FrancophonIA/ELRC3.0 huggingface dataset:
English: In one selection, amino acid substitutions M50I and R263K emerged and phenotypic susceptibility to bictegravir was reduced 1.3-, 2.2-, and 2.9-fold for M50I, R263K, and M50I + R263K, respectively.
Danish: I én selektion fremkom aminosyresubstitutionerne M50I og R263K, og den fænotypiske følsomhed over for bictegravir blev reduceret 1,3-, 2,2- og 2,9-foldigt for hhv. M50I, R263K og M50I + R263K.
English: Co-administration of ciclosporin (IV or oral use) is expected to increase plasma concentrations of both bictegravir and tenofovir alafenamide.
Danish: Samtidig administration af ciclosporin (intravenøs eller oral anvendelse) forventes at øge plasmakoncentrationen af både bictegravir og tenofoviralafenamid.
English: Bictegravir (simultaneous administration with food):
Danish: Bictegravir (administration sammen med mad):
English: The active substances are bictegravir, emtricitabine and tenofovir alafenamide.
Danish: Aktive stoffer: bictegravir, emtricitabin og tenofoviralafenamid.
English: In Studies GS-US-380-1489 and GS-US-380-1490, total bilirubin increases were observed in 15% of treatment-naïve patients administered Biktarvy through Week 96.
Danish: I studie GS-US-380-1489 og GS-US-380-1490 blev der set stigninger i total bilirubin hos 15 % af de behandlingsnaive patienter, der fik Biktarvy til og med uge 96.
English: Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Danish: Prækliniske studier af tenofoviralafenamid hos rotter og hunde viste, at knogler og nyrer var de primære målorganer for toksicitet.
English: • sleep disorders
Danish: • søvnforstyrrelser
English: In a second selection, amino acid substitutions T66I and S153F emerged and phenotypic susceptibility to bictegravir was shifted 0.4-, 1.9-, and 0.5-fold for T66I, S153F, and T66I + S153F, respectively.
Danish: I en anden selektion fremkom aminosyresubstitutionerne T66I og S153F, og den fænotypiske følsomhed over for bictegravir ændredes 0,4-, 1,9- og 0,5-foldigt for hhv. T66I, S153F og T66I + S153F.
English: c Pooled from Study GS-US-380-1489 (n = 314) and Study GS-US-380-1490 (n = 320).
Danish: c Samlet fra studie GS-US-380-1489 (n = 314) og studie GS-US-380-1490 (n = 320).
English: • antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide
Danish: • syreneutraliserende lægemidler til behandling af mavesår, halsbrand eller sure opstød, der indeholder aluminium og/eller magnesiumhydroxid
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Danish: Vægtstigning og forhøjede mængder af lipider og glucose i blodet kan forekomme under antiretroviral behandling.
English: Patients were randomised in a 1:1 ratio to either switch to B/F/TAF (n = 290), or stay on their baseline antiretroviral regimen (n = 287).
Danish: Patienterne blev randomiseret i forholdet 1:1 til enten at skifte til B/F/TAF (n = 290) eller til at forblive på deres antiretrovirale regime ved baseline (n = 287).
English: Relative to fasting conditions, the administration of tenofovir alafenamide with a moderate fat meal (~600 kcal, 27% fat) and a high fat meal (~800 kcal, 50% fat) resulted in an increase in AUClast by 48% and 63%, respectively.
Danish: I forhold til fastende tilstand førte administration af tenofoviralafenamid sammen med et måltid med et moderat fedtindhold (~600 kcal, 27 % fedt) og et måltid med et højt fedtindhold (~800 kcal, 50 % fedt) til en stigning i AUClast på hhv. 48 % og 63 %.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4 % og uafhængig af koncentrationsområdet på 0,02-200 µg/ml.
English:  If any of the side effects get serious, tell your doctor.
Danish:  Hvis nogle af bivirkningerne bliver alvorlige, skal De fortælle det til lægen.
