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  1. Article ; Online: Exposure-response relationships for the efficacy and safety of filgotinib and its metabolite GS-829845 in subjects with rheumatoid arthritis based on phase 2 and phase 3 studies.

    Meng, Amy / Anderson, Kacey / Nelson, Cara / Ni, Liyun / Chuang, Shu-Min / Bellanti, Francesco / Chang, Peter / Comisar, Craig / Kearney, Brian P / Bartok, Beatrix / Mathias, Anita

    British journal of clinical pharmacology

    2022  Volume 88, Issue 7, Page(s) 3211–3221

    Abstract: Aims: Filgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in ... ...

    Abstract Aims: Filgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in moderate to severe RA patients.
    Methods: The pharmacokinetic exposures used in ER analyses were derived from population pharmacokinetic analysis. The exposure-efficacy relationships were assessed for efficacy endpoints (ACR20/50/70 and DAS28) over effective area under curve (AUC
    Results: The nonlinear logistic regression showed increasing response with increasing exposure, with exposures at 200 mg dose primarily residing on the curve plateau. Also, AUC
    Conclusions: ER analyses confirmed that filgotinib produced more robust therapeutic effects across the exposure range observed at 200 mg once daily compared to lower doses, and collectively with the lack of exposure-safety relationship, the 200 mg once daily dose was supported for commercialization.
    MeSH term(s) Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Janus Kinase Inhibitors/adverse effects ; Pyridines/adverse effects ; Treatment Outcome ; Triazoles/adverse effects
    Chemical Substances Antirheumatic Agents ; GLPG0634 ; Janus Kinase Inhibitors ; Pyridines ; Triazoles
    Language English
    Publishing date 2022-02-14
    Publishing country England
    Document type Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.15239
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    Zs.A 1118: Show issues Location:
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  2. Article ; Online: Sofosbuvir and risk of estimated glomerular filtration rate decline or end-stage renal disease in patients with renal impairment.

    Sulkowski, Mark / Telep, Laura E / Colombo, Massimo / Durand, Francois / Reddy, K Rajender / Lawitz, Eric / Bourlière, Marc / Cheinquer, Nelson / Scherbakovsky, Stacey / Ni, Liyun / Force, Lindsey / Ramroth, Heribert / Gaggar, Anuj / Chokkalingam, Anand P / Sise, Meghan E

    Alimentary pharmacology & therapeutics

    2022  Volume 55, Issue 9, Page(s) 1169–1178

    Abstract: Background: Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood.: ... ...

    Abstract Background: Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood.
    Methods: We performed a retrospective analysis of patients with estimated glomerular filtration rate (eGFR) 30-89 mL/min/1.73 m
    Results: Among 4642 trial participants with baseline stage 2 CKD (eGFR 60-89 ml/min/1.73 m
    Conclusions: Clinical trial participants with CKD did not experience worsening eGFR during sofosbuvir-based treatment, and sofosbuvir was not associated with an increased risk of ESRD in patients with CKD in a nationally-representative administrative claims database.
    MeSH term(s) Antiviral Agents/adverse effects ; Disease Progression ; Female ; Glomerular Filtration Rate ; Humans ; Kidney Failure, Chronic/complications ; Male ; Renal Insufficiency/chemically induced ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/diagnosis ; Renal Insufficiency, Chronic/drug therapy ; Retrospective Studies ; Sofosbuvir/adverse effects
    Chemical Substances Antiviral Agents ; Sofosbuvir (WJ6CA3ZU8B)
    Language English
    Publishing date 2022-03-02
    Publishing country England
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639012-2
    ISSN 1365-2036 ; 0269-2813 ; 0953-0673
    ISSN (online) 1365-2036
    ISSN 0269-2813 ; 0953-0673
    DOI 10.1111/apt.16830
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    Zs.A 2206: Show issues Location:
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  3. Article ; Online: International multicenter validation of GES score for HCC risk stratification in chronic hepatitis C patients.

