natgillin/translations-raw huggingface dataset:
Ledipasvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse med lymfocytter fra humant perifert blod og in vivo mikronukleusanalyser hos rotter.
Ledipasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Demografi og baselinekarakteristika var afbalanceret på tværs af behandlingsgrupperne.
Demographics and baseline characteristics were balanced across the treatment groups.
Derfor må Harvoni ikke anvendes under amning.
Therefore, Harvoni should not be used during breast-feeding.
• ydre kartoner indeholdende 3 tabletbeholdere med 28 (84) filmovertrukne tabletter.
• outer cartons containing 3 bottles of 28 (84) film-coated tablets.
Sofosbuvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse med lymfocytter fra humant perifert blod og in vivo mikronukleusanalyser hos mus.
Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes race, for ledipasvir, sofosbuvir eller GS-331007.
No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
(Øget pH-værdi i maven)
(Increase in gastric pH)
Tidligere HCV-behandling PEG-IFN+RBV HCV-proteasehæmmer + PEG-IFN+RBV
Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Harvoni kan anvendes hos disse patienter uden dosisjustering, når ingen andre relevante behandlingsmuligheder er tilgængelige (se pkt.
Harvoni can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Administration af Harvoni sammen med rosuvastatin er kontraindiceret (se pkt.
Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).
Patienter, der venter på levertransplantation og efter levertransplantation - SOLAR-1 og SOLAR-2 SOLAR-1 og SOLAR-2 var to åbne kliniske studier, der evaluerede 12 og 24 ugers behandling med ledipasvir/sofosbuvir i kombination med ribavirin hos patienter med genotype 1 og 4 HCV-infektion, der har gennemgået en levertransplantation, og/eller som har dekompenseret leversygdom.
Patients awaiting liver transplantation and post-liver transplant - SOLAR-1 and SOLAR-2 SOLAR-1 and SOLAR-2 were two open-label clinical studies that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir in combination with ribavirin in genotype 1 and 4 HCV-infected patients who have undergone liver transplantation and/or who have decompensated liver disease.
Efter en enkelt 400 mg dosis af [14C]-sofosbuvir hos raske personer, var forholdet af [14C]-radioaktivitet mellem blod og plasma ca. 0,7.
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes køn, for sofosbuvir eller GS-331007.
No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007.
De tre fase 3-studier omfattede et studie udført hos behandlingsnaive patienter uden cirrose (ION-3), et studie med behandlingsnaive patienter med og uden cirrose (ION-1) og et studie med patienter med og uden cirrose, hvor tidligere behandling med et interferon-baseret regime har svigtet, herunder regimer, der indeholder en HCV-proteasehæmmer (ION-2).
The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an
I studie 1118 blev 44 patienter med genotype 1-infektion, herunder 12 patienter med cirrose, hvor behandling med sofosbuvir + ribavirin + PEG-IFN eller med sofosbuvir + ribavirin tidligere havde svigtet, behandlet med ledipasvir/sofosbuvir + ribavirin i 12 uger.
In study 1118, 44 patients with genotype 1 infection, including 12 cirrhotic patients, who had previously failed treatment with sofosbuvir + ribavirin + PEG-IFN or with sofosbuvir + ribavirin were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks; the SVR was 100% (44/44).
CPT klasse B eller C cirrose efter transplantation
CPT Class C cirrhosis pre-transplant CPT Class B or C cirrhosis posttransplant
Tabel 10: Recidivrater pr. baselinekarakteristika i ION-3-studiet, population med virologisk svigt* LDV/SOF
Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Hos behandlingserfarne patienter havde tidligere behandling med PEG-IFN + ribavirin ± en HCV-proteasehæmmer eller sofosbuvir + ribavirin ± PEG-IFN svigtet.
Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
Tabel 15 viser recidivrater med det 12-ugers regime (med eller uden ribavirin) for udvalgte undergrupper (se også tidligere pkt.
Table 15 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”).
Kan ikke fortolkes a. En patient i behandlingsarmen med 24 ugers LDV/SOF og en patient i behandlingsarmen med 24 ugers LDV/SOV+RBV havde oplevet svigt af en tidligere behandling med et non-pegyleret interferonbaseret regimen.
a One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon-based regimen.
