natgillin/translations-raw huggingface dataset:
Breast-feeding It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Ni znano, ali se ledipasvir ali sofosbuvir in njegovi presnovki izločajo v materino mleko.
Table 16: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Preglednica 16: Stopnje odziva (SVR12) z 12-tedenskim dajanjem ledipasvirja/sofosbuvirja bolnikom z okužbo s HCV z genotipom 2, 4, 5 in 6
Table 3: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Preglednica 3: Interakcije med zdravilom Harvoniin drugimi zdravili Zdravila po terapevtskih področjih
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110)
Filmska obloga: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, sončno rumeno FCF (E110).
The clinical data to support the use of Harvoni in patients infected with HCV genotype 2 and 6 are limited (see section 5.1).
Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri bolnikih z okužbo s HCV genotipov 2 in 6, so omejeni (glejte poglavje 5.1).
Of 169 patients with decompensated cirrhosis (pre- or post-transplant CPT B or C), those patients who achieved SVR12 and had post-treatment week 12 laboratory data available (e.g. excluding patients who died, were transplanted, or had missing data at this time-point) were assessed for changes in their MELD and CPT scores.
Od 169 bolnikov z dekompenzirano cirozo (CPT B ali C pred presaditvijo ali po njej) so spremembe rezultatov MELD in CPT ocenili pri bolnikih, ki so dosegli SVR12 in pri katerih so bili na voljo laboratorijski podatki v 12. tednu po zdravljenju (npr. izključili so bolnike, ki so umrli, pri katerih so opravili presaditev ali ni bilo podatkov na tej časovni točki).
Of the 8 genotype 1b patients who qualified for resistance testing, 7/8 (88%) harboured one or more NS5A RAVs at positions L31 and Y93 at failure, while 1/8 patients had no NS5A RAVs at failure.
Od 8 bolnikov z genotipom 1b, ki so bili primerni za testiranje odpornosti, jih je bilo 7 od 8 (88 %) nosilcev enega ali več RAV NS5A na položajih L31 in Y93 ob neuspehu, medtem ko 1 od 8 bolnikov ob neuspehu ni imelo nobene RAV NS5A.
Co-administration of Harvoni with rosuvastatin may significantly increase the concentration of rosuvastatin (several fold-increase in AUC) which is associated with increased risk of myopathy, including rhabdomyolysis.
Sočasno dajanje zdravila Harvoni z rosuvastatinom lahko značilno poveča koncentracijo rosuvastatina (večkrtano povečanje AUC), kar je povezano z večjim tveganjem za miopatijo, vključno z rabdomiolizo.
Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Zdravilo Harvonivsebuje azobarvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis (see section 4.5).
Sočasno dajanje zdravila Harvoniin zaviralcev reduktaze HMG-CoA (statinov) lahko značilno poveča koncentracijo statina, kar poveča tveganje za miopatijo in rabdomiolizo (glejte poglavje 4.5).
Patients with genotype 3 CHC Patients with compensated cirrhosis and/or prior treatment failure
Bolniki s kompenzirano cirozo in/ali predhodno neuspešnim zdravljenjem
Relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
V primerjavi z bolniki z normalnim delovanjem ledvic (eGFR > 80 ml/min/1,73 m2) je bila vrednost AUC0-inf za sofosbuvir za 61 % višja pri bolnikih z blago, za 107 % pri bolnikih z zmerno in za 171 % s hudo ledvično okvaro, medtem ko je bila vrednost AUC0-inf za GS-331007 višja za 55 %, 88 % oz. za 451 %.
Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose.
Mediano najvišje koncentracije GS-331007 v plazmi so opazili 4 ure po odmerku.
The clinical data to support the use of Harvoni in patients infected with HCV genotype 3 are limited (see section 5.1).
Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri bolnikih z okužbo s HCV genotipa 3, so omejeni (glejte poglavje 5.1).
The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir.
izvedenih z bodisi ledipasvirjem/sofosbuvirjem ali ledipasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo z ledipasvirjem/sofosbuvirjem.
- Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options (see section 4.4).
- O 12 tednih zdravila Harvoni + ribavirina ali 24 tednih zdravila Harvoni (brez ribavirina) je treba razmisliti pri predhodno zdravljenih bolnikih z negotovo možnostjo za naknadno ponovno zdravljenje (glejte poglavje 4.4).
