FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean Cmax and AUClast following a single 10 mg dose of tenofovir alafenamide administered in E/C/F/TAF were 0.21 ± 0.10 μg/mL and 0.25 ± 0.08 μg•h/mL, respectively.
Maltese: Il-medja tas-Cmax u l-AUClast wara doża waħda ta'10 mg ta' tenofovir alafenamide mogħti f'E/C/F/TAF kienu 0.21 ± 0.10 μg/mL u 0.25 ± 0.08 μg•h/mL, rispettivament.
English: The median increase from baseline for those parameters was greater in the E/C/F/TAF group compared with the elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) group at Week 144 (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Maltese: Ilmedjan taż-żieda mil-linja bażi għal dawk il-parametri kien akbar fil-grupp ta' E/C/F/TAF meta mqabbel mal-grupp ta' elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (bħala fumarate) 245 mg (E/C/F/TDF) f'Ġimgħa 144 (p < 0.001 għad-differenza bejn ilgruppi tat-trattament għall-kolesterol totali fl-istat sajjem, kolesterol ta' LDL dirett u HDL, u trigliċeridi).
English: In a study of virologically suppressed patients switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent (Study GS-US-311-1089), increases from baseline were observed in the fasting lipid parameters total cholesterol, direct LDL cholesterol and triglycerides in the Descovy arm compared with little change in the emtricitabine/tenofovir disproxil fumarate arm (p ≤ 0.009 for the difference between groups in changes from baseline).
Maltese: Fi studju ta' pazjenti b'soppressjoni virali li qalbu minn emtricitabine/tenofovir disoproxil fumarate għal Descovy filwaqt li żammew it-tielet sustanza antiretrovirali (Studju GS-US-311-1089), kienu osservati żidiet mil-linja bażi fil-parametri tal-lipidi fi stat sajjem tal-kolesterol totali, kolesterol ta' LDL dirett u trigliċeridi fil-grupp ta' Descovy imqabbla ma' ftit li xejn tibdil fil-grupp ta' emtricitabine/tenofovir disproxil fumarate (p ≤ 0.009 għad-differenza bejn il-gruppi fil-bidliet mil-linja bażi).
English: In human clinical studies, a 10 mg oral dose of tenofovir alafenamide (given with emtricitabine and elvitegravir and cobicistat) 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 and elvitegravir and cobicistat).
Maltese: Fi studji kliniċi fuq il-bniedem, doża orali ta' 10 mg ta' tenofovir alafenamide (mogħti ma' emtricitabine u elvitegravir u cobicistat) 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 u elvitegravir u cobicistat).
English: • antiviral medicines used to treat HIV:
Maltese: • mediċini antivirali li jintużaw għal trattament tal-HIV:
English: Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs Week 48.
Maltese: Mill-pazjenti li kienu pożittivi għal HBsAg fil-linja bażi, 3/70 (4.3%) kisbu serokonverżjoni għal anti-HBs f'Ġimgħa 48.
English: Treatment outcomes of Study GS-US-311-1089 through 48 and 96 weeks are presented in Table 6.
Maltese: Ir-riżultati tal-kura ta' Studju GS-US-311-1089 wara 48 u 96 ġimgħa huma ppreżentati f'Tabella 6.
English: Emtricitabine and tenofovir alafenamide demonstrated synergistic antiviral activity in cell culture.
Maltese: Emtricitabine u tenofovir alafenamide urew attività sinerġistika antivirali fil-koltura taċ-ċelluli.
English: Darunavir/cobicistat (800/150 mg once daily), tenofovir alafenamide (25 mg once daily)5
Maltese: Darunavir/cobicistat (800/150 mg darba kuljum), tenofovir alafenamide (25 mg darba kuljum)5
English: The co-administration of Descovy is not recommended with certain anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g., rifampicin, rifabutin, rifapentine), St. John's wort and HIV protease inhibitors (PIs) other than atazanavir, lopinavir and darunavir (see section 4.5).
Maltese: L-għoti flimkien ta' Descovy mhuwiex rakkomandat ma' ċerti antikonvulsanti (eż., carbamazepine, oxcarbazepine, phenobarbital u phenytoin), antimikobatterjali (eż., rifampicin, rifabutin, rifapentine), St.
English: The proportions of patients with plasma HIV-1 RNA < 50 copies/mL and < 20 copies/mL are shown in Table 5.
Maltese: Il-proporzjonijiet ta' pazjenti b'HIV-1 RNA fil-plażma < 50 kopja/mL u < 20 kopja/mL qed jintwerew f'Tabella 5.
English: Of the 10 patients who were not HBV suppressed at baseline (HBV DNA ≥ 29 IU/mL), 7 became suppressed, 2 remained detectable, and 1 had missing data.
Maltese: Mill-10 pazjenti li ma kellhomx soppressjoni ta' HBV fillinja bażi (DNA ta' HBV ≥ 29 IU/mL), 7 saru soppressi, 2 kellhom DNA ta' HBV li baqgħet tiġi osservata, u 1 kellu data nieqsa.
English: The safety of emtricitabine and 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 tenofovir disoproxil fumarate [TDF] in 69 of 72 patients) to E/C/F/TAF.
Maltese: Is-sigurtà ta' emtricitabine u 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 ko-infettati 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 tenofovir disoproxil fumarate [TDF] f'69 minn 72 pazjent) għal E/C/F/TAF.
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: Multinucleoside-resistant HIV-1 with a T69S double insertion mutation or with a Q151M mutation complex including K65R showed reduced susceptibility to tenofovir alafenamide.
Maltese: HIV-1 reżistenti għal multinucleoside b'mutazzjoni ta' inserzjoni doppja ta' T69S jew b'kumpless ta' mutazzjoni Q151M li jinkludi K65R, wera suxxettibilità mnaqqsa għal tenofovir alafenamide.
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Maltese: 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Rilpivirine (25 mg once daily), tenofovir alafenamide (25 mg once daily)
Maltese: Rilpivirine (25 mg darba kuljum), tenofovir alafenamide (25 mg darba kuljum)
English: AUC: ↑ 32% Cmax: ↔
Maltese: ↑ 32% Cmax: ↔
English: Virologic success rates at Week 48 were: Descovy Containing Regimen: 89.7% (227 of 253 subjects); Abacavir/lamivudine Containing Regimen: 92.7%% (230 of 248 subjects).
Maltese: Kors li kien fih Descovy: 89.7% (227 minn 253 individwu);
English: Exposures of emtricitabine and tenofovir alafenamide (given with elvitegravir and cobicistat) achieved in 24 paediatric patients aged 12 to < 18 years who received emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat in Study GS-US-292-0106 were similar to exposures achieved in treatment-naïve adults (Table 7).
Maltese: Esponimenti ta' emtricitabine, u tenofovir alafenamide (mogħtija ma' elvitegravir u cobicistat) li nkisbu f'24 pazjent pedjatriku li kellhom minn 12 sa < 18-il sena li rċivew emtricitabine u tenofovir alafenamide mogħtija ma' elvitegravir u cobicistat fi Studju GS-US-292-0106, kienu simili għal esponimenti li nkisbu f'adulti li qatt ma ngħataw trattament fil-passat (Tabella 7).
English: ANTIDEPRESSANTS Sertraline (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Maltese: Sertraline (50 mg darba kuljum), tenofovir alafenamide (10 mg darba kuljum)3
English: The mean Cmax and AUClast, (mean ± SD) under fed conditions following a single 25 mg dose of tenofovir alafenamide administered in Descovy were 0.21 ± 0.13 μg/mL and 0.25 ± 0.11 μg•h/mL, respectively.
Maltese: Il-medja tas-Cmax u l-AUClast, (medja ± SD) f'kundizzjonijiet wara li wieħed ikun kiel, wara doża waħda ta' 25 mg ta' tenofovir alafenamide mogħti f'Descovy kienu ta' 0.21 ± 0.13 μg/mL u 0.25 ± 0.11 μg•h/mL, rispettivament.
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 Descovy 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 tista' twassal għat-telf tal-effett terapewtiku ta' Descovy u l-iżvilupp ta' reżistenza.
English: Antimycobacterials Rifabutin
Maltese: Antimikobatterjali
English: Grey, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “210” on the other side of the tablet.
Maltese: Pillola miksija b'rita, griża, b'forma rettangolari, b'daqs ta' 12.5 mm x 6.4 mm imnaqqxa b'“GSI” fuq naħa waħda u “210” fuq in-naħa l-oħra tal-pillola.
English: Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1) (see sections 4.2 and 5.1).
Maltese: Descovy huwa indikat flimkien ma' mediċini antiretrovirali oħrajn għall-trattament ta' adulti u adolexxenti (minn età ta' 12-il sena u aktar b'piż tal-ġisem ta' mill-inqas 35 kg) infettati bil-virus ta' tip 1 tal-immunodefiċjenza umana (HIV-1) (ara sezzjonijiet 4.2 u 5.1).
English: At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Maltese: F'Ġimgħa 144, 83.1% (197/237 pazjent) żammew HIV-1 RNA ta' < 50 kopja/mL wara li qalbu għal emtricitabine u tenofovir alafenamide mogħtija ma' elvitegravir u cobicistat bħala pillola kombinata ta' doża fissa.
English: SEDATIVES/HYPNOTICS Orally administered midazolam (2.5 mg single dose), tenofovir alafenamide (25 mg once daily)
Maltese: SEDATTIVI/MEDIĊINI IPNOTIĊI Midazolam li jingħata mill-ħalq (2.5 mg doża waħda), tenofovir alafenamide (25 mg darba kuljum)
English: In Study GS-US-311-1089, the efficacy and safety of switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults (n = 663).
Maltese: Fi Studju GS-US-311-1089, l-effikaċja u s-sigurtà li wieħed jaqleb minn jew emtricitabine/tenofovir disoproxil fumarate għal Descovy, filwaqt li tinżamm it-tielet mediċina antiretrovirali, ġew evalwati fi studju li fih il-parteċipanti ntgħażlu b'mod randomised, double - blind, li sar fuq adulti b'soppressjoni virali, infettati bl-HIV-1 (n = 663).
English: Do not stop taking Descovy without talking to your doctor: see section 3, Do not stop taking Descovy.
Maltese: Tiqafx tieħu Descovy mingħajr ma tkellem lit-tabib tiegħek: ara sezzjoni 3, Tiqafx tieħu Descovy.
English: Descovy in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Maltese: Descovy flimkien ma' mediċini oħrajn hu għat-trattament għal virus ta' l-immunodefiċjenza umana 1 (HIV-1) fl-adulti u adolexxenti li jkollhom 12-il sena u aktar, li jiżnu mill-inqas 35 kg.
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 kienet ta' < 4% u indipendenti millkonċentrazzjoni fil-medda ta' 0.
English: Descovy should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Maltese: Descovy għandu jiġi evitat f'pazjenti li fil-passat kienu ġew ikkurati b'antiretrovirali, b'HIV-1 li jkun fiha l-mutazzjoni K65R (ara sezzjoni 5.1).
English: Intravenously administered midazolam (1 mg single dose), tenofovir alafenamide (25 mg once daily)
Maltese: Midazolam li jingħata ġol-vini (1 mg doża waħda), tenofovir alafenamide (25 mg darba kuljum)
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Maltese: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg darba kuljum)7/ emtricitabine (200 mg darba kuljum)/ tenofovir alafenamide (10 mg darba kuljum)3
English: In studies in treatment-naïve patients, increases from baseline were observed in both the tenofovir alafenamide fumarate and tenofovir disoproxil fumarate containing treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
Maltese: Fi studji fost pazjenti li qatt ma ngħataw trattament fil-passat, żidiet mil-linja bażi ġew osservati fiżżewġ gruppi ta' trattament li kien fihom tenofovir alafenamide fumarate u tenofovir disoproxil fumarate għall-parametri tal-lipidi fl-istat sajjem tal-kolesterol totali, kolesterol ta' lipoproteina diretta ta' densità baxxa (LDL) u lipoproteina ta' densità għolja (HDL), u trigliċeridi f'Ġimgħa 144.
English: No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, or tenofovir alafenamide.
Maltese: L-ebda differenzi farmakokinetiċi klinikament rilevanti minħabba l-età, sess jew etniċità ma ġew identifikati għal emtricitabine 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 filfrekwenza ta' anormalitajiet tal-funzjoni tal-fwied waqt it-terapija antiretrovirali kombinata (CART) u jeħtieġ li jiġu monitorjati skont il-prattika normali.
English: Descovy film-coated tablets are blue, rectangular-shaped tablets, debossed on one side with “GSI” and the number “225” on the other side of the tablet.
Maltese: Descovy pilloli miksija b'rita huma blu, b'forma rettangolari, b'“GSI” imnaqqxa fuq naħa waħda u nnumru “225” fuq in-naħa l-oħra tal-pillola.
English: Clinical efficacy of Descovy in treatment-naïve patients was also established from a study conducted with emtricitabine and tenofovir alafenamide (10 mg) when given with darunavir (800 mg) and cobicistat as a fixed-dose combination tablet (D/C/F/TAF).
Maltese: L-effikaċja klinika ta' Descovy f'pazjenti li qatt ma ngħataw trattament fil-passat, ġiet stabbilita wkoll minn studju li sar b'emtricitabine u tenofovir alafenamide (10 mg) meta ngħataw ma' darunavir (800 mg) u cobicistat bħala pillola kombinata ta' doża fissa (D/C/F/TAF).
English: In a study of virologically suppressed adult patients switching from abacavir/lamivudine to Descovy while maintaining the third antiretroviral agent (Study GS-US-311-1717), there were minimal changes in lipid parameters.
Maltese: Kien hemm bidliet minimi fil-parametri tal-lipidi fi studju ta' pazjenti adulti b'soppressjoni virali li qalbu minn abacavir/lamivudine għal Descovy filwaqt li żammew it-tielet sustanza antiretrovirali (Studju GS-US-311-1717).
English: Darunavir, cobicistat and emtricitabine/tenofovir disoproxil fumarate (n = 50)
Maltese: Darunavir, cobicistat u emtricitabine/tenofovir disoproxil fumarate
English: Through Week 144, the development of one or more primary emtricitabine, tenofovir alafenamide, or elvitegravir resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and E/C/F/TAF treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF group (12 of 867 patients [1.4%]).
Maltese: Sa Ġimgħa 144, l-iżvilupp ta' mutazzjoni primarja waħda jew aktar, assoċjati mar-reżistenza, għal emtricitabine, tenofovir alafenamide, jew elvitegravir ġew osservati f'iżolati ta' HIV-1 minn 12 fost 22 pazjent b'dejta ġenotipika evalwabbli minn iżolati akkopjati fil-linja bażi u iżolati minn trattament bi E/C/F/TAF li ma rnexxitx (12 minn 866 pazjent [1.4%]) meta mqabbla ma' 12 minn 20 iżolat minn trattament li ma rnexxiex minn pazjenti b'dejta ġenotipika evalwabbli fil-grupp b'E/C/F/TDF (12 minn 867 pazjent [1.4%]).
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily)4
Maltese: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg darba kuljum)7/ emtricitabine (200 mg darba kuljum)/ tenofovir alafenamide (25 mg darba kuljum)4
English: In a study of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in HIV-1 infected adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, efficacy was maintained through 48 weeks but emtricitabine exposure was significantly higher than in patients with normal renal function.
Maltese: Fi studju ta' emtricitabine + tenofovir alafenamide flimkien ma' elvitegravir + cobicistat bħala pillola kkombinata ta' doża fissa (E/C/F/TAF) f'adulti infettati b'HIV-1 b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika, l-effikaċja nżammet sa ġimgħa 48 iżda l-esponiment għal emtricitabine kien ogħla b'mod sinifikanti milli f'pazjenti b'funzjoni tal-kliewi normali.
English: Patients had a mean age of 15 years (range: 12-17), and 56% were female, 12% were Asian, and 88% were Black.
Maltese: Il-pazjenti kellhom età medja ta' 15-il sena (medda: 12-17-il sena), u 56% kienu nisa, 12% kienu Asjatiċi, u 88% kienu Suwed.
