FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatment emergent variants were seen in all 3 drug targets in 30 subjects.
Maltese: Fis-67 individwu infettat bil ġenotip 1a, kienu osservati varjanti NS3 f'50 individwu, kienu osservati varjanti NS5A f'46 individwu, kienu osservati varjanti NS5B f'37 individwu, u kienu osservati varjanti emerġenti f'kuri fit-3 miri ta' mediċini fi 30 individwu.
English: ↓ dasabuvir ombitasvir paritaprevir norethindrone (progestin only pill) 0.35 mg once daily
Maltese: ↑ nor elgestromine dasabuvir ombitasvir paritaprevir nor-ethindrone (pillola ta' progestin biss)
English: Without RBV
Maltese: B'RBV
English: Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine.
Maltese: L-individwi kienu fuq kors ta' terapija antiretrovirali (ART) HIV-1 li tinkludi ritonavir imsaħħaħ b'atazanavir jew raltegravir, amministrati fl-istess ħin b'sinsla ta' tenofovir + emtricitabine jew lamivudine.
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had a similar SVR12 rate (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (97.7%).
Maltese: F'dan l istudju, Exviera u ombitasvir/paritaprevir/ritonavir mingħajr ribavirin kellu rati SVR12 simili (100%) meta mqabbel ma' Exviera u ombitasvir/paritaprevir/ritonavirma' ribavirin (97.7%).
English: What Exviera looks like and contents of the pack Exviera tablets are beige, ovaloid film-coated tablets, of dimensions of 14.0 mm x 8.0 mm, marked with “AV2”.
Maltese: Pilloli Exviera huma beige, ovali miksijin b'rita, b'daqs ta' 14.0 mm x 8.0 mm immarkati bi “AV2”.
English: In a pooled analysis of clinical trials with Exviera and ombitasvir/paritaprevir/ritonavir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment.
Maltese: F'analiżi miġbura ta' provi kliniċi b'Exviera u ombitasvir/paritaprevir/ritonavir flimkien ma' jew mingħajr ribavirin, 1% tas-suġġetti esperjenzaw livelli ta 'ALT fis-serum aktar minn 5 darbiet ogħla mil-limitu tan-normal ( ULN ) wara li beda l-kura.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU per mL.
Maltese: Lanaliżi kellha limitu aktar baxx ta' kwantifikazzjoni (LLOQ) ta' 25 IU għal kull mL.
English: 34 subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Maltese: 34 individwi (29 b'infezzjoni tal-ġenotip 1a HCV u 5 b'infezzjoni tal-ġenotip 1b HCV) kienu rreġistrati li ma kienux irċevew kura għall-infezzjoni ta' HCV wara t-trapjant u li kellhom punteġġ talfibrożi Metavir ta' F2 jew inqas.
English: Patients who are taking ethinylestradiol -containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Exviera with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5).
Maltese: Pazjenti li qed jieħdu prodotti mediċinali li fihom ethinylestradiol (jiġifieri ħafna mill-kontraċettivi orali kkombinati jew ċrieki vaġinali kontraċettivi) għandhom jaqilbu għal metodu alternattiv ta' kontraċezzjoni (pereżempju, kontraċezzjoni li tinvolvi progestin biss jew metodi li m' humiex ormonali) qabel tinbeda terapija b'Exviera ma' ombitasvir/paritaprevir /ritonavir (ara sezzjonijiet 4.3 u 4.5).
English: Geometric mean Cmax, AUC of multiple doses of Exviera 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Maltese: Tabella 17. Cmass, AUC medji ġeometriċi ta' dożi multipli ta' Exviera 250 mg darbtejn kuljum u ombitasvir/paritaprevir/ritonavir25 mg/150 mg/100 mg darba kuljum bl-ikel f'voluntiera b'saħħitom.
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Maltese: Il-proporzjon ta' individwi li waqqfu l-kura b'mod permanenti minħabba avvenimenti avversi kien 0.2% (5/2,044) u
English: Exviera should be used in combination with other medicinal products for the treatment of HCV (see section 5.1).
Maltese: prodotti mediċinali oħra għall-kura ta' HCV(ara sezzjoni 5.1).
English: TURQUOISE-III is a Phase 3b, open-label, single-arm, multicentre study evaluating the efficacy and safety of Exviera and ombitasvir/paritaprevir/ritonavir (without ribavirin) administered for 12 weeks in HCV GT1b-infected, treatment-naïve and pegIFN/RBV treatment-experienced adults with compensated cirrhosis.
