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[PMID]:29276983
[Au] Autor:Notari S; Tempestilli M; Fabbri G; Libertone R; Antinori A; Ammassari A; Agrati C
[Ad] Endereço:Laboratory of Cellular Immunology and Pharmacology, National Institute for Infectious Diseases "Lazzaro Spallanzani", IRCCS, Rome, Italy.
[Ti] Título:UPLC-MS/MS method for the simultaneous quantification of sofosbuvir, sofosbuvir metabolite (GS-331007) and daclatasvir in plasma of HIV/HCV co-infected patients.
[So] Source:J Chromatogr B Analyt Technol Biomed Life Sci;1073:183-190, 2018 Jan 15.
[Is] ISSN:1873-376X
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Direct-acting antiviral agents (DAAs) represent the major advance in hepatitis C virus (HCV) infection treatment leading to extremely high eradication rates in HCV mono- and HIV/HCV co-infected patients. In this scenery, availability of Therapeutic Drug Monitoring (TDM) is of interest to assess plasma concentrations to prevent either therapeutic failure due to suboptimal medication adherence and drug-drug interactions or avoid adverse events. Aim of this study was to develop and validate an Ultra-Performance Liquid Chromatography Mass Spectrometry (UPLC-MS/MS) method for the simultaneous quantification of sofosbuvir, sofosbuvir metabolite (GS-331007), and daclatasvir in human plasma. A simple protein precipitation was applied by adding 200 µL acetonitrile with internal standard 6,7-Dimethyl- 2,3-di(2-pyridyl) quinoxaline to 100 µL plasma sample. Drug separation was performed on analytical C-18 Luna Omega column (50 mm × 2.1 mm I.D.) with particle size of 1.6 µm. The mobile phase consisting of water containing 0.1% formic acid and acetonitrile at flow 0.4 mL/min and a gradient run time of 3.5 min. The injection volume was 10 µL. Anti-HCV drugs were detected in positive electrospray ionization mode. The full scan mass spectral analyses of sofosbuvir, GS-331007, daclatasvir and quinaxoline showed protonated molecule ions and transitions m/z: 530.098 → 243.02, 260.93 → 112.94, 739.4 → 339.27 and 313.03 → 77.99 respectively. The linearity of standard curves was excellent (r > 0.99), the absolute recovery of anti-HCV drugs ranged between 95 and 98%, and both imprecision and inaccuracy were <15% according to FDA guidelines. The UPLC-MS/MS method was applied to 16 plasma samples of as many HIV/HCV co-infected patients treated with sofosbuvir and daclatasvir. While sofosbuvir was not detectable in all samples, the median plasma concentrations of daclatasvir and GS-331007 were 223.6 ±â€¯319.56 ng/mL and 537.11 ±â€¯242.09 ng/mL, respectively. In conclusion, we describe an UPLC-MS/MS method allowing the simultaneous quantification of sofosbuvir, GS-331007 and daclatasvir in plasma samples. The method was sensitive, specific, robust, and time-saving.
[Mh] Termos MeSH primário: Antivirais/sangue
Coinfecção/tratamento farmacológico
Infecções por HIV/tratamento farmacológico
Hepatite C/tratamento farmacológico
Imidazóis/sangue
Sofosbuvir/sangue
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão/métodos
Seres Humanos
Limite de Detecção
Modelos Lineares
Reprodutibilidade dos Testes
Sofosbuvir/análogos & derivados
Sofosbuvir/química
Espectrometria de Massas em Tandem/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (BMS-790052); 0 (Imidazoles); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180302
[Lr] Data última revisão:
180302
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171226
[St] Status:MEDLINE


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[PMID]:29324623
[Au] Autor:Hussar DA
[Ad] Endereço:Remington Professor of Pharmacy Philadelphia College of Pharmacy University of the Sciences Philadelphia, Pa.
[Ti] Título:New Drugs 2018, part 1.
[So] Source:Nursing;48(2):36-44, 2018 Feb.
