FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies VOYAGE-1 and VOYAGE-2 were conducted in China, Singapore, and South Korea in HCV genotype 1-6 subjects without cirrhosis (VOYAGE-1) or with compensated cirrhosis (VOYAGE-2) that were treatmentnaïve (TN) or treatment-experienced to combinations of interferon, peg-interferon, ribavirin and/or sofosbuvir (TE-PRS).
Maltese: L-istudji VOYAGE-1 u VOYAGE-2 saru fiċ-Ċina, Singapor u l-Koreja t'Isfel f'individwi ta' ġenotip 1-6 ta' HCV mingħajr ċirrożi (VOYAGE-1) jew b'ċirrożi kkumpensata (VOYAGE-2) li kienu għadhom qatt ma ħadu kura (TN) jew li kienu ħadu kura b'kombinazzjonijiet ta' interferon, peg-interferon, ribavirin u/jew sofosbuvir (TE-PRS).
English: What you need to know before you take Maviret 3.
Maltese: X'għandek tkun taf qabel ma tieħu Maviret 3.
English: Elevations in total bilirubin of at least 2x upper limit normal (ULN) were observed in 1.3% of subjects related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism.
Maltese: Kienu osservati żidiet fil-bilirubina totali ta' mill-anqas id-doppju tal-limitu ta' fuq tan-normal (ULN) f'1.3% tal-individwi relatati mal-inibizzjoni medjata minn glecaprevir tat-trasportaturi tal-bilirubina u l-metaboliżmu.
English: Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥ 7 days.
Maltese: Kienu osservati żidiet asintomatiċi fl-ALT fis-serum (>5x ULN) f'1 minn 70 individwu b'saħħithom wara dożi multipli ta' glecaprevir (700 mg jew 800 mg) darba kuljum għal ≥ 7 ijiem.
English: In TN subjects without cirrhosis who received the recommended duration of 8 weeks, 97.5% (749/768) achieved SVR12, while 0.1% (1/768) experienced on-treatment virologic failure and 0.7% (5/755) experienced post-treatment relapse.
Maltese: TN mingħajr ċirrożi li rċevew it-tul rakkomandat ta' 8 ġimgħat, 97.5% (749/768) kisbu SVR12, filwaqt li 0.1% (1/768) esperjenzaw falliment viroloġiku waqt il-kura u 0.7% (5/755) esperjenzaw rikaduta wara l-kura.
English: e. GT1, 4 from MAGELLAN-1 Part 1 - Maviret for 12 weeks (n=22); GT1, 4 from MAGELLAN-1 Part 2Maviret for 12 weeks (n=44) or 16 weeks (n=47).
Maltese: GT1, 4 minn MAGELLAN-1 Parti 1 - Maviret għal 12-il ġimgħa (n=22); GT1, 4 minn MAGELLAN-1 Parti 2 - Maviret għal 12-il ġimgħa (n=44) jew għal 16-il ġimgħa (n=47). f. VOYAGE-1 u VOYAGE-2 kienu studji reġjonali Asjatiċi.
English: Relative to healthy subjects (N=230), population estimates of AUC24, ss were similar (10% difference) for glecaprevir and 34% lower for pibrentasvir in HCV-infected patients without cirrhosis.
Maltese: rispettivament, Meta mqabbel ma' individwi b'saħħithom (N=230), l-istimi tal-popolazzjoni għallAUC24,ss kienu simili (differenza ta' 10%) għal glecaprevir u 34% aktar baxxi għal pibrentasvir f'pazjenti infettati bl-HCV mingħajr ċirrożi.
English: Glecaprevir and pibrentasvir AUC were increased ≤ 56% in non-HCV infected subjects with mild, moderate, severe, or end-stage renal impairment not on dialysis compared to subjects with normal renal function.
Maltese: L-AUC ta' glecaprevir u pibrentasvir żdiedu b'≤ 56% f'pazjenti mhux infettati bl-HCV, li kellhom indeboliment ħafif, moderat, sever jew tal-aħħar stadju u li ma kinux fuq dijalisi, meta mqabbel ma' individwi b'funzjoni tal-fwied normali.