Maltese: TURQUOISE-III huwa Fażi 3b, tikketta miftuħa, fergħa waħda, studju multiċentriku li jevalwa leffikaċja u s-sigurtà ta' Exviera u ombitasvir/paritaprevir/ritonavir (mingħajr ribavirin) amministrati għal 12-il ġimgħa f'adulti nfettati bi GT1b HCV, naïve għall-kura u bl-esperjenza għat-trattament bi pegIFN/RBV b'ċirrożi kumpensata.
English: Тел.
Maltese: Tel:
English: Phase 3 global multicentre trials conducted with Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Maltese: Provi ta' Fażi 3 globali multiċentrali mwettqa b'Exviera u ombitasvir/paritaprevir/ritonavirbi jew mingħajr ribavirin (RBV).
English: The safety of Exviera in children and adolescents aged < 18 years has not yet been established.
Maltese: Is-sigurtà u effikaċja ta' dasabuvir fi tfal ta' età inqas minn 18 ma ġewx determinati s'issa.
English: Selected treatment emergent laboratory abnormalities
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Abnormalitajiet tal-laboratorju
English: Clinical Trial in subjects with HCV genotype 1 Infection/HIV-1 co-infection
Maltese: Provi kliniċi f'individwi b'infezzjoni/HIV-1 ko-infezzjoni ta' ġenotip1 HCV
English: Target Emergent amino acid substitutionsa
Maltese: Mira Sostituzzjonijiet tal-amino aċidi emerġenti a
English: Ethinylestradiol is contraindicated in combination with Exviera (see section 4.3).
Maltese: Kontraċettivi orali li fihom ethinylestradiol huma kontraindikati (ara sezzjoni 4.3).
English: r paritaprevir
Maltese: ↔ paritaprevir
English: Exviera should not be used in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.8 and 5.2).
Maltese: Exviera m'għandux jintuża f'pazjenti b'indeboliment epatiku serju (Child-Pugh C) (ara sezzjonijiet 4.2, 4.8 u
English: Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Maltese: L-użu ta' prodotti mediċinali li fihom ethinylestradiol bħal dawk li jinsabu f'ħafna mil-kontraċettivi orali kkombinati jew ċrieki vaġinali kontraċettivi (ara sezzjoni 4.4 u 4.5).
English: OPIOIDS Methadone Exviera
Maltese: OPJOJDI Methadone:
English: Digoxin 0.5 mg single dose
Maltese: 0.5mg doża waħda Mekkaniżmu:
English: Excipient with known effect: each film-coated tablet contains 44.94 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita fiha 44.9 mg lattożju (bħala monoidrat) .
English: Contraceptive medicines that contains ethinylestradiol cannot be used in combination with Exviera.
Maltese: Metodi ta' kontraċezzjoni li fihom ethinylestradiol ma' jistgħux jintużaw f'kombinazzjoni ma' Exviera.
English: In biochemical assays, dasabuvir inhibited a panel of genotype 1a and 1b polymerases with a mean IC50 value of 4.2 nM (range 2.2 to 10.7 nM; n=7).
Maltese: polimerażi ta' ġenotip 1a u 1b b'valur medju ta' IC50 ta' 4.2 nM (firxa ta' 2.2 sa 10.
English: − Tablet core: microcrystalline cellulose (E460(i)), lactose monohydrate, copovidone,
Maltese: − Qalba tal-pillola: microcrystalline cellulose (E460(i)), lactose monohydrate, copovidone, croscarmellose sodium, colloidal anhydrous silica (E551), magnesium stearate (E470b).
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would result in <10% change in dasabuvir exposures.
Maltese: Bidla ta' 10 kg fil-piż tal-ġisem minn 76 kg (piż medjan fl-istudji ta' fażi 3) ser tirriżulta f' bidla <10 % flespożizzjonijiet għal dasabuvir.
English: PEARL-II was a randomised, global multicentre, open-label trial conducted in 179 adults with chronic genotype 1b hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Maltese: PEARL-II kienu prova globali b'aktar minn ċentru wieħed, open-label magħmula b'mod każwali mwettqa f'179 adult b'infezzjoni tal-virus tal-epatite Ċ ta' ġenotip 1b kronika mingħajr ċirrożi li ma kisbux SVR b'kura preċedenti bi pegIFN/RBV.
English: PEARL-IV- genotype 1a, treatment-naïve
Maltese: PEARL-IV- ġenotip 1a, mingħajr esperjenza ta' kura
English: PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis.
