natgillin/translations-raw huggingface dataset:
Genvoya bør generelt undgås, men kan anvendes hos voksne med nyresygdom i slutstadiet (estimeret CrCl < 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 < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Samtidig administration af Genvoya kan føre til øgede plasmakoncentrationer af dette lægemiddel.
Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product.
I fænotypeanalyser af patienter i den sidste resistensanalysepopulation havde 7 ud af 22 patienter (32 %) isolater af hiv 1 med nedsat følsomhed for elvitegravir i Genvoya-gruppen sammenlignet med isolater af hiv 1 fra 7 ud af 20 patienter (35 %) i E/C/F/TDF-gruppen, isolater af hiv 1 fra 8 patienter (36 %) havde nedsat følsomhed for emtricitabin i Genvoya-gruppen sammenlignet med isolater af hiv 1 fra 7 patienter (35 %) i E/C/F/TDF-gruppen.
In phenotypic analyses of patients in the final resistance analysis population, 7 of 22 patients (32%) had HIV-1 isolates with reduced susceptibility to elvitegravir in the Genvoya group compared with HIV-1 isolates from 7 of 20 patients (35%) in the E/C/F/TDF group, HIV-1 isolates from 8 patients (36%) had reduced susceptibility to emtricitabine in the Genvoya group compared with HIV-1 isolates from 7 patients (35%) in the E/C/F/TDF group.
Lactose (som monohydrat), mikrokrystallinsk cellulose, croscarmellosenatrium, hydroxypropylcellulose, siliciumdioxid, natriumlaurilsulfat, magnesiumstearat.
Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.
c Omfattede patienter, som havde ≥ 50 kopier/ml i uge 48- eller 144-vinduet, patienter, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, patienter, som afbrød behandlingen af andre årsager end en adverse event (AE), død eller manglende eller svigtende virkning, og som på tidspunktet for seponering havde en viral load på ≥ 50 kopier/ml.
c Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Derfor bør Genvoya ikke administreres sammen med lægemidler, der omfatter, men ikke er begrænset til, de følgende (se pkt.
Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):
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 < 0,001) og lænderyggen (gennemsnitlig ændring: -0,9 % versus -3,0 %, p < 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 < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001) after 144 weeks of treatment.
Samtidig administration af Genvoya og dabigatran er kontraindiceret.
Co-administration of Genvoya with dabigatran is contraindicated.
Tre patienter med nyopstået hiv 1-resistens over for Genvoya blev identificeret (M184M/I; M184I+E92G; M184V+E92Q) op til uge 96 i et klinisk studie af virologisk supprimerede patienter, der skiftede fra et regime indeholdende emtricitabin/tenofovirdisoproxil og et tredje stof (GS-US-292-0109, n = 959).
Three patients with emergent HIV-1 resistance to Genvoya were identified (M184M/I; M184I+E92G; M184V+E92Q) up to Week 96 in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine/tenofovir disoproxil and a third agent (GS-US-292-0109, n = 959).
Samtidig administration af CYP3A-metaboliserede kortikosteroider anbefales ikke, medmindre den potentielle fordel for patienten opvejer risikoen.
Co-administration with CYP3A-metabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
6 Dette studie blev udført med emtricitabin/tenofoviralafenamid.
6 This study was conducted using emtricitabine/tenofovir alafenamide.
Når der korrigeres for proteinbinding, er plasmakoncentrationerne af ubundet (frit) tenofoviralafenamid sammenlignelige ved svært nedsat leverfunktion og normal leverfunktion.
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Samtidig administration af salmeterol og Genvoya anbefales ikke.
Concurrent administration of salmeterol and Genvoya is not recommended.
d Omfattede patienter, som havde ≥ 50 kopier/ml i uge 48 eller uge 96-vinduet, patienter, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, patienter, som afbrød behandlingen af andre årsager end en adverse event (AE), død eller manglende eller svigtende virkning, og som på tidspunktet for seponering havde en viral load på ≥ 50 kopier/ml.
d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
De hormonale antikonceptiva bør indeholde mindst 30 µg ethinylestradiol og indeholde drospirenon eller norgestimat som progestogenet, eller patienterne skal anvende en anden sikker kontraceptionsmetode (se pkt.
