natgillin/translations-raw huggingface dataset:
Manglende data i tidsvinduet, men får studiemedicin Andel (%) patienter med hiv 1-rna &lt; 50 kopier/ml pr. undergruppe Virusmængde ved baseline ≤ 100.000 kopier/m l &gt; 100.000 kopier/m l CD4+ celletal ved baseline &lt; 200 celler/mm3 ≥ 200 celler/mm3
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA &lt; 50 copies/mL by subgroup By baseline viral load ≤ 100,000 copies/ mL &gt; 100,000 copies/ mL By baseline CD4+ cell count &lt; 200 cells/mm3 ≥ 200 cells/mm3
På tidspunktet for indtræden i studiet havde én behandlingsnaiv patient præeksisterende INSTI-resistens-associerede mutationer Q148H + G140S og havde hiv 1-RNA &lt; 50 kopier/ml ved uge 4 til og med uge 96.
At the time of study entry, one treatment-naïve patient had pre-existing INSTI resistance-associated mutations Q148H + G140S and had HIV-1 RNA &lt; 50 copies/mL at Week 4 through Week 96.
Hiv 1-rna &lt; 20 kopier/ml
HIV-1 RNA &lt; 20 copies/mL
Renal udskillelse af intakt tenofoviralafenamid er en mindre eliminationsvej, idet &lt; 1 % af dosen elimineres i urinen.
Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Emtricitabins binding in vitro til humane plasmaproteiner var &lt; 4 % og uafhængig af koncentrationsområdet på 0,02-200 µg/ml.
In vitro binding of emtricitabine to human plasma proteins was &lt; 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
B/F/TAF var non-inferiør, hvad angik opnåelse af hiv 1-rna &lt; 50 kopier/ml, både ved uge 48 og 96 i forhold til hhv. abacavir/dolutegravir/lamivudin og dolutegravir + emtricitabin/tenofoviralafenamid.
B/F/TAF was non-inferior in achieving HIV-1 RNA &lt; 50 copies/mL at both Weeks 48 and 96 when compared to abacavir/dolutegravir/lamivudine and to dolutegravir + emtricitabine/tenofovir alafenamide, respectively.
Tenofovirs binding in vitro til humane plasmaproteiner er &lt; 0,7 % og uafhængig af koncentrationsområdet på 0,01-25 µg/ml.
In vitro binding of tenofovir to human plasma proteins is &lt; 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Ved uge 96 var 4 patienter HBV-supprimerede og havde hiv 1-rna &lt; 50 kopier/ml.
At Week 96, 4 patients were HBV suppressed and had HIV-1 RNA &lt; 50 copies/mL.
Ved uge 48 var 7 patienter HBV-supprimerede (HBV-dna &lt; 29 IE/ml) og havde hiv 1-rna &lt; 50 kopier/ml.
At Week 48, 7 patients were HBV suppressed (HBV DNA &lt; 29 IU/mL) and had HIV-1 RNA &lt; 50 copies/mL.
Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for bictegravir, tenofoviralafenamid eller tenofovir hos raske forsøgspersoner og hos forsøgspersoner med svært nedsat nyrefunktion (estimeret CrCl &lt; 30 ml/min).
No clinically relevant differences in bictegravir, tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and subjects with severe renal impairment (estimated CrCl &lt; 30 mL/min).
Hiv 1-rna &lt; 50 kopier/ml Behandlingsforskel (95 % CI) B/F/TAF vs. komparator
HIV-1 RNA &lt; 50 copies/mL Treatment difference (95% CI) B/F/TAF vs Comparator
Ved uge 48 i studie GS-US-380-1878 havde 100 % (8/8) af patienterne med samtidig infektion med hiv/HBV ved baseline i B/F/TAF-armen opretholdt HBV-dna &lt; 29 IE/ml (manglende = ekskluderet analyse) og hiv-rna &lt; 50 kopier/ml.
In Study GS-US-380-1878, at Week 48, 100% (8/8) of the patients co-infected with HIV/HBV at baseline in the B/F/TAF arm maintained HBV DNA &lt; 29 IU/mL (missing = excluded analysis) and HIV RNA &lt; 50 copies/mL.
