natgillin/translations-raw huggingface dataset:
There are no data on the safety and efficacy of Vemlidy in HBV infected patients with decompensated liver disease and who have a Child Pugh Turcotte (CPT) score > 9 (i.e. class C).
Nema podataka o sigurnosti i djelotvornosti lijeka Vemlidy u bolesnika zaraženih HBV-om koji imaju dekompenziranu bolest jetre i rezultat po klasifikaciji Child-Pugh-Turcotte (CPT) > 9 (tj. stadij C).
Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications.
U bolesnika s bolešću jetre koji hepatitis B liječe pomoću lijekova za liječenje virusnih infekcija postoji veći rizik od teških i potencijalno smrtonosnih komplikacija bolesti jetre.
However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
No tenofovirdizoproksilfumarat smanjio je stopu preživljenja i težinu mladunčadi u perinatalnim i postnatalnim ispitivanjima toksičnosti pri dozama toksičnim za majku.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
U slučaju predoziranja bolesnik se mora nadzirati zbog moguće pojave toksičnosti (vidjeti dio 4.8).
The safety and efficacy of Vemlidy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Vemlidy u djece mlađe od 12 godina ili tjelesne težine < 35 kg nisu još ustanovljene.
In patients who are co-infected with HBV and HIV, Vemlidy should be co-administered with other antiretroviral agents to ensure that the patient receives an appropriate regimen for treatment of HIV (see section 4.5).
U bolesnika s istodobnom infekcijom HBV-om i HIV-om Vemlidy treba davati istodobno s ostalim antiretrovirusnim lijekovima kako bi se osiguralo da bolesnik dobiva odgovarajući režim liječenja HIV-a (vidjeti dio 4.5).
In analyses at Week 48 (N = 20) and Week 96 (N = 72), no amino acid substitutions associated with resistance to Vemlidy were identified in these isolates (genotypic and phenotypic analyses).
48. tjednu (N = 20) i 96. tjednu (N = 72) u tim izolatima nisu identificirane supstitucije aminokiselina povezane s otpornošću na Vemlidy (genotipske i fenotipske analize).
Co-administration guidance for the treatment of hepatitis C should be followed (see section 4.5).
Potrebno je slijediti smjernice za istodobnu primjenu za liječenje hepatitisa C (vidjeti dio 4.5).
The adverse reactions are listed below by body system organ class and frequency based on the Week 96 analysis.
Nuspojave su navedene u nastavku prema klasifikaciji organskih sustava i učestalosti nuspojava na temelju analize u 96. tjednu.
• Periodic Safety Update reports
• Periodička izvješća o neškodljivosti
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Metabolizam je glavni put eliminacije tenofoviralafenamida u ljudi, kojim se eliminira > 80% oralne doze.
Vemlidy can cause dizziness.
Vemlidy može uzrokovati omaglicu.
No clinically relevant differences in pharmacokinetics according to age or ethnicity have been identified.
Nisu utvrđene nikakve klinički relevantne razlike u farmakokinetici prema dobi ili etničkoj pripadnosti.
• Take steps to avoid getting pregnant during treatment with Vemlidy.
• Poduzmite mjere za sprječavanje trudnoće tijekom liječenja lijekom Vemlidy.
Patients should be informed that dizziness has been reported during treatment with Vemlidy.
Bolesnike treba informirati da je tijekom liječenja lijekom Vemlidy prijavljena omaglica.
Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders
Proljev, povraćanje, mučnina, bol u abdomenu, distenzija abdomena, flatulencija
In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
U bolesnika s teškim oštećenjem funkcije jetre ukupne koncentracije tenofoviralafenamida i tenofovira u plazmi su niže od onih uočenih u osoba s normalnom funkcijom jetre.
Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Medijan poluvijeka tenofoviralafenamida i tenofovira u plazmi iznosi 0,51 odnosno 32,37 sata.
It is recommended that you do not breast-feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.
Preporučuje se ne dojiti kako bi se spriječio prijenos tenofoviralafenamida ili tenofovira na dijete putem majčina mlijeka.
Vemlidy film-coated tablets are yellow, round, printed (or marked) with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Filmom obložene tablete lijeka Vemlidy su žute boje i okrugle, s utisnutim (ili označene sa) „GSI” na jednoj strani i „25” na drugoj strani tablete.
No human data on the effect of Vemlidy on fertility are available.
Nema dostupnih podataka o učinku lijeka Vemlidy na plodnost u ljudi.
However, in animal studies it has been shown that tenofovir is secreted into milk.
No tijekom ispitivanja na životinjama pokazalo se da se tenofovir izlučuje u mlijeko životinja.
b Adjusted by baseline plasma HBV DNA categories and oral antiviral treatment status strata.
b. Prilagođeno prema kategorijama početne vrijednosti HBV DNK u plazmi i statusu liječenja oralnim antivirusnim lijekovima.
• In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
• U bolesnika negativnih na HBeAg koji nemaju cirozu liječenje se treba primjenjivati najmanje do HBs serokonverzije ili do pojave dokaza o gubitku djelotvornosti.
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Tenofoviralafenamid nije inhibitor enzima CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6 in vitro.
Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of mitochondrial toxicity in vitro based on several assays including mitochondrial DNA analyses.
Tenofovirdifosfat je slab inhibitor DNK polimeraza sisavaca koje uključuju mitohondrijsku DNK polimerazu γ, te nema dokaza in vitro toksičnosti za mitohondrije na temelju nekoliko testova uključujući analize mitohondrijske DNK.
Acute exacerbation of hepatitis has been reported in patients who have discontinued treatment for hepatitis B, usually in association with rising HBV DNA levels in plasma.
Akutna egzacerbacija hepatitisa zabilježena je u bolesnika koji su prekinuli liječenje hepatitisa B, a obično je povezana s povećanjem razina HBV DNK u plazmi.
• If it is more than 18 hours after you usually take Vemlidy, then do not take the missed dose.
• Ako je prošlo više od 18 sati od vremena kada obično uzimate Vemlidy, nemojte uzeti propuštenu dozu.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
U bolesnika s cirozom može postojati veći rizik od dekompenzacije jetre nakon egzacerbacije hepatitisa te se stoga trebaju pomno nadzirati tijekom terapije.
• If it is less than 18 hours after you usually take Vemlidy, take it as soon as you can, and then take your next dose at its regular time.
• Ako je prošlo manje od 18 sati od vremena kada obično uzimate Vemlidy, uzmite dozu što prije možete, a potom sljedeću dozu uzmite u redovito vrijeme.
Drug interaction information for Vemlidy with potential concomitant medicinal products is summarised in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”; twice daily as “b.i.d.”, single dose as “s.d.”, once daily as “q.d.”; and intravenously as “IV”).
Informacije o interakcijama lijeka Vemlidy s lijekovima koji se potencijalno mogu istodobno primjenjivati sažeto su prikazane u Tablici 1 u nastavku (povećanje je prikazano oznakom „↑”, smanjenje oznakom „↓”, stanje bez promjene oznakom „↔”, dva puta na dan oznakom „b.i.d.”, jedna doza kao „s.d.”, jedanput na dan oznakom „q.d.” i intravenska primjena oznakom „i.v.”).
Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population (see section 5.2).
Stoga se parametri jetre i žuči te bubrega u toj populaciji bolesnika moraju pomno nadzirati (vidjeti dio 5.2).
Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Tenofoviralafenamid prenose P-gp i protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP).
d Includes patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy, e.g.
d. Uključuje bolesnike koji su prekinuli primjenu lijeka zbog razloga koji ne obuhvaćaju štetni događaj, smrt ili nedjelotvornost, npr. povlačenje pristanka, gubitak tijekom praćenja itd.
Vemlidy has not been tested in children aged less than 12 years old or weighing less than 35 kg.
Vemlidy nije ispitan u djece mlađe od 12 godina ili čija je tjelesna težina manja od 35 kg.
Discontinued study drug due to lack of efficacy Discontinued study drug due to AE or death Discontinued study drug due to other reasonsd
Primjena ispitivanog lijeka prekinuta zbog nedjelotvornosti Primjena ispitivanog lijeka prekinuta zbog nuspojava ili smrti Primjena ispitivanog lijeka prekinuta zbog ostalih razlogad
Relative to fasting conditions, the administration of a single dose of Vemlidy with a high fat meal resulted in a 65% increase in tenofovir alafenamide exposure.
U odnosu na uzimanje lijeka natašte, primjena jedne doze lijeka Vemlidy uz obrok s visokim udjelom masti rezultirala je 65%-tnim povećanjem izloženosti tenofoviralafenamidu.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
U bolesnika s uznapredovalom bolešću jetre ili cirozom ne preporučuje se prekid liječenja jer egzacerbacija hepatitisa nakon liječenja može uzrokovati dekompenzaciju jetre.
Tenofovir is renally eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion.
