FrancophonIA/ELRC3.0 huggingface dataset:
English: Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Maltese: ION-2 kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, open-label li evalwa 12 u 24 ġimgħa ta' kura b'ledipasvir/sofosbuvir bi jew mingħajr ribavirin (b'mod każwali 1:1:1:1) f'pazjenti infettati b'HCV ta' ġenotip 1 bi jew mingħajr ċirrożi li esperjenzaw falliment f'kura preċedenti b'kors ibbażat fuq interferon inkluż korsijiet li fihom inibitur tal-protease tal-HCV.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Maltese: Il frekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni
English: GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or OAT3, or OCT2.
Maltese: GS-331007 mhuwiex substrat għal trasportaturi renali li jinkludu trasportatur anion organiku (OAT) 1
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Maltese: Sofosbuvir jeħel b'rata ta' madwar 61-65% mal-proteini tal-plażma tal-bniedem u t-twaħħil hu indipendenti mill-konċentrazzjoni tal-mediċini fuq il-medda ta' 1 μg/mL sa 20 μg/mL.
English: The clinical data to support the use of Harvoni in patients infected with HCV genotype 2 and 6 are limited (see section 5.1).
Maltese: Id-dejta klinika biex tappoġġa l-użu ta' Harvoni f'pazjenti infettati bil-ġenotip 2 u 6 tal-HCV hija limitata (ara sezzjoni 5.1).
English: Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12.
Maltese: Tibdil f'CPT: 59% (79/133) u 34% (45/133) kellhom titjib jew l-ebda bidla fil-punteġġi CPT mil-linja bażi sa ġimgħa 12 wara l-kura, rispettivament; mid-39 pazjent li kellhom ċirrożi CPT C fil-linja bażi, 56% (22/39) kellhom ċirrożi CPT B f'ġimgħa 12 wara l-kura; mid-99 pazjent li kellhom CPT B ċirrożi fil-linja bażi, 29% (27/92) kellhom ċirrożi CPT A f'ġimgħa 12 wara l-kura.
English: Table 17: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Maltese: Tabella 17: Rati ta' rispons (SVR12) f'pazjenti b' infezzjoni ta' ġenotip 3 (ELECTRON-2)
English: Age (years): median (range) Male gender
Maltese: Età (snin): medjan (medda) Sess maskili Razza: Sewda/ Amerikana Afrikana Bajda
English: 84 (3 bottles of 28) film-coated tablets.
Maltese: 28 pillola miksija b'rita. 84 (3 fliexken ta' 28) pillola miksija b'rita.
English: Exposure to GS-331007 in these studies was up to 17 times (mouse) and 9 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: GS-331007 f'dawn l-istudji kien sa 17-il darba (fil-ġrieden) u 9 darbiet (fil-firien) ogħla mill esponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Maltese: Abacavir/ lamivudine (600 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)
English: Table 12: Response rates in study ION-2 LDV/SOF
Maltese: Tabella 12: Rati ta' rispons fl-istudju ION-2 LDV/SOF
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)
Maltese: INIBITURI TA' REVERSE TRANSCRIPTASE Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ darba kuljum)/ ledipasvir (90 mg darba kuljum)
English: c. Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Maltese: darba f'EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, u Y93C/F/H/N/S
English: 12 weeks (n = 109)
Maltese: (n = 109)
English: Of the 8 genotype 1b patients who qualified for resistance testing, 7/8 (88%) harboured one or more NS5A RAVs at positions L31 and Y93 at failure, while 1/8 patients had no NS5A RAVs at failure.
Maltese: Mit-8 pazjenti ta' ġenotip 1b li kkwalifikaw għal prova ta' reżistenza, 7/8 (88%) laqgħu RAVs ta' NS5A wieħed jew aktar f'pożizzjonijiet L31 u Y93 meta ma rnexxewx, filwaqt li
English: c/ sofosbuvir (400 mg once daily)
Maltese: ċ/ sofosbuvir (400 mg darba kuljum)
English: The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil fumarate flambjent ta' Harvoni u enhancer farmakokinetiku
English: The clinical data to support the use of Harvoni in patients infected with HCV genotype 3 are limited (see section 5.1).
