Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients: A randomized clinical trial

Journal of Antimicrobial Chemotherapy

Volumn 70, Issue 4, 2014, Pages 1139-1145

  Moltó, José ^a,b   Valle, Marta ^b,c   Ferrer, Elena ^d   Domingo, Pere ^e   Curran, Adrian ^b,f   Santos, José Ramón ^a   Mateo, María Gracia ^e   Di Yacovo, María Silvana ^d   Miranda, Cristina ^a   Podzamczer, Daniel ^d   Clotet, Bonaventura ^a,b,g   Coll, Josep ^a   Gel, Silvia ^a   Llibre, Josep Maria ^a   Mothe, Beatriz ^a   Negredo, Eugenia ^a   Pérez Álvarez, Nuria ^a   Sirera, Guillem ^a   Rozas, Nerea ^d   Vila, Antonia ^d   Del Mar Gutiérrez, María ^e   Mateo, Gracia ^e   Burgos, Joaquín ^f   Navarro, Jordi ^f   Ribera, Esteban ^f   more..

^a HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c BIOMEDICAL RESEARCH INSTITUTE SANT PAU IIB SANT PAU   (Spain)

^d HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^e HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^f HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^g UNIVERSITY OF VIC CENTRAL UNIVERSITY OF CATALONIA   (Spain)

Author keywords

ART; Dose optimization; HIV infection

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; DARUNAVIR; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; LIPID; RITONAVIR; ANTIRETROVIRUS AGENT; SULFONAMIDE;

ADULT; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; BACTEREMIA; CD4 LYMPHOCYTE COUNT; CD4+ T LYMPHOCYTE; CONTROLLED STUDY; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; EC50; ESCHERICHIA COLI INFECTION; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEPATITIS C; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; MIXED INFECTION; MULTICENTER STUDY; NONHUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SEPTIC SHOCK; SIDE EFFECT; VIRUS LOAD; ADVERSE EFFECTS; CLINICAL TRIAL; ECONOMICS; HIV INFECTIONS; ISOLATION AND PURIFICATION; MAINTENANCE CHEMOTHERAPY; PLASMA; PROCEDURES; TREATMENT OUTCOME; VIROLOGY;

ADULT; ANTI-RETROVIRAL AGENTS; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; PLASMA; SULFONAMIDES; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84926455588     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dku516     Document Type: Article

References (30)