[Is] ISSN:1538-8689
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas
[Mh] Termos MeSH secundário: Anticorpos Monoclonais/uso terapêutico
Anticorpos Neutralizantes/uso terapêutico
Antipirina/análogos & derivados
Antipirina/uso terapêutico
Benzamidas/uso terapêutico
Benzimidazóis/uso terapêutico
Carbamatos/uso terapêutico
Combinação de Medicamentos
Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico
Seres Humanos
Compostos Macrocíclicos/uso terapêutico
Naltrexona/análogos & derivados
Naltrexona/uso terapêutico
Peptídeos Natriuréticos/uso terapêutico
Piridinas/uso terapêutico
Quinoxalinas/uso terapêutico
Sofosbuvir/uso terapêutico
Sulfonamidas/uso terapêutico
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (ABT-493); 0 (Antibodies, Monoclonal); 0 (Antibodies, Neutralizing); 0 (Benzamides); 0 (Benzimidazoles); 0 (Carbamates); 0 (Drug Combinations); 0 (Heterocyclic Compounds, 4 or More Rings); 0 (Macrocyclic Compounds); 0 (Natriuretic Peptides); 0 (Pyridines); 0 (Quinoxalines); 0 (Sulfonamides); 0 (bezlotoxumab); 0 (naldemedine); 0 (pibrentasvir); 0 (voxilaprevir); 5S6W795CQM (Naltrexone); 74RWP7W0J9 (betrixaban); 7IK8Z952OK (plecanatide); KCU0C7RS7Z (velpatasvir); S798V6YJRP (phenylmethylpyrazolone); T3CHA1B51H (Antipyrine); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:180112
[St] Status:MEDLINE
[do] DOI:10.1097/01.NURSE.0000529803.83288.e1


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Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
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[PMID]:29365309
[Au] Autor:Zeuzem S; Foster GR; Wang S; Asatryan A; Gane E; Feld JJ; Asselah T; Bourlière M; Ruane PJ; Wedemeyer H; Pol S; Flisiak R; Poordad F; Chuang WL; Stedman CA; Flamm S; Kwo P; Dore GJ; Sepulveda-Arzola G; Roberts SK; Soto-Malave R; Kaita K; Puoti M; Vierling J; Tam E; Vargas HE; Bruck R; Fuster F; Paik SW; Felizarta F; Kort J; Fu B; Liu R; Ng TI; Pilot-Matias T; Lin CW; Trinh R; Mensa FJ
[Ad] Endereço:From Goethe University Hospital, Frankfurt (S.Z.), and Medizinische Hochschule Hannover, Hannover (H.W.) - both in Germany; Queen Mary University of London, Barts Health, London (G.R.F.); AbbVie, North Chicago (S.W., A.A., J.K., B.F., R.L., T.I.N., T.P.-M., C.-W.L., R.T., F.J.M.), and Northwestern F
[Ti] Título:Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
[So] Source:N Engl J Med;378(4):354-369, 2018 01 25.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection. METHODS: We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir-pibrentasvir or sofosbuvir-daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir-pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment. RESULTS: In total, 1208 patients were treated. The rate of sustained virologic response at 12 weeks among genotype 1-infected patients was 99.1% (95% confidence interval [CI], 98 to 100) in the 8-week group and 99.7% (95% CI, 99 to 100) in the 12-week group. Genotype 3-infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% (95% CI, 93 to 98; 222 of 233 patients) with glecaprevir-pibrentasvir and 97% (95% CI, 93 to 99.9; 111 of 115) with sofosbuvir-daclatasvir; 8 weeks of treatment with glecaprevir-pibrentasvir yielded a rate of 95% (95% CI, 91 to 98; 149 of 157 patients). Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group. CONCLUSIONS: Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).
[Mh] Termos MeSH primário: Antivirais/uso terapêutico
Benzimidazóis/uso terapêutico
Hepacivirus/genética
Hepatite C Crônica/tratamento farmacológico
Quinoxalinas/uso terapêutico
Sulfonamidas/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Antivirais/efeitos adversos
Benzimidazóis/efeitos adversos
Esquema de Medicação
Combinação de Medicamentos
Feminino
Genótipo
Hepatite C Crônica/virologia
Seres Humanos
Imidazóis/efeitos adversos
Imidazóis/uso terapêutico
Masculino
Meia-Idade
Quinoxalinas/efeitos adversos
RNA Viral/sangue
Sofosbuvir/efeitos adversos
Sofosbuvir/uso terapêutico
Sulfonamidas/efeitos adversos
Carga Viral
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (ABT-493); 0 (Antiviral Agents); 0 (BMS-790052); 0 (Benzimidazoles); 0 (Drug Combinations); 0 (Imidazoles); 0 (Quinoxalines); 0 (RNA, Viral); 0 (Sulfonamides); 0 (pibrentasvir); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180208
[Lr] Data última revisão:
180208
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1702417


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[PMID]:27775854
[Au] Autor:Su F; Green PK; Berry K; Ioannou GN
[Ad] Endereço:Division of Gastroenterology/Medicine, Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle, WA.
