Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial

Madruga, José Valdez; Berger, Daniel; McMurchie, Marilyn; Suter, Fredy; Bánhegyi, Dénes; Ruxrungtham, Kiat; Norris, Dorece; Lefebvre, E.; Béthune, M.-P. De; Tomaka, Frank; Pauw, Martine De; Vangeneugden, Tony; Spinosa‐Guzman, Sabrina

doi:10.1016/s0140-6736(07)61049-6

Cited by 305 publications

(256 citation statements)

References 9 publications

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“…Specifically, the POWER and TITAN [5,6] trials showed that 46% and 77% of patients in the DRV group, respectively, had an HIV-1 RNA viral load < 50 copies/mL, compared with our results of 91%. Moreover, here we used fully active raltegravir and tenofovir as an OBR, whereas the POWER and TITAN trials used reverse transcriptase inhibitors (and enfuvirtide in some cases) as the OBR, thus avoiding the use of raltegravir.…”

Section: Discussioncontrasting

confidence: 70%

“…Tipranavir (TPV) and darunavir (DRV) are the first PIs that were developed for the management of infection caused by PI-resistant viruses, and each of these drugs exhibited potent in vivo and in vitro activity against HIV-1 strains with accumulated multiple mutations associated with resistance to this class of drugs [4]. Each of these drugs has been shown to be superior to equivalent PIs in randomized controlled trials of treatment-experienced patients [5,6]. Although both TPV and DRV represent important options for the management of patients with multi-PI-resistant HIV, currently there are no studies comparing the effectiveness and safety of these two drugs in the Mexican population.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of tipranavir versus darunavir as a salvage therapy in HIV-1 treatment-experienced patients

Domínguez-Hermosillo

Mata‐Marín

Herrera-González

et al. 2016

J Infect Dev Ctries

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Introduction: Although both tipranavir (TPV) and darunavir (DRV) represent important options for the management of patients with multiprotease inhibitor (PI)-resistant human immunodeficiency virus (HIV), currently there are no studies comparing the effectiveness and safety of these two drugs in the Mexican population. The aim of this study was to compare the effectiveness of TPV versus DRV as a salvage therapy in HIV-1 treatment-experienced patients. Methodology: This was a comparative, prospective, cohort study. Patients with HIV and triple-class drug resistance evaluated at the Hospital de Infectología "La Raza", National Medical Center, were included. All patients had the protease and retrotranscriptase genotype; resistance mutation interpretation was done using the Stanford database. Results: A total of 35 HIV-1 triple-class drug-resistant patients were analyzed. All of them received tenofovir and raltegravir, 22 received darunavir/ritonavir (DRV/r), and 13 received tipranavir/ritonavir (TPV/r) therapies. The median baseline RNA HIV-1 viral load and CD4+ cell count were 4.34 log (interquartile range [IQR],) and 267 cells/mm 3 (IQR, for the DRV/r group, and 4.14 log (IQR, 3.51-4.85) and 445 cells/mm 3 (IQR, for the TPV/r group. At week 24 of treatment, 91% of patients receiving DRV/r and 100% of patients receiving TPV/r had an RNA HIV-1 viral load < 50 copies/mL and a CD4+ cell count of 339 cells/mm 3 (IQR, and 556 cells/mm

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Section: Discussioncontrasting

confidence: 70%

Section: Introductionmentioning

confidence: 99%

Effectiveness of tipranavir versus darunavir as a salvage therapy in HIV-1 treatment-experienced patients

Domínguez-Hermosillo

Mata‐Marín

Herrera-González

et al. 2016

J Infect Dev Ctries

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“…In the TITAN study that compared an optimized background regimen (OBR) plus DRV/r vs. lopinavir/ritonavir, 48-week virologic suppression (<400 c/ml) was achieved in 77% and 68% of patients, respectively, though these patients were less treatment experienced than those in the present study. 10 Pooled analysis of the DUET 1 and 2 trials (OBR including DRV/r in all patients, plus ETR vs. Placebo) showed 48-week virologic suppression in (VL <50 c/ml) 61% (ETR) and 40% (Placebo) of individuals.…”

Section: Discussionmentioning

confidence: 96%

“…With various clinical trials highlighting the safety and superior efficacy of these newer agents, complete virologic suppression has become the therapeutic goal for all HIV-infected patients, including those who are treatment-experienced. [1][2][3][4][5][6][7][8][9][10][11][12] Despite the accumulating body of evidence from clinical trials, a paucity of published data addressing the effectiveness of these newer agents in routine clinical care settings exists. Evaluating both the efficacy and effectiveness of newer agents is important to ensure that the results obtained from clinical trials are generalizable to populations treated through routine care.…”

Section: Introductionmentioning

confidence: 99%

Darunavir Outcomes Study: Comparative Effectiveness of Virologic Suppression, Regimen Durability, and Discontinuation Reasons for Three-Class Experienced Patients at 48 Weeks

Willig

Aban²,

Nevin³

et al. 2010

AIDS Research and Human Retroviruses

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Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL <400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL <400 c/ml. In MV modeling DRV/r (OR ¼5.77;95%CI ¼ 1.62-20.58) and RAL (OR ¼ 3.84;95%CI ¼ 1.23-11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL <400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.

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“…16,17 When compared with PIs, NNRTIs have been associated with less dyslipidemia in clinical studies. 15 However, a trial comparing use of the NNRTI efavirenz to atazanavir, a PI, reported significantly increased dyslipidemia with efavirenz.…”

Section: Hiv and Cholesterolmentioning

confidence: 99%

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

Advani

Patel²,

Pichardo³

et al. 2014

JMCP

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Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial

Cited by 305 publications

References 9 publications

Effectiveness of tipranavir versus darunavir as a salvage therapy in HIV-1 treatment-experienced patients

Effectiveness of tipranavir versus darunavir as a salvage therapy in HIV-1 treatment-experienced patients

Darunavir Outcomes Study: Comparative Effectiveness of Virologic Suppression, Regimen Durability, and Discontinuation Reasons for Three-Class Experienced Patients at 48 Weeks

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

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