    Shiha, Gamal / Soliman, Reham / Mikhail, Nabiel N H / Carrat, Fabrice / Azzi, Jessica / Nathalie, Ganne-Carrié / Toyoda, Hidenori / Uojima, Haruki / Nozaki, Akito / Takaguchi, Koichi / Hiraoka, Atsushi / Atsukawa, Masanori / Abe, Hiroshi / Matsuura, Kentaro / Mikami, Shigeru / Watanabe, Tsunamasa / Tsuji, Kunihiko / Ishikawa, Toru / Suri, Vithika /
    Osinusi, Anu / Ni, Liyun / Zou, Jun / Sarin, Shiv Kumar / Kumar, Manoj / Jalal, Prasun Kumar / Hashim, Mahmoud A / Hassan, Manal / Lopez, Sonia Alonso / Bañares, Rafael / Ahumada, Adriana M / Mousa, Nasser Hamed / Eslam, Mohammed / Waked, Imam

    Journal of viral hepatitis

    2022  Volume 29, Issue 9, Page(s) 807–816

    Abstract: We have recently demonstrated the ability of a simple predictive model (GES) score to determine the risk of hepatocellular carcinoma (HCC) after using direct-acting antivirals. However, our results were restricted to Egyptian patients with hepatitis C ... ...

    Abstract We have recently demonstrated the ability of a simple predictive model (GES) score to determine the risk of hepatocellular carcinoma (HCC) after using direct-acting antivirals. However, our results were restricted to Egyptian patients with hepatitis C virus (HCV) genotype 4. Therefore, we studied a large, independent cohort of multiethnic populations through our international collaborative activity. Depending on their GES scores, patients are stratified into low risk (≤ 6/12.5), intermediate risk (> 6-7.5/12.5), and high risk (> 7.5/12.5) for HCC. A total of 12,038 patients with chronic HCV were analyzed in this study, of whom 11,202 were recruited from 54 centers in France, Japan, India, the U.S., and Spain, and the remaining 836 were selected from the Gilead-sponsored randomized controlled trial conducted across the U.S., Europe, Canada, and Australia. Descriptive statistics and log-rank tests. The performance of the GES score was evaluated using Harrell's C-index (HCI). The GES score proved successful at stratifying all patients into 3 risk groups, namely low-risk, intermediate-risk, and high-risk. It also displayed significant predictive value for HCC development in all participants (p < .0001), with HCI ranging from 0.55 to 0.76 among all cohorts after adjusting for HCV genotypes and patient ethnicities. The GES score can be used to stratify HCV patients into 3 categories of risk for HCC, namely low-risk, intermediate-risk, and high-risk, irrespective of their ethnicities or HCV genotypes. This international multicenter validation may allow the use of GES score in individualized HCC risk-based surveillance programs.
    MeSH term(s) Antiviral Agents/therapeutic use ; Carcinoma, Hepatocellular/diagnosis ; Carcinoma, Hepatocellular/drug therapy ; Carcinoma, Hepatocellular/epidemiology ; Hepacivirus/genetics ; Hepatitis C, Chronic/drug therapy ; Humans ; Liver Neoplasms/diagnosis ; Liver Neoplasms/epidemiology ; Liver Neoplasms/etiology ; Retrospective Studies ; Risk Assessment ; Risk Factors
    Chemical Substances Antiviral Agents
    Language English
    Publishing date 2022-06-24
    Publishing country England
    Document type Journal Article ; Multicenter Study
    ZDB-ID 1212497-7
    ISSN 1365-2893 ; 1352-0504
    ISSN (online) 1365-2893
    ISSN 1352-0504
    DOI 10.1111/jvh.13717
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    Zs.A 4119: Show issues Location:
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  4. Article ; Online: Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naïve patients: Findings from two randomized trials.