English: Other HIV antiretrovirals Dolutegravir (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Maltese: HIV oħrajn Dolutegravir (50 mg darba kuljum), tenofovir alafenamide (10 mg darba kuljum)3
English: At Week 48, switching to a
Maltese: F'Ġimgħa 48, 81.
English: The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in patients receiving E/C/F/TAF and 211 cells/mm3 in patients receiving E/C/F/TDF (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: (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: Cross-resistance in HIV-1 infected, treatment-naïve or virologically suppressed patients Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Maltese: Virusijiet reżistenti għal emtricitabine bis-sostituzzjoni M184V/I kienu reżistenza inkroċjata għal lamivudine, iżda żammew is-sensittività għal didanosine, stavudine, tenofovir, u zidovudine.
English: The safety of emtricitabine and tenofovir alafenamide was evaluated through 144 weeks in an openlabel clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Maltese: Is-sigurtà ta' emtricitabine u tenofovir alafenamide ġiet evalwata sa 144 ġimgħa fi studju kliniku openlabel (GS-US-292-0112) li fih 248 pazjent infettati bl-HIV-1 li jew qatt ma ngħataw trattament filpassat (n = 6) jew li kienu b'soppressjoni virali (n = 242), b'indeboliment renali minn ħafif sa moderat (rata tal-filtrazzjoni glomerulari stmata bil-metodu Cockcroft-Gault [eGFRCG]: 30-69 mL/min) irċivew emtricitabine u tenofovir alafenamide flimkien ma' elvitegravir u cobicistat bħala pillola kombinata ta' doża fissa.
English: At baseline, 46% of patients were receiving emtricitabine/tenofovir disoproxil fumarate in combination with a boosted PI and 54% of patients were receiving emtricitabine/tenofovir disoproxil fumarate in combination with an unboosted third agent.
Maltese: Fil-linja bażi, 46% tal-pazjenti kienu qed jirċievu emtricitabine/tenofovir disoproxil fumarate flimkien ma' PI msaħħaħ, u 54% tal-pazjenti kienu qed jirċievu emtricitabine/tenofovir disoproxil fumarate flimkien mat-tielet mediċina mhux imsaħħa.
English: Lopinavir/ritonavir (800/200 mg once daily), tenofovir alafenamide (10 mg once daily)
Maltese: Lopinavir/ritonavir (800/200 mg darban kuljum), tenofovir alafenamide (10 mg darba kuljum)
English: Dose of Descovy
Maltese: Tiqafx tieħu Descovy
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 millkonċentrazzjoni fuq il-medda ta' 0.
English: 1 Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg, administered as a fixed-dose combination tablet, was studied in treatment-naive subjects, see section 5.1.
Maltese: 1 Descovy 200/10 mg flimkien ma' darunavir 800 mg u cobicistat 150 mg, mogħtija bħala pillola kombinata ta' doża fissa, ġie studjat f'individwi li qatt ma ngħataw trattament fil-passat, ara sezzjoni 5
English: Descovy 200 mg/25 mg film-coated tablets
Maltese: Descovy 200/25 mg darba kuljum
English: In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Maltese: Fi Studju GS-US-292-0106, l-effikaċja, is-sigurtà u l-farmakokinetika ta' emtricitabine u tenofovir alafenamide ġew evalwati fi studju kliniku open-label li fih 50 adolexxenti infettati bl-HIV-1, li qatt ma ngħataw trattament fil-passat, irċivew emtricitabine u tenofovir alafenamide (10 mg) mogħtija ma' elvitegravir u cobicistat bħala pillola kombinata ta' doża fissa.
English: AUC: ↑ 37% Cmax: ↔
Maltese: ↑ 37% Cmax: ↔
English: Descovy 200/10 mg once daily
Maltese: Descovy 200/10 mg darba kuljum
English: was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range: 95-1,110), and median CD4+% was 23% (range: 7-45%).
Maltese: Fil-linja bażi, il-medjan ta' HIV-1 RNA fil-plażma kienet ta' 4.7 log10 kopji/mL, il-medjan tal-għadd ta' ċelluli CD4+ kien ta' 456 ċellula/mm3 (medda: 95-1,110), u l-medjan ta' CD4+% kien ta' 23% (medda: 7-45%).