Maltese: Id-dejta klinika biex tappoġġa l-użu ta' Harvoni f'pazjenti infettati bil-ġenotip 3 tal-HCV hija limitata (ara sezzjoni 5.1).
English: Effect of baseline HCV resistance-associated variants on treatment outcome Genotype 1
Maltese: Il-pazjenti kienu fuq terapija antiretrovirali stabbli kontra l-HIV-1
English: ribavirin ± PEG-IFN.
Maltese: Antaċidi eż.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Maltese: ogħla f'pazjenti b'indeboliment moderat u sever tal-fwied, filwaqt li l-AUC0-24 ta' GS-331007 kien 18% u 9% ogħla, rispettivament.
English: Table 15: Response rates (SVR12) in study SOLAR-1 LDV/SOF+RBV 12 weeks (n = 168)
Maltese: Rati ta' rispons (SVR12) fi studju SOLAR-1 LDV/SOF+RBV
English: Interactions between Harvoni and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
Maltese: It-Tabella 3 tipprovdi elenku ta' interazzjonijiet klinikament sinifikanti tal-prodott mediċinali li huma stabbiliti jew potenzjali (fejn 90% intervall ta' kunfidenza [CI - confidence interval] tal-proporzjon tal geometric least-squares mean [GLSM] kien fil-medda ta' “↔”, estiża 'l fuq “↑”, jew estiża 'l isfel “↓”
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Maltese: < 1% u 1% għal pazjenti li kienu qed jirċievu ledipasvir/sofosbuvir għal 8, 12 u 24 ġimgħa, rispettivament; u < 1%, 0%, u 2% għal pazjenti li kienu qed jirċievu kura ta' kombinazzjoni ta' ledipasvir/sofosbuvir + ribavirin għal 8, 12 u 24 ġimgħa, rispettivament.
English: Prior HCV therapy
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: Limited data indicate that such NS5A mutations do not revert on long-term follow-up.
Maltese: Dejta limitata tindika li dawn il-mutazzjonijiet NS5A ma jerġgħux lura għan-normal waqt segwitu fit-tul.
English: Harvoni is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' rifabutin, induttur potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX65
Maltese: Antivirali li jaġixxu b'mod dirett, Kodiċi ATC:
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Maltese: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: ritonavir (800 mg/ 100 mg darba kuljum) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)c/ sofosbuvir (400 mg darba kuljum)c, d
English: Available pharmacokinetic data in animals has shown excretion of ledipasvir and metabolites of sofosbuvir in milk (see section 5.3).
Maltese: Dejta farmakokinetika fl-annimali wriet li kien hemm l-eliminazzjoni ta' ledipasvir u l-metaboliti ta' sofosbuvir fil-ħalib (ara sezzjoni 5.3).
English: Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
Maltese: Wara doża waħda ta' 90 mg [14C]-ledipasvir, l-esponiment sistemiku kien kważi esklussivament dovut għall-mediċina ġenitur
English: For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 16).
Maltese: Għal infezzjoni ta' ġenotip 2, 4, 5 u 6, it-terapija kienet tikkonsisti f'ledipasvir/sofosbuvir mingħajr ribavirin, mogħti għal 12-il ġimgħa (Tabella 16).
English: NS5B RAVs: The NS5B substitution S282T emerged in the HCV of 1/17 genotype 3-failures, and in the HCV of 1/3, 1/1 and 1/1 of genotype 4-, 5- and 6-failures, respectively.
Maltese: Is-sostituzzjoni NS5B S282T ħarġet f'HCV ta' 1/17 tal-fallimenti ta' ġenotip 3, u fl
English: LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110).
Maltese: Fih lactose u sunset yellow FCF aluminium lake (E110).
English: The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 5.
