FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' sofosbuvir u ribavirin f'pazjenti adulti koinfettati b'HCV/HIV kien simili għal dak osservat f'pazjenti infettati b'HCV biss, ikkurati b'sofosbuvir u ribavirin fi studji kliniċi ta' Fażi 3 (ara sezzjoni 5.1).
English: Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Maltese: Korsijiet mingħajr interferon għal pazjenti b'infezzjoni bl-HCV ta' ġenotip 1, 4, 5 u 6 b'Sovaldi ma ġewx investigati fi studji ta' fażi 3 (ara sezzjoni 5.1).
English: This subject harboured <1% HCV S282T at baseline and developed S282T (>99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Maltese: Dan l-individwu kellu < 1% HCV S282T fil-linja bażi u żviluppa S282T (> 99%) 4 ġimgħat wara l-kura, li rriżultat f'bidla ta' 13.5 drabi fl-EC50 ta' sofosbuvir u naqqset il-kapaċità tarreplikazzjoni virali.
English: General
Maltese: Totala
English: Patients were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count >200 cells/mm3.
Maltese: Il-pazjenti ma kinux fuq terapija antiretrovirali b'għadd ta' ċelluli CD4+ ta' > 500 ċelluli/mm3, jew kellhom HIV-1 li kien viroloġikament soppress b'għadd ta' ċelluli CD4+ ta' > 200 ċelluli/mm3. 95% tal-pazjenti rċivew terapija antiretrovirali fil-ħin tar-reġistrazzjoni.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu ta' sofosbuvir fin-nisa tqal.
English: Sovaldi is contraindicated with St. John's wort (see section 4.3).
Maltese: John's wort (ara sezzjoni 4.3).
English: Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Maltese: Sofosbuvir f'kombinazzjoni ta' doża fissa ma' ledipasvir ingħata għal 12-il ġimgħa lil 18-il pazjent b'CHC ta' ġenotip 1 u indeboliment sever tal-kliewi fi studju open-label (Studju 0154).
English: Sovaldi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Maltese: Sovaldi jista' jintuża f'dawn il-pazjenti mingħajr aġġustament fid-doża meta ma jkunx hemm disponibbli għażliet oħra ta' trattament rilevanti (ara sezzjoni 4.4, 4.8, 5.1 u 5.2).
English: Patients received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for patients weighing <75 kg or 1,200 mg for patients weighing ≥75 kg).
Maltese: Il-pazjenti rċivew 400 mg ta' sofosbuvir u ribavirin ibbażat fuq il-piż (1,000 mg għal pazjenti li jiżnu < 75 kg jew 1,200 mg għal pazjenti li jiżnu ≥ 75 kg).
English: Population pharmacokinetics analysis in HCV infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati b'HCV, indikat li ċ-ċirrożi ma kellha l-ebda effett klinikament rilevanti fuq l-esponiment għal sofosbuvir u GS-331007.
English: In a pooled analysis of 991 patients who received sofosbuvir in Phase 3 studies, 226 patients qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA >1,000 IU/mL.
Maltese: F'analiżi miġbura ta' 991 pazjent li rċivew sofosbuvir fi studji ta' Fażi 3, 226 pazjent kkwalifikaw għal analiżi ta' reżistenza minħabba falliment viroloġiku jew waqfien bikri tal-mediċina tal-istudju u kellhom HCV RNA ta' > 1,000 IU/mL.
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, 1.40) Cmin (NA)
Maltese: ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, 1.40) Cmin (NA)
English: • Rifampicin (antibiotic used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Maltese: • Rifampicin (antibijotiku li jintuża għall-kura ta' infezzjonijiet, li jinkludu t-tuberkulożi);
English: Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 24 weeks of treatment with sofosbuvir in combination with ribavirin in 20 genotype 1 or 3 HCV-infected patients with severe renal impairment not requiring dialysis.
Maltese: Studju 0154 kien studju kliniku open-label li evalwa s-sigurtà u l-effikaċja ta' 24 ġimgħa ta' trattament b'sofosbuvir f'kombinazzjoni ma' ribavirin f'20 pazjent infettati bl-HCV ta' ġenotip 1 jew 3 b'indeboliment sever tal-kliewi li ma kinux jeħtieġu dijalisi.
English: Sovaldi should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data.