English: f Includes patients who had ≥ 50 copies/mL in the Week 48 or 96 window; patients who discontinued early due to lack or loss of efficacy (n = 0); patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy (B/F/TAF n = 12 and 15; ABC/DTG/3TC n = 2 and 4; DTG+F/TAF n = 3 and 4, at Weeks 48 and 96,
Danish: f Omfattede patienter, som havde ≥ 50 kopier/ml i uge 48- eller 96-vinduet, patienter, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning (n = 0), patienter, som afbrød behandlingen af andre årsager end en adverse event (AE), død eller manglende eller svigtende virkning (B/F/TAF n = 12 og 15; ABC/DTG/3TC n = 2 og 4; DTG+F/TAF n = 3 og 4, hhv. ved uge 48 og 96), og som på tidspunktet for seponering havde en virusmængde på ≥ 50 kopier/ml.
English: Baseline ATVor DRV-based regimen (n = 287)
Danish: ATV- elle DRVbaseret regime ved baseline (n = 287)
English: Population analyses using pooled pharmacokinetic data from adult studies did not identify any clinically relevant differences due to age, gender or race on the exposures of bictegravir, emtricitabine, or tenofovir alafenamide.
Danish: I populationsanalyser, hvor de samlede farmakokinetiske data fra studier med voksne blev anvendt, blev der ikke identificeret nogen klinisk relevante forskelle i eksponeringen for bictegravir, emtricitabin eller tenofoviralafenamid på baggrund af alder, køn eller race.
English: B/F/TAF was non-inferior in achieving HIV-1 RNA < 50 copies/mL at both Weeks 48 and 96 when compared to abacavir/dolutegravir/lamivudine and to dolutegravir + emtricitabine/tenofovir alafenamide, respectively.
Danish: B/F/TAF var non-inferiør, hvad angik opnåelse af hiv 1-rna < 50 kopier/ml, både ved uge 48 og 96 i forhold til hhv. abacavir/dolutegravir/lamivudin og dolutegravir + emtricitabin/tenofoviralafenamid.
English: Bictegravir (antacid suspension after 2 hours, fasted):
Danish: Bictegravir (antacida-suspension efter 2 timer, faste):
English: Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild, moderate, or severe hepatic impairment.
Danish: Der blev ikke observeret klinisk relevante ændringer i farmakokinetikken for tenofoviralafenamid eller dets metabolit tenofovir hos patienter med let, moderat eller svært nedsat leverfunktion.
English: There were no discontinuations due to renal adverse events through Week 96 in patients administered Biktarvy in clinical studies.
Danish: Der var ingen seponeringer på grund af renale bivirkninger til og med uge 96 hos patienter, som fik Biktarvy i de kliniske studier.
English: Some medicinal products are not recommended for co-administration with Biktarvy: atazanavir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or sucralfate.
Danish: Det frarådes at administrere visse lægemidler samtidig med Biktarvy: Atazanavir, carbamazepin, ciclosporin (intravenøs eller oral anvendelse), oxcarbazepin, phenobarbital, phenytoin, rifabutin, rifapentin eller sucralfat.
English: Table 2: Tabulated list of adverse reactions1
Danish: Tabel 2: Bivirkninger i tabelform1
English: No dose adjustment of Biktarvy is required in elderly patients (see section 5.2).
Danish: Dosisjustering af Biktarvy er ikke nødvendig hos ældre patienter (se pkt.
English: rifampicin used to treat some bacterial infections such as tuberculosis St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
Danish: rifampicin anvendes til at behandle visse bakterieinfektioner som f.eks. tuberkulose perikon (Hypericum perforatum), et naturlægemiddel, der anvendes mod depression og angst, eller et lægemiddel, der indeholder det.
English: The in vitro human blood to plasma bictegravir concentration ratio was 0.64.
Danish: In vitro var forholdet mellem bictegravirkoncentrationen i humant blod og plasma 0,64.
English: Studies of bictegravir in monkeys revealed the liver as the primary target organ of toxicity.
Danish: Studier af bictegravir hos aber viste, at leveren var det primære målorgan for toksicitet.
English: Seventeen percent of patients identified as Hispanic/Latino.
Danish: Sytten procent af patienterne blev identificeret som latinamerikanske.
English: If the patient misses a dose of Biktarvy within 18 hours of the time it is usually taken, the patient should take Biktarvy as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Biktarvy inden for mindre end 18 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Biktarvy så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: Patients co-infected with hepatitis B
Danish: Patienter med samtidig infektion med hepatitis B
English: 3.2% (-1.6% to 8.2%)
Danish: 3,2 % (-1,6 % til 8,2 %)
English: Package leaflet: Information for the user Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Biktarvy 50 mg/200 mg/25 mg filmovertrukne tabletter bictegravir/emtricitabin/tenofoviralafenamid Dette lægemiddel er underlagt supplerende overvågning.
