natgillin/translations-raw huggingface dataset:
No dosing recommendations can be given for patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.4).
Za bolnike s CrCl < 15 ml/min, ki ne prejemajo hemodialize, ni mogoče dati priporočil glede odmerka (glejte poglavje 4.4).
In Study 108, HBeAg-negative treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 285) once daily or tenofovir disoproxil fumarate (300 mg; N = 140) once daily.
V študiji 108 so bili HBeAg-negativni, predhodno nezdravljeni in predhodno zdravljeni bolniki s kompenziranim delovanjem jeter randomizirani v razmerju 2 : 1 za prejemanje zdravila Vemlidy (25 mg; N = 285) enkrat na dan ali dizoproksiltenofovirijev fumarat (300 mg; N = 140) enkrat na dan.
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.
Toksičen vpliv na kosti so opazili kot zmanjšano mineralno gostoto kosti pri podganah in psih pri izpostavljenostih tenofovirju, ki so bile vsaj štirikrat večje kot izpostavljenost, pričakovana pri dajanju tenofoviralafenamida.
No dose adjustment of Vemlidy is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Pri bolnikih z okvarjenim delovanjem jeter ni treba prilagajati odmerka zdravila Vemlidy (glejte poglavji 4.4 in 5.2).
h Study conducted with tenofovir alafenamide 40 mg and emtricitabine 200 mg. i Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
i Študija je bila opravljena z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, pričakovane pri bolnikih, okuženih s HCV.
No human data on the effect of Vemlidy on fertility are available.
Podatkov o vplivu zdravila Vemlidy na plodnost pri ljudeh ni na voljo.
Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Zdravila, ki lahko vplivajo na tenofoviralafenamid Tenofoviralafenamid transportirata P-gp in protein, odporen za raka dojke (BCRP, breast cancer resistance protein).
What Vemlidy looks like and contents of the pack
Izgled zdravila Vemlidy in vsebina pakiranja
HBV isolates expressing the rtV173L, rtL180M, and rtM204V/I substitutions associated with resistance to lamivudine remained susceptible to tenofovir alafenamide (< 2-fold change in EC50).
Izolati HBV, ki izražajo substitucije rtV173L, rtL180M in rtM204V/I, povezane z odpornostjo na lamivudin, so ostali občutljivi na tenofoviralafenamid (< 2-kratna sprememba EC50).
Vemlidy tablets are packaged in high density polyethylene (HDPE) bottles and enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner.
Zdravilo Vemlidy tablete je pakirano v vsebnik iz polietilena visoke gostote (HDPE, high density polyethylene) s polipropilensko, za otroke varno zaporko z neprekinjeno nitko, obloženo z indukcijsko aktivirano aluminijasto folijo.
The following adverse drug reactions have been identified with tenofovir alafenamide in patients with chronic hepatitis B (Table 2).
Naslednje neželene reakcije na zdravilo so bile pri bolnikih s kroničnim hepatitisom B opredeljene za tenofoviralafenamid (preglednica 2).
No dose adjustment of Vemlidy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
Pri odraslih ali mladostnikih (starih vsaj 12 let in s telesno maso vsaj 35 kg) z ocenjenim očistkom kreatinina (CrCl) ≥ 15 ml/min ali pri bolnikih s CrCl < 15 ml/min, ki prejemajo hemodializo, odmerka zdravila Vemlidy ni treba prilagajati.
Ethinylestradiol (0.025 mg orally, q.d.)
etinilestradiol (0,025 mg peroralno, q.d.)
These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions.
Pri teh bolnikih je morda tveganje za resne neželene učinke na jetrih ali ledvicah večje.
The majority of cases are self-limited but severe exacerbations, including fatal outcomes, may occur after discontinuation of treatment for hepatitis B. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of treatment for hepatitis B. If appropriate, resumption of hepatitis B therapy may be warranted.
