FrancophonIA/ELRC3.0 huggingface dataset:
English: Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/mL), group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/mL), and showed limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/mL).
Maltese: Rilpivirine wera wkoll attività antivirali kontra firxa wiesgħa ta' iżolati primarji tal-grupp tal-HIV-1 M (sottotip A, B, C, D, F, G, H) b'valuri EC50 li jvarjaw minn 0.07 sa 1.01 nM (0.03 sa 0.37 ng/mL), iżolati primarji tal-grupp O b'valuri EC50 li jvarjaw minn 2.88 sa 8.45 nM (1.06 sa 3.10 ng/mL), u wera attività in vitro limitata kontra l-HIV-2 b'valuri EC50 li jvarjaw minn 2,510 sa 10,830 nM (920 sa 3,970 ng/mL).
English: The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Maltese: Is-sostituzzjoni K65R kif ukoll K70E jirriżultaw f'suxxettibilità mnaqqsa għal abacavir, didanosine, lamivudine, emtricitabine, u tenofovir, iżda jżommu s-sensittività għal zidovudine.
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Maltese: 3 Studju mwettaq b'voxilaprevir 100 mg addizzjonali biex jinkisbu l-esponimenti għal voxilaprevir mistennija f'pazjenti infettati bl-HCV.
English: • increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
Maltese: • żieda fil-livelli ta' kolesterol u/jew amylase pankreatiċi (enzima diġestiv) fid-demm
English: Midazolam (1 mg, intravenously, single dose)/ Tenofovir alafenamide
Maltese: Midazolam (1 mg, li jingħata ġol-vini, doża waħda)/ Tenofovir alafenamide
English: In a study comparing 8 patients with mild hepatic impairment (Child-Pugh Class A) to 8 matched controls and 8 patients with moderate hepatic impairment (Child-Pugh Class B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Maltese: Fi studju li qabbel 8 pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A) ma' 8 kontrolli mqabbla u 8 pazjenti b'indeboliment epatiku moderat (Child-Pugh Klassi B) ma' 8 kontrolli mqabbla, l-esponiment ta' dożi multipli ta' rilpivirine kien 47% ogħla f'pazjenti b'indeboliment epatiku ħafif u 5% ogħla f'pazjenti b'indeboliment epatiku moderat.
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin (40 mg once daily)/ Rilpivirine1
Maltese: IMPEDITURI TA' HMG-COA REDUCTASE Atorvastatin (40 mg doża waħda kuljum)/Rilpivirine1
English: In Studies GS-US-292-0104 and GS-US-292-0111, the rate of virologic success was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA, or baseline CD4+ cell count).
Maltese: Fl-Istudji GS-US-292-0104 and GS-US-292-0111, ir-rata tas-suċċess viroloġiku kienet simili fis-sottogruppi tal-pazjenti (l-età, is-sess, ir-razza, l-HIV-1 RNA fil-linja bażi, jew għadd ta' ċelluli CD4+ fil-linja bażi).
English: Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Maltese: Rilpivirine hydrochloride jiġi metabolizzat u eliminat prinċipalment mill-fwied.
English: Odefsey should not be co-administered with other medicinal products containing tenofovir alafenamide, lamivudine, tenofovir disoproxil or adefovir dipivoxil (see section 4.5).
Maltese: Odefsey ma għandux jingħata flimkien ma' prodotti mediċinali antiretrovirali oħrajn li fihom tenofovir alafenamide, lamivudine, tenofovir disoproxil jew adefovir dipivoxil (ara sezzjoni 4.5).
English: Emtricitabine triphosphate competitively inhibits HIV-1 reverse transcriptase (RT), resulting in deoxyribonucleic acid (DNA) chain termination.
Maltese: Emtricitabine triphosphate jimpedixxi b'mod kompetittiv ir-reverse transcriptase (RT) tal-HIV-1, li jirriżulta f'terminazzjoni tal-katina tad-deoxyribonucleic acid (DNA).
English: The pharmacokinetics of rilpivirine in antiretroviral-naïve HIV-1 infected paediatric patients 12 to < 18 years of age receiving rilpivirine 25 mg once daily was comparable to that in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
Maltese: Il-farmakokinetika ta' rilpivirine f'pazjenti pedjatriċi infettati bl-HIV-1 li qatt ma ngħataw antiretrovirali fil-passat li għandhom 12 sa < 18 sena li ngħataw rilpivirine 25 mg darba kuljum kienet paragunabbli ma' dik f'adulti infettati bl-HIV-1 li qatt ma ngħataw trattament fil-passat li ngħataw rilpivirine 25 mg darba kuljum.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3) with the components of Odefsey.