• tenofovirdisoproxilfumarat eller andre lægemidler, der indeholder tenofovirdisoproxilfumarat, anvendes til at behandle hiv-infektion;
• tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate,
De kliniske studier inkluderede patienter med eller uden cirrose, som var behandlingsnaive, eller som tidligere havde oplevet behandlingssvigt efter behandling med PEG-IFN + ribavirin +/- en HCVproteasehæmmer.
The clinical studies enrolled patients with or without cirrhosis, who were treatment-naïve or with prior treatment failure after therapy with PEG-IFN + ribavirin +/- an HCV protease inhibitor.
Der blev ikke observeret udtalte forskelle mellem resultaterne afhængigt af, om baselineNS5A-RAVs var til stede eller ikke til stede.
No major differences in outcomes were observed by the presence or absence of baseline NS5A RAVs.
Administration af Harvoni sammen med pravastatin kan forhøje koncentrationen af pravastatin signifikant, hvilket er forbundet med en øget risiko for myopati.
Co-administration of Harvoni with pravastatin may significantly increase the concentration of pravastatin which is associated with increased risk of myopathy.
ION-3 evaluerede 8 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin, og 12 ugers behandling med ledipasvir/sofosbuvir hos behandlingsnaive patienter uden cirrose med CHC forårsaget af infektion med HCV af genotype 1 CHC.
ION-3 evaluated 8 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin and 12 weeks of treatment with ledipasvir/sofosbuvir in treatment-naïve non-cirrhotic patients with genotype 1 CHC.
Indeholder lactose og sunset yellow FCF aluminiumpigment (E110).
Contains lactose and sunset yellow FCF aluminium lake (E110).
Gruppen af NS5A-RAVs, der gav >100 gange skift og som blev observeret hos patienterne, omfattede de følgende substitutioner i genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) eller i genotype 1b (Y93H).
The group of NS5A RAVs that conferred > 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H).
Randomisering blev stratificeret efter cirrose (til stede eller ikke til stede), HCV-genotype (1a versus 1b) og respons på tidligere HCV-behandling (recidiv/gennembrud versus non-respons).
Randomisation was stratified by the presence or absence of cirrhosis, HCV genotype (1a versus 1b) and response to prior HCV therapy (relapse/breakthrough versus non-response).
Blandt patienter med dekompenseret leversygdom (før og efter transplantation) recidiverede 4/16 (25 %) patienter med NS5A RAV'er, der gav en > 100 gange større resistens efter 12 ugers behandling med ledipasvir/sofosbuvir + ribavirin sammenlignet med 7/120 (6 %) patienter uden baseline-NS5A RAV'er eller RAV'er, der gav en ≤ 100 gange større ændring.
Among patients with decompensated liver disease (pre- and posttransplant), 4/16 (25%) patients with NS5A RAVs conferring > 100-fold resistance relapsed after 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin compared to 7/120 (6%) in those without any baseline NS5A RAVs or RAVs conferring a fold-change of ≤ 100.
(Hæmning af lægemiddeltransporterne OATP og BCRP)
↑ Rosuvastatin (Inhibition of drug transporters OATP and BCRP)
Doseret 1 time før dialyse
Dosed 1 hr Before Dialysis
↔ GS-331007 (Øget pH-værdi i maven)
↔ GS-331007 (Increase in gastric pH)
Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) og ESRD, der kræver hæmodialyse.
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Studie 0154 var et ikke-blindet studie, der evaluerede sikkerheden og virkningen af 12 ugers behandling med ledipasvir/sofosbuvir hos 18 genotype 1 HCV-inficerede patienter med svært nedsat nyrefunktion, der ikke krævede dialyse.
Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis.
Tabel 4: Retningslinjer for dosismodifikation af ribavirin ved samtidig administration af Harvoni hos voksne
Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values
Ændring i MELD-score (model for end stage liver disease): Blandt dem, som opnåede SVR12 med 12 ugers behandling med ledipasvir/sofosbuvir + ribavirin, havde hhv. 57 % (70/123) og 19 % (23/123) en forbedring eller ingen ændring i MELD-score fra baseline til 12 uger efter behandling; af de 32 patienter, hvis MELD-score var ≥ 15 ved baseline, havde 59 % (19/32) en MELD-score < 15 ved uge 12 efter behandlingen.
