Examples of using Optimised background in English and their translations into Slovak
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OBT: Optimised Background Therapy.
Key: 1GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
Both arms used an optimised background regimen(OBR) of≥ 2 NRTIs.
CELSENTRI was more effective than placebo in reducing viral loads,when taken in combination with optimised background therapy.
Combinations with optimised background regimen(OBRs) other than≥ 2 NRTIs have not been studied in this population.
During the studies,patients receiving Isentress developed more cancers than patients receiving optimised background therapy.
Both arms used an Optimised Background Regimen(OBR) consisting of at least 2 antiretrovirals(NRTIs with or without NNRTIs).
From the clinical trials, a large proportion of patients used atazanavir and/ or tenofovir,both agents that result in increases in raltegravir plasma levels, in the optimised background regimens.
Taking Fuzeon with optimised background therapy was more effective at reducing viral loads than optimised background therapy alone.
During the clinical studies in treatment-experienced HIV-infected patients there was a slightly higher rate of cancer in the raltegravirgroup compared to the group that received only optimised background therapy.
All of the patients also took‘optimised background therapy'(a combination of other anti- HIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
The proportion of patients who had undetectable levels of HIV in their blood was about 45% when CELSENTRI was added to optimised background therapy compared with 23% of the patients receiving optimised background therapy only.
All of the patients have been receiving‘ optimised background therapy'(a combination of other antiviral medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood) to which either Isentress or placebo(a dummy treatment) has been added.
The proportion of patients who had undetectable levels of HIV in their blood was about 45% when CELSENTRI was added to optimised background therapy compared with 23% of the patients receiving optimised background therapy only.
Both studies compared the effects of Fuzeon, in combination with‘ optimised background therapy'(a combination of other antiviral medicines chosen for each patient as they had the best chances of reducing the levels of HIV in the blood), compared with optimised background therapy without Fuzeon.
The indication in adults is based on week 48 analyses from 2 Phase III trials inhighly pre-treated patients where INTELENCE was investigated in combination with an optimised background regimen(OBR) which included darunavir/ritonavir.
After 16 weeks, 77% of the patients who took Isentress in addition to optimised background therapy had viral loads below 400 copies per millilitre of blood,compared with 42% of the patients who received placebo plus optimised background therapy.
In the multicentre, open-label, single arm VIKING-3 study(ING112574), HIV-1 infected, ART-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received Tivicay 50 mg twice daily with the currentfailing background regimen for 7 days but with optimised background ART from Day 8.
These studies used the recommended dose of400 mg twice daily in combination with optimised background therapy(OBT) in 507 patients, in comparison to 282 patients taking placebo in combination with OBT.
This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled Phase III trials in highly pre-treated patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors,where INTELENCE was investigated in combination with an optimised background regimen(OBR) which included darunavir/ ritonavir(see section 5.1).
The studies compared Isentress with placebo(a dummy treatment),which were added to‘optimised background therapy'(a combination of other anti-HIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
In treatment-experienced patients, the two randomised clinical studies used the recommended dose of400 mg twice daily in combination with optimised background therapy(OBT) in 462 patients, in comparison to 237 patients taking placebo in combination with OBT.
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy,all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Enviage 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio(UACR), i.e. from 58 mg/mmol to 46 mg/mmol.
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