natgillin/translations-raw huggingface dataset:
Ændring fra baseline (celler/ mm3) 1 p- værdi < 0, 0001 2
Change from baseline (cells/ mm3) 1 p-values < 0.0001
63, 13 (44, 28; 81, 99)
63.13 (44.28, 81.99)
For alle effektendepunkter var konfidensintervallet 95%, undtagen for HIV- 1 RNA, hvor ændring fra baseline var 97, 5%
13 2 For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline which was 97.5%
CELSENTRI 300 mg 2 gange dagligt + OB var bedre end OB alene i alle undergrupper af patientanalyser (se tabel 8).
CELSENTRI 300 mg twice daily + OBT was superior to OBT alone across all subgroups of patients analysed (see Table 8).
Patienter med et meget lavt CD4+- tal ved baseline (dvs. < 50 celler/ µl) havde et mindre favorabelt resultat.
Patients with very low CD4+ count at baseline (i. e. < 50 cells/ uL) had a less favourable outcome.
Denne undergruppe havde en høj grad af dårlige prognosemakører, dvs. udpræget resistens og høj viralbelastning ved baseline.
This subgroup had a high degree of bad prognostic markers, i. e. extensive resistance and high baseline viral loads.
Der blev dog påvist en signifikant behandlingsfordel for CELSENTRI sammenlignet med OB alene (se tabel 8).
However, a significant treatment benefit for CELSENTRI compared to OBT alone was still demonstrated (see Table 8).
Andel af patienter som opnåede < 50 kopier/ ml ved uge 48 i henhold til undergrupper (poolede forsøg MOTIVATE- 1 og MOTIVATE- 2, ITT) HIV- 1 RNA < 50 kopier/ ml
Proportion of patients achieving < 50 copies/ ml at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2, ITT)
Undergrupper
twice daily + OBT
2 gange dagligt + OB N=426
N=426
alene
N=209
N=209 Baseline HIV- 1 RNA:
Baseline HIV-1 RNA:
< 5, 0 log10 kopier/ ml ≥5, 0 log10 kopier/ ml
< 5.0 log10 copies/ ml ≥ 5.0 log10 copies/ ml
Baseline CD4 (celler/ µl):
Baseline CD4+ (cells/ uL):
< 50
< 50
101- 200 201- 350 ≥ 350
50-100 101-200 201-350 ≥ 350
56, 7 57, 8 72, 9
36.4 56.7 57.8 72.9
21, 8 21, 0 38, 5
12.0 21.8 21.0 38.5
Antal aktive ARV i OBT1, 2:
Number of active ARVs in OBT1,2:
0 1
0 1 2
32, 7% 44, 5%
32.7% 44.5% 58.2%
2, 0% 7, 4%
2.0% 7.4% 31.7%
Afbrydelse af behandling eller virologisk svigt betragtes som behandlingssvigt.
Discontinuations or virological failures considered as failures.
2 Baseret på GSS- score.
2 Based on GSS.
Der blev
Study A4001029 was an exploratory study in patients infected with dual/ mixed or CXCR4 tropic HIV-1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
15 hverken vist forbedring eller non- inferioritet til OB alene i dette forsøg, skønt der ikke var negativt resultat af viralbelastning eller CD4+- celletal.
In this study, neither superiority nor non-inferiority to OBT alone were demonstrated although there was no adverse outcome on viral load or CD4+ cell count
Maravirocs absorption er variabel med multiple toppe.
Absorption: the absorption of maraviroc is variable with multiple peaks.
Maravirocs mediane plasmakoncentration nås 2 timer (0, 5- 4 timer) efter en enkeltdosis på 300 mg kommerciel tablet indgivet til raske frivillige forsøgspersoner.
Median peak maraviroc plasma concentrations is attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.
Den absolutte biotilgængelighed af en dosis på 100 mg er 23% og estimeres til 33% for 300 mg.
The absolute bioavailability of a 100 mg dose is 23% and is predicted to be 33% at 300 mg.
Maraviroc er et substrat for efflux- transporteren P - glycoprotein.
Maraviroc is a substrate for the efflux transporter P-glycoprotein.
Samtidig anvendelse af 300 mg- tabletten og et morgenmåltid med højt fedtindhold reducerede maravirocs Cmax og AUC med 33% hos raske frivillige forsøgspersoner.
Coadministration of a 300 mg tablet with a high fat breakfast reduced maraviroc Cmax and AUC by 33% in healthy volunteers.
Der var ingen resitriktioner med hensyn til fødeindtagelse i forsøgene, der demonstrerede sikkerhed og effekt af maraviroc (se pkt.
There were no food restrictions in the studies that demonstrated the efficacy and safety of CELSENTRI (see section 5.1).
4. 2).
Therefore, CELSENTRI can be taken with or without food at the recommended doses (see section 4.2).
76%), og udviser moderat affinitet til albumin og alfa- 1 glycoproteinsyre.
Distribution: maraviroc is bound (approximately 76%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
194 l.
The volume of distribution of maraviroc is approximately 194 L.
Forsøg med mennesker og in vitro- forsøg, hvor der anvendes humane levermikrosomer og udtrykte enzymer viste, at maraviroc fortrinsvis metaboliseres af cytochrom P450- systemet til metabolitter, der er essentielt inaktive over for HIV- 1.
14 Metabolism: studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system to metabolites that are essentially inactive against HIV-1.
In vitro- forsøg tyder på, at CYP3A4 er et vigtigt enzym for maravirocs metabolisme.
In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
In vitro- forsøg tyder også på, at polymorfiske enzymer som CYP2C9, CYP2D6 og CYP2C19 ikke signifikant medvirker til maravirocs metabolisme.
In vitro studies also indicate that polymorphic enzymes CYP2C9, CYP2D6 and CYP2C19 do not contribute significantly to the metabolism of maraviroc.
42% radioaktivitet) efter en enkelt oral dosis på 300 mg.
Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.
22% radioaktivitet), der er dannet ved N- dealkylering.
The most significant circulating metabolite in humans is a secondary amine (approximately 22% radioactivity) formed by N-dealkylation.
Andre metabolitter er produkter af mono- oxidation og er kun mindre komponenter med plasmaradioaktivitet.
Other metabolites are products of mono-oxidation and are only minor components of plasma radioactivity.
Der er udført et massebalance/ ekskretionsforsøg med en enkeltdosis på 300 mg 14C - mærket maraviroc.
Elimination: a mass balance/ excretion study was conducted using a single 300 mg dose of 14C-labeled maraviroc.
20% af det radioaktivt mærkede stof genfundet i urinen, og 76% blev genfundet i fæces.
Approximately 20% of the radiolabel was recovered in the urine and 76% was recovered in the faeces over 168 hours.
Maraviroc var den væsentligste komponent i urin (gennemsnit på 8% dosis) og i fæces (gennemsnit på 25% dosis).
Maraviroc was the major component present in urine (mean of 8% dose) and faeces (mean of 25% dose).
Efter en intravenøs administration (30 mg) var maravirocs halveringstid 13, 2 timer, 22% af dosis blev udskilt uændret i urinen, total- clearance var 44, 0 l/ time og renal clearance var 10, 17 l/ time.
After intravenous administration (30 mg), the half-life of maraviroc was 13.2 h, 22% of the dose was excreted unchanged in the urine and the values of total clearance and renal clearance were 44.0 L/ h and 10.17 L/ h respectively.
4. 2).
Children: the pharmacokinetics of maraviroc in paediatric patients have not been established (see section 4.2).
Der er udført populationsanalyser af fase 1/ 2a og fase 3 forsøgene (16- 65 år), og der er ikke fundet nogen påvirkning, som kan tilskrives alder (se pkt. 4. 2).
Elderly: population analysis of the Phase 1/ 2a and Phase 3 studies (16-65 years of age) has been conducted and no effect of age has been observed (see section 4.2).
Maravirocs farmakokinetik er ikke undersøgt hos patienter med nedsat nyrefunktion.
Renal impairment: the pharmacokinetics of maraviroc have not been studied in patients with renal impairment.
Renal clearance bidrager dog med < 25% af maravirocs total- clearance i fravær af CYP3A4- hæmmere, hvorfor maravirocs elimination kun påvirkes minimalt af nedsat nyrefunktion.
However, renal clearance contributes less than 25% of maraviroc total clearance in the absence of CYP3A4 inhibitors, therefore the impact of renal impairment on maraviroc elimination should be minimal.
4. 2 og 4. 4).
In the presence of metabolic inhibitors, renal clearance may account for up to 70% of total clearance of maraviroc and hence renal impairment may result in increased maraviroc exposures in this case (see sections 4.2 and 4.4).
Maraviroc metaboliseres og elimineres primært i leveren.
Hepatic impairment: maraviroc is primarily metabolized and eliminated by the liver.
Et forsøg sammenlignede farmakokinetikken af en enkeltdosis på 300 mg CELSENTRI hos patienter med mild (Child- Pugh klasse A, n=8) og moderat (Child- Pugh klasse B, n=8) nedsat leverfunktion og hos raske forsøgspersoner (n=8).
A study compared the pharmacokinetics of a single 300 mg dose of CELSENTRI in patients with mild (Child- Pugh Class A, n=8), and moderate (Child-Pugh Class B, n=8) hepatic impairment compared to healthy subjects (n=8).
16 11% og 25% højere for forsøgspersoner med mild nedsat leverfunktion, og henholdsvis 32% og 46% højere for forsøgspersoner med moderat nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion.
Geometric mean ratios for Cmax and AUClast were 11% and 25% higher respectively for subjects with mild hepatic impairment, and 32% and 46% higher respectively for subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
4. 2 og 4. 4).
The pharmacokinetics of maraviroc have not been studied in subjects with severe hepatic impairment (see sections 4.2 and 4.4).
Der er ikke observeret relevante forskelle mellem hvide, asiater og sorte forsøgspersoner.
Race: no relevant difference between Caucasian, Asian and Black subjects has been observed.
Der er ikke observeret relevant forskel i farmakokinetikken.
Gender: no relevant differences in pharmacokinetics have been observed.
Primær farmakologisk aktivitet (CCR5- receptoraffinitet) er tilstede hos aber (100% receptorokkupation) og begrænset hos mus, rotter, kaniner og hunde.
Primary pharmacological activity (CCR5 receptor affinity) was present in the monkey (100% receptor occupancy) and limited in the mouse, rat, rabbit and dog.
Hos mus og mennesker, der mangler CCR5- receptorer gennem genetisk udeladelse, blev der ikke rapporteret om signifikante, betydende bivirkninger.
In mice and human beings that lack CCR5 receptors through genetic deletion, no significant adverse consequences have been reported.
In vitro - og in vivo- forsøg viser, at maraviroc har et potentiale for at øge QTc- intervallet ved supraterapeutiske doser uden tegn på arrytmi.
15 In vitro and in vivo studies showed that maraviroc has a potential to increase QTc interval at supratherapeutic doses with no evidence of arrhythmia.
Gentagne dosistoksicitetsforsøg hos rotter identificerede leveren som primært målorgan for toksicitet (stigning i transaminaser, galdegang- hyperplasi, nekrose).
Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, necrosis).
Maraviroc er undersøgt for karcinogenicitet i dyreforsøg af 6 måneders varighed med transgene mus og af 24 måneders varighed med rotter.
Maraviroc was evaluated for carcinogenic potential by a 6 month transgenic mouse study and a 24 month study in rats.
Hos mus ses ingen statistisk signifikant stigning i hyppigheden af tumorer ved en systemisk eksponering fra 7- 39 gange den humane eksponering (ubundet AUC0- 24 timers måling) ved en dosis på 300 mg 2 gange dagligt.
In mice, no statistically significant increase in the incidence of tumors was reported at systemic exposures from 7 to 39-times the human exposure (unbound AUC 0-24h measurement) at a dose of 300 mg twice daily.
I et forsøg med rotter ved en systemisk eksponering, der er mindst 15 gange den forventede humane dosis, blev der rapporteret cholangiocarcinom (2/ 60 hanner ved 900 mg/ kg) og cholangiom (1/ 60 hunner ved 500 mg/ kg).
In addition, cholangiocarcinomas (2/ 60 males at 900 mg/ kg) and cholangioma (1/ 60 females at 500 mg/ kg) were reported in the rat study at a systemic exposure at least 15-times the expected free human exposure.
Maraviroc er ikke mutagent eller genotoksisk i en række in vitro - og in vivo- forsøg, herunder bakteriel revers- mutationstest, kromosomafvigelser i humane lymfocytter og rotte- knoglemarv- micronucleus.
Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and rat bone marrow micronucleus.
Maraviroc forringer ikke parringen eller fertiliteten hos han - eller hunrotter, og det påvirker ikke spermen hos rotter, der er behandlet med doser op til 1000 mg/ kg.
Maraviroc did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats up to 1000 mg/ kg.
Denne dosiseksponering svarer til 39 gange det estimerede frie kliniske AUC med en dosis på 300 mg 2 gange dagligt.
The exposure at this dose level corresponded to 39-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Der er udført dyreforsøg for embryoets/ fostrets udvikling med rotter og kaniner i doser op til 39 og 34 gange det estimerede frie kliniske AUC med en dosis på 300 mg 2 gange dagligt.
Embryofoetal development studies were conducted in rats and rabbits at doses up to 39- and 34-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Hos kaniner havde 7 fostre ydre misdannelser ved administration af dosis som var toksisk for moderdyret, og 1 foster havde misdannelse ved en middeldosis på 75 mg/ kg.
In rabbit, ,7 foetuses had external anomalies at maternally toxic doses and 1 foetus at the mid dose of 75 mg/ kg.
Der er udført præ - og postnatale udviklingsforsøg i rotter i doser op til 27 gange det estimerede frie kliniske AUC ved en dosis på 300 mg 2 gange dagligt.
Pre- and post-natal developmental studies were performed in rats at doses up to 27-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Der ses en lille stigning i den motoriske aktivitet i høj- dosis hanrotter ved både fravænning og som voksne, mens der ikke ses påvirkninger hos hunnerne.
A slight increase in motor activity in high-dose male rats at both weaning and as adults was noted, while no effects were seen in females.
Tabletkerne Cellulose, mikrokrystallinsk Calciumhydrogenphosphat, vandfrit Natriumstivelsesglycolat Magnesiumstearat
Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate
Polyvinylalkohol Titandioxid Macrogol 3350 Talcum Sojalecithin Indigocarmin (E132)
Poly (vinyl alcohol) Titanium dioxide Macrogol 3350 Talc Soya Lecithin Indigo carmine aluminium lake (E132)
6. 3 Opbevaringstid
16 6.3 Shelf life
High density polyethylenbeholder (HDPE) med børnesikret polypropylenlåg og med en aluminiumsfolie/ polyethylen varmeinduceret forsegling, der indeholder 180 filmovertrukne tabletter.
High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/ polyethylene heat induction seal containing 180 film-coated tablets.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
CELSENTRI 300 mg filmovertrukne tabletter.
CELSENTRI 300 mg film-coated tablets.
Hver tablet indeholder 300 mg maraviroc.
Each film-coated tablet contains 300 mg of maraviroc.
Hver 300 mg filmovertrukken tablet indeholder 1, 68 mg sojalechitin.
Excipients Each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Blå, bikonvekse, ovale filmovertrukne tabletter, der er præget med ” Pfizer ” på den ene side og” MVC 300 ” på den anden side.
Blue, biconvex, oval film-coated tablets debossed with “ Pfizer” on one side and “ MVC 300” on the other.
20 Børn:
Children:
Derfor bør CELSENTRI gives med forsigtighed til denne patientgruppe.
18 Elderly: there is limited experience in patients > 65 years of age (see section 5.2), therefore CELSENTRI should be used with caution in this population.
CELSENTRI bør kun anvendes hos patienter smittet kun med HIV- 1 - virus med verificeret CCR5 - tropisme (dvs.
CELSENTRI should only be used when only CCR5-tropic HIV-1 is detectable (i. e.
21 Baggrundsresistens over for andre klasser af antiretrovirale produkter har vist sig at være den samme hos tidligere ikke påvist CXCR4- tropisme virus hos den lave viralpopulation, som det, der blev fundet i CCR5- tropisme virus.
Background resistance to other classes of antiretrovirals have been shown to be similar in previously undetected CXCR4-tropic virus of the minor viral population, as that found in CCR5-tropic virus.
Patienter skal informeres om, at antiretrovirale lægemidler, herunder CELSENTRI, ikke forebygger risikoen for at overføre HIV til andre gennem seksuel kontakt eller blodkontaminering.
19 Information for patients: patients should be advised that antiretroviral therapies including CELSENTRI have not been shown to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
22 Seponering af behandling bør overvejes hos patienter, der viser tegn og symptomer på akut hepatitis, især ved mistænkt lægemiddelrelateret overfølsomhed eller ved stigning i levertransaminaserne kombineret med udslæt eller systemiske symptomer på mulig overfølsomhed (f. eks. kløende udslæt, eosinofili eller stigning i IgE).