Change in MELD score: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir + ribavirin, 57% (70/123) and 19% (23/123) had an improvement or no change in MELD score from baseline to post-treatment week 12, respectively; of the 32 patients whose MELD score was ≥ 15 at baseline, 59% (19/32) had a MELD score < 15 at post-treatment Week 12.
Randomisering blev stratificeret efter cirrose (til stede eller ikke til stede) og HCV-genotype (1a versus 1b).
Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Ingen dosisjustering af Harvoni eller raltegravir er nødvendig.
No dose adjustment of Harvoni or raltegravir is required.
• carbamazepin, phenobarbital og phenytoin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); • rosuvastatin (a medicine used to treat high cholesterol).
Der er aktuelt ingen data, der støtter virkningen af genbehandling med et efterfølgende regime, som indholder en NS5A-hæmmer hos patienter, hvor ledipasvir/sofosbuvir har svigtet.
There are presently no data to support the effectiveness of retreatment of patients who have failed ledipasvir/sofosbuvir with a subsequent regimen that contains an NS5A inhibitor.
Manglende dosis
Missed dose
12 uger (n = 109)
12 weeks (n = 109)
NS5B RAVs: NS5B-substitutionen S282T opstod i HCV hos 1/17 genotype 3-svigt, og i HCV hos henh.
NS5B RAVs: The NS5B substitution S282T emerged in the HCV of 1/17 genotype 3-failures, and in the HCV of 1/3, 1/1 and 1/1 of genotype 4-, 5- and 6-failures, respectively.
Tæt overvågning anbefales, hvis dette lægemiddel administreres med Harvoni (se pkt.
Close monitoring is recommended if this medicinal product is administered with Harvoni (see sections 4.4 and 4.8).
Ændring i CPT-score og klasse: Blandt patienter, som opnåede SVR12 med 12 ugers behandling med ledipasvir/sofosbuvir med ribavirin, havde hhv. 60 % (74/123) og 34 % (42/123) en forbedring eller ingen ændring af CPT-scorer fra baseline til uge 12 efter behandlingen; af de 32 patienter, som havde CPT C cirrose ved baseline, havde 53 % (17/32) CPT B cirrose ved uge 12 efter behandlingen; af de 88 patienter, som havde CPT B cirrose ved baseline, havde 25 % (22/88) CPT A cirrose ved uge 12 efter behandlingen.
Change in CPT score and class: Among those who achieved SVR12 with 12 weeks treatment with ledipasvir/sofosbuvir with ribavirin, 60% (74/123) and 34% (42/123) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 32 patients who had CPT C cirrhosis at baseline, 53% (17/32) had CPT B cirrhosis at post-treatment Week 12; of the 88 patients who had CPT B cirrhosis at baseline, 25% (22/88) had CPT A cirrhosis at post-treatment Week 12.
Substitutionen S282T i NS5B, som er forbundet med resistens over for sofosbuvir, blev ikke detekteret i noget isolat fra virologisk svigt fra fase 3-studier.
The sofosbuvir resistance-associated substitution S282T in NS5B was not detected in any virologic failure isolate from the Phase 3 studies.
Efter 12 ugers behandling med ledipasvir/sofosbuvir sammen med ribavirin hos behandlingserfarne patienter med kompenseret cirrose (SIRIUS, n = 77) opnåede 8/8 patienter med NS5A-RAVs ved baseline, der gav >100 gange nedsat følsomhed for ledipasvir, SVR12.
Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12.
FCH = fibroserende kolestatisk hepatitis.
c CPT = Child-Pugh-Turcotte, FCH = Fibrosing cholestatic hepatitis.
Harvoni indeholder sunset yellow FCF aluminiumpigment (E110), som kan forårsage allergiske reaktioner
Harvoni contains sunset yellow FCF aluminium lake (E110) which can cause allergic reactions
Ved niveauet for ingen observeret virkning, var AUC-eksponeringen over for ledipasvir hhv. ca. 7 og 3 gange større, hos hanog hunrotter, end den humane eksponering ved den anbefalede kliniske dosis.
At the no observed effect level, AUC exposure to ledipasvir was approximately 7- and 3-fold, in males and females, respectively, the human exposure at the recommended clinical dose.
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.
Samtidig administration af lægemidler, der hæmmer P-gp og/eller BCRP, kan øge plasmakoncentrationerne af ledipasvir og sofosbuvir uden at øge plasmakoncentrationen af GS-331007.
Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors.
Tabel 11: Demografi og baselinekarakteristika i studie ION-1 Patientdisposition
Table 11: Demographics and baseline characteristics in study ION-1 Patient disposition
Tabel 8: Demografi og baselinekarakteristika i studie ION-3 Patientdisposition
Table 8: Demographics and baseline characteristics in study ION-3 Patient disposition
Methadon (Methadon vedligeholdelsesbehandling [30 til 130 mg/dagligt])/ sofosbuvir (400 mg én gang dagligt)d
Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Ingen dosisjustering af Harvoni eller abacavir/ lamivudin er nødvendig.
No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Svært RI (eGFR <30 ml/ min/ 1,73 m2)
Severe RI (eGFR <30 mL/min/1.73 m2)
Der blev ikke observeret nogen teratogen virkning i udviklings-toksicitetsstudier med ledipasvir hos rotter og kaniner.
No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir.
Studie 4063 var et åbent klinisk studie med tre grupper, som evaluerede 8, 12 og 24 ugers behandling med ledipasvir/sofosbuvir hos i alt 95 patienter med genotype 1 (72 %), 2 (22 %), 4 (2 %), 5 (1 %) eller 6 (2 %) CHC og ESRD, der krævede dialyse: 45 behandlingsnaive genotype 1 HCV-inficerede patienter uden cirrose fik ledipasvir/sofosbuvir i 8 uger; 31 behandlingserfarne genotype 1 HCVinficerede patienter, og behandlingsnaive eller behandlingserfarne patienter med genotype 2, 5 og 6 infektion uden cirrose fik ledipasvir/sofosbuvir i 12 uger; og 19 genotype 1, 2 og 4 HCV-inficerede patienter med kompenseret cirrose fik ledipasvir/sofosbuvir i 24 uger.
Study 4063 was an open-label three-arm clinical study that evaluated 8, 12, and 24 weeks of treatment with ledipasvir/sofosbuvir in a total of 95 patients with genotype 1 (72%), 2 (22%), 4 (2%), 5 (1%), or 6 (2%) CHC and ESRD requiring dialysis: 45 treatment-naïve genotype 1 HCV-infected patients without cirrhosis received ledipasvir/sofosbuvir for 8 weeks; 31 treatment-experienced genotype 1
Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) og nyresygdom i slutstadiet (ESRD, end stage renal disease), der kræver dialyse.
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring dialysis.
Lægemidler, der er moderate P-gp-inducere i tarmen (f.eks. oxcarbazepin), kan nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir og medføre reduceret terapeutisk virkning af Harvoni.
Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni.
Doseret 1 time efter dialyse
Dosed 1 hr After Dialysis
Ingen dosisjustering af Harvoni eller midazolam er påkrævet.
No dose adjustment of Harvoni or midazolam is required.
Omeprazol doseret sammen med Harvoni
Omeprazole dosed simultaneously with Harvoni
LDV/SOF+RBV 24 uger (n = 307)a,b
LDV/SOF+RBV 24 weeks (n = 307)a,b
For en sikkerheds skyld bør Harvoni undgås under graviditeten.
As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy.
Ingen dosisjustering af Harvoni eller darunavir (ritonavir-boostet) er nødvendig.
No dose adjustment of Harvoni or darunavir (ritonavir boosted) is required.
Efter 12 ugers behandling med ledipasvir/sofosbuvir (uden ribavirin) hos behandlingserfarne patienter (arm 1 af ION-2-studiet) opnåede 4/4 patienter SVR med baseline-NS5A-RAVs, der gav ≤100 gange mindre ændring af ledipasvir.
Following 12 weeks of treatment with ledipasvir/sofosbuvir (without ribavirin) in treatmentexperienced patients (arm 1 of ION-2 study) 4/4 patients with baseline NS5A RAVs conferring a ledipasvir fold-change of ≤ 100 achieved SVR.
Samtidig brug med HMG-CoA reductasehæmmere
Use with HMG-CoA reductase inhibitors
Medianalderen var 56 år (interval 23 til 77), 74 % af patienterne var mænd, 97 % var hvide, 63 % havde genotype 1a HCV-infektion, 94 % havde non-CC IL28B-alleller (CT eller TT).
The median age was 56 years (range: 23 to 77); 74% of patients were male; 97% were white; 63% had genotype 1a HCV infection; 94% had non-CC IL28B alleles (CT or TT).
Harvoni indeholder azo-farvestoffet sunset yellow FCF aluminiumpigment (E110), som kan forårsage allergiske reaktioner.
Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Ud af de i alt 95 patienter havde ved baseline 20 % af patienterne cirrose, 22 % var behandlingserfarne, 21 % havde fået foretaget en nyretransplantation, 92 % var i hæmodialyse, og 8 % var i peritoneal dialyse; den gennemsnitlige varighed i dialyse var 11,5 år (interval: 0,2 til 43,0 år).
Of the 95 total patients, at baseline, 20% of patients had cirrhosis, 22% were treatment experienced, 21% had received a kidney transplant, 92% were on hemodialysis, and 8% were on peritoneal dialysis;
Tidligere behandlede voksne med eller uden cirrose - ION-2 (studie 0109) - genotype 1 ION-2 var et randomiseret, åbent studie, der evaluerede 12 og 24 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin (randomiseret 1:1:1:1) hos genotype 1 HCV-inficerede patienter med eller uden cirrose, hvor tidligere behandling med et interferon-baseret regime svigtede, herunder regimer, hvor der indgik en HCV-proteasehæmmer.
Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Blandt de 100 behandlede patienter var medianalderen 15 år (interval: 12 til 17); 63 % af patienterne var kvinder; 90 % var hvide, 7 % var sorte og 2 % var asiatere; 13 % var latinamerikanere; den gennemsnitlige kropsvægt var 61,3 kg (interval: 33,0 til 126,0 kg; 55 % havde baseline HCV RNA-niveauer større end eller lig med 800.000 IU/ml; 81 % havde genotype 1a HCV-infektion; 76 % havde non-CC IL28B-alleller (CT eller TT) og 1 % havde kendt cirrose.
Of the 100 treated patients, the median age was 15 years (range: 12 to 17); 63% of the patients were female; 90% were White, 7% were Black, and 2% were Asian; 13% were Hispanic/Latino; mean weight was 61.3 kg (range: 33.0 to 126.0 kg); 55% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 81% had genotype 1a HCV infection; 76% had non-CC IL28B alleles (CT or TT) and 1% had known cirrhosis.
Virkningen af ledipasvir/sofosbuvir hos patienter, hvor behandling med sofosbuvir + ribavirin ± PEG-IFN svigtede, understøttes af to kliniske studier.
Previously treated adults who have failed on sofosbuvir + ribavirin ± PEG-IFN The efficacy of ledipasvir/sofosbuvir in patients who had previously failed treatment with sofosbuvir + ribavirin ± PEG-IFN is supported by two clinical studies.
ION-4 var et åbent klinisk studie, der evaluerede sikkerhed og virkning af 12 ugers behandling med ledipasvir/sofosbuvir uden ribavirin hos HCV-behandlingsnaive og -behandlingserfarne patienter med genotype 1- eller 4-CHC med samtidig hiv 1-infektion.
ION-4 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir without ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 or 4 CHC who were co-infected with HIV-1.
ORALE ANTIKONTRACEPTIVA Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ ledipasvir (90 mg én gang dagligt)d
ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
Brug af anden medicin sammen med Harvoni
Other medicines and Harvoni