natgillin/translations-raw huggingface dataset:
Kliniske studier hos patienter med kronisk hepatitis C med genotype 1, 4, 5 og 6 Behandlingsnaive voksne patienter - NEUTRINO (studie 110) NEUTRINO var et open-label, enarmet studie, der evaluerede 12 ugers behandling med sofosbuvir i kombination med peginterferon alfa 2a og ribavirin hos behandlingsnaive patienter med HCV-infektion af genotype 1, 4, 5 eller 6.
Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection.
HCV-inficerede patienter, uanset genotype, med hepatocellulært karcinom (HCC), der opfylder MILAN-kriterierne, fik 400 mg sofosbuvir og 1.000-1.200 mg ribavirin dagligt i maks.
HCV infected patients, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first.
Meget almindelig nedsat hæmoglobin anæmi, neutropeni, nedsat lymfocyttal, nedsat trombocyttal
Very common haemoglobin decreased anaemia, neutropenia, lymphocyte count decreased, platelet count decreased
Genotype 2/3 behandlingsnaive SOF+RBV 12 uger (n = 68)
Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68)
Tabel 15 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 24 uger.
Table 15 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Ingen dosisjustering af sofosbuvir eller tacrolimus er nødvendig ved påbegyndelse af samtidig administration.
No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration.
Tabel 13 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 16 uger.
Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Tabel 18 viser analyse af undergrupper efter genotype for cirrose.
Table 18 presents the subgroup analysis by genotype for cirrhosis.
• humørsvingninger, depression, angstfølelse og ophidselse
• changes in your mood, feeling depressed, feeling anxious and feeling agitated
Hos HCV-inficerede patienter med svært nedsat nyrefunktion, som blev behandlet med en dosis på 200 mg sofosbuvir med ribavirin (n=10) eller 400 mg sofosbuvir med ribavirin (n=10) i 24 uger, eller med 90/400 mg ledipasvir/sofosbuvir (n=18) i 12 uger, var farmakokinetikken af sofosbuvir og GS
In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Studie 4062 var et åbent klinisk forsøg, som evaluerede en fast dosiskombination af sofosbuvir og velpatasvir hos 59 HCV-inficerede patienter med ESRD, der krævede dialyse.
Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis.
Genotype 1 behandlingsnaive SOF+RBV 24 uger (n = 114)
Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114)
Behandlingsnaivea (NEUTRINO)
Treatment-naïvea (NEUTRINO)
Behandlingsprogram/varighed
Regimen/Duration
Ingen dosisjustering af norgestimat/ethinylestradiol er nødvendig, når sofosbuvir og norgestimat/ethinylestradiol anvendes samtidigt.
No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Sådan skal du tage Sovaldi
How to take Sovaldi
Mave-tarm-kanalen: Meget almindelig kvalme diarré, kvalme, opkastning
Gastrointestinal disorders: Very common nausea diarrhoea, nausea, vomiting
NARKOTISKE ANALGETIKA Methadonf (Methadon vedligeholdelsesbehandling [30 til 130 mg/dagligt])
NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Interferonfri behandling af HCV-genotype 1, 4, 5 og 6-infektion
Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection
Tabel 7 viser responsraterne for behandlingsgruppen med sofosbuvir + peginterferon alfa + ribavirin.
Table 7 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Tabel 11: Responsrater i POSITRON-studiet
Table 11: Response rates in study POSITRON
Anden speciel population/andre specielle populationer
Other special population(s)
Tidligere behandlede voksne - FUSION (studie 108) FUSION var et randomiseret, dobbeltblindet studie, der evaluerede 12 eller 16 ugers behandling med sofosbuvir og ribavirin hos patienter, der ikke opnåede SVR med tidligere interferon-baseret behandling (patienter med recidiv og non-responders).
FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in patients who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
Et studie blev udført hos behandlingsnaive patienter med genotype 1, 4, 5 eller 6 kronisk hepatitis C i kombination med peginterferon alfa 2a og ribavirin, og de andre 4 studier blev udført hos patienter med genotype 2 eller 3 kronisk hepatitis C i kombination med ribavirin, herunder et studie hos behandlingsnaivepatienter, et studie hos patienter, som var interferon-intolerante, -uegnede eller -uvillige, et studie hos patienter, der tidligere blev behandlet med et interferon-baseret program, og et studie hos alle patienter, uanset tidligere behandling eller egnethed til at få behandling med interferon.