[Ti] Título:The association between race/ethnicity and the effectiveness of direct antiviral agents for hepatitis C virus infection.
[So] Source:Hepatology;65(2):426-438, 2017 02.
[Is] ISSN:1527-3350
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Black race and Hispanic ethnicity were associated with lower rates of sustained virologic response (SVR) to interferon-based treatments for chronic hepatitis C virus infection, whereas Asian race was associated with higher SVR rates compared to white patients. We aimed to describe the association between race/ethnicity and effectiveness of new direct-acting antiviral regimens in the Veterans Affairs health care system nationally. We identified 21,095 hepatitis C virus-infected patients (11,029 [52%] white, 6,171 [29%] black, 1,187 [6%] Hispanic, 348 [2%] Asian/Pacific Islander/American Indian/Alaska Native, and 2,360 [11%] declined/missing race or ethnicity) who initiated antiviral treatment with regimens containing sofosbuvir, simeprevir + sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ombitasvir/ritonavir/dasabuvir during the 18-month period from January 1, 2014, to June 30, 2015. Overall SVR rates were 89.8% (95% confidence interval [CI] 89.2-90.4) in white, 89.8% (95% CI 89.0-90.6) in black, 86.0% (95% CI 83.7-88.0) in Hispanic, and 90.7% (95% CI 87.0-93.5) in Asian/Pacific Islander/American Indian/Alaska Native patients. However, after adjustment for baseline characteristics, black (adjusted odds ratio = 0.77, P < 0.001) and Hispanic (adjusted odds ratio = 0.76, P = 0.007) patients were less likely to achieve SVR than white patients, a difference that was not explained by early treatment discontinuations. Among genotype 1-infected patients treated with ledipasvir/sofosbuvir monotherapy, black patients had significantly lower SVR than white patients when treated for 8 weeks but not when treated for 12 weeks. CONCLUSION: Direct-acting antivirals produce high SVR rates in white, black, Hispanic, and Asian/Pacific Islander/American Indian/Alaska Native patients; but after adjusting for baseline characteristics, black race and Hispanic ethnicity remain independent predictors of treatment failure. Short 8-week ledipasvir/sofosbuvir monotherapy regimens should perhaps be avoided in black patients with genotype 1 hepatitis C virus. (Hepatology 2017;65:426-438).
[Mh] Termos MeSH primário: Antivirais/uso terapêutico
Hepatite C/tratamento farmacológico
Hepatite C/etnologia
[Mh] Termos MeSH secundário: Adulto
Grupo com Ancestrais do Continente Africano/estatística & dados numéricos
Idoso
Americanos Asiáticos/estatística & dados numéricos
Estudos de Coortes
Grupos de Populações Continentais/estatística & dados numéricos
Bases de Dados Factuais
Quimioterapia Combinada
Grupos Étnicos/estatística & dados numéricos
Grupo com Ancestrais do Continente Europeu/estatística & dados numéricos
Feminino
Hepacivirus/efeitos dos fármacos
Hepacivirus/genética
Hepatite C/diagnóstico
Hepatite C/mortalidade
Hepatite C Crônica/diagnóstico
Hepatite C Crônica/tratamento farmacológico
Hepatite C Crônica/etnologia
Hispano-Americanos/estatística & dados numéricos
Seres Humanos
Interferon-alfa/uso terapêutico
Modelos Logísticos
Masculino
Meia-Idade
Análise Multivariada
Prognóstico
Ribavirina/uso terapêutico
Medição de Risco
Simeprevir/uso terapêutico
Sofosbuvir/uso terapêutico
Taxa de Sobrevida
Resultado do Tratamento
Estados Unidos
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Interferon-alpha); 49717AWG6K (Ribavirin); 9WS5RD66HZ (Simeprevir); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:180121
[Lr] Data última revisão:
180121
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE
[do] DOI:10.1002/hep.28901


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[PMID]:28470850
[Au] Autor:Maan R; Al Marzooqi SH; Klair JS; Karkada J; Cerocchi O; Kowgier M; Harrell SM; Rhodes KD; Janssen HLA; Feld JJ; Duarte-Rojo A
[Ad] Endereço:Toronto Centre for Liver Disease, Sandra Rotman Centre for Global Health, University of Toronto, Toronto, Canada.