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3) bil-komponenti ta' Odefsey.
English: The most frequently reported adverse reactions in clinical studies of treatment-naïve patients taking rilpivirine hydrochloride in combination with emtricitabine + tenofovir disoproxil fumarate were nausea (9%), dizziness (8%), abnormal dreams (8%), headache (6%), diarrhoea (5%) and insomnia (5%).
Maltese: L-aktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti fi studji kliniċi ta' pazjenti li qatt ma ngħataw trattament fil-passat li kienu qed jirċievu rilpivirine hydrochloride flimkien ma' emtricitabine + tenofovir disoproxil fumarate kienu tqalligħ (9%), sturdament (8%), ħolm mhux normali (8%), uġigħ ta' ras (6%), dijarea (5%) u insomnja (5%).
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Maltese: ANALĠESIĊI Paracetamol (500 mg doża waħda)/Rilpivirine1
English: The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in E/C/F/TAF-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48 and 326 cells/mm3 in E/C/F/TAF-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
Maltese: Il-medja taż-żieda mil-linja bażi fl-għadd ta' ċelluli CD4+ kienet ta' 230 ċellula/mm3 f'pazjenti ttrattati bi E/C/F/TAF u 211 ċellula/mm3 f'pazjenti ttrattati b'E/C/F/TDF (p = 0.024) f'Ġimgħa 48 u 326 ċellula/mm3 f'pazjenti ttrattati b'E/C/F/TAF u 305 ċelluli/mm3 f'pazjenti ttrattati b'E/C/F/TDF (p = 0.06) f'Ġimgħa 144.
English: Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 2,396 patients received emtricitabine + tenofovir alafenamide given with elvitegravir + cobicistat as a fixed-dose combination tablet, pooled data from 686 patients who received rilpivirine 25 mg once daily in combination with other antiretroviral medicinal products in the controlled studies TMC278-C209 and TMC278-C215, 754 patients who received Odefsey in Studies GS-US-366-1216 and GS-US-366-1160, and post-marketing experience.
Maltese: L-evalwazzjoni tar-reazzjonijiet avversi hi bbażata fuq dejta dwar is-sigurtà mill-istudji kollha ta' Fażi 2 u 3, li fihom 2,396 pazjent rċivew emtricitabine + tenofovir alafenamide mogħti ma' elvitegravir + cobicistat bħala pillola kombinata ta' doża fissa, dejta miġbura minn 686 pazjent li rċivew rilpivirine 25 mg darba kuljum flimkien ma' prodotti mediċinali antiretrovirali oħra fl-istudji kontrollati TMC278-C209 u TMC278-C215, 754 pazjent li rċivew Odefsey fl-Istudji GS-US-366-1216 u GS-US-366-1160, u l-esperjenza ta' wara t-tqegħid fis-suq.
English: In human clinical studies, a 10 mg oral dose of tenofovir alafenamide given with emtricitabine, cobicistat and elvitegravir resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 245 mg oral dose of tenofovir disoproxil (as fumarate) given with emtricitabine, cobicistat and elvitegravir.
Maltese: Fi studji kliniċi fuq il-bniedem, doża orali ta' 10 mg ta' tenofovir alafenamide mogħtija ma' emtricitabine, cobicistat u elvitegravir, irriżultat f'konċentrazzjonijiet ta' tenofovir diphosphate ta' > 4 darbiet ogħla f'PBMCs u konċentrazzjonijiet > 90% iktar baxxi ta' tenofovir fil-plażma, meta mqabbla ma' doża orali ta' 245 mg ta' tenofovir disoproxil (bħala fumarate) mogħti ma' emtricitabine, cobicistat u elvitegravir.
English: ANTIDIABETICS Metformin (850 mg single dose)/ Rilpivirine
Maltese: ANTIDIJABETIĊI Metformin (850 mg doża waħda)/ Rilpivirine
English: a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102).
Maltese: n = 19 adulti (GS-US-292-0102).
English: Treatment-naïve adults in Studies GS-US-292-0104 and GS-US-292-0111b
Maltese: Adulti li qatt ma ngħataw trattament fil-passat fl-Istudji GS-US-292-0104 u GS-US-292-0111b
English: In studies in treatment-naïve adult patients, E/C/F/TAF was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF through 144 weeks of treatment as measured by dual energy X ray absorptiometry (DXA) analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001).