Maltese: Il-valuri ta' EC50 ta' ledipasvir u sofosbuvir kontra sekwenzi ta' replikons ta' tul sħiħ jew kimeriċi li jikkodifikaw NS5A u NS5B minn iżolati kliniċi huma murija fid-dettall f'Tabella 5.
English: Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1
Maltese: Adulti li rċivew kura fil-passat bi jew mingħajr ċirrożi - ION-2 (studju 0109) - Ġenotip 1
English: At the no observed effect level, AUC exposure to ledipasvir was approximately 7- and 3-fold, in males and females, respectively, the human exposure at the recommended clinical dose.
Maltese: Fil-livell ta' ebda effett osseervat, l esponiment AUC għal ledipasvir kien madwar 7 u 3 darbiet, fl-irġiel u fin-nisa, rispettivament, lesponiment tal-bniedem fid-doża klinika rakkomandata.
English: Patients with a CPT score > 12 were excluded.
Maltese: Pazjenti b'punteġġ CPT ta' > 12 ġew esklużi.
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Maltese: Il-farmakokinetika ta' ledipasvir ġew studjati b'doża waħda ta' 90 mg ledipasvir f'pazjenti negattivi għal HCV b'indeboliment tal-kliewi sever (eGFR < 30 mL/min minn Cockcroft-Gault, medjan
English: Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Maltese: Bl-istess mod, bħalissa m'hemmx dejta li tappoġġja l-effettività ta' inibituri tal-protease NS3/4A f'pazjenti li fil-passat ma rnexxewx b'terapija li kienet tinkludi inibitur tal-protease NS3/4A.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Konsegwentement, pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew għandhom problemi biex jassorbu lglucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: The safety of ledipasvir/sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Maltese: Is-sigurtà ta' ledipasvir/sofosbuvir ma ġietx evalwata f'pazjenti b'indeboliment sever tal kliewi (stima tar-rata tal-filtrazzjoni glomerulari [eGFR - estimated glomerular filtration rate] ta' < 30 mL/min/1.73 m2) jew b'mard tal-kliewi li jinsab fl-aħħar stadju (ESRD - end stage renal disease)
English: c/ sofosbuvir (400 mg once daily)c, d
Maltese: sofosbuvir (400 mg doża waħda)h
English: If the starting dose is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Maltese: Jekk id-doża tal-bidu tiġi ttollerata sewwa, id-doża tista' tiġi titrata 'l fuq sa massimu ta' 1,000-1,200 mg kuljum (1,000 mg għal pazjenti li jiżnu < 75 kg u 1,200 mg għal pazjenti li jiżnu ≥ 75 kg).
English: SIRIUS included patients with compensated cirrhosis who first failed therapy with pegylated interferon (PEG-IFN) + ribavirin, and then failed a regimen consisting of a pegylated interferon + ribavirin + an NS3/4A protease inhibitor.
Maltese: Adulti li rċivew kura fil-passat b'ċirrożi - SIRIUS - Ġenotip 1 SIRIUS kien jinkludi pazjenti b'ċirrożi kumpensata li l-ewwel ma rnexxewx bit-terapija b'pegylated interferon (PEG-IFN) + ribavirin, u ma rnexxewx fuq kors li kien jikkonsisti minn pegylated interferon + ribavirin + u inibitur tal-protease NS3/4A.
English: SVR was achieved in all 24 patients (n = 20 with L159F+C316N; n = 1 with L159F; and n = 3 with N142T) who had baseline variants associated with resistance to NS5B nucleoside inhibitors.
Maltese: SVR intlaħaq fl-24 pazjent kollha (n = 20 b'L159F+C316N; n = 1 b'L159F;
English: ↔ Cmin 0.86 (0.78, 0.96) Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92)
Maltese: ↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta Harvoni jintuża ma' amiodarone konkomitanti u/jew mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb (ara s sezzjonijiet 4.4 u 4.5).
English: Ledipasvir 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: Ledipasvir 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: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)
Maltese: INIBITURI TA' INTEGRASE Raltegravir (400 mg darbtejn kuljum)/ ledipasvir (90 mg darba kuljum)
English: d. Lack of pharmacokinetics interaction bounds 70-143%.
