FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single 100 mg oral dose of [14C]-velpatasvir, mean total recovery of the [14C]-radioactivity was 95%, consisting of approximately 94% and 0.4% recovered from the faeces and urine, respectively.
Maltese: Wara doża orali waħda ta' 100 mg ta' [14C]-velpatasvir, il-medja tal-irkupru totali tar-radjuattività ta' [14C] kienet iktar minn 95%, u kienet tikkonsisti minn madwar 94% u 0.4% irkuprata fl-ippurgar u flawrina, rispettivament.
English: No patients in the placebo group achieved SVR12.
Maltese: L-ebda pazjent fil-grupp tal-plaċebo ma kiseb SVR12.
English: At baseline, 29% of patients had cirrhosis, 22% were treatment experienced, 32% had received a kidney transplant, 92% were on haemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7.3 years (range: 0 to 40 years).
Maltese: Fil-linja bażi, 29% tal-pazjenti kellhom ċirrożi, 22% kienu rċevew trattament filpassat, 32% kienu rċevew trapjant tal-kliewi, 92% kienu fuq emodijalisi, u 8% kienu fuq dijalisi talperitonew; it-tul ta' żmien medju fuq dijalisi kien ta' 7.3 snin (medda: 0 sa 40 sena).
English: Epclusa is contraindicated with St. John's wort (see section 4.3).
Maltese: John's wort (ara sezzjoni 4.3).
English: 76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Maltese: L-ebda pazjent b'infezzjoni bl-HCV ta' ġenotip 5 ma ġie rreġistrat. 76% tal-pazjenti kellhom alleli non-CC IL28B (CT jew TT); 56% kellhom livelli HCV RNA fil-linja bażi ta' mill-inqas 800,000
English: Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Maltese: Pravastatin (40 mg doża waħda)/velpatasvir (100 mg doża waħda)d
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate (150/150/200 mg/10 mg darba kuljum)/sofosbuvir/velpata svir (400/100 mg darba kuljum)ċ, d
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: Efavirenz/emtricitabine/ tenofovir disoproxil fumarate (600/200/300 mg/darba kuljum)/sofosbuvir/ velpatasvir (400/100 mg darba kuljum)ċ, d
English: These data indicate that renal clearance is the major elimination pathway for GS-331007.
Maltese: Din iddejta tindika li t-tneħħija mill-kliewi hi l-passaġġ ewlieni tat-tneħħija għal GS-331007.
English: Epclusa has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: Epclusa ntwera li jżid l-esponiment għal tenofovir, speċjalment meta jintuża flimkien ma' kors talHIV li jkun fih tenofovir disoproxil fumarate u enhancer farmakokinetiku (ritonavir jew cobicistat).
English: The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively.
Maltese: L-ogħla dożi dokumentati ta' sofosbuvir u velpatasvir kienu doża waħda ta' 1,200 mg u doża waħda ta' 500 mg, rispettivament.
English: However, on the basis of NS5A resistance associated variants (RAVs) typically seen in patients who have failed therapy with other NS5A inhibitor containing regimens, the in vitro pharmacology of velpatasvir, and the outcomes of sofosbuvir/velpatasvir treatment in NS5A-naïve patients with baseline NS5A RAVs enrolled into the ASTRAL-studies, treatment with Epclusa + RBV for 24 weeks can be considered for patients who have failed therapy on an NS5A-containing regimen and who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Maltese: Madankollu, fuq il-bażi tal-varjanti assoċjati mar-reżistenza (RAVs, resistance associated variants) ta' NS5A tipikament osservati f'pazjenti li ma rnexxewx fil-kura b'korsijiet oħrajn li fihom inibituri ta' NS5A, il-farmakoloġija in vitro ta' velpatasvir, u r-riżultati tal-kura b'sofosbuvir/velpatasvir f'pazjenti li qatt ma rċivew NS5A fil-passat b'NS5A RAVs fil-linja bażi li pparteċipaw fl-istudji ASTRAL, il-kura b'Epclusa + RBV għal 24 ġimgħa tista' titqies għall-pazjenti li ma rnexxewx fil-kura fuq kors li fih NS5A u li huma meqjusin f'riskju ogħla ta' progressjoni tal-marda klinika u li ma għandhomx għażliet ta' kuri alternattivi.
English: Of the 266 treated patients, the median age was 58 years (range: 23 to 81); 59% of the patients were male; 88% were White, 7% were Black; 33% had a baseline body mass index of at least 30 kg/m2; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels of at least 800,000 IU/mL; 14% had compensated cirrhosis and 15% were treatment-experienced.