NS5B transient replicons Median (range)
Stabilni replikoni prehodni replikoni NS5B mediana (razpon)
NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets
IME ZDRAVILA Harvoni 90 mg/400 mg filmsko obložene tablete
When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
Ko so ledipasvir/sofosbuvir preučevali z ribavirinom, so bili najpogostejši neželeni učinki kombinirane terapije ledipasvirja/sofosbuvirja + ribavirina skladni z znanim profilom varnosti zdravljenja z ribavirinom,
Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Pokazalo se je, da zdravilo Harvoni poveča izpostavljenost tenofovirju, zlasti, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirat fumarat in farmakokinetični ojačevalec
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.
V združeni analizi bolnikov, ki so prejeli ledipasvir/sofosbuvir v študijah 3. faze (ION-3, ION-1 in 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
Otherb
Drugoc
• Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110”
• Povejte zdravniku, če ste alergični na barvilo sončno rumeno FCF (E110) preden uporabite to zdravilo.
Taking Harvoni with any of these may make Harvoni work less well or make any side effects of the medicines worse.
Jemanje zdravila Harvoni s katerim koli od teh zdravil lahko povzroči, da bo morda zdravilo Harvoni slabše delovalo ali pa se bodo kateri od neželenih učinkov zdravila okrepili.
Concentrations of ledipasvir, sofosbuvir and simeprevir are increased when simeprevir is co-administered with Harvoni.
Koncentracije ledipasvirja, sofosbuvirja in simeprevirja se povečajo pri sočasnem dajanju simeprevirja z zdravilom Harvoni.
24% (4/17)e a. These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Da e a. Ti 4 bolniki brez ciroze z relapsom so imeli izhodiščne z odpornostjo povezane polimorfizme NS5A.
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.
Trenutno ni na voljo podatkov, ki bi podprli učinkovitost ponovnega zdravljenja z naknadnim režimom, ki vključuje zaviralca NS5A, pri bolnikih,
Genotype Genotype 1a Genotype 1b a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Genotip Genotip 1a Genotip 1b a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
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.
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 (eGFR < 30 ml/min/1,73 m2) ter pri bolnikih z ESRD, zaradi katere bolnik potrebuje hemodializo, po enkratnem 400-miligramskem odmerku sofosbuvirja.
No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Odmerka zdravila Harvoni ali abakavirja/ lamivudina ni treba prilagajati.
Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Podobno trenutno ni na voljo podatkov, ki bi podprli učinkovitost zaviralcev proteaze NS3/4A pri bolnikih, pri katerih zdravljenje,
Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12.
Sprememba rezultata CPT: 59 % (79/133) oziroma 34 % (45/133) je imelo izboljšanje ali nobene spremembe rezultatov CPT od izhodišča do 12. tedna po zdravljenju; od 39 bolnikov s cirozo CPT C ob izhodišču jih je imelo 56 % (22/39) cirozo CPT B v 12. tednu po zdravljenju; od 99 bolnikov s cirozo CPT B ob izhodišču jih je imelo 29 % (27/92) cirozo CPT A v 12. tednu po zdravljenju.
Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Klinično pomembnih medsebojnih delovanj z ledipasvirjem/sofosbuvirjem, pri katerih bi posredovali encimi CYP450 ali
• St. John's wort (Hypericum perforatum - herbal medicine used to treat depression);
• šentjanževka (Hypericum perforatum - zdravilo rastlinskega izvora, ki se uporablja za zdravljenje depresije),
Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Jedro tablete: kopovidon, laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat, koloidni brezvodni silicijev dioksid, magnezijev stearat.
Not interpretable a. Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Razlaga ni mogoča a. Dva bolnika v skupini 12-tedenskega zdravljenja z LDV/SOF, en bolnik v skupini 12-tedenskega zdravljenja z LDV/SOF+RBV, dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF in dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF+RBV niso imeli potrjenega podtipa genotipa 1.
including those with cirrhosis (randomised 1:1:1:1).
CHC genotipa 1, vključno s tistimi s cirozo (randomiziranih v razmerju 1:1:1:1).
In the SOLAR-1 study (see “Clinical efficacy and safety”, below) 13 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with ribavirin.
V študiji SOLAR-1 (glejte spodnje poglavje »Klinična učinkovitost in varnost«) so pri 13 bolnikih z okužbo genotipa 1 opazili relaps po zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom.
Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated.
Učinkovitosti ledipasvirja/sofosbuvirja pri bolnikih, okuženih s HCV genotipa 5 in genotipa 6 z dekompenzirano cirozo, in/ali pri bolnikih, ki čakajo na presaditev jeter ali bolnikih po presaditvi jeter, niso preučevali.
