natgillin/translations-raw huggingface dataset:
Changes in MELD and CPT score from baseline to post-treatment Week 12 were analyzed for all patients with decompensated cirrhosis (pre- or post-transplant) who achieved SVR12 and for whom data were available (n = 123) to assess the effect of SVR12 on hepatic function.
Kako bi se procijenio učinak SVR12 na funkciju jetre, za sve bolesnike s dekompenziranom cirozom (prije ili poslije transplantacije) koji su postigli SVR12 i za koje su bili dostupni podaci (n = 123), analizirane su promjene u rezultatu MELD i CPT od početnih vrijednosti do 12. tjedna nakon liječenja.
Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
Liječnik će Vam možda trebati dati drugi lijek ili prilagoditi dozu lijeka koji uzimate.
Harvoni contains sunset yellow FCF aluminium lake (E110) which can cause allergic reactions
Harvoni sadrži boju sunset yellow FCF aluminium lake (E110), koja može izazvati alergijske reakcije
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.
Table 11: Demographics and baseline characteristics in study ION-1 Patient disposition
Tablica 11: Demografske i početne značajke u ispitivanju ION-1 Raspodjela bolesnika
SEDATIVES/HYPNOTICS Midazolam (2.5 mg single dose)/ ledipasvir (90 mg single dose)
Midazolam (2,5 mg jedna doza)/ ledipasvir (90 mg jedna doza)
• The active substances are ledipasvir and sofosbuvir.
• Djelatne tvari su ledipasvir i sofosbuvir.
f One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
f. Za jednog bolesnika u kojeg je virusno opterećenje postiglo < LLOQ na kraju liječenja nedostajali su početni podaci za
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); • rosuvastatin (a medicine used to treat high cholesterol).
• karbamazepin, fenobarbital i fenitoin (lijekovi koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja);
Table 8: Demographics and baseline characteristics in study ION-3 Patient disposition
Tablica 8: Demografske i početne značajke u ispitivanju ION-3 Raspodjela bolesnika
No dose adjustment required.
Nije potrebna prilagodba doze.
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.
AUC sofosbuvira i GS-331007 bili su gotovo proporcionalni dozi u rasponu doza od 200 mg do 400 mg.
Genotype 1b 0.004 Genotype 2a
Genotip 1a Genotip 1b Genotip 2a Genotip 2b
Following 12 weeks of treatment with ledipasvir/sofosbuvir (without ribavirin) in treatmentexperienced patients (arm 1 of ION-2 study) 4/4 patients with baseline NS5A RAVs conferring a ledipasvir fold-change of ≤ 100 achieved SVR.
Nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom (bez ribavirina) prethodno liječenih bolesnika (skupina 1 u ispitivanju ION-2), 4/4 bolesnika s početnim NS5A RAV-ovima koji nose promjenu u osjetljivosti na ledipasvir ≤ 100 puta postiglo je SVR.
24 weeks (n = 111)
24 tjedna (n = 111)
No dose adjustment of Harvoni or raltegravir is required.
Nije potrebna prilagodba doze lijeka Harvoni ili raltegravira.
No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007.
Nisu utvrđene nikakve klinički važne razlike u farmakokinetici sofosbuvira ili GS-331007 zbog spola.
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.
Promjena CPT rezultata i stadija: Među onima koji su postigli SVR12 u 12 tjedana liječenja kombinacijom ledipasvir/sofosbuvir + ribavirin, poboljšanje CPT rezultata imalo je 60 % (74/123), a 34 % (42/123) nije imalo nikakvu promjenu CPT rezultata od početka do 12. tjedna nakon liječenja; od 32 bolesnika koji su na početku imali cirozu CPT stadija C, 53 % (17/32) imalo je u 12. tjednu nakon liječenja cirozu CPT stadija B; od 88 bolesnika koji su na početku imali cirozu CPT stadija B, 25 % (22/88) imalo je u 12. tjednu nakon liječenja cirozu CPT stadija A.
Genotype 4d 0.60 Genotype 5a
Genotip 3a Genotip 4a Genotip 4d Genotip 5a
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Raltegravir (400 mg dvaput na dan)/ sofosbuvir (400 mg jedanput na dan)d
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
Ispitivanje 4063 bilo je otvoreno kliničko ispitivanje s tri skupine ispitanika u kojem se procijenilo liječenje ledipasvirom/sofosbuvirom u trajanju od 8, 12 i 24 tjedna u ukupno 95 bolesnika s CHC-om uzrokovanim genotipom 1 (72 %), 2 (22 %), 4 (2 %), 5 (1 %) ili 6 (2 %) i s ESRD-om koji je zahtijevao dijalizu: 45 prethodno neliječenih bolesnika zaraženih HCV-om genotipa 1 bez ciroze primalo je ledipasvir/sofosbuvir tijekom 8 tjedana; 31 prethodno liječen bolesnik zaražen HCV-om genotipa 1 i prethodno neliječeni ili već liječeni bolesnici zaraženi HCV-om genotipa 2, 5 i 6 bez ciroze primali su ledipasvir/sofosbuvir tijekom 12 tjedana; a 19 bolesnika zaraženih HCV-om genotipa 1, 2 i 4 s kompenziranom cirozom primalo je ledipasvir/sofosbuvir tijekom 24 tjedna.