The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon.
Andetb a. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
Otherb a. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Tabel 14 viser analyse af undergrupper efter genotype for cirrose og respons på tidligere HCV-behandling.
Table 14 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Tabel 9 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og peginterferon alfa + ribavirin.
Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af sofosbuvir i kombination med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
Cases of severe bradycardia and heart block have been observed when sofosbuvir containing-regimes are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Tabel 16 viser analyse af undergrupper efter genotype overfor cirrose og eksponering for tidligere HCV-behandling.
Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Klinisk virkning og sikkerhed hos specielle populationer Voksne patienter med samtidig infektion med HCV og hiv - PHOTON-1 (studie 123) Sofosbuvir blev undersøgt i et open-label klinisk studie, der evaluerede sikkerheden og virkningen af 12 eller 24 ugers behandling med sofosbuvir og ribavirin hos patienter med kronisk hepatitis C af genotype 1, 2 eller 3 og samtidig infektion med hiv-1.
HCV/HIV co-infected adult patients - PHOTON-1 (study 123) 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 patients with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Genotype 4, 5 eller 6 97 % (34/35) Cirrose
Genotype 4, 5 or 6 Cirrhosis
For genotypespecifik aktivitet af hepatitis C-virus (HCV), se pkt.
For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Almindelig koncentrationsbesvær migræne, hukommelsessvigt, koncentrationsbesvær
Common disturbance in attention migraine, memory impairment, disturbance in attention
Almindelig dyspnø, dyspnø under anstrengelse, hoste dyspnø under anstrengelse
Common dyspnoea, dyspnoea exertional, cough dyspnoea exertional
Eksponeringen for den primære metabolit, GS-331007, ved den dosis, der forårsagede bivirkninger, var imidlertid 29 gange (rotter) og 123 gange (hunde) højere end den kliniske eksponering ved 400 mg sofosbuvir.
Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at the adverse dose was 29 times (rat) and 123 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Knogler, led, muskler og bindevæv: Meget almindelig artralgi, myalgi
Musculoskeletal and connective tissue disorders: Very common arthralgia, myalgia
Ingen dosisjustering af sofosbuvir eller darunavir (ritonavir-boostet) er nødvendig, når sofosbuvir og darunavir anvendes samtidigt.
No dose adjustment of sofosbuvir or darunavir (ritonavir boosted) is required when sofosbuvir and darunavir are used concomitantly.
Behandlingserfarne patienter med HCV-genotype 1, 4, 5 og 6-infektion
Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection
Samtidig administration af sådanne lægemidler og Sovaldi anbefales ikke (se pkt.
Co-administration of such medicinal products is not recommended with Sovaldi (see section 4.5).
Tabel 18: SVR12-rater for udvalgte undergrupper efter genotype i PHOTON-1-studiet
Table 18: SVR12 rates for selected subgroups by genotype in study PHOTON-1
influenzalignende symptomer, blærer i munden, øjnene og/eller på kønsorganerne
- a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
• mavebesvær, forstoppelse, mundtørhed, fordøjelsesbesvær, sure opstød
• stomach discomfort, constipation, dry mouth, indigestion, acid reflux
Lægemidler, der er stærke P-gp-inducere i tarmen (carbamazepin, phenobarbital, phenytoin, rifampicin og perikon), kan nedsætte plasmakoncentrationen af sofosbuvir signifikant og medføre reduceret terapeutisk virkning af Sovaldi.
Medicinal products that are strong P-gp inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi and thus are contraindicated with Sovaldi (see section 4.3).
Tabel 12: SVR12-rater for udvalgte undergrupper efter genotype i POSITRON
Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Almindelig mavebesvær, forstoppelse, dyspepsi forstoppelse, mundtørhed, mave-tarm refluks
Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux
Genotype 1
Genotype Genotype 1
Sovaldi er kontraindiceret sammen med carbamazepin (se pkt.
Sovaldi is contraindicated with carbamazepine (see section 4.3).
Nedsat leverfunktion
Common weight decreased
Sikkerhedsprofilen for sofosbuvir og ribavirin hos voksne patienter med samtidige HCV/hiv-infektioner var sammenlignelig med den observerede sikkerhedsprofil hos monoinficerede patienter med HCV, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Andetc a. Virkningsanalysen omfatter 6 patienter med rekombinant genotype 2/1 HCV-infektion.
Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection.
Administration af Sovaldi sammen med oxcarbazepin forventes at nedsætte koncentrationen af sofosbuvir og føre til en nedsat terapeutisk virkning af Sovaldi.
Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
≥ 30 og
(eGFR ≥30
Administration af Sovaldi sammen med rifapentin forventes at nedsætte koncentrationen af sofosbuvir og føre til en nedsat terapeutisk virkning af Sovaldi.
Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Almindelig artralgi, rygsmerter, muskelspasmer, myalgi rygsmerter, muskelspasmer
Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
Tabel 14: SVR12-rater for udvalgte undergrupper efter genotype i FUSION-studiet
Table 14: SVR12 rates for selected subgroups by genotype in study FUSION
Administration af Sovaldi sammen med modafinil forventes at nedsætte koncentrationen af sofosbuvir og føre til en nedsat terapeutisk virkning af Sovaldi.
Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Den anbefalede dosis Sovaldi er en tablet en gang dagligt, som skal tages sammen med mad (se pkt.
Adolescents (12 to 18 years of age) The recommended dose of Sovaldi is one tablet once daily with food (see section 5.2).
Cirrose
Cirrhotic
Tabel 16: SVR12-rater for udvalgte undergrupper efter genotype i VALENCE-studiet
Table 16: SVR12 rates for selected subgroups by genotype in study VALENCE
Ingen dosisjustering af sofosbuvir eller methadon er nødvendig, når sofosbuvir og methadon anvendes samtidigt.
No dose adjustment of sofosbuvir or methadone is required when sofosbuvir and methadone are used concomitantly.
Behandlingsnaive voksne - FISSION (studie 1231)
Clinical studies in patients with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Andetc a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
SOF+PEG+RBV 12 uger
SOF+PEG+RBV 12 weeks
Cirrose Nej Ja a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
Yes a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Sikkerhedsprofilen for sofosbuvir og ribavirin hos voksne patienter med HCV-infektion før levertransplantation var sammenlignelig med den observerede sikkerhedsprofil hos patienter, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Emtricitabin ↔ Cmax 0,97 (0,88; 1,07) ↔ AUC 0,99 (0,94; 1,05) ↔ Cmin 1,04 (0,98; 1,11)
Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11)
Ingen dosisjustering af sofosbuvir eller raltegravir er nødvendig, når sofosbuvir og raltegravir anvendes samtidigt.
No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly.
≥ 50 og
(eGFR ≥50
Rilpivirin ↔ Cmax 1,05 (0,97; 1,15) ↔ AUC 1,06 (1,02; 1,09) ↔ Cmin 0,99 (0,94; 1,04)
Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04)
S-methadon ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
Tabel 23 Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 4, 5 og 6-infektion
Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Sofosbuvir blev undersøgt i et åbent klinisk studie, der evaluerede sikkerheden og virkningen af 24 ugers behandling med sofosbuvir og ribavirin hos patienter med kronisk hepatitis C, der havde gennemgået en levertransplantation.
Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible patients were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
R-methadon ↔ Cmax 0,99 (0,85; 1,16) ↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
R-methadone ↔ Cmax 0.99 (0.85, 1.16) ↔ AUC 1.01 (0.85, 1.21) ↔ Cmin 0.94 (0.77, 1.14)
Det bør overvejes at behandle disse patienter, og muligvis forlænge behandlingsvarigheden med sofosbuvir, peginterferon alfa og ribavirin på over 12 uger og op til 24 uger, især for de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater for interferon-baserede behandlinger (fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort race, IL28B non CC-genotype).
Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Ingen dosisjustering af sofosbuvir eller rilpivirin er nødvendig, når sofosbuvir og rilpivirin anvendes samtidigt.
No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly.
b. Det bør overvejes at forlænge behandlingsvarigheden på over 12 uger og op til 24 uger, især for de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater for interferon-baserede behandlinger (f.eks. fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort race, IL28B non CC-genotype, tidligere nul-respons til peginterferon alfa og ribavirinbehandling).
b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
PEG+RBV 24 uger (n = 176)
PEG+RBV 24 weeks (n = 176)
SOF+RBV 24 uger
SOF+RBV 24 weeks
SOF+RBV 24 uger (n = 250)
SOF+RBV 24 weeks (n = 250)
SOF+RBV 16 uger
SOF+RBV 16 weeks
Sofosbuvir 1,6 gange↑ 2,1 gange↑ 2,7 gange↑ 1,3 gange↑
Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑
PEG+RBV 24 uger (n = 243)
PEG+RBV 24 weeks (n = 243)
a. Se tabel 4 angående anbefalet vægtbaseret ribavirindosering b. Det bør overvejes at forlænge behandlingsvarigheden fra 12 uger til op til 24 uger, især til de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater i forbindelse med interferonbaserede behandlinger (f.eks. fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort etnisk oprindelse, IL28B non CC-genotype, tidligere nul-respons på behandling med peginterferon alfa og ribavirin).
a. See Table 4 for weight based ribavirin dosing recommendations b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Behandlede patienter (n = 419) havde en gennemsnitsalder på 51 år (interval: 19 til 74); 60 % af patienter var mænd, gennemsnitlige body mass index var 25 kg/m2 (interval: 17 til 44 kg/m2), gennemsnitlige baseline HCV-rna-niveau var 6,4 log10 IE/ml, 21 % havde cirrose, 78 % havde HCVgenotype 3, 65 % havde tidligere recidiv.
Treated patients (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the patients were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
SOF+RBV 16 uger (n = 98)a
SOF+RBV 16 weeks (n = 98)a
Monoterapi med Sovaldi bør ikke anvendes (se pkt.
Monotherapy of Sovaldi is not recommended (see section 5.1).
• diarré, kvalme, opkastning
• diarrhoea, feeling sick (nausea), being sick (vomiting)
SOF+RBV 12 uger (n = 256)a
SOF+RBV 12 weeks (n = 256)a
Resultat for patienter uden SVR12 Virologisk svigt under behandling 0/327 Recidiva
On-treatment virologic failure 0/207 Relapsea
Ingen dosisjustering af sofosbuvir eller tenofovirdisoproxil er nødvendig, når sofosbuvir og tenofovirdisoproxil anvendes samtidigt.
No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Det bør overvejes at behandle disse patienter, og muligvis forlænge behandlingsvarigheden med sofosbuvir, peginterferon alfa og ribavirin på over 12 uger og op til 24 uger, især for de undergrupper, der har en eller flere faktorer, der historisk er forbundet med lavere responsrater for interferon-baserede behandlinger (tidligere nul-respons til peginterferon alfa og ribavirinbehandling, fremskreden fibrose/cirrose, høje virale koncentrationer ved baseline, sort race, IL28B non CC-genotype).
Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Hvis du har taget for meget Sovaldi
If you take more Sovaldi than you should
PEG+RBV 24 uger (n = 67)
PEG+RBV 24 weeks (n = 67)
Patienter, der har gennemgået en levertransplantation Sikkerhedsprofilen for sofosbuvir og ribavirin hos voksne patienter med kronisk hepatitis C, der har gennemgået en levertransplantation, var sammenlignelig med den observerede sikkerhedsprofil hos patienter, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Ingen dosisjustering af sofosbuvir eller emtricitabin er nødvendig, når sofosbuvir og emtricitabin anvendes samtidigt.
No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly.
SOF+RBV 12 uger (n = 183)
SOF+RBV 12 weeks (n = 183)
Tabel 20: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 1-infektion
Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
• stakåndethed, hoste
• shortness of breath, cough
SOF+RBV 12 uger (n = 103)a
SOF+RBV 12 weeks (n = 103)a