Tenofovir se putem bubrega iz tijela eliminira glomerularnom filtracijom i aktivnom tubularnom sekrecijom.
• antifungal medicines used to treat fungal infections, containing: ketoconazole or itraconazole
• antimikotike koji se koriste za liječenje gljivičnih infekcija, a sadrže: ketokonazol ili itrakonazol
 If any of these apply to you, talk to your doctor before taking Vemlidy.
Ako se bilo što od navedenog odnosi na vas, obavijestite liječnika prije uzimanja lijeka Vemlidy.
Table 1: Interactions between Vemlidy and other medicinal products
Tablica 1: Interakcije između lijeka Vemlidy i drugih lijekova Lijek prema terapijskim područjima
Normalised ALT (AASLD)c
Normalizirani ALT (AASLD)d
Vemlidy is used to treat chronic (long-term) hepatitis B in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Vemlidy se koristi za liječenje kroničnog (dugotrajnog) hepatitisa B u odraslih i adolescenata u dobi od 12 godina i starijih, tjelesne težine od najmanje 35 kg.
Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Žute okrugle filmom obložene tablete promjera 8 mm, s utisnutom oznakom „GSI” na jednoj strani, te „25” na drugoj strani tablete.
There are no safety data on the use of Vemlidy to treat HBV infected patients with CrCl < 30 mL/min.
Ne postoje podaci o sigurnosti upotrebe lijeka Vemlidy pri liječenju bolesnika zaraženih HBV-om u kojih je CrCl < 30 ml/min.
Assessment of adverse reactions is based on pooled safety data from 2 controlled Phase 3 studies in which 866 HBV infected patients received tenofovir alafenamide 25 mg once daily in a double-blind fashion through Week 96 (median duration of blinded study drug exposure of 104 weeks) and from post-marketing experience.
Procjena nuspojava utemeljena je na objedinjenim sigurnosnim podacima iz 2 kontrolirana ispitivanja faze 3 u kojima je 866 bolesnika zaraženih HBV-om primalo 25 mg tenofoviralafenamida jedanput na dan na dvostruko slijepi način do 96. tjedna (medijan trajanja zaslijepljenog izlaganja ispitivanom lijeku od 104 tjedna) te iz razdoblja nakon stavljanja u promet.
Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg) (see section 5.1).
Vemlidy je indiciran za liječenje kroničnog hepatitisa B u odraslih i adolescenata (u dobi od 12 godina i starijih tjelesne težine od najmanje 35 kg) (vidjeti dio 5.1).
21% were treatment-experienced (previous treatment with oral antivirals, including entecavir (N = 41), lamivudine (N = 42), tenofovir disoproxil fumarate (N = 21), or other (N = 18)).
21% prethodno je bilo liječeno (prethodno liječenje oralnim antivirusnim lijekovima, uključujući entekavir (N = 41), lamivudin (N = 42), tenofovirdizoproksilfumarat (N = 21) ili druge lijekove (N = 18)).
On days of haemodialysis, Vemlidy should be administered after completion of haemodialysis treatment (see section 5.2).
Na dane kada se provodi hemodijaliza Vemlidy se treba primijeniti nakon dovršetka postupka hemodijalize (vidjeti dio 5.2).
Oxcarbazepine Phenobarbital
Okskarbazepin Fenobarbital
The efficacy and safety of Vemlidy in patients with chronic hepatitis B are based on 48- and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-320-0108 (“Study 108”) and GS-US-320-0110 (“Study 110”).
B utemeljene su na podacima za 48 i 96 tjedana dobivenima tijekom dva randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja, GS-US-320-0108 („Ispitivanje 108”) i GS-US-320-0110 („Ispitivanje 110”).
Patients co-infected with HBV and hepatitis C or D virus
Bolesnici s istodobnom infekcijom HBV-om i virusom hepatitisa C ili D
• anticonvulsants used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital or phenytoin
• antikonvulzive koji se koriste za liječenje epilepsije, kao što su: karbamazepin, okskarbazepin, fenobarbital ili fenitoin
Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination.
Tenofovirdifosfat inhibira replikaciju HBV-a ugradnjom u virusnu DNK pomoću HBV reverzne transkriptaze, što rezultira prekidom lanca DNK.
If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule.
Ako je prošlo više od 18 sati od uobičajena vremena uzimanja doze, bolesnik ne smije uzeti propuštenu dozu, te jednostavno treba nastaviti uzimati lijek prema uobičajenom rasporedu.
