECT; VIRUS CONCENTRATION; VIRUS LOAD;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; CYCLOHEXANES; DRUG THERAPY, COMBINATION; FEMALE; HIV FUSION INHIBITORS; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MALE; PILOT PROJECTS; RITONAVIR; RNA STABILITY; RNA, VIRAL; SULFONAMIDES; TREATMENT OUTCOME; TRIAZOLES; VIRAL LOAD;

EID: 84885207300     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3182a03d95     Document Type: Conference Paper

References (35)

1. 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.
2. Reynes J, Trinh R, Pulido F, et al. Lopinavir/ritonavir (LPV/r) combined with raltegravir (RAL) or tenofovir/emtricitabine (TDF/FTC) in antiretroviral (ARV)-naïve subjects: 96 week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2012;29: 256-265.
3. Kozal MJ, Lupo S, De Jesus E, et al. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in treatment-naïve HIVinfected patients: SPARTAN study results. HIV Clin Trials. 2012;13: 119-130.
4. Taiwo B, Zheng L, Gallien S, et al. Efficacy of a nucleoside sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naïve HIV-1- infected patients (ACTG A5262). AIDS. 2011;25: 2113-2122.
5. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services. Available at: http://www.aidsinfo.nih. gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed June 5, 2013.
6. Thompson MA, Aberg JA, Hoy F, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International AIDS Society- USA panel. JAMA. 2012;308: 387-402.
7. WHO. Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents 2009. Available at: http://www.who.int/hiv/pub/arv/rapid-advice- art.pdf. Accessed January 30, 2013.
8. European AIDS Clinical Society Guildelines. Version 6.1. November 2012. Available at: http://www.europeanaidsclinicalsociety.org/images/stories/EACS- Pdf/EacsGuidelines-v6.1-2edition.pdf. Accessed January 30, 2013.
9. British HIV Association Guidelines for the Treatment of HIV-1 Positive Adults With Antiretroviral Therapy 2012. Available at: http://www.bhiva. org/documents/Guidelines/Treatment/2012/120430TreatmentGuidelines.pdf. Accessed January 30, 2013.
10. Taiwo B, Murphy RL, Katlama C. Novel antiretroviral combinations in treatment-experienced patients with HIV infection: rationale and results. Drugs. 2010;70: 1629-1642.
11. Abel S, Back DJ, Vourvahis M. Maraviroc: pharmacokinetics and drug interactions. Antivir Ther. 2009;14: 607-618.
12. Wilkin TJ, Lalama CM, McKinnon J, et al. A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4+ T-cell recovery despite sustained virologic suppression: ACTG A5256. J Infect Dis. 2012;206: 534-542.
13. Funderburg N, Kalinowska M, Eason J, et al. Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. PLoS One. 2010; 5:e13188.
14. De Meyer S, Lathouwers E, Dierynck I, et al. Characterization of virologic failure patients on darunavir/ritonavir in treatment-experienced patients. AIDS. 2009;23: 1829-1840.
15. Yilmaz A, Watson V, Else L, et al. Cerebrospinal fluid maraviroc concentrations in HIV-1 infected patients. AIDS. 2009;23: 2537-2540.
16. Croteau D, Rossi SS, Best BM, et al Darunavir is predominantly unbound to protein in cerebrospinal fluid and concentrations exceed the wild-type HIV-1 median 90% inhibitory concentration. J Antimicrob Chemother. 2013;68: 684-689.
17. Wasmuth JC, Rockstroh JK, Hardy WD. Drug safety evaluation of maraviroc for the treatment of HIV infection. Expert Opin Drug Saf. 2012; 11: 161-174.
18. Cooper DA, Heera J, Goodrich J, et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviralnaïve subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010;201: 803-813.
19. Ortiz R, Dejesus E, Khanlou H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1- infected patients at week 48. AIDS. 2008;22: 1389-1397.
20. McFadyen L, Jacqmin P, Wade J, et al. Maraviroc exposure-efficacy (,50 copies/mL) analysis in HIV-1-infected treatment-naïve subjects - ITT population (MERIT study) [abstract TUPE0053]. In: Abstracts of the XVII International AIDS Conference; August 3-8, 2008; Mexico City.
21. Kakuda TN, Abel S, Davis J, et al. Pharmacokinetic interactions of maraviroc with darunavir-ritonavir, etravirine and etravirine-darunavirritonavir in healthy volunteers: results of two drug interaction trials. Antimicrob Agents Chemother. 2011;55: 2290-2296.
22. Okoli C, Siccardi M, Thomas-William S, et al. Once daily maraviroc 300 mg or 150 mg in combination with ritonavir-boosted darunavir 800/100 mg. J Antimicrob Chemother. 2012;67: 671-674.
23. Gulick RM, Lalezari J, Goodrich J, et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008;359: 1429-1441.
24. Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instrument. Patient Care Committee and Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000;12: 255-266.
25. Tsibris AM, Sagar M, Gulick RM, et al. In vivo emergence of vicriviroc resistance in a human immunodeficiency virus type 1 subtype C-infected subject. J Virol. 2008;82: 8210-8214.
26. D'Argenio DZ, Schumitzky A, Wang X. ADAPT 5 User's Guide: Pharmacokinetic/Pharmacodynamic Systems Analysis Software. Los Angeles, CA: Biomedical Simulations Resource; 2009.
27. Wu H, Ding AA. Population HIV-1 dynamics in vivo: applicable models and inferential tool for virological data from AIDS clinical trials. Biometrics. 1999;55: 410-418.
28. Haubrich RH, Riddler SA, Ribaudo H, et al. Initial viral decay to assess the relative antiretroviral potency of protease inhibitor-sparing, and nucleoside reverse transcriptase inhibitor-sparing regimens for first-line therapy of HIV infection. AIDS. 2011;25: 2269-2278.
29. Kuritzkes DR, Ribaudo HJ, Squires KE, et al. Plasma HIV-1 RNA dynamics in antiretroviral-naïve subjects receiving either triple-nucleoside or efavirenzcontaining regimens: ACTG A5166s. J Infect Dis. 2007;195: 1169-1176.
30. Mills A, Mildvan D, Podzamczer D, et al. Once-daily maraviroc in combination with ritonavir-boosted atazanavir in treatment-naive patients infected with CCR5-tropic HIV-1 (study A4001078): 96-week results [TUAB0102]. Paper presented at: XIX International AIDS Conference; July 22-27, 2012; Washington, DC.
31. Best BM, Letendre SL, Brigid E, et al. Low atazanavir concentrations in cerebrospinal fluid. AIDS. 2009;23: 83-87.
32. Mora-Peris B, Croucher A, Else L, et al. Pharmacokinetic profile of maraviroc 150 mg dosed with darunavir/ritonavir once daily with and without nucleoside analogues in HIV-infected subjects. J Antimicrob Chemother. 2013;68: 1348-1353.
33. Weatherley B, McFadyen L, Chan PLS, et al. Population pharmacokinetic covariate analysis of maraviroc in the MERIT study in treatment naïve studies [Poster 17B]. In: Abstracts of the 9th International Workshop on Clinical Pharmacology of HIV Therapy; April 7-9, 2008; New Orleans.
34. Dahl V, Josefsson L, Palmer S. HIV reservoirs, latency, and reactivation: prospects for eradication. Antivir Res. 2010;85: 286-294.
35. Polis MA, Sidorov IA, Yoder C, et al. Correlation between reduction in plasma HIV-1 RNA concentration 1 week after start of antiretroviral treatment and long-term efficacy. Lancet. 2001;358: 1760-1765.