natgillin/translations-raw huggingface dataset:
Sofosbuvir-derived material was transferred through the placenta in pregnant rats and into the milk of lactating rats.
Tvari koje potječu od sofosbuvira prolazile su kroz placentu u skotnih ženki štakora i u mlijeko ženki štakora tijekom laktacije.
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.
U ispitivanjima kancerogenosti u trajanju od 2 godine nisu opaženi nikakvi nalazi na jetri ili srcu pri izloženostima koje su 17 puta (miš) i 9 puta (štakor) veće od kliničke izloženosti.
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).
Varijante NS5A povezane s rezistencijom (engl. resistance-associated variants, RAV) opažene su u izolatima nakon početka ispitivanja kod 29/37 bolesnika (22/29 s genotipom 1a i 7/8 s genotipom 1b) koji nisu postigli održani virološki odgovor (SVR).
In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products
Mogućnost utjecaja ledipasvira/sofosbuvira in vitro na druge lijekove
Harvoni 90 mg/400 mg film-coated tablets
NAZIV LIJEKA Harvoni 90 mg/400 mg filmom obložene tablete
The study (double-blind and placebo-controlled) evaluated 24 weeks of treatment ledipasvir/sofosbuvir (with ribavirin placebo) versus 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin.
U tom se ispitivanju (dvostruko slijepom i placebom kontroliranom) procijenilo liječenje ledipasvirom/sofosbuvirom (s placebom umjesto ribavirina) u trajanju od 24 tjedna naspram liječenja ledipasvirom/sofosbuvirom s ribavirinom u trajanju od 12 tjedana.
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.
Sofosbuvir nije bio genotoksičan u bateriji testova in vitro ili in vivo, uključujući test bakterijske mutagenosti, kromosomske aberacije na ljudskim limfocitima iz periferne krvi i in vivo mišji mikronukleusni test.
Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Harvoni.
Preporučuje se kliničko praćenje, u kojem se traže znakovi krvarenja i anemije, kada se dabigatraneteksilat primjenjuje istovremeno s lijekom Harvoni.
Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Jedna filmom obložena tableta sadrži 90 mg ledipasvira i 400 mg sofosbuvira.
Of the 29 genotype 1a patients who qualified for resistance testing, 22/29 (76%) patients harboured one or more NS5A RAVs at positions K24, M28, Q30, L31, S38 and Y93 at failure, while the remaining 7/29 patients had no NS5A RAVs detected at failure.
Od 29 bolesnika s genotipom 1a koji su zadovoljili mjerila za provjeru rezistencije, 22/29 (76 %) bolesnika nosilo je jednu ili više NS5A RAV na položajima K24, M28, Q30, L31, S38 i Y93 u vrijeme virološkog neuspjeha, dok se u preostalih 7/29 bolesnika nije otkrila niti jedna NS5A RAV u vrijeme virološkog neuspjeha.
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.
Ledipasvir nije bio genotoksičan u bateriji testova in vitro ili in vivo, uključujući test bakterijske mutagenosti, kromosomske aberacije na ljudskim limfocitima iz periferne krvi i in vivo mikronukleusni test u štakora.
↑ Statins
↑ statina
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.
Među bolesnicima s dekompenziranom bolešću jetre (prije i poslije transplantacije), 4/16 (25 %) bolesnika s NS5A RAV-ovima koji nose rezistenciju > 100 puta imalo je relaps nakon 12 tjedana liječenja kombinacijom ledipasvir/sofosbuvir + ribavirin, u usporedbi sa 7/120 (6 %) onih bez ikakvih početnih NS5A RAV-ova ili RAV-ova koji nose promjenu ≤ 100 puta.
Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Kopovidon, laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, silicijev dioksid, koloidni bezvodni, magnezijev stearat.
White
Bijelci
This is so that:
Razlog tome je taj da:
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).
Kombinacija ledipasvira/sofosbuvira primjenjivala se tijekom 12 tjedana u 18 bolesnika s CHC-om uzrokovanim genotipom 1 i s teškim oštećenjem bubrega u otvorenom ispitivanju (ispitivanje 0154).
The table is not all-inclusive.
Tablica nije zaključna.
Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
PEG-IFN+RBV Inhibitor proteaze HCV-a + PEG-IFN+RBV
The relative efficacy of a 12-week regimen consisting of ledipasvir/sofosbuvir + ribavirin, compared to a 24-week regimen of sofosbuvir + ribavirin has not been investigated.
+ ribavarina u usporedbi s 24-tjednim režimom sofosbuvirom + ribavirinom nije ispitana.
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Tijekom ili nakon liječenja direktno djelujućim antivirusnim lijekovima, zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV), neki od njih sa smrtnim ishodom.
Table 16: Response rates in study ION-4
Tablica 16: Stope odgovora u ispitivanju ION-4.
