Efficacy, Safety, and Tolerability of Etravirine With and Without Darunavir/Ritonavir or Raltegravir in Treatment-Experienced Patients: Analysis of the Etravirine Early Access Program in the United States

Towner, William; Lalezari, Jacob; Sension, Michael; Wohlfeiler, Michael; Gathe, Joseph; Appelbaum, Jonathan; Bellman, Paul; Gottlieb, Michael; Ryan, Robert J.; Nijs, Steven; Hoogstoel, Annemie; Solingen‐Ristea, Rodica Van; Witek, James

doi:10.1097/qai.0b013e3181cdebb1

Cited by 23 publications

(19 citation statements)

References 4 publications

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“…ETR with raltegravir and darunavir (or other boosted PIs) has shown outstanding efficacy rates and a good safety profile in preliminary clinical trials and different expanded-access programs, achieving undetectable viral loads at 48 weeks in as many as 70% and 81% of patients after 48 weeks of treatment. 9,10,12,16 Our results are consistent with these findings, and darunavir and raltegravir were the most frequently used antiretroviral agents in the optimized baseline treatments, with high rates of treatment response and virological suppression. In addition, viral suppression has also been observed in 92% of patients in a setting with more limited therapeutic options, namely, a PI and NRTI-sparing regimen containing ETR plus maraviroc and raltegravir.…”

Section: Discussionsupporting

confidence: 94%

“…2,3 The safety and efficacy of ETR in combination with the remaining new antiretrovirals have not been evaluated outside the strictly controlled conditions of a clinical trial, although preliminary reports on the combination of these new drugs have shown promising results. [9][10][11][12] We evaluated the effectiveness of rescue regimens containing ETR combined with all the available active agents in routine clinical practice. We also analyzed the relationship between the 1 Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona number of additional active drugs in the optimized regimen and other factors associated with the response to ETR.…”

Section: Introductionmentioning

confidence: 99%

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Short Communication: High Effectiveness of Etravirine in Routine Clinical Practice in Treatment-Experienced HIV Type 1-Infected Patients

Santos

Llibre

Domingo

et al. 2011

AIDS Research and Human Retroviruses

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The effectiveness of etravirine has not been thoroughly investigated in routine clinical practice, where adherence rates and the heterogeneous nature of patients differ from the clinical trial setting. We evaluated the effectiveness of rescue regimens containing etravirine and the factors associated with treatment response. Multicenter retrospective cohort of all consecutive patients was recruited in a routine clinical practice setting. Patients were taking rescue regimens containing etravirine plus an optimized background regimen. The primary endpoint was the percentage of patients with HIV-1 RNA <50 copies/ml at week 48. The secondary endpoints were those factors associated with treatment response to etravirine. Endpoints were evaluated using univariate and multivariate analysis. A total of 122 patients were included with a median viral load of 11,938 (1055-55,500) copies/ml at baseline. The most frequent drugs in the backbone were darunavir/ritonavir in 98 (80.3%) patients and raltegravir in 76 (62.3%). In the full dataset analysis, 73% (89/122; 95% CI, 64-81%) of patients responded to treatment at week 48; in the on-treatment analysis, 82% (89/109; 95% CI, 71-87%) responded. The factors associated with treatment failure to etravirine [HR (95% CI)] were baseline CD4(+) T cell count <200 cells/mm(3) [2.45 (1.17-5.16)] and use of raltegravir [0.47 (0.22-0.99)] and darunavir [0.45 (0.21-0.98)] as backbone drugs. Skin rash was the only adverse event directly related to etravirine and led to withdrawal in three patients (2.5%). In routine clinical practice, rescue ETR-containing regimens are well tolerated and achieve rates of virological suppression higher than those observed in its pivotal clinical trials, especially when combined with darunavir and raltegravir.

