FrancophonIA/ELRC3.0 huggingface dataset:
English: The 50% effective concentration (EC50) values of sofosbuvir, velpatasvir and voxilaprevir against full-length or chimeric replicons encoding NS5B, NS5A and NS3 protease sequences from the laboratory strains are presented in Table 4.
Maltese: Il-valuri ta' 50% tal-konċentrazzjoni effettiva (EC50 - 50% effective concentration) ta' sofosbuvir, velpatasvir u voxilaprevir meta mqabbla ma replicons ta' tul sħiħ (full-length) jew kimeriċi li jikkodifikaw sekwenzi ta' protease NS5B, NS5A u NS3 mill-istrains tal-laboratorju huma ppreżentati fit-Tabella 4.
English: Observed: Ciclosporin ↔ ↔
Maltese: Ciclosporin ↔ ↔
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Maltese: Is-sindrome ta' Stevens-Johnson Anormalitajiet tal-laboratorju
English: Observed: Darunavir
Maltese: Darunavir
English: The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir,relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata f'pazjenti li kienu negattivi għal HCV, b'indeboliment ħafif (eGFR ≥ 50 u < 80 mL/min/1.73 m2), moderat (eGFR ≥ 30 u < 50 mL/min/1.73m2), u sever (eGFR < 30 mL/min/1.73 m2) tal-kliewi u pazjenti b'ESRD li kienu jeħtieġu l-emodijaliżi wara doża waħda ta' 400 mg ta' sofosbuvir, meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (eGFR > 80 mL/min/1.73 m2).
English: Relative to healthy subjects (n = 137), velpatasvir AUC0-24 and Cmax were 41% lower and 39% lower, respectively, in HCV-infected patients.
Maltese: Meta mqabbla ma' pazjenti f'saħħithom (n = 137), l-AUC0-24 u s-Cmax ta' velpatasvir kienu 41% aktar baxxi u 39% aktar baxxi, rispettivament, f'pazjenti infettati bl-HCV.
English: Digoxin (0.25 mg single dose)e + velpatasvir (100 mg single dose)
Maltese: Digoxin (0.25 mg doża waħda)e + velpatasvir (100 mg doża waħda)
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets
Maltese: Vosevi 400 mg/100 mg/100 mg pilloli miksija b'rita
English: The following pack size is available:
Maltese: Id-daqs tal-pakkett li ġej huwa disponibbli:
English: Table 5: Activity of sofosbuvir, velpatasvir and voxilaprevir against transient replicons containing NS5A, NS5B or NS3 protease from clinical isolates
Maltese: L-attività ta' sofosbuvir, velpatasvir u voxilaprevir kontra replicons temporanji li fihom NS5A, NS5B jew protease NS3 minn iżolati kliniċi Ġenotip tar replicons
English: Velpatasvir and voxilaprevir are inhibitors of drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Maltese: Velpatasvir u voxilaprevir huma inibituri tat-trasportaturi tal-mediċina P-gp, il-proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein), il-polypeptide organiku li jittrasporta l-anjoni (OATP - organic anion-transporting polypeptide) 1B1 u OATP1B3.
English: Efavirenz/emtricitabine/
Maltese: Emtricitabine/rilpivirine/
English: Total bilirubin
Maltese: Bilirubina totali
English: Observed: Velpatasvir ↑
Maltese: Velpatasvir darbiet↑
English: The median time to re-treatment was 414 days (range 1981271).
Maltese: Iż-żmien medjan għal trattament mill-ġdid kien ta' 414-il jum (firxa 1981271).
English: Table 9: Demographics and baseline characteristics for patients enrolled into POLARIS-1, -2, -3 and -4
Maltese: Tabella 9: Demografika u karatteristiċi fil-linja bażi għall-pazjenti rreġistrati f'POLARIS-1, -2,
English: There was an increase in tenofovir exposure (AUC and Cmax) of around 40% during co-treatment with Vosevi and darunavir + ritonavir + tenofovir disoproxil fumarate/emtricitabine.
Maltese: Kien hemm żieda fl-esponiment għal tenofovir (AUC u Cmax) ta' madwar 40% matul il-kura b'Vosevi flimkien ma' darunavir + ritonavir + tenofovir disoproxil fumarate/emtricitabine.