Maltese: Mill266 pazjent ikkurati, l-età medjana kienet ta' 58 sena (medda: 23 sa 81); 59% tal-pazjenti kienu rġiel; 88% kienu Bojod; 7% kienu Suwed; 33% kellhom indiċi tal-massa tal-ġisem fil-linja bażi ta' millinqas 30 kg/m2; 62% kellhom alleli non-CC IL28B (CT jew TT); 80% kellhom livelli HCV RNA fillinja bażi ta' mill-inqas 800,000
English: Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Maltese: Mill-106 pazjenti ttrattati, l-età medjana kienet ta' 57 sena (medda: 25 sa 72); 86% tal-pazjenti kienu rġiel; 51% kienu bojod; 45% kienu suwed; 22% kellhom indiċi tal-massa tal-ġisem fil-linja bażi ta' ≥ 30 kg/m2; 19-il pazjent (18%) kellhom ċirrożi kumpensata; u 29% kellhom esperjenza ta' trattament.
English: Table 2: Guidance for ribavirin dosing when administered with Epclusa to patients with decompensated cirrhosis
Maltese: Tabella 3: Interazzjonijiet bejn Epclusa u prodotti mediċinali oħrajn Prodott mediċinali skont iż-żoni terapewtiċi/
English: Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Maltese: Mill-267 pazjent ikkurati, l-età medjana kienet ta' 59 sena (medda: 40 sa 73); 70% tal-pazjenti kienu rġiel; 90% kienu Bojod; 6% kienu Suwed; 42% kellhom indiċi tal-massa tal-ġisem fil-linja bażi ta' mill-inqas 30 kg/m2.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Maltese: ANTIMIKOBATTERJALI Rifampicin (600 mg darba kuljum)/velpatasvir (400 mg doża waħda)d
English: Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Maltese: Adulti infettati bl-HCV ta' ġenotip 2 - ASTRAL-2 (studju 1139) ASTRAL-2 kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, open-label li evalwa 12-il ġimgħa ta' kura b'Epclusa mqabbel ma' 12-il ġimgħa ta' kura b'SOF+RBV f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 2.
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Maltese: Il-farmakokinetika ta' velpatasvir kienet studjata b'doża waħda ta' 100 mg ta' velpatasvir f'pazjenti negattivi għal HCV b'indeboliment moderat u sever tal-fwied (CPT Klassi B u Ċ).
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Maltese: L-użu fl-istess ħin ta' amiodarone kien limitat permezz tal-iżvilupp kliniku ta' sofosbuvir.
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Maltese: 215 mg/ 0.25 mg/ethinyl estradiol 0.025 mg)/sofosbuvir (100 mg darba kuljum)d
English: H2-receptor antagonists Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Maltese: Antagonisti tar-riċetturi H2 Famotidine (40 mg doża waħda)/sofosbuvir/velpata svir (400/100 mg doża waħda)ċ
English: Table 15 presents the virologic outcome for patients with genotype 1 or 3 HCV infection in the ASTRAL-4 study.
Maltese: Tabella 15 tippreżenta r-riżultat viroloġiku għal pazjenti b'infezzjoni bl-HCV ta' ġenotip 1 jew 3 flistudju ASTRAL-4.
English: Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital and phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir.
Maltese: In vitro, kien osservat li ċ-ċiklu metaboliku ta' velpatasvir b'CYP2B6, CYP2C8 u CYP3A4 kien bil-mod. Prodotti meċinali li huma indutturi qawwija ta' P-gp u/jew indutturi qawwija ta' CYP2B6, CYP2C8, jew CYP3A4 (eż. carbamazepine, phenobarbital u phenytoin, rifampicin, rifabutin u St.
English: When Epclusa is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance < 50 mL/min (see section 5.2).
Maltese: Meta Epclusa jintuża flimkien ma' ribavirin, irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott għal ribavirin għal pazjenti bi tneħħija tal-kreatinina ta' < 50 mL/min (ara sezzjoni 5.2).
English: The film-coated tablets are pink, diamond-shaped tablets debossed with “GSI” on one side and “7916” on the other side.
Maltese: Il-pilloli miksija b'rita huma roża, b'forma ta' djamant, imnaqqxa b'“GSI” fuq naħa waħda u “7916” fuq in-naħa l-oħra.
English: GT-4 (n = 5)
Maltese: (n = 5)
English: Effects on medicinal product levels.
