Examples of using Sofosbuvir in English and their translations into German
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This medicine is taken with another antiviral drug named sofosbuvir.
Sofosbuvir(400 mg single dose sofosbuvir)/ elbasvir(50 mg once daily)/ grazoprevir 200 mg once daily.
Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir.
Do not take any other medicine that contains sofosbuvir, one of the active substances in Epclusa.
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
All patients with or without cirrhosis receiving 12 weeks of simeprevir+ sofosbuvir achieved SVR12 table 16.
Co-administration will significantly decrease sofosbuvir plasma concentration and could result in loss of efficacy of Sovaldi see section 4.5.
The response rates for patients with orwithout cirrhosis receiving 12 weeks of simeprevir+ sofosbuvir are shown in table 13.
Sofosbuvir(400 mg once daily)/ Elvitegravir(150 mg once daily)/ Cobicistat(150 mg once daily)/ Emtricitabine(200 mg once daily)/ Tenofovir alafenamide(10 mg once daily)5.
The most common adverse drug reactions occurring in subjects receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
Sofosbuvir and ribavirin therapy is recommended for patients with hepatocellular carcinoma awaiting liver transplantation to prevent posttransplant HCV reinfection.
Medicinal products that are moderate P-gp or moderate CYP inducers(e.g. oxcarbazepine, modafinil or efavirenz) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
The chimeric replicons carrying NS5A genes from genotype 2b, 5a, 6a and 6e were used for testing ledipasvir while the chimeric replicons carrying NS5B genes from genotype 2b,5a or 6a were used for testing sofosbuvir.
Patients with genotype 3 infection were treated with daclatasvir+ sofosbuvir+/- ribavirin for 12 or 24 weeks, where the longer treatment duration was associated with a lower risk for relapse(around 5%) in a preliminary analysis.
Table 6: Treatment-emergent laboratory abnormalities in amylase and lipase inpatients receiving 12 or 24 weeks of simeprevir in combination with sofosbuvir 12 weeks: pooled studies HPC2002, HPC3017 and HPC3018; 24 weeks: study HPC2002.
Due to the long elimination half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodaronewithin the past few months and are to be initiated on OLYSIO combination treatment with sofosbuvir.
In study HPC2002, rash(grouped term) was reported in 10.7% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 20.4% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Site-directed mutagenesis of the S282T substitution in replicons of genotype 1 to 6 conferred 2-to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
In a pooled analysis of 629 patients who received daclatasvir and sofosbuvir with or without ribavirin in Phase 2 and 3 studies for 12 or 24 weeks, 34 patients qualified for resistance analysis due to virologic failure or early study discontinuation and having HCV RNA greater than 1,000 IU/ml.
The overall safety profile of daclatasvir is based on data from 2215 patients with chronic HCV infection who receivedDaklinza once daily either in combination with sofosbuvir with or without ribavirin(n=679, pooled data) or in combination with peginterferon alfa and ribavirin(n=1536, pooled data) from a total of 14 clinical studies.
VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis.
FISSION was a randomised, open-label,active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 or 3 HCV infection.
In 9 phase 2/3 studies with daclatasvir in combination with peginterferonalfa+ ribavirin or in combination with sofosbuvir+/- ribavirin, the following frequencies of such RAVs were seen at baseline: 7% in genotype 1a infection(M28T, Q30, L31, and/or Y93), 11% in genotype 1b infection(L31 and/or Y93H), 51% in genotype 2 infection(L31M), 8% in genotype 3 infection(Y93H) and 64% in genotype 4 infection L28 and/or L30.
Co-administration of Sovaldi with medicinal products that inhibitP-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
The overall safety profile of simeprevir is based on data from 580 HCV genotype 1infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin(pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir(or placebo) in combination with peginterferon alfa and ribavirin pooled data from the clinical phase 2 studies C205 and C206 and the clinical phase 3 studies C208, C216 and HPC3007.
The safety and efficacy of Daklinza in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALLY-1(AI444215, Daklinza+ sofosbuvir+ ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daklinza+ sofosbuvir+/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C see sections 4.2 and 5.1.
In subjects with ESRD, relative to subjects with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Hepcinat lp is aunique drug that combines the properties of lepidavir and sofosbuvir, which can suppress at once two types of proteins involved in the spread of the hepatitis C virus in the body, these are the NS5A and NS5B polymerases.
Dizziness has been reported during treatment with Daklinza in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daklinza in combination with peginterferon alfa and ribavirin.