Delovanje jeter je treba spremljati v rednih intervalih klinično in z laboratorijskimi preiskavami še vsaj 6 mesecev po prekinitvi zdravljenja zaradi hepatitisa B. Če je ustrezno, se lahko zdravljenje hepatitisa B nadaljuje.
Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi orally, q.d.)
sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/ 100 mg + 100 mgi peroralno, q.d.)
Steady state Cmax for tenofovir alafenamide and tenofovir were 0.18 and 0.02 µg/mL, respectively.
Vrednost Cmax v stanju dinamičnega ravnovesja je bila za tenofoviralafenamid 0,18 µg•hr/ml, za tenofovir pa 0,02 µg/ml.
If the patient vomits more than 1 hour after taking Vemlidy, the patient does not need to take another tablet.
Če bolnik bruha več kot 1 uro po tem, ko je vzel zdravilo Vemlidy, mu ni treba ponovno vzeti tablete.
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
In vivo se tenofoviralafenamid v celicah hidrolizira v tenofovir (glavni presnovek), ki se fosforilizira v aktivni presnovek, tenofovir difosfat.
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.
Če bolnik izpusti odmerek in je od časa, ko ga običajno vzame, minilo manj kot 18 ur, mora bolnik zdravilo Vemlidy vzeti takoj, ko je možno, nato pa z jemanjem nadaljevati kot običajno.
ANTIDEPRESSANTS Sertraline (50 mg orally, s.d.) Tenofovir alafenamidee (10 mg orally, q.d.)
ANTIDEPRESIVI sertralin (50 mg peroralno, s.d.) tenofoviralafenamide (10 mg peroralno, q.d.)
• Tell your doctor if you have a history of liver disease.
• Povejte svojemu zdravniku, če imate bolezen jeter v anamnezi.
c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the central laboratory range at baseline.
c Populacija, uporabljena za analizo normalizacije ALT, je vključevala le bolnike z ALT nad ULN razpona centralnega laboratorija ob izhodišču.
1 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
1 Neželeni učinek, opredeljen v okviru nadzora za zdravila, ki vsebujejo tenofoviralafenamid, v obdobju trženja zdravil.
• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
• Zdravniku takoj povejte, če imate nove ali neobičajne simptome, ko se prenehate zdraviti,
How to take Vemlidy Always take this medicine exactly as your doctor has told you.
Kako jemati zdravilo Vemlidy Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
Vemlidy 25 mg film-coated tablets.
IME ZDRAVILA Vemlidy 25 mg filmsko obložene tablete
Sertraline (50 mg orally, s.d.)
sertralin (50 mg peroralno, s.d.)
In the open-label phase of both studies, mean percentage change in BMD from Week 96 to Week 120 in patients who remained on Vemlidy was +0.6% at the lumbar spine and 0% at the total hip, compared to +1.7% at the lumbar spine and +0.6% at the total hip in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
V odprti fazi obeh študij je bila povprečna sprememba v odstotkih BMD od 96. tedna do 120. tedna pri bolnikih, ki so nadaljevali zdravljenje z zdravilom Vemlidy, +0,6 % na ledveni hrbtenici in 0 % na celotnem kolku, v primerjavi s +1,7 % na ledveni hrbtenici in +0,6 % na celotnem kolku pri tistih, ki so v 96. tednu z zdravljenja z dizoproksiltenofovirijevim fumaratom prešli na zdravljenje z zdravilom Vemlidy.
Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Intracelično se tenofovir nato fosforilizira v farmakološko aktivni presnovek tenofovir difosfat.
Midazolamd (1 mg IV, s.d.)
midazolamd (1 mg i.v., s.d.)
c Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
b Preiskovanci, ki niso bili predhodno zdravljeni, so < 12 tednov prejemali peroralno protivirusno zdravljenje s poljubnim nukleozidom ali nukleotidnim analogom, vključno z dizoproksiltenofovirijevim fumaratom ali tenofoviralafenamidom.
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxic assays.
V običajnih testih genotoksičnosti tenofoviralafenamid ni bil mutagen ali klastogen.
Vemlidy should not be co-administered with medicinal products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil.
