natgillin/translations-raw huggingface dataset:
No liver or heart findings were observed in chronic toxicity studies at exposures 5 times (rat) and 16 times (dog) higher than the clinical exposure.
V študijah kronične toksičnosti pri izpostavljenostih, ki so bile 5-krat (podgana) oz. 16-krat (pes) večje od klinične izpostavljenosti, ni bilo izsledkov na jetrih ali srcu.
Do not take proton pump inhibitors before Harvoni.
Zaviralcev protonske črpalke ne jemljite pred uporabo zdravila Harvoni.
HCV-Negative Subjects
Osebe, negativne za HCV
Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Jedro tablete: kopovidon, laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat,
No dose adjustment of Harvoni or midazolam is required.
Odmerka zdravila Harvoni ali midazolama ni treba prilagajati.
GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or OAT3, or OCT2.
GS-331007 ni substrat za ledvične prenašalce, vključno z prenašalcem organskih anionov (OAT-organic anion transporter) 1,
Close monitoring is recommended if this medicinal product is administered with Harvoni (see sections 4.4 and 4.8).
Kadar se to zdravilo uporablja sočasno z zdravilom Harvoni, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Po enkratnem 400-miligramskem odmerku [14C]-sofosbuvirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi približno
Among post-transplant patients with compensated liver disease or patients with decompensated liver disease either pre- or post-transplant (SOLAR-1 and SOLAR-2 studies), relapse was associated with the detection of one or more of the following NS5A RAVs: K24R, M28T, Q30R/H/K, L31V, H58D and Y93H/C in 12/14 genotype 1a patients, and L31M, Y93H/N in 6/6 genotype 1b patients.
Pri bolnikih s kompenzirano jetrno boleznijo po presaditvi ali bolnikih z dekompenzirano jetrno boleznijo tako pred presaditvijo kot po njej (študiji SOLAR-1 in SOLAR-2) je bil relaps povezan z zaznavo enega ali več naslednjih RAV NS5A: K24R, M28T, Q30R/H/K, L31V, H58D in Y93H/C
HCV-Infected Subjects
Osebe, okužene s HCV
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Harvoni.
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Harvoni,
Yes a One patient was excluded from the LDV/SOF 12-week treatment arm and one patient was excluded from the
Ne Da a. En bolnik iz skupine 12-tedenskega zdravljenja z LDV/SOF in en bolnik iz skupine 24-tedenskega zdravljenja z
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.
ION-4 je bila odprta klinična študija, ki je ocenjevala varnost in učinkovitost 12-tedenskega zdravljenja z ledipasvirjem/sofosbuvirjem brez ribavirina pri predhodno nezdravljenih in zdravljenih bolnikih s HCV s CHC genotipa 1 ali 4, ki so imeli sočasno okužbo z virusom HIV-1.
The physician in charge of the diabetic care of the patient should be informed when direct-acting antiviral therapy is initiated.
O začetku zdravljenja z neposredno delujočim protivirusnim zdravilom je treba obvestiti zdravnika, odgovornega za zdravljenje sladkorne bolezni pri zadevnem bolniku.
SEDATIVES/HYPNOTICS Midazolam (2.5 mg single dose)/ ledipasvir (90 mg single dose)
Midazolam (2,5 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)
No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir.
V študijah razvojne toksičnosti z ledipasvirjem pri podganah in kuncih niso opazili teratogenih učinkov.
No liver or heart findings were observed in the 2-year carcinogenicity studies at exposures 17 times (mouse) and 9 times (rat) higher than the clinical exposure.
V 2-letnih študijah kancerogenosti pri izpostavljenostih, ki so bile 17-krat (miš) oz. 9-krat (podgana) večje od klinične izpostavljenosti, ni bilo izsledkov na jetrih ali srcu.
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z neposredno delujočim protivirusnim zdravilom izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
AUC, Cmax, Cmina, b
Povprečno razmerje (90-odstotni interval zaupanja) za AUC, Cmax, Cmina,b
The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis.
Mediana starosti je bila 52 let (razpon: od 26 do 72); 82 % bolnikov je bilo moškega spola; 61 % jih je bilo belcev, 34 % jih je bilo črncev; 75 % jih je imelo okužbo HCV genotipa 1a; 2 % jih je imelo okužbo genotipa 4; 76 % jih je imelo alele IL28B ne-CC (CT ali TT) in 20 % jih je imelo kompenzirano cirozo.
Ledipasvir/sofosbuvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Ledipasvir/sofosbuvir so 12 tednov dajali v odprti študiji (študija 0154) 18 bolnikom s CHC genotipa 1 in hudo ledvično okvaro.
