Similar antiviral efficacy and tolerability between efavirenz and lopinavir/ritonavir, administered with abacavir/lamivudine (Kivexa®), in antiretroviral-naïve patients: A 48-week, multicentre, randomized study (Lake Study)

Echeverría, Patricia; Negredo, Eugènia; Carosi, Giampiero; Gálvez, Juan Francisco Pérez; Gómez, Juan Luís; Ocampo, Antonio; Portilla, Joaquín; Prieto, Á.; López, Juan Carlos; Rubio, Rafael; Mariño, Ana; Pedrol, Enric; Viladés, Consuelo; Arco, Alfonso del; Moreno, A.; Bravo, Isabel; López-Blázquez, Raquel; Pérez-Álvarez, Núria; Clotet, Bonaventura

doi:10.1016/j.antiviral.2009.11.008

Cited by 31 publications

(39 citation statements)

References 17 publications

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“…The Lake study also showed that patients on LPV/r-containing regimens had a lower CD4 + count increase, although the differences were not significant. 7 It is likely that the discrepancy in the results of the Lake study and our clinical trial as compared with the rest of the studies could be due to the small number of patients included. However, it could not be excluded that the higher increase in the expression of CD127 in T cell subsets in the EFV group observed in our clinical trial could also explain this difference, since expression of CD127 has been previously associated with CD4 gains in treated patients.…”

Section: Discussionmentioning

confidence: 54%

“…[4][5][6] Conversely, other clinical trials that compared NNRTI and PI-based regimens did not find significant differences in the increases in CD4 + counts in both groups. [7][8][9] It is unclear if the potential differences in recovery of the CD4 T cell count with different cART regimens have any clinical or immunological relevance. First, regarding different clinical outcomes with EFV vs. LPV/r-containing regimens, it has been reported that PI-and NNRTI-based cART regimens are equally effective in protection against Kaposi sarcoma.…”

Section: Introductionmentioning

confidence: 99%

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Immunological Function Restoration with Lopinavir/Ritonavir Versus Efavirenz Containing Regimens in HIV-Infected Patients: A Randomized Clinical Trial

Torres

Rallón

Loncá

et al. 2014

AIDS Research and Human Retroviruses

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CD4+ count increase has been reported to be different with lopinavir/r (LPV/r) and efavirenz (EFV)-containing regimens. The different effect of these two regimens on other immune function parameters and the relationship with the gain of CD4 + count have not been assessed in a randomized clinical trial. Fifty antiretroviral treatment (cART) naïve HIV-infected individuals were randomized to receive LPV/r or EFV both with tenofovir/emtricitabine for 48 weeks. A substudy of immunological function restoration was performed in 22 patients (LPV/r n = 10 and EFV n = 12). Activation, thymic function, apoptosis, senescence, exhaustion, Treg cells, interleukin (IL)-7-receptor/IL-7 system, thymic volume, and lymphoid tissue fibrosis were evaluated at baseline and at week 48. Both groups experienced a CD4 + count increase that was higher in the EFV group (DCD4 + 88 vs. 315 cells/ll LPV/r vs. EFV, respectively, p < 0.001). Despite this difference in CD4 + gain, the change in other immune function parameters was similar in both treatment groups. Most of parameters evaluated tended to normalize after 48 weeks of cART. A significant decrease in levels of activation, senescence, exhaustion, and apoptosis on CD4 + and CD8 + T cells ( p < 0.001 for all) and a significant increase in markers of thymic function, IL-7 receptor, and in the levels of central memory CD4+ T cells and naive subsets of CD8 + T cells ( p < 0.001 for all) with respect to baseline values were observed without any difference between groups. These data indicate that the differences in CD4 + gain with different cART regimens are not immunologically meaningful and might explain the similar clinical efficacy of these regimens.