Zdravila Vemlidy se ne sme dajati skupaj z zdravili, ki vsebujejo tenofoviralafenamid, dizoproksiltenofovirijev fumarat ali adefovirdipivoksilat.
• adefovir dipivoxil
• adefovirdipivoksilat
(may affect up to 1 in 100 people)
Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov)
c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the American Association of the Study of Liver Diseases (AASLD) criteria (> 30 U/L males and > 19 U/L females) at baseline.
c Populacija, uporabljena za analizo normalizacije ALT, je vključevala samo bolnike z vrednostjo ALT nad ULN po kriterijih Ameriškega združenja za preučevanje bolezni jeter (AASLD, American Association of the Study of Liver Diseases) (> 30 e./l za moške in > 19 e./l za ženske) ob izhodišču.
Midazolamd (2.5 mg orally, s.d.)
midazolamd (2,5 mg peroralno, s.d.)
Serology HBeAg loss / seroconversiond
Serologija Izguba/serokonverzija HBeAgd n/v n/v
No dose adjustment of Vemlidy or norgestimate/ethinyl estradiol is required.
Prilagoditev odmerka zdravila Vemlidy ali norgestimata/etinilestradiola ni potrebna.
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).
z dekompenzirano boleznijo jeter, ki imajo oceno > 9 (tj. razred C) po Child Pugh Turcotte (CPT), ni.
Do not swallow desiccant.
Ne zaužijte sušilnega sredstva.
The antiviral activity of tenofovir alafenamide was evaluated against a panel of isolates containing nucleos(t)ide reverse transcriptase inhibitor mutations in HepG2 cells.
Protivirusno aktivnost tenofoviralafenamida so ovrednotili v baterijskem testu izolatov, ki so vsebovali mutacije nukleozidnih/nukleotidnih zaviralcev reverzne transkriptaze v celicah HepG2.
Vemlidy 25 mg film-coated tablets tenofovir alafenamide
IME ZDRAVILA Vemlidy 25 mg filmsko obložene tablete tenofoviralafenamid
ANTICONVULSANTS Carbamazepine (300 mg orally, b.i.d.)
ANTIEPILEPTIKI karbamazepin (300 mg peroralno, b.i.d.)
ALT Normalised ALT (Central lab)b
Normalizirana ALT (centralni laboratorij)b Normalizirana ALT (AASLD)c
If the patient vomits within 1 hour of taking Vemlidy, the patient should take another tablet.
Če bolnik v 1 uri od jemanja zdravila Vemlidy bruha, naj vzame še eno tableto.
Vemlidy [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Vemlidy [samo zunanja ovojnina]
Table 1: Interactions between Vemlidy and other medicinal products
Preglednica 1: Interakcije med zdravilom Vemlidy in drugimi zdravili Učinkovine po terapevtskih področjih
ritonavir or cobicistat boosted darunavir, lopinavir or atazanavir
darunavir, lopinavir ali atazanavir, ojačani z ritonavirjem ali kobicistatom,
In the open-label phase of Studies 108 and 110, the mean (±SD) change in serum creatinine from Week 96 to Week 120 was -0.002 (0.10) mg/dL in those who remained on Vemlidy, compared to -0.008 (0.09) mg/dL in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
V odprti fazi študij 108 in 110 je bila povprečna (±SD) sprememba serumskega kreatinina od 96. tedna do 120. tedna pri tistih, ki so nadaljevali z zdravljenjem z zdravilom Vemlidy, -0,002 (0,10) mg/dl, v primerjavi z -0,008 (0,09) mg/dl pri tistih,
• Joint pain (arthralgia)
• bolečina v sklepih (artralgija)
No special hazard for humans was revealed in conventional studies of carcinogenic potential with tenofovir disoproxil (as fumarate) and toxicity to reproduction and development with tenofovir disoproxil (as fumarate) or tenofovir alafenamide.