Maltese: PEARL-III kienet prova kkontrollata, double-blind, multiċentrika globali, randomizzata f'419 adult li qatt ma ħa l-kura qabel b'infezzjoni tal-virus tal-epatite Ċ kronika tal-ġenotip 1b mingħajr ċirrożi.
English: Clinical Comments ritonavir.
Maltese: mingħajr ritonavir,
English: TURQUOISE-II was a randomised, global multicentre, open-label trial conducted exclusively in 380 genotype 1-infected subjects with compensated cirrhosis (Child-Pugh A) who were either treatmentnaïve or did not achieve SVR with prior treatment with pegIFN/RBV.
Maltese: TURQUOISE-II kienet prova globali b'aktar minn ċentru wieħed, open-label magħmula b'mod każwali mwettqa esklussivament fi 380 individwu infettati b'ġenotip 1 b'ċirrożi kkumpensata (Child
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Maltese: Individwi kkurati (N=63) kellhom medja ta' età ta' 51-il sena (medda 31 sa 69); 24% tal-individwi kienu Suwed; 81% tal-individwi kellhom ġenotip IL28B non-CC; 19% tal-individwi kellhom ċirrożi kkumpensata; 67% tal-individwi kienu naive għall-kura ta' HCV; 33% tal-individwi fallew qabel ilkura bi pegIFN/RBV; 89% tal-individwi kellhom infezzjoni tal-ġenotip 1a HCV.
English: In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Maltese: Fi TURQUOISE-I, ir-rati ta' SVR12 f'individwi b'ko-infezzjoni ta' HCV/HIV-1 kienu konsistenti ma' r-rati ta' SVR12 fil-provi kliniċi ta' fażi 3 ta' individwi mono-infettati b'HCV.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Maltese: Kull pillola miksija b'rita fiha 250 mg ta' dasabuvir (bħala sodju monohydrate).
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 bi problemi ereditarji rari ta' intolleranza għall-galattożju, defiċjenza Lapp lactase jew assorbiment ħażin ta' glukożju u galattożju m'għandhomx jieħdu din il-mediċina.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV
Maltese: Fergħa B: Exviera u ombitasvir/paritaprevir/ritonavir + RBV
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Maltese: F'fażi 2, multiċentriku, open-label, studju b'fergħha waħda, 38 li kienu naïve għal-kura jew esperjenzati bil-kura ta' pegIFN/RBV, individwi mhux biċ-ċirrożi bl-infezzjoni tal-ġenotip 1 li kienu fuq doża stabbli ta' methadone (N=19) jew buprenorphine +/- naloxone (N=19) irċevew 12-il ġimgħa ta' Viekirax u dasabuvir ma' ribavirin.
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 21.8% had a body mass index of at least 30 kg/m2; 12.8% had a history of depression or bipolar disorder; 90.5% had IL28B non-CC genotype; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Maltese: Il-pazjenti kkurati (N=179) kellhom età medja ta' 57 sena (medda: 26 sa 70); 35.2% kienu persuni li ma tawx risposta għal pegIFN/RBV qabel; 28.5% kienu taw risposta parzjali għal pegIFN/RBV, 36.3% kienu rikadew wara pegIFN/RBV; 54.2% kienu rġiel; 3.9% kienu Suwed; 21.8% kellhom indiċi tal-massa tal-ġisem ta' mill-inqas 30 kg/m2; 12.8% kellhom storja ta' dipressjoni jew disturb bipolari; 90.5% kellhom ġenotip IL28B mhux CC; 87.7% kellhom linja bażi ta' livelli ta' RNA talHCV ta' mill-inqas 800,000
English: Mechanism:
Maltese: Mekkaniżmu:
English: Exviera ombitas vir/parit aprevir/ ritonavi r atazanavir
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir atazanavir
English: Genotype 1a, without cirrhosis
Maltese: Ġenotip 1a, mingħajr ċirrożi
English: In the 7 genotype 1b infected subjects,treatment-emergent variants were observed in NS3 in 4 subjects, in NS5A in 2 subjects, and in both NS3 and NS5A in 1 subject.
