Kunena :: Тема: Posted by Erik Bernard on 19.12.2016 16:05:03: sofosbuvir 400 mg ledipasvir 90 mg (1/2)

Навигация: Главная Форум Главный раздел Сообщество базовых площадокPosted by Erik Bernard on 19.12.2016 16:05:03: sofosbuvir 400 mg ledipasvir 90 mg

Добро пожаловать, Гость

Форум

Главный раздел

Сообщество базовых площадок

Posted by Erik Bernard on 19.12.2016 16:05:03: sofosbuvir 400 mg ledipasvir 90 mg

Страница:
1
2

ТЕМА: Posted by Erik Bernard on 19.12.2016 16:05:03: sofosbuvir 400 mg ledipasvir 90 mg

Posted by Erik Bernard on 19.12.2016 16:05:03: sofosbuvir 400 mg ledipasvir 90 mg 8 года 3 мес. назад #1114

akipk

We deliver you hope and ability to escape of hepatitis C and leave this life experience behind you.

*
[Show abstract] [hide] ABSTRACT: Risks and benefits of simeprevir plus sofosbuvir in patients with advanced cirrhosis are unknown. We assessed the safety and sustained virologic responses (SVR) of simeprevir plus sofosbuvir with and without ribavirin in patients with Child-Pugh (CP)-B/C vs. CP-A cirrhosis and compared to matched untreated controls. Multicenter cohort of adults with HCV genotype 1 and cirrhosis treated with simeprevir plus sofosbuvir with/without ribavirin for 12 weeks. Controls were matched on treatment center, age, CP class and model for end-stage liver disease (MELD) score. Of 160 patients treated with simeprevir plus sofosbuvir with/without ribavirin, 35% had CP-B/C and 64% had CP-A, with median baseline MELD 9 (IQR 8-11). SVR12 was achieved by 73% of CP-B/C vs. 91% of CP-A (p<0.01). CP-B/C vs. CP-A had more early treatment discontinuations (11% vs. 1%), adverse events requiring hospitalization (22% vs. 2%), infections requiring antibiotics (20% vs. 1%) and hepatic decompensating events (20% vs. 3%) (all p<0.01). There were 2 deaths: 1 CP-B/C (liver-related) and 1 CP-A (not liver-related). In multivariate analysis, CP-B/C independently predicted lack of SVR12 (OR 0.27, 95% CI 0.08-0.92). In comparing simeprevir plus sofosbuvir treated patients vs. matched untreated controls, adverse events requiring hospitalization (9% vs. 13%, p=0.55), infections (8% vs. 6%, p=0.47) and events of decompensation (9% vs. 10%, p=0.78) occurred at similar frequency. Simeprevir plus sofosbuvir with/without ribavirin has lower efficacy and higher rates of adverse events in patients with CP-B/C cirrhosis compared to CP-A. The frequency of adverse safety outcomes were similar to matched untreated controls, suggesting safety events reflect the natural history of cirrhosis and are not related to treatment. This article is protected by copyright. All rights reserved. © 2015 by the American Association for the Study of Liver Diseases.
Sofosbuvir (Sovaldi ) is a polymerase inhibitor. It works by stopping the virus from replicating. This effect eventually causes the virus to die off.
5. Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet . 2014;383(9916):515-523.
Sofosbuvir and simeprevir combination
Take sofosbuvir and velpatasvir exactly as your healthcare provider tells you to take it.
Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med . 2014 May 15. 370(20):1879-88. [Medline]. [Full Text] .
SVR12 rates were available for 237 patients treated with sofosbuvir and daclatasvir alone. SVR12 rates were 84.9% after 12 weeks of treatment vs 93.4% after 24 weeks. However, the majority of analyses were performed on data available after 4 weeks of follow-up (SVR4) derived from 409 patients (Table 1). Sofosbuvir and daclatasvir yielded SVR4 rates of 85.2% with 12 weeks of treatment vs 95.1% with 24 weeks. With the addition of ribavirin, SVR4 rates were 100% with 12 weeks vs 98.7% with 24 weeks. Among patients with cirrhosis, the addition of ribavirin improved SVR4. Without ribavirin, SVR4 was 76.5% with 12 weeks of treatment vs 94.0% with 24 weeks. With ribavirin, SVR4 rose to 100% and 98.3%, respectively. All patients without cirrhosis achieved SVR4, regardless of treatment duration and use of ribavirin.
dnz2.rosvita.rv.ua/index.php/forum/skrin...ofosbuvir-genotype-5
Despite that price, which spooked payers into finding new ways to limit their spending, Sovaldi raced to blockbuster status in the U.S. and is on track to top $10 billion in sales this year. In Europe, where roll-outs depend on country-by-country reimbursement approvals, the growth has been much slower. And with European prices tracking much lower, the slower rate of growth is bound to continue.
Gilead’s drug development program has been swift, flexible, efficient – and ruthless. The company is seeking to shorten treatment with once-daily, multiclass, pangenotypic FDCs. Gilead’s FDC of sofosbuvir and GS-5816 (an NS5A inhibitor) is in phase III. It remains to be seen whether GS-5816 has advantages over daclatasvir (aside from being owned by Gilead). The company is also developing a triple-class combination with the sofosbuvir/GS-5816 FDC and GS-9857 (a protease inhibitor), currently in phase II.
