FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 740 treated patients, the median age was 56 years (range: 18 to 82); 60% of the patients were male; 79% were White, 9% were Black; 21% had a baseline body mass index of at least 30 kg/m2; the proportions of patients with genotype 1, 2, 4, 5, or 6 HCV infection were 53%, 17%, 19%, 5% and 7%, respectively; 69% had non-CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 19% had compensated cirrhosis; and 32% were treatment-experienced.
Maltese: Mis-740 pazjent ikkurati, l-età medjana kienet ta' 56 sena (medda: 18 sa 82); 60% tal-pazjenti kienu rġiel; 79% kienu bojod; 9% kienu suwed; 21% kellhom indiċi tal-massa tal-ġisem fil-linja bażi ta' mill-inqas 30 kg/m2; il-proporzjonijiet ta' pazjenti b'infezzjoni bl-HCV ta' ġenotip 1, 2, 4, 5 jew 6 kienu 53%, 17%, 19%, 5% u 7%, rispettivament; 69% kellhom alleli non-CC IL28B (CT jew TT); 74% kellhom livelli HCV RNA fil-linja bażi ta' mill-inqas 800,000
English: Study 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected patients with ESRD requiring dialysis.
Maltese: Studju 4062 kien prova klinika open-label li evalwat 12-il ġimgħa ta' trattament b'Epclusa f'59 pazjent infettati bl-HCV b'ESRD li kienu jeħtieġu dijalisi.
English: 100% (8/8)a
Maltese: Ġenotipi 2, 4 u 6 100% (8/8)a
English: Table 9: Studies conducted with Epclusa in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection
Maltese: Tabella 9: Studji mwettqa b'Epclusa f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 1, 2, 3, 4, 5 jew 6 Studju
English: Replicons containing NS5A from clinical isolates
Maltese: Replikons li fihom NS5A minn iżolati kliniċi
English: Clinical studies in patients with decompensated cirrhosis - ASTRAL-4 (study 1137) ASTRAL-4 was a randomised, open-label study in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and CPT Class B cirrhosis.
Maltese: Studji kliniċi f'pazjenti b'ċirrożi dikumpensata - ASTRAL-4 (studju 1137) ASTRAL-4 kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, open-label, f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 1, 2, 3, 4, 5 jew 6 u ċirrożi CPT Klassi B.
English: Median velpatasvir EC50, nM (range)
Maltese: EC50 medjan ta' velpatasvir, nM (medda)
English: Expected.
Maltese: Mistennija.
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Maltese: INIBITURI TA' HMG-CoA REDUCTASE Atorvastatin (40 mg doża waħda) + sofosbuvir / velpatasvir (400/ 100 mg darba kuljum)d
English: GT-2 (n = 104)
Maltese: (n = 104)
English: Other medicines and Epclusa
Maltese: Mediċini oħra u Epclusa
English: Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Maltese: Kull pillola miksija b'rita fiha 400 mg sofosbuvir u 100 mg velpatasvir.
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Maltese: • rifapentine (antibijotiku li jintuża għall-kura ta' infezzjonijiet, li jinkludu t-tuberkulożi);
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom 1 flixkun ta' 28 pillola miksija b'rita.
English: Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Maltese: L-emodijaliżi tista' tneħħi b'mod effiċjenti l-metabolit predominanti li jiċċirkola ta' sofosbuvir, GS-331007, bi proporzjon ta' estrazzjoni ta' 53%.
English: Epclusa 12 weeks (106)
Maltese: Epclusa għal 12-il ġimgħa (106)
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.7 fold the human exposure at recommended clinical dose.
Maltese: Madankollu, effett teratoġeniku possibbli ġie indikat filfniek, fejn żieda fil-malformazzjonijiet vixxerali totali ġiet osservata f'annimali esposti f'esponimenti AUC li kienu sa 0.7 darbiet tal-esponiment fil-bniedem fid-doża klinika rakkomandata.
English: Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed.
Maltese: Mill-1,035 pazjent ikkurati b'sofosbuvir/velpatasvir fit-tliet studji kliniċi ta' Fażi 3, 1,023 pazjent kienu inklużi fl-analiżi ta' NS5A RAVs; 7 pazjenti kienu esklużi minħabba li dawn la kisbu rispons viroloġiku sostnut (SVR12, sustained virologic risponse) u lanqas ma kellhom falliment viroloġiku u 5 pazjenti oħra kienu esklużi minħabba li s-sekwenzar tal-ġeni NS5A ma rnexxiex.
