Darunavir

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Darunavir (Prezista/TMC-114)

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Last Update: September 03, 2010

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New and Noteworthy

August 2010

Resistance analyses in highly experienced patients failing raltegravir, etravirine
and darunavir/ritonavir regimen.
Charpentier C, Roquebert B, Colin C, et al AIDS. 2010 Aug 26

Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral
suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136.
Katlama C, Valantin MA, Algarte-Genin M, et al AIDS. 2010 Aug 26

Darunavir concentrations exceed the protein-corrected EC50 for wild-type HIV in the semen of
HIV-1-infected men.
Taylor S, Jayasuriya AN, Berry A, Gilleran G, et alAIDS. 2010 Aug 25

800 mg Darunavir tablets prepared by hot melt extrusion.
Thommes M, Baert L, Rosier J.Pharm Dev Technol. 2010 Aug 23.

A WEEK-IN-REVIEW FEATURED REPORT
Efficacy, safety and pharmacokinetics of 900/100 mg of darunavir/ritonavir once daily in
treatment-experienced patients.
Curran A, Gutirerrez M, Deig E, et al J Antimicrob Chemother. 2010 Aug 16

Low frequency of intermittent HIV-1 semen excretion in patients treated by darunavir/ritonavir (
600/100 mg BID) + 2 nucleoside reverse transcriptase inhibitors or monotherapy.
Lambert-Niclot S, Peytavin G, Duvivier C, et al Antimicrob Agents Chemother. 2010 Aug 16

Pharmacokinetics of Darunavir/r and Rifabutin Co-administered in HIV-Negative
Healthy Volunteers.
Sekar V, Lavreys L, Van de Casteele T, et alAntimicrob Agents Chemother. 2010 Jul 26

July 2010

XVIII IAC Citations

A WEEK-IN-REVIEW FEATURED REPORT
POSTER
METABOLIK (Metabolic Evaluation in Treatment-naïves Assessing the impact of two BOosted
protease inhibitors on LIpids and other marKers): comparison of the metabolic effects of
darunavir/ritonavir versus atazanavir/ritonavir over 12 weeks
J. Aberg, T. Overton, S. Gupta, et al
PDF Poster     Abstract

POSTER
Drug-resistant genotyping to guide selection of etravirine, darunavir and raltegravir in salvage
therapy for multi-drug-resistant cases improves outcomes
N. Miyazaki1, S. Matsushita, T. Fujii, et al
PDF Poster     Abstract

POSTER
Duration of antiretroviral regimens including Raltegravir, Maraviroc, Darunavir and/or Etravirine in
clinical practice
I. Castillo Romera, A. Ais Larisgoitia, V. Escudero Vilaplana, et al
PDF Poster     Abstract

Comparison of liver toxicity in HIV/HCV coinfected and HIV monoinfected patients during 72 weeks
ART including darunavir/ritonavir
G. Morsica, G. Bianchi, S. Bagaglio, et al

A WEEK-IN-REVIEW FEATURED REPORT
The MONET trial 96 week analysis: darunavir/ritonavir monotherapy versus DRV/r + 2NRTIs, for
patients with HIV RNA < 50 copies/mL at baseline
A. Rieger, D. Banhegyi, W. Schmidt, et al

Hepatic safety of darunavir 600/100 in HCV coinfected patients with HAART experience
M.A. von Wichmann, M. Saenz-Cuesta, K. Aguirrebengoa, et al

Effects of once-daily (qd) versus twice-daily (bid) darunavir/ritonavir (DRV/r) on lipid parameters
at week 48 in treatment-experienced, HIV-1-infected patients with no DRV resistance-associated
mutations (RAMs) in the ODIN study
J. Arribas, E. Arathoon, C.R. Gonsalez, et al

Darunavir/ritonavir (DRV/rtv) increases rosuvastatin (RSV) concentrations but does not alter
lipid-lowering effect in healthy volunteers
C. Fichtenbaum, D. Samineni, E. Moore, et al

Hard rescue: prospective study of effectiveness and safety of new drugs (Darunavir-DRV,
Etravirina-ETR, Raltegravir-RTG and Maraviroc-MVC) in the last four years (2006-2009)
H. Azkune Galparsoro, J.A. Iribarren Loyarte, M.J. Aramburu Bengoechea

