natgillin/translations-raw huggingface dataset:
Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af sofosbuvir i kombination med et andet direkte virkende antiviralt middel (DAA (direct acting antiviral), herunder daclatasvir, simeprevir og ledispavir) samtidig med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another direct-acting antiviral (DAAs, including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone with or without other drugs that lower heart rate.
Tabel 10: SVR12-rater for udvalgte undergrupper efter genotype i POSITRON SOF+RBV 12 uger
Table 10: SVR12 rates for selected subgroups by genotype in POSITRON SOF+RBV 12 weeks
Interferonfri behandling af HCV-genotype 1, 4, 5 og 6-infektion Interferonfrie behandlingsprogrammer for patienter med HCV-genotype 1, 4, 5 og 6-infektion med Sovaldi er ikke blevet undersøgt i fase III-studier (se pkt.
Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Er du i tvivl, så tal med lægen eller apotekspersonalet.
If you are not sure, talk to your doctor or pharmacist.
FISSION var et randomiseret, open-label, aktivt kontrolleret studie, der evaluerede 12 ugers behandling med sofosbuvir og ribavirin, sammenlignet med 24 ugers behandling med peginterferon alfa 2a og ribavirin hos behandlingsnaive patienter med HCV-infektion af genotype 2 eller 3.
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.
De filmovertrukne tabletter er gule, kapselformede tabletter, præget på den ene side med ”GSI” og med ”7977” på den anden side.
What Sovaldi looks like and contents of the pack The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Sikkerheden og den passende dosis af Sovaldi er ikke blevet klarlagt hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] < 30 ml/min/1,73 m2) eller nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse (se pkt.
The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Tabel 1: Anbefalet samtidigt administreret lægemiddel/anbefalede samtidigt administrerede lægemidler og behandlingsvarighed for Sovaldi kombinationsbehandling Patientpopulation
Table 1: Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy
Personerne havde HCV-rna ≥ 104 IE/ml ved screening og dokumenteret evidens for kronisk HCV-infektion inden transplantationen.
Subjects had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic
gennemsnitlige baseline HCV-rna-niveau var 6,4 log10 IE/ml, 21 % havde cirrose, 78 % havde HCVgenotype 3, 65 % havde tidligere recidiv.
level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
12 uger (n = 327)
12 weeks (n = 327)
12 uger (n = 207)
12 weeks (n = 207)
b. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
b. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Sovaldi er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis C (CHC) hos voksne (se pkt.
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Lægemidler, der er moderate P-gp-inducere i tarmen (f.eks. oxcarbazepin og modafinil), kan nedsætte plasmakoncentrationen af sofosbuvir og medføre reduceret terapeutisk virkning af Sovaldi.
Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine and modafinil) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
• Perikon (Hypericum perforatum - et naturlægemiddel, der anvendes til at behandle depression)
• St. John's wort (Hypericum perforatum - herbal medicine used to treat depression);
AUC0-inf for GS-331007 hos personer med ESRD kunne ikke bestemmes på pålidelig vis. Data indikerer imidlertid en mindst 10 gange og 20 gange højere eksponering for GS-331007 hos personer med ESRD, sammenlignet med normale personer, når Sovaldi blev administreret hhv. 1 time før eller 1 time efter hæmodialyse.
However, data indicate at least 10-fold and 20-fold higher exposure to GS-331007 in ESRD compared to normal subjects when Sovaldi was administered 1 hour before or 1 hour after haemodialysis, respectively.
Pædiatrisk population Farmakokinetikken af sofosbuvir og GS-331007 hos pædiatriske personer er ikke klarlagt (se pkt.
The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2).
Patienterne fik 400 mg sofosbuvir og vægtbaseret ribavirin (1.000 mg til patienter, der vejede < 75 kg eller 1.200 mg for patienter, der vejede ≥ 75 kg).
Subjects received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for subjects weighing <75 kg or 1,200 mg for subjects weighing ≥75 kg).
(Methadon vedligeholdelsesbehandli ng [30 til
NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Tabel 15 viser responsrater efter genotype og eksponering overfor tidligere HCV-behandling.