Bictegravir udviste antiviral aktivitet i cellekultur mod hiv 1-gruppen (M, N, O), herunder undertype A, B, C, D, E, F og G (EC50-værdierne var i intervallet fra &lt; 0,05 til 1,71 nM), og aktivitet mod hiv 2 (EC50 = 1,1 nM).
Bictegravir displayed antiviral activity in cell culture against HIV-1 group (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from &lt; 0.05 to 1.71 nM), and activity against HIV-2 (EC50 = 1.1 nM).
Seponerede studiemedicin som følge af andre årsager, og sidste tilgængelige hiv 1-rna &lt; 50 kopier/mlh
Discontinued study drug due to other reasons and last available HIV1 RNA &lt; 50 copies/mLh
Hiv 1-rna &lt; 50 kopier/ml Behandlingsforskel (95 % CI)
HIV-1 RNA &lt; 50 copies/mL Treatment difference (95% CI)
Hiv 1-inficerede, virologisk supprimerede patienter I studie GS-US-380-1844 blev virkningen og sikkerheden ved skift fra et regime med dolutegravir + abacavir/lamivudin eller abacavir/dolutegravir/lamivudin til B/F/TAF vurderet i et randomiseret, dobbeltblindet studie af virologisk supprimerede (hiv 1-rna &lt; 50 kopier/ml) hiv 1inficerede voksne (n = 563).
In Study GS-US-380-1844, the efficacy and safety of switching from a regimen of dolutegravir + abacavir/lamivudine or abacavir/dolutegravir/lamivudine to B/F/TAF were evaluated in a randomised, double-blind study of virologically-suppressed (HIV-1 RNA &lt; 50 copies/mL) HIV-1 infected adults (n = 563).
Seponerede studiemedicin som følge af AE eller død og sidste tilgængelige hiv 1-rna &lt; 50 kopier/ml
Discontinued study drug due to AE or death and last available HIV-1 RNA &lt; 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA &lt; 50 copies/mLc
Ud af disse havde alle enkelt- og dobbeltmutantisolater uden Q148H/K/R og 10 ud af 24 isolater med Q148H/K/R med yderligere
Of these, all single and double mutant isolates lacking Q148H/K/R and 10 of 24 isolates with Q148H/K/R with additional INSTI resistance associated substitutions had ≤ 2.5-fold reduced susceptibility to bictegravir; &gt; 2.5-fold reduced susceptibility to bictegravir was found for 14 of the 24 isolates that contained G140A/C/S and Q148H/R/K substitutions in integrase.
Således metaboliseres &gt; 80 % af en oral dosis.
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for &gt; 80% of an oral dose.
Følgende konvention er anvendt til klassificering af de indberettede bivirkninger i fase 3-kliniske undersøgelser (se tabel 1 nedenfor): Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1 000 til &lt; 1/100), sjælden (≥ 1/10 000 til &lt; 1/1 000), meget sjælden ( &lt; 1/10 000), ikke kendt (kan ikke beregnes af forhåndenværende data).
The following convention has been used for classification of the adverse reactions reported in the Phase 3 clinical trials (see Table 1 below): very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Infusionsrelaterede reaktioner havde tendens til at optrÃ¦de hos en stÃ¸rre andel af de patienter, hvis legemsvÃ¦gt var over 100 kg.
Infusion-related reactions showed a tendency to occur in a greater proportion of patients with over 100 kg bodyweight.
Sådanne reaktioner blev indberettet hos 54 % af patienter i vægtgruppen 70 til ≤100 kg, 70 % af patienterne i vægtgruppen &gt; 100 til ≤120 kg og 75 % af patienterne i vægtgruppen &gt; 120kg.
They were reported in 54% of the patients in the 70 to ≤100 kg weight group, 70% of the patients in the &gt; 100 to ≤120 kg weight group, and 75% of patients in the &gt; 120 kg weight group, respectively.
Infusionsposen med den fortyndede oplÃ¸sning af KRYSTEXXA mÃ¥ ikke omrystes.
The infusion bag containing diluted KRYSTEXXA should not be shaken.