Maltese: Sovaldi għandu jingħata flimkien ma' prodotti mediċinali antivirali oħrajn li jaġixxu b'mod dirett biss jekk il-benefiċċju jiġi kkunsidrat li jiżboq ir-riskji bbażati fuq id-dejta disponibbli.
English: 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: 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: Baseline NS5B sequences were obtained for 1,292 patients from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Maltese: Sekwenzi ta' NS5B fil-linja bażi nkisbu għal 1,292 pazjent minn studji ta' Fażi 3 permezz ta' sekwenzar tal-popolazzjoni, u s-sostituzzjoni S282T ma nstabet fl-ebda individwu b'sekwenza disponibbli fil-linja bażi.
English: The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Maltese: Il-pilloli miksija b'rita huma sofor, b'forma ta' kapsula, imnaqqxa b'“GSI” fuq naħa waħda u “7977” fuq in-naħa l-oħra.
English: In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
Maltese: Fl-istudju ELECTRON (N = 11), it-tul tal-kura b'peginterferon alfa varja minn 4-12-il ġimgħa flimkien ma' sofosbuvir +ribavirin.
English: Sovaldi 400 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Sovaldi 400 mg pilloli miksija b'rita
English: Eight patients (20%) received epoetin and/or a blood product.
Maltese: Tmien pazjenti (20%) irċivew epoetin u/jew prodott tad-demm.
English: No dose adjustment of sofosbuvir or darunavir (ritonavir boosted) is required when sofosbuvir and darunavir are used concomitantly.
Maltese: L-ebda aġġustament fid-doża ta' sofosbuvir jew darunavir (imsaħħaħ b'ritonavir) mhu meħtieġ meta sofosbuvir u darunavir jintużaw fl-istess ħin.
English: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 u ġew stratifikati skont iċ-ċirrożi (preżenza kontra assenza) u ġenotip HCV (2 kontra 3).
English: Treatment-experienced (VALENCE)
Maltese: Qatt ma rċivew kura fil-passat (VALENCE)
English: A 4-hour haemodialysis session removed 18% of the administered dose.
Maltese: Sessjoni ta' emodijaliżi ta' 4 sigħat neħħiet 18% tad-doża mogħtija.
English: HCV infected patients, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first.
Maltese: Pazjenti infettati b'HCV, irrispettivament mill-ġenotip, b'karċinoma epatoċellulari (HCC - hepatocellular carcinoma) li ssodisfaw il-kriterji MILAN, irċivew 400 mg ta' sofosbuvir u 1,000-1,200 mg ta' ribavirin kuljum għal massimu ta' 24 ġimgħa, sussegwentement emendata għal 48 ġimgħa, jew saż-żmien meta sar ittrapjant tal-fwied, liema minnhom seħħ l-ewwel.
English: The SVR12 rate was 100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3 patients.
Maltese: Ir-rata ta' SVR12 kienet ta' 100% (13/13) f'pazjenti b'ġenotip 2 u 97% (36/37) f'pazjenti b'ġenotip 3. L-ebda pazjent ma kellu insuffiċjenza viroloġika jew rikaduta meta kien fuq il-kura.
English: post-transplant (pTVR)b
Maltese: Ġimgħa 12 wara t-trapjant (pTVR)b
English: Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Maltese: Data dwar is-sigurtà hija limitata f'pazjenti b'indeboliment sever tal-kliewi (eGFR ta' < 30 mL/min/1.73 m2) u ESRD li jkunu jeħtieġu l-emodijaliżi.
English: Sofosbuvir was administered at a dose of 400 mg once daily.
Maltese: Sofosbuvir ingħata f'doża ta' 400 mg darba kuljum.
English: • rash, itchy skin
Maltese: • raxx, ħakk fil-ġilda
English: No dose adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Sovaldi mhu meħtieġ għal pazjenti b'indeboliment ħafif, moderat jew sever tal-fwied (Child-Pugh-Turcotte [CPT] klassi A, B jew Ċ) (ara sezzjoni 5.2).
English: Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Maltese: Studji dwar il-karċinoġeniċità fil-ġrieden u l-firien ma jindikaw l-ebda potenzjal karċinoġeniku ta' sofosbuvir mogħti f'dożi sa 600 mg/kg/jum fil-ġrieden u 750 mg/kg/jum fil-firien.