Table 15 presents the response rates by genotype and exposure to prior HCV treatment.
Tabel 4: Bivirkninger identificeret med sofosbuvir i kombination med ribavirin eller peginterferon alfa og ribavirin
Table 4: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Tabel 9 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og placebo.
Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
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 subjects, 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.
Tabel 6: SVR12-rater for udvalgte undergrupper i NEUTRINO SOF+PEG+RBV
Table 6: SVR12 rates for selected subgroups in NEUTRINO SOF+PEG+RBV
Sovaldi tages altid sammen med andre lægemidler (se pkt.
Sovaldi is always taken with other medicines (see section 1 above).
Ingen dosisjustering er nødvendig for patienter med let til moderat nedsat nyrefunktion.
No dose adjustment is required for patients with mild or moderate renal impairment.
Hæmoglobin hos personer med tidligere stabil hjertesygdom
Haemoglobin in subjects with history of stable cardiac disease
Tabel 11 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 16 uger.
Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Tabel 13 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin efter 12 uger og 24 uger.
Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Tabel 16 viser analyse af undergrupper efter genotype for cirrose.
Table 16 presents the subgroup analysis by genotype for cirrhosis.
Almindelig dyspnø, dyspnø under anstrengelse, hoste dyspnø under anstrengelse
Common dyspnoea, dyspnoea exertional, cough dyspnoea exertional Gastrointestinal disorders:
Kliniske studier hos patienter med kronisk hepatitis C med genotype 1, 4, 5 og 6 Behandlingsnaive 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 personer med HCV-infektion af genotype 1, 4, 5 eller 6.
Clinical studies in subjects with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve subjects - 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 subjects with genotype 1, 4, 5 or 6 HCV infection.
NATURMEDICIN Perikon (Hypericum perforatum)
HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af sofosbuvir i kombination med et andet DAA (herunder daclatasvir, simeprevir og ledispavir) samtidig med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another DAA (including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Sovaldi er kontraindiceret sammen med carbamazepin, phenobarbital og phenytoin, potente P-gp-inducere i tarmen (se pkt.
Sovaldi is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
LÆGEMIDLETS NAVN Sovaldi 400 mg filmovertrukne tabletter sofosbuvir
NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets sofosbuvir
Sovaldi + ribavirin + peginterferon alfa 12 ugera, b
Sovaldi + ribavirin + peginterferon alfa 12 weeksa,b
Tabel 16: SVR12-rater for udvalgte undergrupper efter genotype i PHOTON-1-studiet HCV-genotype 2
Table 16: SVR12 rates for selected subgroups by genotype in study PHOTON-1 HCV genotype 2
Tabel 5 viser responsraterne for behandlingsgruppen med sofosbuvir + peginterferon alfa + ribavirin.
Table 5 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Tabel 8: SVR12-rater efter cirrose og genotype i FISSION-studiet Genotype 2
Table 8: SVR12 rates by cirrhosis and genotype in study FISSION
Tabel 7 viser responsraterne for behandlingsgrupperne med sofosbuvir + ribavirin og peginterferon alfa + ribavirin.
Table 7 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Andetc a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
Otherc a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Klinisk virkning og sikkerhed hos specielle populationer 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 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 subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
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 subjects who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
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 subjects with HCV RNA <LLOQ at their last on-treatment assessment.
R-methadon ↔ Cmax 0,99 (0,85; ↔ AUC 1,01 (0,85; ↔ Cmin 0,94 (0,77; 1,14) S-methadon ↔ Cmax 0,95 (0,79; ↔ AUC 0,95 (0,77; ↔ Cmin 0,95 (0,74; 1,22) Sofosbuvir ↓ Cmax 0,95c (0,68; 1,33) ↑ AUC 1,30c (1,00;
R-methadone ↔ Cmax 0.99 (0.85, ↔ AUC 1.01 (0.85, ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, ↔ AUC 0.95 (0.77, ↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, Cmin (NA)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 400 mg sofosbuvir.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of sofosbuvir.