English: Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) (see section 4.5).
Maltese: L-użu konkomitanti ma' prodotti li fihom atazanavir, atorvastatin, simvastatin, dabigatran etexilate, prodotti li fihom ethinyl oestradiol, indutturi b'saħħithom tal-P-gp u ta' CYP3A (eż., rifampicin, carbamazepine, St.
English: Τηλ: +357 22 34 74 40
Maltese: Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40
English: The median age was 14 years (range: 12 to 17); 79% had HCV genotype 1, 6% had HCV genotype 2, 9% had HCV genotype 3, 6% had HCV genotype 4; 55% were female; 11% were Black; 77% were HCV treatment-naïve; 23% were treatment-experienced to interferon; 4% had HIV-coinfection; none had cirrhosis; the mean weight was 59 kg (range: 32 to 109 kg).
Maltese: L-età medjana kienet 14-il sena (medda: 12 sa 17); 79 % kellhom HCV ġenotip 1, 6 % kellhom HCV ġenotip 2, 9 % kellhom HCV ġenotip 3, 6 % kellhom HCV ġenotip 4; 55 % kienu nisa; 11 % kienu Suwed; 77 % qatt ma kienu ħadu kura qabel għal HCV; 23 % kienu ħadu kura qabel b'interferon; 4 % kellhom koinfezzjoni tal-HIV; ħadd ma kellu ċirrożi; il-piż medju kien 59 kg (medda: 32 sa 109 kg).
English: Of the 84 subjects treated, the median age was 59 years (range 24-79); 27% had HCV genotype 5, 73% had HCV genotype 6; 54% were female, 30% were White, 68% were Asian; 90% were HCV TN; 11% had compensated cirrhosis.
Maltese: Mill-84 individwu ttrattat, l-età medjana kienet ta' 59 sena (firxa 24-79); 27% kellhom HCV ġenotip 5, 73% kellhom HCV ġenotip 6; 54% kienu nisa, 30% kienu Bojod, 68% kienu Asjatiċi; 90% kienu HCV TN; 11% kellhom ċirrożi kkumpensata.
English: Table 7 summarizes clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 infection.
Maltese: Tabella 7 tiġbor fil-qosor l-istudji kliniċi mwettqa b'Maviret f'individwi b'infezzjoni tal-ġenotip 1, 2, 3, 4, 5 jew 6 tal-HCV.
English: The following adverse reactions were identified in patients treated with Maviret.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu identifikati f'pazjenti li ngħataw Maviret.
English: Purpose of the medicine ciclosporin, tacrolimus to suppress the immune system darunavir, efavirenz, lopinavir, ritonavir for HIV infection digoxin for heart problems fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol warfarin and other similar medicines*
Maltese: Għan tal-mediċina ciclosporin, tacrolimus biex titrażżan is-sistema immuni darunavir, efavirenz, lopinavir, ritonavir għal infezzjoni tal-HIV
English: EXPEDITION-5 was an open-label study in 101 HCV GT1-6 infected subjects without cirrhosis or with compensated cirrhosis and chronic kidney disease (CKD) stage 3b, 4, or 5.
Maltese: Studju Kliniku f'Individwi b'Indeboliment tal-Kliewi EXPEDITION-5 kien studju open-label f'101 individwu infettati b'HCV GTI-6 mingħajr ċirrożi jew b'ċirrożi kkumpensata u marda kronika tal-kliewi (CKD, chronic kidney disease) ta' stadju 3b, 4, jew 5.