Maltese: Fi studji f'pazjenti li qatt ma ngħataw trattament fil-passat, E/C/F/TAF ġie assoċjat ma' tnaqqis iżgħar fid-densità minerali tal-għadam (BMD, bone mineral density) meta mqabbel ma' E/C/F/TDF matul 144 ġimgħa ta' trattament kif imkejjel permezz ta' analiżi dual energy X ray absorptiometry (DXA) tal-ġenbejn (bidla medja: -0.8% kontra -3.4%, p < 0.001) u tas-sinsla lumbari (bidla medja: -0.9% kontra -3.0%, p < 0.001).
English: Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Maltese: Viruses reżistenti għal emtricitabine bis-sostituzzjoni M184V/I kellhom reżistenza inkroċjata għal lamivudine, iżda żammew is-sensittività għal didanosine, stavudine, tenofovir, u zidovudine.
English: Table 3: Virologic outcomes of Studies GS-US-292-0104, GS-US-292-0111 at Week 48 and Week 144a, and GS-US-292-0109 at Week 48a
Maltese: Tabella 3: Riżultati viroloġiċi ta' Studji GS-US-292-0104 u GS-US-292-0111 f'Ġimgħat 48 u
English: The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C, and M230I.
Maltese: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C, u M230I.
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Maltese: L-attività ta' rilpivirine kontra razez fil-laboratorju ta' HIV-1 tat-tip selvaġġ f'razza ta' ċelluli T infettata b'mod akut b'valur medjan ta' EC50 għal HIV-1/IIIB ta' 0.73 nM (0.27 ng/mL).
English: The median age was 36 years, 78% were male and 62% White and 24% Black/African American.
Maltese: L-età medjana kienet ta' 36 sena, 78% kienu rġiel u 62% kienu Bojod u 24% kienu Suwed/Afro-Amerikani.
English: In Studies GS-US-292-0104 and GS-US-292-0111, E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
Maltese: Fl-Istudji GS-US-292-0104 and GS-US-292-0111, il-grupp ta' E/C/F/TAF wera superjorità statistika meta kiseb HIV-1 RNA < 50 kopja/mL meta mqabbel ma' E/C/F/TDF f'Ġimgħa 144.
English: It is important not to stop taking Odefsey without talking to your doctor: see section 3, Do not stop taking Odefsey.
Maltese: Hu importanti li ma tiqafx tieħu Odefsey mingħajr ma tkellem lit-tabib tiegħek: ara sezzjoni 3, Tiqafx tieħu Odefsey.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Maltese: Il-bijotrasformazzjoni ta' emtricitabine tinkludi l-ossidazzjoni tat-thiol moiety biex tifforma 3'-sulphoxide diastereomers (madwar 9% tad-doża) u l-konjugazzjoni ma' glucuronic acid biex tifforma 2'-O-glucuronide (madwar 4% tad-doża).
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells,
Maltese: L-attività antivirali ta' tenofovir alafenamide kontra iżolati tal-laboratorju u kliniċi ta' HIV-1 sottotip B ġiet evalwata f'razza ta' ċelluli limfoblastojdi, PBMCs, ċelluli monoċiti/makrofagi primarji u CD4+ T limfoċiti.
English: Odefsey is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg.
Maltese: Odefsey jintuża f'adulti u adolexxenti li jkollhom 12-il sena u aktar, li jiżnu mill-inqas 35 kg.
English: Antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Rilpivirine
Maltese: Aġenti antivirali Ledipasvir/Sofosbuvir (90 mg/400 mg darba kuljum)/ Rilpivirine
English: 3 Adverse reactions identified from clinical studies of emtricitabine + tenofovir alafenamide-containing products.
Maltese: 3 Reazzjonijiet avversi identifikati minn studji kliniċi ta' prodotti li fihom emtricitabine + tenofovir alafenamide.
English: Odefsey regimen
Maltese: Odefsey
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
Maltese: L-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' tenofovir alafenamide jew tenofovir ma ġew osservati bejn individwi f'saħħithom u pazjenti b'indeboliment renali sever (CrCl stmata ta' ≥ 15-il mL/min u < 30 mL/min) fi studju ta' Fażi 1 ta' tenofovir alafenamide.
English: Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Maltese: Odefsey huwa indikat għat-trattament ta' infezzjoni bil-virus tal-immunodefiċjenza umana-1 (HIV-1) f'adulti u adolexxenti (minn età ta' 12-il sena u aktar b'piż tal-ġisem ta' mill-inqas 35 kg) mingħajr xi mutazzjoni magħrufa assoċjati ma' reżistenza għall-klassi ta' impedituri ta' transcriptase inversi mhux nukleosidi (NNRTI, non-nucleoside reverse transcriptase inhibitor), tenofovir jew emtricitabine u b'ammont virali ≤ 100,000 HIV-1 kopja ta' RNA/mL (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1,360) and 13% had CD4+ cell counts < 200 cells/mm3.