English: Of the 10 genotype 3 virologic failure patients, Y93H was observed in all 10 patients at failure (6 had Y93H emerge post-treatment and 4 patients had Y93H at baseline and post-treatment).
Maltese: Mill-10 pazjenti b'falliment viroloġiku ta' ġenotip 3, Y93H kien osservat fl-10 pazjenti kollha filfalliment (6 kellhom Y93H wara l-kura u 4 pazjenti kellhom Y93H fil-linja bażi u wara l-kura).
English: Table 8: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (study ASTRAL-4)
Maltese: Tabella 8: SVR12 f'pazjenti b'NS5A RAVs fil-linja bażi u mingħajrhom skont il-ġenotip talHCV (studju ASTRAL-4)
English: • a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).
Maltese: • raxx sever u mifrux bi tqaxxir tal-ġilda li jista' jkun akkumpanjat minn deni, sintomi bħal tal influwenza, infafet fil-ħalq, fl-għajnejn u/jew fil-ġenitali (sindromu ta' Stevens-Johnson).
English: Table 4: Activity of sofosbuvir and velpatasvir against full-length or chimeric laboratory replicons
Maltese: Tabella 4: L-attività ta' sofosbuvir u velpatasvir kontra replikons tal-laboratorju ta' tul sħiħ jew kimeriċi
English: (Inhibition of P-gp)
Maltese: (Inibizzjoni ta' P-gp)
English: Genotype 2
Maltese: Ġenotip 2
English: No individual substitutions tested in genotypes 2a, 4a, or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Maltese: L-ebda sostituzzjonijiet individwali ttestjati f'ġenotipi 2a, 4a, jew 5a ma taw tnaqqis ta' > 100 darba fis-suxxettibilità għal velpatasvir.
English: Ribavirin Dose
Maltese: Doża ta' Ribavirin
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba r-razza jew is-sess ma ġiet identifikata għal sofosbuvir, GS-331007 jew velpatasvir.
English: GT-4 (n = 116)
Maltese: (n = 116)
English: Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Maltese: Velpatasvir huwa inibitur tal-HCV li jimmira l-proteina NS5A tal-HCV, li hija essenzjali kemm għal replikazzjoni tal-RNA kif ukoll għall-assemblaġġ tal-virjoni tal-HCV.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Maltese: Pazjenti infettati bl-HBV/HCV f'daqqa huma f'riskju ta' attivazzjoni mill-ġdid ta' HBV, u għalhekk għandhom jiġu mmonitorjati u mmaniġjati skont il-linji gwida kliniċi kurrenti.
English: Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Maltese: Dolutegravir (50 mg darba kuljum)/sofosbuvir/velpata svir (400/100 mg darba kuljum)
English: Median sofosbuvir EC50, nM (range)
Maltese: EC50 medjan ta' sofosbuvir, nM (medda)
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, indikat li ċ-ċirrożi (inkluż iċ-ċirrożi dikumpensata) ma kellha l-ebda effett klinikament rilevanti fuq lesponiment għal sofosbuvir u GS-331007.
English: Median peak plasma concentration of GS-331007 was observed 3 hours post-dose.
Maltese: L-ogħla konċentrazzjoni medjana ta' GS-331007 fil-plażma ġiet osservata 3 sigħat wara d-doża.
English: Epclusa 12 weeks (59)
Maltese: Epclusa għal 12-il ġimgħa (59)
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint to determine the HCV cure rate.
Maltese: Rispons viroloġiku sostnut (SVR12), li ġie definit bħala HCV RNA ta' inqas minn LLOQ wara 12-il ġimgħa wara l-waqfien tal-kura, kien il-punt aħħari primarju għad-determinazzjoni tar-rata ta' kura tal-HCV.
English: Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Maltese: Ciclosporin (600 mg doża waħda)f/ velpatasvir (100 mg doża waħda)d
English: Epclusa is contraindicated with rifampicin (see section 4.3).
Maltese: Epclusa hu kontraindikat ma' rifampicin (ara sezzjoni 4.3).
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑ Velpatasvir
Maltese: GS-331007 1.6 darbiet↑ 1.9 darbiet↑ 5.5 darbiet↑
English: GT-1b (n = 118)
Maltese: (n = 118)
English: Both patients had virus at baseline harboring NS5A RAVs.