Sovaldi + ribavirin + peginterferon alfa 12 ugerb
Sovaldi + ribavirin + peginterferon alfa 12 weeksb
Tabel 5: Responsrater i NEUTRINO-studiet SOF+PEG+RBV
Table 5: Response rates in study NEUTRINO SOF+PEG+RBV
Tabel 12 viser analyse af undergrupper efter genotype for cirrose og respons på tidligere HCV-behandling.
Table 12 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Lægemidler, der er potente P-gp-inducere i tarmen (rifampicin, rifabutin, perikon, carbamazepin, phenobarbital og phenytoin), kan nedsætte plasmakoncentrationen af sofosbuvir signifikant og medføre reduceret terapeutisk virkning af Sovaldi.
Medicinal products that are potent P-gp inducers in the intestine (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi and thus are contraindicated with Sovaldi (see section 4.3).
Tabel 14: SVR12-rater for udvalgte undergrupper efter genotype i VALENCE-studiet Genotype 2
Table 14: SVR12 rates for selected subgroups by genotype in study VALENCE Genotype 2
Tabel 14 viser analyse af undergrupper efter genotype overfor cirrose og eksponering for tidligere HCV-behandling.
Table 14 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Sikkerhedsprofilen for sofosbuvir og ribavirin hos personer med samtidige HCV/hiv-infektioner var sammenlignelig med den observerede sikkerhedsprofil hos monoinficerede personer 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 subjects was similar to that observed in mono-infected HCV subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Tabel 12: SVR12-rater for udvalgte undergrupper efter genotype i FUSION-studiet Genotype 2
Table 12: SVR12 rates for selected subgroups by genotype in study FUSION Genotype 2
Rilpivirin ↔ Cmax 1,05 (0,97; ↔ AUC 1,06 (1,02; ↔ Cmin 0,99 (0,94; 1,04) Sofosbuvir ↑ Cmax 1,21 (0,90; 1,62) ↔ AUC 1,09 (0,94; Cmin (NA)
Rilpivirine ↔ Cmax 1.05 (0.97, ↔ AUC 1.06 (1.02, ↔ Cmin 0.99 (0.94, 1.04) Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, Cmin (NA)
Behandlingsnaive voksne - FISSION (studie 1231)
Clinical studies in subjects with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Hæmoglobin hos personer uden hjertesygdom
Haemoglobin in subjects with no cardiac disease
Cirrose Nej Ja a. Virkningsanalysen omfatter 3 patienter med rekombinant genotype 2/1 HCV-infektion.
Cirrhosis No Yes a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Ingen dosisjustering af sofosbuvir eller ciclosporin er nødvendig, når sofosbuvir og ciclosporin anvendes samtidigt.
No dose adjustment of sofosbuvir or ciclosporin is required when sofosbuvir and ciclosporin are used concomitantly.
Ingen dosisjustering af sofosbuvir eller tacrolimus er nødvendig, når sofosbuvir og tacrolimus anvendes samtidigt.
No dose adjustment of sofosbuvir or tacrolimus is required when sofosbuvir and tacrolimus are used concomitantly.
• brystsmerter, svaghedsfølelse • forkølelse (nasofaryngitis)
• getting a cold (nasopharyngitis)
Tabel 21 Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 4, 5 og 6-infektion
Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Tabel 11: Responsrater i FUSION-studiet SOF+RBV
Table 11: Response rates in study FUSION SOF+RBV
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 subjects were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
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),
Treated subjects (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA
HIV-ANTIVIRALE STOFFER: HIV-PROTEASEHÆMMERE Darunavir boostet med ritonavirf (800/100 mg én gang dagligt)
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Darunavir ↔ Cmax 0,97 (0,94; ↔ AUC 0,97 (0,94; ↔ Cmin 0,86 (0,78; 0,96) Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92)
Darunavir ↔ Cmax 0.97 (0.94, ↔ AUC 0.97 (0.94, ↔ Cmin 0.86 (0.78, 0.96) Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Sikkerhedsprofilen for sofosbuvir og ribavirin hos personer med HCV-infektion før levertransplantation var sammenlignelig med den observerede sikkerhedsprofil hos personer, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
The safety profile of sofosbuvir and ribavirin in HCV infected subjects prior to liver transplantation was similar to that observed in subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Ingen dosisjustering af sofosbuvir eller tenofovirdisoproxilfumarat er nødvendig, når sofosbuvir og tenofovirdisoproxilfumarat anvendes samtidigt.