• outer cartons containing 3 bottles of 28 (84) film-coated tablets.
• kutije koje sadrže 3 boce s 28 (84) filmom obloženih tableta.
In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir.
U ispitivanje ION-4 bilo je uključeno 13 bolesnika istovremeno zaraženih virusima HCV genotipa 1/HIV-1, uključujući 1 bolesnika s cirozom, u kojih je liječenje režimom sofosbuvira s ribavirinom bilo neuspješno; SVR je iznosio 100 % (13/13) nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom.
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
1. Tri ispitivanja faze 3 uključivala su jedno ispitivanje provedeno u bolesnika bez ciroze koji prethodno nisu bili liječeni (ION-3); jedno ispitivanje u bolesnika s cirozom i bez ciroze koji prethodno nisu bili liječeni (ION-1); i jedno ispitivanje u bolesnika s cirozom i bez ciroze u kojih je prethodna terapija režimom na temelju interferona bila neuspješna, uključujući režime koji su sadržavali inhibitor proteaze HCV-a (ION-2).
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da ciroza (uključujući dekompenziranu cirozu) nije imala klinički važan utjecaj na izloženost sofosbuviru i GS-331007.
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.
Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) i ESRD-om koji zahtijeva hemodijalizu.
No dose adjustment of Harvoni or darunavir (ritonavir boosted) is required.
Nije potrebna prilagodba doze lijeka Harvoni ili darunavira (pojačanog ritonavirom).
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]).
U relapsu su u 5/5 bolesnika opaženi NS5A RAV-ovi (za genotip 1a: Q30R/H + L31M/V [n = 1] i Q30R [n = 1]; za genotip 1b: Y93H [n = 3]).
(Increase in gastric pH)
(Povećanje želučanog pH)
Tipranavir boosted with ritonavir
Tipranavir pojačan ritonavirom
Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat
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).
Farmakokinetika ledipasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min prema Cockcroft-Gaultu, medijan [raspon] CrCl 22 [17-29] ml/min) nakon jedne doze od 90 mg ledipasvira.
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%).
Nakon jedne peroralne doze od 90 mg [14C]-ledipasvira, srednja vrijednost ukupno otkrivene [14C]-radioaktivnosti u stolici i mokraći iznosila je 87 %, s time da je najviše radioaktivne doze otkriveno u stolici (86 %).
Treatment of patients with prior exposure to HCV direct-acting antivirals
Liječenje bolesnika prethodno izloženih direktno djelujućim antivirusnim lijekovima
The efficacy of ledipasvir/sofosbuvir in HCV infected adolescents aged 12 to < 18 years was evaluated in a Phase 2, open label clinical study that enrolled 100 patients with genotype 1 CHC (Study 1116).
Djelotvornost ledipasvira/sofosbuvira u adolescenata u dobi od 12 do < 18 godina zaraženih HCV-om procijenjena je u otvorenom kliničkom ispitivanju faze 2 u koje je bilo uključeno 100 bolesnika s CHC-om genotipa 1 (ispitivanje 1116).
Genotype 6a
Genotip 6a
For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Za djelovanje na određeni genotip virusa hepatitisa C (HCV), vidjeti dijelove 4.4 i 5.1. 4.2 Doziranje i način primjene
No dose adjustment of Harvoni or atazanavir (ritonavir boosted) is required.
Nije potrebna prilagodba doze lijeka Harvoni ili atazanavira (pojačanog ritonavirom).
28 film-coated tablets.
OBLIK I SADRŽAJ 28 filmom obloženih tableta.
Patients with compensated cirrhosis
Bolesnici s kompenziranom cirozom
Your doctor may give you a different medicine or adjust the dose of the medicine you are taking;
Liječnik Vam može dati drugi lijek ili prilagoditi dozu lijeka koji uzimate;
Site-directed mutagenesis of NS5A RAVs showed that substitutions conferring a fold-change > 100 and ≤ 1,000 in ledipasvir susceptibility are Q30H/R, L31I/M/V, P32L and Y93T in genotype 1a and P58D and Y93S in genotype 1b; and substitutions conferring a fold-change > 1,000 are M28A/G, Q30E/G/K, H58D, Y93C/H/N/S in genotype 1a and A92K and Y93H in genotype 1b.
Ciljana mutageneza NS5A RAV-ova pokazala je da su supstitucije koje nose promjenu osjetljivosti > 100 i ≤ 1000 puta na ledipasvir Q30H/R, L31I/M/V, P32L i Y93T u genotipu 1a te P58D i Y93S u genotipu 1b; a supstitucije koje nose promjenu > 1000 puta su M28A/G, Q30E/G/K, H58D, Y93C/H/N/S u genotipu 1a i A92K i Y93H u genotipu 1b.