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Section: Discussionsupporting

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Short Communication: High Effectiveness of Etravirine in Routine Clinical Practice in Treatment-Experienced HIV Type 1-Infected Patients

Santos

Llibre

Domingo

et al. 2011

AIDS Research and Human Retroviruses

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“…This response was observed when etravirine was administered alone or when combined with raltegravir or darunavir-ritonavir. 57 The collection, analysis, and interpretation of the data by employees or individuals who had conflicts of interest with its manufacturer are among the limitations of the etravirine clinical trials. The pooled 24-week, individual 48-week, and pooled 48-week results of DUET-1 and DUET-2 have not been formally published.…”

Section: -Week Analysismentioning

confidence: 99%

“…71,72 Clinicians anticipate the final results of the Phase III early-access program trial and future etravirine trials to guide their selection of medications in the background regimen of etravirine. 45,57 Obtaining data on etravirine use with other antiretrovirals is especially important, because darunavirritonavir has been approved for treatment-naive patients, and the number of darunavir-ritonavir mutations in treatment-experienced patients may gradually increase.…”

Section: Role In Therapymentioning

confidence: 99%

Etravirine: A novel nonnucleoside reverse transcriptase inhibitor for managing human immunodeficiency virus infection

Elsayed

Caldwell

2010

American Journal of Health-System Pharmacy

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“…Several clinical trials have reported a dramatic increase in the proportion of patients safely achieving virological response despite harboring multidrug-resistant HIV-1 viruses [8][9][10]. Among these investigations, the ANRS 139 TRIO trial reported that 86% of patients reached HIV-1 RNA < 50 copies/mL at week 48 with a salvage regimen containing raltegravir (RAL), ETV and DRV/r, and OBR with NRTIs or enfuvirtide [9].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of etravirine-based therapy for treatment-experienced HIV-infected patients

García

Mata‐Marín

Domínguez-Hermosillo

et al. 2016

J Infect Dev Ctries

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Introduction: Treatment options are limited for HIV-1-infected individuals who have received extensive previous antiretroviral therapy. ETV has shown significant clinical benefits in treatment-experienced HIV-1+ patients with antiretroviral resistance. The aim of this study was to evaluate the effectiveness of ETV plus optimized background regimen in real-life conditions in a cohort of highly HIV-1 antiretroviralexperienced patients. Methodology: Retrospective cohort of treatment-experienced HIV-1-infected adults with virological failure who started therapy with an ETVcontaining regimen. The effectiveness was evaluated using HIV-1 RNA viral load and changes in CD4+ cell count after 48 weeks of treatment. Results: Forty-two patients ≥ 16 years of age were included; 74% were men, and the median age was 45 years (IQR 41-53). All participants had prior non-nucleoside reverse transcriptase inhibitor use (55% nevirapine, 83%, efavirenz, and 28% both). Baseline median HIV-1 RNA viral load was 15,598 copies/mL (IQR 2651-84,175) and CD4+ cell count was 276 cells/L . After 48 weeks of treatment, 90.5% (95% CI 78-96) of patients had HIV-1 RNA viral load < 200 copies/mL and 76% (95% CI 61-86) had < 50 copies/mL. CD4+ cell counts increased from baseline to 48 weeks of treatment to a median of 407 cells/L (IQR 242-579); p < 0.001. Virological outcome was associated with virological failure at baseline HIV-1 RNA viral load ≥ 100,000 copies/mL (OR 7.6; 95% CI 1.2-44.80; p = 0.025). Conclusions: Our study provides clinically important evidence of the effectiveness and safety of ETV in highly antiretroviral-experienced HIV-1-infected patients.

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Efficacy, Safety, and Tolerability of Etravirine With and Without Darunavir/Ritonavir or Raltegravir in Treatment-Experienced Patients: Analysis of the Etravirine Early Access Program in the United States

Abstract: Etravirine combined with a BR, often including other new antiretrovirals, such as darunavir/ritonavir and/or raltegravir, provided an effective treatment option in treatment-experienced patients with HIV-1.

Cited by 23 publications

References 4 publications

Short Communication: High Effectiveness of Etravirine in Routine Clinical Practice in Treatment-Experienced HIV Type 1-Infected Patients

Short Communication: High Effectiveness of Etravirine in Routine Clinical Practice in Treatment-Experienced HIV Type 1-Infected Patients

Etravirine: A novel nonnucleoside reverse transcriptase inhibitor for managing human immunodeficiency virus infection

Effectiveness of etravirine-based therapy for treatment-experienced HIV-infected patients

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