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Section: Discussionmentioning

confidence: 54%

Section: Introductionmentioning

confidence: 99%

Immunological Function Restoration with Lopinavir/Ritonavir Versus Efavirenz Containing Regimens in HIV-Infected Patients: A Randomized Clinical Trial

Torres

Rallón

Loncá

et al. 2014

AIDS Research and Human Retroviruses

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“…32 Several studies have been reported that compare efavirenz or ritonavir-boosted other protease inhibitor with 2 nucleoside reverse transcriptase inhibitors (NRTIs) to LPV/r with 2 NRTIs. [33][34][35][36] The goal of these trials is the proportion of patients with HIV-1 RNA levels ,50 copies/ml at the endpoint time (48 weeks or 144 weeks). The study by Pulido et al assessed the longtermefficacyandsafetyofFosamprenavir+ ritonavir (FPV/r) compared to LPV/r both in combination with abacavir/lamivudine over 144 weeks.…”

Section: Clinical Trialsmentioning

confidence: 99%

“…38 Several trials were reported that compared the use of LPV/r with efavirenz as a nucleosidesparing regimen. 33,35,39,40 The dosing for LPV/r was 533.3/133.3 mg twice-daily along with efavirenz 600 mg daily. The proportion of patients (n = 86) with HIV-1 RNA levels ,50 copies/ml at 48 weeks was 69% using an intent-to-treat analysis.…”

Section: Clinical Trialsmentioning

confidence: 99%

Lopinavir/Ritonavir: A Review for 2011

Teply

Goodman²,

Destache

2011

Clinical Medicine Insights: Therapeutics

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Ritonavir-boosted lopinavir (LPV/r) is a boosted protease inhibitor (PI) combination used as an alternative agent in the management of the human immunodeficiency virus (HIV). HIV treatment consists of combinations of classes of medications with complementing mechanisms of action. Protease inhibitor-based therapy is one of the mainstays of therapy. Ritonavir-boosted lopinavir can be dosed once-or twice-daily based on previous antiretroviral therapy, patient characteristics, and concomitant medications. It is currently available as an oral solution or tablet formulation and can be given without regard to food if given as a tablet. Lopinavir is extensively metabolized via the cytochrome (CYP) P450 3A4 and 3A5 hepatic isoenzymes and ritonavir is a potent inhibitor of CYP34A. Co-administration of low-dose ritonavir leads to increased plasma concentrations of lopinavir. There is potential for numerous drug-drug interactions when additional medications are administered. Clinical trials have been reported previously demonstrating the safety and efficacy of LPV/r in children, adolescents and adults and it is readily used throughout these populations. Current clinical trials are focused on examining the efficacy and toxicity of boosted-PI monotherapy as a treatment option in previously suppressed adults.

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“…Several antiretroviral combinations have proven sufficiently potent to achieve viral suppression in most treated patients. However, maintaining efficacy depends on other factors, such as the durability of antiviral suppression, tolerability, risk of long-term toxicity, and patient convenience [3].…”

Section: Introductionmentioning

confidence: 99%

Molecular Structure, Vibrational Spectra and Docking Studies of Abacavir by Density Functional Theory

Solaichamy

Karpagam

2017

ILCPA

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Abstract. In this study, optimized geometry, spectroscopic (FT-IR, FT-Raman, UV) analysis, and electronic structure analysis of Abacavir were investigated by utilizing DFT/B3LYP with 6-31G(d,p) as a basis set. Complete vibrational assignments and correlation of the fundamental modes for the title compound were carried out. The calculated molecular geometry has been compared with available X-ray data of Abacavir. The calculated HOMO and LUMO energies show that charge transfer occurs within the molecule. The molecular stability and bond strength have been investigated by applying the Natural Bond Orbital (NBO) analysis. The computational molecular docking studies of title compound have been performed.

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Similar antiviral efficacy and tolerability between efavirenz and lopinavir/ritonavir, administered with abacavir/lamivudine (Kivexa®), in antiretroviral-naïve patients: A 48-week, multicentre, randomized study (Lake Study)

Cited by 31 publications

References 17 publications

Immunological Function Restoration with Lopinavir/Ritonavir Versus Efavirenz Containing Regimens in HIV-Infected Patients: A Randomized Clinical Trial

Immunological Function Restoration with Lopinavir/Ritonavir Versus Efavirenz Containing Regimens in HIV-Infected Patients: A Randomized Clinical Trial

Lopinavir/Ritonavir: A Review for 2011

Molecular Structure, Vibrational Spectra and Docking Studies of Abacavir by Density Functional Theory

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