Maltese: Il-medja tal-għadd ta' ċelluli CD4+ fil-linja bażi kienet ta' 427 ċellula/mm3 (medda 0-1,360) u 13% kellhom għadd ta' ċelluli CD4+ ta' < 200 ċellula/mm3.
English: PROTON PUMP INHIBITORS Omeprazole (20 mg once daily)/ Rilpivirine1
Maltese: TAL-POMPI TAL-PROTONI Omeprazole (20 mg darba kuljum)/Rilpivirine1
English: In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
Maltese: Fi studju separat ta' Fażi 1 b'emtricitabine waħdu, il-medja tal-esponiment sistemiku ta' emtricitabine kienet ogħla f'pazjenti b'indeboliment renali sever (CrCl stmata ta' < 30 mL/min) (33.7 µg•h/ml) milli f'individwi b'funzjoni normali renali (11.8 µg•h/mL).
English: ketoconazole fluconazole itraconazole posaconazole voriconazole
Maltese: • Antifungali li jintużaw għal trattament ta' infezzjonijiet fungali: ketoconazole fluconazole itraconazole posaconazole voriconazole
English: In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were 21%, 29% and 35% lower, respectively, as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were 20%, 31% and 42% lower, respectively, as compared to postpartum.
Maltese: Fin-nisa li kienu qed jirċievu rilpivirine 25 mg darba kuljum matul it-tieni trimestru tat-tqala, il-valuri intraindividwali medji għall-valuri Cmax, AUC24h u Cmin ta' rilpivirine totali kienu 21%, 29% u 35% iktar baxxi, rispettivament, meta mqabbla ma' wara l-ħlas; matul it-tielet trimestru ta' tqala, il-valuri Cmax, AUC24h u Cmin kienu 20%, 31% u 42% iktar baxxi, rispettivament, meta mqabbla ma' wara lħlas.
English: Through Week 96, in patients who switched to Odefsey from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) (Studies GS-US-366-1216 and GS-US-366-1160; n = 754), no treatment-emergent resistance-associated mutations were detected.
Maltese: Matul Ġimgħa 96, f'pazjenti li qalbu għal Odefsey minn emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) jew efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) (Studji GS-US-366-1216 u GS-US-366-1160; n = 754), ma ġiet osservata l-ebda mutazzjoni assoċjata mar-reżistenza li żviluppat minħabba t-trattament.
English: Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Maltese: Sofosbuvir (400 mg darba kuljum)/Rilpivirine (25 mg darba kuljum)
English: Simeprevir (150 mg once daily)/ Rilpivirine
Maltese: Simeprevir (150 mg darba kuljum)/Rilpivirine
English: At baseline, median plasma HIV-1 RNA was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range 95 to 1,110), and median CD4+% was 23% (range 7-45).
Maltese: Fil-linja bażi, il-medjan ta' HIV-1 RNA fil-plażma kien ta' 4.7 log10 kopji/mL, il-medjan tal-għadd ta' ċelluli CD4+ kien ta' 456 ċellula/mm3 (medda: 95 sa 1,110), u l-medjan ta' ċelluli CD4+% kien 23% (medda ta' 7-45).
English: FTC/RPV /TDF
Maltese: RPV + FTC/TDF
English: Studies conducted with other medicinal products Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with the following medicinal products: buprenorphine, naloxone and norbuprenorphine.
Maltese: Fuq il-bażi ta' studji ta' interazzjoni bejn mediċina u oħra bil-komponenti ta' Odefsey, mhuma mistennija l-ebda interazzjonijiet klinikament sinifikanti meta Odefsey jkun ikkombinat mal-prodotti mediċinali li ġejjin: buprenorphine, naloxone u norbuprenorphine.
English: The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E.
Maltese: Il-mutazzjonijiet assoċjati mar-reżistenza għal NRTI li żviluppaw fi 3 iżolati tal-pazjent jew iktar kienu: K65R, K70E, M184V/I u K219E.
English: One patient with emergent resistance (M184M/I) was identified in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine + tenofovir disoproxil fumarate to E/C/F/TAF in a fixed-dose combination (FDC) tablet (GS-US-292-0109, n = 959).
Maltese: Pazjent wieħed b'reżistenza emerġenti (M184M/I) ġie identifikat fi studju kliniku dwar pazjenti b'soppressjoni virali li qalbu minn kors li kien fih emtricitabine + tenofovir disoproxil fumarate għal E/C/F/TAF f'pillola kombinata ta' doża fissa (FDC) (GS-US-292-0109, n = 959).