Plasmaurinsyre &lt; 0,360 mmol/l ( &lt; 6 mg/dl) i mindst 80 % af tiden i måned 3 og 6 Behandlingsgruppe
Plasma Uric Acid &lt; 6 mg/dl for at Least 80% of the Time During Months 3 and 6 Treatment Group
Behandlingsvarigheden bør baseres på opretholdelse af respons (serumurinsyre &lt; 0,360 mmol/l (6 mg/dl) og en klinisk vurdering.
The duration of treatment should be based upon maintenance of response (serum uric acid levels &lt; 6 mg/dl) and clinical judgment.
Høj titer af anti-pegloticase-antistoffer var forbundet med manglende normalisering af urinsyreniveau ( &lt; 0,360 mmol/l).
High anti-pegloticase antibody titres were associated with a failure to maintain normalisation of uric acid ( &lt; 6 mg/dl).
Infusionsreaktioner kan forekomme efter pÃ¥begyndelse af enhver infusion, uanset om patienterne er prÃ¦medicineret med oralt antihistamin, intravenÃ¸st kortikosteroid og/eller paracetamol.
Infusion-related reactions can occur after initiation of any infusion, in spite of patients being premedicated with oral antihistamine, intravenous corticosteroid and/or paracetamol, and generally during or within 1 hour after the infusion is completed.
Hos responderende patienter var PUA-værdien &lt; 0,360 mmol/l ( &lt; 6 mg/dl) i hele den 6 måneders behandlingsperiode.
Responders maintained PUA values &lt; 6 mg/dl throughout the 6-month treatment period.
Bivirkningerne er opdelt efter organklassesystem med følgende betegnelser: Meget almindelig (1/10), almindelig (1/100 til &lt; 1/10), ikke almindelig (1/1.000 til &lt; 1/100), sjælden (1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Infektioner hos heste forÃ¥rsaget af mikroorganismer, der er sensitive over for trimethoprim og sulfonamid, f.eks. infektioner i luftveje, mave-tarm-kanalen, urogenitalsystemet og sÃ¥r.
Trimethoprim 2.6g and Sulfadiazine 13.0g horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GItract, urogenital-tract and wound infections.
Infektioner hos heste forÃ¥rsaget af mikroorganismer, der er sensitive over for trimethoprim og sulfonamid, f.eks. infektioner i luftveje, mave-tarm-kanalen,
1 g contain: Sulfadiazine 288.3 mg horses Infections in horses caused by micro-organisms sensitive to trimetoprim + sulphonamide, e.g. infections in the airways, GI
Infunderes over en periode pÃ¥ 30 minutter.
Infuse over a period of 30 minutes.
frekvens for erhvervet resistens &gt; 50% i nogle medlemslande.
frequency of acquired resistance &gt; 50 % in some Member States.
Almindelig (1/100 til &lt; 1/10); ikke almindelig ( 1/1.000 til &lt; 1/100); sjælden (1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra de tilgængelige data).
Common (≥ 1/100 to &lt; 1/10); Uncommon (≥ 1/1,000 to &lt; 1/100); Rare (≥ 1/10,000 to &lt; 1/1,000); Very rare ( &lt; 1/10,000); Not known (cannot be estimated from the available data)
I kliniske studier af behandling af samfundserhvervet pneumoni hos voksne, havde 25% af de evaluerbare patienter behandlet med ertapenem svær sygdom (defineret som pneumoni-sværhedsindex &gt; III).
In clinical studies for the treatment of community-acquired pneumonia, in adults, 25 % of evaluable patients treated with ertapenem had severe disease (defined as pneumonia severity index &gt; III).
Hos raske, unge frivillige (25 - 45 år) falder ertapenems proteinbinding når plasmakoncentrationen stiger, fra ca. 95% binding ved en ca. plasmakoncentration på  50 mikrogram/ml til ca. 92% binding ved en ca. plasmakoncentration på 155 mikrogram/ml (gennemsnitlig koncentration nået ved afslutning af infusion af 1 g intravenøst).
In healthy young adults (25 to 45 years of age), the protein binding of ertapenem decreases, as plasma concentrations increase, from approximately 95 % bound at an approximate plasma concentration of &lt; 50 micrograms/mL to approximately 92 % bound at an approximate plasma concentration of 155 micrograms/mL (average concentration achieved at the end of infusion following 1 g intravenously).
• Non species relaterede grænseværdier: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l (NB: Staphylococci følsomheden over for ertapenem udledes fra methicillinfølsomhed og gruppe A-, B-, C- og G-streptokokkers følsomhed udledes fra benzylpenicillinfølsomhed).
(NB: Susceptibility of staphylococci to ertapenem is inferred from methicillin susceptibility and susceptibility of group A, B, C, &amp; G streptococci is inferred from benzylpenicillin susceptibility)
Ændring i bindingen var &lt; 12 % ved peak plasma ertapenem koncentration efter en dosis på 1 g. In vivo, probenecid (500 mg hver 6. time) reducerede den bundne fraktion af ertapenem i plasma ved slutningen af infusionen hos patienter, som fik en enkelt 1 g intravenøs dosis fra ca. 91% til ca. 87%.
In vivo, probenecid (500 mg every 6 hours) decreased the bound fraction of ertapenem in plasma at the end of infusion in subjects administered a single 1 g intravenous dose from approximately 91 % to approximately 87 %.
• Streptococcus pneumoniae: S≤ 0,5 mg/l og R &gt; 0,5 mg/l
• Streptococcus pneumoniae: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
• M. catarrhalis: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l
• M. catarrhalis: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
• Haemophilus influenzae: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l
• Haemophilus influenzae: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
• Gram positive anaerober: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l
• Gram positive anaerobes: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
• Gram negative anaerober: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l
• Gram negative anaerobes: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
• Enterobakterier: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l
• Enterobacterales: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
• Streptokokker af viridans-gruppen: S ≤ 0,5 mg/l og R &gt; 0,5 mg/l
• Viridans group streptococci: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
Alder &lt; 50 år ≥ 50 år
&lt; 50 years ≥ 50 years
Hyppighed er defineret som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10) og ikke almindelig (≥ 1/1.000
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10) and uncommon (≥ 1/1,000 to
Denne indlægsseddel blev senest ændret &lt; {MM/ÅÅÅÅ} &gt; &lt; {måned ÅÅÅÅ} &gt;
This leaflet was last revised in &lt; {MM/YYYY} &gt; &lt; {month YYYY} &gt;
2T = andet trimester; 3T = tredje trimester; PP =postpartum a parrede sammenligninger b P &lt; 0,10 sammenlignet med postpartum
2T = second trimester; 3T = third trimester; PP =postpartum a paired comparisons b P &lt; 0.10 compared with postpartum
Børn i alderen 8 til &lt; 12 år, &gt; 25 kg
Children aged 8 to &lt; 12 years, &gt; 25 kg
Den renale udskillelse af intakt tenofoviralafenamid er en mindre metaboliseringsvej med &lt; 1 % af dosen elimineret i urinen.
Renal excretion of intact tenofovir alafenamide is a minor pathway with &lt; 1% of the dose eliminated in urine.
Ved baseline havde 80 patienter (33 %) eGFRCG &lt; 50 ml/min, og 162 patienter havde eGFRCG ≥ 50 ml/min.
At baseline, 80 patients (33%) had eGFRCG &lt; 50 mL/min and 162 patients had eGFRCG ≥ 50 mL/min.
Genvoyas sikkerhed og virkning hos børn under 6 år, eller der vejer &lt; 25 kg, er endnu ikke klarlagt.
The safety and efficacy of Genvoya in children younger than 6 years of age, or weighing &lt; 25 kg, have not yet been established.
Unge i alderen 12 til &lt; 18 år, ≥ 35 kg
Adolescents aged 12 to &lt; 18 years, ≥ 35 kg
86 procent af patienterne (62/72) var HBV-supprimerede (HBV DNA &lt; 29 IE/ml), og 42 % (30/72) var HBeAg-positive ved baseline.
Eighty-six percent of patients (62/72) were HBV suppressed (HBV DNA &lt; 29 IU/mL) and 42% (30/72) were HBeAg positive at baseline.
Genvoya udviste statistisk superioritet ved at opnå hiv 1-rna &lt; 50 kopier/ml, sammenlignet med E/C/F/TDF ved uge 144.
Genvoya demonstrated statistical superiority in achieving HIV-1 RNA &lt; 50 copies/mL when compared to E/C/F/TDF at Week 144.