English: Methadone (Methadone maintenance therapy [30 to 130 mg daily]) + sofosbuvir (400 mg once daily)f
Maltese: Methadone (Terapija ta' manteniment b'methadone [30 sa 130 mg/kuljum]) + sofosbuvir (400 mg darba kuljum)f
English: Of these 3 patients, 1 patient (33%) had virus with emergent NS5A RAV Y93N at failure.
Maltese: Minn dawn it-3 pazjenti, pazjent wieħed (33%) kellu virus li fih fiġġu RAVs Y93N f'NS5A fil-falliment.
English: Table 15: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of SOF, GS331007, Velpatasvir and Voxilaprevir Compared to Subjects with Normal Renal Function
Maltese: Effett ta' Gradi Differenti ta' Indeboliment tal-Kliewi fuq Esponimenti (AUC) għal SOF, GS-331007, Velpatasvir u Voxilaprevir Imqabbla ma' Individwi b'Funzjoni Normali talKliewi
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of Vosevi were 0.5 and 29 hours, respectively.
Maltese: Il-medjan tal-half-lives terminali ta' sofosbuvir u ta' GS-331007 wara l-għoti ta' Vosevi kien ta' 0.5 u 29 siegħa, rispettivament.
English: Relative to healthy subjects (n = 63), voxilaprevir AUC0-24 and Cmax were both 260% higher in HCV-infected patients.
Maltese: Meta mqabbla ma' pazjenti f'saħħithom (n = 63), l-AUC0-24 u s-Cmax ta' voxilaprevir it-tnejn kienu 260% ogħla f'pazjenti infettati bl-HCV.
English: These data indicate that renal clearance is the major elimination pathway for GS-331007.
Maltese: Din id-data tindika li t-tneħħija mill-kliewi hi r-rotta maġġuri tat-tneħħija għal GS-331007.
English: Unchanged velpatasvir was the major species in faeces accounting for a mean of 77% of the administered dose, followed by monohydroxylated velpatasvir (5.9%) and desmethylated velpatasvir (3.0%).
Maltese: Velpatasvir mhux mibdul kien l-ispeċi maġġuri preżenti fl-ippurgar li ammonta għal medja ta' 77% tad-doża mogħtija, segwit minn monohydroxylated velpatasvir (5.9%) u desmethylated velpatasvir (3.0%).
English: (Inhibition of OATP1B and BCRP)
Maltese: (Inibizzjoni ta' OATP1B u BCRP)
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir and voxilaprevir by 13- and 6.8-fold, respectively, against genotype 1a HCV replicons.
Maltese: Il-preżenza ta' 40% serum tal-bniedem ma kellha l-ebda effett fuq l-attività kontra HCV ta' sofosbuvir iżda naqqset l-attività kontra HCV ta' velpatasvir u voxilaprevir bi 13-il darba u 6.8 darbiet, rispettivament, kontra replicons tal-ġenotip 1a tal-HCV.
English: ↑ Edoxaban (active metabolite) ↔ Sofosbuvir ↔ Velpatasvir ↔ Voxilaprevir
Maltese: ↑ Edoxaban (metabolit attiv) ↔ Sofosbuvir ↔ Velpatasvir ↔ Voxilaprevir
English: Vosevi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' phenobarbital u phenytoin (ara sezzjoni 4.3).
English: Use with moderate P-gp inducers or moderate CYP inducers
Maltese: L-użu ma' indutturi moderati ta' P-gp u indutturi moderati ta' CYP
English: Tacrolimus (5 mg single dose)e + sofosbuvir (400 mg single dose)f
Maltese: Tacrolimus (5 mg doża waħda)e + sofosbuvir (400 mg doża waħda)f
English: Velpatasvir is > 99% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 μg/mL to 1.8 μg/mL.
Maltese: Velpatasvir jintrabat b'rata ta' > 99% mal-proteini tal-plażma tal-bniedem u l-irbit hu indipendenti mill-konċentrazzjoni tal-mediċina fuq il-medda ta' 0.09 μg/mL sa 1.8 μg/mL.
English: Alternative methods of contraception (e.g. progestin only contraception or non-hormonal methods) should be considered.
Maltese: Għandhom jitqiesu metodi alternattivi ta' kontraċezzjoni (eż. kontraċezzjoni bi progestin biss jew metodi mhux ormonali).
English: Concomitant use with ethinylestradiol-containing medicinal products may increase the risk of alanine aminotransferase (ALT) elevations and is contraindicated (see section 4.3 and Table 2).