sovaldi generic name Austin
And that's just one of several legal fights brewing as an FDA marketing decision on sofosbuvir looms in early December.
pdd-video.com/index.php/kunena/razdel-pr...ablet-price-in-india
This may not be as bad as it appears Despite having its patent application for Sovaldi in China shown the door, this may not be all bad news for Gilead Sciences after all.
. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study [abstract LB-3]. 64th Annual Meeting of the American Association for the Study of Liver Diseases ; November 1–5, 2013 ; Washington, DC.
Sovaldi ribavirin side effects hepatitis c treatment sovaldi sofosbuvir china Why sofosbuvir resistance mutation Are sofosbuvir druginfosys sofosbuvir velpatasvir and gs 9857 daclatasvir plus sofosbuvir for previously sofosbuvir buy what is sofosbuvir Prescription gilead sofosbuvir genotype 3 Drugs sovaldi logo sofosbuvir daclatasvir genotype 4 sovaldi hepatitis c cure So zeuzem sofosbuvir Expensive? sovaldi drug info simeprevir and sofosbuvir clinical trials sovaldi sofosbuvir 400 mg price india sofosbuvir 400 sofosbuvir 400 mg india sovaldi costo Big sofosbuvir ledipasvir pdufa Pharma gilead sofosbuvir acquisition sovaldi hepatitis b side effects of sovaldi Points sovaldi canada price gilead's sovaldi tied to slow heartbeat in hepatitis c patients sofosbuvir simeprevir off label sovaldi drug price To sovaldi india cost simeprevir sofosbuvir croi sofosbuvir patient assistance The sofosbuvir velpatasvir sovaldi 400 mg tablet price Cost hepatitis c treatment pill sovaldi india cost sovaldi sofosbuvir 400 mg price Of daklinza sovaldi ribavirin sovaldi 400 tab sovaldi cost in usa sofosbuvir tablets 400 mg price in india Research sovaldi medicine price sovaldi hepatitis And sovaldi prices gilead sovaldi japan sofosbuvir 400 mg price Development, sofosbuvir cost in egypt sofosbuvir price in china Critics sovaldi price in malaysia hcv treatment sofosbuvir gilead sciences sofosbuvir olysio sovaldi Say sovaldi hepatitis c sovaldi success rate That's sovaldi купить в египте sovaldi animation sofosbuvir tablets india sovaldi thearika sovaldi availability in pakistan No sofosbuvir fda submission sofosbuvir supplier in india sofosbuvir treatment guidelines sovaldi hepatitis Excuse sofosbuvir clinical trial sofosbuvir clinical trial
i) IN 6087/DELNP/2005 which covers Sofosbuvir metabolites. ii) IN 3658/KOLNP/2009 which covers Sofosbuvir as a main product.
Lawitz E et al. Suppression of viral load through 4 weeks post-treatment results of a once-daily regimen of simeprevir + sofosbuvir with or without ribavirin in hepatitis C virus GT 1 null responders. 20th CROI, 2013. Oral late breaker abstract 155LB. www.retroconference.org/2013b/Abstracts/47930.htm
shcentral.ru/index.php/forum/razdel-pred...ir-ledipasvir-lancet
The drug maker attributed this decline to discounts given to private insurers and higher rebates for patients in health plans, like Medicaid. The HCV drugs are priced at $84,000, for Sovaldi, and $94,500, for Harvoni, for a full-course treatment.
An extra patient leaflet is available with sofosbuvir. Talk to your pharmacist if you have questions about this information.
flower-mist.ru/index.php/forum/4/427-pos...lence-and-sofosbuvir
Two hepatitis C drugs, simeprevir and sofosbuvir, received promising internal FDA reviews on the eve of advisory board meetings at which government experts will decide whether to recommend approval for both medications.
sovaldi ribavirin Delaware
sovaldi ribavirin forum WY
Buy Sovaldi ( Sofosbuvir ) Online With Paypal 14076 6 мес. 2 дн. ago #10103
Natco Pharma announced that the Drugs Controller General of India has approved the sale of generic sofosbuvir in 400-mg tablets for the treatment of chronic hepatitis C infection. The drug will be marketed through strategic partners in India under the brand HEPCINAT.
tsariki.ru/forum/vakansii-v-rajone-tsari...fosbuvir-arbitration
Le comité économique des produits de santé (CEPS) a ainsi fixé le prix du médicament Sovaldi à 13 667€ HT par boîte de 28 comprimés, soit 41 000 euros pour un traitement de 12 semaines avec le nouveau prix. Le sofosbuvir (Sovaldi® de Gilead), nouveau antiviral direct (AVD) contre l’hépatite C, avait vu son prix fixé initialement, dans le cadre de l’Autorisation temporaire d’utilisation ( ATU ) à 56 000 euros environ pour un traitement de 12 semaines (19 000 euros la boite).
SOVALDI TM (sofosbuvir) Gilead Sciences Farmacêutica do Brasil Ltda Comprimidos revestidos 400 mg Bula do Médico R47 Apr15 Página 1 de 27 BULA AO PROFISSIONAL DE SAÚDE I - IDENTIFICAÇÃO DO MEDICAMENTO
Sofosbuvir Newsmax Media 947612
