FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients had a mean age of 15 years (range 12-17), were 56% female, 12% Asian, and 88% Black.
Maltese: Il-pazjenti kellhom età medja ta' 15-il sena (medda 12 sa 17-il sena), kienu 56% nisa, 12% Asjatiċi, u 88% Suwed.
English: The safety of emtricitabine + tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [E/C/F/TAF]) was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included TDF in 69 of 72 patients) to E/C/F/TAF.
Maltese: Is-sigurtà ta' emtricitabine + tenofovir alafenamide flimkien ma' elvitegravir u cobicistat bħala pillola kombinata ta' doża fissa (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [E/C/F/TAF]) ġiet evalwata fi 72 pazjent koinfettati bl-HIV/HBV li kienu qed jirċievu trattament għall-HIV fi studju kliniku open-label (GS-US-292-1249), sa tul Ġimgħa 48, fejn il-pazjenti nqalbu minn kors antiretrovirali ieħor (li kien jinkludi TDF f'69 minn 72 pazjent) għal E/C/F/TAF.
English: HIV-1 RNA < 20 copies/mL Treatment difference
Maltese: HIV-1 RNA < 20 kopja/mL
English: The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 636 ċellula/mm3 (firxa ta' 263-1,498).
English: As a precautionary measure, it is preferable to avoid the use of Odefsey during pregnancy.
Maltese: Bћala prekawzjoni, hu preferibbli li ma jintużax Odefsey waqt it-tqala.
English: Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Maltese: Kull pillola miksija b'rita fiha 200 mg ta' emtricitabine, rilpivirine hydrochloride ekwivalenti għal 25 mg ta' rilpivirine u tenofovir alafenamide fumarate ekwivalenti għal 25 mg ta' tenofovir alafenamide.
English: Each Odefsey tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Maltese: Kull pillola ta' Odefsey fiha 200 mg ta' emtricitabine, rilpivirine hydrochloride ekwivalenti għal 25 mg ta' rilpivirine u tenofovir alafenamide fumarate ekwivalenti għal 25 mg ta' tenofovir alafenamide.
English: Rifabutin (300 mg once daily)/ Rilpivirine1
Maltese: Rifabutin (300 mg darba kuljum)/ Rilpivirine1
English: The NNRTI resistance-associated mutations that developed most commonly were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C.
Maltese: Il-mutazzjonijiet assoċjati mar-reżistenza għal NNRTI li żviluppaw l-aktar komunement kienu: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y u F227C.
English: 0% (95% CI: -4.8% to 4.8%)
Maltese: 0% (CI ta' 95%: -4.8% sa 4.8%)
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi huma deskritti kif ġej bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) jew mhux komuni (≥ 1/1,000 sa < 1/100).
English: No dose adjustment of Odefsey is required in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża ta' Odefsey mhu meħtieġ f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A) jew moderat (Child-Pugh Klassi B).
English: The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range 1.3-7.0) and 23% of patients had baseline viral loads > 100,000 copies/mL.
Maltese: Il-medja tal-HIV-1 RNA fil-plażma fil-linja bażi kienet ta' 4.5 log10 kopji/mL (medda 1.3-7.0) u 23% tal-pazjenti kellhom ammont virali fil-linja bażi ta' > 100,000 kopja/mL.
English: The most frequently reported adverse reactions in clinical studies of treatment-naïve patients taking emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat were nausea (11%), diarrhoea (7%), and headache (6%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti fi studji kliniċi ta' pazjenti li qatt ma ngħataw trattament fil-passat li kienu qed jirċievu emtricitabine + tenofovir alafenamide ma elvitegravir + cobicistat kienu t-tqalligħ (11%), dijarea (7%) u wġigħ ta' ras (6%).
English: Following multiple dose oral administration of emtricitabine to 20 HIV-1 infected subjects, the (mean ± SD) area-under the plasma concentration-time curve over a 24-hour dosing interval (AUC) was 10.0 ± 3.1 h•µg/mL.
Maltese: Wara l-għoti orali ta' dożi multipli ta' emtricitabine lil 20 individwu infettati bl-HIV-1, l-erja (medja ± SD) taħt il-kurva konċentrazzjoniżmien tal-plażma fuq intervall ta' dożaġġ ta' 24 siegħa (AUC) kienet ta' 10.0 ± 3.1 μg•h/mL.
English: In the pooled efficacy analysis from the two Phase 3 clinical studies in adults (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz).