English: Clinical studies in treatment-naïve or treatment-experienced subjects with or without cirrhosis Of the 2,409 subjects with compensated liver disease (with or without cirrhosis) treated who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir, the median age was 53 years (range: 19 to 88); 73.3% were treatment-naïve, 26.7% were treatment-experienced to a combination containing either sofosbuvir, ribavirin and/or peginterferon; 40.3% were HCV genotype 1; 19.8% were HCV genotype 2; 27.8% were HCV genotype 3; 8.1% were HCV genotype 4; 3.4% were HCV genotype 5-6; 13.1% were ≥65 years; 56.6% were male; 6.2% were Black; 12.3% had cirrhosis; 4.3% had severe renal impairment or end stage renal disease; 20.0% had a body mass index of at least 30 kg per m2; 7.7% had HIV-1 coinfection and the median baseline HCV RNA level was 6.2 log10 IU/mL
Maltese: Mill-2,409 individwu b'mard tal-fwied ikkumpensat (bi jew mingħajr ċirrożi) ittrattati, li qatt ma kienu ħadu kura qabel jew li kienu ħadu kura qabel b'kombinazzjonijiet ta' peginterferon, ribavirin u/jew sofosbuvir, l-età medjana kienet ta' 53 sena (medda: 19 sa 88); 73.3% qatt ma kienu ħadu kura qabel, 26.7% kienu ħadu kura qabel b'kombinazzjoni li kienet tinkludi jew sofosbuvir, ribavirin u/jew peginterferon; 40.3% kellhom il-ġenotip 1 tal-HCV; 19.8% kellhom il-ġenotip 2 tal-HCV; 27.8% kellhom il-ġenotip 3 tal-HCV; 8.1% kellhom il-ġenotip 4 tal-HCV; 3.4% kellhom il-ġenotip 5-6 talHCV; 13.1% kellhom ≥65 sena; 56.6% kienu rġiel; 6.2% kienu Suwed; 12.3% kellhom ċirrożi; 4.3% kellhom indeboliment sever tal-kliewi jew mard renali tal-aħħar stadju; 20.
English: The ability to assess the impact of baseline polymorphisms in NS5A was limited among treatment-naïve subjects with cirrhosis and treatment-experienced subjects due to low prevalence of A30K (1.6%, 2/128) or Y93H (3.9%,
Maltese: L-abilità li jiġi valutat limpatt tal-polimorfiżmi tal-linja bażi f'NS5A kienet limitata fost l-individwi b'ċirrożi li qatt ma kienu ħadu kura qabel u l-individwi esperjenzati bil-kura minħabba l-prevalenza baxxa ta' A30K (1.6%, 2/128) jew Y93H (3.9%, 5/128).
English: Single substitutions important for the NS5A inhibitor class at positions 24, 28, 30, 31, 58, 92, or 93 in NS5A in genotypes 1 to 6 had no impact on the activity of pibrentasvir.
Maltese: Sostituzzjonijiet waħdiena importanti għall-klassi tal-inibitur ta' NS5A fil-pożizzjonijiet 24, 28, 30, 31, 58, 92, jew 93 f'NS5A fil-ġenotipi 1 sa 6 ma kellhom l-ebda impatt fuq l-attività ta' pibrentasvir.
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: X'għandek tkun taf qabel ma tieħu Maviret
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: Glecaprevir and pibrentasvir were 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 rodent micronucleus assays.
Maltese: Glecaprevir u pibrentasvir ma kinux ġenotossiċi f'sensiela ta' testijiet in vitro jew in vivo, inkluża lmutaġeniċità batterika, l-aberrazzjoni tal-kromożoni billi ntużaw limfoċiti tad-demm periferali talbniedem u testijiet in vivo fuq mikronuklei tal-annimali gerriema.
English: Race/ethnicity No dose adjustment of Maviret is required based on race or ethnicity.
Maltese: Razza/etniċità Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' Maviret abbażi tar-razza jew l-etniċità.
English: In vitro data indicate that the majority of the resistance-associated substitutions in NS5A at amino acid positions 24, 28, 30, 31, 58, 92, or 93 that confer resistance to ombitasvir, daclatasvir, ledipasvir, elbasvir, or velpatasvir remained susceptible to pibrentasvir.