Effect of adherence on virological response to once-daily (qd) versus twice-daily (bid)
darunavir/ritonavir (DRV/r) in treatment-experienced, HIV-1-infected patients with no DRV
resistance-associated mutations (RAMs): ODIN 48-week data
C. Workman, P. Benson, J. Valdez Madruga, et al

Genotypic resistance to darunavir, tipranavir and etravirine in patients with failure to two or more
ARV combinations in Mexico
E. Vidal-Laurencio, L. Cabrera-Ruiz, A. Flores-Gaxiola, et al

Low prevalence of darunavir resistance mutations among HIV-1-infected patients exposed to
second-line protease inhibitors in South India
S. Saravanan, M. Vidya, R. Kantor, et al

Subgroup analysis and predictors of virologic response in treatment-experienced HIV-1-infected
patients in the ODIN trial
P. Cahn, S. Hodder, P. Mootsikapun, et al

Journal Citations

Pharmacokinetics of darunavir at 900 milligrams and ritonavir at 100 milligrams once daily
when coadministered with efavirenz at 600 milligrams once daily in healthy volunteers.
Soon GH, Shen P, Yong EL,et al. Antimicrob Agents Chemother. 2010 Jul;54(7):2775-80.

Suboptimal adherence to darunavir/ritonavir has minimal effect on efficacy compared with
lopinavir/ritonavir in treatment-naive, HIV-infected patients: 96 week ARTEMIS data.
Nelson M, Girard PM, Demasi R, et al J Antimicrob Chemother. 2010 Jul;65(7):1505-9.

Product Information

FULL-TEXT PDF DOCUMENT
Prezista PI
June 25, 2006
Document

Pediatric Data

USPHS Pediatric Antiretroviral Drug Information

US Treatment Guidelines

Journal Abstracts, Papers and Commentaries

A WEEK-IN-REVIEW FEATURED REPORT
Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced
children and adolescents
Blanche S, Bologna R, Cahn P, et al
AIDS. 2009 Aug 30
Abstract

FULL-TEXT ARTICLE
Managing treatment-experienced pediatric and adolescent HIV patients: role of darunavir.
Neely M, Kovacs A.
Ther Clin Risk Manag. 2009 Jun;5(3):595-615.
Paper

Managing treatment-experienced pediatric and adolescent HIV patients: role of darunavir.
Neely M, Kovacs A.
Ther Clin Risk Manag. 2009 Jun;5(3):595-615
Abstract

Successful rescue therapy with a darunavir/ritonavir and etravirine antiretroviral regimen in a child
with vertically acquired multidrug-resistant HIV-1.
Viganò A, Meroni L, Marchetti G, et al
Antivir Ther. 2008;13(6):839-43.
Abstract

Conference Reports, Abstracts and Posters

48-week lipid- and glucose-related safety profile of darunavir/ritonavir in treatment-experienced,
paediatric patients in DELPHI
T. Meyers, E. Joao, J.H. Pilotto, et a
(5th IAS Conference)
Abstract

Safety and Efficacy of Darunavir Co-administered with Low-dose Ritonavir in Treatment-experienced
Children and Adolescents at Week 24
R Bologna, S Rugina, P Cahn, et al
(15th CROI)
Abstract

Dose selection of darunavir co-administered with low-dose ritonavir (DRV/r) in
treatment-experienced HIV-1-infected children and adolescents
Spinosa-Guzman S, Sekar VJ, Van Baelen B, et al
(4th IAS Conference)
Abstract

Salvage therapy in perinatally acquired HIV infection: first UK experience of TMC114
A Bamford, C Foster, NE Mackie, et al|
(8th Int Congress on Drug Therapy in HIV Infection)
Abstract

Perinatal Data

Guidelines

     United States
          Internet Documents

FULL TEXT PDF DOCUMENT
Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs
in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce
Perinatal HIV Transmission in the United States.
Perinatal HIV Guidelines Working Group.
November 2, 2007
Guidelines

FULL TEXT PDF DOCUMENT
Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy
Perinatal HIV Guidelines Working Group.
November 2, 2007
Guidelines

          Journal Abstracts, Papers and Commentaries

Use of darunavir and enfuvirtide in a pregnant woman.
Sued O, Lattner J, Gun A, et al
Int J STD AIDS. 2008 Dec;19(12):866-7.
Abstract

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Darunavir (Prezista/TMC114)