natgillin/translations-raw huggingface dataset:
Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose. 
Medijan vršne koncentracije GS-331007 u plazmi bio je opažen 4 sata nakon uzimanja doze.
HCV/HBV (hepatitis B virus) co-infection 
Istovremena infekcija HCV/HBV-om (virusom hepatitisa B)
Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203. 
Sofosbuvir se opsežno metabolizira u jetri i nastaje farmakološki aktivan nukleozidni analog trifosfat GS-461203.
a TE: number of treatment-experienced patients. 
TE: broj bolesnika koji su prethodno bili liječeni.
NS5A RAVs: No genotype 2 infected patients experienced relapse in the clinical study and therefore there are no data regarding NS5A RAVs at the time of failure. 
NS5A RAV-ovi: Niti jedan bolesnik zaražen genotipom 2 nije imao relaps u kliničkom ispitivanju te stoga nema podataka o NS5A RAV-ovima u vrijeme virološkog neuspjeha.
Adolescents: for ribavirin dosing recommendations see table 3 below. 
Adolescenti: preporuke za doziranje ribavirina vidjeti u tablici 3 niže.
The safety assessment of Harvoni was mainly based on pooled Phase 3 clinical studies, without a control, in 1952 patients who received Harvoni for 8, 12 or 24 weeks, including 872 patients who received Harvoni in combination with ribavirin. 
Procjena sigurnosti lijeka Harvoni uglavnom se temeljila na objedinjenim podacima iz kliničkih ispitivanja faze 3 bez kontrolne skupine u kojima je 1952 bolesnika primalo Harvoni tijekom 8, 12 ili 24 tjedna (uključujući i 872 bolesnika koji su primali Harvoni u kombinaciji s ribavirinom).
Therefore, Harvoni should not be used during breast-feeding. 
Stoga se Harvoni ne bi trebao primjenjivati tijekom dojenja.
In clinical studies - Adults-Genotype 2, 3, 4, 5 and 6 
U kliničkim ispitivanjima - odrasli, genotip 2, 3, 4, 5 i 6
In rabbit studies exposure to sofosbuvir was 6 times the expected clinical exposure. 
U ispitivanjima na kunićima izloženost sofosbuviru bila je 6 puta veća od očekivane kliničke izloženosti.
* - If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of Harvoni + ribavirin should be considered in order to minimize the risk for relapse. 
* Ako zbog podnošljivosti nije moguće postići normaliziraniju dozu ribavirina (prema težini i funkciji bubrega), potrebno je razmotriti 24-tjednu primjenu lijeka Harvoni + ribavirin kako bi se rizik od relapsa smanjio na najmanju moguću mjeru.
The proportion of such baseline NS5A RAVs seen with deep sequencing varied from very low (cut off for assay = 1%) to high (main part of the plasma population). 
Udio takvih početnih NS5A RAV-ova koji se vidio pomoću detaljnog sekvencioniranja kretao se od vrlo malog (granična vrijednost testa = 1 %) do velikog (veći dio populacije plazme).
• rifapentine (antibiotic used to treat infections, including tuberculosis); 
• rifapentin (antibiotik koji se primjenjuje za liječenje infekcija, uključujući tuberkulozu);
Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side. 
Narančasta, filmom obložena tableta u obliku romba, veličine 19 mm x 10 mm, s utisnutim “GSI” na jednoj strani i “7985” na drugoj strani.
Harvoni + ribavirinA for 12 weeks or 
Harvoni s ribavirinomA tijekom 12 tjedana ili
d Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2. 
d. Metavir-rezultat = 4 ili rezultat po Ishaku ≥ 5 na biopsiji jetre ili rezultat FibroTesta > 0,75 i (APRI) > 2.
Interactions between Harvoni and other medicinal products 
Interakcije između lijeka Harvoni i drugih lijekova
At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6). 
Na početku ispitivanja, dva su bolesnika imala cirozu i srednja vrijednost eGFR bila je 24,9 ml/min (raspon: 9,0-39,6).
In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite was approximately 5 times higher than the clinical exposure at 400 mg sofosbuvir. 
U ispitivanjima na štakorima, izloženost sofosbuviru nije se mogla odrediti, ali granice izloženosti na temelju glavnog metabolita u ljudi bile su približno 5 puta veće od kliničke izloženosti kod doze od 400 mg sofosbuvira.
