FrancophonIA/ELRC3.0 huggingface dataset:
English: Five subjects were discontinued from the study due to efficacy related reasons per investigator's assessment (physician decision), of which 3 had last on treatment HIV-1 RNA <50 copies/mL.
Danish: Fem forsøgsdeltagere forlod studiet af virkningsrelaterede årsager i henhold til investigators vurdering (lægens beslutning), hvoraf 3 havde sidste hiv-1 RNA under behandlingen < 50 kopier/ml.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre med hiv, selvom du tager dette lægemiddel, men risikoen reduceres med effektiv antiretroviral terapi (medicin mod retrovirus, f.eks. hiv).
English: Other medicines and Symtuza Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med Symtuza Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Talk to your doctor before taking Symtuza.
Danish: Kontakt lægen, før du tager Symtuza.
English: The use of Symtuza in ART-naïve adolescent patients from the age of 12 years to < 18 years, and weighing at least 40 kg is supported by two trials in HIV-1 infected paediatric patients (TMC114-C230 and GS-US-292-0106).
Danish: Brugen af Symtuza hos ART-naive unge patienter i alderen 12 år til < 18 år, og som vejer mindst 40 kg, understøttes af to studier af hiv-1-inficerede pædiatriske patienter (TMC114-C230 og GS-US-292-0106).
English: The emtricitabine-resistant virus with the M184M/I/V mutation was cross-resistant to lamivudine, but retained sensitivity to abacavir, stavudine, tenofovir, and zidovudine.
Danish: Det emtricitabin-resistente virus med M184M/IV/-mutation var krydsresistent over for lamivudin, men bevarede følsomheden over for abacavir, stavudin, tenofovir og zidovudin.
English: ANTIMALARIALS Artemether/Lumefantrine
Danish: MALARIAMIDLER Artemether/lumefantrin
English: Tell your doctor if you take: - Bosentan (to treat high blood pressure in the pulmonary circulation) - Dexamethasone (injection) (corticosteroid) - Boceprevir (to treat hepatitis C virus infection) - Rifapentine, rifabutin (to treat bacterial infections) - Oxcarbazepine (to prevent seizures).
Danish: Fortæl det til din læge, hvis du tager: - Bosentan (til behandling af for højt blodtryk i lungekredsløbet) - Dexamethason (injektion) (kortikosteroid) - Boceprevir (til behandling af hepatitis C-infektion) - Rifapentin, rifabutin (til behandling af bakterieinfektioner) - Oxcarbazepin (til forebyggelse af krampeanfald).
English: There are other uses for sildenafil.
Danish: Sildenafil anvendes også til andre formål.
English: Atorvastatin (10 mg once daily): atorvastatin AUC ↑ 290% atorvastatin Cmax ↑ 319% atorvastatin Cmin ND
Danish: Atorvastatin (10 mg en gang dagligt): atorvastatin AUC ↑ 290 % atorvastatin Cmax ↑ 319 % atorvastatin Cmin ND
English: The safety and efficacy of Symtuza in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Danish: Symtuzas sikkerhed og virkning hos patienter med samtidig hiv-1- og hepatitis C-virusinfektion (HCV) er ikke blevet klarlagt.
English: • Remove the unscrewed cap.
Danish: • Fjern det løse låg.
English: In a multiple dose trial with darunavir/ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, N = 8) and moderate (Child-Pugh Class B, N = 8) hepatic impairment were comparable with those in healthy subjects.
Danish: I et flerdosisstudie med darunavir/ritonavir (600/100 mg) to gange dagligt blev det påvist, at den totale plasmakoncentration af darunavir hos forsøgspersoner med let (Child-Pugh klasse A, N=8) og moderat (Child-Pugh klasse B, N=8) nedsat leverfunktion var sammenlignelige med dem, der sås hos raske forsøgspersoner.
English: Mean systemic emtricitabine exposure was higher in patients with severe renal impairment (eGFRCG < 30 mL/min) (33.7 mcg•h/mL) than in subjects with normal renal function (11.8 mcg•h/mL).
Danish: Den gennemsnitlige systemisk emtricitabineksponering var højere hos patienter med svært nedsat nyrefunktion (eGFRCG <30 ml/min) (33,7-μg•t/ml) end hos personer med normal nyrefunktion (11,8 μg•t/ml).
English: No virologic data
Danish: Ingen virologiske data
English: There is no specific antidote for overdose with Symtuza.
Danish: Der findes ingen specifik antidot mod Symtuza.
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues.
Danish: Der foreligger rapporter om mitokondriel dysfunktion hos hiv-negative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller efter fødslen.
English: Purpose of the medicine
Danish: Formålet med lægemidlet
English: When Symtuza is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Danish: Når Symtuza co-administreres med et lægemiddel, som indeholder drospirenon, anbefales klinisk monitorering på grund af risikoen for hyperkaliæmi.
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism.
Danish: Cobicistats hæmning af CYP3A-medieret metabolisme øger den systemiske eksponering over for CYP3A-substrater såsom darunavir, hvor biotilgængeligheden er begrænset og halveringstiden forkortet på grund af den CYP3A-afhængige metabolisme.
English: Co-administration of cobicistat with medicinal products that are substrates of these transporters can result in increased plasma concentrations of the co-administered medicinal products.
Danish: Co-administration af cobicistat med lægemidler, der er substrater for disse transportører, kan medføre øgede plasmakoncentrationer af de samtidigt administrerede lægemidler.
English: - Budesonide, fluticasone (to control asthma).
Danish: - Budesonid, fluticason (til behandling af astma).
English: Thirteen percent of the dose was recovered in the urine as three putative metabolites.
Danish: Tretten procent af dosis blev genfundet i urinen som tre formodede metabolitter.
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A inhibitors
Danish: DIREKTE VIRKENDE ANTIVIRALE MIDLER MOD HEPATITIS C (HCV) NS3-4A-hæmmere
English: Darunavir is approximately 95% bound to plasma protein.
Danish: Ca. 95 % af darunavir bindes til plasmaprotein.
English: Always take Symtuza exactly as your doctor or pharmacist has told you.
Danish: Tag altid Symtuza nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: The combination may result in increased risk of cardiovascular adverse events with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Danish: Kombinationen kan medføre øget risiko for kardiovaskulære bivirkninger med salmeterol, herunder QT-forlængelse, palpitationer og sinustakykardi.
English: At Week 96, the median change in eGFRCG was -5.2 mL/min with D/C/F/TAF.
Danish: Ved uge 96 var middelændringen i eGFRCG -5,2 ml/min med D/C/F/TAF.
English: Symtuza might increase the risk of bleeding.
Danish: Symtuza kan øge risikoen for blødning.
English: The exposure to darunavir and cobicistat administered as the Symtuza was 30-45% lower and 16-29% lower, respectively, in fasted compared to fed condition.
Danish: Eksponeringen for darunavir og cobicistat administreret som Symtuza var henholdsvis 30-45 % og 16-29 % lavere i fastende sammenlignet med ikke-fastende tilstand.
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 L (mean ± SD) and increased to 131 ± 49.9 L (mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Danish: Efter intravenøs administration var fordelingsvolumen for darunavir administreret alene 88,1 ± 59,0 l (gennemsnit ± SD) og steg til 131 ± 49,9 l (gennemsnit ± SD) ved kombination med 100 mg ritonavir to gange dagligt.
English: Symtuza can be co-administered with H2-receptor antagonists without dose adjustments.
Danish: Symtuza kan co-administreres med H2-receptorantagonister uden dosisjusteringer.
English: There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope).
Danish: Der er øget risiko for sildenafil-relaterede bivirkninger (herunder synsforstyrrelser, hypotension, forlænget erektion og synkope).
English: Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jirovecii
Danish: Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumoni forårsaget af Pneumocystis jirovecii (tidligere kendt som Pneumocystis carinii).
English: No adjustment of methadone dosage is expected when initiating co-administration with Symtuza.
Danish: Justering af methadondosis forventes ikke at være nødvendig, når co-administration med Symtuza påbegyndes.
English: Symtuza is an antiretroviral medicine used to treat infection with human immunodeficiency virus 1 (HIV-1).
Danish: Symtuza er et lægemiddel, der anvendes til behandling af hiv-1-infektion (humant immundefekt virus 1).
English: Based on this limited experience, the safety profile of emtricitabine/tenofovir alafenamide in patients with HIV/HBV co-infection appears to be similar to that in patients with HIV-1 monoinfection (see section 4.4).
Danish: Baseret på denne begrænsede erfaring forekommer sikkerhedsprofilen for emtricitabin/tenofoviralafenamid hos patienter co-inficeret med hiv/HBV at svare til den, der gælder for patienter, der kun er inficeret med hiv-1 (se pkt.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller skrumpelever (cirrose) kan en afbrydelse af behandlingen medføre en forværring af hepatitis, der kan være livstruende.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 mcg/mL.
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4 % og uafhængig af koncentrationen i intervallet 0,02-200 μg/ml.
English: Please see section ‘Other medicines and Symtuza'.
Danish: Se afsnittet 'Brug af anden medicin sammen med Symtuza'.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Danish: Darunavir metaboliseres i udstrakt grad via det hepatiske CYPsystem og næsten udelukkende af isozym CYP3A4.
English: • symptoms of infection or of autoimmune disorders (immune reconstitution inflammatory syndrome)
Danish: • symptomer på infektion eller på autoimmune lidelser (immunrekonstitutionsinflammatorisk syndrom (IRIS))
English: Amitriptyline Desipramine Imipramine Nortriptyline Trazodone
Danish: Amitriptylin Desipramin Imipramin Nortriptylin Trazodon
English: As limited information is available on the use of Symtuza in patients aged 65 and over, caution should be exercised, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Danish: Da der foreligger begrænsede oplysninger om brug af Symtuza til patienter i alderen 65 år og derover, skal der udvises forsigtighed, hvilket afspejler den hyppigere forekomst af nedsat leverfunktion, samtidige sygdomme og andre behandlinger (se pkt.
English: Interactions that have been identified in studies with individual components of Symtuza, i.e. with darunavir (in combination with low dose ritonavir), cobicistat, emtricitabine or tenofovir alafenamide, determine the interactions that may occur with Symtuza.
Danish: De interaktioner, der er identificeret i studier med de individuelle komponenter i Symtuza, dvs. med darunavir (i kombination med lavdosis ritonavir), cobicistat, emtricitabin eller tenofoviralafenamid, er afgørende for, hvilke interaktioner der kan forekomme med Symtuza.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm
Danish: Den gennemsnitlige stigning fra baseline i CD4+-celletal ved uge 48 var 224 celler/mm
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle symptomer på inflammation skal vurderes og behandling påbegyndes ved behov.
English: Caution should be used with co-administration of Symtuza and parenteral midazolam.
Danish: Der skal udvises forsigtighed ved co-administration af Symtuza og parenteral midazolam.
English: Poly (vinyl alcohol)- partially hydrolysed Talc
Danish: Poly(vinylalkohol) - delvist hydrolyseret Talcum
English: Low levels of metabolites are observed in urine and feces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Danish: Lave niveauer af metabolitter blev genfundet i urin og fæces og bidrager ikke til cobicistats CYP3A-hæmmende aktivitet.
English: During the darunavir/ritonavir clinical development program (N = 3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Danish: Under det kliniske udviklingsprogram med darunavir/ritonavir (N=3.063) rapporteredes hepatitis hos 0,5 % af de patienter, der fik antiretroviral kombinationsbehandling med darunavir/ritonavir.
English: Yellow to yellowish-brown capsule shaped tablet of 22 mm x 11 mm, debossed with “8121” on one side and “JG” on the other side.
Danish: Gul til gullig-brun kapselformet tablet på 22 mm x 11 mm, præget med „8121“ på den ene side og „JG“ på den anden side.
English: Nervous system disorders very common headache common dizziness
Danish: Nervesystemet meget almindelig hovedpine almindelig svimmelhed
English: Symtuza, therefore, must not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3 or table below).
Danish: Symtuza må derfor ikke kombineres med lægemidler, hvis clearance er meget afhængig af CYP3A, og for hvilke øget systemisk eksponering er forbundet med alvorlige og/eller livstruende bivirkninger (snævert terapeutisk vindue) (se pkt.
English: ANTIPSYCHOTICS/NEUROLEPTICS Perphenazine
Danish: ANTIPSYKOTIKA/NEUROLEPTIKA Perphenazin
English: H2-RECEPTOR ANTAGONISTS Cimetidine
Danish: H2-RECEPTORANTAGONISTER Cimetidin
English: Lurasidone Pimozide Quetiapine Sertindole
Danish: Lurasidon Pimozid Quetiapin Sertindol
English: Studies in animals have demonstrated that darunavir, cobicistat and tenofovir are excreted in milk.
Danish: Dyrestudier har påvist, at darunavir, cobicistat og tenofovir udskilles i mælk.
English: Caution should be exercised when clarithromycin is combined with Symtuza.
Danish: Der skal udvises forsigtighed, når clarithromycin kombineres med Symtuza.
English: If concomitant use of Symtuza with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Danish: Hvis samtidig brug af Symtuza og sildenafil, vardenafil eller tadalafil er indiceret, anbefales det at give en enkeltdosis sildenafil på højst 25 mg i løbet af 48 timer, en enkeltdosis vardenafil på højst 2,5 mg i løbet af 72 timer eller en enkeltdosis tadalafil på højst 10 mg i løbet af 72 timer.
English: Do not take Symtuza - if you are allergic (hypersensitive) to darunavir, cobicistat, emtricitabine, tenofovir alafenamide, or any of the other ingredients of Symtuza (listed in section 6).
Danish: Tag ikke Symtuza - hvis du er allergisk over for darunavir, cobicistat, emtricitabin, tenofoviralafenamid eller et af de øvrige indholdsstoffer i Symtuza (angivet i punkt 6).
English: 6 cells/mm 3).
Danish: celler/mm 3).
English: Patients with co-existing conditions
Danish: Patienter med samtidigt forekommende tilstande
English: How to take Symtuza
Danish: Sådan skal du tage Symtuza
English: The median change in eGFRCG was -5.5 mL/min with D/C/F/TAF and -12.0 mL/min with D/C+F/TDF (p < 0.001).
Danish: Middelændringen i eGFRCG var -5,5 ml/min med D/C/F/TAF og -12,0 ml/min med D/C+F/TDF (p=<0,001).
English: The safety of Symtuza in paediatric patients has not been investigated.
Danish: Symtuzas sikkerhed hos pædiatriske patienter er ikke blevet undersøgt.
English: In the Phase 3 trial of Symtuza in treatment-naïve patients, increases from baseline were observed in the fasting lipid parameters total cholesterol, direct LDL and HDL cholesterol, and triglycerides at Week 48 and 96 (see Table 3).
Danish: I fase 3-studiet med Symtuza af behandlingsnaive patienter sås der stigninger fra baseline i de fastende lipidparametre total kolesterol, direkte LDL- og HDL-kolesterol og triglycerider ved uge 48 og 96 (se tabel 3).
English: Overall, 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Danish: I alt havde 22 % hiv-1 RNA i plasma ved baseline på >100.000 kopier/ml.
English: Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Danish: Cobicistat hæmmer transportørerne p-glykoprotein (P-gp), BCRP, MATE1, OATP1B1 og OATP1B3.
English: After 96 weeks of treatment with Symtuza, the (95% CI) percent changes from baseline in BMD at the hip and spine region were respectively: -0.26 (-0.96; 0.45) % and -0.93 (-1.82; -0.05) %.
Danish: Efter 96 ugers behandling med Symtuza var de (95 % CI) procentvise ændringer i BMD i hofte- og rygradsregionen i forhold til baseline henholdsvis: -0,26 (0,96; 0,45) % og -0,93 (-1,82; -0,05) %.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with Symtuza has not been established.
Danish: En sikker og effektiv dosis af sildenafil til behandling af pulmonal arteriel hypertension co-administreret med Symtuza er ikke fastlagt.
English: C]-darunavir could be retrieved in faeces and urine, respectively.
Danish: C]-darunavir genfindes i henholdsvis fæces og urin.
English: Patients had a median age of 15 years (range: 12-17), and 56% were female, 12% were Asian, and 88% were Black.
Danish: Patienterne havde en gennemsnitsalder på 15 år (interval 12 til 17 år), 56 % var kvinder, 12 % var asiater og 88 % var sorte.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (N = 12, age ≥ 65 years) (see section 4.4).
Danish: En populationsfarmakokinetisk analyse af hiv-inficerede patienter viste, at darunavirs farmakokinetik ikke er væsentligt forskellig i aldersgruppen (18-75 år) vurderet hos hiv-inficerede patienter (N=12, alder ≥ 65 år) (se pkt.
English: 2 consecutive HIV-1 RNA ≥ 50 copies/mL, or in case of discontinuation or at Week 48/96 for any reason, (single) HIV-1 RNA ≥ 50 copies/mL as of baseline (included)
Danish: 2 på hinanden følgende hiv-1 RNA ≥ 50 kopier/ml, eller i tilfælde af afbrydelse eller ved uge 48/96 af enhver årsag, (enkelt) hiv-1 RNA ≥ 50 kopier/ml ved baseline (inkluderet)
English: Virologic Outcomes in AMBER at Week 48 and 96 (FDA Snapshot) Week 48
Danish: Virologiske resultater i AMBER ved uge 48 og 96 (FDA-snapshot)
English: One film-coated tablet of Symtuza once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10
Danish: Én filmovertrukket Symtuza-tablet taget én gang dagligt sammen med mad kan anvendes til patienter med tidligere eksponering for antiretrovirale lægemidler, men uden mutationer forbundet med darunavir-resistens (DRV-RAM'er)*, og som har hiv-1 RNA < 100.000 kopier/ml i plasma og CD4+celletal ≥ 100 x 10
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Danish: Tenofoviralafenamid var ikke mutagent eller klastogent i konventionelle genotoksicitetsanalyser.
English: Blood and lymphatic system disorders common anaemia
Danish: Blod og lymfesystem almindelig anæmi
English: Symtuza and sofosbuvir, sofosbuvir/ledipasvir, or daclatasvir can be used concomitantly without dose adjustment
Danish: Symtuza og sofosbuvir, sofosbuvir/ledipasvir eller daclatasvir kan anvendes samtidig uden dosisjustering
English: • abnormal blood test results such as some tests for your kidney.
Danish: • unormale resultater af blodprøver såsom nogle test af dine nyrer.
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Danish: DRESS (lægemiddelrelateret udslæt med eosinofili og systemiske symptomer) og Stevens-Johnsons syndrom er rapporteret i sjældne tilfælde (< 0,1 %), og efter markedsføringen er toksisk epidermal nekrolyse og akut generaliseret eksantematøs pustulose blevet rapporteret.
English: Cobicistat is a mechanism-based inhibitor of cytochrome P450 of the CYP3A subfamily.
Danish: Cobicistat er en mekanismebaseret hæmmer af cytochrom P450 i CYP3A-underfamilien.
English: Paroxetine Sertraline
Danish: Paroxetin Sertralin
English: These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Danish: Disse kan omfatte, men er ikke begrænset til, alvorligt udslæt eller udslæt ledsaget af feber, almen utilpashed, træthed, muskel- eller ledsmerter, blæredannelse, mundsår, konjunktivitis, hepatitis og/eller eosinofili.
English: Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis.
Danish: Blandt 1.968 behandlingserfarne patienter, der fik darunavir co-administreret med ritonavir, 600/100 mg to gange dagligt, havde 236 patienter også hepatitis B eller C. Co-inficerede patienter var mere tilbøjelige til at have forhøjede levertransaminaser ved baseline og efter behandlingsstart end patienter uden kronisk viral hepatitis.
English: Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
Danish: Baseline-virusbelastning ≤100.000 kopier/ml >100.000 kopier/ml
English: Symtuza should not be administered concomitantly with medicinal products requiring pharmacokinetic enhancement with ritonavir or cobicistat.
Danish: Symtuza bør ikke administreres samtidig med antiretrovirale lægemidler, der kræver farmakokinetisk forstærkning med ritonavir eller cobicistat.
English: • if you notice any muscle or bone problems.
Danish: • Hvis du har problemer med muskler eller knogler.
English: The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Danish: Sikkerheden af emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet blev evalueret hos cirka 70 hiv/HBV co-inficerede patienter, der aktuelt var i behandling for hiv i et åbent klinisk studie (GS-US-292-1249).