How to take Harvoni
Kako uzimati Harvoni
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.
Prethodno liječeni odrasli u kojih je liječenje sofosbuvirom s ribavirinom ± PEG-IFN bilo neuspješno Djelotvornost ledipasvira/sofosbuvira u bolesnika u kojih je prethodno liječenje sofosbuvirom s ribavirinom ± PEG-IFN bilo neuspješno potkrijepljena je u dva klinička ispitivanja.
Potential for Harvoni to affect other medicinal products Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters.
Ledipasvir je in vitro inhibitor prijenosnika lijekova P-gp i proteina rezistencije karcinoma dojke na lijekove (BCRP) te može povećati crijevnu apsorpciju istovremeno primijenjenih supstrata ovih prijenosnika.
b The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
b. Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
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.
Od 40 bolesnika s genotipom 4 CHC uključenih u ispitivanja SOLAR-1 i SOLAR-2, SVR 12 imalo je 92 % (11/12) i 100 % (10/10) ispitanika bez dekompenzirane ciroze poslije transplantacije te 60 % (6/10) i 75 % (6/8) bolesnika s dekompenziranom cirozom (prije i poslije transplantacije jetre) liječenih 12 odnosno 24 tjedna.
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.
Ispitivanje 0154 bilo je otvoreno kliničko ispitivanje u kojem se procijenila sigurnost i djelotvornost 12-tjednog liječenja ledipasvirom/sofosbuvirom u 18 bolesnika zaraženih HCV-om genotipa 1 s teškim oštećenjem bubrega, ali bez potrebe za dijalizom.
How to store Harvoni
Kako čuvati Harvoni
Co-administration of Harvoni with pravastatin may significantly increase the concentration of pravastatin which is associated with increased risk of myopathy.
Istodobna primjena lijeka Harvoni s pravastatinom može značajno povećati koncentraciju pravastatina, što je povezano s povećanim rizikom od miopatije.
12 weeks (n = 109)
12 tjedana (n = 109)
Methadone (Methadone maintenance therapy [30 to 130 mg/daily])/ sofosbuvir (400 mg once daily)d
Metadon (terapija održavanja metadonom [30 do 130 mg na dan])/ sofosbuvir (400 mg jedanput na dan)d
The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n=94) for 8, 12, or 24 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials.
Farmakokinetika ledipasvira, sofosbuvira i GS-331007 ispitana je u ispitivanjima ledipasvira/sofosbuvira faze 2/3 u bolesnika zaraženih HCV-om s ESRD-om koji je zahtijevao dijalizu liječenih ledipasvirom/sofosbuvirom (n = 94) u trajanju od 8, 12 ili 24 tjedna te uspoređenih s bolesnicima bez oštećenja bubrega.
Co-administration with rosuvastatin (see section 4.5).
Istovremena primjena s rosuvastatinom (vidjeti dio 4.5).
The E237G substitution showed a 1.3-fold reduction in susceptibility to sofosbuvir in the genotype 1a replicon assay.
U testu replikona genotipa 1a, supstitucija E237G pokazala je smanjenje osjetljivosti na sofosbuvir za 1,3 puta.
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.
Pri dozi bez vidljivog učinka, AUC izloženost ledipasviru bila je približno 7 puta veća u mužjaka i 3 puta veća u ženki od izloženosti ljudi pri preporučenoj kliničkoj dozi.
Impact of DAA therapy on drugs metabolized by the liver
Utjecaj terapije direktno djelujućim antiviroticima na lijekove koji se metaboliziraju putem jetre
- a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
simptomima nalik gripi, mjehurićima u ustima, na očima i/ili na genitalijama
Dosed 1 hr After Dialysis
Doza 1 h poslije dijalize
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.
Lijekovi koji su umjereni induktori P-gp-a u crijevima (npr. okskarbazepin) mogu smanjiti koncentracije ledipasvira i sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
Contains lactose and sunset yellow FCF aluminium lake (E110).
Sadrži laktozu i boju sunset yellow FCF aluminium lake (E110).
Such co-administration is not recommended.
Ne preporučuje se njihova istovremena primjena.
LDV/SOF+RBV 24 weeks (n = 307)a,b
LDV/SOF+RBV 24 tjedna (n = 307)a,b
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.
Promjena MELD rezultata: Među onima koji su postigli SVR12 u 12 tjedana liječenja kombinacijom ledipasvir/sofosbuvir + ribavirin, njih 57 % (70/123) imalo je poboljšanje, a u 19 % (23/123) nije bilo promjene u MELD rezultatu od početka do 12. tjedna nakon liječenja; od 32 bolesnika čiji je MELD rezultat bio ≥ 15 na početku, 59 % (19/32) imalo je u 12. tjednu nakon liječenja MELD rezultat < 15.