The hormonal contraceptive should contain at least 30 µg ethinyloestradiol and contain drospirenone or norgestimate as the progestogen or patients should use an alternative reliable method of contraception (see sections 4.4 and
Interaktion er ikke undersøgt med Genvoya.
Interaction not studied with Genvoya.
Koncentrationer af sertralin er ikke påvirket ved samtidig administration med Genvoya.
Concentrations of sertraline are not affected upon co-administration with Genvoya.
Sikkerheden af elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid er ikke klarlagt hos disse patienter.
The safety of elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide has not been established in these patients.
Efter oral administration af [14C]-cobicistat blev hhv. 86 % og 8,2 % af dosis genfundet i fæces og urin.
Following oral administration of [14C]-cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Samtidig administration med lægemidler, som er meget afhængige af CYP3A for clearance, og for hvilke forhøjede plasmakoncentrationer er associeret med alvorlige eller livstruende bivirkninger, er kontraindiceret.
Co-administration is contraindicated with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious or life-threatening adverse reactions.
Elvitegravir gennemgår primært oxidativ metabolisme via CYP3A og glukuronideres i mindre grad via UGT1A1/3-enzymer.
Elvitegravir undergoes primarily oxidative metabolism via CYP3A, and is secondarily glucuronidated via UGT1A1/3 enzymes.
Samtidig administration af apixaban, rivaroxaban eller edoxaban og Genvoya anbefales ikke.
Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.
Patienter, co-inficeret med hiv og HBV
Patients co-infected with HIV and HBV
Tag altid den dosis, Deres læge har anbefalet for at sikre, at medicinen er fuldt ud effektiv, og for at reducere udviklingen af resistens mod behandlingen.
This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Det er vigtigt, at De husker at tage hver dosis af Genvoya.
It is important not to miss a dose of Genvoya.
f Omfatter patienter, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
f Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
På dage med hæmodialyse, skal Genvoya administreres efter fuldført hæmodialysebehandling.
On days of haemodialysis, Genvoya should be administered after completion of haemodialysis treatment.
Patienter med nyresygdom i slutstadiet i kronisk hæmodialyse
Patients with end stage renal disease on chronic haemodialysis
Cobicistat er en kraftig mekanismebaseret hæmmer af CYP3A samt et CYP3A-substrat.
Cobicistat is a strong mechanism-based inhibitor of CYP3A and is also a CYP3A substrate.
Samtidig administration af Genvoya og andre lægemidler metaboliseres primært af CYP3A, såsom amiodaron, quinidin, cisaprid, pimozid, lurasidon, alfuzosin og sildenafil mod pulmonal arteriel hypertension er kontraindiceret (se pkt.
Co-administration of Genvoya and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, lurasidone, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
Tenofoviralafenamid metaboliseres kun minimalt af CYP3A4.
Tenofovir alafenamide is minimally metabolised by CYP3A4.
Efter oral administration af boosted [14C]-elvitegravir var elvitegravir det dominerende stof i plasma og udgjorde ~ 94 % af den cirkulerende radioaktivitet.
Following oral administration of boosted [14C]-elvitegravir, elvitegravir was the predominant species in plasma, representing ~94% of the circulating radioactivity.
Derfor bør behandling med Genvoya ikke påbegyndes under graviditet, og kvinder, der bliver gravide under behandling med Genvoya, skal skiftes til et andet regime (se pkt.
Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.2 and 4.4).
Patienter med leversygdom, inklusiv kronisk hepatitis B eller C, som behandles med antiretrovirale midler, har en forhøjet risiko for alvorlige og potentielt livstruende bivirkninger i leveren.