English: Bictegravir (antacid suspension 2 hours prior, fasted):
Danish: Bictegravir (antacida-suspension 2 timer inden, faste):
English: Biktarvy has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore Biktarvy is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Biktarvy er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C), derfor frarådes det at bruge Biktarvy hos patienter med svært nedsat leverfunktion (se pkt.
English: Interaction not studied with any of the components of Biktarvy.
Danish: Interaktion ikke undersøgt med nogen af Biktarvys indholdsstoffer.
English: Studies of bictegravir and tenofovir alafenamide, administered separately, in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see section 5.3).
Danish: Studier af bictegravir og tenofoviralafenamid, administreret separat, fra dyr har ikke vist evidens for skadelige virkninger på fertilitetsparametre, graviditet eller føtal udvikling (se pkt.
English: The prevalence of different subtypes was comparable across treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Danish: Forekomsten af forskellige undertyper var sammenlignelig i behandlingsgrupperne, med undertype B som dominerende i begge grupper; 11 %
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chaintermination.
Danish: Tenofovirdiphosphat hæmmer hiv-replikation via indbygning i viralt dna af hiv-RT, hvilket resulterer i dna-kædeblokering.
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.
Danish: Tenofovirs binding in vitro til humane plasmaproteiner er < 0,7 % og uafhængig af koncentrationsområdet på 0,01-25 µg/ml.
English: ANTIDEPRESSANTS Sertraline (50 mg single dose), Tenofovir alafenamide6
Danish: ANTIDEPRESSIVA Sertralin (50 mg enkeltdosis), tenofoviralafenamid6
English: Recommendation concerning co-administration with Biktarvy
Danish: samtidig administration af Biktarvy
English: Tenofovir is eliminated by the kidneys by both glomerular filtration and active tubular secretion.
Danish: Tenofovir elimineres fra kroppen af nyrerne, både ved glomerulusfiltration og aktiv tubulær sekretion.
English:  If you notice any of these symptoms, tell your doctor immediately.
Danish:  Hvis De bemærker nogle af disse symptomer, skal De straks fortælle det til lægen.
English: -1.4% (-5.5% to 2.6%)
Danish: -1,4 % (-5,5 % til 2,6 %)
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Danish: Tenofoviralafenamid var ikke mutagent eller klastogent i konventionelle genotoksicitets-assays.
English: 3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products.
Danish: 3 Denne bivirkning blev identificeret under sikkerhedsovervågningen efter markedsføring for lægemidler indeholdende emtricitabin.
English: Bictegravir has activity against HIV-1 and HIV-2.
Danish: Bictegravir har aktivitet mod hiv 1 og hiv 2.
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations, ATC code: J05AR20
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; antivirale midler til behandling af hiv-infektioner, kombinationer.
English: At Week 96, 4 patients were HBV suppressed and had HIV-1 RNA < 50 copies/mL.
Danish: Ved uge 96 var 4 patienter HBV-supprimerede og havde hiv 1-rna < 50 kopier/ml.
English: HIV-1 RNA ≥ 50 copies/mLf
Danish: Hiv 1-rna ≥ 50 kopier/mlf
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
Danish: In vivo hydrolyseres tenofoviralafenamid i cellerne til at danne tenofovir (primær metabolit), som fosforyleres til den aktive metabolit tenofovirdiphosphat.
English: • bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI)
Danish: • bictegravir, et antiretroviralt lægemiddel, der kaldes en integrase-streng-transfer-hæmmer (INSTI)
English: Bictegravir is a substrate of CYP3A and UGT1A1.
Danish: Bictegravir er et substrat for CYP3A og UGT1A1.
English: What you need to know before you take Biktarvy Do not take Biktarvy:
Danish: Det skal De vide, før De begynder at tage Biktarvy Tag ikke Biktarvy:
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400/100/100 + 100 mg3 once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide (Inhibition of P-gp/BCRP)
Danish: Sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 + 100 mg3 én gang dagligt), bictegravir/emtricitabin/ tenofoviralafenamid (Hæmning af P-gp/BCRP)
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Hos patienter med kronisk hepatitis B eller C, som er i antiretroviral behandling, er der en øget risiko for svære og potentielt letale, hepatiske bivirkninger.
