natgillin/translations-raw huggingface dataset:
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).
Table 2: Ribavirin dose modification guideline for co-administration with Harvoni Laboratory values 
Preglednica 2: Smernice za prilagajanje odmerka ribavirina pri sočasnem dajanju z zdravilom Harvoni
• simeprevir (a medicine used to treat hepatitis C infection); 
• simeprevir (zdravilo, ki se uporablja za zdravljenje okužbe s hepatitisom C), • tipranavir (uporablja se za zdravljenje okužbe s HIV).
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); 
• če sočasno jemljete katero izmed naslednjih zdravil: • rifampicin in rifabutin (antibiotika, ki se uporabljata za zdravljenje okužb, vključno s tuberkulozo),
c. Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in 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).
The safety of ledipasvir/sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2). 
Varnost ledipasvirja/sofosbuvirja ni bila ocenjena pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
Table 13: Relapse rates for selected subgroups in study ION-2 LDV/SOF 
Preglednica 13: Stopnje relapsa za izbrane podskupine v študiji ION-2 LDV/SOF
Not applicable. 
ni mogoče izključiti.
Treatment-naïve Patients without cirrhosis Patients with cirrhosis Treatment-experienced 
Predhodno nezdravljeni Bolniki brez ciroze Bolniki s cirozo Predhodno zdravljeni
- Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin. 
- O 24 tednih zdravila Harvoni (brez ribavirina) je možno razmisliti pri bolnikih, pri katerih zdravljenje z ribavirinom ni primerno ali ga ne prenašajo.
HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily) 
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI PROTEAZE HIV Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)
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. 
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 Med 29 bolniki genotipa 1a, ki so bile primerni za testiranje odpornosti, je bilo 22 od 29 (76 %) bolnikov ob neuspehu nosilcev enega ali več RAV NS5A na položajih K24, M28, Q30, L31, S38 in Y93, medtem ko preostalih 7 od 29 bolnikov ob neuspehu ni imelo zaznavnih RAV NS5A.
Harvoni is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3). 
Zdravilo Harvoni je kontraindicirano s karbamazepinom, fenobarbitalom in fenitoinom, ki so močni induktorji P-gp v črevesju (glejte poglavje 4.3).
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d 
Norgestimat/ etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ sofosbuvir (400 mg enkrat na dan)d
b. The chimeric replicons carrying NS5A genes from genotype 2b, 5a, 6a and 6e were used for testing ledipasvir while the chimeric replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing sofosbuvir. 
a genotip 1a genotip 1b genotip 2a genotip 2b b b genotip 3a genotip 4a genotip 4d genotip 5a b b genotip 6a b b genotip 6e b a. Prehodni replikoni ki nosijo NS5A ali NS5B,iz izolatov bolnikov, b. Himerični replikoni, ki nosijo gene NS5A genotipov 2b, 5a, 6a in 6e, so bili uporabljeni za preskušanje ledipasvirja, himerični replikoni, ki nosijo gene NS5B genotipov 2b, 5a ali 6a so bili uporabljeni za preskušanje sofosbuvirja.
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 [CPT]) odmerka zdravila Harvoni ni treba prilagajati (glejte poglavje 5.2).
Table 9: Demographics and baseline characteristics in study ION-1 Patient disposition 
Preglednica 9: Demografske in izhodiščne značilnosti za študijo ION-1
No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir. 
V študijah razvojne toksičnosti z ledipasvirem pri podganah in kuncih niso opazili teratogenih učinkov.
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. 
Razlaga ni mogoča a. En bolnik v skupini 24-tedenskega zdravljenja z LDV/SOF in en bolnik v skupini 24-tedenskega zdravljenja z LDV/SOF+RBV sta doživela predhodni neuspeh zdravljenja z režimom zdravljenja na podlagi nepegiliranega interferona.
No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007. 
Klinično pomembnih farmakokinetičnih razlik zaradi spola za sofosbuvir in GS-331007
The pharmacokinetics of ledipasvir, sofosbuvir and GS-331007 in paediatric patients have not been established (see section 4.2). 
Pediatrična populacija Farmakokinetike ledipasvirja, sofosbuvirja in GS-331007 pri pediatričnih bolnikih niso ugotavljali
Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3). 
Sočasno dajanje zdravila Harvoni in rosuvastatina je kontraindicirano (glejte poglavje 4.3).
c/ sofosbuvir (400 mg once daily) 
c/ sofosbuvir (400 mg enkrat na dan)
Rabeprazolee Pantoprazole e 
Pantoprazole Esomeprazol e
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. 
Usmerjena mutageneza RAV NS5A je pokazala, da so substitucije, ki doprinesejo večkratno spremembo dovzetnosti za ledipasvir za > 100 in ≤ 1.000-krat, Q30H/R, L31I/M/V, P32L in Y93T pri genotipu 1a ter P58D in Y93S pri genotipu 1b; substiticije, ki doprinesejo večkratno spremembo dovzetnosti za > 1.000-krat so M28A/G, Q30E/G/K, H58D, Y93C/H/N/S pri genotipu 1a ter A92K in Y93H pri genotipu 1b.
c. Patients with missing cirrhosis status were excluded from this subgroup analysis. 
c. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily) 
Z ritonavirjem okrepljeni darunavir (800 mg/ 100 mg enkrat na dan)/ sofosbuvir (400 mg enkrat na dan)
(listed in section 6 of this leaflet). 