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.
Patienter med CrCl over eller lig med 60 ml/min:
Patients with CrCl greater than or equal to 60 mL/min:
13 % procent af patienterne blev identificeret som af spansk/latinsk herkomst.
Thirteen percent of patients were identified as Hispanic/Latino.
Patienter, co-inficeret med hiv- og hepatitis B- eller C-virus
Patients co-infected with HIV and hepatitis B or C virus
Op til uge 144 blev der observeret udvikling af en eller flere primære elvitegravir-, emtricitabin- eller tenofoviralafenamid-resistensassocierede mutationer i isolater af hiv 1 fra 12 ud af 22 patienter med evaluerbare genotypedata fra parrede isolater ved baseline og efter behandlingssvigt med Genvoya (12 ud af 866 patienter [1,4 %]), sammenlignet med 12 ud af 20 isolater efter behandlingssvigt fra patienter med evaluerbare genotypedata i E/C/F/TDF- behandlingsgruppen (12 ud af 867 patienter [1,4 %]).
Up to Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir alafenamide resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and Genvoya treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF treatment group (12 of 867 patients [1.4%]).
Indlægsseddel: Information til brugeren Genvoya 150 mg/150 mg/200 mg/10 mg filmovertrukne tabletter
Package leaflet: Information for the user Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets
Tenofovirdiphosphat hæmmer hiv-replikation via indbygning i viralt dna af hiv-RT, hvilket resulterer i dna-kædeblokering.
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
In vivo hydrolyseres tenofoviralafenamid i cellerne til at danne tenofovir (primær metabolit), som fosforyleres til den aktive metabolit tenofovirdiphosphat.
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite tenofovir diphosphate.
Hos patienter i behandling med Genvoya opnåede 92 % (46/50) hiv 1-rna < 50 kopier/ml.
In patients treated with Genvoya, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL.
Indigocarmin aluminiumpigment (E132) Jernoxid, gul (E172)
Indigo carmine aluminium lake (E132) Iron oxide yellow (E172)
Mens De tager Genvoya
While you are taking Genvoya
Forskellen i procent var 4,2 % (95 % CI: 0,6 % til 7,8 %).
The difference in percentage was 4.2% (95% CI: 0.6% to 7.8%).
Emtricitabin har aktivitet mod hiv 1-, hiv 2- og HBV.
Emtricitabine has activity against HIV-1, HIV-2, and HBV.
Samtidig brug af Genvoya og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroidbivirkninger, herunder Cushings syndrom og binyrebarksuppression.
Concomitant use of Genvoya and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
4,1 % (95 % CI: 1,6 % til 6,7 %, p < 0,001c)
4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
Genvoya bør derfor ikke anvendes under amning.
Therefore, Genvoya should not be used during breast-feeding.
Carbamazepin reducerer plasmakoncentrationerne af elvitegravir og cobicistat, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.
Carbamazepine decreases plasma concentrations of elvitegravir and cobicistat, which may result in loss of therapeutic effect and development of resistance.
e Omfatter patienter, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
e Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
I et studie med Genvoya hos hiv 1-inficerede voksne med nyresygdom i slutstadiet (estimeret CrCl < 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 < 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 < 0,7 % og uafhængig af koncentrationsområdet på 0,01-25 μg/ml.
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.
Den totale plasmakoncentration af tenofoviralafenamid og tenofovir var lavere end hos personer med normal leverfunktion.
In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
Samtidig infektion med hepatitis B- og/eller hepatitis C-virus Emtricitabins og tenofoviralafenamids farmakokinetik er ikke blevet fuldt evalueret hos patienter med samtidig infektion med hepatitis B- og/eller hepatitis C-virus.
The pharmacokinetics of emtricitabine and tenofovir alafenamide have not been fully evaluated in patients co-infected with hepatitis B and/or C virus.
19 % procent af patienterne blev identificeret som af spansk/latinsk herkomst.