Maltese: L-użu fl-istess waqt ma' prodotti mediċinali li fihom ethinylestradiol jista' jżid ir-riskju ta' żidiet fl-alanine aminotransferase (ALT) u hu kontraindikat (ara sezzjoni 4.3 u Tabella 2).
English: Clinically significant medicinal product interactions with Vosevi mediated by P-gp, BCRP and CYP inhibitors are not expected.
Maltese: Interazzjonijiet klinikament sinifikanti ta' prodotti mediċinali ma' Vosevi medjati permezz ta' inibituri ta' P-gp, BCRP u CYP mhumiex mistennija.
English: Omeprazole dosed 4 hours after Vosevi
Maltese: Omeprazole iddożat 4 sigħat wara Vosevi
English: SOF/VEL/VOX 8 weeks
Maltese: SOF/VEL/VOX għal
English: At clinically relevant concentrations, velpatasvir is not an inhibitor of hepatic transporters BSEP, sodium taurocholate cotransporter protein (NTCP), OATP1A2 or OCT1, renal transporters OCT2, OAT1, OAT3, MRP2 or MATE1, or CYP or UGT1A1 enzymes.
Maltese: F'konċentrazzjonijiet klinikament rilevanti, velpatasvir mhuwiex inibitur tat-trasportaturi epatiċi BSEP, tal-proteina kotrasportatur tas-sodium taurocholate (sodium taurocholate cotransporter protein) (NTCP), ta' OATP1A2 jew OCTI, tat-trasportaturi renali OCT2, OAT1, OAT3, MRP2 jew MATE1, jew tal-enzimi CYP jew UGT1A1.
English: Table 8: Studies conducted with Vosevi
Maltese: Tabella 8: Studji mwettqa b'Vosevi Studju
English: Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) (see section 4.5).
Maltese: L-użu fl-istess waqt ma' prodotti mediċinali li huma indutturi qawwija tal-glikoproteina P (P-gp) u/jew indutturi qawwija taċ-ċitokrom P450 (CYP) (eż. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin u St.
English: tenofovir disoproxil fumarate (600/200/300 mg once daily)g + sofosbuvir/
Maltese: tenofovir disoproxil fumarate (200/300 mg darba kuljum)j +
English: Replicons containing NS5B from clinical isolates
Maltese: Replicons li fihom NS5B minn iżolati kliniċi
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in patients with moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Maltese: Imqabbla ma' pazjenti b'funzjoni normali tal-fwied, l-AUC0-24 ta' sofosbuvir kienet 126% u 143% ogħla f'pazjenti b'indeboliment moderat u sever tal-fwied, filwaqt li l-AUC0-24 ta' GS-331007 kienet 18% u 9% ogħla, rispettivament.
English: Although exposures of the fixed-dose combination sofosbuvir, GS-331007, velpatasvir, and voxilaprevir were not directly evaluated in HCV-infected patients with ESRD requiring dialysis after administration of Vosevi, the exposures of sofosbuvir, GS-331007, and velpatasvir are expected to be similar to those observed after administration of sofosbuvir/velpatasvir 400/100 mg in HCV-infected patients with ESRD requiring dialysis.
Maltese: Għalkemm l-esponimenti għall-kombinazzjoni ta' doża fissa ta' sofosbuvir, GS-331007, velpatasvir, u voxilaprevir ma ġewx evalwati b'mod dirett f'pazjenti infettati bl-HCV b'ESRD li kienu jeħtieġu dijalisi wara għoti ta' Vosevi, l-esponimenti għal sofosbuvir, GS-331007, u velpatasvir huma mistennija li jkunu simili għal dawk osservati wara għoti ta' sofosbuvir/velpatasvir 400/100 mg f'pazjenti infettati bl-HCV b'ESRD li jeħtieġu dijalisi.
English: Relative to patients with normal hepatic function, the voxilaprevir AUCinf was 299% and 500% higher in patients with moderate and severe hepatic impairment, respectively.
Maltese: Imqabbla ma' pazjenti b'funzjoni normali tal-fwied, l-AUCinf ta' voxilaprevir kienet 299% u 500% ogħla f'pazjenti b'indeboliment moderat u sever tal-fwied, rispettivament.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Vosevi compared to subjects with normal renal function, as described in the text below, are provided in Table 15.