Maltese: Dejta in vitro tindika li l-maġġoranza tas-sostituzzjonijiet assoċjati mar-reżistenza f'NS5A filpożizzjonijiet 24, 28, 30, 31, 58, 92, jew 93 tal-aċidu amminiku li jipprovdu reżistenza għal ombitasvir, daclatasvir, ledipasvir, elbasvir, jew velpatasvir baqgħu suxxettibbli għal pibrentasvir.
English: The highest documented doses administered to healthy volunteers is 1,200 mg once daily for 7 days for glecaprevir and 600 mg once daily for 10 days for pibrentasvir.
Maltese: L-ogħla dożi dokumentati mogħtija lil voluntiera b'saħħithom huma 1,200 mg darba kuljum għal 7 ijiem għal glecaprevir u 600 mg darba kuljum għal 10 ijiem għal pibrentasvir.
English: Maviret 12 weeks (N=40)
Maltese: 12-il ġimgħa (N=40)
English: Table 3 provides the least-squares mean Ratio (90% Confidence Interval) effect on concentration of Maviret and some common concomitant medicinal products.
Maltese: Tabella 3 tipprovdi l-effett tal-Proporzjon tal-medja tal-inqas kwadri (Intervall ta' Kunfidenza ta' 90%) fuq il-konċentrazzjoni ta' Maviret u xi prodotti mediċinali konkomitanti komuni.
English: Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy Genotype
Maltese: Tabella 1: Tul rakkomandat tal-kura b'Maviret għal pazjenti mingħajr terapija preċedenti għall-HCV
English: No dose adjustment of Maviret is required in patients with any degree of renal impairment including patients on dialysis (see sections 5.1 and 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża ta' Maviret f'pazjenti bi kwalunkwe grad ta' indeboliment tal-kliewi, inklużi pazjenti fuq dijalisi (ara sezzjonijiet 5.1 u 5.2).
English: Among the 2 genotype 2-infected subjects, no treatment-emergent substitutions were observed in NS3 or NS5A (the M31 polymorphism in NS5A was present at baseline and post-treatment in both subjects).
Maltese: Fost iż-żewġ individwi infettati bil-ġenotip 2, ma kinux osservati sostituzzjonijiet emerġenti mill-kura f'NS3 jew f'NS5A (il-polimorfiżmu M31 f'NS5A kien preżenti fil-linja bażi u wara l-kura fiż-żewġ individwi).
English: • St. John's wort (Hypericum perforatum), (herbal remedy used for mild depression).
Maltese: John's wort (Hypericum perforatum), (rimedju mill-ħxejjex użat għall-kura ta' dipressjoni ħafifa).
English: Genotype (GT) Clinical study Summary of study design TN and PRS-TE subjects without cirrhosis
Maltese: Ġenotip (GT) Studju kliniku Sommarju tad-disinn tal-istudju Individwi
English: Ten of 113 subjects treated with Maviret in the MAGELLAN-1 study for 12 or 16 weeks experienced virologic failure.
Maltese: Għaxra mill-113-il individwu li ngħataw Maviret fl-istudju MAGELLAN-1 għal 12 jew għal 16-il ġimgħa esperjenzaw falliment viroloġiku.
English: The non-linear exposure increase <120 mg may be related to saturation of efflux transporters.
Maltese: Iż-żieda mhux lineari fl-esponiment b'dożi ta' <120 mg tista' tkun relatata mas-saturazzjoni tat-trasportaturi tal-effluss.
English: EC50 values of glecaprevir and pibrentasvir against chimeric replicons encoding NS3 or NS5A from clinical isolates are presented in Table 6.
Maltese: Il-valuri EC50 ta' glecaprevir u pibrentasvir kontra replikons kimeriċi li jikkodifikaw NS3 jew NS5A minn iżolati kliniċi huma ppreżentati f'Tabella 6.
English: ↑ EE ↑ norgestrel norethidrone or norgestimate as contraceptive progestagen.