Nineteen percent of patients were identified as Hispanic/Latino.
• kolesterolsænkende lægemidler, såsom:
• cholesterol lowering medicines, such as:
dyspepsi
dyspepsia
Eksponering for emtricitabin og tenofovir hos 12 patienter med nyresygdom i slutstadiet (estimeret CrCl < 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 < 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.
Patienterne i studiet havde en medianalder på 15 år (interval: 12 til 17 år), 64 % var kvinder, og 98 % var sorte.
Patients in the study had a median age of 15 years (range: 12 to 17 years), 64% were female and 98% were Black.
Systemisk lidocain Mexiletin Propafenon
Disopyramide Flecainide Systemic lidocaine Mexiletine Propafenone
Sikkerheden af Genvoya blev evalueret hos 72 patienter co-inficeret med hiv/HBV, som fik behandling mod hiv i et ublindet klinisk studie (GS-US-292-1249), til og med uge 48, hvor patienterne skiftede fra et andet antiretroviralt regime (som inkluderede tenofovirdisoproxil hos 69 ud af 72 patienter) til Genvoya.
The safety of Genvoya was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included tenofovir disoproxil in 69 of 72 patients) to Genvoya.
Den gennemsnitlige stigning fra baseline i Genvoya-gruppen var mindre end i elvitegravir-gruppen 150 mg/cobicistat 150 mg/emtricitabin 200 mg/tenofovirdisoproxil (som fumarat) 245 mg (E/C/F/TDF) ved uge 144 (forskel -0,04; p < 0,001)
Mean increases from baseline in the Genvoya group were smaller than in the elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) group at Week 144 (difference -0.04, p < 0.001).
Der bør udvises forsigtighed, når Genvoya og hormonale antikonceptiva administreres samtidigt.
Caution should be exercised when co-administering Genvoya and a hormonal contraceptive.
Se indlægssedlen for yderligere oplysninger.
Contains lactose, see leaflet for further information.
Tenofovir har aktivitet mod hiv 1-, hiv 2- og HBV-virus.
Tenofovir has activity against HIV-1, HIV-2, and HBV.
• lægemidler, der anvendes til at behandle sukkersyge:
• medicines used to treat diabetes:
Tilsvarende steady-state gennemsnitlige værdier for hhv. Cmax, AUCtau og Ctrough (gennemsnit ± SD) var 1,1 ± 0,40 µg/ml, 8,3 ± 3,8 µg•t/ml og 0,05 ± 0,13 µg/ml for cobicistat; 1,9 ± 0,5 µg/ml, 13 ± 4,5 µg•t/ml og 0,14 ± 0,25 µg/ml for emtricitabin.
Corresponding steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) were 1.1 ± 0.40 µg/mL, 8.3 ± 3.8 µg•h/mL, and 0.05 ± 0.13 µg/mL for cobicistat; 1.9 ± 0.5 µg/mL, 13 ± 4.5 µg•h/mL, and 0.14 ± 0.25 µg/mL for emtricitabine.
Genvoya bør ikke administreres sammen med andre antiretrovirale lægemidler (se pkt.
Genvoya should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Samtidig administration af Genvoya og lægemidler, som inducerer CYP3A kan føre til reducerede plasmakoncentrationer af elvitegravir og nedsat terapeutisk virkning af Genvoya (se ”Samtidig brug kontraindiceret” og pkt.
Co-administration of Genvoya with medicinal products that induce CYP3A may result in decreased plasma concentrations of elvitegravir and reduced therapeutic effect of Genvoya (see “Concomitant use contraindicated” and section 4.3).
Samtidig administration af carbamazepin, en kraftig CYP3A-inducer, kan reducere plasmakoncentrationerne af cobicitat signifikant.
Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations.
Patienterne i kohorte 2 havde en gennemsnitsalder på 10 år (interval: 8 til 11), en gennemsnitlig baselinevægt på 32 kg (interval: 26 til 58), 39 % var mænd, 13 % asiatere, 78 % sorte.
Patients in Cohort 2 had a mean age of 10 years (range: 8 to 11), a mean baseline weight of 32 kg (range: 26 to 58), were 39% male, 13% Asian, and 78% Black.
Selektive serotoningenoptagshæmmere (SSRI'er, selective serotonine reuptake inhibitors)
Selective serotonin reuptake inhibitors (SSRIs) Escitalopram
Den gennemsnitlige stigning i CD4+-celletal fra baseline var 230 celler/mm3 hos patienter i Genvoyagruppen og 211 celler/mm3 hos patienter i E/C/F/TDF-gruppen (p = 0,024) ved uge 48 og 326 celler/mm3 i Genvoya-gruppen og 305 celler/mm3 i E/C/F/TDF-gruppen (p = 0,06) ved uge 144.
The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in Genvoya-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48, and 326 cells/mm3 in Genvoya-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
• elvitegravir, et antiretroviralt lægemiddel, der kaldes en integrasehæmmer
• elvitegravir, an antiretroviral medicine known as an integrase inhibitor
Tabel 5: Farmakokinetik for elvitegravir, cobicistat, emtricitabin, tenofovir og tenofoviralafenamid hos antiretroviral-naive unge og voksne
Table 5: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Der identificeredes ingen nye sikkerhedsproblemer hos patienter med nyresygdom i slutstadiet i kronisk hæmodialyse, som fik Genvoya (se pkt.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 4.8).
 Hvis nogle af bivirkningerne bliver alvorlige, skal De fortælle det til lægen.
 If any of the side effects get serious tell your doctor.
3,7 % (95 % CI: 0,4 % til 7,0 %, p < 0,017c)
3.7% (95% CI: 0.4% to 7.0%, p < 0.017c)
Koncentrationer af disse HMG Co-A-reduktasehæmmere forventes at øges forbigående ved administration af elvitegravir og cobicistat.
Concentrations of these HMG Co-A reductase inhibitors are expected to transiently increase when administered with elvitegravir and cobicistat.
Studier af tenofoviralafenamid fra dyr har ikke vist evidens for skadelige virkninger af tenofoviralafenamid på fertilitetsparametre, graviditet eller føtal udvikling (se pkt.
Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects of tenofovir alafenamide on fertility parameters, pregnancy, or foetal development (see section 5.3).
Den gennemsnitlige plasma hiv 1-rna ved baseline var 4,5 log10 kopier/ml (interval 1,3-7,0), og 23 % havde viral load ved baseline på > 100.000 kopier/ml.
The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range 1.3-7.0) and 23% had baseline viral loads > 100,000 copies/mL.
Magnesium/aluminium-indeholdende antacidum-suspension (20 ml enkeltdosis)/Elvitegravir (50 mg enkeltdosis)/Ritonavir (100 mg enkeltdosis)
Magnesium/aluminium-containing antacid suspension (20 mL single dose)/ Elvitegravir (50 mg single dose)/ Ritonavir (100 mg single dose)
Steady-state gennemsnitlige værdier for hhv. Cmax, AUCtau og Ctrough (gennemsnit ± SD) hos hiv 1-inficerede patienter var 1,7 ± 0,39 µg/ml, 23 ± 7,5 µg•t/ml og 0,45 ± 0,26 µg/ml for elvitegravir, hvilket giver en hæmningskvotient på ~ 10 (forholdet mellem Ctrough: proteinbindingsjusteret IC95 for vildtype hiv 1-virus).
The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) in HIV-1 infected patients, respectively, were 1.7 ± 0.39 µg/mL, 23 ± 7.5 µg•h/mL, and 0.45 ± 0.26 µg/mL for elvitegravir, which provides inhibitory quotient of ~10 (ratio of Ctrough: protein binding-adjusted IC95 for wild-type HIV-1 virus).