1. Palella FJ, Delaney KM, Moorman AC et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998; 338:853-60.
2. Antiretroviral Therapy Cohort Collaboration. Life expectancy of individuals on combination antiretroviral therapy in high-income countries: a collaborative analysis of 14 cohort studies. Lancet 2008; 372: 293-9.
3. Wood E, Kerr T, Marshall BD et al. Longitudinal community plasma HIV-1 RNA concentrations and incidence of HIV-1 among injecting drug users:prospective cohort study. BMJ 2009; 338: b1649.
4. Montaner JS, Hogg R, Wood E et al. The case for expanding access to highly active antiretroviral therapy to curb the growth of the HIV epidemic. Lancet 2006; 368: 531-6.
5. Cohen MS, Chen YQ, McCauley M et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365: 493-505.
6. Delva W, Eaton JW, Meng F et al. HIV treatment as prevention: optimising the impact of expanded HIV treatment programmes. PLoS Med 2012; 9: e1001258.
7. Rodger A, Bruun T, Cambiano V et al. HIV Transmission risk through condomless sex if HIV+ partner on suppressive ART: PARTNER Study. In: Abstracts of the Twenty-first Conference on Retroviruses and Opportunistic Infections, Boston, MA, 2014. Abstract 153LB. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
8. Thompson MA, Aberg JA, Hoy JF et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA panel. JAMA 2012; 308: 387-402.
9. 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. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
10. WHO. Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care for Key Populations. http://apps.who.int/iris/bitstream/10665/128048/1/9789241507431_eng.pdf?ua=1&ua=1.
11. Crawford KW, Ripin DH, Levin AD et al. Optimising the manufacture, formulation, and dose of antiretroviral drugs for more cost-efficient delivery in resource-limited settings: a consensus statement. Lancet Infect Dis 2012; 12: 550-60.
12. Hill A, Ananworanich J, Calmy A. Dose optimization: a strategy to improve tolerability and lower antiretroviral drug prices in low and middle income countries. Open Infect Dis J 2010; 4: 85-91.
13. Boyd MA, Cooper DA. Optimisation of HIV care and service delivery:doing more with less. Lancet 2012; 380: 180-6.
14. Volberding PA, Lagakos SW, Koch MA et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. N Engl J Med 1990; 322: 941-9.
15. Kahn JO, Lagakos SW, Richman DD et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group. N Engl J Med 1992; 327: 581-7.
16. Hill A, Ruxrungtham K, Hanvanich M et al. Systematic review of clinical trials evaluating low doses of stavudine as part of antiretroviral treatment. Expert Opin Pharmacother 2007; 8: 679-88.
17. Katlama C, Esposito R, Gatell JM et al. Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1. AIDS 2007; 21: 395-402.
18. Haubrich R, Berger D, Chiliade P et al. Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients. AIDS 2007; 21: F11-8.
19. Clotet B, Bellos N, Molina JM et al. Efficacy and safety of darunavirritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet 2007; 369: 1169-78.
20. de Meyer SMJ, Spinosa-Guzman S, Vangeneugden TJ et al. Efficacy of once-daily darunavir/ritonavir 800/100 mg in HIV-infected, treatment-experienced patients with no baseline resistance-associated mutations to darunavir. J Acquir Immune Defic Syndr 2008; 49: 179-82.
21. Sekar V, De Meyer S, Vangeneugden T et al. Pharmacokinetic/pharmacodynamic (PK/PD) analyses of the POWER 1 and the POWER 2 trials in treatment-experienced HIV-infected patients. In: Abstracts of the Thirteenth Conference on Retroviruses and Opportunistic Infections, Denver, CO, 2006. Abstract J-121. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
22. Droste JA, Aarnoutse RE, Koopmans PP et al. Evaluation of antiretroviral drug measurements by an interlaboratory quality control program. J Acquir Immune Defic Syndr 2003; 32: 287-91.
23. De Meyer S, Azijn H, Surleraux D et al. TMC114, a novel human immunodeficiency virus type 1 protease inhibitor active against protease inhibitorresistant viruses, including a broad range of clinical isolates. Antimicrob Agents Chemother 2005; 49: 2314-21.
24. Orkin C, DeJesus E, Khanlou H et al. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial. HIV Med 2013; 14: 49-59.
25. Arribas JR, Clumeck N, Nelson M et al. The MONET trial: week 144 analysis of the efficacy of darunavir/ritonavir (DRV/r) monotherapy versus DRV/r plus two nucleoside reverse transcriptase inhibitors, for patients with viral load <50 HIV-1 RNA copies/mL at baseline. HIV Med 2012; 13:398-405.
26. Llibre JM. First-line boosted protease inhibitor-based regimens in treatment-naive HIV-1-infected patients-making a good thing better. AIDS Rev 2009; 11: 215-22.
27. ENCORE1 Study Group. Efficacy of 400 mg efavirenz versus standard 600 mg dose in HIV-infected, antiretroviral-naïve adults (ENCORE1): a randomized, double blind, placebo-controlled, non-inferiority trial. Lancet 2014; 383: 1474-82.
28. Wilson D, Fraser N. Who pays and why? Costs, effectiveness, and feasibility of HIV treatment as prevention. Clin Infect Dis 2014; 59 Suppl 1: S28-31.
29. Deeks ED. Darunavir: a review of its use in the management of HIV-1 infection. Drugs 2014; 74: 99-125.
30. Calcagno C, Yilmaz A, Cusato J et al. Determinants of darunavir cerebrospinal fluid concentrations: impact of once-daily dosing and pharmacogenetics. AIDS 2012; 26: 1529-33.