(glejte poglavje 4.2).
PEG-IFN+RBV 39% (43) 
Belci Genotip 1a Predhodno zdravljenje HCV PEG-IFN+RBV 39 % (43)
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Harvoni. 
priporoča se tudi spremljanje terapevtske koncentracije digoksina.
Table 4: Adverse drug reactions identified with Harvoni Frequency 
Preglednica 4: Neželeni učinki zdravila, identificirani pri pri zdravljenju z zdravilom Harvoni
What Harvoni contains 
Kaj vsebuje zdravilo Harvoni
LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110). 
Vsebuje laktozo in barvilo sončno rumeno FCF (E110).
ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC 
ION-1 je bila randomizirana, odprta študija, ki je ocenila 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega pri 865 predhodno nezdravljenih bolnikih s
The NS5A substitution Y93C emerged in the HCV of 1 patient (genotype 4), while NS5A RAVs present at baseline were observed at the time of failure in all patients. 
Substitucija Y93C v polimerazi NS5A se je pojavila pri HCV pri 1 bolniku (genotip 4),
Lansoprazole e 
Harvoni Lansoprazole Rabeprazol e
Such patients may therefore be dependent on other drug classes 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.
No dose adjustment of Harvoni or darunavir (ritonavir boosted) is required. 
Odmerka zdravila Harvoni ali darunavirja (okrepljenega z ritonavirjem) ni treba prilagajati.
b. Patients with missing cirrhosis status were excluded from this subgroup analysis. 
b. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily) 
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI INTEGRAZE Raltegravir (400 mg dvakrat na dan)/ ledipasvir (90 mg enkrat na dan)d
Marketing Authorisation Holder Gilead Sciences International Ltd. Cambridge 
Imetnik dovoljenja za promet z zdravilom Gilead Sciences International Ltd. Cambridge
d. Patients with missing cirrhosis status were excluded from this subgroup analysis. 
d. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
BOTTLE AND CARTON LABELLING 
OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily) 
Raltegravir (400 mg dvakrat na dan)/ sofosbuvir (400 mg enkrat na dan)d
Table 6: Demographics and baseline characteristics in study ION-3 Patient disposition 
Preglednica 6: Demografske in izhodiščne značilnosti za študijo ION-3
NS5A RAVs were seen at the time of relapse in 11/13 patients (for genotype 1a: Q30R alone [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]). 
odpornostjo povezane različice RAV NS5A so ob času relapsa opazili pri 11/13 bolnikih (za genotip 1a: samo Q30R [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1], za genotip 1b: Y93H [n = 3], Y93H/C [n = 1]).
Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + 
Pri predhodno zdravljenih bolnikih je bilo predhodno zdravljenje s PEG-IFN + ribavirinom ± zaviralcem proteaze HCV ali sofosbuvirjem + ribavirinom ± PEG-IFN neuspešno.
Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d 
Rifampicin (600 mg enkrat na dan)/ sofosbuvir (400 mg enkratni odmerek)d
Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in patients with decompensated disease (irrespective of liver transplantation status), 3/7 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir relapsed, as compared to 4/68 in those without any baseline RAVs or RAVs conferring ≤ 100-fold reduced susceptibility to ledipasvir. 
Po 12-tedenskem zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom pri bolnikih z dekompenzirano boleznijo (ne glede na presaditev jeter) je do relapsa prišlo pri 3/7 bolnikov z izhodiščnimi RAV NS5A, ki so doprinesle k > 100-kratni zmanjšani dovzetnosti za ledipasvir, v primerjavi s 4/68 bolnikov brez izhodiščnih RAV ali RAV, ki so doprinesle k ≤ 100-kratni spremembi dovzetnosti za ledipasvir.
The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis. 
Varnost zdravila Harvoni ni bila ocenjena pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
virus. 
odmerka.
Table 8: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF 
Preglednica 8: Stopnje relapsov glede na izhodiščne značilnosti v študiji ION-3, populacija bolnikov z virološkim neuspehom*
Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203. 
Sofosbuvir se obširno presnovi v jetrih, kjer tvori v farmakološko aktivni nukleozidni analog trifosfat
Common side effects (may affect up to 1 in 10 people) 
(pojavijo se lahko pri do 1 od 10 bolnikov)
Table 13 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").
Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2). 
< 50 ml/min (glejte poglavje 5.2).
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. 
Odrasli s sočasno okužbo HCV/HIV - ION 4 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.
SVR Outcome for patients without SVR On-treatment virologic failure a 
SVR Izid za bolnike brez SVR Virološki neuspeh med zdravljenjem a
NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir 
Navodilo za uporabo Harvoni 90 mg/400 mg filmsko obložene tablete ledipasvir/sofosbuvir
Very common side effects (may affect more than 1 in 10 people) 
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)
No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required. 
Odmerka zdravila Harvoni ali emtricitabina/ rilpivirina/ dizoproksiltenofovirat fumarata ni treba prilagajati.
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)d 
Z ritonavirjem okrepljeni darunavir (800 mg/ 100 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)
↔ GS-331007 (Increase in gastric pH) 
↔ GS-331007 (zaviranje P-gp)
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose) 
Rifampicin (600 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)
Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d 
Emtricitabin/ rilpivirin/ dizoproksiltenofovirat fumarat (200 mg/ 25 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir (400 mg enkrat na dan)c, d
Relapse a 
Relaps a