The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV virus.
Spremembe v jetrih med zdravljenjem z neposredno delujočim protivirusnim zdravilom lahko vplivajo na farmakokinetiko zdravil, ki se presnavljajo v jetrih (npr. imunosupresivi, kot so zaviralci kalcinevrina), zaradi očistka virusa HCV.
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.
Sprememba rezultata in stopnje CPT: Med tistimi, ki so z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem in ribavirinom dosegli SVR12, jih je 60 % (74/123) oziroma 34 % (42/123) od izhodišča do 12. tedna po zdravljenju izboljšalo rezultat CPT oziroma imelo nespremenjen rezultat CPT; od 32 bolnikov, ki so ob izhodišču imeli cirozo CPT C, jih je 53 % (17/32) v 12. tednu po zdravljenju imelo cirozo CPT B; od 88 bolnikov, ki so ob izhodišču imeli cirozo CPT B, jih je 25 % (22/88) v 12. tednu po zdravljenju imelo cirozo CPT A. Izboljšanje rezultatov CPT je bilo večinoma posledica izboljšanja skupne ravni bilirubina in albumina.
LDV/SOF+RBV 24 weeks
LDV/SOF+RBV 24 tednov
The table is not all-inclusive.
Preglednica ne vključuje vseh možnih interakcij.
b The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
b. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
Co-administration of Harvoni with pravastatin may significantly increase the concentration of pravastatin which is associated with increased risk of myopathy.
Sočasno dajanje zdravila Harvoni s pravastatinom lahko značilno poveča koncentracijo pravastatina, kar je povezano z večjim tveganjem za miopatijo.
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
Študija 4063 je bila odprta klinična študija s tremi skupinami, v kateri so ocenili 8-, 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem pri skupaj 95 bolnikih s CHC z genotipom 1 (72 %), 2 (22 %), 4 (2 %), 5 (1 %) ali 6 (2 %) in ESRD, zaradi katere je potrebna dializa: 45 predhodno nezdravljenih bolnikov, okuženih s HCV genotipa 1, brez ciroze, je 8 tednov prejemalo ledipasvir/sofosbuvir; 31 predhodno zdravljenih bolnikov, okuženih s HCV genotipa 1, in predhodno nezdravljenih ali predhodno zdravljenih bolnikov z okužbo z genotipom 2, 5 in 6 brez ciroze je 12 tednov prejemalo ledipasvir/sofosbuvir; in 19 bolnikov, okuženih s HCV genotipa 1, 2 in 4, s kompenzirano cirozo je 24 tednov prejemalo ledipasvir/sofosbuvir.
(Increase in gastric pH)
(povečanje vrednosti pH v želodcu)
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;
Od skupaj 95 bolnikov je imelo ob izhodišču 20 % bolnikov cirozo, 22 % se jih je predhodno zdravilo, 21 % jih je imelo presaditev ledvic, 92 % jih je bilo na hemodializi in 8 % jih je bilo na peritonealni dializi; povprečno trajanje dialize je bilo 11,5 leta (razpon: od 0,2 do 43,0 let).
Such patients may therefore be dependent on other classes of medicinal products for clearance of HCV infection.
Takšni bolniki bodo morda odvisni od drugih razredov zdravil za odpravljanje okužbe s HCV. Posledično je treba razmisliti o dolgotrajnejšem zdravljenju pri bolnikih z negotovimi možnostmi naknadnega ponovnega zdravljenja.
Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values
Preglednica 4: Smernice za prilagajanje odmerka ribavirina pri sočasnem dajanju z zdravilom Harvoni odraslim bolnikom
24 weeks (n = 111)
24 tednov (n = 111)
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Harvoni.
Po začetku jemanja zdravila Harvoni morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
Your doctor may give you a different medicine or adjust the dose of the medicine you are taking;
Vaš zdravnik vam lahko predpiše drugo zdravilo ali prilagodi odmerek zdravila, ki ga že jemljete,
- Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients (see section 5.1, ION-3 study).
- O 8 tednih zdravila Harvoni je možno razmisliti pri predhodno nezdravljenih bolnikih, okuženih z genotipom 1
Famotidine dosed simultaneously with Harvonid
Famotidin uporabljen sočasno z zdravilom
8 weeks (n = 215)
8 tednov (n = 215)
It is recommended to separate antacid and Harvoni administration by 4 hours.
Priporoča se, da med uporabo antacida in zdravila Harvoni minejo 4 ure.
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ sofosbuvir (400 mg enkrat na dan)d
Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
AUC0-24 in Cmax za ledipasvir pri bolnikih, okuženih s HCV, za 24 % oz. 32 % manjši.
≥ 2 g/dL decrease in haemoglobin during any 4-week treatment period
Hemoglobin pri bolnikih s stabilno boleznijo srca v anamnezi zmanjšanje hemoglobina za ≥ 2 g/dl v 4-tedenskem obdobju zdravljenja
The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
bolnikov, ki so 8, 12 oz. 24 tednov prejemali ledipasvir/sofosbuvir, in < 1 %, 0 % oz. 2 % bolnikov, ki so 8, 12 oz. 24 tednov prejemali kombinirano terapijo z ledipasvirjem/sofosbuvirjem + ribavirinom.
No dose adjustment of Harvoni or methadone is required.
Odmerka zdravila Harvoni ali metadona ni treba prilagajati.
No dose adjustment of Harvoni or ciclosporin is required at initiation of co-administration.
Odmerka zdravila Harvoni ali ciklosporina ni treba prilagajati ob uvedbi sočasnega dajanja.
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Harvoni.
Pri sočasni uporabi z zdravilom Harvoni je potrebna previdnost, priporoča se tudi spremljanje terapevtske koncentracije digoksina.
In a pooled analysis of patients who received ledipasvir/sofosbuvir in Phase 3 studies (ION-3, ION-1 and ION-2), 37 patients (29 with genotype 1a and 8 with genotype 1b) qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA > 1,000 IU/mL.
ION-2), je bilo 37 bolnikov (29 z genotipom 1a in 8 z genotipom 1b) primernih za analizo odpornosti zaradi virološkega neuspeha ali predčasne prekinitve uporabe preiskovanega zdravila in zaradi HCV RNA > 1.000 i.e./ml.
Forty patients with genotype 4 CHC were enrolled in SOLAR-1 and SOLAR-2 studies, SVR12 were 92% (11/12) and 100% (10/10) in post-transplant patients without decompensated cirrhosis and 60% (6/10) and 75% (6/8) in patients with decompensated cirrhosis (pre- and post-liver transplantation) treated for 12 or 24 weeks, respectively.
V študijah SOLAR-1 in SOLAR-2 je bilo vključenih štirideset bolnikov s CHC genotipa 4, SVR12 sta bila 92 % (11/12) in 100 % (10/10) pri bolnikih brez dekompenzirane ciroze pred presaditvijo ter 60 %
and <50 mL/min/1.73 m2)
min/1,73 m2)
d Patients with missing cirrhosis status were excluded from this subgroup analysis.
d. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
b Patients with missing cirrhosis status were excluded from this subgroup analysis.
b. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
↑ Rosuvastatin (Inhibition of drug transporters OATP and BCRP)
(zaviranje prenašalcev OATP in BCRP)
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d
UČINKOVINE ZA ZDRAVLJENJE INFEKCIJ Z MIKOBAKTERIJAMI Rifampicin (600 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)d
c Patients with missing cirrhosis status were excluded from this subgroup analysis.
c. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
Genotype 4d 0.60 Genotype 5a
15b genotip 3a genotip 4a genotip 4d genotip 5a
The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir,relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in < 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro
12 weeks (n = 111)
12 tednov (n = 111)
a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration.
Odmerka zdravila Harvoni ali takrolimusa ni treba prilagajati ob uvedbi sočasnega dajanja.
NS5A resistance-associated variants (RAVs) were observed in post-baseline isolates from 29/37 patients (22/29 genotype 1a and 7/8 genotype 1b) not achieving sustained virologic response (SVR).
V izolatih po izhodišču 29 od 37 bolnikov (22/29 z genotipom 1a in 7/8 z genotipom 1b), ki niso dosegli trajnega virološkega odziva (SVR-sustained virologic response), so opazili z odpornostjo povezane različice (RAV-resistance-associated variants) NS5A..
The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Farmakokinetiko ledipasvirja so preučili z enkratnim 90-miligramskim odmerkom ledipasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi Cockcroft-Gault,
Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3).
Zdravilo Harvoni je kontraindicirano sfenobarbitalom in fenitoinom (glejte poglavje 4.3).
Dosed 1 hr After Dialysis
1 uro po dializi
A total of 2 out of 100 patients (2%), both treatment- naïve, did not achieve SVR12 (due to loss to follow-up).
Skupaj 2 od 100 bolnikov (2 %), oba predhodno nezdravljena,
24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
a. Ti 4 bolniki brez ciroze z relapsom so imeli izhodiščne z odpornostjo povezane polimorfizme NS5A.