1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~6-fold↑ 23-fold↑ Ledipasvir 
1,6 puta↑ 2,1 puta↑ 2,7 puta↑ 1,3 puta↑ 1,6 puta↑ ~2 puta↑ 1,9 puta↑ GS-331007 1,6 puta↑ 1,9 puta↑ 5,5 puta↑
Harvoni tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil. 
Harvoni tablete isporučuju se u bocama od polietilena visoke gustoće (HDPE), s polipropilenskim sigurnosnim zatvaračem za djecu, koje sadrže 28 filmom obloženih tableta sa sredstvom za sušenje od silikagela i poliesterskom vaticom.
When Harvoni is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2). 
Kad se Harvoni primjenjuje u kombinaciji s ribavirinom, pročitajte također sažetak opisa svojstava lijeka za ribavirin za bolesnike s klirensom kreatinina (CrCl) < 50 ml/min (vidjeti dio 5.2).
↑ Rosuvastatin (Inhibition of drug transporters OATP and BCRP) 
↑ Rosuvastatin (Inhibicija prijenosnika lijekova OATP i BCRP)
• digoxin used to treat heart conditions; 
• digoksin koji se primjenjuje za liječenje srčanih bolesti;
Previously treated adults with cirrhosis - SIRIUS - Genotype 1 
Prethodno liječeni odrasli bolesnici s cirozom - SIRIUS - genotip 1
Fifty-five percent (55%) of the patients were treatment-experienced. 
Prethodno je bilo liječeno 55 % bolesnika.
Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively. 
Podaci detaljnog sekvenciranja za NS5A i NS5B (granična vrijednost testa od 1 %) nakon početka ispitivanja bili su dostupni za 37/37 odnosno 36/37 bolesnika.
Male gender 
Spol muški ženski
Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below. 
Klinička djelotvornost i sigurnost kod genotipa 2, 3, 4, 5 i 6 (vidjeti također dio 4.4) Ledipasvir/sofosbuvir procijenjen je za liječenje infekcije koja nije uzrokovana genotipom 1 u malim ispitivanjima faze 2, kako je sažeto prikazano niže.
Haemoglobin in patients with history of stable cardiac disease 
Hemoglobin u bolesnika sa stabilnom srčanom bolesti u anamnezi
Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro. 
Defosforilacija dovodi do stvaranja nukleozidnog metabolita GS-331007 koji se ne može učinkovito ponovno fosforilirati i nema anti-HCV djelovanje in vitro.
In clinical studies - Adults-Genotype 1 
U kliničkim ispitivanjima - odrasli, genotip 1
B For ribavirin dosing recommendations in patients with decompensated cirrhosis, see table 2 below. 
B Preporuke za doziranje ribavirina u bolesnika s dekompenziranom cirozom vidjeti u tablici 2 niže.
• If you are sick (vomit) more than 5 hours after taking Harvoni, you do not need to take another tablet until your next scheduled tablet. 
• Ako povratite nakon više od 5 sati nakon uzimanja lijeka Harvoni, ne trebate uzeti drugu tabletu prije sljedeće tablete prema rasporedu.
↔ indicates no clinically relevant change in the exposure of Ledipasvir. 
↔ nema klinički relevantne promjene u izloženosti ledipasviru.
Table 20: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Ledipasvir Compared to Subjects with Normal Renal Function 
Tablica 20: Utjecaj različitih stupnjeva oštećenja bubrega na izloženost (AUC) sofosbuviru, GS-331007 i ledipasviru u usporedbi s ispitanicima s normalnom funkcijom bubrega
Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively. 
U odnosu na bolesnike s normalnom jetrenom funkcijom, AUC0-24 sofosbuvira bila je 126 % odnosno 143 % viša kod umjerenog i teškog oštećenja funkcije jetre, dok je AUC0-24 GS-331007 bila 18 % odnosno 9 % viša.
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. 
NS5A supstitucija Y93C pojavila se u HCV-u kod 1 bolesnika (genotip 4), dok su NS5A RAV-ovi prisutni na početku bili opaženi u vrijeme neuspjeha u svih bolesnika.
GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase. 
GS-461203 (djelatni metabolit sofosbuvira) nije inhibitor ni ljudskih DNK- i RNK-polimeraza niti je inhibitor mitohondrijske RNK-polimeraze.
The improvement in MELD scores observed was driven largely by improvements in total bilirubin. 