Maltese: Fis-7 individwi infettati bil-ġenotip 1b, kienu osservati varjanti emerġenti mill-kura f'NS3 f'4 individwi, f'NS5A f'2 individwi, u kemm NS3 kif ukoll NS5A
English: Exviera ombitas vir/parit aprevir/ ritonavi r amlodipine
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir amlodipine
English: The overall safety profile in HCV-infected transplant recipients who were administered Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Maltese: Il-profil tas-sigurtà globali, f'pazjenti sottoposti għal trapjant tal-fwied li huma infettati b'HCV u li kienu amministrati Exviera u ombitasvir/paritaprevir/ritonavir u ribavirin (minbarra l-mediċinali immunosoppressanti tagħhom ) kien simili għal suġġetti kkurati b'Exviera u ombitasvir/paritaprevir/ritonavir u ribavirin fil-fażi provi kliniċi 3, għalkemm xi reazzjonijiet avversi kienu żdiedu fil-frekwenza.
English: Exviera should not be used in patients with severe hepatic impairment (ChildPugh C) (see section 5.2).
Maltese: Exviera m'għandhomx jintużaw f'pazjenti b'indeboliment epatiku sever (Child-Pugh Ċ) (ara sezzjoni 5.2).
English: Interactions between Exviera with ombitasvir/paritaprevir/ritonavir and other medicinal products
Maltese: Tabella 2 Interazzjonijiet bejn Exviera ma' ombitasvir/paritaprevir/ritonavir u prodotti mediċinali oħrajn
English: metabolite were not meaningfully different in subjects with hepatic impairment compared to normal control subjects (see sections 4.2, 4.4 and 4.8).
Maltese: Ir-rabta ta' dasabuvir mal-proteini tal-plażma u l-metabolit M1 tiegħu ma kinux sinifikament differenti f'suġġetti b'indeboliment epatiku meta mqabbla ma' suġġetti normali tal-kontroll (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: No dose adjustment needed for Exviera + ombitasvir/paritaprevir/
Maltese: Exviera + ombitasvir/ paritaprevi
English: Patients should be informed that fatigue has been reported during treatment with Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin (see section 4.8).
Maltese: Dikompensazzjoni epatika, insuffiċjenza tal-fwied kienu osservati waqt trattament b'Exviera b'ombitasvir/paritaprevir/ritonavir, bi jew mingħajr ribavirin (ara sezzjoni 4.4).
English: Mechanism: CYP3A4 inhibition by ritonavir
Maltese: Inibizzjoni ta' CYP3A4 b' ritonavir
English: Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Maltese: Exviera hija mediċina antivirali użata biex tikkura adulti bl-epatite Ċ (marda infettiva li taffettwa lfwied, ikkawżata mill-virus ta' l-epatite Ċ) kronika (fit-tul).
English: Exviera ombitas vir/parit aprevir/ ritonavi r duloxetine
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir duloxetine
English: A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 68.4% had IL28B non-CC genotype; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Maltese: IU/mL; 81.8% kellhom ġenotip IL28B mhux CC; u 24.7% kellhom storja ta' dipressjoni jew disturb bipolari; 68.7 % kellhom infezzjoni tal-ġenotip 1a HCV; 31.3% kellhom infezzjoni tal-ġenotip 1b HCV.
English: Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Maltese: L31F/V jew Y93H flimkien ma' L28M, L31F/V jew P58S fil-ġenotip 1b; u l-varjanti f'NS5B Y448H fil ġenotip 1a, u M414T u Y448H fil-ġenotip 1b.
English: Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
Maltese: Eta, snin medja (firxa) Sess maskil, n (%) Ġenotip mhux CC
English: Adverse reactions identified with Exviera in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Maltese: Tabella 3. Reazzjonijiet avversi identifikati b'Exviera f'kombinazzjoni ma' ombitasvir/paritaprevir/ritonavir jew ombitasvir/paritaprevir/ritonavir u ribavirin
English: Exviera and ombitasvir/paritaprevir /ritonavir + ribavirin
Maltese: Exviera u ombitasvir/paritaprevir /ritonavir + ribavirin
English: Table 7 shows the SVR12 rates for genotype 1-infected, treatment-naïve subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-I.
Maltese: Tabella 7 turi rati ta' SVR12 għal individwi mingħajr esperjenza infettati b'ġenotip 1 li kienu qed jirċievu Exviera u ombitasvir/paritaprevir/ritonavir f'kombinazzjoni ma' ribavirin għal 12-il ġimgħa f'SAPPHIRE-I.