Maltese: Effetti fuq il-livelli tal-prodott mediċinali.
English: Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Maltese: Tabella 13: SVR12 għal sottogruppi magħżula fi studju ASTRAL-3 (HCV ta' ġenotip 3) Epclusa għal 12-il ġimgħa
English: Lopinavir boosted with ritonavir (4x200 mg/ 50 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: Lopinavir imsaħħaħ b'ritonavir (4x200 mg/50 mg darba kuljum) + emtricitabine/tenofovir disoproxil fumarate (200/300 mg darba kuljum)/sofosbuvir/velpata svir (400/100 mg darba kuljum)ċ, d
English: Medicinal product by therapeutic areas/Possible Mechanism of Interaction
Maltese: Prodott mediċinali skont iż-żoni terapewtiċi/ Mekkaniżmu Possibbli ta' Interazzjoni
English: The safety and efficacy of Epclusa in children and adolescents aged less than 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Epclusa fit-tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Compared to subjects with normal hepatic function velpatasvir total plasma exposure (AUCinf) was similar in patients with moderate or severe hepatic impairment.
Maltese: Imqabbla ma' individwi b'funzjoni normali tal-fwied, l-esponiment totali ta' velpatasvir fil-plażma (AUCinf) kienet simili f'pazjenti b'indeboliment moderat jew sever tal-fwied.
English: No dose adjustment of Epclusa is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C) (see section 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Epclusa mhu meħtieġ għal pazjenti b'indeboliment ħafif, moderat jew sever tal-fwied (Klassi CPT A, B, jew Ċ)(ara sezzjoni 5.2).
English: Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Maltese: Tabella 14 tippreżenta l-SVR12 għall-istudju ASTRAL-4 skont il-ġenotipi tal-HCV.
English: The overall SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed Epclusa treatment and relapsed and two did not meet virologic failure criteria.
Maltese: Ir-rata ta' SVR globali kienet ta' 95% (56/59); mit-tliet pazjenti li ma kisbux SVR12, pazjent wieħed kien lesta t-trattament b'Epclusa u rkada u tnejn ma ssodisfawx il-kriterji ta' falliment viroloġiku.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: Elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (150/150/200 mg/300 mg darba kuljum)/sofosbuvir/velpata svir (400/100 mg darba kuljum)ċ, d
English: Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
Maltese: Tabella 11: SVR12 fl-istudju ASTRAL-2 (HCV ta' ġenotip 2) Epclusa għal 12-il ġimgħa (n = 134)
English: Table 1: Recommended treatment and duration for all HCV genotypes
Maltese: Tabella 1: Kura u tul rakkomandat għall-ġenotipi kollha tal-HCV Popolazzjoni ta' pazjentia
English: Velpatasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all velpatasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Maltese: Velpatasvir kien attiv għal kollox kontra s-sostituzzjoni S282T assoċjata ma' reżistenza għal sofosbuvir f'S282T f'NS5B filwaqt li s-sostituzzjonijiet kollha assoċjati mar-reżistenza ta' velpatasvir f'NS5A kienu suxxettibbli għal kollox għal sofosbuvir.
English: f Bioequivalence/Equivalence boundary 80-125%.
Maltese: f. Bijoekwivalenza/Limitu tal-ekwivalenza 80-125% ġ. Medda ta' 50-200% li fiha ma jseħħu l-ebda interazzjonijiet farmakokinetiċi
English: Observed: Atorvastatin
Maltese: Atorvastatin
English: No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Maltese: Mhux meħtieġ aġġustament fiddoża ta' Epclusa atazanavir (imsaħħaħ b'ritonavir) jew emtricitabine/tenofovir disoproxil fumarate.
English: • The active substances are sofosbuvir and velpatasvir.
Maltese: • Is-sustanzi attivi huma sofosbuvir u velpatasvir.
English: Velpatasvir 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 rat micronucleus assays.
Maltese: Velpatasvir 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: Epclusa 12 weeks (90)
Maltese: Epclusa għal 12-il ġimgħa (90)
English: Both sofosbuvir and velpatasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Maltese: Kemm sofosbuvir kif ukoll velpatasvir kienu attivi b'mod sħiħ kontra sostituzzjonijiet assoċjati ma' reżistenza għal klassijiet oħrajn ta' antivirali li jaġixxu b'mod dirett b'mekkaniżmi ta' azzjoni differenti, bħal inibituri non-nucleoside ta' NS5B u inibituri ta' protease ta' NS3. L-effikaċja ta' Epclusa ma ġietx evalwata f'pazjenti li kellhom kura li ma rnexxietx b'korsijiet oħrajn li jinkludu inibitur ta' NS5A.