Običajne študije kancerogenega potenciala z dizoproksiltenofoviratom (v obliki fumarata) in vpliva na sposobnost razmnoževanja in razvoja z dizoproksiltenofoviratom (v obliki fumarata) ali tenofoviralafenamida ne kažejo posebnega tveganja za človeka.
ANTIMYCOBACTERIALS Rifampicin
rifampicin rifapentin
In the open-label phase, the median change in eGFR from Week 96 to Week 120 was -0.6 mL/min in patients who remained on Vemlidy, compared to +1.8 mL/min in patients who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
V odprti fazi je bila mediana sprememba vrednosti eGFR od 96. tedna do 120. tedna pri bolnikih, ki so nadaljevali z zdravljenjem z zdravilom Vemlidy, -0,6 ml/min, v primerjavi s +1,8 ml/min pri bolnikih, ki so v 96. tednu z zdravljenja z dizoproksiltenofovirijevim fumaratom prešli na zdravljenje z zdravilom Vemlidy.
b The population used for analysis of ALT normalisation included only patients with ALT above upper limit of normal (ULN) of the central laboratory range at baseline.
b Populacija, uporabljena za analizo normalizacije ALT, je vključevala le bolnike z izhodiščno zgornjo mejo normalne vrednosti (ULN, upper limit of normal) ALT nad razponom centralnega laboratorija.
Not applicable.
ni treba prilagajati.
Vemlidy contains lactose
Zdravilo Vemlidy vsebuje laktozo
Baseline HBV DNA < 8 log10 IU/mL ≥ 8 log10 IU/mL
< 8 log10 i.e./ml ≥ 8 log10 i.e./ml n/v n/v
ORAL CONTRACEPTIVES Norgestimate (0.180 mg/0.215 mg/ 0.250 mg orally, q.d.)
(0,180 mg/0,215 mg/0,250 mg peroralno, q.d.)
Lactose monohydrate, microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), magnesium stearate (E470b).
Laktoza monohidrat, mikrokristalna celuloza (E460(i)), premreženi natrijev karmelozat (E468),
Lopinavir/ritonavir (800 mg/200 mg orally, q.d.)
lopinavir/ritonavir (800 mg/200 mg peroralno, q.d.)
90 (3 bottles of 30) film-coated tablets.
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 HDPE vsebniki po 30) filmsko obloženih tablet
No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between adolescent and adult HIV-1 infected subjects.
Pri mladostnikih in odraslih preiskovancih, okuženih s HIV-1, niso opazili nobenih klinično pomembnih razlik pri farmakokinetiki tenofoviralafenamida ali tenofovirja.
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)).
24 % jih je imelo genotip HBV B, 38 % jih je imelo genotip HBV C in 31 % jih je imelo genotip HBV D. 21 % se jih je predhodno zdravilo (predhodno zdravljenje s peroralnimi antivirusnimi zdravili, vključno z entekavirjem (N = 41), lamivudinom (N = 42), dizoproksiltenofovirijevim fumaratom (N = 21) ali drugim (N = 18)).
Recommendation concerning co-administration with Vemlidy
Priporočila glede sočasne uporabe z zdravilom Vemlidy nevirapin
Rilpivirine (25 mg orally, q.d.)
rilpivirin (25 mg peroralno, q.d.)
• Feeling bloated
• občutek napihnjenosti
↑ Tenofovir alafenamide
↔ velpatasvir ↑ tenofoviralafenamid
At baseline, mean plasma HBV DNA was 5.8 log10 IU/mL, mean serum ALT was 94 U/L, and 9% of patients had a history of cirrhosis.
Ob izhodišču je bila povprečna vrednost HBV DNA v plazmi 5,8 log10 i.e./ml, povprečna vrednost serumske ALT je bila 94 e./l in
Atazanavir/ritonavir (300 mg/100 mg orally, q.d.)
atazanavir/ritonavir (300 mg/100 mg peroralno, q.d.)
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”).
Učinkovitost in varnost zdravila Vemlidy pri bolnikih s kroničnim hepatitisom B temelji na 48 in 96tedenskih podatkih iz dveh randomiziranih, dvojno slepih, z učinkovino nadzorovanih študij,
Co-administration of Vemlidy with certain anticonvulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g. rifampicin, rifabutin and rifapentine) or St. John's wort, all of which are inducers of P-glycoprotein (P-gp) and may decrease tenofovir alafenamide plasma concentrations, is not recommended.
Sočasna uporaba zdravila Vemlidy z nekaterimi antikonvulzivnimi zdravili (npr. karbamazepin, okskarbazepin, fenobarbital in fenitoin), učinkovinami za zdravljenje okužb z mikobakterijami (npr. rifampicin, rifabutin in rifapentin) ali šentjanževko ni priporočljiva, saj so induktorji
• tenofovir disoproxil fumarate
• dizoproksiltenofovirijev fumarat
Oral administration.
Peroralno dajanje.
Vemlidy (N = 285)
(N = 285)
General disorders and administration site conditions Common
Splošne težave in spremembe na mestu aplikacije
26% were treatment-experienced (previous treatment with oral antivirals, including adefovir (N = 42), entecavir (N = 117), lamivudine (N = 84), telbivudine
17 % jih je imelo genotip HBV B, 52 % jih je imelo genotip HBV C in 23 % jih je imelo genotip HBV D. 26 % se jih je predhodno zdravilo (predhodno zdravljenje s peroralnimi antivirusnimi zdravili, vključno z adefovirjem (N = 42), entekavirjem (N = 117), lamivudinom (N = 84), telbivudinom (N = 25), dizoproksiltenofovirijevim fumaratom (N = 70) ali drugim (N = 17)).
Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Tenofoviralafenamid in vitro pri človeku ni zaviralec uridindifosfat-glukuronoziltransferaze
What Vemlidy is and what it is used for What you need to know before you take Vemlidy How to take Vemlidy
Kaj morate vedeti, preden boste vzeli zdravilo Vemlidy Kako jemati zdravilo Vemlidy
c Study conducted with emtricitabine/tenofovir alafenamide fixed-dose combination tablet.
c Študija je bila opravljena s tableto s kombinacijo emtricitabina/tenofoviralafenamida v fiksnem odmerku.
f Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
f Študija je bila opravljena s tableto s kombinacijo emtricitabina/rilpivirina/tenofoviralafenamida v fiksnem odmerku.
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.
Če bolnik izpusti odmerek in je od časa, ko ga običajno vzame, minilo več kot 18 ur, bolnik ne sme vzeti izpuščenega odmerka in mora z jemanjem nadaljevati kot običajno.
The pharmacokinetics of tenofovir alafenamide and tenofovir were evaluated in HIV-1 infected, treatment-naïve adolescents who received tenofovir alafenamide (10 mg) given with elvitegravir,
Farmakokinetika tenofoviralafenamida in tenofovirja je bila ocenjena pri mladostnikih, okuženih s HIV-1, ki niso bili predhodno zdravljeni in so prejemali tenofoviralafenamid (10 mg) skupaj z elvitegravirjem, kobicistatom in emtricitabinom kot kombinirano tableto v fiksnem odmerku (E/C/F/TAF; Genvoya).
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide yellow (E172)
titanov dioksid (E171) makrogol (E1521)
↑ Cmin 1.85 (1.78, 1.92)
↑ AUC 1,75 (1,69; 1,81) ↑ Cmin 1,85 (1,78; 1,92)
↔ Tenofovir alafenamide ↔ Maraviroc
↔ tenofoviralafenamid ↔ maravirok
How to store Vemlidy
Shranjevanje zdravila Vemlidy
Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.
Ena filmsko obložena tableta zdravila Vemlidy vsebuje tenofoviralafenamidijev fumarat, kar ustreza 25 mg tenofoviralafenamida.
Vemlidy contains lactose monohydrate.
Neprenašanje laktoze Zdravilo Vemlidy vsebuje laktozo monohidrat.