In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
V klinično doseženih koncentracijah ledipasvir ni zaviralec jetrnih prenašalcev, vključno z OATP 1B1 ali 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, prenašalca za ekstruzijo več zdravil in toksičnih spojin (MATE-multidrug and toxic compound extrusion) 1, beljakovine z odpornostjo proti več zdravilom
Skin and subcutaneous tissue disorders: Common rash
Bolezni kože in podkožja: pogosti izpuščaj
Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Ledipasvir je zaviralec HCV, ki deluje na beljakovino HCV NS5A, ki je bistvena za replikacijo RNA
Ledipasvir AUC is dose proportional over the dose range of 3 to 100 mg. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Vrednosti AUC za sofosbuvir in GS-331007 sta skoraj sorazmerni z odmerkom v razponu odmerka od 200 mg do 400 mg.
Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Po enkratnem 90-miligramskem peroralnem odmerku [14C]-ledipasvirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali v blatu in urinu, 87 %, pri čemer so večino radioaktivnega odmerka izolirali v blatu (86 %).
Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1
Predhodno nezdravljeni odrasli s cirozo ali brez nje - ION-1 (študija 0102) - genotip 1
In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1.
CYP3A4 in UGT1A1 v črevesju.
For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
Za kombinacijo tenofovirja/emtricitabina + darunavirja/ritonavirja glejte spodaj.
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.
GT n TE
GT n PZa
Patients receiving Harvoni concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovirassociated adverse reactions.
Bolnike, ki prejemajo zdravilo Harvonisočasno z elvitegravirjem/kobicistatom/emtricitabinom/dizoproksiltenofovirat fumaratomali s dizoproksiltenofoviratom fumaratom in okrepljenim zaviralcem proteaze HIV, je treba spremljati za pojav s tenofovirjem povezanih neželenih učinkov.
Dose modification of ribavirin in patients taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Če se zdravilo Harvoni uporablja v kombinaciji z ribavirinom in ima bolnik resne neželene učinke, ki so morebiti povezani z ribavirinom, je treba odmerek ribavirina prilagoditi ali ukiniti, kakor je ustrezno, dokler ni neželeni učinek odpravljen ali postane manj resen.
SOLAR-1 is an open-label, multicentre study evaluating 12 and 24 weeks of treatment with ledipasvir/sofosbuvir + ribavirin in patients with genotype 1 or 4 CHC who have advanced liver disease and/or who have undergone liver transplantation.
SOLAR-1 je odprta, multicentrična študija, v kateri ocenjujejo 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem + ribavirinom pri bolnikih s CHC genotipa 1 ali 4 z napredovalo boleznijo jeter in/ali s presaditvijo jeter.
Treatment of patients with prior exposure to HCV direct-acting antivirals In patients who fail treatment with ledipasvir/sofosbuvir, selection of NS5A resistance mutations that substantially reduce the susceptibility to ledipasvir is seen in the majority of cases (see section 5.1).
Pri bolnikih, pri katerih zdravljenje z ledipasvirjem/sofosbuvirjem ni bilo uspešno, so v večini primerov opazili selekcijo mutacij odpornosti na zaviralec NS5A, ki pomembno znižajo dovzetnost za ledipasvir (glejte poglavje 5.1).
Presence of baseline NS5A resistance-associated substitutionsc No
Prisotnost izhodiščnih substitucij NS5A, povezanih z odpornostjo c
4 hour haemodialysis removed 18% of administered sofosbuvir dose.
18 % uporabljenega odmerka sofosbuvirja.
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 doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Izpostavljenosti sofosbuvirju v študijah pri glodavcih ni bilo mogoče zaznati, verjetno zaradi visoke aktivnosti esteraze; vendar pa je bila izpostavljenost glavnemu presnovku GS-331007 pri odmerku, ki je povzročil neželene učinke, 16-krat (podgana) in
Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Pri uporabi zdravila Harvoni s sočasno uporabo amiodarona in/ali drugih zdravil, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4 in 4.5).
and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Usmerjena mutageneza substitucije Y93H v obeh genotipih 1a in 1b ter substitucija Q30R in L31M v genotipu 1a je doprinesla visoke ravni zmanjšane dovzetnosti za ledipasvir (večkratna sprememba EC50 je bila v razponu od 544-krat do 1,677-krat).
H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)
Antagonisti receptorjev H2 Famotidin (40 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)
Further data include a double-blind comparison of the safety of ledipasvir/sofosbuvir (12 weeks) and placebo in 155 cirrhotic patients (see section 5.1).