English: No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Maltese: L-ebda pazjent b'infezzjoni bl-HCV ta' ġenotip 2, 4 jew 6 ma kellu falliment viroloġiku.
English: Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Maltese: Iż-żieda ta' ribavirin tista' tiġi kkunsidrata għal pazjenti infettati b'ġenotip 3, b'ċirrożi kkumpensata (ara sezzjoni 5.1.)
English: Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Maltese: Tabella 10 tippreżenta l-SVR12 għall-istudju ASTRAL-1 skont il-ġenotipi tal-HCV.
English: Pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Maltese: It-tagħrif farmakokinetiku minn dan ilpazjent kien konsistenti man-nuqqas ta' osservanza tal-kura.
English: No data are available.
Maltese: M'hemm l-ebda dejtadisponibbli.
English: Epclusa + ribavirin for 12 weeks a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.
Maltese: Tinkludi pazjenti infettati wkoll bil-virus tal-immonodefiċjenza umana (HIV) u pazjenti b'HCV rikorrenti wara trapjant tal-fwied (ara sezzjoni 4.4).
English: The potential risks and benefits associated with co-administration of Epclusa with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Maltese: Ir-riskji u l-benefiċċji potenzjali assoċjati mal-għoti flimkien ta' Epclusa mal-pillola kombinata ta' doża fissa, li fiha elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate jew tenofovir disoproxil fumarate mogħtija fl-istess ħin ma' inibitur tal-protease tal-HIV imsaħħaħ (eż. atazanavir jew darunavir), għandhom jiġu kkunsidrati, b'mod partikulari f'pazjenti b'riskju miżjud ta' disfunzjoni renali.
English: The efficacy of Epclusa was evaluated in three Phase 3 studies in patients with genotype 1 to 6 HCV infection with or without compensated cirrhosis, one Phase 3 study in patients with genotype 1 to 6 HCV infection with decompensated cirrhosis, one Phase 3 study in HCV/HIV-1 co-infected patients with genotype 1 to 6 HCV infection and one Phase 2 trial in patients with HCV infection and ESRD requiring dialysis, as summarised in Table 9.
Maltese: L-effikaċja ta' Epclusa kienet evalwata fi tliet studji tal-Fażi 3 f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 1 sa 6 b'ċirrożi kumpensata jew mingħajrha, studju wieħed tal-Fażi 3 f'pazjenti b'infezzjoni bl-HCV ta' ġenotip 1 sa 6 b'ċirrożi dikumpensata, studju wieħed tal-Fażi 3 f'pazjenti ko-infettati b'HCV/HIV-1 b'infezzjoni bl-HCV ta' ġenotip 1 sa 6 u prova waħda ta' Fażi
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 tal-virus tal-immunodefiċjenza tal-bniedem (HIV), billi t-tabib tiegħek jista' jkun jixtieq li jissorveljak aktar mill-qrib.
English: TN and TE, without cirrhosis or with compensated cirrhosis, with HCV/HIV-1 co-infection
Maltese: TN u TE, mingħajr ċirrożi jew b'ċirrożi kumpensata, b'ko-infezzjoni ta' HCV/HIV-1
English: Velpatasvir solubility decreases as pH increases.
Maltese: Is-solubilità ta' velpatasvir tonqos hekk kif il-pH jiżdied.
English: • oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
Maltese: • oxcarbazepine (mediċina li tintuża għall-kura ta' epilessija u għall-prevenzjoni ta'
English: Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk.
Maltese: Dejta farmakokinetika fl-annimali wriet li kien hemm l-eliminazzjoni ta' velpatasvir u l-metaboliti ta' sofosbuvir fil-ħalib.
English: Velpatasvir is also a substrate of OATP1B.
Maltese: Velpatasvir huwa ukoll sottostrat ta' OATP1B.
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: TAL-PROTEASE TAL-HIV Atazanavir imsaħħaħ b'ritonavir (300/100 mg darba kuljum) + emtricitabine/tenofovir disoproxil fumarate (200/300 mg darba kuljum)/ sofosbuvir/velpatasvir (400/100 mg darba kuljum)ċ, d
English: Replicon genotype
Maltese: Ġenotip tar replikons
English: d Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184.
Maltese: Velpatasvir ma kellu ebda effett avvers fuq it-tgħammir u l-fertilità.