English: Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Maltese: L-analiżi tal-effikaċja tinkludi 3 pazjenti b'infezzjoni ta' ġenotip HCV 2/1 rikombinanti.
English: Mild RI
Maltese: TAGĦRIF
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. modafinil, oxcarbazepine and rifapentine) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
Maltese: Prodotti mediċinali li huma indutturi moderati ta' P-gp fl-imsaren (eż. modafinil, oxcarbazepine u rifapentine) jistgħu jnaqqsu l-konċentrazzjoni ta' sofosbuvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Sovaldi.
English: Available pharmacokinetic data in animals have shown excretion of metabolites in milk (for details see section 5.3).
Maltese: Dejta farmakokinetika fl-annimali wriet li kien hemm l-eliminazzjoni tal-metaboliti fil-ħalib (għaddettalji ara sezzjoni 5.3).
English: Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
Maltese: RBV = ribavirin; ċ. PEG = peginterferon alfa.
English: Study 4063 was an open-label study that evaluated a fixed dose combination of sofosbuvir and ledipasvir in 95 patients with HCV-infection and ESRD requiring dialysis.
Maltese: Studju 4063 kien studju open-label li evalwa kombinazzjoni ta' doża fissa ta' sofosbuvir u ledipasvir f'95 pazjent b'infezzjoni tal-HCV u b'ESRD li kienu jeħtieġu dijalisi.
English: Sofosbuvir was studied in HCV infected patients prior to undergoing liver transplantation in an open-label clinical study evaluating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection.
Maltese: Sofosbuvir ġie studjat f'pazjenti infettati b'HCV qabel ma sarilhom trapjant tal-fwied, fi studju kliniku open-label li evalwa s-sigurtà u l-effikaċja ta' sofosbuvir u ribavirin mogħtija qabel it-trapjant biex jipprevjeni infezzjoni mill-ġdid b'HCV wara t-trapjant.
English: Musculoskeletal and connective tissue disorders: Very common arthralgia, myalgia
Maltese: Komuni ħafna artralġja, mijalġja
English: The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study.
Maltese: Issostituzzjoni S282T f'NS5B ġiet osservata f'individwu wieħed li kien qed jirċievi Sovaldi waħdu fi studju ta' Fażi 2.
English: The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant).
Maltese: Il-punt aħħari primarju tal-istudju kien rispons viroloġiku wara t-trapjant (pTVR, HCV RNA < LLOQ 12-il ġimgħa wara t-trapjant).
English: The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Maltese: Id-dejta klinika li tappoġġja l-użu ta' Sovaldi f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 5 u 6 hi limitata ħafna (ara sezzjoni 5.1).
English: Exposure to GS-331007 in these studies was up to 30 times (mouse) and 15 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: L-esponiment għal GS-331007 f'dawn l-istudji kien sa 30 darba (fil-ġrieden) u 15-il darba (fil-firien) ogħla millesponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group.
Maltese: L-ebda ċirrożi Ċirrożi n = numru ta' pazjenti b'rispons għal SVR12; N = numru total ta' pazjenti f'kull grupp.
English: HIV/HCV co-infection
Maltese: Koinfezzjoni b'HIV/HCV
English: Sofosbuvir and GS-331007 are not inhibitors of P-gp and BCRP and thus are not expected to increase exposures of medicinal products that are substrates of these transporters.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri ta' P-gp u BCRP u għalhekk mhumiex mistennija li jżidu l-esponimenti tal-prodotti mediċinali li huma substrati ta' dawn it-trasportaturi.
English: NA = not available/not applicable a. Mean ratio (90% CI) of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug.
Maltese: Proporzjon medju (90% CI) tal-farmakokinetika tal-mediċina mogħtija flimkien ma'/mingħajr sofosbuvir u l-proporzjon medju ta' sofosbuvir u GS-331007 ma'/mingħajr il-mediċina mogħtija flimkien.
English: In patients that discontinued therapy at 24 weeks, according to protocol, the relapse rate was 11/15.
Maltese: F'pazjenti li waqqfu t-terapija wara 24 ġimgħa, skont il-protokoll, ir-rata ta' rikaduta kienet ta' 11/15.