Maltese: Sommarju tal-effett ta' gradi differenti ta' indeboliment tal-kliewi (RI - renal impairment) fuq lesponimenti għall-komponenti ta' Vosevi meta mqabbla ma' individwi b'funzjoni normali tal-kliewi, kif deskritt fit-test hawn taħt, huwa pprovdut fit-Tabella 15.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 85 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV uriet li fil-medda ta' età (18 sa 85 sena) analizzata, l-età ma kellhiex effett klinikament rilevanti fuq l-esponiment għal sofosbuvir, GS-331007, velpatasvir jew voxilaprevir.
English: (Inhibition of OATP1B, P-gp/BCRP and CYP3A)
Maltese: (Inibizzjoni ta' OATP1B, P-gp/BCRP u CYP3A)
English: Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Maltese: Kull pillola miksija b'rita fiha 400 mg sofosbuvir, 100 mg velpatasvir u 100 mg voxilaprevir.
English: Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate (150/150/200/10 mg once daily)l + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Maltese: Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate (150/150/200 mg/10 mg darba kuljum)l + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg darba kuljum) + voxilaprevir (100 mg darba kuljum)f
English: Voxilaprevir acts as a noncovalent, reversible inhibitor of the NS3/4A protease.
Maltese: Voxilaprevir jaġixxi bħala inibitur nonkovalenti u riversibbli tal-protease NS3/4A.
English: Table 14: SVR12 and virologic outcome in study POLARIS-3 (HCV genotype 3 with compensated cirrhosis)*
Maltese: SVR12 u riżultat viroloġiku fl-istudju POLARIS-3 (ġenotip 3 tal-HCV b'ċirrożi kumpensata)*
English: SVR12 was achieved in all 39 patients who had baseline NS5B NI RAVs in POLARIS-2 and 2 of 3 (67%) patients in POLARIS-3.
Maltese: SVR12 inkiseb fid-39 pazjent kollha li kellhom RAVs għal NI f'NS5B fil-linja bażi f'POLARIS-2 u 2 minn 3 (67%) pazjenti f'POLARIS-3.
English: Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1, OATP1B3 and OATP2B1, and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Maltese: Velpatasvir huwa inibitur tat-trasportaturi tal-mediċina P-gp, BCRP, OATP1B1, OATP1B3 u OATP2B1, u l-involviment tiegħu fl-interazzjonijiet tal-mediċini ma' dawn it-trasportaturi huwa limitat primarjament għall-proċess ta' assorbiment.
English: Protein binding of GS-331007 was minimal in human plasma.
Maltese: L-irbit ta' GS-331007 mal-proteini kien minimu fil-plażma tal-bniedem.
English: • Placebo 12 weeks (N=152)
Maltese: • Plaċebo għal 12-il ġimgħa (N=152)
English: In patients with genotype 1a without cirrhosis treated with Vosevi for 8 weeks, outcome was influenced by the following baseline factors: BMI ≥ 30 kg/m2, Q80K/L/R RAVs, IL28B non-CC, HCV RNA ≥ 800,000 IU/mL.
Maltese: BMI ≥ 30 kg/m2, RAVs Q80K/L/R, IL28B mhux CC, RNA ta' HCV ≥ 800,000
English: Table 1: Recommended treatment durations for Vosevi for all HCV genotypes
Maltese: Tabella 1: Tulijiet ta' żmien tal-kura rakkomandati għal Vosevi għall-ġenotipi kollha tal-HCV Popolazzjoni ta' pazjenti
English: • are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.
Maltese: • qed tieħu kura għal infezzjoni bil-virus uman tal-immunodefiċjenza (HIV), billi t-tabib tiegħek jista' jkun jixtieq li jissorveljak aktar mill-qrib.
English: Of these 21 patients, 1 patient had virus with emergent NS5A RAVs Q30R and L31M at failure.
Maltese: Minn dawn il-21 pazjent, pazjent wieħed kellu virus li fih fiġġu RAVs Q30R u L31M f'NS5A fil-falliment.
English: Genotype 6
Maltese: Ġenotip 6
English: The pharmacokinetic properties of sofosbuvir, GS-331007, velpatasvir and voxilaprevir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C.
Maltese: Il-propjetajiet farmakokinetiċi ta' sofosbuvir, GS-331007, velpatasvir u voxilaprevir ġew evalwati f'individwi adulti f'saħħithom u f'pazjenti b'epatite Ċ kronika.
English: Median peak plasma concentration of GS-331007 was observed 4 hours post-dose.
Maltese: L-ogħla konċentrazzjoni medjana ta' GS-331007 fil-plażma ġiet osservata 4 sigħat wara d-doża.