[Ti] Título:The frequency of acute kidney injury in patients with chronic hepatitis C virus infection treated with sofosbuvir-based regimens.
[So] Source:Aliment Pharmacol Ther;46(1):46-55, 2017 07.
[Is] ISSN:1365-2036
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Guidelines recommend withholding sofosbuvir (SOF) in patients with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min. AIM: To assess the risk of acute kidney injury (AKI) in patients with no renal contraindications for SOF-based treatment. METHODS: This multicenter retrospective observational study included all consecutive patients that were treated with SOF-based or telaprevir/boceprevir (TVR/BOC)-based regimens at two tertiary university centers in North America. AKI was defined as an increase of ≥0.3 mg/dL (≥26.5 µmol/L) in serum creatinine level. Multivariable logistic regression analysis was used to identify risk factors for the occurrence of AKI. RESULTS: In total, 426 patients were included and treated with a SOF-based regimen (n=233, 54.7%) or TVR/BOC-based regimen (n=193, 45.3%). Among patients treated with a TVR/BOC-based regimen 34 (18%) of 193 patients experienced AKI compared to 26 (11%) of 233 patients treated with SOF-based regimens (P=.056). Multivariable logistic regression analysis showed that the presence of ascites (OR: 4.44, 95%CI: 1.46-13.54, P=.009) and the use of NSAIDs (OR: 4.47, 95%CI: 1.32-15.19, P=.016) were associated with a risk of AKI during SOF-based antiviral therapy. Creatinine levels returned to normal at end of follow-up in 23 (88%) of the 26 patients who experienced AKI with a SOF-based regimen and had a creatinine level available during follow-up. CONCLUSIONS: Although the risk for AKI was lower than for patients treated with TVR/BOC-based regimens, AKI was seen during 11% of SOF-based regimens and was mostly reversible. Patients with ascites and patients using NSAIDs have an increased risk for AKI during SOF-based antiviral therapy.
[Mh] Termos MeSH primário: Lesão Renal Aguda/induzido quimicamente
Antivirais/efeitos adversos
Hepatite C Crônica/tratamento farmacológico
Sofosbuvir/efeitos adversos
[Mh] Termos MeSH secundário: Adulto
Idoso
Antivirais/uso terapêutico
Quimioterapia Combinada
Feminino
Seres Humanos
Masculino
Meia-Idade
Oligopeptídeos/efeitos adversos
Oligopeptídeos/uso terapêutico
Prolina/efeitos adversos
Prolina/análogos & derivados
Prolina/uso terapêutico
Fatores de Risco
Sofosbuvir/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Oligopeptides); 655M5O3W0U (telaprevir); 89BT58KELH (N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide); 9DLQ4CIU6V (Proline); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171220
[Lr] Data última revisão:
171220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1111/apt.14117


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[PMID]:29045448
[Au] Autor:Uemura H; Tsukada K; Mizushima D; Aoki T; Watanabe K; Kinai E; Teruya K; Gatanaga H; Kikuchi Y; Sugiyama M; Mizokami M; Oka S
[Ad] Endereço:AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
[Ti] Título:Interferon-free therapy with direct acting antivirals for HCV/HIV-1 co-infected Japanese patients with inherited bleeding disorders.