Elderly No dose adjustment of Vemlidy is required in patients aged 65 years and older (see section 5.2).
Pri bolnikih, starih 65 let ali več, odmerka zdravila Vemlidy ni treba prilagajati (glejte poglavje 5.2).
• Feeling sick (nausea)
• driska • slabost (bruhanje)
Antiviral activity
PERORALNI KONTRACEPTIVI
No dose adjustment of Vemlidy or sertraline is required.
Prilagoditev odmerka zdravila Vemlidy ali sertralina ni potrebna.
The active substance is tenofovir alafenamide.
Učinkovina je tenofoviralafenamid.
rifabutin, rifampicin or rifapentine
rifabutin, rifampicin ali rifapentin,
Rash, pruritus
Pogosti izpuščaj, pruritus
No dose adjustment of Vemlidy or nevirapine is required.
Prilagoditev odmerka zdravila Vemlidy ali nevirapina ni potrebna.
HBV DNA ≥ 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
< 7 log10 i.e./ml ≥ 7 log10 i.e./ml n/v n/v
Discontinued study drug due to lack of efficacy Discontinued study drug due to AE or death Discontinued study drug due to other reasonsd
Brez predhodnega zdravljenja z nukleozidic Zdravljeni z nukleozidi V oknu 48. tedna ni viroloških podatkov Prekinitev uporabe študijskega zdravila zaradi neučinkovitosti Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrti
No dose adjustment of Vemlidy or raltegravir is required.
Prilagoditev odmerka zdravila Vemlidy ali raltegravirja ni potrebna.
The safety of Vemlidy is also supported by pooled data from patients in Studies 108 and 110 who remained on blinded treatment from Week 96 through Week 120 and additionally from patients in the open-label phase of Studies 108 and 110 from Week 96 through Week 120 (N = 361 remained on Vemlidy; N = 180 switched from tenofovir disoproxil fumarate to Vemlidy at Week 96).
Varnost zdravila Vemlidy je prav tako podprta z združenimi podatki bolnikov v študijah 108 in 110, ki so nadaljevali s slepim zdravljenjem od 96. tedna do konca 120. tedna, ter dodatno od bolnikov v odprti fazi študij 108 in 110
Table 4: Additional efficacy parameters at Week 48a
Preglednica 4: Dodatni parametri učinkovitosti v 48. tednua Študija 108 (HBeAg-negativni)
TDF = tenofovir disoproxil fumarate a Missing = failure analysis b Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
b Prilagojeno za izhodiščne plazemske kategorije HBV DNA in stratume statusa peroralnega protivirusnega zdravljenja c Preiskovanci, ki predhodno niso bili zdravljeni, so < 12 tednov prejemali peroralno protivirusno zdravljenje s poljubnim nukleozidom ali nukleotidnim analogom, vključno z dizoproksiltenofovirijevim fumaratom ali tenofoviralafenamidom.
System organ class Frequency
Organski sistem
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).
V dvojno slepi fazi in v podskupini oseb, ki so se odprto zdravile z zdravilom Vemlidy, od 96. tedna do konca 120. tedna niso ugotovili nobenih dodatnih neželenih učinkov zdravila Vemlidy (glejte poglavje 5.1).
Tenofovir ↑ Cmax 1.62 (1.56, 1.68)
↑ Cmax 1,62 (1,56; 1,68)
Changes in measures of bone mineral density In both studies tenofovir alafenamide was associated with smaller mean percentage decreases in bone mineral density (BMD; as measured by hip and lumbar spine dual energy X ray absorptiometry
V obeh študijah je bil tenofoviralafenamid povezan z manjšim povprečnim odstotnim zmanjšanjem mineralne gostote kosti (BMD, bone mineral density; izmerjeno v kolku in hrbtenici z analizo dvoenergijske rentgenske absorpciometrije [DXA]) v primerjavi z dizoproksiltenofovirijevim fumaratom po 96. tednih zdravljenja.
Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination.
Tenofovir difosfat zavira replikacijo HBV tako,