English: GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
Maltese: 77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
English: Cirrhosis
Maltese: Ciclosporin
English: Of the 50 treated patients, the median age was 15 years (range: 12 to 17); 42% of the patients were female; 90% were White, 4% were Black, and 2% were Asian; 4% were Hispanic/Latino; mean body mass index was 22 kg/m2 (range: 16 to 32 kg/m2); 18% were treatment experienced; 66% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 74% of patients had non-CC IL28B alleles (CT or TT); and no patients had known cirrhosis.
Maltese: Mill-50 pazjent ikkurati, l-età medjana kienet ta' 15-il sena (medda: 12 sa 17); 42% tal-pazjenti kienu nisa; 90% kienu Bojod, 4% kienu Suwed, u 2% kienu Ażjatiċi; 4% kienu Ispaniċi/mill-Amerika Latina; il-medja tal-indiċi tal-massa tal-ġisem kien 22 kg/m2 (medda: 16 sa 32 kg/m2); 18% irċivew kura fil-passat; 66% kellhom livelli ta' HCV RNA fil-linja bażi li kienu akbar minn jew daqs 800,000
English: • Have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Maltese: • Bħalissa għandek infezzjoni jew kellek infezzjoni preċedenti bil-virus tal-epatite B, minħabba li t-tabib tiegħek jista' jkun irid jimmonitorjak aktar mill-qrib;
English: The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon.
Maltese: Studju wieħed twettaq f'pazjenti li qatt ma rċivew kura filpassat, b'ġenotip 1, 4, 5 jew 6 ta' epatite Ċ kronika flimkien ma' peginterferon alfa 2a u ribavirin, u l-erba' studji l-oħrajn twettqu f'pazjenti b'ġenotip 2 jew 3 ta' epatite Ċ kronika flimkien ma' ribavirin, li jinkludi wieħed li sar f'pazjenti li qatt ma rċivew kura fil-passat, wieħed f'pazjenti intolleranti, ineliġibbli jew ma jridux jirċievu interferon, wieħed f'pazjenti li fil-passat ġew ikkurati b'kors ibbażat fuq interferon, u waħda fil-pazjenti kollha irrispettivament mill-istorja ta' kura fil-passat jew ilkapaċità li jirċievu kura b'interferon.
English: No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Maltese: L-ebda aġġustament fid-doża ta' norgestimate/ethinyl estradiol mhu meħtieġ meta sofosbuvir u norgestimate/ethinyl estradiol jintużaw fl-istess ħin.
English: Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate for all studies which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12).
Maltese: Rispons viroloġiku sostnut (SVR - sustained virologic response) kien il-punt aħħari primarju li ddetermina r-rata ta' kura ta' HCV għall-istudji kollha li ġie definit bħala HCV RNA ta' inqas minn LLOQ wara 12-il ġimgħa wara t-tmiem tal-kura (SVR12).
English: In rabbit studies exposure to sofosbuvir was 9 times the expected clinical exposure.
Maltese: Fi studji fil-fniek, l-esponiment għal sofosbuvir kien ta' 9 darbiet tal-esponiment kliniku mistenni.
English: Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection.
Maltese: L-analiżi tal-effikaċja tinkludi 6 pazjenti b'infezzjoni ta' ġenotip HCV 2/1 rikombonanti.
English: • Sovaldi is commonly used together with ribavirin.
Maltese: • Sovaldi jintuża b'mod komuni flimkien ma' ribavirin.
English: Genotype 3 (n = 98)
Maltese: (n = 98)
English: Medicinal products that are strong P-gp inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi and thus are contraindicated with Sovaldi (see section 4.3).
Maltese: John's wort) jistgħu jnaqqsu b'mod sinifikanti l-konċentrazzjoni ta' sofosbuvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Sovaldi u għalhekk huma kontraindikati ma' Sovaldi (ara sezzjoni 4.3).
English: Treated patients (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the patients were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers.
Maltese: Il-pazjenti kkurati (n = 201) kellhom età medjana ta' 56 sena (medda: 24 sa 70); 70% tal-pazjenti kienu rġiel; 87% kienu Bojod; 3% kienu Suwed; 9% kienu Ispaniċi jew mill-Amerika Latina; il-medja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 29 kg/m2 (medda: 19 sa 44 kg/m2); 73% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
English: After oral administration of Sovaldi, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic and intestinal metabolism.