I kliniske studier af mennesker resulterede en 10 mg oral dosis af tenofoviralafenamid i Genvoya i tenofovirdiphosphatkoncentrationer &gt; 4 gange højere i PBMC'er og &gt; 90 % lavere koncentrationer af tenofovir i plasma sammenlignet med en 245 mg oral dosis af tenofovirdisoproxil (som fumarat) i E/C/F/TDF.
In human clinical studies, a 10 mg oral dose of tenofovir alafenamide in Genvoya resulted in tenofovir diphosphate concentrations &gt; 4-fold higher in PBMCs and &gt; 90% lower concentrations of tenofovir in plasma as compared to a 245 mg oral dose of tenofovir disoproxil (as fumarate) in E/C/F/TDF.
Den mediane stigning fra baseline for disse parametre var større i Genvoya-gruppen sammenlignet med E/C/F/TDFgruppen ved uge 144 (p &lt; 0,001 for forskellen mellem behandlingsgrupperne for fastende total kolesterol, direkte LDL- og HDL-kolesterol samt triglycerider).
The median increase from baseline for those parameters was greater in the Genvoya group compared with the E/C/F/TDF group at Week 144 (p &lt; 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Ved starten af behandlingen med Genvoya havde 72 patienter været hiv-supprimerede (hiv-1 RNA &lt; 50 kopier/ml) i mindst 6 måneder med eller uden supprimering af HBV DNA, og de havde kompenseret leverfunktion.
At the start of treatment with Genvoya, the 72 patients had been HIV suppressed (HIV-1 RNA &lt; 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
I et separat fase 1-studie af emtricitabin alene var den gennemsnitlige systemiske emtricitabin-eksponering højere hos patienter med svært nedsat nyrefunktion (estimeret CrCl &lt; 30 ml/min) (33,7 µg•t/ml) end hos personer med normal nyrefunktion (11,8 µg•t/ml).
In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl &lt; 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
Genvoya frarådes hos patienter med en estimeret CrCl ≥ 15 ml/min og &lt; 30 ml/min eller &lt; 15 ml/min, som ikke er i kronisk hæmodialyse, da Genvoyas sikkerhed hos disse populationer ikke er blevet klarlagt.
Genvoya should be avoided in patients with estimated CrCl ≥ 15 mL/min and &lt; 30 mL/min, or &lt; 15 mL/min who are not on chronic haemodialysis, as the safety of Genvoya has not been established in these populations.
Et skift fra et tenofovirdisoproxil-baseret regime til Genvoya var bedre til at bevare hiv 1-rna &lt; 50 kopier/ml, sammenlignet med at blive på regimet ved baseline (tabel 4).
Switching from a tenofovir disoproxil-based regimen to Genvoya was superior in maintaining HIV-1 RNA &lt; 50 copies/mL compared to staying on the baseline regimen (Table 4).
Viral load ved baseline ≤ 100.000 kopier/ml &gt; 100.000 kopier/ml CD4+ celletal ved baseline &lt; 200 celler/mm3 ≥ 200 celler/mm3
Baseline viral load ≤ 100,000 copies/mL &gt; 100,000 copies/mL Baseline CD4+ cell count &lt; 200 cells/mm3 ≥ 200 cells/mm3
I alt havde 22 % hiv 1-rna i plasma ved baseline på &gt; 100.000 kopier/ml.
Overall, 22% had baseline plasma HIV-1 RNA &gt; 100,000 copies/mL.
Til og med 144 ugers behandling fik ingen forsøgsdeltagere seponeret Genvoya på grund af behandlingsrelaterede renale bivirkninger, sammenlignet med 12 forsøgsdeltagere, der fik seponeret E/C/F/TDF (p &lt; 0,001).
Through 144 weeks of treatment, no subject discontinued Genvoya due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p &lt; 0.001).
92 procent (66/72 patienter) havde HBV DNA &lt; 29 IE/ml ved brug af analyse, hvor manglende data = svigt ved uge 48.
Ninety-two percent (66/72 patients) had HBV DNA &lt; 29 IU/mL using missing = failure analysis at Week 48.
Patienterne var virologisk supprimerede (hiv 1-rna &lt; 50 kopier/ml) i mindst 6 måneder, før de skiftede til Genvoya.