Opaženo poboljšanje MELD rezultata uglavnom je bilo odraz poboljšanja ukupnog bilirubina.
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. 
I sofosbuvir i ledipasvir su bili potpuno djelatni protiv supstitucija povezanih s rezistencijom na druge direktno djelujuće antivirotike i različitim mehanizmom djelovanja, kao što su NS5B nenukleozidni inhibitori i NS3 inhibitori proteaze.
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. 
Izloženost sofosbuviru u ispitivanjima na glodavcima nije se mogla otkriti, vjerojatno zbog jake aktivnosti esteraze; međutim, izloženost glavnom metabolitu GS-331007 u dozama koje uzrokuju štetne učinke bila je 16 puta (štakor) i 71 puta (pas) veća od kliničke izloženosti kod doze od 400 mg sofosbuvira.
Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1). 
Sigurnost i djelotvornost ledipasvira/sofosbuvira ustanovljene su u bolesnika s dekompenziranom cirozom (vidjeti dio 5.1).
Close monitoring is recommended if this medicinal product is administered with Harvoni (see sections 4.4 and 4.8). 
Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje s lijekom Harvoni (vidjeti dijelove 4.4 i 4.8).
In this setting, exposure of sofosbuvir metabolite GS331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials. 
U takvim okolnostima, izloženost metabolitu sofosbuvira GS-331007 povećana je 20 puta i premašuje razine pri kojima su nuspojave opažene u pretkliničkim ispitivanjima.
In the pooled analysis of the Phase 3 studies, 16% of patients had baseline NS5A RAVs identified by population or deep sequencing irrespective of subtype. 
U analizi objedinjenih podataka iz ispitivanja faze 3, 16 % bolesnika imalo je početne NS5A RAV utvrđene populacijskim ili detaljnim sekvencioniranjem bez obzira na podtip.
Site-directed mutagenesis of the Y93H substitution in both genotype 1a and 1b as well as the Q30R 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). 
Ciljana mutageneza u vidu supstitucije Y93H u oba genotipa 1a i 1b, kao i Q30R i L31M supstitucija u genotipu 1a, dovela je do jako smanjene osjetljivosti na ledipasvir (promjena u EC50 u rasponu od 544 do 1677 puta).
The physician in charge of the diabetic care of the patient should be informed when direct-acting antiviral therapy is initiated. 
Liječnik zadužen za praćenje dijabetesa u bolesnika mora biti obaviješten o uvođenju terapije direktno djelujućim antivirotikom.
The SVR12 rate was 98% overall (98% [78/80] in treatment-naïve patients and 100% [20/20] in treatment experienced patients). 
Stopa SVR12 iznosila je ukupno 98 % (98 % [78/80] u prethodno neliječenih bolesnika i 100 % [20/20] u prethodno liječenih bolesnika).
Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated. 
Početna doza od 600 mg koja se može titrirati do najviše 1000/1200 mg (1000 mg za bolesnike težine < 75 kg i 1200 mg za one težine ≥ 75 kg) ako se dobro podnosi.
There were no effects on survival, physical and behavioural development and reproductive performance in the offspring at maternal exposures similar to the exposure in humans at the recommended clinical dose. 
Nije bilo učinaka na preživljenje, fizički i bihevioralni razvoj te reproduktivne sposobnosti potomstva pri izloženostima majke sličim izloženosti ljudi pri preporučenoj kliničkoj dozi.
Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose. 
Na nepromijenjeni ledipasvir izlučen u stolici otpadala je srednja vrijednost od 70 % primijenjene doze, a na oksidativni metabolit M19 2,2 % doze.
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. 
Pri koncentracijama koje se postižu u kliničkoj primjeni, ledipasvir nije inhibitor jetrenih prijenosnika, uključujući OATP 1B1 ili 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, prijenosnika za izbacivanje mnogih lijekova i toksičnih spojeva (MATE) 1, proteina odgovornog za rezistenciju na mnoge lijekove (MRP) 2 ili MRP4.
The adverse reactions are listed below by body system organ class and frequency. 
Nuspojave su navedene niže prema klasifikaciji organskih sustava i učestalosti.
Within ledipasvir/sofosbuvir, GS-331007 accounts for approximately 85% of total systemic exposure. 
Kod ledipasvira/sofosbuvira, na GS-331007 otpada približno 85 % ukupne sistemske izloženosti.
a Twelve patients transplanted prior to post-treatment Week 12 with HCV RNA< LLOQ at last measurement prior to transplant were excluded. 
Dvanaest bolesnika transplantiranih prije 12. tjedna nakon liječenja, s HCV RNK < LLOQ na zadnjem mjerenju prije transplantacije bilo je isključeno iz analize.
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. 
Opisane interakcije lijekova temelje se na ispitivanjima provedenima s ledipasvirom/sofosbuvirom ili ledipasvirom i sofosbuvirom kao pojedinačnim tvarima ili su predviđene interakcije lijekova koje mogu nastati s ledipasvirom/sofosbuvirom.
The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively. 
Najviše zabilježene doze bile su 120 mg ledipasvira dvaput na dan tijekom 10 dana i jedna doza sofosbuvira od 1200 mg.
CPT A = CPT score 5-6 (compensated), CPT B = CPT score 7-9 (decompensated), CPT C = CPT score 10-12 (decompensated). 
c. CPT = Child-Pugh-Turcotte, FCH = fibrozirajući kolestatski hepatitis, CPT A = CPT rezultat 5-6 (kompenzirani), CPT B = CPT rezultat 7-9 (dekompenzirani), CPT C = CPT rezultat 10-12 (dekompenzirani).
No major differences in outcomes were observed by the presence or absence of baseline NS5A RAVs. 
Nisu bile opažene velike razlike u ishodima ovisno o prisutnosti ili odsutnosti početnih NS5A RAV-ova.
The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 have not been established in paediatric patients aged < 12 years (see section 4.2). 
Farmakokinetika ledipasvira, sofosbuvira i GS-331007 nije ustanovljena u pedijatrijskih bolesnika u dobi mlađoj od 12 godina (vidjeti dio 4.2).
A Adults: weight based ribavirin (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg), administered orally in two divided doses with food. 
Odrasli: ribavirin na temelju tjelesne težine (< 75 kg = 1000 mg i ≥ 75 kg = 1200 mg), primijenjen peroralno, raspodijeljeno u dvije doze, s hranom.
Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Harvoni. 
Ako se istovremena primjena amiodarona smatra neophodnom, preporučuje se da se bolesnike pažljivo prati na početku uzimanja lijeka Harvoni.
Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort). 
Lijekovi koji su jaki induktori P-glikoproteina (P-gp) u crijevima (karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin i gospina trava).
Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate, administered with efavirenz, rilpivirine or raltegravir. 
Bolesnici su primali stabilnu antiretrovirusnu terapiju protiv virusa HIV-1 koja je uključivala emtricitabin/tenofovirdizoproksilfumarat, primijenjen s efavirenzom, rilpivirinom ili raltegravirom.
Observed: 
Opaženo:
This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted. 
Ovi podaci pokazuju da je bubrežni klirens glavni put eliminacije GS-331007 s time da se veliki dio izlučuje aktivno.
Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome. 
Provedene su analize da se istraži povezanost između početnih NS5A RAV koje su postojale od ranije i ishoda liječenja.
At the time of the interim analysis 40 patients have reached 12 weeks post treatment and SVR12 was 98% (39/40). 
U vrijeme interim analize, u 40 bolesnika proteklo je 12 tjedana od liječenja, a SVR12 je bio 98 %
In cirrhotic patients relapses occurred with both regimens, and in the absence and presence of baseline NS5A RAVs. 
Bolesnici s cirozom imali su relaps uz oba režima te i u prisutnosti i odsutnosti početnih NS5A RAV.
6 years. 
6.3 Rok valjanosti 6 godina
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. 
Istovremena primjena s lijekovima koji inhibiraju P-gp i/ili BCRP može povećati koncentracije ledipasvira i sofosbuvira u plazmi bez povećanja koncentracije GS-331007 u plazmi; Harvoni se može istovremeno primjenjivati s inhibitorima P-gp i/ili BCRP.
HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines. 
Bolesnici istodobno zaraženi HBV-om/HCV-om izloženi su riziku od reaktivacije HBV-a te ih stoga treba pratiti i liječiti sukladno važećim kliničkim smjernicama.
LDV/SOF 12 weeks 
LDV/SOF 12 tjedana
Ledipasvir (90 mg once daily) 
Ledipasvir (90 mg jedanput na dan)
Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone with or without other drugs that lower heart rate. 