    Tam, Edward / Luetkemeyer, Anne F / Mantry, Parvez S / Satapathy, Sanjaya K / Ghali, Peter / Kang, Minhee / Haubrich, Richard / Shen, Xianlin / Ni, Liyun / Camus, Gregory / Copans, Amanda / Rossaro, Lorenzo / Guyer, Bill / Brown, Robert S

    Liver international : official journal of the International Association for the Study of the Liver

    2017  Volume 38, Issue 6, Page(s) 1010–1021

    Abstract: Background & aims: We report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who ... ...

    Abstract Background & aims: We report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who failed to achieve sustained virological response (SVR) with prior SOF-based, non-NS5A inhibitor-containing regimens.
    Methods: The RESCUE study enrolled HCV mono-infected adults with genotype (GT) 1 or 4. Non-cirrhotic participants were randomized to 12 weeks of LDV/SOF or LDV/SOF + RBV. Compensated cirrhotic participants were randomized to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). The AIDS Clinical Trials Group A5348 study randomized genotype 1 adults with HCV/HIV co-infection to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). Both studies used SVR at 12 weeks post-treatment (SVR12) as the primary endpoint.
    Results: In the RESCUE study, 82 participants were randomized and treated, and all completed treatment. Overall, SVR12 was 88% (72/82); 81-100% in non-cirrhotic participants treated with LDV/SOF or LDV/SOF + RBV for 12 weeks and 80-92% in cirrhotic participants treated with LDV/SOF + RBV for 12 weeks or LDV/SOF for 24 weeks. Adverse events (AEs), mostly mild-to-moderate in severity, were experienced by 78% of participants, with headache and fatigue most frequently reported. One serious AE, not related to treatment, was observed. No premature discontinuations of study drug, or deaths occurred. In the A5348 study, seven participants were randomized (cirrhotic n = 1; GT1a n = 5) and all attained SVR12, with no serious AEs or premature discontinuations.
    Conclusions: In this SOF-experienced, NS5A inhibitor-naïve population, which included participants with cirrhosis or HCV/HIV co-infection, high SVR12 rates were achieved.
    MeSH term(s) Adult ; Aged ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Benzimidazoles/administration & dosage ; Benzimidazoles/adverse effects ; Coinfection/drug therapy ; Coinfection/virology ; Fatigue/etiology ; Female ; Fluorenes/administration & dosage ; Fluorenes/adverse effects ; HIV Infections/drug therapy ; HIV Infections/virology ; Headache/etiology ; Hepacivirus/genetics ; Hepatitis C, Chronic/drug therapy ; Humans ; Liver Cirrhosis ; Male ; Middle Aged ; Pregnancy ; Ribavirin/administration & dosage ; Ribavirin/adverse effects ; Sofosbuvir ; Sustained Virologic Response ; Uridine Monophosphate/administration & dosage ; Uridine Monophosphate/adverse effects ; Uridine Monophosphate/analogs & derivatives
    Chemical Substances Antiviral Agents ; Benzimidazoles ; Fluorenes ; ledipasvir, sofosbuvir drug combination ; Ribavirin (49717AWG6K) ; Uridine Monophosphate (E2OU15WN0N) ; Sofosbuvir (WJ6CA3ZU8B)
    Language English
    Publishing date 2017-12-05
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2102783-3
    ISSN 1478-3231 ; 1478-3223
    ISSN (online) 1478-3231
    ISSN 1478-3223
    DOI 10.1111/liv.13616
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    Zs.A 1632: Show issues Location:
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  5. Article: Assessment of blinding in clinical trials.

    Bang, Heejung / Ni, Liyun / Davis, Clarence E

    Controlled clinical trials

    2004  Volume 25, Issue 2, Page(s) 143–156

    Abstract: Success of blinding is a fundamental issue in many clinical trials. The validity of a trial may be questioned if this important assumption is violated. Although thousands of ostensibly double-blind trials are conducted annually and investigators ... ...