Patients were virologically suppressed (HIV-1 RNA &lt; 50 copies/mL) for at least 6 months before switching to Genvoya.
Emtricitabins binding in vitro til humane plasmaproteiner var &lt; 4 % og uafhængig af koncentrationsområdet på 0,02-200 µg/ml.
In vitro binding of emtricitabine to human plasma proteins was &lt; 4% and independent of concentration over the range of 0.02-200 µg/mL.
Patienterne skal have haft stabil supprimering (hiv 1-rna &lt; 50 kopier/ml) i deres regime ved baseline i mindst 6 måneder og have hiv 1 uden resistensmutationer for nogen af Genvoyas komponenter, før de indgik i studiet.
Patients must have been stably suppressed (HIV-1 RNA &lt; 50 copies/mL) on their baseline regimen for at least 6 months and had HIV-1 with no resistance mutations to any of the components of Genvoya prior to study entry.
b I begge studier blev patienterne stratificeret ved baseline hiv 1-rna (≤ 100.000 kopier/ml, &gt; 100.000 kopier/ml til ≤ 400.000 kopier/ml eller &gt; 400.000 kopier/ml) ved CD4+ celletal ( &lt; 50 celler/μl, 50-199 celler/μl eller ≥ 200 celler/μl), og ved region (USA eller uden for USA).
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, &gt; 100,000 copies/mL to ≤ 400,000 copies/mL, or &gt; 400,000 copies/mL), by CD4+ cell count ( &lt; 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex-US).
Sikkerheden af Genvoya er ikke klarlagt hos patienter med svær nedsat nyrefunktion (estimeret CrCl ≥ 15 ml/min og &lt; 30 ml/min).
The safety of Genvoya has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and &lt; 30 mL/min).
Genvoya bør generelt undgås, men kan anvendes hos voksne med nyresygdom i slutstadiet (estimeret CrCl &lt; 15 ml/min) i kronisk hæmodialyse, hvis de potentielle fordele opvejer de potentielle risici (se pkt.
Genvoya should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl &lt; 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
I studier af behandlingsnaive patienter var Genvoya forbundet med mindre reduktioner i knoglemineraltæthed (BMD [bone mineral density] sammenlignet med E/C/F/TDF, målt ved DXAanalyse af hofte (gennemsnitlig ændring: -0,8 % versus-3,4 %, p &lt; 0,001) og lænderyggen (gennemsnitlig ændring: -0,9 % versus -3,0 %, p &lt; 0,001) efter 144 ugers behandling.
In studies in treatment-naïve patients, Genvoya was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF as measured by DXA analysis of hip (mean change: -0.8% versus -3.4%, p &lt; 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p &lt; 0.001) after 144 weeks of treatment.
Hos patienter i behandling med Genvoya opnåede 92 % (46/50) hiv 1-rna &lt; 50 kopier/ml.
In patients treated with Genvoya, 92% (46/50) achieved HIV-1 RNA &lt; 50 copies/mL.
4,1 % (95 % CI: 1,6 % til 6,7 %, p &lt; 0,001c)
4.1% (95% CI: 1.6% to 6.7%, p &lt; 0.001c)
I et studie med Genvoya hos hiv 1-inficerede voksne med nyresygdom i slutstadiet (estimeret CrCl &lt; 15 ml/min) i kronisk hæmodialyse opretholdtes effekten til og med 48 uger, men eksponering for emtricitabin var signifikant højere end hos patienter med normal nyrefunktion.
In a study of Genvoya in HIV-1 infected adults with end stage renal disease (estimated CrCl &lt; 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.
Tenofovirs binding in vitro til humane plasmaproteiner er &lt; 0,7 % og uafhængig af koncentrationsområdet på 0,01-25 μg/ml.
In vitro binding of tenofovir to human plasma proteins is &lt; 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Eksponering for emtricitabin og tenofovir hos 12 patienter med nyresygdom i slutstadiet (estimeret CrCl &lt; 15 ml/min) i kronisk hæmodialyse, som fik Genvoya i studie GS-US-292-1825, var signifikant højere end hos patienter med normal nyrefunktion.
Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl &lt; 15 mL/min) on chronic haemodialysis who received Genvoya in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.