No dose adjustment of sofosbuvir or tenofovir disoproxil fumarate is required when sofosbuvir and tenofovir disoproxil fumarate are used concomitantly.
Tabel 9: Responsrater i POSITRON-studiet SOF+RBV
Table 9: Response rates in study POSITRON SOF+RBV
Recidiva
Relapsea
Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir udgjorde sofosbuvir og GS-331007 ca. hhv. 4 %
After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Meget almindelig hovedpine svimmelhed, hovedpine
Nervous system disorders: Very common headache dizziness, headache
Tabel 7: Responsrater i FISSION-studiet SOF+RBV
Table 7: Response rates in study FISSION SOF+RBV
Cirrose Nej
Cirrhosis No
Gilead Sciences s.r.o.
Česká republika Gilead Sciences s.r.o.
Tabel 18: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 1-infektion
Table 18: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
(300 mg én gang dagligt)d
(800/100 mg once daily)
Sofosbuvir ↓ Cmax 0,81 (0,60; 1,10)
Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76,
Uden cirrose
Non-cirrhotic
Samlet SVR12 Genotype 2 Genotype 3 Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidivb Andetc a. Virkningsanalysen omfatter 6 patienter med rekombinant genotype 2/1 HCV-infektion.
Overall SVR12 Genotype 2 Genotype 3 Outcome for subjects without SVR12 On-treatment virologic failure 0/103 Relapse b
Mave-tarm-kanalen: Meget almindelig kvalme diarré, kvalme, opkastning
Very common nausea diarrhoea, nausea, vomiting
Sovaldi er kontraindiceret sammen med rifampicin, en kraftig P-gp-inducer i tarmen (se pkt.
Sovaldi is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Patienter, der har gennemgået en levertransplantation Sikkerhedsprofilen for sofosbuvir og ribavirin hos patienter med kronisk hepatitis C, der har gennemgået en levertransplantation, var sammenlignelig med den observerede sikkerhedsprofil hos personer, der blev behandlet med sofosbuvir og ribavirin i kliniske fase III-studier (se pkt.
The safety profile of sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C was similar to that observed in subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Sovaldi er kontraindiceret sammen med rifabutin, en kraftig P-gp-inducer i tarmen (se pkt.
Sovaldi is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
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 subjects with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve subjects 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 subjects with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve subjects, one in interferon intolerant,
Behandlede patienter (n = 327) havde en gennemsnitsalder på 54 år (interval: 19 til 70), 64 % af patienterne var mænd, 79 % var hvide, 17 % var sorte, 14 % var af spansk eller latinamerikansk herkomst, gennemsnitligt body mass index var 29 kg/m2 (interval: 18 til 56 kg/m2), 78 % havde baseline HCV-rna over 6 log10 IE/ml, 17 % havde cirrose, 89 % havde HCV-genotype 1 og 11 % havde HCV-genotype 4, 5 eller 6.
Treated subjects (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the subjects were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Tabel 20: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 3-infektion
Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Tabel 19: Resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier af HCV-genotype 2-infektion
Table 19: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Samtidig administration af lægemidler, der er potente P-glykoprotein (P-gp)-induktorer i tarmen (rifampicin, rifabutin, perikon [Hypericum perforatum], carbamazepin, phenobarbital og phenytoin) vil nedsætte plasmakoncentrationen af sofosbuvir signifikant og kan medføre manglende virkning af Sovaldi (se pkt.
Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Anden speciel population/andre specielle populationer Samtidig infektion med hiv/HCV
HIV/HCV co-infection
• vægttab
Relapseb