[So] Source:PLoS One;12(10):e0186255, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Almost 30 years ago, about 30% of Japanese hemophiliacs became infected with HIV-1 and hepatitis C virus (HCV) after receiving contaminated blood products. While several studies have reported the high efficacy and safety of direct acting antivirals (DAA) in HIV-1 co-infected patients, such data are limited in hemophiliacs. METHODS: We conducted a single-center, open-label study involving 27 Japanese patients (median age; 45 years) with inherited bleeding disorders who were co-infected with HCV/HIV-1. Patients with HCV genotype 1 (GT1) and GT4 received ledipasvir (90 mg) plus sofosbuvir (400 mg), those with HCV GT2 received sofosbuvir plus weight-based ribavirin, and those with HCV GT3 received daclatasvir (60 mg) plus sofosbuvir. Treatment was continued for 12 weeks in all patients. The primary endpoints were rate of sustained virologic response at 12 weeks after end of therapy (SVR12) and occurrence of adverse events during DAA therapy. RESULTS: Eighteen (67%) patients had had received interferon-based therapy, and 11 (41%) had compensated cirrhosis. HCV genotypes were GT1a 4 (15%), GT1b 16 (59%), GT1 undetermined 2 (7%), GT2a 1 (4%), GT3a 3 (11%) and GT4a 1 (4%). All patients were on combination antiretroviral therapy (cART) and had undetectable HIV-1 viral load (<20 copies/µL) at baseline. All patients achieved SVR12. Serious adverse events were observed in 3 patients: arteritis of the leg, which resolved after completion of DAA therapy, asymptomatic QT prolongation and gastrointestinal hemorrhage. cART failure was noted in one patient due to emergence of raltegravir resistance during ledipasvir/sofosbuvir treatment. Although α-fetoprotein, Mac-2 binding protein glycosylation isomer (M2BPGi), and Fibro Scan (FS) scores decreased in most patients during DAA therapy, M2BPGi (>2.0 cutoff index) and FS scores (>15.0 kPa) were still high in 6 patients at week 36. CONCLUSIONS: DAA therapy is effective in all patients. However, adverse events and efficacy of cART should be monitored closely.
[Mh] Termos MeSH primário: Antivirais/administração & dosagem
Coinfecção/tratamento farmacológico
Infecções por HIV/tratamento farmacológico
Hemofilia A/tratamento farmacológico
Hepatite C Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Antivirais/efeitos adversos
Benzimidazóis/administração & dosagem
Coinfecção/complicações
Coinfecção/virologia
Quimioterapia Combinada/efeitos adversos
Feminino
Fluorenos/administração & dosagem
Infecções por HIV/complicações
Infecções por HIV/virologia
HIV-1/efeitos dos fármacos
HIV-1/patogenicidade
Hemofilia A/complicações
Hemofilia A/virologia
Hepacivirus/efeitos dos fármacos
Hepacivirus/patogenicidade
Hepatite C Crônica/complicações
Hepatite C Crônica/virologia
Seres Humanos
Imidazóis/administração & dosagem
Interferons/uso terapêutico
Cirrose Hepática/complicações
Cirrose Hepática/tratamento farmacológico
Cirrose Hepática/virologia
Masculino
Meia-Idade
RNA Viral/efeitos dos fármacos
Sofosbuvir/administração & dosagem
Carga Viral/efeitos dos fármacos
[Pt] Tipo de publicação:CLINICAL TRIAL; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (BMS-790052); 0 (Benzimidazoles); 0 (Fluorenes); 0 (Imidazoles); 0 (RNA, Viral); 013TE6E4WV (ledipasvir); 9008-11-1 (Interferons); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171019
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0186255


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[PMID]:28981513
[Au] Autor:Nagaty A; Abd El-Wahab EW
[Ad] Endereço:Consultant of Hepatology and Infectious Diseases, Ministry of Health, Alexandria, Egypt.
[Ti] Título:Real-life results of sofosbuvir based therapy in chronic hepatitis C -naïve and -experienced patients in Egypt.
[So] Source:PLoS One;12(10):e0184654, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: More than ten million Egyptians are infected with HCV. Every one of them is going to infect about three to four persons every year. Treating those patients is a matter of national security. A dramatic improvement in hepatitis C virus (HCV) infection treatment was achieved in the last five years. A new era of direct-acting antivirals is now dawning in Egypt. OBJECTIVE(S): We share in this report our clinical experience in treating chronic HCV Egyptian patients with Sofosbuvir based regimens to evaluate its safety and efficacy on real life practical ground. METHODS: A total of 205 chronic HCV patients (195 naive and 15 experienced) were enrolled in the study. Patient were treated with Sofosbuvir+Ribavirin 24 weeks as standard of care. Two interferon eligible patients were treated with PEG-INF+ Sofosbuvir+Ribavirin for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response at 24 weeks after cessation of therapy. RESULTS: The overall response rate was 97.1%. Sustained virological response rate did not differ among treatment-naive patients and patients with previous history of IFN-based therapy. Portal hypertension, prediabetes, and lack of early virologic response were predictors of non response. No clinically significant treatment-emergent adverse effects were noted. No treatment discontinuation was encountered. CONCLUSION: In the real-life setting, Sofosbuvir based regimens for 24 weeks has established an efficacious and well tolerated treatment in naïve and experienced patients with chronic HCV genotype 4 infection; although shorter treatment durations may be possible. However, patient follow up should extent to at least 6 months post-treatment and verifying viral load on yearly basis is warranted to track any late relapse.