    Abstract Success of blinding is a fundamental issue in many clinical trials. The validity of a trial may be questioned if this important assumption is violated. Although thousands of ostensibly double-blind trials are conducted annually and investigators acknowledge the importance of blinding, attempts to measure the effectiveness of blinding are rarely discussed. Several published papers proposed ways to evaluate the success of blinding, but none of the methods are commonly used or regarded as standard. This paper investigates a new approach to assess the success of blinding in clinical trials. The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding. It has the ability to detect a relatively low degree of blinding, response bias and different behaviors in two arms. The proposed method is applied to a clinical trial of cholesterol-lowering medication in a group of elderly people.
    MeSH term(s) Aged ; Anticholesteremic Agents/therapeutic use ; Bias ; Controlled Clinical Trials as Topic/methods ; Controlled Clinical Trials as Topic/statistics & numerical data ; Double-Blind Method ; Humans ; Models, Statistical ; Reproducibility of Results ; Research Design
    Chemical Substances Anticholesteremic Agents
    Language English
    Publishing date 2004-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 603595-4
    ISSN 1879-050X ; 0197-2456
    ISSN (online) 1879-050X
    ISSN 0197-2456
    DOI 10.1016/j.cct.2003.10.016
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    Zs.A 1581: Show issues Location:
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  6. Article: Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies.

    Grebely, Jason / Feld, Jordan J / Wyles, David / Sulkowski, Mark / Ni, Liyun / Llewellyn, Joe / Mir, Heshaam M / Sajed, Nika / Stamm, Luisa M / Hyland, Robert H / McNally, John / Brainard, Diana M / Jacobson, Ira / Zeuzem, Stefan / Bourlière, Marc / Foster, Graham / Afdhal, Nezam / Dore, Gregory J

    Open forum infectious diseases

    2018  Volume 5, Issue 2, Page(s) ofy001

    Abstract: Background: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate ... ...

    Abstract Background: Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST.
    Methods: Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir in GT1-6). Patients with clinically significant drug use (last 12 months) or noncannabinoids detected at screening were ineligible.
    Results: Among 4743 patients, 4% (n = 194) were receiving OST (methadone; n = 113; buprenorphine, n = 75; other, n = 6). Compared with those not receiving OST (n = 4549), those receiving OST (n = 194) were younger (mean age, 48 vs 54), more often male (73% vs 61%), GT3 (38% vs 17%), treatment-naïve (78% vs 65%), and cirrhotic (36% vs 23%). Among those receiving and not receiving OST, there was no significant difference in treatment completion (97% vs 99%,
    Conclusion: Sofosbuvir-based therapies are effective and safe in patients receiving OST.
    Language English
    Publishing date 2018-02-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofy001
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  7. Article: An extended terminal half-life for darbepoetin alfa: results from a single-dose pharmacokinetic study in patients with chronic kidney disease not receiving dialysis.

    Padhi, Desmond / Ni, Liyun / Cooke, Blaire / Marino, Rafael / Jang, Graham

    Clinical pharmacokinetics

    2006  Volume 45, Issue 5, Page(s) 503–510

    Abstract: Background and objective: Anaemia is a major and persistent manifestation of chronic kidney disease (CKD) caused by the deficient production of erythropoietin in the kidneys, the prevalence of which is proportional to the deterioration in kidney ... ...