Adult and adolescent patients 12 years of age or older with genotype 1, 4, 5 or 6 CHC Patients without cirrhosis
Odrasli i adolescenti u dobi od 12 ili više godina s CHC-om uzrokovanim genotipom 1, 4, 5 ili 6
Presence of baseline NS5A resistance-associated substitutionsc No
Prisutnost početnih supstitucija u NS5A povezanih s rezistencijom c
Genotype 1a
Genotip 1a
Dose modification of ribavirin in adults 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.
Ako se Harvoni primjenjuje u kombinaciji s ribavirinom, a bolesnik ima ozbiljnu nuspojavu potencijalno povezanu s ribavirinom, dozu ribavirina potrebno je prilagoditi ili prekinuti njegovu primjenu, ako je to primjereno, sve dok se nuspojava ne povuče ili se ne smanji težina nuspojave.
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.
Udio bolesnika u kojih je liječenje trajno prekinuto zbog štetnih događaja iznosio je 0 %, < 1 % odnosno 1 % kod bolesnika koji su primali ledipasvir/sofosbuvir tijekom 8, 12 odnosno 24 tjedna; te < 1 %, 0 %, odnosno 2 % kod bolesnika koji su primali kombiniranu terapiju ledipasvirom/sofosbuvirom
Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Harvoni sadrži azo boju sunset yellow FCF aluminium lake (E110), koja može uzrokovati alergijske reakcije.
Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1).
Harvoni s ribavirinomA tijekom 24 tjedna (vidjeti dijelove 4.4 i
therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Ni jedan bolesnik nije bio prethodno liječen terapijom protiv HCV-a i ni jedan nije imao cirozu; 26 % (13/50) bolesnika prethodno nije bilo liječeno antiretrovirusnim lijekovima protiv HIV-a, a 74 % (37/50) bolesnika istovremeno je primalo antiretrovirusnu terapiju protiv HIV-a.
Sunset yellow FCF aluminium lake (E110)
talk boja sunset yellow FCF aluminium lake (E110)
Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Od 8 bolesnika koji nisu imali NS5A RAV u vrijeme virološkog neuspjeha, 7 bolesnika primalo je liječenje tijekom 8 tjedana (n = 3 ledipasvirom/sofosbuvirom; n = 4 ledipasvirom/sofosbuvirom +ribavirinom), a 1 je bolesnik primao ledipasvir/sofosbuvir tijekom 12 tjedana.
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).
Medijan dobi bio je 56 godina (raspon: od 23 do 77); 74 % bolesnika bili su muškarci; 97 % bili su bijelci; 63 % imalo je infekciju HCV-om genotipa 1a; 94 % imalo je ne-CC IL28B alele (CT ili TT).
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.
Nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom prethodno liječenih bolesnika s kompenziranom cirozom (SIRIUS, n = 77), 8/8 bolesnika s početnim NS5A RAV-ovima koji nose smanjenu osjetljivost na ledipasvir za > 100 puta postiglo je SVR12.
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).
Skupinu NS5A RAV-ova koji su nosili povećanje > 100 puta i koji su bili opaženi u bolesnika činile su sljedeće supstitucije u genotipu 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) ili u genotipu 1b (Y93H).
No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Nije potrebna prilagodba doze lijeka Harvoni ili emtricitabina/ rilpivirina/ tenofovirdizoproksilfumarata.
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.
Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) i završnim stadijem bolesti bubrega (engl. end stage renal disease, ESRD) koji zahtijeva dijalizu.
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.
Klinička ispitivanja uključila su bolesnike s cirozom ili bez nje, koji prethodno nisu bili liječeni ili u kojih je prethodno liječenje PEG-IFN + ribavirinom +/- inhibitorom proteaze HCV-a bilo neuspješno.
Severe RI (eGFR <30 mL/min/1.73 m2)
Teško oštećenje bubrega (eGFR < 30 ml/min/ 1,73 m2)
Dosed 1 hr Before Dialysis
Doza 1 h prije dijalize
For the same treatment arm, patients with baseline NS5A RAVs conferring a fold-change of > 100, relapse occurred in 4/13 (31%), as compared to 3/95 (3%) in those without any baseline RAVs or RAVs conferring a fold-change of ≤ 100.
NS5A RAV-ovima koji su nosili promjenu > 100 puta, relaps je nastupio u 4/13 (31 %) u usporedbi s 3/95 (3 %) u onih bez ikakvih početnih RAV ili RAV koji nose promjenu ≤ 100 puta.
Use with HMG-CoA reductase inhibitors
INHIBITORI HMG-CoA REDUKTAZE
For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
+ darunavir/ritonavir, molimo vidjeti niže.
Nervous system disorders: Very common headache
Poremećaji živčanog sustava: