natgillin/translations-raw huggingface dataset:
Odefsey frarådes til patienter med en estimeret CrCl ≥ 15 ml/min og < 30 ml/min, eller < 15 ml/min, som ikke er i kronisk hæmodialyse, da Odefseys sikkerhed hos disse populationer ikke er klarlagt.
Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
Der skal tages hensyn til disse resultater for alle børn, der er blevet eksponeret for nukleoside/nukleotide analoger in utero, og som præsenterer svære kliniske fund af ukendt ætiologi, især neurologiske fund.
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Blandt disse 12 hiv 1-isolater var de mutationer, der opstod, M184V/I (n = 11) og K65R/N (n = 2) i RT og T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) og N155H (n = 2) i integrase.
Among these 12 HIV-1 isolates, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Patienter med hiv-infektion, som samtidig er inficerede med HBV, og som ophører med Odefsey, bør monitoreres tæt med opfølgning både klinisk og i laboratoriet i flere måneder eller længere efter ophør af behandlingen.
Patients co-infected with HIV and HBV who discontinue Odefsey should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
H2-antagonister må ikke tages to gange om dagen.
H2-antagonists should not be taken twice a day.
I/R 10,6 (28,5)
N/A 10.6 (28.5)
Desuden hæmmede emtricitabin ikke uridine-5'-diphosphoglucuronyltransferase (UGT), det enzym, der er ansvarligt for glucuronidation.
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase (UGT), the enzyme responsible for glucuronidation.
Hos patienter med allerede eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis, er der en forhøjet forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling (CART, combination antiretroviral therapy), og disse patienter bør monitoreres i henhold til standardprocedurer.
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Efter administration af tenofoviralafenamid viste plasma [14C]-radioaktivitet en tidsafhængig profil med tenofoviralafenamid som det hyppigste stof i de første par timer og urinsyre i den resterende periode.
Following administration of tenofovir alafenamide, plasma [14C] -radioactivity showed a time-dependent profile, with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
artralgi3
arthralgia3
GLUKOKORTIKOIDER Dexamethason (systemisk, med undtagelse af anvendelse af en enkelt dosis)
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Emtricitabins binding in vitro til humane plasmaproteiner var < 4 % og uafhængig af koncentrationen i intervallet 0,02-200 µg/ml.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
52 % af hiv 1-isolater med nyopstået resistent i rilpivirin-armen udviklede samtidige NNRTI- og NRTI-mutationer, oftest E138K og M184V.
Fifty-two percent of HIV-1 isolates with emergent resistance in the rilpivirine arm developed concomitant NNRTI and NRTI mutations, most frequently E138K and M184V.
Sofosbuvirmetabolit GS-331007:
Sofosbuvir metabolite GS-331007:
e f.eks. manglende opfølgning, manglende compliance, samtykke trukket tilbage.
e e.g., lost to follow up, non-compliance, withdrew consent.
Grå, kapselformede, filmovertrukne tabletter, der måler 15 mm x 7 mm, præget med ”GSI” på den ene side af tabletten og med ”255” på den anden side af tabletten.
Grey, capsule-shaped, film-coated tablets, of dimensions 15 mm x 7 mm, debossed with “GSI” on one side of the tablet and “255” on the other side of the tablet.
Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af alder, køn eller etnicitet for emtricitabin, rilpivirin eller tenofoviralafenamid.
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide.
Odefseys sikkerhed og virkning hos patienter med signifikant underliggende leversygdom er ikke klarlagt.
The safety and efficacy of Odefsey in patients with significant underlying liver disorders have not been established.
En minimal infiltration af histiocytter var til stede i øjet på hunde ved eksponeringer over for hhv. tenofoviralafenamid og tenofovir, der var ca. 4 og 17 gange større, end hvad der forventes efter administration af Odefsey.
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Odefsey.
Odefsey 200 mg/25 mg/25 mg filmovertrukne tabletter
Odefsey 200 mg/25 mg/25 mg film-coated tablets
H2-antagonister (famotidin, cimetidin, nizatidin eller ranitidin) Disse lægemidler kan mindske mængden af rilpivirin (et indholdsstof i Odefsey) i Deres blod.
H2-antagonists (famotidine, cimetidine, nizatidine or ranitidine) These medicines can decrease the amount of rilpivirine (a component of Odefsey) in your blood.
Patienter med en virusbelastning ved baseline > 100.000 hiv 1-rna-kopier/ml, som fik virologisk svigt, havde en højere forekomst af resistens over for NNRTI-klassen som følge af behandlingen.
Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og tabletbeholderen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
c n = 539 (TAF) eller 841 (TFV) voksne (GS-US-292-0111 og GS-US-292-0104, populationsfarmakokinetisk analyse).
c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis).