    Abstract Background and objective: Anaemia is a major and persistent manifestation of chronic kidney disease (CKD) caused by the deficient production of erythropoietin in the kidneys, the prevalence of which is proportional to the deterioration in kidney function. Darbepoetin alfa, an erythropoiesis-stimulating protein, exhibits a lower clearance and longer terminal half-life in serum than recombinant human erythropoietin, thereby allowing for a reduced dosing frequency. A recent study in patients with CKD, using a 4-week sampling period, suggested that the terminal half-life of darbepoetin alfa in serum is longer than that reported in previous studies, which were based on a 1-week sampling period. This study was conducted to characterise the pharmacokinetic profile of a single subcutaneous dose of darbepoetin alfa 1 microg/kg in patients with CKD, using a sampling duration of 4 weeks, which was hypothesised to allow better characterisation of the terminal half-life in serum.
    Methods: Twenty patients with CKD not on dialysis, with a calculated glomerular filtration rate of 20-60 mL/min and who had not been treated with erythropoietic agents in the previous 12 weeks, were enrolled into this single-dose, open-label study. Patients received a single subcutaneous dose of darbepoetin alfa (Aranesp) 1 microg/kg on day 1, and blood samples were collected for pharmacokinetic analyses predose, 6 and 12 hours postdose and up to 28 days postdose. Seroreactivity sampling and further safety laboratory tests (clinical chemistry and urinalysis) were also performed. Patients were assessed for adverse events at each study visit. The primary endpoint was characterisation of the terminal half-life following a single subcutaneous dose of darbepoetin alfa 1 microg/kg.
    Results: The mean terminal half-life in serum of darbepoetin alfa was determined to be 69.6 hours. Peak serum concentrations were reached in a median time of 36 hours postdose, and a mean apparent clearance of 3.51 mL/h/kg was comparable to that observed previously in this patient population.
    Conclusion: Based on an extended sampling schedule of 4 weeks, the terminal half-life of darbepoetin alfa was approximately 70 hours. This is longer than the 48.8 hours reported previously in patients with CKD on dialysis. These data suggest that the pharmacokinetic properties of darbepoetin alfa make this erythropoietic agent well suited to an extended dosing regimen.
    MeSH term(s) Adult ; Aged ; Anemia/drug therapy ; Anemia/metabolism ; Darbepoetin alfa ; Erythropoietin/adverse effects ; Erythropoietin/analogs & derivatives ; Erythropoietin/blood ; Erythropoietin/pharmacokinetics ; Female ; Half-Life ; Humans ; Kidney Failure, Chronic/drug therapy ; Kidney Failure, Chronic/metabolism ; Male ; Middle Aged ; Renal Dialysis
    Chemical Substances Erythropoietin (11096-26-7) ; Darbepoetin alfa (15UQ94PT4P)
    Language English
    Publishing date 2006-04-26
    Publishing country Switzerland
    Document type Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 197627-8
    ISSN 1179-1926 ; 0312-5963
    ISSN (online) 1179-1926
    ISSN 0312-5963
    DOI 10.2165/00003088-200645050-00005
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    Zs.A 1246: Show issues Location:
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  8. Article: Bioequivalence of liquid and reconstituted lyophilized etanercept subcutaneous injections.

    Sullivan, John T / Ni, Liyun / Sheelo, Claudia / Salfi, Margaret / Peloso, Paul M

    Journal of clinical pharmacology

    2006  Volume 46, Issue 6, Page(s) 654–661

    Abstract: The objective of this study was to compare the pharmacokinetics of liquid and reconstituted lyophilized etanercept. This single-center, open-label study had a 2-period crossover design in which 36 healthy subjects were randomly assigned in a 1:1 ratio to ...

    Abstract The objective of this study was to compare the pharmacokinetics of liquid and reconstituted lyophilized etanercept. This single-center, open-label study had a 2-period crossover design in which 36 healthy subjects were randomly assigned in a 1:1 ratio to etanercept (liquid/lyo or lyo/liquid). The treatments were separated by 28 days. Blood samples were obtained predose and at 10 predetermined time points postdose. Serum concentrations were determined by enzyme-linked immunosorbent assay. Noncompartmental pharmacokinetic parameters were analyzed using a standard crossover analysis of variance model. Thirty-three subjects completed both treatment periods. Geometric mean values (adjusted) of area under the serum drug concentration-time curve from time zero to the time of the final quantifiable sample, area under the serum drug concentration-time curve from time zero to infinity, and maximum concentration obtained with the 50-mg/mL liquid etanercept injection were 93.0%, 90.7%, and 98.5% of the respective parameters for 2 injections of 25 mg/mL reconstituted formulation. All associated confidence intervals were within the predefined equivalence interval of 80% to 125%. No differences in safety profiles of the 2 formulations were apparent. Liquid etanercept was bioequivalent to the reconstituted lyophilized etanercept formulation.
    MeSH term(s) Adult ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/pharmacokinetics ; Cross-Over Studies ; Etanercept ; Female ; Freeze Drying ; Humans ; Immunoglobulin G/administration & dosage ; Immunoglobulin G/adverse effects ; Injections, Subcutaneous ; Male ; Receptors, Tumor Necrosis Factor/administration & dosage ; Therapeutic Equivalency
    Chemical Substances Antirheumatic Agents ; Immunoglobulin G ; Receptors, Tumor Necrosis Factor ; Etanercept (OP401G7OJC)
    Language English
    Publishing date 2006-06
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 188980-1
    ISSN 1552-4604 ; 0091-2700 ; 0021-9754
    ISSN (online) 1552-4604
    ISSN 0091-2700 ; 0021-9754
    DOI 10.1177/0091270006287705
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  9. Article ; Online: Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study.