Maltese: Ma huwa meħtieġ lebda aġġustament fid-doża b'levonorgestrel, norethidrone jew norgestimate bħala proġestoġen kontraċettiv.
English: Co-administration of Maviret with medicinal products that are moderate inducers P-gp/CYP3A may decrease glecaprevir and pibrentasvir plasma concentrations (e.g. oxcarbazepine, eslicarbazepine, lumacaftor, crizotinib).
Maltese: L-għoti fl-istess ħin ta' Maviret ma' prodotti mediċinali li huma indutturi moderati tal-P-gp/CYP3A jista' jżid il-konċentrazzjonijiet ta' glecaprevir u pibrentasvir fil-plażma (eż. oxcarbazepine, eslicarbazepine, lumacaftor, crizotinib).
English: In genotype 3b replicon, the presence of naturally occurring polymorphisms K30 and M31 in NS5A reduced susceptibility to pibrentasvir by 24-fold relative to the activity of pibrentasvir in genotype 3a replicon.
Maltese: K30 u M31 li jinstabu b'mod naturali fi NS5A naqqsu is-suxxetibiltà għal pibrentasvir b'24 darba relattiv għall-attività ta' pibrentasvir f'replicon ta' ġenotip 3b.
English: Pibrentasvir is a pan-genotypic inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Maltese: Pibrentasvir huwa inibitur pan-ġenotipiku tal-HCV NS5A, li huwa essenzjali għar-replikazzjoni virali tal-RNA u l-assemblaġġ tal-virjon.
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint in all the studies to determine the HCV cure rate.
Maltese: Rispons viroloġiku sostnut (SVR12), definit bħala HCV RNA ta' anqas minn LLOQ 12-il ġimgħa wara l waqfien tal-kura, kien il-punt tat-tmiem primarju fl-istudji kollha għad-determinazzjoni tar-rata ta'kura tal-HCV.
English: Among the 2 genotype 1-infected subjects who experienced virologic failure, one had treatmentemergent substitutions A156V in NS3 and Q30R/L31M/H58D in NS5A, and one had Q30R/H58D (while Y93N was present at baseline and post-treatment) in NS5A.
Maltese: Fost iż-żewġ individwi infettati bil-ġenotip 1 li esperjenzaw falliment viroloġiku, wieħed kellu ssostituzzjonijiet emerġenti mill-kura A156V f'NS3 u Q30R/L31M/H58D f'NS5A, u wieħed kellu Q30R/H58D (filwaqt li Y93N kienet preżenti fil-linja bażi u wara l-kura) f'NS5A.
English: Maviret is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.3, and
Maltese: Maviret mhuwiex rakkomandat f'pazjenti b'indeboliment moderat tal-fwied (Child-Pugh B) u huwa kontraindikat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) (ara sezzjonijiet 4.2, 4.3, u
English: ENDURANCE-1a Maviret for 8 weeks (n=351) or 12 weeks (n=352) SURVEYOR-1 Maviret for 8 weeks (n=34)
Maltese: Maviret għal 8 ġimgħat (n=351) jew għal 12-il ġimgħa (n=352)
English: Specifically in genotype 3a, A30K or Y93H had no impact on pibrentasvir activity.
Maltese: B'mod speċifiku fil-ġenotip 3a, A30K jew Y93H ma kellhom l-ebda impatt fuq l-attività ta' pibrentasvir.
English: Maviret is not recommended in patients with moderate hepatic impairment (Child Pugh-B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3, 4.4, and
Maltese: Maviret mhuwiex rakkomandat f'pazjenti b'indeboliment moderat tal-fwied (ChildPugh B) u huwa kontraindikat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) (ara sezzjonijiet 4.3, 4.4, u 5.2).
English: EXPEDITION-2 Maviret for 8 weeks (n=137) or 12 weeks (n=16) Liver or Kidney Transplant Recipients GT1-6
Maltese: EXPEDITION-2 Maviret għal 8 ġimgħat (n=137) jew għal 12-il ġimgħa (n=16) Riċevituri ta' Trapjant tal-Fwied jew tal-Kliewi GT1-6
English: Genotype 3: For subjects who received the recommended regimen (n=309), baseline polymorphisms in NS5A (Y93H included) or NS3 did not have a relevant impact on treatment outcomes.