Slučajevi teške bradikardije i srčanog bloka uočeni su kada se Harvoni koristi s amiodaronom i drugim lijekovima koji snižavaju srčanu frekvenciju ili bez njih.
The adverse reactions observed were consistent with those observed in clinical studies of ledipasvir/sofosbuvir in adults (see Table 6). 
Opažene nuspojave bile su sukladne onima opaženima u kliničkim ispitivanjima ledipasvira/sofosbuvira u odraslih (vidjeti tablicu 6).
If you are not sure about taking any other medicines, talk to your doctor or pharmacist. 
Ako niste sigurni u vezi s uzimanjem drugih lijekova, obratite se svom liječniku ili ljekarniku.
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1. 
Sofosbuvir i GS-331007 nisu inhibitori prijenosnika lijekova P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1, a GS-331007 nije inhibitor OAT1, OCT2 i MATE1.
Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b). 
Bolesnici su bili randomizirani u omjeru 1:1:1 u jednu od tri terapijske skupine i stratificirani prema genotipu HCV-a (1a naspram 1b).
What you need to know before you take Harvoni Do not take Harvoni 
Što morate znati prije nego počnete uzimati Harvoni
HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b. 
Replikoni HCV-a sa smanjenom osjetljivošću na ledipasvir odabrani su u staničnoj kulturi za genotip 1a i 1b.
No human data on the effect of Harvoni on fertility are available. 
Nema dostupnih podataka o utjecaju lijeka Harvoni na plodnost u ljudi.
Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. 
Ispitivanja na životinjama ne ukazuju na izravan štetan učinak na reprodukciju.
TOTAL (n = 865) 
UKUPNO (n = 865)
Relative to fasting conditions, the administration of a single dose of ledipasvir/sofosbuvir with a moderate fat or high fat meal increased the sofosbuvir AUC0-inf by approximately 2-fold, but did not significantly affect the sofosbuvir Cmax. 
U odnosu na stanje natašte, primjena jedne doze ledipasvira/sofosbuvira s umjereno masnim ili visoko-masnim obrokom povećala je AUC0-inf sofosbuvira za približno 2 puta, ali nije značajno utjecala na Cmax sofosbuvira.
Use with certain HIV antiretroviral regimens 
Primjena s određenim antiretrovirusnim režimima liječenja HIV-a
Such co-administration is not recommended (see section 4.4). 
Ne preporučuje se njihova istodobna primjena (vidjeti dio 4.4).
Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility. 
Ispitivanja na životinjama ne ukazuju na štetne učinke ledipasvira ili sofosbuvira na plodnost.
Table 18: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection 
Tablica 18: Stope odgovora (SVR12) na ledipasvir/sofosbuvir tijekom 12 tjedana u bolesnika s infekcijom genotipom 2, 4, 5 i 6 HCV-a
Cirrhosis was defined by biopsy, Fibroscan (> 12.5 kPa) or FibroTest > 0.75 and an AST:platelet ratio index (APRI) of > 2. 
Ciroza je bila definirana na temelju biopsije, Fibroscana (> 12,5 kPa) ili FibroTesta > 0,75 i indeksa omjera AST-a i trombocita (APRI) > 2.
Table 3: Guidance for ribavirin dosing when administered with Harvoni to adolescents aged 12 to < 18 years. 
Tablica 3: Smjernice za doziranje ribavirina kada se primjenjuje s lijekom Harvoni, kod adolescenata u dobi od 12 do < 18 godina
c Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up). 
c. Ostalo uključuje bolesnike koji nisu postigli SVR i nisu zadovoljili kriterije virološkog neuspjeha (npr. izgubljeni iz praćenja).
Lopinavir boosted with ritonavir + emtricitabine/ tenofovir disoproxil fumarate 
Lopinavir pojačan ritonavirom + emtricitabin/ tenofovirdizoproksilfumarat
• You or your partner must use an effective birth control method during treatment with Harvoni together with ribavirin and for some time afterwards. 
• Vi ili Vaš(a) partner(ica) morate primjenjivati učinkovitu metodu kontrole začeća tijekom i neko vrijeme nakon liječenja lijekom Harvoni zajedno s ribavirinom.
Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%). 
Nakon jedne doze od 90 mg [14C]-ledipasvira, sistemska izloženost bila je gotovo isključivo posljedica izloženosti ishodišnom lijeku (> 98 %).
Relapsea 
Relapsa