natgillin/translations-raw huggingface dataset:
Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort). 
Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (karbamazepin, fenobarbital,
The most common variants were Q30R, Y93H and L31M. 
Najpogostejše različice so bile Q30R,
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
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; substitucije, 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.
Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 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 including those with cirrhosis (randomised 1:1:1:1). 
Predhodno nezdravljeni odrasli s cirozo ali brez nje - ION-1 (študija 0102) - genotip 1 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 CHC genotipa 1, vključno s tistimi s cirozo (randomiziranih v razmerju 1:1:1:1).
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. 
Sofosbuvir je nukleotidno predzdravilo, ki se znotraj celice presnavlja in tvori farmakološko aktivni uridinski analog trifosfat (GS-461203), ki ga polimeraza NS5B lahko vgradi v
Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1). 
Zdravilo Harvoni + ribavirinA 24 tednov (glejte poglavji 4.4 in
In female rats, the mean number of corpora lutea and implantation sites were slightly reduced at maternal exposures 6-fold the exposure in humans at the recommended clinical dose. 
Pri podganjih samicah se je povprečno število rumenega telesca in vsaditvenih mest pri izpostavljenosti matere, ki je bila 6-krat večja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, nekoliko zmanjšalo.
Table 17: Combined response rates (SVR12) in studies SOLAR-1 and SOLAR-2 LDV/SOF+RBV 12 weeks (n = 307)a,b 
Preglednica 17: Kombinirane stopnje odziva (SVR12) v študijah SOLAR-1 in SOLAR-2 LDV/SOF+RBV 12 tednov
Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors. 
Sočasno dajanje z zdravili, ki zavirajo P-gp in/ali BCRP, lahko poveča koncentracijo ledipasvirja in sofosbuvirja v plazmi brez povečanja koncentracije GS-331007 v plazmi,
No patient experienced virologic failure (see section 4.2 for information on paediatric use). 
(glejte poglavje 4.2 za informacije o pediatrični uporabi).
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
c Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up). 
c. Med drugo so bili vključeni bolniki, ki niso dosegli SVR in niso izpolnjevali kriterijev za virološki neuspeh (npr.
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.
Genotype 1b a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment. 
Genotip 1a Genotip 1b a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
No dose adjustment required. 
Odmerka ni treba prilagajati.
Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir 
Harvoni 90 mg/400 mg filmsko obložene tablete ledipasvir/sofosbuvir
GT n TEa 
GT n PZa
A conservative 24 weeks of therapy is advised in all treatment-experienced genotype 3 patients and those treatment-naïve genotype 3 patients with cirrhosis (see section 4.2). 
Konzervativno 24-tedensko zdravljenje je priporočljivo pri vseh predhodno zdravljenih bolnikih z genotipom 3 in pri predhodno nezdravljenih bolnikih z genotipom 3 s cirozo
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. 
V klinične študije so vključili bolnike s cirozo ali brez nje, ki se predhodno še niso zdravili ali pri katerih je bilo predhodno zdravljenje s PEG-IFN + ribavirinom +/- zaviralcem proteaze HCV neuspešno.
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. 
Sprememba rezultata MELD: Med tistimi, ki so dosegli SVR12 z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem + ribavirinom, jih je 57 % (70/123) oziroma 19 % (23/123) od izhodišča do 12. tedna po zdravljenju izboljšalo rezultat MELD oziroma ohranilo nespremenjen rezultat MELD; od 32 bolnikov, ki so ob izhodišču imeli rezultat MELD ≥ 15, jih je 59 % (19/32) v 12. tednu po zdravljenju imelo rezultat MELD < 15.
No dose adjustment of Harvoni or raltegravir is required. 
Odmerka zdravila Harvoni ali raltegravirja ni treba prilagajati.
SVR was achieved in all 24 patients (n = 20 with L159F+C316N; n = 1 with L159F; and n = 3 with N142T) who had baseline variants associated with resistance to NS5B nucleoside inhibitors. 
Vseh 24 bolnikov, ki je imelo izhodiščne različice, povezane z odpornostjo na nukleozidne zaviralce NS5B, je doseglo SVR (n = 20 z L159F+C316N; n = 1 z L159F; in n = 3 z N142T).
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. 
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.
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.
Table 15: Relapse rates for selected subgroups in study ION-2 LDV/SOF 
Preglednica 15: Stopnje relapsa za izbrane podskupine v študiji ION-2 LDV/SOF
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,