Maltese: Iż-żewġ pazjenti kellhom virus fil-linja bażi b'NS5A RAVs.
English: and <50 mL/min/1.73 m2)
Maltese: (eGFR ≥30 u <50 mL/ min/1.73m2)
English: Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Maltese: L-użu ma' indutturi moderati ta' P-gp u/jew indutturi moderati ta' CYP Prodotti mediċinali li huma indutturi moderati ta' P-gp u/jew indutturi moderati ta' CYP (eż. efavirenz, modafinil, oxcarbazepine jew rifapentine) jistgħu jnaqqsu l-konċentrazzjonijiet ta' sofosbuvir jew velpatasvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Epclusa.
English: Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Maltese: Famotidine (40 mg doża waħda)/sofosbuvir/velpata svir (400/100 mg doża waħda)ċ
English: Table 5: Activity of sofosbuvir and velpatasvir against transient replicons containing NS5A or NS5B from clinical isolates
Maltese: L-attività ta' sofosbuvir u velpatasvir kontra replikons transitorji li fihom NS5A jew NS5B minn iżolati kliniċi
English: Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Maltese: Ketoconazole (200 mg darbtejn kuljum)/velpatasvir (100 mg doża waħda)d
English: Pharmacotherapeutic group: Direct acting antiviral, ATC code: J05AP55
Maltese: Antivirali li jaġixxi direttament, kodiċi ATC:
English: Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Maltese: Tacrolimus (5 mg doża waħda)f/velpatasvir (400 mg doża waħda)d
English: GT-2 (n = 11)
Maltese: (n = 11)
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2)and end stage renal disease (ESRD) requiring haemodialysis.
Maltese: Data dwar is-sigurtà hija limitata f'pazjenti b'indeboliment sever tal-kliewi (stima tar-rata ta' filtrazzjoni glomerulari [eGFR - estimated glomerular filtration rate] < 30 mL/min/1.73 m2) u b'mard tal-kliewi li jinsab fl-aħħar stadju (ESRD - end stage renal disease) li jkunu jeħtieġu l-emodijalisi.
English: Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Maltese: Wara doża waħda ta' 100 mg [14C]-velpatasvir, il-maġġoranza (> 98%) tar-radjuattività fil-plażma kienet il-mediċina prinċipali.
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered dose.
Maltese: Wara doża waħda ta' 400 mg ta' sofosbuvir, emodijaliżi ta' 4 sigħat neħħiet madwar 18% tad-doża mogħtija.
English: One additional patient with genotype 3 HCV infection at baseline was reinfected with genotype 1a HCV at virologic failure and was excluded from the virological analysis.
Maltese: Pazjent ieħor b'infezzjoni bl-HCV ta' ġenotip 3 fil-linja bażi reġa' ġie infettat b'HCV ta' ġenotip 1a minħabba falliment viroloġiku u kien eskluż millanaliżi viroloġika.
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Maltese: 215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg darba kuljum)d
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to velpatasvir (see section 4.2).
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, indikat li ċ-ċirrożi (inkluż iċ-ċirrożi dikumpensata) ma kellha l-ebda effett klinikament rilevanti fuq l-esponiment għal velpatasvir (ara sezzjoni 4.2).
English: Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir.
Maltese: Prodotti mediċinali li jinibixxu OATP, CYP2B6, CYP2C8, jew CYP3A4 jistgħu jżidu l-konċentrazzjoni ta' velpatasvir fil-plażma.
English: ↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
Maltese: ↔ ↔ ↔ Mhux meħtieġ aġġustament fiddoża ta' Epclusa jew methadone.
English: Epclusa + RBV 12 weeks
Maltese: Epclusa + RBV għal 12-il ġimgħa
English: No patients with genotype 2, 4, 5, or 6 HCV infection experienced virologic failure.
Maltese: L-ebda pazjent b'infezzjoni bl-HCV ta' ġenotip 2, 4, 5 jew 6 ma kellu falliment viroloġiku.
English: Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
Maltese: Elvitegravir ↔ ↔ ↔ Mhux meħtieġ aġġustament fiddoża ta' Epclusa jew elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate.
English: Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.
Maltese: Prodotti mediċinali li huma indutturi moderati ta' P-gp u/jew indutturi moderati ta' CYP (eż. efavirenz, modafinil, oxcarbazepine jew rifapentine), jistgħu jnaqqsu lkonċentrazzjoni ta' sofosbuvir jew velpatasvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Epclusa.