English: Considering all of the available in vitro data and data generated in treatment-naïve patients, the following resistance-associated mutations in HIV-1 RT, when present at baseline, may affect the activity of Odefsey: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L and the combination of L100I and K103N.
Maltese: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L u l-kombinazzjoni ta' L100I u K103N.
English: In the Week 96 pooled analysis for patients receiving emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) + rilpivirine hydrochloride in the Phase 3 clinical studies TMC278-C209 and TMC278-C215, HIV-1 isolates from 43 patients had an amino acid substitution associated with NNRTI (n = 39) or NRTI (n = 41) resistance.
Maltese: Fl-analiżi miġbura f'Ġimgħa 96 għal pazjenti li rċivew emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) + rilpivirine hydrochloride fl-istudji kliniċi ta' Fażi 3 TMC278-C209 u TMC278-C215, l-iżolati tal-HIV-1 minn 43 pazjenti kellhom sostituzzjoni tal-amino acids assoċjata mar-reżistenza għal NNRTI (n = 39) jew NRTI (n = 41).
English: At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF FDC tablet.
Maltese: F'Ġimgħa 144, 83.1% (197/237 pazjent) żammew HIV-1 RNA ta' < 50 kopja/mL wara li qalbu għal pillola E/C/F/TAF
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
Maltese: It-twaħħil in vitro ta' emtricitabine ma' proteini tal-plażma umana kien ta' < 4% u indipendenti mill-konċentrazzjoni fil-medda ta' 0.
English: No Grade 3-4 laboratory abnormalities for AST/ALT or Grade 3-4 adverse reactions of transaminase increased were reported (see section 5.1).
Maltese: L-ebda anormalitajiet fil-laboratorju ta' Grad 3-4 għal AST/ALT jew reazzjonijiet avversi ta' Grad 3-4 ta' żieda fit-transaminase ma kienu rrappurtati (ara sezzjoni 5.1).
English: FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to FTC/TDF + efavirenz.
Maltese: FTC/TDF + rilpivirine hydrochloride ma kienx inferjuri fil-kisba ta' HIV-1 RNA < 50 kopja/mL meta mqabbel ma' FTC/TDF + efavirenz.
English: The mean baseline CD4+ cell count was 709 cells/mm3 (range 104-2,527).
Maltese: Il-medja tal-għadd ta' ċelluli CD4+ fil-linja bażi kienet ta' 709 ċelluli/mm3 (medda 104-2,527).
English: Odefsey: Emtricitabine and tenofovir alafenamide exposures were bioequivalent when comparing one Odefsey 200/25/25 mg film-coated tablet to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (150/150/200/10 mg) fixed-dose combination tablet following single dose administration to healthy subjects (n = 82) under fed conditions.
Maltese: L-esponimenti għal emtricitabine u tenofovir alafenamide kienu bijoekwivalenti meta jiġu mqabbla Odefsey 200/25/25 mg pillola miksija b'rita waħda ma' pillola kombinata ta' doża fissa ta' elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (150/150/200/10 mg) wara għoti ta' doża waħda lil individwi b'saħħithom (n = 82) li jkunu kielu.
English: Virologically suppressed adults in Study GS-US-292-0109
Maltese: Adulti b'soppressjoni virali fl-Istudju GS-US-292-0109
English: The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs.
Maltese: L-attività antivirali ta' emtricitabine kontra iżolati tal-laboratorju u kliniċi ta' HIV-1 ġiet evalwata f'razez ta' ċelluli limfoblastojde, ir-razza ta' ċelluli MAGI CCR5, u PBMCs.
English: The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 664 ċellula/mm3 (medda ta' 126-1,813).
English: In the pooled Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.85; -7.37) nmol/L in the rilpivirine arm and of -0.6 (-13.29; 12.17) nmol/L in the efavirenz arm. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L).
Maltese: Fl-istudji miġbura flimkien ta' Fażi 3 TMC278-C209 u TMC278-C215 ta' pazjenti li ma ngħatawx trattament qabel, f'Ġimgħa 96, kien hemm tibdil medju globali mil-linja bażi fil-kortisol bażali ta' -19.1 (-30.85; -7.37) nmol/L fil-fergħa tal-istudju b'rilpivirine u ta' -0.6
English: 2.0% (95% CI: -0.7% to 4.7%) 4.2% (95% CI: 0.6% to 7.8%) 4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
Maltese: 4.1% (95% CI: 1.6% sa 6.7%, p < 0.001c)