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172).
Poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol (E1521), talk (E553b), žuti željezov oksid (E172).
Stopping treatment with Vemlidy may cause your hepatitis B to get worse.
Prekid liječenja lijekom Vemlidy može uzrokovati pogoršanje hepatitisa B.
Medicinal products that may affect tenofovir alafenamide
Lijekovi koji mogu utjecati na tenofoviralafenamid
In a pooled analysis of patients receiving Vemlidy, sequence analysis was performed on paired baseline and on-treatment HBV isolates for patients who either experienced virologic breakthrough (2 consecutive visits with HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or 1.0 log10 or greater increase in HBV DNA from nadir) or patients with HBV DNA ≥ 69 IU/mL at Week 96 or at early discontinuation at or after Week 24.
Tijekom objedinjene analize bolesnika koji su primali Vemlidy provedena je analiza sekvenci na uparenim početnim, i izolatima HBV-a tijekom liječenja u bolesnika u kojih je došlo do virološkog proboja (tijekom 2 uzastopna posjeta HBV DNK ≥ 69 IU/ml nakon što je bio < 69 IU/ml, ili povećanje HBV DNK od 1,0 log10 ili veće u odnosu na najnižu vrijednost) ili u bolesnika u kojih je u 96. tjednu ili prilikom rana prekida u 24. tjednu ili nakon njega utvrđen HBV DNK ≥ 69 IU/ml.
Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Tenofoviralafenamid se uglavnom eliminira nakon što se metabolizira u tenofovir.
Because there is a lower tenofovir exposure in rats and mice after tenofovir alafenamide administration compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate.
Budući da je izloženost tenofoviru u štakora i miševa nakon primjene tenofoviralafenamida manja nego nakon primjene tenofovirdizoproksilfumarata, ispitivanja kancerogenosti te perinatalna i postnatalna ispitivanja na štakorima provedena su samo s tenofovirdizoproksilfumaratom.
BOTTLE AND CARTON LABELLING
OZNAČIVANJE BOCE I KUTIJE
Elderly No dose adjustment of Vemlidy is required in patients aged 65 years and older (see section 5.2).
Prilagodba doze lijeka Vemlidy nije potrebna u bolesnika u dobi od 65 godina ili starijih (vidjeti dio 5.2).
Flares after treatment discontinuation
Pogoršanja bolesti nakon prekida liječenja
• herbal remedies used to treat depression and anxiety, containing: St. John's wort (Hypericum perforatum)
• biljne pripravke koji se koriste za liječenje depresije i anksioznosti, a sadrže: gospinu travu (Hypericum perforatum)
You do not need to take another tablet if you are sick (vomit) more than 1 hour after taking Vemlidy.
Drugu tabletu ne trebate uzimati ako ste povraćali nakon što je prošlo više od 1 sata od uzimanja lijeka Vemlidy.
ORAL CONTRACEPTIVES Norgestimate (0.180 mg/0.215 mg/ 0.250 mg orally, q.d.)
Norgestimat (0,180 mg/0,215 mg/0,250 mg peroralno, q.d.)
No dose adjustment of midazolam (administered orally or IV) is required.
Nije potrebna prilagodba doze midazolama (koji se primjenjuje peroralno ili intravenski).
ANTIFUNGALS Itraconazole Ketoconazole
Itrakonazol Ketokonazol
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Nakon korekcije koja je uzela u obzir vezanje za proteine, koncentracije nevezanog (slobodnog) tenofoviralafenamida u plazmi pri teškom oštećenju funkcije jetre bile su slične onima pri normalnoj funkciji jetre.
HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Gospina trava (Hypericum perforatum)
Serology HBeAg loss / seroconversiond
Serologija gubitak/serokonverzija HBeAge
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
U bolesnika s kompenziranom bolešću jetre povećanja ALT-a u serumu obično nisu popraćena povećanjem koncentracija bilirubina u serumu ili dekompenzacijom jetre.
Vemlidy contains lactose
Vemlidy sadrži laktozu
Medicinal product by therapeutic areas
Lijek prema terapijskim područjima
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide yellow (E172)
Film ovojnica poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b) žuti željezov oksid (E172)
Bone toxicity was observed as reduced BMD in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of tenofovir alafenamide.
Toksičnost za kosti utvrđena je kao smanjeni BMD u štakora i pasa pri izloženostima tenofoviru koja su najmanje četiri puta veća od onih očekivanih nakon primjene tenofoviralafenamida.
