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Darunavir in childrens

Erica Lazarus, Simone Nicol, Lisa Frigati, Martina Penazzato, Mark F Cotton, Elizabeth Centeno-Tablante, Avy Violari, Liesl Nicol
BACKGROUND: The World Health Organization (WHO) identified a need for evidence to inform revision of second and third-line antiretroviral therapy (ART) options in children failing ART. We performed an in-depth scoping review of all available literature on second and subsequent line ART regimens in children younger than 18 years. METHODS: We comprehensively searched, without language or date limitations, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the WHO International Clinical Trials Registry Platform and ClinicalTrials...
December 15, 2016: Pediatric Infectious Disease Journal
Kajal B Larson, Tim R Cressey, Ram Yogev, Andrew Wiznia, Rohan Hazra, Patrick Jean-Philippe, Bobbie Graham, Amy Gonzalez, Paula Britto, Vincent J Carey, Edward P Acosta
BACKGROUND: Limited data are available for once-daily (QD) darunavir (DRV)/ritonavir (r) in the pediatric population. Coadministration of etravirine (ETR) may alter the pharmacokinetics (PK) of DRV. We evaluated the PK interactions between DRV/r (QD) and ETR QD or twice-daily (BID) in children, adolescents, and young adults. METHODS: Human immunodeficiency virus-infected subjects 9 to < 24 years old on optimized background therapy including DRV/r 800/100 mg QD alone or combined with ETR 200 mg BID or ETR 400 mg QD were enrolled...
June 2016: Journal of the Pediatric Infectious Diseases Society
Gloria Huerta-García, José G Vazquez-Rosales, José A Mata-Marín, Leoncio Peregrino-Bejarano, Eric Flores-Ruiz, Fortino Solórzano-Santos
BACKGROUND: Genotyping tests were developed to attenuate the impact of viral resistance. Information about the efficacy in genotype base antiretroviral therapy in children is rare and even more in low- and middle-income countries. METHODS: Sixteen children with antiretroviral therapy (ART) failure and triple-class drug-resistant viruses were included in this study. Protease and retrotranscriptase genotypes were available for all patients. Switch of ART regimen was guided by genotyping data...
2016: Pediatric Research
(no author information available yet)
BACKGROUND: Surveillance for mid- and long-term antiretroviral therapy (ART) toxicity in children is important for informing treatment guidelines. We assessed the safety of darunavir (DRV) and atazanavir (ATV), commonly used as second-line protease inhibitors following lopinavir/ritonavir, in Europe and Thailand. METHODS: Cohorts contributed individual patient data on adverse events (AE) in those aged <18 years taking DRV and ATV, respectively, to 02/2014. Rates of Division of AIDS (DAIDS) grade ≥3 laboratory AEs were calculated...
2016: Antiviral Therapy
Gillian M Keating
Darunavir (Prezista®), administered in combination with ritonavir and background antiretroviral therapy, is approved in the USA and the EU for the treatment of HIV-1 infection in pediatric patients aged ≥3 years. Ritonavir-boosted darunavir provided effective virologic suppression in treatment-naïve adolescents with HIV-1 infection, according to the results of the noncomparative, phase II DIONE trial. Ritonavir-boosted darunavir also had sustained efficacy in treatment-experienced children and/or adolescents with HIV-1 infection, according to the results of the noncomparative, phase II DELPHI and ARIEL trials...
October 2015: Paediatric Drugs
A Brochot, T N Kakuda, T Van De Casteele, M Opsomer, F L Tomaka, A Vermeulen, P Vis
An existing population pharmacokinetic model of darunavir in adults was updated using pediatric data from two studies evaluating weight-based, once-daily dosing of darunavir/ritonavir (ARIEL, NCT00919854 and DIONE, NCT00915655). The model was then used to provide once-daily dosing recommendations for darunavir/ritonavir in pediatric patients aged ≥3 to <12 years. The final model comprised two compartments with first-order absorption and apparent clearance dependent on the concentration of α1-acid glycoprotein...
July 2015: CPT: Pharmacometrics & Systems Pharmacology
Lisa L Ross, Mark F Cotton, Haseena Cassim, Eugeny Voronin, Naomi Givens, Jorg Sievers, Katharine Y Cheng
Treatment-emergent mutations and drug resistance were analyzed in virus from HIV-infected children meeting virologic failure (VF) criteria over 48 weeks following treatment with unboosted fosamprenavir or fosamprenavir/ritonavir-containing regimens in studies APV20002 and APV29005. Both antiretroviral therapy (ART)-naïve and ART-experienced patients were enrolled. Patients met VF criteria by either failing to suppress HIV-RNA to <400 copies/mL through week 24 or after confirmed viral rebound (≥400 copies/mL) anytime through week 48...