English: Epclusa 400 mg/100 mg film-coated tablets.
Maltese: IL-PRODOTT MEDIĊINALI Epclusa 400 mg/100 mg pilloli miksija b'rita
English: The EC50 values of sofosbuvir and velpatasvir against clinical isolates are presented in Table 5.
Maltese: Il-valuri ta' EC50 ta' sofosbuvir u velpatasvir kontra iżolati kliniċi huma ppreżentati f'Tabella 5.
English: Epclusa is sometimes taken with another medicine, ribavirin.
Maltese: Xi kultant, Epclusa jittieħed ma' mediċina oħra, ribavirin.
English: Epclusa is contraindicated with rifabutin (see section 4.3).
Maltese: Epclusa hu kontraindikat ma' rifabutin (ara sezzjoni 4.3).
English: GT-6 (n = 41)
Maltese: (n = 41)
English: Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Maltese: Rifampicin (600 mg darba kuljum)/velpatasvir (100 mg doża waħda)
English: b Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
Maltese: Ir-replikons 1b kimeriċi stabbli li jġorru ġeni NS5A minn ġenotip 2b, 5a jew 6a intużaw għall-ittestjar.
English: ↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Maltese: ↔ ↔ ↔ Mhux meħtieġ aġġustament fid-doża ta' Epclusa darunavir (imsaħħaħ b'ritonavir) jew emtricitabine/tenofovir disoproxil fumarate.
English: Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p < 0.001) compared to treatment with SOF+RBV for 24 weeks (treatment difference +14.8%; 95% confidence interval: +9.6% to +20.0%).
Maltese: Il-kura b'Epclusa għal 12-il ġimgħa wriet is-superjorità statistika (p < 0.001) meta mqabbla mal-kura b'SOF+RBV għal 24 ġimgħa (differenza fil-kura +14.8%; intervall ta' kunfidenza ta' 95%: +9.6% sa
English: Ribavirin dose adjustments were performed according to the ribavirin prescribing information.
Maltese: Ma sarux aġġustamenti fid-doża ta' ribavirin skont l-informazzjoni dwar il-preskrizzjoni ta' ribavirin.
English: ↔ ↔ ↔ No dose adjustment of Epclusa, lopinavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Maltese: ↔ ↔ ↔ Mhux meħtieġ aġġustament fiddoża ta' Epclusa lopinavir (imsaħħaħ b'ritonavir) jew emtricitabine/tenofovir disoproxil fumarate.
English: Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Maltese: Sofosbuvir ma kienx ġenotossiku f'sensiela ta' assaġġi in vitro jew in vivo, li kienu jinkludu mutaġeniċità batterjali, aberrazzjoni fil-kromożomi bl-użu ta' limfoċiti tad-demm periferali uman, u assaġġi tal-mikronuklei tal-ġrieden in vivo.
English: Co-administration of Epclusa with rosuvastatin increases the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis.
Maltese: L-għoti flimkien ta' Epclusa ma' rosuvastatin jista' jżid ilkonċentrazzjoni ta' rosuvastatin li hija assoċjata ma' riskju miżjud ta' mijopatija, inkluż rabdomijolożi.
English: No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 31- and 6-fold higher, respectively, than the human exposure at the recommended clinical dose.
Maltese: Ma ġewx osservati effetti teratoġeniċi fl-istudji dwar it-tossiċità fl-iżvilupp li saru fuq il-ġrieden u firien b'velpatasvir f'esponimenti AUC ta' bejn wieħed u ieħor 31 u 6 darbiet ogħla, rispettivament, mill-esponiment filbniedem fid-doża klinika rakkomandata.
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200/ 25/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: Emtricitabine/rilpivirine/ tenofovir disoproxil fumarate (200/25/300 mg darba kuljum)/ sofosbuvir/velpatasvir (400/100 mg darba kuljum daily)ċ, d
English: Relative to fasting conditions, the administration of a single dose of Epclusa with a moderate fat (~600 kcal, 30% fat) or high fat (~800 kcal, 50% fat) meal resulted in a 34% and 21% increase in velpatasvir AUC0-inf, respectively, and a 31% and 5% increase in velpatasvir Cmax, respectively.