[Mh] Termos MeSH primário: Antivirais/uso terapêutico
Hepatite C Crônica/tratamento farmacológico
Sofosbuvir/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Quimioterapia Combinada
Egito
Feminino
Seres Humanos
Masculino
Meia-Idade
Estudos Prospectivos
Ribavirina/uso terapêutico
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antiviral Agents); 49717AWG6K (Ribavirin); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171022
[Lr] Data última revisão:
171022
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171006
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0184654


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[PMID]:28858753
[Au] Autor:Miraghaei S; Mohammadi B; Babaei A; Keshavarz S; Bahrami G
[Ad] Endereço:Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
[Ti] Título:Development and validation of a new HPLC-DAD method for quantification of sofosbuvir in human serum and its comparison with LC-MS/MS technique: Application to a bioequivalence study.
[So] Source:J Chromatogr B Analyt Technol Biomed Life Sci;1063:118-122, 2017 Sep 15.
[Is] ISSN:1873-376X
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Although for many analyses tandem mass spectrometry (LC-MS/MS) systems have significant advantage over the high-performance liquid chromatography with diode array detection (HPLC-DAD) however, the HPLC methods are easier, cheaper and more available to perform. As no published method is available for quantitative HPLC analysis of sofosbuvir (SOF), an orally administered anti-hepatitis drug in human serum, this study was aimed to evaluate applicability of the HPLC technique to quantify sofosbuvir and comparison of the two methods for analytical performance. Following extraction of the drug and an internal standard (Hexobarbital), same chromatographic conditions were used for both the systems. After the chromatographic separation on a reverse phase C18 column using a mobile phase consisting of water (containing formic acid 0.5mL/L) and acetonitrile (57:43; v/v) at a flow rate of 0.8mL/min, the eluate was introduced into a DAD detector set at 261nm, then passed through the mass spectrometry system in single ion monitoring mode (SIM). For UV and mass spectrometry detections the calibration curves were linear over a concentration range of 25-3200 and 10-3200ng/mL, respectively and the linearity was over 0.998 for both the systems. Lower limit of quantification (LLOQ) for mass spectrometry and DAD detections were 10 and 25ng/mL, respectively. In conclusion sensitivity of DAD detection is sufficient enough to determine concentrations down to 0.5% of C which achieved in bioequivalence study of sofosbuvir and meet FDA requirements for these types of studies.
[Mh] Termos MeSH primário: Cromatografia Líquida de Alta Pressão/métodos
Sofosbuvir/sangue
Espectrometria de Massas em Tandem/métodos
[Mh] Termos MeSH secundário: Seres Humanos
Modelos Lineares
Reprodutibilidade dos Testes
Sensibilidade e Especificidade
Sofosbuvir/química
Sofosbuvir/farmacocinética
Equivalência Terapêutica
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171002
[Lr] Data última revisão:
171002
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170901
[St] Status:MEDLINE


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[PMID]:28753040
[Au] Autor:Soriano V; Benítez-Gutiérrez L; Arias A; Carrasco I; Barreiro P; Peña JM; de Mendoza C
[Ad] Endereço:a Infectious Diseases Unit , La Paz University Hospital & Autonomous University , Madrid , Spain.
[Ti] Título:Evaluation of sofosbuvir, velpatasvir plus voxilaprevir as fixed-dose co-formulation for treating hepatitis C.
[So] Source:Expert Opin Drug Metab Toxicol;13(9):1015-1022, 2017 Sep.
[Is] ISSN:1744-7607
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The fixed-dose combination of three direct-acting antivirals (DAA), namely sofosbuvir, velpatasvir and voxilaprevir is the first pangenotypic, single tablet regimen developed for the treatment of HCV infection. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy and safety of the co-formulation are reviewed. Information on drug absorption, distribution, metabolism and excretion of each of the three antivirals is evaluated. Finally, antiviral activity, safety and potential for drug interactions in phase II/III clinical trials in distinct patient populations are discussed. Expert opinion: The triple co-formulation of sofosbuvir-velpatasvir-voxilaprevir represents a major step towards HCV eradication. It depicts high efficacy even in patients infected with viruses harboring resistance-associated substitutions (RAS), including those selected after DAA failures. Likewise, very high success rates and good tolerance are seen in special patient populations, including decompensated cirrhotics, HIV coinfection, organ transplantation or renal insufficiency. A pill once daily for 8 weeks gives SVR rates above 95%. In prior DAA failures, extending treatment to 12 weeks maximizes SVR rates.