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).
Odrasli s cirozom ili bez nje koji prethodno nisu bili liječeni - ION-1 (ispitivanje 0102) - genotip 1 Ispitivanje ION-1 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u 865 bolesnika s CHC-om uzrokovanim genotipom 1, uključujući one s cirozom (randomizirani u omjeru 1:1:1:1), koji prethodno nisu bili liječeni.
Patients without cirrhosis 89% (25/28)
Bolesnici s cirozom 73% (16/22)
No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits.
Nisu opaženi značajni učinci ledipasvira ili sofosbuvira na fetalni razvoj u štakora i kunića.
Rifapentine
Rifapentin
Famotidine dosed simultaneously with Harvonid
Famotidin primijenjen istovremeno s lijekom
Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5).
Ne preporučuje se istodobna primjena takvih lijekova s lijekom Harvoni (vidjeti dio 4.5).
8 weeks (n = 215)
8 tjedana (n = 215)
No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Nije potrebna prilagodba doze lijeka Harvoni ili efavirenza/ emtricitabina/ tenofovirdizoproksilfumarata.
Table 4: Ribavirin dose modification guideline for co-administration with Harvoni in adults Laboratory values
Tablica 4: Smjernica za prilagodbu doze ribavirina u odraslih kod istovremene primjene s lijekom Harvoni
No dose adjustment of Harvoni or methadone is required.
Nije potrebna prilagodba doze lijeka Harvoni ili metadona.
Harvoni [Outer packaging only]
16. PODACI NA BRAILLEOVOM PISMU Harvoni [samo vanjsko pakiranje]
Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy.
Medijan dobi 670 liječenih bolesnika bio je 59 godina (raspon: od 21 do 81 godine); 77 % bolesnika bili su muškarci; 91 % bili su bijelci; srednja vrijednost indeksa tjelesne mase iznosila je 28 kg/m2 (raspon: od 18 do 49 kg/m2); 94 % imalo je infekciju HCV-om genotipa 1, a 6 % imalo je infekciju HCV-om genotipa 4; u 78 % bolesnika prethodna HCV terapija nije bila uspješna.
No dose adjustment of Harvoni or ciclosporin is required at initiation of co-administration.
Nije potrebna prilagodba doze lijeka Harvoni ili ciklosporina na početku njihove istodobne primjene.
Age (years): median (range) Male gender
Dob (godine): medijan (raspon) 56 (24-67) Muški spol
Table 15: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Tablica 15: Stope relapsa u odabranim podskupinama u ispitivanju ION-2 LDV/SOF
Use with moderate P-gp inducers
Primjena s umjerenim induktorima P-glikoproteina
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).
Y93C/F/H/N/S za infekciju HCV-om genotipa 1a i L31I/F/M/V, P32L, P58D, A92K i Y93C/H/N/S za infekciju
Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
4.4 Posebna upozorenja i mjere opreza pri uporabi Harvoni se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže sofosbuvir.
Cross-resistance
Ukrižena rezistencija
- Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see section 4.4).
U bolesnika za koje se smatra da imaju niski rizik od progresije kliničke bolesti i koji imaju daljnje mogućnosti ponovnog liječenja može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (vidjeti dio 4.4).
↔ Emtricitabine ↑ Tenofovir
↑ Tenofovir
Table 10: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Tablica 10: Stope relapsa prema početnim značajkama u ispitivanju ION-3, populacija s virološkim neuspjehom*
24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Ova 4 bolesnika bez ciroze s relapsom imala su početne polimorfizme NS5A povezane s rezistencijom.
Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3).
Harvoni je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
b Patients with missing cirrhosis status were excluded from this subgroup analysis.
b. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Očekuje se da će istovremena primjena lijeka Harvoni s tipranavirom (pojačanim ritonavirom) smanjiti koncentraciju ledipasvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Harvoni.
Nakon što počnete uzimati lijek Harvoni, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
12 weeks (n = 111)
12 tjedana (n = 111)
- Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin.