Maltese: [THRIVE]) tul 96 ġimgħa, pazjenti kkurati b'emtricitabine/tenofovir disoproxil fumarate + rilpivirine b'ammont virali fil-linja bażi > 100,000 HIV-1 kopja ta' RNA/mL kellhom riskju ogħla ta' falliment viroloġiku (17.6% b'rilpivirine kontra 7.6% b'efavirenz) mqabbla ma' pazjenti b'ammont virali fil-linja bażi ≤ 100,000 HIV-1 kopja ta' RNA/mL (5.9% b'rilpivirine kontra 2.4% b'efavirenz).
English: The pharmacokinetics, safety, tolerability, and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, were evaluated in Study TMC278-C213, a single-arm, open-label Phase 2 study in antiretroviral-naïve HIV-1 infected paediatric patients 12 to < 18 years of age and weighing at least 32 kg.
Maltese: Il-farmakokinetika, is-sigurtà, it-tollerabilità u l-effikaċja ta' rilpivirine 25 mg darba kuljum, flimkien ma' BR magħżul mill-investigatur li fih żewġ NRTI, kienu evalwati fl-Istudju TMC278-C213, studju ta' Fażi 2 open-label b'fergħa waħda f'pazjenti pedjatriċi infettati bl-HIV-1 li qatt ma ngħataw antiretrovirali fil-passat, li kellhom 12 sa < 18 sena u jiżnu mill-inqas 32 kg.
English: Tenofovir alafenamide is rapidly absorbed following oral administration, with peak plasma concentrations occurring at 15-45 minutes post-dose.
Maltese: Tenofovir alafenamide jiġi assorbit malajr wara l-għoti orali, b'konċentrazzjonijiet massimi fil-plażma li jseħħu bejn 15 u 45 minuta wara d-doża.
English: Odefsey should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Maltese: Odefsey ma għandux jingħata flimkien ma' prodotti mediċinali antiretrovirali oħrajn (ara sezzjoni 4.5).
English: RPV + FTC/TDF (n = 550)
Maltese: FTC/ RPV/TDF (n = 313)ċ
English: Rifabutin (300 mg once daily)/ Rilpivirine
Maltese: Rifabutin (300 mg darba kuljum)/ Rilpivirine
English: The mean baseline CD4+ cell count was 700 cells/mm3 (range 140-1,862).
Maltese: Il-medja tal-għadd ta' ċelluli CD4+ fil-linja bażi kienet ta' 700 ċellula/mm3 (medda 140-1,862).
English: HIV-1 RNA ≥ 50 copies/mLd
Maltese: HIV-1 RNA < 50 kopja/mL
English: No new adverse reactions were identified through Week 96 in 2 clinical studies of virologically suppressed patients who switched from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) to Odefsey (Study GS-US-366-1216) or from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to Odefsey (Study GS-US-366-1160).
Maltese: L-ebda reazzjonijiet avversi ġodda ma kienu identifikati matul Ġimgħa 96 f'2 studji kliniċi ta' pazjenti b'soppressjoni virali li qalbu minn emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) għal Odefsey (Studju GS-US-366-1216) jew minn efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) għal Odefsey (Studju GS-US-366-1160).
English: Emtricitabine + tenofovir alafenamide
Maltese: Kors ta' emtricitabine + tenofovir alafenamide
English: Severe skin reactions with systemic symptoms have been reported during post-marketing experience of emtricitabine/rilpivirine/tenofovir disoproxil fumarate including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia.
Maltese: Reazzjonijiet tal-ġilda severi b'sintomi sistematiċi kienu rrappurtati matul l-esperjenza ta' wara t-tqegħid fis-suq ta' emtricitabine/rilpivirine/tenofovir disoproxil fumarate, u kienu jinkludu raxx akkumpanjat minn deni, infafet, konġuntivite, anġjoedema, riżultati għoljin fit-testijiet tal-funzjoni tal-fwied, u/jew eosinofilja.
English: fatigue1, 3
Maltese: għeja1,3
English: -0.3% (95% CI: -4.2% to 3.7%)
Maltese: -0.3% (CI ta' 95%: -4.2% sa 3.7%)
English: 2 Study conducted with emtricitabine/rilpivirine/tenofovir disoproxil fumarate fixed-dose combination tablet.
Maltese: 2 Studju mwettaq b'pillola kombinata ta' doża fissa ta' emtricitabine/rilpivirine/tenofovir disoproxil fumarate.
English: Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black.
Maltese: Il-pazjenti kellhom età medja ta' 48 sena (medda 19-76), 87% kienu rġiel, 67% kienu Bojod, u 27% kienu Suwed.
English: Odefsey [Outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Odefsey [Pakkett ta' barra biss]
English: In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received E/C/F/TAF for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis.
Maltese: Fi studju kliniku ta' pazjenti bl-HIV b'soppressjoni virali koinfettati b'epatite B kronika, li rċevew E/C/F/TAF, għal 48 ġimgħa (GS-US-292-1249, n = 72), 2 pazjenti kkwalifikaw għall-analiżi tarreżistenza.
English: The presence of V90I and V189I at baseline did not affect the response.
Maltese: Il-preżenza ta' V90I u V189I fil-linja bażi ma affettwatx ir-rispons.
English: rash1, 3
Maltese: raxx1,3
English: d There were 10 new virologic failures between the Week 48 primary analysis and Week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
Maltese: d Kien hemm 10 falliment viroloġiċi ġodda bejn l-analiżi primarja ta' Ġimgħa 48 u Ġimgħa 96 (3 pazjenti b'ammont virali fil-linja bażi ta' ≤ 100,000 kopja/mL u 7 pazjenti b'ammont virali fil-linja bażi ta' > 100,000 kopja/mL).
English: HIV-1 isolates with reduced susceptibility to tenofovir alafenamide expressed a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Maltese: Iżolati ta' HIV-1 b'suxxettibilità mnaqqsa għal tenofovir alafenamide jesprimu mutazzjoni K65R f'HIV-1 RT; barra minn hekk, mutazzjoni K70E f'HIV-1 RT ġiet osservata b'mod temporanju.
English: Median plasma HIV-1 RNA was 5.0 log10 copies/mL and median CD4+ cell count was 255 cells/mm3.
Maltese: Il-medjan ta' HIV-1 RNA fil-plażma kienet ta' 5 log10 kopji/mL u il-medjan tal-għadd ta' ċelluli CD4+ kien ta' 255 ċellula/mm3.
English: The mean baseline CD4+ cell count was 697 cells/mm3 (range
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 697 ċelluli/mm3 (medda
English: No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide.
Maltese: L-ebda differenzi farmakokinetiċi klinikament rilevanti minħabba l-età, sess jew etniċità ma ġew identifikati għal emtricitabine, rilpivirine jew tenofovir alafenamide.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jbatu minn disfunzjoni tal-fwied li tinkludi epatite attiva kronika, għandhom żieda fil-frekwenza ta' anormalitajiet tal-funzjoni tal-fwied waqt it-terapija antiretrovirali kombinata (CART, combination antiretroviral therapy) u jeħtieġ li jiġu monitorjati skont il-prattika normali.
English: In the Week 144 pooled analysis of antiretroviral-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in the Phase 3 studies GS-US-292-0104 and GS-US-292-0111, the development of one or more primary resistance-associated mutations was observed in HIV-1 isolates from 12 of 866 (1.4%) patients treated with E/C/F/TAF.
Maltese: Pazjenti adulti li qatt ma ngħataw trattament fil-passat F'analiżi miġbura fiĠimgħa 144 ta' pazjenti li qatt ma ngħataw antiretrovirali fil -passat li rċivew elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fl-istudji ta' Fażi 3 GS-US-292-0104 u GS-US-292-0111, l-iżvilupp ta' mutazzjoni assoċjata mar-reżistenza primarja waħda jew iktar kienu osservati f'iżolati tal-HIV-1 minn 12 minn 866 (1.4%) pazjent ittrattati b'E/C/F/TAF.
English: Co-administration of Odefsey with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Maltese: L-għoti flimkien ta' Odefsey ma' prodotti mediċinali li jinibixxu l-attività tal-enzimi CYP3A kien osservat li jżid il-konċentrazzjonijiet fil-plażma ta' rilpivirine.
English: Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Odefsey and development of resistance.
Maltese: Il-prodotti mediċinali li jinduċu l-attività ta' P-gp (eż., rifampicin, rifabutin, carbamazepine, phenobarbital) huma mistennija li jnaqqsu l-assorbiment ta' tenofovir alafenamide, li jirriżulta fi tnaqqis tal-konċentrazzjoni ta' tenofovir alafenamide fil-plażma, li jista' jwassal għat-telf tal-effett terapewtiku ta' Odefsey u l-iżvilupp ta' reżistenza.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li kienu rrappurtati jinkludu disturbi ematoloġiċi (anemija, newtropenja), u disturbi fil-metaboliżmu (iperlaktejtimja, iperlajpejżimja).
English: Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Xi disturbi newroloġiċi li dehru iktar tard ġew irrappurtati rarament (ipertonja, aċċessjoni, imġiba mhux normali).
English: At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF.
Maltese: F'Ġimgħa 48, 92% tal-pazjenti (66/72) żammew RNA ta' HIV-1 < 50 kopja/mL wara li qalbu għal E/C/F/TAF.
English: Emtricitabine did not inhibit in vitro drug metabolism mediated by any of the major human CYP isoforms involved in drug biotransformation.
Maltese: Emtricitabine ma inibixxiex il-metaboliżmu tal-mediċina in vitro medjat minn kwalunkwe waħda mill-isoformi CYP umani ewlenin involuti fil-bijotrasformazzjoni tal-mediċina.
English: In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96.
Maltese: Fi studju ta' pazjenti b'soppressjoni virali li qalbu minn FTC/RPV/TDF għal Odefsey (Studju GS-US-366-1216), ġew osservati żidiet mil-linja bażi fil-valuri fi stat sajjem ta' kolesterol totali, kolesterol LDL dirett, kolesterol HDL, u trigliċeridi fil-fergħa b'Odefsey; u ma ġie osservat l-ebda tibdil klinikament rilevanti mil-linja bażi fil-valuri medjana fi stat sajjem għall-proporzjon talkolesterol totali ma' kolesterol HDL fl-ebda fergħa ta' trattament f'Ġimgħa 96.
English: Odefsey is a grey, capsule-shaped, film-coated tablet debossed on one side with “GSI” and “255” on the other side.
Maltese: Odefsey hija pillola miksija b'rita griża, b'forma ta' kapsula, b'“GSI” imnaqqxa fuq naħa waħda u n-numru “255” fuq in-naħa l-oħra tal-pillola.
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Maltese: Is-sigurtà ta' emtricitabine + tenofovir alafenamide kienet evalwata sa 48 ġimgħa fi studju kliniku (GS-US-292-1825) open label, bi grupp wieħed li fih 55 pazjent infettati bl-HIV-1 soppressi b'mod viroloġiku u b'marda tal-kliewi fl-aħħar stadju (eGFRCG < 15-il mL/min) fuq emodijalisi kronika rċivew emtricitabine + tenofovir alafenamide flimkien ma' elvitegravir + cobicistat bħala pillola kkombinata ta' doża fissa.
English: Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption, increase in gastric pH).
Maltese: Tnaqqis sinifikanti fil-konċentrazzjonijiet fil-plażma ta' rilpivirine huwa mistenni (tnaqqis fl-assorbiment, żieda fil-pH gastriku).
English: severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon:
Maltese: reazzjonijiet severi tal-ġilda b'sintomi sistematiċi4, anġjoedema5,6, ħakk3, urtikarja6
English: Exposures of emtricitabine and tenofovir alafenamide given with elvitegravir + cobicistat achieved in 24 paediatric patients aged 12 to < 18 years were similar to exposures achieved in treatment-naïve adults (Table 6).
Maltese: Esponimenti ta' emtricitabine u tenofovir alafenamide mogħtija ma' elvitegravir + cobicistat li nkisbu f'24 pazjent pedjatriku li kellhom minn 12 sa < 18-il sena kienu simili għal esponimenti li nkisbu f'adulti li qatt ma ngħataw trattament fil-passat (Tabella 6).
English: Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
Maltese: Odefsey għandu jiġi evitat f'pazjenti b'CrCl stmata ta' ≥ 15-il mL/min u < 30 mL/min, jew < 15-il mL/min li mhumiex fuq emodijalisi kronika, peress li s-sigurtà ta' Odefsey ma ġietx stabbilita f'dawn il-popolazzjonijiet.
English: Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black.
Maltese: Il-pazjenti kellhom età medja ta' 45 sena (medda 23-72), 90% kienu rġiel, 75% kienu Bojod, u 19% kienu Suwed.
English: Co-administration of Odefsey and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class.
Maltese: L-għoti flimkien ta' Odefsey u prodotti mediċinali li jinduċu CYP3A kien osservat li jnaqqas il-konċentrazzjonijiet fil-plażma ta' rilpivirine li jista' jwassal potenzjalment għal telf ta' rispons viroloġiku għal Odefsey (ara sezzjoni 4.3) u possibilment reżistenza għal rilpivirine u għall-klassi NNRTI.
English: Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased tenofovir alafenamide exposure (AUC) by 45-53%.
Maltese: Fir-rigward tal-kundizzjonijiet fi stat sajjem, l-għoti ta' Odefsey lil individwi adulti b'saħħithom mal-ikel irriżulta f'żieda fl-esponiment ta' tenofovir alafenamide (AUC) b'45-53%.
English: The pharmacokinetics of rilpivirine in paediatric patients < 12 years of age is under investigation.
Maltese: Il-farmakokinetika ta' rilpivirine f'pazjenti pedjatriċi ta' < 12-il sena qed tiġi investigata.
English: Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see section 5.3).
Maltese: Studji f'annimali ma jindikawx effetti li jagħmlu ħsara ta' emtricitabine, rilpivirine hydrochloride jew tenofovir alafenamide fuq il-fertilità (ara sezzjoni 5.3).
English: c There were 17 new virologic failures between the Week 48 primary analysis and Week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
Maltese: ċ Kien hemm 17-il falliment viroloġiku ġdid bejn l-analiżi primarja ta' Ġimgħa 48 u Ġimgħa 96 (6 pazjenti b'ammont virali fil-linja bażi ta' ≤ 100,000 kopja/mL u 11-il pazjent b'ammont virali fil-linja bażi ta' > 100,000 kopja/mL).
English: Due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in loading tenofovir into peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Maltese: Minħabba ż-żieda tal-istabbiltà fil-plażma u l-attivazzjoni intraċellulari permezz ta' idrolisi minn cathepsin A, tenofovir alafenamide hu aktar effiċjenti minn tenofovir disoproxil fumarate fl-ammont ta' tenofovir fiċ-ċelluli mononukleari fid-demm periferali (PBMCs, peripheral blood mononuclear cells) (li jinkludu limfoċiti u ċelluli HIV oħrajn) u fil-makrofaġi.
English: Median (Q1, Q3) change from baseline at Week 144 in total cholesterol to HDL-cholesterol ratio was 0.2 (-0.3, 0.7) in patients receiving FTC + TAF and 0.1 (-0.4, 0.6) in patients receiving FTC + TDF (p = 0.006 for the difference between treatment groups).
Maltese: FTC + TAF u ta' 0.1 (-0.4, 0.6) f'pazjenti li ngħataw FTC + TDF (p = 0.006 għad-differenza bejn il-gruppi tat-trattament).
English: 0.7% (95% CI: -4.3% to 5.8%)
Maltese: 0.7% (CI ta' 95%: -4.3% sa 5.8%)
English: In open-label Study GS-US-292-1249, the efficacy and safety of E/C/F/TAF were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
Maltese: Fl-Istudju open-label GS-US-292-1249, l-effikaċja u s-sigurtà ta' E/C/F/TAF, kienu evalwati f'pazjenti adulti koinfettati b'HIV-1 u epatite B kronika.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Maltese: It-twaħħil in vitro ta' tenofovir ma' proteini tal-plażma umana hu ta' < 0.7% u hu indipendenti mill-konċentrazzjoni fuq il-medda ta' 0.
English: In a study of virologically suppressed patients switching from EFV/FTC/TDF to Odefsey (Study GS-US-366-1160), decreases from baseline were observed in the fasting values of total cholesterol and HDL-cholesterol in the Odefsey arm; no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio, direct LDL-cholesterol or triglycerides were observed in either treatment arm at Week 96.
Maltese: Fi studju ta' pazjenti b'soppressjoni virali li qalbu minn EFV/FTC/TDF għal Odefsey (Studju GS-US-366-1160), ġie osservat tnaqqis mil-linja bażi fil-valuri fi stat sajjem ta' kolesterol totali u kolesterol HDL fil-fergħa b'Odefsey; u ma ġie osservat l-ebda tibdil klinikament rilevanti mil-linja bażi fil-valuri medjana fi stat sajjem għall-proporzjon tal-kolesterol totali ma' kolesterol HDL, kolesterol LDL dirett jew trigliċeridi fl-ebda fergħa ta' trattament f'Ġimgħa 96.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Odefsey.
Maltese: Infiltrazzjoni minimali ta' istjoċiti kienet preżenti fl-għajnejn tal-klieb f'esponimenti ta' tenofovir alafenamide u tenofovir ta' madwar 4 u 17-il darba ikbar, rispettivament, minn dawn mistennija wara l-għoti ta' Odefsey.