Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials

Katlama, Christine; Haubrich, Richard; Lalezari, Jacob; Lazzarin, Adriano; Madruga, José Valdez; Molina, Jean Michel; Schechter, Mauro; Peeters, Monika; Picchio, Gastón; Vingerhoets, Johan; Woodfall, Brian; Smedt, Goedele De

doi:10.1097/qad.0b013e3283316a5e

Cited by 172 publications

(203 citation statements)

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“…Laboratory abnormalities, adherence and antiretroviral-related adverse events are summarized in Table 1. In adults, etravirine-based therapy has demonstrated durable antiretroviral activity [2][3][4]. However, to date, no interim data have been published on efficacy and tolerability in paediatric patients harbouring multidrug resistance mutations.…”

Section: Betweenmentioning

confidence: 99%

“…However, the emergence of HIV quasispecies resistant to these drugs compromises current treatment options, thus creating the need to develop new antiretrovirals for children and adolescents infected with multiresistant strains of HIV. Etravirine (Intelence s , Tibotec, Beerse, Belgium), a second-generation nonnucleoside reverse transcriptase inhibitor (NNRTI), has produced promising results in the DUET-1 and DUET-2 trials in treatment-experienced HIV-1-infected adults with documented resistance to efavirenz and nevirapine [2][3][4]. However, the results of clinical trials in adults may not be representative of children and adolescents, because of the special features of these populations.…”

Section: Introductionmentioning

confidence: 99%

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Etravirine-based highly active antiretroviral therapy in HIV-1-infected paediatric patients

et al. 2011

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We evaluated the efficacy, safety and tolerability of etravirine in paediatric patients vertically infected with HIV-1. MethodsA multicentre retrospective study of 23 multidrug-resistant paediatric patients (five children and 18 adolescents) enrolled in the study from 1 September 2007 to 28 February 2010 was carried out. We performed a longitudinal analysis of immunological, virological and clinical data. ResultsThe median age of the patients was 14.2 years [interquartile range (IQR) 12.5-15.8 years]. At baseline, the median HIV-1 RNA was 29 000 (4.5 log 10 ) HIV-1 RNA copies/mL (range 4300-83 000 copies/mL), the median CD4 T-cell count was 445 cells/mL (range 221-655 cells/mL) and the median CD4 percentage was 19.6% (IQR 13.0-31.0). Remarkably, 16 of 23 patients (70%) harboured one or more etravirineassociated resistance mutations. The backbone regimen included at least two fully active drugs in 91% of patients. After etravirine-based therapy, 20 patients (87%) achieved HIV-1 RNAo400 copies/mL and 18 of 23 (78%) achieved HIV-1 RNAo50 copies/mL: three (13%) within the first month, seven (30%) within the first 4 months, and six (26%) between the 5th and 8th months. CD4 T-cell recovery was observed in 19 patients (83%). The median follow-up time was 48.4 weeks .4 weeks); four patients (17%) were exposed to etravirine for 4120 weeks. Three mild/short-term and two moderate skin rashes were observed in the adolescents. Laboratory abnormalities included hypercholesterolaemia (11 of 23 patients), hypertriglyceridaemia (eight of 23 patients), and reduced high-density lipoprotein cholesterol (10 of 23 patients). Adherence was complete in seven patients (30%). No patients showed complete resistance to etravirine after follow-up. However, three of 21 patients (14%) who initially showed intermediate resistance interrupted etravirine treatment because of virological failure. ConclusionsWe observed a sustained antiviral response and improved immunological parameters in multidrugresistant paediatric patients, most of whom had received etravirine as part of salvage regimens with at least two fully active drugs.

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Section: Betweenmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Etravirine-based highly active antiretroviral therapy in HIV-1-infected paediatric patients

et al. 2011

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“…The POWER trials evaluated the use of boosted darunavir in patients with more than one primary protease inhibitor resistance mutation to optimized regimen and darunavir versus a control protease inhibitor. At 48 weeks 45 versus 10% of patients receiving darunavir/ritonavir versus control protease inhibitor were able to maintain virologic Adapted from [1] with permission.…”

Section: Expert Opinionmentioning

confidence: 99%

“…Etravirine in combination with darunavir/ritonavir and optimized background regimen results in suppression of HIV replication in treatment-experienced patients 1…”

Section: Clinical Trial Evaluationmentioning

confidence: 99%

“…The pooled 48-week analysis of the DUET (TMC125 to Demonstrate Undetectable viral load in patients Experienced with antretroviral Therapy)-1 and -2 studies designed to compare etravirine with placebo in combination with a darunavir/ ritonavir-containing optimized background regimens has updated the preliminary 24-week data from both trials [1][2][3]. Treatment goals in treatment-experienced HIV-infected patients remain similar to that of treatment-naive patients, with a target of virologic suppression (plasma viral load <50 copies/ml) [4].…”

Section: Introductionmentioning

confidence: 99%

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Etravirine in combination with darunavir/ritonavir and optimized background regimen results in suppression of HIV replication in treatment-experienced patients

Hull

Montaner²

2010

Expert Opinion on Pharmacotherapy

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Antiretroviral Treatment of Adult HIV Infection

Thompson

Aberg²,

Cahn³

et al. 2010

JAMA

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289

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UCCESSFUL ANTIRETROVIRAL therapy (ART) is associated with dramatic decreases in AIDSdefining conditions and their associated mortality. Expansion of treatment options and evolving knowledge require revision of guidelines for the initiation and long-term management of ART in adults with HIV infection.Since the 2008 International AIDS Society-USA ART guidelines, 1 new data have emerged regarding timing of therapy, optimal regimen choices, and monitoring. There are also issues of special relevance to circumstances such as pregnancy, hepatitis virus coinfections, kidney disease, cardiovascular disease, and primary HIV infection.Analyses of clinical trials and epidemiologic cohorts have shed light on the role of ART in mitigating serious non-AIDS events associated with uncontrolled HIV replication. Newer drugs are better understood in terms of efficacy, toxicity, and potential uses. New data also suggest a role for ART in the prevention of HIV transmission. METHODSThe panel was convened in 1995 to develop evidence-based recommendations for ART for HIV-infected adults in developed-world settings. 2 Members are appointed by International AIDS Society-USA according to clinical and research expertise. Current panel members do not participate in pharmaceutical marketing or promotional activities (eg, speakers' bureaus, industry satellites) during tenure on the panel. The current panel convened in January 2010 and met weekly in person or by teleconference. Data published or presented in specific scientific meetings since the last report 1 CME available online at www.jamaarchivescme.com and questions on p 357.

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Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials

Cited by 172 publications

References 18 publications

Etravirine-based highly active antiretroviral therapy in HIV-1-infected paediatric patients

Etravirine-based highly active antiretroviral therapy in HIV-1-infected paediatric patients

Etravirine in combination with darunavir/ritonavir and optimized background regimen results in suppression of HIV replication in treatment-experienced patients

Antiretroviral Treatment of Adult HIV Infection

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