2015: Open AIDS Journal
Tammy Meyers, Shobna Sawry, Jessica Y Wong, Harry Moultrie, Francoise Pinillos, Lee Fairlie, Gert van Zyl
OBJECTIVE: To report the outcomes, clinical management decisions and results of resistance testing among a group of children who developed virologic failure on first-line lopinavir/ritonavir (LPV/r)-based therapy from a large cohort of antiretroviral therapy-treated children in Soweto. DESIGN: Historical cohort study. METHODS: Children with virologic failure were identified from a group of 1692 children <3 years who had initiated first-line LPV/r-containing therapy since 2000 up to the end November 2011...
February 2015: Pediatric Infectious Disease Journal
Avy Violari, Rosa Bologna, Nagalingeswaran Kumarasamy, Jose Henrique Pilotto, Annemie Hendrickx, Thomas N Kakuda, Erkki Lathouwers, Magda Opsomer, Tom Van de Casteele, Frank L Tomaka
BACKGROUND: ARIEL (Darunavir in treatment-experienced pediatric population) was a phase II, open-label study assessing safety and antiviral activity of darunavir/ritonavir twice daily with an optimized background regimen (OBR) in treatment-experienced, HIV-1-infected pediatric patients (3 to <6 years, weighing 10 to <20 kg). METHODS: The study consisted of an initial 4-week screening period, 48 weeks of treatment and a 4-week follow-up period. Patients initially received darunavir/ritonavir 20/3 mg/kg twice-daily for 2 weeks...
May 2015: Pediatric Infectious Disease Journal
P Rojas Sánchez, M de Mulder, E Fernandez-Cooke, L Prieto, P Rojo, S Jiménez de Ory, M José Mellado, M Navarro, J Tomas Ramos, Á Holguín
Drug resistance mutations compromise the success of antiretroviral treatment in human immunodeficiency virus type 1 (HIV-1)-infected children. We report the virologic and clinical follow-up of the Madrid cohort of perinatally HIV-infected children and adolescents after the selection of triple-class drug-resistant mutations (TC-DRM). We identified patients from the cohort carrying HIV-1 variants with TC-DRM to nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors and protease inhibitors according to IAS-USA-2013...
June 2015: Clinical Microbiology and Infection
Patricia Flynn, Svitlana Komar, Stephane Blanche, Carlo Giaquinto, Antoni Noguera-Julian, Steven Welch, Erkki Lathouwers, Tom Van de Casteele, Thomas N Kakuda, Magda Opsomer
BACKGROUND: Twice-daily darunavir/ritonavir is indicated in treatment-experienced children (≥3 years). This study assessed once-daily administration in treatment-naïve adolescents. METHODS: Phase 2, 48-week, open-label, single-arm study evaluating pharmacokinetics, safety and efficacy of once-daily darunavir/ritonavir 800/100 mg in treatment-naïve, HIV-1-infected adolescents (≥12 to <18 years, ≥40 kg) with zidovudine/lamivudine or abacavir/lamivudine...
September 2014: Pediatric Infectious Disease Journal
Angela Colbers, José Moltó, Jelena Ivanovic, Kabamba Kabeya, David Hawkins, Andrea Gingelmaier, Graham Taylor, Katharina Weizsäcker, S Tariq Sadiq, Marchina Van der Ende, Carlo Giaquinto, David Burger
OBJECTIVES: To describe the pharmacokinetics of darunavir in pregnant HIV-infected women in the third trimester and post-partum. PATIENTS AND METHODS: This was a non-randomized, open-label, multicentre, Phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe. HIV-infected pregnant women treated with darunavir (800/100 mg once daily or 600/100 mg twice daily) as part of their combination ART were included. Pharmacokinetic curves were recorded in the third trimester and post-partum...
February 2015: Journal of Antimicrobial Chemotherapy
Joanna Dobroszycki, Jacobo Abadi, Andrew A Wiznia, Michael G Rosenberg
The introduction of protease inhibitors (PI) containing antiretroviral regimens in the treatment of HIV infection in infants, children, and adolescents has dramatically decreased morbidity and mortality. Darunavir, the latest PI to be FDA approved for pediatric patients older than 6 years and currently the preferred PI for use in adult patients, was added as an alternative PI for use in children based on a combination of data from both adult and pediatric trials. This review of darunavir in the treatment of HIV-infected children and adolescents looks at the major published clinical trials findings, pharmacokinetic and resistance studies, and preliminary data on use in younger children...
2011: Adolescent Health, Medicine and Therapeutics
L Iu Afonina, E E Voronin
The use of antiretroviral drugs (ARVDs) in a mother and a child can reduce the risk of vertical transmission of human immunodeficiency virus (HIV) to less than 1%; therefore, highly active antiretroviral therapy is used in all pregnant women regardless of indications for HIV-infection treatment. The major requirements for choosing an ARVD to prevent mother-to-child HIV transmission are its high safety for a pregnant woman, a fetus, and a baby and its high therapeutic efficacy. Clinical trials of darunavir (DRV) in adults and children have shown a high virologic response, good tolerance, and safety...
2013: Terapevticheskiĭ Arkhiv
Emma D Deeks
The latest HIV-1 protease inhibitor (PI) darunavir (Prezista™) has a high genetic barrier to resistance development and is active against wild-type HIV and HIV strains no longer susceptible to some older PIs. Ritonavir-boosted darunavir, as a component of antiretroviral therapy (ART), is indicated for the treatment of HIV-1 infection in adult and paediatric patients (aged ≥3 years), with or without treatment experience (details vary depending on region of approval). Several open-label or partially-blinded trials have evaluated the efficacy of ritonavir-boosted darunavir ART regimens for up to 192 weeks in these settings...
January 2014: Drugs
R Chris Rathbun, Staci M Lockhart, Misty M Miller, Michelle D Liedtke
OBJECTIVE: To review the pharmacology, safety, and efficacy of dolutegravir, an integrase strand-transfer inhibitor (INSTI), and to discuss its role in the treatment of HIV-1-infected patients. DATA SOURCES: PubMed articles indexed through August 2013 were identified using the search terms S/GSK1349572, dolutegravir, and integrase inhibitor. Information was also identified from the package insert, cited publication references, professional meeting abstracts, and the ClinicalTrials...
March 2014: Annals of Pharmacotherapy
Gert U Van Zyl, Tommy F Liu, Mathilda Claassen, Susan Engelbrecht, Tulio de Oliveira, Wolfgang Preiser, Natasha T Wood, Simon Travers, Robert W Shafer
OBJECTIVES: South Africa's national antiretroviral (ARV) treatment program expanded in 2010 to include the nucleoside reverse transcriptase (RT) inhibitors (NRTI) tenofovir (TDF) for adults and abacavir (ABC) for children. We investigated the associated changes in genotypic drug resistance patterns in patients with first-line ARV treatment failure since the introduction of these drugs, and protease inhibitor (PI) resistance patterns in patients who received ritonavir-boosted lopinavir (LPV/r)-containing therapy...
2013: PloS One
Kathleen Squires, Judith Feinberg, Dawn Averitt Bridge, Judith Currier, Robert Ryan, Setareh Seyedkazemi, Yaswant K Dayaram, Joseph Mrus
The Gender, Race And Clinical Experience (GRACE) study was conducted between October 2006 and December 2008 to evaluate sex- and race-based differences in outcomes after treatment with a darunavir/ritonavir-based antiretroviral regimen. Between June 2010 and June 2011, former participants of the GRACE trial at participating sites were asked to complete a 40-item questionnaire as part of the GRACE Participant Survey study, with a primary objective of assessing patients' characteristics, experiences, and opinions about participation in GRACE...
June 2013: AIDS Patient Care and STDs
Nisha Andany, Mona R Loutfy
The impact of antiretroviral therapy (ART) on the natural history of HIV-1 infection has resulted in dramatic reductions in disease-associated morbidity and mortality. Additionally, the epidemiology of HIV-1 infection worldwide is changing, as women now represent a substantial proportion of infected adults. As more highly effective and tolerable antiretroviral regimens become available, and as the prevention of mother-to-child transmission becomes an attainable goal in the management of HIV-infected individuals, more and more HIV-positive women are choosing to become pregnant and have children...
March 2013: Drugs
Brianna L Kirk, Andres Gomila, Mogomotsi Matshaba, Marape Marape, Dipesalema R Joel, Gabriel Anabwani, Michael A Tolle
BACKGROUND: Data on the use of ritonavir-boosted darunavir (DRV/r) and/or raltegravir (RAL) in resource-limited settings are rare and there is currently no published data regarding their use among African children. Botswana has recently made DRV/r and RAL available for patients failing second-line antiretroviral therapy (ART). METHODS: Retrospective chart review of 4 multidrug-resistant pediatric patients on DRV/r- and/or RAL-based regimens. Viral load, CD4 count, adherence by pill count, and World Health Organization (WHO) clinical stage prior to and after switch to DRV/r- and/or RAL-based regimen were assessed...
March 2013: Journal of the International Association of Providers of AIDS Care
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