Maltese: Ġenotip 3: Għall-individwi li rċevew il-kors rakkomandat (n=309), il-polimorfiżmi tal-linja bażi f'NS5A (inkluż Y93H) jew f'NS3 ma kellhomx impatt rilevanti fuq ir-riżultati tal-kura.
English: % Bound to human plasma proteins Blood-to-plasma ratio
Maltese: Distribuzzjoni % Li jeħel mal-proteini tal-plażma talbniedem
English: b. GT2 from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=54) or 12 weeks (n=25); GT2 from SURVEYOR-2 Part 4 - Maviret for 8 weeks (n=145).
Maltese: GT2 minn SURVEYOR-2 Parti 1 u 2 - Maviret għal 8 ġimgħat (n=54) jew għal 12-il ġimgħa (n=25);
English: ↔ glecaprevir ↔ pibrentasvir tacrolimus exposure is expected.
Maltese: Hija mistennija żieda fl-esponiment għal tacrolimus.
English: The SVR12 rate in TN or TE-PRS HCV/HIV-1 co-infected subjects treated for 8 or 12 weeks (without cirrhosis and with compensated cirrhosis, respectively) was 98.2% (165/168) from ENDURANCE-1 and EXPEDITION-2.
Maltese: TN jew TE-PRS koinfettati b'HCV / HIV-1 ikkurati għal 8 jew 12-il ġimgħa (mingħajr ċirrożi u b'ċirrożi kkumpensata, rispettivament) kienet ta' 98.2% (165/168) minn ENDURANCE-1 u EXPEDITION-2.
English: Both glecaprevir and pibrentasvir inhibit the bile salt export pump (BSEP) in vitro.
Maltese: Kemm glecaprevir kif ukoll pibrentasvir jinibixxu l-pompa ta' esportazzjoni tal-melħ tal-bila (BSEP) in vitro.
English: ANTIMYCOBACTERIALS Rifampicin
Maltese: MEDIĊINI KONTRA L-KONVULŻJONIJIET Carbamazepine
English: Of the 280 subjects treated, the median age was 60 years (range: 34 to 88); 81.8% had HCV genotype 1, 10% had HCV genotype 2, 4.6% had HCV genotype 4, 0.4% had HCV genotype 5; 3.2% had HCV genotype 6; 60% were male; 9.6% were Black.
Maltese: 8% kellhom ġenotip HCV 1, 10% kellhom ġenotip HCV 2, 4.6% kellhom ġenotip HCV 4, 0.4% kellhom ġenotip HCV 5; 3.2% kellhom ġenotip HCV 6; 60% kienu irġiel; 9.6% kienu Suwed.
English: Ciclosporin 400 mg single dose
Maltese: Ciclosporin doża waħda ta' 400 mg
English: Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT'.
Maltese: Pillola miksija b'rita, roża, oblonga, bikonvessa, b'qisien ta' 18.8 mm x 10.
English: Of the 101 subjects treated, the median age was 58 years (range 32-87); 53% had HCV genotype 1; 27% had HCV genotype 2; 15% had HCV genotype 3; 4% had HCV genotype 4; 59% were male; 73% were White; 80% were HCV treatment-naïve; 13% had cirrhosis and 65% had a baseline fibrosis state of F0 or F1; 7% were CKD stage 3b; 17% were CKD Stage 4, and 76% were CKD Stage 5 (all receiving dialysis); 84 subjects received 8 weeks of treatment, 13 subjects received 12 weeks of treatment, and 4 subjects received 16 weeks of treatment.