Maltese: Wara l-għoti orali ta' Sovaldi, sofosbuvir jiġi assorbit malajr u soġġett għal metaboliżmu epatiku estensiv first-pass u metaboliżmu intestinali.
English: Common depression depression, anxiety, agitation
Maltese: Komuni dipressjoni dipressjoni, ansjetà, aġitazzjoni
English: GS-331007 ↓ Cmax 0.73c (0.65, 0.83) ↔ AUC 1.04c (0.89, 1.22) Cmin (NA)
Maltese: ↓ Cmax 0.73ċ (0.65, 0.83) ↔ AUC 1.04ċ (0.89, 1.22) Cmin (NA)
English: Week 12
Maltese: Tabella 16:
English: An interim analysis was conducted on 61 patients who received sofosbuvir and ribavirin; the majority of patients had HCV genotype 1, 44 patients were CPT class A and 17 patients were CPT class B. Of these 61 patients, 44 patients underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation.
Maltese: Minn dawn il-61 pazjent, 44 pazjent kellhom trapjant talfwied wara sa 48 ġimgħa ta' kura b'sofosbuvir u ribavirin; 41 kellhom HCV RNA < LLOQ fil-ħin tattrapjant.
English: Treated patients (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the patients were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL; 16% had cirrhosis; 49% had HCV genotype 3.
Maltese: Il-pazjenti kkurati (n = 278) kellhom età medjana ta' 54 sena (medda: 21 sa 75); 54% tal-pazjenti kienu rġiel; 91% kienu Bojod; 5% kienu Suwed; 11% kienu Ispaniċi jew mill-Amerika Latina; ilmedja tal-indiċi tal-piż tal-ġisem (BMI) kienet ta' 28 kg/m2 (medda: 18 sa 53 kg/m2); 70% kellhom livelli ta' HCV RNA fil-linja bażi ta' iktar minn 6 log10
English: Cirrhotic
Maltese: Ċirrotiċi
English: If patients maintained haemoglobin levels ≥12 g/dL, ribavirin dose was increased at weeks 2, 4, and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in patients <75 kg, 1,200 mg daily in patients ≥75 kg).
Maltese: Jekk il-pazjenti żammew livelli ta' emoglobina ta' ≥12 g/dL, id-doża ta' ribavirin żdiedet f'ġimgħat 2, 4, u sa kull 4 ġimgħat sakemm id-doża adatta bbażata fuq il-piż tkun intlaħqet (1,000 mg kuljum f'pazjenti li jiżnu < 75 kg, 1,200 mg kuljum f'pazjenti li jiżnu ≥ 75 kg).
English: • stomach discomfort, constipation, dry mouth, indigestion, acid reflux
Maltese: • skonfort fiż-żaqq, stitikezza, ħalq xott, indiġestjoni, rifuss tal-aċidu
English: Gilead Sciences Ireland UC Tel: + 353 (0) 214 825999
Maltese: Tel: + 353 (0) 214 825999
English: Adult patients awaiting liver transplantation - Study 2025
Maltese: Pazjenti adulti li jkunu qed jistennew trapjant tal-fwied - Studju 2025
English: Baseline NS5B sequences were obtained for 47 patients in the Phase 2 study.
Maltese: Sekwenzi ta' NS5B fil-linja bażi nkisbu għal 47 pazjent fl-istudju ta' Fażi 2.
English: Table 18 presents the subgroup analysis by genotype for cirrhosis.
Maltese: Tabella 18 tippreżenta l-analiżi tas-sottogrupp skont il-ġenotip għaċ-ċirrożi.
English: Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑
Maltese: Dawn ir-rakkomandazzjonijiet huma bbażati fuq il-kinetika ta' assorbiment ta' sofosbuvir u GS-331007 li tissuġġerixxi li l-maġġoranza tad-doża tiġi assorbita fi żmien sagħtejn wara d-dożaġġ.
English: Patients with HCV genotype 2 or 3 infection in the trial were treated with sofosbuvir with ribavirin for 12 or 24 weeks, respectively.
Maltese: Pazjenti b'infezzjoni bl-HCV ta' ġenotip 2 jew 3 fil-prova ġew ikkurati b'sofosbuvir ma' ribavirin għal 12 jew 24 ġimgħa, rispettivament.
English: Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali: