natgillin/translations-raw huggingface dataset:
DTG = dolutegravir 3TC = lamivudin F/TAF = emtricitabin/tenofoviralafenamid a Uge 48-vindue var fra dag 295 til 378 (inklusive). 
DTG = dolutegravir 3TC = lamivudine F/TAF = emtricitabine/tenofovir alafenamide a Week 48 window was between Day 295 and 378 (inclusive).
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). 
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).
• lægemidler, der anvendes til at behandle hiv og/eller hepatitis B, og som indeholder: 
Talk to your doctor if you are taking: • medicines used for treating HIV and/or hepatitis B, containing:
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. 
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).
Ferrofumarat (324 mg enkeltdosis), bictegravir 
Ferrous fumarate (324 mg single dose), Bictegravir
ORALE KONTRACEPTIVA Norgestimat (0,180/0,215/0,250 mg én gang dagligt)/ethinylestradiol (0,025 mg én gang dagligt), bictegravir1 
ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
Jerntilskud: De skal tage Biktarvy mindst 2 timer før jerntilskud eller tage dem i forbindelse med et måltid. 
Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you can take them together with food.
Tenofoviralafenamid elimineres primært efter metabolisme til tenofovir. 
Tenofovir alafenamide is eliminated following metabolism to tenofovir.
I begge studier blev patienterne stratificeret efter hiv 1-rna ved baseline (under eller lig med 100.000 kopier/ml; over 100.000 kopier/ml til under eller lig med 400.000 kopier/ml; eller over 400.000 kopier/ml), efter CD4+ celletal (under 50 celler/μl, 
In both studies, patients were stratified by baseline HIV-1 RNA (less than or equal to 100,000 copies/mL, greater than 100,000 copies/mL to less than or equal to 400,000 copies/mL, or greater than 400,000 copies/mL), by CD4+ cell count (less than 50 cells/µL, 50-199 cells/µL, or greater than or equal to 200 cells/µL), and by region (US or ex-US).
Hvis De kaster op mindre end 1 time efter, De har taget Biktarvy, skal De tage en ny tablet. 
If you vomit less than 1 hour after taking Biktarvy, take another tablet.
Samtidig administration af itraconazol eller posaconazol kan øge plasmakoncentrationen af bictegravir. 
Co-administration of itraconazole or posaconazole may increase bictegravir plasma concentrations.
Hiv 1-rna < 50 kopier/ml Behandlingsforskel (95 % CI) B/F/TAF vs. komparator 
HIV-1 RNA < 50 copies/mL Treatment difference (95% CI) B/F/TAF vs Comparator
Biktarvy bør administreres mindst 2 timer før jerntilskud eller tages sammen med mad. 
Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food.
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 < 29 IE/ml (manglende = ekskluderet analyse) og hiv-rna < 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 < 29 IU/mL (missing = excluded analysis) and HIV RNA < 50 copies/mL.
Når De snart ikke har mere af Biktarvy, skal De bede om mere fra lægen eller på apoteket. 
When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist.
Samtidig administration af Biktarvy og andre lægemidler, der hæmmer P-gp og BCRP, kan øge absorptionen og plasmakoncentrationen af tenofoviralafenamid. 
Co-administration of Biktarvy with other medicinal products that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.
Tabel 4: Virologiske resultater af studie GS-US-380-1844 og GS-US-380-1878 ved uge 48a 
Table 4: Virologic outcomes of Studies GS-US-380-1844 and GS-US-380-1878 at Week 48a
Hvis De kaster op mere end 1 time efter, at De har taget Biktarvy, er det ikke nødvendigt at tage en ny tablet før den sædvanlige planlagte tablet. 
If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.
(Hæmning af CYP3A) 
(Inhibition of CYP3A)
Syreneutraliserende midler og magnesiumtilskud: De skal tage Biktarvy mindst 2 timer før syreneutraliserende midler eller tilskud indeholdende aluminium og/eller magnesium. 
Antacids and magnesium supplements: you will need to take Biktarvy at least 2 hours before antacids or supplements containing aluminium and/or magnesium.
Interaktion ikke undersøgt med tenofoviralafenamid. 
Interaction not studied with tenofovir alafenamide.
Biktarvy 50 mg/200 mg/25 mg filmovertrukne tabletter bictegravir/emtricitabin/tenofoviralafenamid 
Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide
Virkningen og sikkerheden af Biktarvy hos virologisk supprimerede hiv 1-inficerede voksne er baseret på data fra et randomiseret, dobbeltblindet, aktivt kontrolleret studie af 48 ugers varighed, GS-US-380-1844 (n = 563), og et randomiseret, aktivt kontrolleret, ublindet studie, GS-US-380-1878 
The efficacy and safety of Biktarvy in virologically-suppressed HIV-1 infected adults are based on 48-week data from a randomised, double-blind, active-controlled study, GS-US-380-1844 (n = 563); and a randomised, open label, active-controlled study, GS-US-380-1878 (n = 577).
Hvis patienten kaster op mere end 1 time efter at have taget Biktarvy, er det ikke nødvendigt at tage en ny dosis Biktarvy før den næste planlagte dosis. 
If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose.
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 < 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 < 0.05 to 1.71 nM), and activity against HIV-2 (EC50 = 1.1 nM).
Tenofoviralafenamid er en nukleotid-revers transkriptasehæmmer (NtRTI, nucleotide reverse transcriptase inhibitor) og et phosphonamidat-prodrug for tenofovir (2'-deoxyadenosinmonophosphat-analog). 
Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
4 Denne bivirkning blev identificeret under sikkerhedsovervågning efter markedsføring for lægemidler indeholdende tenofoviralafenamid. 
4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Biktarvy bør ikke administreres sammen med magnesium-/aluminiumholdige antacida eller jerntilskud hos fastende patienter. 
Biktarvy should not be co-administered simultaneously with magnesium/aluminium-containing antacids or iron supplements under fasted conditions.
Samtidig administration af oxcarbazepin, phenobarbital eller phenytoin kan reducere plasmakoncentrationen af bictegravir og tenofoviralafenamid. 
Co-administration of oxcarbazepine, phenobarbital, or phenytoin may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Norgestimat (0,180/0,215/0,250 mg en gang dagligt)/ethinylestradiol (0,025 mg én gang dagligt),emtricitabin/ tenofoviralafenamid4 
Norgestimate (0.180/0.215/0.250 mg once daily), Ethinylestradiol (0.025 mg once daily), Emtricitabine/Tenofovir alafenamide4
Emtricitabin har aktivitet mod hiv 1-, hiv 2- og HBV. 
Emtricitabine has activity against HIV-1, HIV-2 and HBV.
Hvis patienten kaster op inden for 1 time efter at have taget Biktarvy, skal der tages en ny tablet. 
If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken.
Emtricitabin viste antiviral aktivitet i cellekultur mod hiv 1-kladerne A, B, C, D, E, F og G (EC50-værdier var i intervallet fra 0,007 til 0,075 µM) og viste stammespecifik aktivitet mod hiv 2 (EC50-værdier var i intervallet fra 0,007 til 1,5 µM). 
Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Efter oral administration af B/F/TAF sammen med eller uden mad hos hiv 1-inficerede voksne var de gennemsnitlige (CV%) farmakokinetiske parametre for tenofoviralafenamid efter gentagen dosering: Cmax = 0,121 µg/ml (15,4 %) og AUCtau = 0,142 µg•t/ml (17,3 %). 
Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of tenofovir alafenamide were Cmax = 0.121 µg/mL (15.4%), and AUCtau = 0.142 µg•h/mL (17.3%).
Tenofovir har aktivitet mod hiv 1-, hiv 2- og HBV-virus. 
Tenofovir has activity against HIV-1, HIV-2 and HBV.
2 Dette studie blev udført med bictegravir/emtricitabin/tenofoviralafenamid 75/200/25 mg én gang dagligt. 
2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily.
ANTIKONVULSIVA Carbamazepin (titreret fra 100 mg til 300 mg to gange dagligt), emtricitabin/tenofoviralafenamid4 
ANTICONVULSANTS Carbamazepine (titrated from 100 mg to 300 mg twice a day), Emtricitabine/Tenofovir alafenamide4
I studie GS-US-380-1878 blev virkningen og sikkerheden ved skift fra enten abacavir/lamivudin eller emtricitabin/tenofovirdisoproxilfumarat (200/300 mg) plus atazanavir eller darunavir (boostet med enten cobicistat eller ritonavir) til B/F/TAF vurderet i et randomiseret, ublindet studie med virologisk supprimerede hiv 1-inficerede voksne (n = 577). 
In Study GS-US-380-1878, the efficacy and safety of switching from either abacavir/lamivudine or emtricitabine/tenofovir disoproxil fumarate (200/300 mg) plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) to B/F/TAF were evaluated in a randomised, open-label study of virologically-suppressed HIV-1 infected adults (n = 577).
Emtricitabin er en nukleosid-revers transkriptasehæmmer (NRTI, nucleoside reverse transcriptase inhibitor) og nukleosidanalog af 2'-deoxycytidin. 
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
I studie GS-US-380-1490 blev patienterne randomiseret i forholdet 1:1 til at få enten B/F/TAF (n = 320) eller dolutegravir + emtricitabin/tenofoviralafenamid (50+200/25 mg) (n = 325) én gang dagligt. 
In Study GS-US-380-1490, patients were randomised in a 1:1 ratio to receive either B/F/TAF (n = 320) or dolutegravir + emtricitabine/tenofovir alafenamide (50+200/25 mg) (n = 325) once daily.
Imidlertid metaboliseres emtricitabin ikke signifikant af leverenzymer, så påvirkningen af nedsat leverfunktion bør være begrænset. 
The pharmacokinetics of emtricitabine have not been studied in subjects with hepatic impairment; however, emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Behandlingsresultaterne fra studie GS-US-380-1489 og GS-US-380-1490 til og med uge 48 og 96 er præsenteret i tabel 3. 
Treatment outcomes of Studies GS-US-380-1489 and GS-US-380-1490 through Weeks 48 and 96 are presented in Table 3.
Bictegravirs farmakokinetik efter gentagen dosering er dosisproportional i dosisområdet 25 til 100 mg. Emtricitabins farmakokinetik efter gentagen dosering er dosisproportional i dosisområdet 25 til 200 mg. Eksponeringen for tenofoviralafenamid er dosisproportionel i dosisområdet 8 mg til 125 mg. 
The multiple dose pharmacokinetics of emtricitabine are dose proportional over the dose range of 25 to 200 mg. Tenofovir alafenamide exposures are dose proportional over the dose range of 8 mg to 125 mg.
ORALE ANTIDIABETIKA Metformin (500 mg to gange dagligt), bictegravir/emtricitabin/ tenofoviralafenamid 
ORAL ANTI-DIABETICS Metformin (500 mg twice daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide
hovedpine, svimmelhed 
headache, dizziness
ABC/DTG/3T C (n = 315)d 
ABC/DTG/ 3TC (n = 315)d
(Induktion af CYP3A og P-gp) 
(Induction of CYP3A and P-gp)
Samtidig administration af azithromycin eller clarithromycin kan øge plasmakoncentrationen af bictegravir 
Co-administration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.
I studie GS-US-380-1489 blev patienterne randomiseret i forholdet 1:1 til at få enten bictegravir/emtricitarabin/tenofoviralfenamid (B/F/TAF) (n = 314) eller abacavir/dolutegravir/lamivudin (600/50/300 mg) (n = 315) én gang dagligt. 
In Study GS-US-380-1489, patients were randomised in a 1:1 ratio to receive either bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (n = 314) or abacavir/dolutegravir/lamivudine (600/50/300 mg) (n = 315) once daily.
Ved maksimale plasmakoncentrationer var forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blodet ~ 1,0 og forholdet mellem gennemsnitlig lægemiddelkoncentration i sæd og plasma var ~ 4,0. 
At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was
e Studie GS-US-380-1490. 
e Study GS-US-380-1490.
Seponerede studiemedicin som følge af andre årsager, og sidste tilgængelige hiv 1-rna < 50 kopier/mlh 
Discontinued study drug due to other reasons and last available HIV1 RNA < 50 copies/mLh
Antivirale midler mod hiv 1 Atazanavir (300 mg én gang dagligt), cobicistat (150 mg én gang dagligt), bictegravir1 
HIV-1 antiviral agents Atazanavir (300 mg once daily), Cobicistat (150 mg once daily), Bictegravir1
I studie GS-US-380-1489 og GS-US-380-1490 var den gennemsnitlige stigning i CD4+ celletallet ved uge 96 i forhold til baseline 262, 288 og 281 celler/mm3 i de samlede grupper med hhv. B/F/TAF, abacavir/dolutegravir/lamivudin og dolutegravir + emtricitabin/tenofoviralafenamid. 
In Studies GS-US-380-1489 and GS-US-380-1490, the mean increase from baseline in CD4+ cell count at Week 96 was 262, 288, and 281 cells/mm3 in the pooled B/F/TAF, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
d Studie GS-US-380-1489. 
d Study GS-US-380-1489.
4 Dette studie blev udført med emtricitabin/tenofoviralafenamid 200/25 mg én gang dagligt. 
4 This study was conducted using emtricitabine/tenofovir alafenamide 200/25 mg once daily.
 Spørg lægen eller apotekspersonalet til råds, hvis De tager: 
Get advice from a doctor or pharmacist if you are taking:
Den antivirale aktivitet af emtricitabin mod isolater af hiv 1 fra laboratoriet og klinikken blev vurderet i lymfoblastoide cellelinjer, MAGI-CCR5-cellelinjen og PBMC'er. 
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs.
 Hvis De tager nogen af disse lægemidler, må De ikke tage Biktarvy. 
 If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.
Atazanavir (400 mg én gang dagligt), bictegravir1 
Atazanavir (400 mg once daily), Bictegravir1
Ved uge 48 i GS-US-380-1878 var den gennemsnitlige ændring i forhold til baseline i CD4+ celletallet 25 celler/mm3 hos de patienter, der skiftede til B/F/TAF, og 0 celler/mm3 hos de patienter, der forblev på deres regime ved baseline. 
In GS-US-380-1878, the mean change from baseline in CD4+ cell count at Week 48 was 25 cells/mm3 in patients who switched to B/F/TAF and 0 cells/mm3 in patients who stayed on their baseline regimen.
Biktarvy bør administreres mindst 2 timer før jerntilskud eller tages sammen med mad (se pkt. 
Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food (see section 4.5).
artralgi 
arthralgia
Tabel 3: Samlede virologiske resultater i studie GS-US-380-1489 og GS-US-380-1490 ved uge 48a og 96b 
Table 3: Pooled virologic outcomes of Studies GS-US-380-1489 and GS-US-380-1490 at Weeks 48a and 96b
Der foreligger utilstrækkelige data for virkningen af alle indholdsstofferne i Biktarvy hos nyfødte/spædbørn. 
There is insufficient information on the effects of all the components of Biktarvy in newborns/infants, therefore Biktarvy should not be used during breast-feeding.
DTG + F/TAF (n = 325) 
DTG + F/TAF (n = 325)e
Hos rotter og kaniner var der ingen toksikologisk signifikante virkninger på de udviklingsrelaterede endepunkter hos afkommet fra moderdyr, der havde fået bictegravir i drægtighedsperioden. 
In offspring from rat and rabbit dams treated with bictegravir during pregnancy, there were no toxicologically significant effects on developmental endpoints.
Antivirale midler mod Hepatitis C-virus Ledipasvir/sofosbuvir (90 mg/400 mg én gang dagligt), Bictegravir/emtricitabin/ tenofoviralafenamid2 
Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide2
Der blev ikke observeret nogen klinisk relevante forskelle i bictegravirs farmakokinetik hos personer med moderat nedsat leverfunktion. 
Clinically relevant changes in the pharmacokinetics of bictegravir were not observed in subjects with moderate hepatic impairment.
Hiv 1-rna < 50 kopier/ml Behandlingsforskel (95 % CI) 
HIV-1 RNA < 50 copies/mL Treatment difference (95% CI)
Tenofoviralafenamid absorberes hurtigt efter oral administration med maksimale plasmakoncentrationer 0,5-2,0 timer efter administration af B/F/TAF. 
Tenofovir alafenamide is rapidly absorbed following oral administration with peak plasma concentrations occurring at 0.5-2.0 hours after administration of B/F/TAF.
Voriconazol (300 mg to gange dagligt), bictegravir1 
Voriconazole (300 mg twice daily), Bictegravir1
Ved uge 48 i GS-US-380-1844 var den gennemsnitlige ændring i forhold til baseline i CD4+ celletallet -31 celler/mm3 hos de patienter, der skiftede til B/F/TAF, og 4 celler/mm3 hos de patienter, der forblev på abacavir/dolutegravir/lamivudin. 
In GS-US-380-1844, the mean change from baseline in CD4+ cell count at Week 48 was -31 cells/mm3 in patients who switched to B/F/TAF and 4 cells/mm3 in patients who stayed on abacavir/dolutegravir/lamivudine.
Den antivirale aktivitet af bictegravir mod isolater af hiv 1 fra laboratoriet og klinikken blev vurderet i lymfoblastoide cellelinjer, PBMC'er, primære monocyt-/makrofagceller og CD4+ T-lymfocytter. 
The antiviral activity of bictegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells, and CD4+ T-lymphocytes.
Behandlingsresultaterne fra studie GS-US-380-1844 og GS-US-380-1878 til og med uge 48 er vist i tabel 4. 
Treatment outcomes of Studies GS-US-380-1844 and GS-US-380-1878 through Week 48 are presented in Table 4.
• Perikon (Hypericum perforatum), et naturlægemiddel, der anvendes til depression og angst, 
• St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
Hiv 1-rna ≥ 50 kopier/mlb Behandlingsforskel (95 % CI) 
HIV-1 RNA ≥ 50 copies/mLb Treatment difference (95% CI)
Efter oral administration absorberes bictegravir med opnåelse af maksimale plasmakoncentrationer 2,0-4,0 timer efter administration af B/F/TAF. 
Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF.
Mulige bivirkninger: Fortæl det straks til lægen • Ethvert tegn på betændelse eller infektion. 
Possible side effects: tell a doctor immediately
• emtricitabin, et antiretroviralt lægemiddel, af en type, der kaldes en nukleosid-revers transkriptase-hæmmer (NRTI) 
• emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
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 < 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 < 50 copies/mL) HIV-1 infected adults (n = 563).
(Hæmning af CYP3A og UGT1A1) 
(Inhibition of CYP3A and UGT1A1)
Samtidig administration af bictegravir og lægemidler, der er potente inducere af både CYP3A og UGT1A1, såsom rifampicin eller perikon, kan reducere plasmakoncentrationen af bictegravir i betydelig grad, hvilket kan resultere i tab af den terapeutiske virkning af Biktarvy og resistensudvikling. 
Co-administration of bictegravir and medicinal products that potently induce both CYP3A and UGT1A1, such as rifampicin or St. John's wort, may significantly decrease plasma concentrations of bictegravir, which may result in a loss of therapeutic effect of Biktarvy and development of resistance, therefore co-administration is contraindicated (see section 4.3).
 Hvis noget af dette gælder for Dem, må De ikke tage Biktarvy. 
 If any of these apply to you, do not take Biktarvy and tell your doctor immediately.
Hver Biktarvy tablet indeholder bictegravirnatrium svarende til 50 mg bictegravir, 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 25 mg tenofoviralafenamid. 
Each Biktarvy tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
B/F/TAF (n = 634) 
B/F/TAF (n = 634)c
Seponerede studiemedicin som følge af AE eller død og sidste tilgængelige hiv 1-rna < 50 kopier/ml 
Discontinued study drug due to AE or death and last available HIV-1 RNA < 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLc
Samtidig administration af carbamazepin kan reducere plasmakoncentrationen af bictegravir. 
Co-administration of carbamazepine may decrease bictegravir plasma concentrations.
• tenofoviralafenamid, et antiretroviralt lægemiddel, af en type, der kaldes en nukleotid-revers transkriptase-hæmmer (NtRTI) 
• tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
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; > 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.
Den rapporterede tidsperiode før sådanne opstår, er imidlertid variabel, og kan opstå mange måneder efter påbegyndelse af behandlingen (se pkt. 
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
sandsynligvis på grund af forekomsten af bictegravir i mælken; dette var uden virkninger på de diede unger. 
In animal studies, bictegravir was detected in the plasma of nursing rat pups likely due to the presence of bictegravir in milk, without effects on nursing pups.