Anvendelsen af Odefsey til børn i alderen 11 år eller derunder, eller som vejer under 35 kg, er endnu ikke undersøgt.
The use of Odefsey in children aged 11 years or under or weighing less than 35 kg has not yet been studied.
De mutationer associeret med NRTI-resistens, der udviklede sig i 3 eller flere patientisolater, var: K65R, K70E, M184V/I og K219E.
The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E.
Rilpivirin udviste aktivitet mod laboratoriestammer af vildtype hiv 1 i en stærkt inficeret T-cellelinje med en median EC50-værdi for hiv 1/IIIB på 0,73 nM (0,27 ng/ml).
Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Dosisjusteringer er ikke nødvendige.
No dose adjustments are required.
Det er muligt, at patienter i fremtiden, der har brugt Odefsey gennem længere tid, kan få nyreproblemer.
It is possible that in the future, long-term users of Odefsey may get kidney problems.
• Lægemidler mod mavesår, halsbrand og sure opstød som f.eks.:
• Medicines for stomach ulcers, heartburn or acid reflux such as:
Dyrestudier tyder ikke på skadelige virkninger af emtricitabin, rilpivirinhydrochlorid eller tenofoviralafenamid på fertiliteten (se pkt.
Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see section 5.3).
Den mediane stigning fra baseline for disse parametre var større hos patienter, der fik FTC + TAF, sammenlignet med patienter, der fik FTC + TDF (p < 0,001 for forskellen mellem behandlingsgrupperne angående fasteværdier for total-kolesterol, direkte LDL- og HDL-kolesterol samt triglycerider).
The median increase from baseline for these parameters was greater in patients receiving FTC + TAF compared with patients receiving FTC + TDF (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Lægemidler, der inducerer eller hæmmer CYP3A, kan således påvirke rilpivirin-clearance (se pkt.
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Behandlingsnaive voksne i studierne GS-US-292-0104 og GS-US-292-0111b
Treatment-naïve adults in Studies GS-US-292-0104 and GS-US-292-0111b
Nukleosid/nukleotid-analoger kan påvirke mitokondriefunktionen i varierende grad; dette er mest udtalt ved stavudin, didanosin og zidovudin.
Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
svære hudreaktioner med systemiske symptomer4, angioødem5,6, pruritus3, urticaria6 Knogler, led, muskler og bindevæv Ikke almindelig:
severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon:
I studierne GS-US-292-0104 og GS-US-292-0111 var den virologiske succesrate den samme i alle patientundergruppe (alder, køn, race, hiv 1-rna ved baseline eller CD4+ celletal ved baseline).
In Studies GS-US-292-0104 and GS-US-292-0111, the rate of virologic success was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA, or baseline CD4+ cell count).
• forhøjede niveauer af leverenzymer i blodet
• increased levels of liver enzymes in the blood
Forekomsten af virologisk svigt hos patienter behandlet med emtricitabin/tenofovirdisoproxilfumarat + rilpivirin var i uge 48 og uge 96 henholdsvis 9,5 % og 11,5 %, og 4,2 % og 5,1 % i armen med emtricitabin/tenofovirdisoproxilfumarat + efavirenz.
The virologic failure rate in patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine at Week 48 and Week 96 was 9.5% and 11.5% respectively, and 4.2% and 5.1% in the emtricitabine/tenofovir disoproxil fumarate + efavirenz arm.
depression1, unormale drømme1,3, søvnforstyrrelser1, forsænket stemningsleje1
depression1, abnormal dreams1, 3, sleep disorders1, depressed mood1
På dage med hæmodialyse, skal Odefsey administreres efter fuldført hæmodialysebehandling.
On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment.
Rilpivirin er en hæmmer af transportøren MATE-2K in vitro med en IC50 på < 2,7 nM.
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Tenofovirs binding in vitro til humane plasmaproteiner var < 0,7 % og er uafhængig af koncentrationen i intervallet 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 farmakokinetiske eksponering for rilpivirin hos patienter med samtidig infektion, var sammenlignelig med den hos patienter uden samtidig infektion.
The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Som følge af en øget plasmastabilitet og intracellulær aktivering via hydrolyse af cathepsin A er tenofoviralafenamid mere effektivt end tenofovirdisoproxilfumarat til indføring af tenofovir i mononukleære celler i perifert blod (PBMC'er, peripheral blood mononuclear cells) (herunder lymfocytter og andre hiv-målceller) og makrofager.
Due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in loading tenofovir into peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
I et panel med 67 hiv 1-rekombinante laboratoriestammer med én resistensassocieret mutation på RT-positioner associeret med NNRTI-resistens var de eneste enkeltresistensassocierede mutationer associeret med tab af modtagelighed for rilpivirin K101P og Y181V/I.
In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, the only single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were K101P and Y181V/I.
Odefsey bør ikke administreres sammen med andre antiretrovirale lægemidler (se pkt.
Odefsey should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Der er observeret lavere eksponeringer for rilpivirin (et af indholdsstofferne i Odefsey) under graviditet, hvorfor virusbelastningen bør monitoreres tæt.
Lower exposures of rilpivirine (one of the components of Odefsey) were observed during pregnancy; therefore viral load should be monitored closely.
Det er ukendt, om rilpivirin eller tenofoviralafenamid udskilles i human mælk.
It is not known whether rilpivirine or tenofovir alafenamide are excreted in human milk.
2 Denne bivirkning blev ikke observeret i fase 3-studierne med emtricitabin + tenofoviralafenamid i kombination med elvitegravir + cobicistat eller i fase 3-studierne med Odefsey, men den blev identificeret for emtricitabin i kombination med andre antiretrovirale midler i kliniske studier eller efter markedsføring.
2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
Tenofoviralafenamid er ikke en hæmmer eller induktor af CYP3A in vivo.
Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
b I begge studier blev patienterne stratificeret efter baseline hiv 1-rna (≤ 100.000 kopier/ml, > 100.000 kopier/ml til ≤ 400.000 kopier/ml eller > 400.000 kopier/ml) ved CD4+ celletal (< 50 celler/μl, 50-199 celler/μl eller ≥ 200 celler/μl), og efter region (USA eller uden for USA).
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex US).
• Ciclosporin, et lægemiddel der anvendes til at reducere styrken af kroppens immunsystem: Dette lægemiddel kan øge mængden af rilpivirin og tenofoviralafenamid (indholdsstoffer i Odefsey) i Deres blod.
• Ciclosporin, a medicine used to reduce the strength of the body's immune system: This medicine can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
Tabel 3: Virologiske resultater af studierne GS-US-292-0104, GS-US-292-0111 ved uge 48 og uge 96 144a og GS-US-292-0109 ved uge 48a
Table 3: Virologic outcomes of Studies GS-US-292-0104, GS-US-292-0111 at Week 48 and Week 144a, and GS-US-292-0109 at Week 48a
 Hvis noget af dette gælder for Dem, skal De kontakte lægen, før De tager Odefsey.
 If any of these applies to you, talk to your doctor before taking Odefsey.
Hvis De har glemt at tage Odefsey
If you forget to take Odefsey
PHOSPHODIESTERASE TYPE 5 (PDE-5)-HÆMMERE Sildenafil (enkelt dosis på 50 mg)/ rilpivirin1
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil (50 mg single dose)/ Rilpivirine1
Det skal De vide, før De begynder at tage Odefsey Tag ikke Odefsey:
What you need to know before you take Odefsey Do not take Odefsey:
I et klinisk lægemiddelinteraktionsstudie med tenofoviralafenamid, som er mere følsomt over for hæmning af P-gp i tarmene, påvirkede rilpivirin desuden ikke eksponering for tenofoviralafenamid ved samtidig administration, hvilket tyder på, at rilpivirin ikke er en P-gphæmmer in vivo.
Additionally, in a clinical drug-drug interaction study with tenofovir alafenamide, which is more sensitive to intestinal P-gp inhibition, rilpivirine did not affect tenofovir alafenamide exposures when administered concurrently, indicating that rilpivirine is not a P-gp inhibitor in vivo.
Dosisjustering af Odefsey er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh klasse A) eller moderat nedsat leverfunktion (Child-Pugh klasse B).
No dose adjustment of Odefsey is required in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment.
I fase III-studierne (C209 og C215) er lavere eksponering for rilpivirin, som ligner den der ses under graviditet, blevet associeret med øget risiko for virologisk svigt, hvorfor virusbelastningen bør monitoreres tæt (se pkt.
In the Phase 3 studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
FTC/TDF + rilpivirinhydrochlorid var non-inferiørt for så vidt angår hiv 1-rna < 50 kopier/ml sammenlignet med FTC/TDF + efavirenz.
FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to FTC/TDF + efavirenz.
Tenofoviralafenamid er et substrat for organisk aniontransporterende polypeptid (OATP) 1B1 og OATP1B3 in vitro.
Tenofovir alafenamide is a substrate of organic anion transporting polypeptide (OATP) 1B1 and OATP1B3 in vitro.
ketoconazol fluconazol itraconazol posaconazol voriconazol
ketoconazole fluconazole itraconazole posaconazole voriconazole
Andel (%) patienter med hiv 1-rna < 50 kopier/ml pr. tidligere behandlingsregimed EFV/FTC/TDF FTC/TDF plus boosted atazanavir E/C/F/TDF
Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimend EFV/FTC/TDF FTC/TDF plus boosted atazanavir E/C/F/TDF
Voksne og unge i alderen 12 år og ældre, der vejer mindst 35 kg Én tablet tages én gang daglig sammen med mad (se pkt.
Adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet to be taken once daily with food (see section 5.2).
• alvorlige hudreaktioner, herunder udslæt, sammen med feber, hævelser og leverproblemer
• severe skin reactions including rash accompanied by fever, swelling and liver problems
92 % (66/72 patienter) havde HBV DNA < 29 IE/ml ved brug af analyse, hvor manglende data = svigt ved uge 48.
Ninety-two percent (66/72 patients) had HBV DNA < 29 IU/mL using missing = failure analysis at Week 48.
I forhold til fastende tilstand førte administration af Odefsey sammen med mad hos raske, voksne forsøgspersoner til en øget eksponering for tenofoviralafenamid (AUC) på 45-53 %.
Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased tenofovir alafenamide exposure (AUC) by 45-53%.
Tenofovirdiphosphat hæmmer hiv RT, hvilket resulterer i dna-kædeblokering.
Tenofovir diphosphate inhibits HIV RT, resulting in DNA chain termination.
Emtricitabin fosforyleres af celleenzymer, hvorved der dannes emtricitabintriphosphat.
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate.
Norgestimat (0,180/0,215/0,250 mg en gang dagligt)/ ethinylestradiol (0,025 mg en gang dagligt)/ emtricitabin/ tenofoviralafenamid (200/25 mg en gang dagligt)
Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)
Knogletoksicitet blev observeret som nedsat knoglemineraltæthed hos rotter og hunde ved eksponeringer for tenofovir, der var mindst fire gange større, end hvad der forventes efter administration af Odefsey.
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Odefsey.
Hos hiv-inficerede patienter med svær immuninsufficiens ved påbegyndelsen af CART kan der opstå en inflammatorisk reaktion over for asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
mavesmerter1,3, opkastning1,3, forhøjet lipase1, mavegener1, mundtørhed1, flatulens3, diarré3
abdominal pain1, 3, vomiting1, 3, increased lipase1, abdominal discomfort1, dry mouth1, flatulence3, diarrhoea3
Interaktion er ikke blevet undersøgt med tenofoviralafenamid.
Interaction not studied with tenofovir alafenamide.
Alvorlige hudreaktioner med systemiske symptomer er blevet rapporteret i forbindelse med erfaring efter markedsføringen for emtricitabin/rilpivirin/tenofovirdisoproxilfumarat, herunder udslæt med feber, blærer, conjunctivitis, angioødem, forhøjede leverfunktionstal og/eller eosinofili.
Severe skin reactions with systemic symptoms have been reported during post-marketing experience of emtricitabine/rilpivirine/tenofovir disoproxil fumarate including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia.
Da rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at det i signifikant grad vil fjernes ved hæmodialyse eller peritonealdialyse (se pkt.
As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.9).
Odefseys sikkerhed og virkning hos patienter, som samtidig er inficerede med hiv 1 og hepatitis Cvirus (HCV), er ikke klarlagt.
The safety and efficacy of Odefsey in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Croscarmellosenatrium, lactose (som monohydrat), magnesiumstearat, mikrokrystallinsk cellulose, polysorbat 20, povidon.
Croscarmellose sodium, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
Ved samtidig administration af et teststof, den moderate CYP3A-induktor efavirenz, var eksponeringen af tenofoviralafenamid ikke påvirket signifikant.
Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Rilpivirin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
Rilpivirine has not been studied in patients with severe hepatic impairment (Child Pugh Class C) (see section 4.2).
Samtidig infektion med hepatitis B- og/eller hepatitis C-virus Emtricitabins, rilpivirins og tenofoviralafenamids farmakokinetik er ikke blevet fuldt evalueret hos patienter med samtidig infektion med hepatitis B- og/eller hepatitis C-virus.
Hepatitis B and/or hepatitis C virus co-infection The pharmacokinetics of emtricitabine, rilpivirine and tenofovir alafenamide have not been fully evaluated in patients co-infected with hepatitis B and/or C virus.
Seponerede studiemedicin som følge af andre årsager, og sidste tilgængelige hiv 1rna < 50 kopier/mlf
Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLf
36 patienter havde en median alder på 14,5 år, og 55,6 % var piger, 88,9 % var sorte og 11,1 % var asiater.
Thirty-six patients had a median age of 14.5 years and were 55.6% female, 88.9% Black, and 11.1% Asian.
d Inkluderer patienter, der havde ≥ 50 kopier/ml i uge 48- eller uge 96-vinduet; patienter, der udgik tidligt på grund af manglende eller tab af effekt; patienter, der udgik af andre grunde end manglende eller tab af effekt og på tidspunktet for afbrydelsen havde virustal ≥ 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 lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
b n = 23 unge (GS-US-292-0106, populationsfarmakokinetisk analyse).
b n = 23 adolescents (GS-US-292-0106, population PK analysis).