There are no data on the safety and efficacy of Vemlidy in patients co-infected with hepatitis C or D virus.
Ne postoje podaci o sigurnosti i djelotvornosti upotrebe lijeka Vemlidy u bolesnika s istodobnom infekcijom virusom hepatitisa C ili D.
↔ Tenofovir alafenamide ↔ Raltegravir
↔ Tenofoviralafenamid ↔ Raltegravir
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Tenofoviralafenamid je fosforoamidatni prolijek tenofovira (analog 2'-deoksiadenozin monofosfata).
If you stop taking Vemlidy Do not stop taking Vemlidy without your doctor's advice.
Nemojte prestati uzimati Vemlidy bez savjetovanja s liječnikom.
• Tell your doctor if you have a history of liver disease.
• Obavijestite liječnika ako u anamnezi imate bolest jetre.
No additional adverse reactions to Vemlidy were identified from Week 96 through Week 120 in the double-blind phase and in the subset of subjects receiving open-label Vemlidy treatment (see section 5.1).
Od 96. do 120. tjedna nisu ustanovljene nikakve dodatne nuspojave lijeka Vemlidy u dvostruko slijepoj fazi niti u podskupini ispitanika koji su otvoreno primali terapiju lijekom Vemlidy (vidjeti dio 5.1).
If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take Vemlidy as soon as possible and then resume their normal dosing schedule.
Ako je bolesnik propustio uzeti dozu lijeka, a prošlo je manje od 18 sati od uobičajena vremena uzimanja doze, bolesnik treba što prije uzeti Vemlidy i potom ga nastaviti uzimati prema uobičajenom rasporedu.
HIV antibody testing should be offered to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy with Vemlidy.
Svim bolesnicima zaraženima HBV-om u kojih stanje infekcije virusom HIV-1 nije poznato, prije početka terapije lijekom Vemlidy potrebno je ponuditi testiranje antitijela na HIV.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Nema podataka ili su podaci o primjeni tenofoviralafenamida u trudnica ograničeni (manje od 300 trudnoća).
(may affect up to 1 in 10 people)
Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba)
• Do not breast-feed during treatment with Vemlidy.
• Nemojte dojiti tijekom liječenja lijekom Vemlidy.
Medicinal products that are P-gp inducers (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital or St. John's wort) are expected to decrease plasma concentrations of tenofovir alafenamide, which may lead to loss of therapeutic effect of Vemlidy.
Očekuje se da će lijekovi koji su induktori P-gp-a (npr. rifampicin, rifabutin, karbamazepin, fenobarbital ili gospina trava) smanjiti koncentraciju tenofoviralafenamida u plazmi, što može uzrokovati gubitak terapijskog učinka lijeka Vemlidy.
Steady state Cmax for tenofovir alafenamide and tenofovir were 0.18 and 0.02 µg/mL, respectively.
Cmax u stanju dinamičke ravnoteže za tenofoviralafenamid i tenofovir bio je 0,18 odnosno 0,02 µg/ml.
HBV isolates expressing the rtA181T, rtA181V, or rtN236T single substitutions associated with resistance to adefovir remained susceptible to tenofovir alafenamide; however, the HBV isolate expressing rtA181V plus rtN236T exhibited reduced susceptibility to tenofovir alafenamide (3.7-fold change in EC50).
Izolati HBV-a koji eksprimiraju pojedinačne supstitucije rtA181T, rtA181V ili rtN236T povezane s rezistencijom na adefovir ostale su osjetljive na tenofoviralafenamid, no izolat HBV-a koji eksprimira rtA181V plus rtN236T pokazao je smanjenu osjetljivost na tenofoviralafenamid (3,7-struka promjena u EC50).
In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Tenofoviralafenamid se in vitro ne metabolizira enzimima CYP1A2, CYP2C8, CYP2C9, CYP2C19 ili
HBV DNA < 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
HBV DNK < 29 IU/ml HBV DNK na početku < 7 log10 IU/ml ≥ 7 log10 IU/ml
The antiviral activity of tenofovir alafenamide was assessed in HepG2 cells against a panel of HBV clinical isolates representing genotypes A-H.
Antivirusno djelovanje tenofoviralafenamida procjenjivano je u stanicama HepG2 u odnosu na seriju kliničkih izolata HBV-a koji predstavljaju genotipe A-H.
No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between adolescent and adult HIV-1 infected subjects.
Ne postoje klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira između adolescenata i odraslih osoba zaraženih virusom HIV-1.