Maltese: d. Medda ta' 70-143% li fiha ma jseħħu l-ebda interazzjonijiet farmakokinetiċi e.
English: Efavirenz ↔ Cmax 0.87 (0.79, 0.97) ↔ AUC 0.90 (0.84, 0.96) ↔ Cmin 0.91 (0.83, 0.99)
Maltese: Darunavir ↔ Cmax 0.97 (0.94, 1.01) ↔ AUC 0.97 (0.94, 1.00) ↔ Cmin 0.86 (0.78, 0.96)
English: b. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Maltese: b. Pazjenti bi status taċ-ċirrożi nieqes ġew esklużi minn din l-analiżi tas-subgrupp.
English: Race: Black/ African American
Maltese: Sewda /Amerikana
English: NS5A RAVs were seen at the time of relapse in 11/13 patients (for genotype 1a: Q30R alone [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]).
Maltese: NS5A RAVs ġew osservati meta seħħet ir-rikaduta fi 11/13-il pazjent (għal ġenotip 1a: Q30R waħdu [n = 2], Y93C [n = 1], Y93H/C
English: The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
Maltese: Is-sigurtà ta' Harvoni ma ġietx evalwata f'pazjenti b'indeboliment sever tal-kliewi (stima tar-rata tal-filtrazzjoni glomerulari [eGFR - estimated glomerular filtration rate] ta' < 30 mL/min/1.73 m2) jew b'mard tal-kliewi li jinsab fl-aħħar stadju (ESRD - end stage renal disease)
English: IL28CC genotype FibroTest-Determined Metavir scoreb
Maltese: Punteġġ Metavir Stabbilit b'Test Fibrob
English: In study 1118, 44 patients with genotype 1 infection, including 12 cirrhotic patients, who had previously failed treatment with sofosbuvir + ribavirin + PEG-IFN or with sofosbuvir + ribavirin were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks; the SVR was 100% (44/44).
Maltese: Fi studju 1118, 44 pazjent b'infezzjoni ta' ġenotip 1, li jinkludu 12-pazjent ċirrotiku, li ma rnexxewx f'kura preċedenti fuq b'sofosbuvir + ribavirin + PEG-IFN jew b'sofosbuvir + ribavirin ġew ikkurati b'ledipasvir/sofosbuvir + ribavirin għal
English: Table 11: Demographics and baseline characteristics in study ION-2 Patient disposition LDV/SOF 12 weeks (n = 109)
Maltese: Tabella 11: Demografiċi u karatteristiċi tal-linja bażi fl-istudju ION-2 Dispożizzjoni tal pazjent
English: In the SOLAR-1 study (see “Clinical efficacy and safety”, below) 13 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with ribavirin.
Maltese: Fl-istudju SOLAR-1 (ara “Effikaċja klinika u sigurtà”, hawn taħt) 13-il pazjent b'infezzjoni ta'
English: Ledipasvir was not carcinogenic in the 6-month rasH2 transgenic mouse study at exposures up to 26-fold higher than human exposure.
Maltese: f'esponimenti li kienu sa 26 darba ogħla mill-esponiment uman.
English: Not interpretable a. Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Maltese: Pazjent wieħed fil-fergħat ta' kura ta' 24 ġimgħa ta' LDV/SOF u pazjent wieħed fil-fergħa ta' kura ta' 24 ġimgħa ta' LDV/SOF + RBV kienu diġà fallew minn kura preċedenti ta' kors ibbażat fuq interferon mhux pegylated.
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: GS-331007 f'dożi li jikkawżaw effetti avversi kien 16-il darba (fil-firien) u 71 darba (fil klieb) ogħla mill-esponiment kliniku f'doża ta' 400 mg ta' sofosbuvir.