Maltese: Mill-101 individwu ttrattati, l-età medjana kienet ta' 58 sena (medda ta' 32-87); 53% kellhom HCV ġenotip 1; 27% kellhom HCV ġenotip 2; 15% kellhom HCV ġenotip 3; 4% kellhom HCV ġenotip 4; 59% kienu rġiel; 73% kienu Bojod; 80% qatt ma kienu ħadu t-trattament għall-HCV; 13% kellhom ċirrożi u 65% kellhom stat tal-fibrożi fil-linja bażi ta' F0 jew F1; 7% kienu CKD stadju 3b; 17% kienu CKD Stadju 4, u 76% kienu CKD Stadju 5 (kollha rċivew dijalisi); 84 individwu rċivew 8 ġimgħat ta' trattament, 13-il individwu rċivew 12-il ġimgħa ta' trattament, u 4 individwi rċivew 16-il ġimgħa ta' trattament.
English: Patients treated with vitamin K antagonists
Maltese: Pazjenti mogħtija antagonisti tal-vitamina K
English: GT3b is a subtype reported in a relatively small number of HCV infected patients in China and a few countries in South and Southeast Asia, but rarely outside of this region.
Maltese: GT3b huwa sottotip irrapurtat f'numru relattivament żgħir ta' pazjenti infettati b'HCV fiċ-Ċina u fi ftit pajjiżi tan-nofsinhar u x-xlokk tal-Asja, iżda rarament barra dan ir-reġjun.
English: Adverse Reactions in Subjects with Liver or Kidney Transplant The safety of Maviret was assessed in 100 post-liver or -kidney transplant recipients with genotypes 1, 2, 3, 4, or 6 chronic HCV infection without cirrhosis (MAGELLAN-2).
Maltese: Reazzjonijiet Avversi f'suġġetti bi Trapjant tal-Fwied jew tal-Kliewi Is-sigurtà ta' Maviret ġiet evalwata f'100 riċevitur ta' trapjant ta' wara l-fwied jew tal-ġisem bilġenotipi 1, 2, 3, 4 jew 6 infezzjoni kronika HCV mingħajr ċirrożi (MAGELLAN-2).
English: Table 2: Recommended Maviret treatment duration for patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin Genotype Recommended treatment duration No cirrhosis
Maltese: Tabella 2: Tul rakkomandat tal-kura b'Maviret għal pazjenti li fallew terapija preċedenti b'pegIFN + ribavirin +/- sofosbuvir, jew sofosbuvir + ribavirin Ġenotip Tul rakkomandat tal-kura L-ebda ċirrożi Ċirrożi GT 1, 2, 4-6 8 ġimgħat
English: Belgique/Belgien Tél/Tel: +32 10 477811
Maltese: AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
English: Direct hyperbilirubinemia was reported in 0.3% of subjects.
Maltese: Iperbilirubinimja diretta kienet irrappurtata f'0.3% tal-individwi.
English: Substitutions at amino acid position 168 in NS3 had no impact in genotype 2, while some substitutions at position 168 reduced glecaprevir susceptibility by up to 55-fold (genotypes 1, 3, 4), or reduced susceptibility by > 100-fold (genotype 6).
Maltese: Issostituzzjonijiet fil-pożizzjoni 168 tal-aċidu amminiku f'NS3 ma kellhom l-ebda impatt fil-ġenotip 2, filwaqt li xi sostituzzjonijiet fil-pożizzjoni 168 naqqsu s-suxxettibilità għal glecaprevir b'sa 55 darba (ġenotipi 1, 3, 4), jew naqqsu s-suxxettibilità b'> 100 darba (ġenotip 6).
English: Three GT3b TN subjects experienced relapse and two GT3b TEPRS subjects experienced on-treatment virologic failure.
Maltese: Tliet individwi GT3b TN esperjenzaw rikaduta u żewġ individwi GT3b TE-PRS esperjenzaw falliment viroloġiku waqt il-kura.
English: Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection
Maltese: Studji kliniċi mwettqa b'Maviret f'individwi b'Infezzjoni tal-ġenotip 1, 2, 3, 4, 5 jew 6 tal-HCV