English: Studies in patients with decompensated cirrhosis (CPT Class B) Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients with decompensated cirrhosis in one Phase 3 study (ASTRAL-4).
Maltese: Studji f'pazjenti b'ċirrożi dikumpensata(CPT Klassi B) Saru analiżijiet biex jesploraw l-assoċjazzjoni bejn NS5A RAVs fil-linja bażi preeżistenti u r-riżultat tal-kura għal pazjenti b'ċirrożi kumpensata fi studju kliniku wieħed ta' Fażi 3 (ASTRAL-4).
English: Active
Maltese: Axxite
English: The adverse events observed were consistent with expected clinical sequelae of decompensated liver disease, or the known toxicity profile of ribavirin for patients receiving Epclusa in combination with ribavirin.
Maltese: L-avvenimenti avversi osservati kienu konsistenti mal-konsegwenzi kliniċi mistennija ta' mard tal-fwied dikumpensat, jew il-profil ta' tossiċità magħruf ta' ribavirin għal pazjenti li jingħataw Epclusa flimkien ma' ribavirin.
English: Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet.
Maltese: Epclusa hi mediċina li fiha s-sustanzi attivi sofosbuvir u velpatasvir f'pillola waħda.
English: The safety of Epclusa has been evaluated in a 12-week non-controlled study including 59 subjects with ESRD requiring dialysis (Study 4062).
Maltese: Is-sigurtà ta' Epclusa ġiet evalwata fi studju mhux ikkontrollat ta' 12-il ġimgħa li kien jinkludi 59 individwu b'ESRD li kienu jeħtieġu emodijalisi (Studju 4062).
English: Darunavir boosted with ritonavir (800/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Maltese: Darunavir imsaħħaħ b'ritonavir (800 mg/100 mg darba kuljum) + emtricitabine/tenofovir disoproxil fumarate (200/300 mg darba kuljum)/ sofosbuvir/velpatasvir (400/100 mg darba kuljum)ċ, d
English: Ascites
Maltese: INIBITURI
English: The single genotype 3 patient who had baseline NS5A RAVs and failed to achieve SVR12 had NS5A substitution Y93H at baseline; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Maltese: Il-pazjent uniku b'ġenotip 3 li kellu NS5A RAVs fil-linja bażi u li ma kisibx SVR12 kellu sostituzzjoni ta' NS5A Y93H fil-linja bażi; it-tagħrif farmakokinetiku minn dan il-pazjent kien konsistenti man-nuqqas ta' osservanza tal-kura.
English: Epclusa 12 weeks (n = 277)
Maltese: L-Individwi Kollha (n=274)
English: Epclusa 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: Epclusa 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: The moderate or high fat meal did not alter GS-331007 AUC0-inf, but resulted in a 25% and 37% decrease in its Cmax, respectively.
Maltese: L-ikla b'kontenut ta' xaħam moderat jew għoli ma bidlitx l-AUC0-inf ta' GS-331007, iżda rriżultat fi tnaqqis ta' 25% u 37% fis-Cmax tiegħu, rispettivament.
English: Sofosbuvir was not a carcinogen in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 15 and 9 times, respectively, higher than human exposure.
Maltese: Sofosbuvir ma kienx karċinoġenu fl-istudji li damu sentejn dwar il-karċinoġeniċità fuq il-ġrieden u l-firien f'esponimenti ta' GS-331007 ta' sa 15 u 9 darbiet, rispettivament, ogħla mill-esponiment talbniedem.
English: Table 16: Changes in CPT score parameters from baseline to week 12 and 24 post-treatment in patients achieving SVR12, ASTRAL-4
Maltese: Bidliet fil-parametri tal-punteġġ CPT mil-linja bażi sa ġimgħa 12 u 24 wara l-kura f'pazjenti li kisbu SVR12, ASTRAL-4
English: • If you are sick (vomit) less than 3 hours after taking Epclusa, take another tablet.
Maltese: • Jekk tirremetti inqas minn 3 sigħat wara li tkun ħadt Epclusa, ħu pillola oħra.
English: Treatmentexperienced (n = 69)
Maltese: (n = 69)
English: Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Maltese: Tabella 12: SVR12 fl-istudju ASTRAL-3 (HCV ta' ġenotip 3) Epclusa għal 12-il ġimgħa (n = 277)
English: Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4).
Maltese: L-użu ta' prodotti mediċinali bħal dawn ma' Epclusa hu kontroindikat (ara sezzjoni 4.3).