The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Substitucije S282T, povezane z odpornostjo na sofosbuvir, niso v izhodiščnem zaporedju NS5B odkrili pri nobenem bolniku v študijah 3. faze s karakterizacijo nukleotidnih sledi genoma ali karakterizacijo strukture genoma.
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.
Po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem (brez ribavirina) so SVR dosegli 4 od 4 bolnikov med predhodno zdravljenimi bolniki (skupina 1 v študiji ION-2) z izhodiščnimi RAV NS5A, ki so doprinesle k ≤ 100-krat spremembi dovzetnosti za ledipasvir.
Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Harvoni s tipranavirjem (okrepljenim z ritonavirjem) zmanjšalo koncentracijo ledipasvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
No dose adjustment of Harvoni is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (stopnja A, B ali C po Child-Pugh-Turcotteu
If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
Če ste v zvezi s katerimi drugimi zdravili negotovi, se posvetujte z zdravnikom ali farmacevtom.
Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5).
Sočasna uporaba teh zdravil z zdravilom Harvoni ni priporočljiva (glejte poglavje 4.5).
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.
SOLAR-1 in SOLAR-2 sta bili dve odprti klinični študiji, v katerih so ocenili 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem v kombinaciji z ribavirinom pri s HCV okuženih bolnikih z genotipoma 1 in 4, ki so imeli presaditev jeter in/ali imajo dekompenzirano jetrno bolezen.
Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Preglednica 10: Stopnje relapsov glede na izhodiščne značilnosti v študiji ION-3, populacija bolnikov z virološkim neuspehom*
When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Pri sočasni uporabi z dizoproksiltenofoviratom fumaratom v povezavi z atazanavirjem/ritonavirjem je zdravilo Harvoni povečalo koncentracijo tenofovirja.
H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Antagonisti receptorjev H2 Famotidin (40 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
If you take Harvoni you may get one or more of the side effects below:
Če jemljete zdravilo Harvoni, boste morda dobili enega ali več spodaj navedenih neželenih učinkov: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Outcome for patients without SVR On-treatment virologic failure Relapseb Otherc SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
Bolniki s cirozo Predhodno zdravljeni bolniki s cirozo a. 8 bolnikov z okužbo HCV genotipa 4 je bilo vključenih v študijo, pri čemer jih je 8/8 doseglo SVR12.
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”).
za izbrane podskupine (glejte tudi prejšnje poglavje "Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja").
24 weeks (n = 217)
24 tednov (n = 217)
EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
c. V analizo (s karakterizacijo strukture genoma) so bili vključeni polimorfizmi NS5A, povezani z odpornostjo, ki so doprinesli k > 2,5-kratni spremembi vrednosti EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T in Y93C/F/H/N/S za okužbo s HCV genotipa 1a in L31I/F/M/V, P32L, P58D, A92K in Y93C/H/N/S za okužbo s HCV genotipa 1b).
Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy.
Mediana starost 670 zdravljenih bolnikov je bila 59 let (razpon: 21 do 81 let); 77 % bolnikov je bilo moškega spola; 91 % je bilo belcev; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 18 do 49 kg/m2);
Genotype 1b
Genotip 1 Genotip 1b
Atazanavir ↔ Cmax 1.07 (1.00, 1.15) ↔ AUC 1.33 (1.25, 1.42) ↑ Cmin 1.75 (1.58, 1.93)
↔ Cmax 1,07 (1,00; 1,15) ↔ AUC 1,33 (1,25; 1,42) ↑ Cmin 1,75 (1,58; 1,93)
The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side.
»GSI« na eni in »7985« na drugi strani.
Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side.
Oranžne, filmsko obložene tablete v obliki romba z merami 19 mm x 10 mm, z vtisnjeno oznako
Breast-feeding Do not breast-feed during treatment with Harvoni.
Med zdravljenjem z zdravilom Harvoni ne smete dojiti.
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.
Študija ION-2 je bila randomizirana, odprta študija, v kateri so ocenjevali 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega (randomizirane v razmerju 1:1:1:1) pri bolnikih, okuženih s HCV genotipa 1 s cirozo ali brez nje, pri katerih predhodno zdravljenje na podlagi interferona, vključno z režimi, ki so vključevali zaviralca proteaze HCV, ni bilo uspešno.
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
• rifampicin in rifabutin (antibiotika, ki se uporabljata za zdravljenje okužb, vključno s tuberkulozo),
12 weeks (n = 214)
12 tednov (n = 214)