English: In Studies GS-US-380-1489 and GS-US-380-1490, median (Q1, Q3) serum creatinine increased by 0.09 (0.01, 0.16) mg/dL (8.0 [0.9, 14.1] µmol/L), 0.09 (0.03, 0.17) mg/dL (8.0 [2.6, 15.0] µmol/L), and 0.11 (0.04, 0.18) mg/dL (9.7 [3.5, 15.9] μmol/L) from baseline to Week 96 in the Biktarvy, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
Danish: I studie GS-US-380-1489 og GS-US-380-1490 steg gennemsnitlig (Q1, Q3) serumkreatinin med 0,09 (0,01; 0,16) mg/dl (8,0 [0,9; 14,1] µmol/l, 0,09 (0,03; 0,17) mg/dl (8,0 [2,6; 15,0] µmol/l) og 0,11 (0,04; 0,18) mg/dl (9,7 [3,5; 15,9] μmol/l) fra baseline til uge 96 i grupperne, der fik hhv. Biktarvy, abacavir/dolutegravir/lamivudin og dolutegravir + emtricitabin/tenofoviralafenamid.
English: While you are taking Biktarvy
Danish: Mens De tager Biktarvy
English: Bictegravir (simultaneous administration, fasted):
Danish: Bictegravir (samtidig administration, faste):
English: Co-administration of bictegravir with medicinal products that potently inhibit both CYP3A and UGT1A1, such as atazanavir, may significantly increase plasma concentrations of bictegravir, therefore co-administration is not recommended.
Danish: Samtidig administration af bictegravir og lægemidler, der er potente hæmmere af både CYP3A og UGT1A1, såsom atazanavir, kan øge plasmakoncentrationen af bictegravir betydeligt, og samtidig administration er derfor frarådet.
English: Each bottle contains silica gel desiccant and polyester coil.
Danish: Hver tabletbeholder indeholder silicagel-tørremiddel og en vatspiral af polyester.
English: Patients were stratified by prior treatment regimen.
Danish: var ikke undertype B. Patienterne blev stratificeret efter tidligere behandlingsregime.
English: Rifapentine (Induction of CYP3A and P-gp)
Danish: Rifapentin (Induktion af CYP3A og P-gp)
English: Calcium carbonate (1,200 mg single dose), Bictegravir
Danish: Calciumcarbonat (1.200 mg enkeltdosis), bictegravir
English: Co-administration of Biktarvy with medicinal products that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption.
Danish: Samtidig administration af Biktarvy og lægemidler, der påvirker P-gp- og BCRP-aktiviteten kraftigt, kan føre til ændringer i absorptionen af tenofoviralafenamid.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Danish: Fås i pakninger, der indeholder 1 tabletbeholder med 30 filmovertrukne tabletter og i pakninger, der indeholder 90 (3 tabletbeholdere med 30) filmovertrukne tabletter.
English: If a patient misses a dose of Biktarvy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis patienten glemmer at tage en dosis Biktarvy i mere end 18 timer, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
English: 6 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg once daily.
Danish: 6 Dette studie blev udført med elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid 150/150/200/10 mg én gang dagligt.
English: Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Danish: Emtricitabintriphosphat hæmmer hiv-replikation via indbygning i viralt dna af hiv-revers transkriptase (RT), hvilket resulterer i dna-kædeblokering.
English: Co-administration is contraindicated due to the effect of rifampicin on the bictegravir component of Biktarvy.
Danish: Samtidig administration er kontraindiceret på grund af rifampicins virkning på indholdsstoffet bictegravir i Biktarvy.
English: 0.7% (-1.0% to 2.8%)
Danish: 0,7 % (-1,0 % til 2,8 %)
English: Nineteen percent of patients identified as Hispanic/Latino.
Danish: Nitten procent af patienterne blev identificeret som latinamerikanske.
English: Animal studies indicate no effects of bictegravir, emtricitabine or tenofovir alafenamide on mating or fertility (see section 5.3).
Danish: Dyrestudier viser ingen virkninger af bictegravir, emtricitabin eller tenofoviralafenamid på parring eller fertilitet (se pkt.
English: It is important not to miss a dose of Biktarvy.
Danish: Det er vigtigt, at De husker at tage hver dosis af Biktarvy.
English: Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium.
Danish: Biktarvy bør administreres mindst 2 timer før eller sammen med mad 2 timer efter antacida indeholdende magnesium og/eller aluminium.