Durante l’esame da parte dell’FDA sono stati aggiunti alla domanda di approvazione di nuovo farmaco i dati derivati da altri due studi di Fase 3, VALENCE e PHOTON-1, in conseguenza della concessione dello stato di farmaco innovativo. Nello studio VALENCE, pazienti affetti da HVC di genotipo 3 sono stati trattati con Sovaldi e RBV per 24 settimane. L’ottantaquattro per cento dei pazienti partecipanti a questa sperimentazione ha raggiunto una risposta virologica sostenuta alla Settimana 12 (SVR12). Nello studio PHOTON-1 si è valutata l’efficacia di Sovaldi e RBV per 12 settimane in pazienti affetti da HCV di genotipo 2 coinfetti da HIV-1 e per 24 settimane in pazienti con HCV di genotipo 1 o 3 coinfetti da HIV-1. I partecipanti alla sperimentazione hanno raggiunto tassi SVR12 compresi tra il 76 e il 92 per cento. In tutti gli studi di Fase 3 condotti su Sovaldi non è stata constatata alcuna resistenza virale al farmaco nei pazienti che hanno accusato una recidiva a terapia ultimata.
L’Agenzia regolatoria degli Stati Uniti, FDA ( Food and Drug Administration ) ha approvato le modifiche alle Avvertenze e Precauzioni ( Warnings and Precautions ) della scheda tecnica di Simeprevir ( Olysio ) per il trattamento della infezione da virus dell'epatite C, indicando che il farmaco può causare scompenso epatico e insufficienza epatica, e grave bradicardia sintomatica quando co-somministrato con Sofosbuvir ( Sovaldi ) e Amiodarone ( Cordarone ).
Sovaldi Generico De Crestor 737089
Pregnancy Category B: Sofosbuvir
Foi aprovado no dia 7 de dezembro pelo FDA nos Estados Unidos para ser comercializado com o nome de (Sovaldi®).
supershop.od.ua/index.php?option=com_kun...func=post&Itemid=130
sovaldi 400 mg tablet price in pakistan New Hampshire
sovaldi ribavirin forum Atlanta
Sovaldi is usually given with ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) with or without peginterferon alfa (Pegasys, PegIntron). Gilead Drug Exporters Ribavirin Sovaldi Hep C Cost California USA.
Posts Tagged ‘sofosbuvir’
Sovaldi must be given in combination with other antiviral medications and should not be used alone. Sovaldi is usually given with ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) with or without peginterferon alfa (Pegasys, PegIntron). Sovaldi is also used together with Daklinza (daclatasvir) to treat hepatitis C genotype 3 infection in adults.
n-fisher.ru/forum/14---/1926-posted-by-c...f-sovaldi-and-olysio
Genotype 3, treatment naive or treatment experienced with Peg IFN/RBV without cirrhosis; Sovaldi 400 mg plus Daklinza 60 mg PO QD
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 4, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. Gilead filed the NDA for SOF/VEL on October 28, 2015, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.
Staffs of R. Wyden & C. Grassley. The Price of Sovaldi and Its Impact on the US Health Care System www.docfoc.com/1-the-price-of-sovaldi-an...stem-full-report-pdf (Committee on Finance, US Senate, December 2015 ).
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection
For Gilead's (NASDAQ:GILD ) long-term investors, the important thing to remember here is that management's topline growth estimate of 6-8% excluding Sovaldi is impressive on its own. Although things might get very bumpy this year, that's hardly a reason to let go now.
Given that ribavirin adds side effects but did not appear to improve efficacy, a pair of Phase 3 trials testing sofosbuvir/simeprevir alone -- OPTIMIST-1 for non-cirrhotics and OPIMIST-2 for people with cirrhosis -- are now recruiting. Since 12 weeks of treatment was highly effective in COSMOS, the new studies will compare 8 vs 12 weeks to see if treatment can safely be shortened to just 2 months.
Análisis coste-efectividad de sofosbuvir con peginterferón/ribavirina (SOF/PEG-IFN/RBV) en pacientes con hepatitis C crónica genotipo 1 (HCC-GT1) no tratados previamente con diferentes grados de fibrosis, desde la perspectiva del Sistema Nacional de Salud (SNS).
bunrazhe.ru/dose-of-sovaldi.html
Il prezzo di un prodotto farmaceutico non pu� essere arbitrario e giustificato solo da una logica di profitto, come avviene per qualunque altro oggetto: spesso di mezzo c'� la vita umana - Il caso del sofosbuvir, l'unico con cui si cura l'epatite C: costa 1000 dollari a pasticca negli Usa, solo 11 in Egitto. E il Senato americano � insorto
The FDA granted Sovaldi Priority Review and Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. “I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C,” said Ira Jacobson, MD, Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City and a principal investigator in the Sovaldi clinical trials. “In clinical studies, Sovaldi in combination with other agents achieved very high cure rates while shortening the duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype.”