- U bolesnika koji nisu pogodni za liječenje ribavirinom ili ga ne podnose može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (u bolesnika bez ciroze) ili 24 tjedna (u bolesnika s cirozom).
No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
Nisu utvrđene nikakve klinički važne razlike u farmakokinetici ledipasvira, sofosbuvira i GS-331007 zbog rase.
d 3/3 of these patients had cirrhosis.
d. 3/3 bolesnika imalo je cirozu. e. 0/4 bolesnika imalo je cirozu.
If you have any questions about your medicines, please ask your doctor or pharmacist.
Ako imate bilo kakvih pitanja o ovim lijekovima, obratite se svom liječniku ili ljekarniku.
c Patients with missing cirrhosis status were excluded from this subgroup analysis.
c. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
ION-3 evaluated 8 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin and 12 weeks of treatment with ledipasvir/sofosbuvir in treatment-naïve non-cirrhotic patients with genotype 1 CHC.
U ispitivanju ION-3 procjenjivalo se 8 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega te 12 tjedana liječenja ledipasvirom/sofosbuvirom bolesnika s CHC-om uzrokovanim genotipom 1, bez ciroze, koji prethodno nisu bili liječeni.
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.
Medijan dobi iznosio je 52 godine (raspon: od 26 do 72); 82 % bolesnika bili su muškarci; 61 % su bili bijelci; 34 % su bili crnci; 75 % ih je imalo infekciju HCV-om genotipa 1a; 2 % je imalo infekciju genotipa 4; 76 % je imalo ne-CC IL28B alele (CT ili TT); a 20 % je imalo kompenziranu cirozu.
No dose adjustment of Harvoni or midazolam is required.
Nije potrebna prilagodba doze lijeka Harvoni ili midazolama.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Jezgra tablete kopovidon laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni bezvodni magnezijev stearat
Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Pročitajte sažetke opisa svojstava lijeka za tenofovirdizoproksilfumarat, emtricitabin/tenofovirdizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat zbog preporuka o nadziranju funkcije bubrega.
Omeprazole dosed simultaneously with Harvoni
Preporuka za istovremenu primjenu s lijekom Harvoni
Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
HCV RNK < 6 milijuna IU/ml 2 % (2/121) HCV RNK > 6 milijuna IU/ml 10 % (9/92)
Potential for other medicinal products to affect Harvoni Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not.
Ledipasvir i sofosbuvir supstrati su prijenosnika lijekova P-gp i BCRP, dok GS-331007 to nije.
ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
Norgestimat/etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ ledipasvir (90 mg jedanput na dan)d
Dosed simultaneouslyf
Relapsb Ostaloc
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 jedanput na dan)d
Other statins
Drugi statini
Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
U bolesnika koji su prethodno bili liječeni, prethodno liječenje PEG-IFN + ribavirinom ± inhibitorom proteaze HCV-a ili sofosbuvirom + ribavirinom ± PEG-IFN bilo je neuspješno.
The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively.
Nakon primjene ledipasvira/sofosbuvira, medijan terminalnog poluvijeka sofosbuvira iznosio je 0,5 sati, a GS-331007 27 sati.
d Patients with missing cirrhosis status were excluded from this subgroup analysis.
d. Bolesnici bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d
Rifampicin (600 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)d
24 weeks (n = 217)
24 tjedna (n = 217)
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 ukupno 95 bolesnika, na početku ispitivanja njih 20 % imalo je cirozu, 22 % bilo je prethodno liječeno, 21 % imalo je transplantiran bubreg, 92 % bilo je na hemodijalizi, a 8 % na peritonejskoj dijalizi; srednja vrijednost trajanja dijalize iznosila je 11,5 godina (raspon: od 0,2 do 43,0 godine).
Patients awaiting liver transplantation and post-liver transplant - SOLAR-1 and SOLAR-2 SOLAR-1 and SOLAR-2 were two open-label clinical studies that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir in combination with ribavirin in genotype 1 and 4 HCV-infected patients who have undergone liver transplantation and/or who have decompensated liver disease.
U dva otvorena klinička ispitivanja SOLAR-1 i SOLAR-2, procjenjivalo se 12-tjedno i 24-tjedno liječenje ledipasvirom/sofosbuvirom u kombinaciji s ribavirinom u bolesnika s infekcijom HCV-om genotipa 1 i 4, kojima je transplantirana jetra i/ili koji imaju dekompenziranu bolest jetre.
Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Rifampicin (600 mg jedanput na dan)/ sofosbuvir (400 mg jedna doza)d
No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration.
Nije potrebna prilagodba doze lijeka Harvoni ili takrolimusa na početku njihove istodobne primjene.