    Molina, Jean-Michel / Orkin, Chloe / Iser, David M / Zamora, Francisco-Xavier / Nelson, Mark / Stephan, Christoph / Massetto, Benedetta / Gaggar, Anuj / Ni, Liyun / Svarovskaia, Evguenia / Brainard, Diana / Subramanian, G Mani / McHutchison, John G / Puoti, Massimo / Rockstroh, Jürgen K

    Lancet (London, England)

    2015  Volume 385, Issue 9973, Page(s) 1098–1106

    Abstract: Background: Although interferon-free regimens are approved for patients co-infected with HIV and genotype-2 or genotype-3 hepatitis C virus (HCV), interferon-based regimens are still an option for those co-infected with HIV and HCV genotypes 1 or 4. ... ...

    Abstract Background: Although interferon-free regimens are approved for patients co-infected with HIV and genotype-2 or genotype-3 hepatitis C virus (HCV), interferon-based regimens are still an option for those co-infected with HIV and HCV genotypes 1 or 4. These regimens are limited by clinically significant toxic effects and drug interactions with antiretroviral therapy. We aimed to assess the efficacy and safety of an interferon-free, all-oral regimen of sofosbuvir plus ribavirin in patients with HIV and HCV co-infection.
    Methods: We did this open-label, non-randomised, uncontrolled, phase 3 study at 45 sites in seven European countries and Australia. We enrolled patients (aged ≥18 years) co-infected with stable HIV and chronic HCV genotypes 1-4, including those with compensated cirrhosis. Once-daily sofosbuvir (400 mg) plus twice-daily ribavirin (1000 mg in patients with bodyweights <75 kg and 1200 mg in those with weights ≥75 kg) was given for 24 weeks to all patients except treatment-naive patients with genotype-2 HCV, who received a 12-week regimen. The primary efficacy endpoint was sustained virological response 12 weeks after treatment. We did analysis by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT01783678.
    Findings: Between Feb 7, 2013, and July 29, 2013, we enrolled 275 eligible patients, of whom 262 (95%) completed treatment; 274 patients were included in the final analysis. Overall rates of sustained virological response 12 weeks after treatment were 85% (95% CI 77-91) in patients with genotype-1 HCV, 88% (69-98) in patients with genotype-2 HCV, 89% (81-94) in patients with genotype-3 HCV, and 84% (66-95) in patients with genotype-4 HCV. Response rates in treatment-naive patients with HCV genotypes 2 or 3 (89% [95% CI 67-99] and 91% [81-97], respectively) were similar to those in treatment-experienced patients infected with those genotypes (83% [36-100] and 86% [73-94], respectively). There was no emergence of sofosbuvir-resistance mutations in patients with HCV viral relapse. Six (2%) patients discontinued treatment because of adverse events. The most common adverse events were fatigue, insomnia, asthenia, and headache. Four (1%) patients had serious adverse events regarded as related to study treatment. Additionally, four (1%) patients receiving antiretroviral treatment had a transient HIV viral breakthrough; however, none required changes in antiretroviral regimen.
    Interpretation: Sofosbuvir and ribavirin provided high rates of sustained virological response after 12 weeks of treatment in treatment-naive and treatment-experienced patients co-infected with HIV and HCV genotypes 1-4. The characteristics of this interferon-free combination regimen make sofosbuvir plus ribavirin a useful treatment option for this patient population.
    Funding: Gilead Sciences.
    MeSH term(s) Adolescent ; Adult ; Aged ; Antiviral Agents/therapeutic use ; Coinfection/drug therapy ; Drug Therapy, Combination ; Female ; HIV Infections/complications ; Hepacivirus/genetics ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Liver Cirrhosis/etiology ; Male ; Middle Aged ; RNA, Viral/blood ; Ribavirin/therapeutic use ; Sofosbuvir ; Treatment Outcome ; Uridine Monophosphate/analogs & derivatives ; Uridine Monophosphate/therapeutic use ; Viral Load ; Young Adult
    Chemical Substances Antiviral Agents ; RNA, Viral ; Ribavirin (49717AWG6K) ; Uridine Monophosphate (E2OU15WN0N) ; Sofosbuvir (WJ6CA3ZU8B)
    Language English
    Publishing date 2015-03-21
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(14)62483-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection.