English: CPT C
Maltese: Oħrajn c
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 80 years) analysed, age did not have a clinically relevant effect on the exposure to ledipasvir, sofosbuvir or GS-331007.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati b'HCV uriet li fil-medda ta' età (18 sa 80 sena) analizzata, l-età ma kellhiex effett klinikament rilevanti fuq l-esponiment għal ledipasvir,
English: d. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Maltese: d. Pazjenti bi status taċ-ċirrożi nieqes ġew esklużi minn din l-analiżi tas-subgrupp.
English: Harvoni 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: L-użu ma' ċerti korsijiet antiretrovirali tal-HIV Harvoni ntwera li jżid l-esponiment għal tenofovir, speċjalment meta użat flimkien ma' kors tal-HIV li fih tenofovir disoproxil fumarate u enhancer farmakokinetiku (ritonavir jew cobicistat).
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively.
Maltese: ledipasvir/sofosbuvir kien ta' 0.5 u 27 siegħa rispettivament.
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Maltese: Inibituri tal-pompa tal-protoni Omeprazole (20 mg darba kuljum)/ ledipasvir (90 mg doża waħda)
English: (listed in section 6 of this leaflet).
Maltese: (ara sezzjoni 4.5).
English: Table 8: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Maltese: Tabella 8: Rati ta' rikaduta skont il-karatteristiċi tal-linja bażi fl-istudju ION-3, popolazzjoni b'falliment viroloġiku*
English: - Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options (see section 4.4).
Maltese: - Harvoni + ribavirin għal 12-il ġimgħa jew Harvoni (mingħajr ribavirin) għal 24 ġimgħa għandhom jiġu kkunsidrati għal pazjenti li rċivew kura fil-passat mingħajr għażliet ta' kura sussegwenti mill-ġdid inċerti (ara sezzjoni 4.4).
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
Maltese: ↓ Cmax 0.23 (0.19, 0.29)
English: The AUC0-inf of GS-331007 in patients with ESRD administered with sofosbuvir 1 hour before or 1 hour after haemodialysis was at least 10-fold and 20-fold higher, respectively.
Maltese: L-AUC0-inf ta' GS-331007 f'pazjenti b'ESRD mogħtija sofosbuvir siegħa qabel jew siegħa wara l-emodijaliżi kienet għallinqas 10 u 20 darba aktar, rispettivament.
English: Absorption
Maltese: Famotidine
English: In patients with ESRD, relative to patients with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Maltese: F'pazjenti b'ESRD, meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi, l-AUC0-inf ta' sofosbuvir kienet ta' 28% ogħla meta d-doża ta' sofosbuvir ingħatat siegħa qabel l-emodijaliżi, meta mqabbla ma' 60% ogħla meta d-doża ta' sofosbuvir ingħatat siegħa wara lemodijaliżi.
English: Harvoni is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Maltese: Harvoni hu kontraindikat ma' rifampicin, induttur potenti fl-imsaren ta' P-gp (ara sezzjoni 4.3).
English: Ethinyl estradiol ↔ Cmax 1.15 (0.97, 1.36)
Maltese: ↑ Cmin 1.23 (1.00, 1.51) Ethinyl estradiol ↔ Cmax 1.15 (0.97, 1.36)
English: Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Maltese: ↑ Cmin 1.47 (1.38, 1.57) Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
English: Table 7: Response rates in study ION-3 LDV/SOF
Maltese: Rati ta' rispons fl-istudju ION-3 LDV/SOF
English: SVR Outcome for patients without SVR On-treatment virologic failure a
Maltese: Falliment viroloġiku waqt il-kura Rikaduta a
English: Gilead Sciences International Ltd. Tel: + 44 (0) 20 7136 8820
Maltese: Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
English: Gilead Sciences Ltd. Tel: + 353 214 825999
Maltese: Tel: + 353 214 825999
English: Copovidone
Maltese: Amiodarone
English: ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Maltese: Adulti ko-infettati b'HCV/HIV - ERADICATE ERADICATE kien studju open-label sabiex jevalwa 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir f'50 pazjent b'CHC tal-ġenotip 1 ko-infettati bl-HIV.