English: Co-administration of Vosevi with efavirenz/emtricitabine/tenofovir disoproxil fumarate is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Vosevi ma' efavirenz/emtricitabine/ tenofovir disoproxil fumarate mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Patients with GT5-6 infection were enrolled into the SOF/VEL/VOX 8 week group only.
Maltese: Pazjenti b'infezzjoni GT5-6 ġew irreġistrati fil-grupp ta' 8 ġimgħat ta' SOF/VEL/VOX biss.
English: Vosevi is contraindicated with carbamazepine (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' carbamazepine (ara sezzjoni 4.3).
English: Lopinavir (Inhibition of OATP1B)
Maltese: Lopinavir (Inibizzjoni ta' OATP1B)
English: Of the 263 NS5A inhibitor-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 (see Table 10), 7 of 263 (3%) patients (2 with genotype 1, 4 with genotype 3, and 1 with genotype 4) did not achieve sustained virologic response (SVR12) and qualified for resistance analysis; 6 relapsed and 1 experienced virologic breakthrough with pharmacokinetic data consistent with nonadherence.
Maltese: Mill-263 pazjent li rċivew inibitur NS5A fil-passat ikkurati b'sofosbuvir/velpatasvir/voxilaprevir għal 12-il ġimgħa f'POLARIS-1 (ara Tabella 10), 7 minn 263 (3%) pazjent (2 bil-ġenotip 1, 4 bil-ġenotip 3, u 1 bil-ġenotip 4) ma kisbux rispons viroloġiku sostnut (SVR12 - sustained virologic risponse) u kkwalifikaw għal analiżi ta' reżistenza; 6 irkadew u 1 esperjenza avvanz viroloġiku b'data farmakokinetika konsistenti ma' nuqqas ta' aderenza mal-kura.
English: The patient with genotype 1a and virologic breakthrough developed the NS5A RAVs L31M and Y93H.
Maltese: Il-pazjent bil-ġenotip 1a u b'avvanz viroloġiku żviluppa l-RAVs L31M u Y93H f'NS5A.
English: Vosevi is contraindicated with dabigatran etexilate (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' dabigatran etexilate (ara sezzjoni 4.3).
English: In vitro, slow metabolic turnover of velpatasvir primarily by CYP2B6, CYP2C8, and CYP3A4 and of voxilaprevir primarily by CYP3A4 was observed.
Maltese: In vitro, rata bil-mod taċ-ċiklu metaboliku (slow metabolic turnover) ta' velpatasvir kienet osservata primarjament b'CYP2B6, CYP2C8 u CYP3A4 u ta' voxilaprevir primarjament b'CYP3A4.
English: Vosevi is contraindicated with ethinylestradiol-containing medicinal products (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' prodotti mediċinali li fihom ethinylestradiol (ara sezzjoni 4.3).
English: velpatasvir (400/100 mg once daily)f, h
Maltese: sofosbuvir/velpatasvir (400/100 mg darba kuljum)f, h
English: NS5A inhibitor-experienced adults (POLARIS-1)
Maltese: Adulti li rċivew inibitur ta' NS5A fil-passat (POLARIS-1)
English: Vosevi is contraindicated with rosuvastatin (see section 4.3).
Maltese: Vosevi hu kontraindikat ma' rosuvastatin (ara sezzjoni 4.3).
English: Paediatric population The pharmacokinetics of Vosevi in paediatric patients have not been established (see section 4.2).
Maltese: Il-farmakokinetika ta' Vosevi f'pazjenti pedjatriċi ma ġietx stabbilita (ara sezzjoni 4.2).
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 and Cmax for sofosbuvir (n = 1038) were 1665 ng•hr/mL and 678 ng/mL, respectively; mean steady-state AUC0-24 and Cmax for GS-331007 (n = 1593) were 12834 ng•hr/mL and 744 ng/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, il-medji tal-AUC0-24 u s-Cmax fl-istat fiss għal sofosbuvir (n = 1038) kienu 1665 ng•siegħa/mL u 678 ng/mL, rispettivament; il-medji tal-AUC0-24 u s-Cmax fl-istat fiss għal GS-331007 (n = 1593) kienu 12834 ng•siegħa/mL u 744 ng/mL, rispettivament.
English: Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU per mL.