[Mh] Termos MeSH primário: Carbamatos/administração & dosagem
Hepatite C/tratamento farmacológico
Compostos Heterocíclicos de 4 ou mais Anéis/administração & dosagem
Compostos Macrocíclicos/administração & dosagem
Sofosbuvir/administração & dosagem
Sulfonamidas/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Antivirais/administração & dosagem
Antivirais/efeitos adversos
Antivirais/farmacocinética
Carbamatos/efeitos adversos
Combinação de Medicamentos
Interações Medicamentosas
Farmacorresistência Viral
Hepatite C/virologia
Compostos Heterocíclicos de 4 ou mais Anéis/efeitos adversos
Seres Humanos
Compostos Macrocíclicos/efeitos adversos
Compostos Macrocíclicos/farmacocinética
Sofosbuvir/efeitos adversos
Sofosbuvir/farmacocinética
Sulfonamidas/efeitos adversos
Sulfonamidas/farmacocinética
Comprimidos
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Carbamates); 0 (Drug Combinations); 0 (Heterocyclic Compounds, 4 or More Rings); 0 (Macrocyclic Compounds); 0 (Sulfonamides); 0 (Tablets); 0 (voxilaprevir); KCU0C7RS7Z (velpatasvir); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170729
[St] Status:MEDLINE
[do] DOI:10.1080/17425255.2017.1359254


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[PMID]:28724837
[Au] Autor:Uchiyama N; Kamakura H; Masada S; Tsujimoto T; Hosoe J; Tokumoto H; Maruyama T; Goda Y; Hakamatsuka T
[Ad] Endereço:National Institute of Health Sciences (NIHS).
[Ti] Título:Chemical Analysis of Counterfeit Hepatitis C Drug Found in Japan.
[So] Source:Yakugaku Zasshi;137(10):1265-1276, 2017 10 01.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:In January 2017, counterfeits of the hepatitis C drug 'HARVONI Combination Tablets' (HARVONI ) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR. In samples 2A, 3 and 4B, sofosbuvir, the active component of another hepatitis C drug, SOVALDI Tablets 400 mg (SOVALDI ), was detected. In sample 4A, sofosbuvir and ledipasvir, the active components of HARVONI , were found. A direct comparison of the four samples and genuine products showed that three samples (2A, 3, 4B) are apparently SOVALDI and that sample 2A is HARVONI . In samples 1 and 5, several vitamins but none of the active compounds usually found in HARVONI (i.e., sofosbuvir and ledipasvir) were detected. Our additional investigation indicates that these two samples are likely to be a commercial vitamin supplement distributed in Japan. Sample 2B, looked entirely different from HARVONI and contained several herbal constitutents (such as ephedrine and glycyrrhizin) that are used in Japanese Kampo formulations. A further analysis indicated that sample 2B is likely to be a Kampo extract tablet of Shoseiryuto which is distributed in Japan. Considering this case, it is important to be vigilant to prevent a recurrence of distribution of counterfeit drugs.
[Mh] Termos MeSH primário: Antivirais/química
Benzimidazóis/química
Medicamentos Falsificados/química
Fluorenos/química
Hepatite C/tratamento farmacológico
Uridina Monofosfato/análogos & derivados
[Mh] Termos MeSH secundário: Benzimidazóis/análise
Cromatografia Líquida
Medicamentos de Ervas Chinesas/análise
Efedrina/análise
Fluorenos/análise
Cromatografia Gasosa-Espectrometria de Massas
Ácido Glicirrízico/análise
Japão
Espectroscopia de Ressonância Magnética
Espectrometria de Massas
Sofosbuvir/análise
Comprimidos
Uridina Monofosfato/química
Vitaminas/análise
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antiviral Agents); 0 (Benzimidazoles); 0 (Counterfeit Drugs); 0 (Drugs, Chinese Herbal); 0 (Fluorenes); 0 (Tablets); 0 (Vitamins); 0 (ledipasvir, sofosbuvir drug combination); 0 (sho-seiryu-to); 013TE6E4WV (ledipasvir); 6FO62043WK (Glycyrrhizic Acid); E2OU15WN0N (Uridine Monophosphate); GN83C131XS (Ephedrine); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170721
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00136



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