English: Patients co-infected with HIV and hepatitis B or C virus
Danish: Patienter med samtidig infektion med hiv- og hepatitis B- eller C-virus
English: 0.0% (-2.5% to 2.5%)
Danish: 0,0 % (-2,5 % til 2,5 %)
English: angioedema3,4, rash, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
Danish: angioødem3, 4, udslæt, pruritus, urticaria4 Knogler, led, muskler og bindevæv Ikke almindelig:
English:  If you notice any of these symptoms tell your doctor.
Danish:  Hvis De bemærker nogle af disse symptomer, skal De fortælle det til lægen.
English: Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Danish: herunder kronisk hepatitis B eller C, som bliver behandlet med antiretrovirale lægemidler, har en højere risiko for alvorlige og potentielt dødelige leverkomplikationer.
English: At Week 48, 7 patients were HBV suppressed (HBV DNA < 29 IU/mL) and had HIV-1 RNA < 50 copies/mL.
Danish: Ved uge 48 var 7 patienter HBV-supprimerede (HBV-dna < 29 IE/ml) og havde hiv 1-rna < 50 kopier/ml.
English: Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1.5-2.0 hours after administration of B/F/TAF.
Danish: Emtricitabin absorberes hurtigt og i omfattende grad efter oral administration med maksimale plasmakoncentrationer 1,5-2,0 timer efter administration af B/F/TAF.
English: Twenty-four percent of patients identified as Hispanic/Latino.
Danish: Fireogtyve procent af patienterne blev identificeret som latinamerikanere.
English: Biktarvy may interact with other medicines.
Danish: Biktarvy kan påvirke eller påvirkes af anden medicin.
English: No clinically relevant differences in bictegravir, tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and subjects with severe renal impairment (estimated CrCl < 30 mL/min).
Danish: 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 < 30 ml/min).
English: DTG = dolutegravir 3TC = lamivudine F/TAF = emtricitabine/tenofovir alafenamide a Week 48 window was between Day 295 and 378 (inclusive).
Danish: DTG = dolutegravir 3TC = lamivudin F/TAF = emtricitabin/tenofoviralafenamid a Uge 48-vindue var fra dag 295 til 378 (inklusive).
English: The efficacy and safety of Biktarvy in HIV-1 infected, treatment-naïve adults are based on 48-week and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-380-1489 (n = 629) and GS-US-380-1490 (n = 645).
Danish: Virkningen og sikkerheden af Biktarvy hos hiv 1-inficerede, behandlingsnaive voksne er baseret på data fra to randomiserede, dobbeltblindede, aktivt kontrollerede studier af 48 ugers og 96 ugers varighed, GS-US-380-1489 (n = 629) og GS-US-380-1490 (n = 645).
English: Talk to your doctor if you are taking: • medicines used for treating HIV and/or hepatitis B, containing:
Danish: • lægemidler, der anvendes til at behandle hiv og/eller hepatitis B, og som indeholder:
English: In 16 HIV/HBV co-infected adults administered Biktarvy (8 HIV/HBV treatment-naïve adults in Study GS-US-380-1490; 8 HIV/HBV suppressed adults in Study GS-US-380-1878), the safety profile of Biktarvy was similar to that in patients with HIV-1 monoinfection (see section 5.1).
Danish: Hos 16 voksne med samtidig infektion med hiv/HBV, som fik Biktarvy (8 behandlingsnaive voksne med hiv/HBV i studie GS-US-380-1490; 8 hiv/HBV-supprimerede voksne i studie GS-US-380-1878), var sikkerhedsprofilen af Biktarvy den samme som hos patienter med hiv 1-monoinfektion (se pkt.
English: Ferrous fumarate (324 mg single dose), Bictegravir
Danish: Ferrofumarat (324 mg enkeltdosis), bictegravir
English: ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
Danish: ORALE KONTRACEPTIVA Norgestimat (0,180/0,215/0,250 mg én gang dagligt)/ethinylestradiol (0,025 mg én gang dagligt), bictegravir1
English: Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you can take them together with food.
Danish: Jerntilskud: De skal tage Biktarvy mindst 2 timer før jerntilskud eller tage dem i forbindelse med et måltid.
English: Tenofovir alafenamide is eliminated following metabolism to tenofovir.
Danish: Tenofoviralafenamid elimineres primært efter metabolisme til tenofovir.