Maltese: Il-valuri tal-RNA ta' HCV fis-serum tkejlu matul l-istudji kliniċi bl-użu tat-test COBAS AmpliPrep/COBAS Taqman HCV (verżjoni 2.0) bl-aktar limitu ta' kwantifikazzjoni baxx (LLOQlower limit of quantification) ta' 15 IU għal kull mL.
English: In the POLARIS-2 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 12), a total of 21 of 501 (4%) patients (16 with genotype 1, 2 with genotype 2, 2 with genotype 4, and 1 with genotype 5) qualified for resistance analysis due to relapse.
Maltese: Fil-grupp ta' kura ta' 8 ġimgħat b'sofosbuvir/velpatasvir/voxilaprevir f'POLARIS-2 (ara Tabella 12), total ta' 21 minn 501 (4%) pazjent (16 bil-ġenotip 1, 2 bil-ġenotip 2, 2 bil-ġenotip 4, u 1 bil-ġenotip 5) ikkwalifikaw għal analiżi ta' reżistenza minħabba rkaduta.
English: In the sofosbuvir/velpatasvir 12-week treatment group, 2 of 109 (2%) patients qualified for resistance analysis due to virologic failure.
Maltese: Fil-grupp ta' kura ta' 12-il ġimgħa b'sofosbuvir/velpatasvir, 2 minn 109 (2%) pazjenti kkwalifikaw għal analiżi ta' reżistenza minħabba falliment viroloġiku.
English: HCV/HBV co-infection
Maltese: Infezzjoni b'HCV/HBV fl-istess ħin
English: Other medicines and Vosevi
Maltese: Mediċini oħra u Vosevi
English: (Inhibition of P-gp and CYP3A)
Maltese: (Inibizzjoni ta' P-gp u CYP3A)
English: Table 2 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Maltese: It-Tabella 2 tipprovdi elenku ta' interazzjonijiet klinikament sinifikanti tal-prodott mediċinali li huma stabbiliti jew potenzjali (fejn 90% intervall ta' kunfidenza [CI - confidence interval] tal-proporzjon tal-geometric least-squares mean [GLSM] kien fil-medda ta' “↔”, estenda aktar “↑”, jew estenda inqas “↓” mill-limiti determinati minn qabel tal-interazzjoni).
English: Velpatasvir is a pan-genotypic HCV inhibitor targeting the HCV NS5A protein, which is required for viral replication.
Maltese: Velpatasvir huwa inibitur pan-ġenotipiku tal-HCV li jimmira għall-proteina NS5A tal-HCV, li hija meħtieġa għar-replikazzjoni virali.
English: GTs)a (n = 263)
Maltese: Total (il-GTs kollha)a (n = 263)
English: Sofosbuvir, velpatasvir, and voxilaprevir were fully active against substitutions associated with resistance to other classes of DAAs with different mechanisms of actions, e.g. voxilaprevir was fully active against NS5A and NS5B NI RAVs.
Maltese: Sofosbuvir, velpatasvir, u voxilaprevir kienu attivi b'mod sħiħ kontra sostituzzjonijiet assoċjati ma' reżistenza għal klassijiet oħrajn ta' DAAs b'mekkaniżmi ta' azzjoni differenti, eż. voxilaprevir kien attiv b'mod sħiħ kontra RAVs għal NI f'NS5A u NS5B.
English: No individual RAV tested in genotypes 2b, 5a or 6a conferred a > 100-fold reduction in voxilaprevir susceptibility.
Maltese: L-ebda RAV individwali ttestjat f'ġenotipi 2b, 5a jew 6a ma ta tnaqqis ta' > 100 darba fis-suxxettibilità għal voxilaprevir.
English: In POLARIS-4, a total of 14 patients had virus with NS5B NI RAVs at baseline and all achieved SVR12.
Maltese: F'POLARIS-4, total ta' 14-il pazjent kellhom virus b'RAVs għal NI f'NS5B fil-linja bażi u kollha kisbu SVR12.
English: Replicons containing NS5A from clinical isolates
Maltese: Replicons li fihom NS5A minn iżolati kliniċi
English: Median voxilaprevir EC50, nM (range)
Maltese: EC50 medjan ta' voxilaprevir, nM (medda)
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Maltese: Sofosbuvir jintrabat b'rata ta' madwar 61-65% mal-proteini tal-plażma tal-bniedem u l-irbit hu indipendenti mill-konċentrazzjoni tal-mediċina fuq il-medda ta' 1 μg/mL sa 20 μg/mL.