Maltese: Meta mqabbel mal-istat sajjem, l-għoti ta' doża waħda ta' Epclusa ma' ikla b'kontenut moderat ta' xaħam (~600 kcal, 30% xaħam) jew kontenut għoli ta' xaħam (~800 kcal, 50% xaħam) irriżulta f'żieda ta' 34% u 21% fl-AUC0-inf ta' velpatasvir, rispettivament, u żieda ta' 31% u 5% fis-Cmax ta' velpatasvir, rispettivament.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3)
English: The safety of tenofovir disoproxil fumarate in the setting of Epclusa and a pharmacokinetic enhancer has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil fumarate fl-ambitu ta' Epclusa u enhancer farmakokinetiku ma ġietx stabbilita.
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Maltese: Wara doża orali waħda ta' 400 mg ta' [14C]-sofosbuvir, il-medja tal-irkupru totali tar-radjuattività ta' kienet iktar minn 92%, u kienet tikkonsisti minn madwar 80%, 14%, u 2.5% irkuprata fl-awrina, flippurgar u fl-arja li tintrema 'l barra man-nifs, rispettivament.
English: Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Maltese: Tabella 17 tippreżenta s-SVR12 għall-istudju ASTRAL-5 skont il-ġenotip ta' HCV.
English: Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced.
Maltese: Mill552 pazjent ikkurati, l-età medjana kienet ta' 52 sena (medda: 19 sa 76); 62% tal-pazjenti kienu rġiel; 89% kienu Bojod; 9% kienu Asjatiċi; 1% kienu Suwed; 20% kellhom indiċi tal-massa tal-ġisem fillinja bażi ta' mill-inqas 30 kg/m2; 61% kellhom alleli non-CC IL28B (CT jew TT); 70% kellhom livelli HCV RNA fil-linja bażi ta' mill-inqas 800,000
English: Impact of DAA therapy on drugs metabolized by the liver The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Maltese: L-impatt ta' terapija b'DAA fuq mediċini metabolizzati mill-fwied Il-farmakokinetika ta' mediċini li huma metabolizzati mill-fwied (eż. sustanzi immunosoppressivi bħal inibituri ta' calcineurin) tista' tiġi affettwata minn bidliet fil-funzjoni tal-fwied waqt terapija b'DAA, relatati mat-tneħħija tal-HCV.
English: After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.52 and 0.67.
Maltese: Wara doża waħda ta' 100 mg ta' [14C]-velpatasvir f'individwi b'saħħithom, il-proporzjon tad-demm mal-plażma ta' radjuattività ta' [14C] kien bejn 0.52 u 0.67.
English: If ribavirin is used in genotype 3 infected patients with compensated cirrhosis (pre- or post-transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Maltese: Jekk ribavirin jintuża f'pazjenti b'ġenotip 3 infettati b'ċirrożi kumpensata (qabel jew wara t-trapjant), id-doża rakkomandata ta' ribavirin hi ta' 1,000/1,200 mg (1,000 mg għal pazjenti li jiżnu < 75 kg u 1,200 mg għal pazjenti li jiżnu ≥ 75 kg).
English: GT-3 (n = 12)
Maltese: (n = 12)
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with Epclusa (n=59) for 12 weeks, and compared to patients without renal impairment in the sofosbuvir/velpatasvir Phase 2/3 trials.
Maltese: Il-farmakokinetika ta' sofosbuvir, GS-331007, u velpatasvir ġiet studjata f'pazjenti infettati bl-HCV b'ESRD li kienu jeħtieġu dijalisi ttrattati b'Epclusa (n=59) għal 12-il ġimgħa, u mqabbla ma' pazjenti mingħajr indeboliment tal-kliewi fil-provi ta' Fażi 2/3 b'sofosbuvir/velpatasvir.
English: Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively.
Maltese: Fost is-87 pazjent li kienu kkurati b'Epclusa+ RBV għal 12-il ġimgħa, seħħ tnaqqis fl-emoglobina għal inqas minn 10 g/dL u 8.5 g/dL matul il-kura f'23% u 7% tal-pazjenti, rispettivament.
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Maltese: Id-doża tal-bidu ta' 600 mg, li tista' tiġi ttitrata ‘l fuq sa massimu ta' 1,000/1,200 mg (1,000 mg għal pazjenti li jiżnu < 75 kg u 1,200 mg għal pazjenti li jiżnu ≥ 75 kg) jekk tkun ittollerata tajjeb.