    Sulkowski, Mark S / Naggie, Susanna / Lalezari, Jacob / Fessel, Walford Jeffrey / Mounzer, Karam / Shuhart, Margaret / Luetkemeyer, Anne F / Asmuth, David / Gaggar, Anuj / Ni, Liyun / Svarovskaia, Evguenia / Brainard, Diana M / Symonds, William T / Subramanian, G Mani / McHutchison, John G / Rodriguez-Torres, Maribel / Dieterich, Douglas

    JAMA

    2014  Volume 312, Issue 4, Page(s) 353–361

    Abstract: Importance: Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.: Objective: To ...

    Abstract Importance: Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.
    Objective: To determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.
    Design, setting, and participants: Open-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.
    Interventions: Treatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.
    Main outcomes and measures: The primary study outcome was the proportion of patients with SVR (serum HCV <25 copies/mL) 12 weeks (SVR12) after cessation of HCV therapy.
    Results: Among treatment-naive participants, 87 patients (76%) of 114 (95% CI, 67%-84%) with genotype 1, 23 patients (88%) of 26 with genotype 2 (95% CI, 70%-985), and 28 patients (67%) of 42 with genotype 3 (95% CI, 51%-80%) achieved SVR12. Among treatment-experienced participants, 22 patients (92%) of 24 with genotype 2 (95% CI, 73%-99%) and 16 patients (94%) of 17 (95% CI, 71%-100%) achieved SVR12. The most common adverse events were fatigue, insomnia, headache, and nausea. Seven patients (3%) discontinued HCV treatment due to adverse events. No adverse effect on HIV disease or its treatment was observed.
    Conclusions and relevance: In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of SVR12. Further studies of this oral regimen in diverse populations of coinfected patients are warranted.
    Trial registration: clinicaltrials.gov Identifier: NCT01667731.
    MeSH term(s) Administration, Oral ; Adult ; Aged ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Coinfection ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Genotype ; HIV Infections/drug therapy ; HIV Infections/virology ; Hepacivirus/genetics ; Hepatitis C/drug therapy ; Humans ; Male ; Middle Aged ; RNA, Viral/blood ; Ribavirin/adverse effects ; Ribavirin/therapeutic use ; Sofosbuvir ; Treatment Outcome ; Uridine Monophosphate/adverse effects ; Uridine Monophosphate/analogs & derivatives ; Uridine Monophosphate/therapeutic use ; Viral Load ; Young Adult
    Chemical Substances Antiviral Agents ; RNA, Viral ; Ribavirin (49717AWG6K) ; Uridine Monophosphate (E2OU15WN0N) ; Sofosbuvir (WJ6CA3ZU8B)
    Language English
    Publishing date 2014-07-21
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2014.7734
    Database MEDical Literature Analysis and Retrieval System OnLINE

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