Nadaljnji podatki vključujejo dvojno slepo primerjavo varnosti ledipasvirja/sofosbuvirja (12 tednov) in placeba pri
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.
HCV PRODUCTS Simeprevir (150 mg once daily)/ ledipasvir (30 mg once daily)
ZDRAVILA ZA ZDRAVLJENJE HCV Simeprevir (150 mg enkrat na dan)/ ledipasvir (30 mg enkrat na dan)
Pre-transplant
Pred presaditvijo
Interactions cannot be excluded with other HMG-CoA reductase inhibitors.
Interakcij z drugimi zaviralci reduktaze HMG-CoA
NS5A RAVs were seen at relapse in 5/5 patients (for genotype 1a: Q30R/H + L31M/V [n = 1] and Q30R [n = 1]; for genotype 1b: Y93H [n = 3]).
RAV NS5A so opazili pri 5/5 bolnikih ob relapsu (za genotip 1a: Q30R/H + L31M/V [n = 1] in Q30R [n = 1]; za genotip 1b: Y93H [n = 3]).
Both sofosbuvir and ledipasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
povezanih z odpornostjo na druga zdravila z direktnim delovanjem na viruse z različnimi mehanizmi delovanja, kot so nenukleozidni zaviralci NS5B in zaviralci proteaze NS3.
Cirrhosis d
Harvoni d
The safety assessment of ledipasvir/sofosbuvir is based on pooled data from three Phase 3 clinical studies (ION-3, ION-1 and ION-2) including 215, 539 and 326 patients who received ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and 216, 328 and 328 patients who received ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
(ION-3, ION-1 in ION-2), v katere je bilo vključenih 215, 539 in 326 bolnikov, ki so ledipasvir/sofosbuvir prejemali 8, 12 oz. 24 tednov, in 216, 328 in 328 bolnikov, ki so kombinirano terapijo z ledipasvirjem/sofosbuvirjem + ribavirinom prejemali 8, 12 oz. 24 tednov.
Harvoni + ribavirin for 24 weeks (see sections 4.4 and 5.1).
Zdravilo Harvoni + ribavirin 24 tednov (glejte poglavji 4.4 in
c/ sofosbuvir (400 mg once daily)c, d
c/ sofosbuvir (400 mg enkrat na dan)c, d
What you need to know before you take Harvoni
Kaj morate vedeti, preden boste vzeli zdravilo Harvoni Ne jemljite zdravila Harvoni
b. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
b. Med drugo so bile vključene bolnikov, ki niso dosegli SVR in niso izpolnjevali kriterijev za virološki neuspeh (npr.
The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
povezana s sočasno uporabo zdravila Harvoni s tableto s kombinacijo fiksnih odmerkov, ki vsebuje elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat fumarat ali dizoproksiltenofoviratom fumaratom, dajanim v povezavi z okrepljenim zaviralcem proteaze HIV (npr. atazanavirjem ali darunavirjem), zlasti pri bolnikih, pri katerih je tveganje za ledvično disfunkcijo povečano.
How to take Harvoni
Kako jemati zdravilo Harvoni
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Abakavir/ lamivudin (600 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)
Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with ledipasvir/sofosbuvir.
Spojine, ki so substrati teh encimov, imajo ob sočasnem dajanju z ledipasvirjem/sofosbuvirjem lahko zmanjšane koncentracije v plazmi.
Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Metadon (vzdrževalna terapija z metadonom [30 do 130 mg/dan])/ sofosbuvir (400 mg enkrat na dan)d
Biochemical confirmation of NS5A inhibition by ledipasvir is not currently possible as NS5A has no enzymatic function.
Trenutno ni mogoče biokemično potrditi, da ledipasvir zavira NS5A, saj
Gender Male Female IL28 genotype CC Non-CC Baseline HCV RNAa
Moški Ženski IL28 genotip CC
ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
ERADICATE je bila odprta študija, v kateri so ocenjevali 12-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem pri 50 bolnikih z okužbo CHC genotipa 1 in sočasno okužbo s HIV.
Do not breast-feed during treatment with Harvoni.
Med zdravljenjem z zdravilom Harvoni ne smete dojiti.
Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in patients with decompensated liver disease and/or those post-liver transplant was assessed in an open-label study (SOLAR-1).
Varnostni profil ledipasvirja/sofosbuvirja z ribavirinom 12 ali 24 tednov pri bolnikih z dekompenzirano boleznijo jeter in/ali bolnikih po presaditvi jeter so ocenili v odprti študiji (SOLAR-1).