Skin and subcutaneous tissue disorders: Common rash
Poremećaji kože i potkožnog tkiva:
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Abakavir/ lamivudin (600 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
Co-administration with such medicinal products is not recommended with Harvoni (see section 4.4).
Ne preporučuje se istodobna primjena takvih lijekova s lijekom Harvoni (vidjeti dio 4.4).
When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
+ ribavirin bile su sukladne poznatom sigurnosnom profilu kod liječenja ribavirinom, bez povećanja učestalosti ili težine očekivanih nuspojava.
This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
+ ribavirinom tijekom 24 tjedna i postigao je SVR nakon ponovnog liječenja.
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
• rifampicin i rifabutin (antibiotici koji se primjenjuju za liječenje infekcija, uključujući tuberkulozu);
Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
ION-2 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u bolesnika (randomiziranih u omjeru 1:1:1:1) s cirozom ili bez nje zaraženih HCV-om genotipa 1 u kojih je prethodna terapija režimom na temelju interferona bila neuspješna, uključujući režime koji su sadržavali inhibitor proteaze HCV-a.
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.
Supstitucija S282T povezana s rezistencijom na sofosbuvir nije bila otkrivena populacijskim ili detaljnim sekvencioniranjem u početnoj NS5B sekvenci ni u jednog bolesnika u ispitivanjima faze 3, SVR je postignut u sva 24 bolesnika (n = 20 s L159F+C316N; n = 1 s L159F; i n = 3 s N142T) koji su na početku imali varijante povezane s rezistencijom na NS5B nukleozidne inhibitore.
• fainting
• nesvjesticu
Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).
Istovremena primjena lijeka Harvoni s rosuvastatinom je kontraindicirana (vidjeti dio 4.3).
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.
Ispitivanje ION-4 bilo je otvoreno kliničko ispitivanje kojim se procijenila sigurnost i djelotvornost liječenja ledipasvirom/sofosbuvirom bez ribavirina tijekom 12 tjedana u bolesnika s CHC-om uzrokovanim HCV-om genotipa 1 ili 4 te istovremeno zaraženih virusom HIV-1, koji prethodno nisu bili liječeni i koji su prethodno bili liječeni.
No teratogenic effects were observed in rat and rabbit developmental toxicity studies with ledipasvir.
Nisu bili opaženi teratogeni učinci ledipasvira u ispitivanjima njegove razvojne toksičnosti na štakorima i kunićima.
Harvoni is contraindicated with rifabutin (see section 4.3).
Harvoni je kontraindiciran s rifabutinom (vidjeti dio 4.3).
virus.
HIV-om)
↑ Dabigatran ↔ Ledipasvir
↑ Lopinavir ↑ Ritonavir
Harvoni is contraindicated with carbamazepine (see section 4.3).
Harvoni je kontraindiciran s karbamazepinom (vidjeti dio 4.3).
Breast-feeding Do not breast-feed during treatment with Harvoni.
Nemojte dojiti tijekom liječenja lijekom Harvoni.
12 weeks (n = 214)
12 tjedana (n = 214)
When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Kad se daje s elvitegravirom/kobicistatom/ emtricitabinom/tenofovirdizoproksilfumaratom, očekuje se da će Harvoni povećati koncentraciju tenofovira.
No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
U bolesnika s dekompenziranom cirozom i/ili onih poslije transplantacije jetre i koji su primali ledipasvir/sofosbuvir s ribavirinom, nisu otkrivene nove nuspojave.
Table 9: Response rates in study ION-3 LDV/SOF
Tablica 9: Stope odgovora u ispitivanju ION-3 LDV/SOF
Tabulated list of adverse events
Tablični popis nuspojava
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
Sofosbuvir ↓ Cmax 0,23 (0,19; 0,29) ↓ AUC 0,28 (0,24; 0,32)
Relapseb
Relapsb
Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
Takrolimus (jedna doza od 5 mg)/ sofosbuvir (jedna doza od 400 mg)h
Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45)
Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30)
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Tel: + 44 (0) 8000 113700
SVR Outcome for patients without SVR On-treatment virologic failure
Ishod u bolesnika bez SVR
The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe hepatic impairment (CPT class C).
Farmakokinetika ledipasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem jetre (CPT stadij C) nakon jedne doze od 90 mg ledipasvira.
When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Kad se daje s tenofovirdizoproksilfumaratom koji se primjenjivao zajedno s atazanavirom/ritonavirom, Harvoni će povećati koncentraciju tenofovira.
12 weeks (n = 217)
12 tjedana (n = 217)
Table 12: Response rates in study ION-1 LDV/SOF
Tablica 12: Stope odgovora u ispitivanju ION-1 LDV/SOF