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 28.4% had a body mass index of at least 30 kg/m2; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 81.8% had IL28B non-CC genotype; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Maltese: Il-pazjenti kkurati (N=380) kellhom età medja ta' 58 sena (medda: 21 sa 71); 42.1% kienu naïve għall kura; 36.1% kienu pazjenti li preċedentement ma rrispondewx għal pegIFN/RBV; 8.2% kienu pazjenti li rrispondew b'mod parzjali għal pegIFN/RBV, 13.7% kienu pazjenti li preċedentement irkadew għal pegIFN/RBV; 70.3% kienu rġiel; 3.2% kienu Suwed; 28.4% kellhom indiċi ta' piż tal-ġisem ta' 30 kg/m2; 14.7% kellhom għadd ta' plejtlits ta' anqas minn 90 x 109/L; 49.7% kellhom albumin anqas 40
English: Clinical trials in peginterferon+ribavirin-experienced adults
Maltese: Provi kliniċi f'adulti li esperjenzaw peginterferon+ribavirin
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 19.8% had a body mass index of at least 30 kg/m2; 20.6% had a history of depression or bipolar disorder; 89.6% had IL28B non-CC genotype; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Maltese: Il-pazjenti kkurati (N=394) kellhom età medja ta' 54 sena (medda: 19 sa 71); 49.0% kienu pazjenti li ma rrispondew xejn preċedentement għal pegIFN/RB; 21.8/% kienu pazjenti li preċedentement irrispondew b'mod parzjali għal pegIFN/RBV, u 29.2% kienu pazjenti li preċedentement irkadew għal pegIFN/RBV; 57.6% kienu rġiel; 8.1% kienu Suwed; 19.8% kellhom indiċi ta' piż tal-ġisem ta' 30 kg/m2; 20.
English: In contrast, the rate of ALT elevations in subjects using other types of estrogens as typically used in hormonal replacement therapy (i.e., oral and topical estradiol and conjugated estrogens) was similar to the rate observed in subjects who were not using estrogen-containing products (approximately 1% in each group).
Maltese: elevazzjonijiet ta' ALT f'individwi li jużaw tipi oħra ta ' estroġeni kif tipikament jiġu użati fit-terapija bl-ormoni, bħala sostitut (jiġifieri estradiol orali u topiku u estroġeni konjugat ) kien simili għar-rata osservata f'pazjenti li ma kinux jużaw prodotti li fihom estroġenu (madwar 1% f'kull grupp) .
English: Exviera ombitas vir/parit aprevir/r itonavir cyclobenzap rine
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir cyclobenzapr ine
English: ↑ norgestrel ↑ nor elgestromin e
Maltese: Wara t-Tqegħid fuq is-Suq
English: In an open-label clinical trial (TURQUOISE-I) the safety and efficacy of 12 or 24 weeks of treatment with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin was evaluated in 63 subjects with genotype 1 chronic hepatitis C co-infected with HIV-1.
Maltese: Fi provi kliniċi (TURQUOISE-I) li kienu open-label is-sigurtà u l-effikaċja ta' 12 jew 24 ġimgħa ta' kura b'Exviera u ombitasvir/paritaprevir/ritonavir u ribavirin kienu evalwati f'63 individwu b' koinfezzjoni tal-epatite Ċ kronika tal-ġenotip 1 ma' HIV-1.
English: For dosing recommendations with HIV antiviral agents, refer to sections 4.4 and 4.5.
Maltese: HIV, irreferi għal sezzjonijiet 4.4 u 4.5.
English: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Maltese: Ko-amministrazzjoni ta' dasabuvir ma' ombitasvir/paritaprevir/ritonavir tikkombina tlett aġenti anti virali li jaħdmu b'mod dirett b' mekkanizmi differenti ta' kif jaħdmu u profili ta' reżistenza differenti sabiex jaħdmu fuq HCV fi stadji differenti tal-ħajja tal-virus.
English: Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Maltese: Fergħa B: Exviera u ombitasvir/paritaprevir/ritonavir
English: Darunavir/ ritonavir 800/100 mg once daily (administere d in the evening)
Maltese: 800/100 mg darba kuljum (amministrati fil għaxija)
English: Mechanism: CYP3A4 induction by enzalutamide or mitotane.
Maltese: induzzjoni ta' CYP3A4 minn enzalutamide jew mitotane.
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Maltese: Għandha tintuża kawtela estrema biex tiġi evitata tqala f'pazjenti femminili u fil-partner femminili ta' pazjenti maskili meta Exviera jintuża flimkien ma' ribavirin, ara sezzjoni 4.6 u rreferi għas- Sommarju tal-Karrateristiċi tal-Prodott ta' ribavirin għal informazzjoni addizzjonali.