Discontinuation of CELSENTRI should be considered in any patient with signs or symptoms of acute hepatitis, in particular if drug-related hypersensitivity is suspected or with increased liver transaminases combined with rash or other systemic symptoms of potential hypersensitivity (e. g. pruritic rash, eosinophila or elevated IgE).
4. 2 og 5. 2).
20 There is limited experience in patients with reduced hepatic function, therefore CELSENTRI should be used with caution in this population (see sections 4.2 and 5.2).
23 maraviroc.
Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors.
In vitro- resultater tyder på, at maraviroc kan hæmme P - glycoprotein i tarmen, og dette kan måske påvirke biotilgængeligheden af visse lægemidler.
In vitro results indicate that maraviroc could inhibit P- glycoprotein in the gut and may thus affect bioavailability of certain drugs..
Interaktioner og dosisanbefalinger med andre lægemidler Lægemiddel efter terapeutisk område (dosis af CELSENTRI anvendt i studier) ANTIINFEKTIVA Antiretrovirale NRTI
Medicinal product by therapeutic areas (dose of CELSENTRI used in study) ANTI-INFECTIVES Antiretrovirals NRTIs
Lamivudin 150 mg 2 gange dagligt (maraviroc 300 mg 2 gange dagligt)
Lamivudine 150 mg BID (maraviroc 300 mg BID)
24 Saquinavir/ ritonavir 1000 mg/ 100 mg 2 gange dagligt (maraviroc 100 mg 2 gange dagligt)
Saquinavir/ ritonavir 1000 mg/ 100 mg BID (maraviroc 100 mg BID)
Der findes begrænset dokumentation for samtidig administration med nelfinavir.
administration with nelfinavir.
Methadon
23
Ikke undersøgt.
ribavirin can be coadministered without dose adjustment.
4. 8 Bivirkninger
24 4.8 Undesirable effects
De klinisk betydende bivirkninger, som forekom hos under 1% af voksne patienter, der fik CELSENTRI, i fase 3- forsøgene Systemorganklasser Hjerte
Clinically important adverse reactions occurring in less than 1% of adult patients receiving CELSENTRI in Phase 3 studies
pancytopeni, neutropeni, lymfadenopati
System Organ Class Cardiac disorders
28 Nervesystemet
Frequency uncommon
ikke almindelige
25 ischaemia
respirationsbesvær, bronkospasmer
Blood and lymphatic system disorders
pancreatitis, rektalblødning
Nervous system disorders
Nyrer og urinvej
uncommon
Knogler, led, muskler og bindevæv
respiratory distress, bronchospasm
Laboratorieabnormaliteter Tabel 5 viser hyppigheden ≥1% af grad 3- 4 abnormiteter (ACTG- kriterier) baseret på den maksimale grænse i laboratorieværdier uden hensyn til baselineværdier.
Laboratory abnormalities Table 5 shows the incidence ≥ 1% of Grade 3-4 Abnormalities (ACTG Criteria) based on the maximum shift in laboratory test values without regard to baseline values.
Hyppigheden ≥1% af grad 3- 4 abnormaliteter (ACTG- kriterier) baseret på den maksimale grænse i laboratorieværdier uden hensyn til baseline forsøg MOTIVATE 1 og MOTIVATE 2 (poolede analyser op til 48 uger)
Incidence ≥ 1% of grade 3-4 abnormalities (ACTG criteria) based on maximum shift in laboratory test values without regard to baseline studies MOTIVATE 1 and MOTIVATE 2 (pooled analysis, up to 48 weeks)
Der er set forlænget QT- interval hos hunde og aber ved plasmakoncentrationer, der er henholdsvis 6 gange og 12 gange højere end dem, der er set hos mennesker ved den maksimalt anbefalede dosis på
Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the maximum recommended dose of 300 mg twice daily.
Der er ingen specifik antidot for overdosering med CELSENTRI.
26 There is no specific antidote for overdose with CELSENTRI.
Positionen af disse mutationer er ikke konsistente mellem
Genotypic resistance: mutations were found to accumulate in the gp120 envelope glycoprotein (the viral protein that binds to the CCR5 co-receptor).
30 forskellige isolater.
The position of these mutations was not consistent between different isolates.
31 Kliniske resultater
Clinical Results
Den kliniske effekt af CELSENTRI (i kombination med andre antiretrovirale lægemidler) på plasma - HIV- RNA- koncentrationer og CD4+- celletal er undersøgt i to igangværende, pivotale, randomiserede, dobbeltblindede, multicenterforsøg (MOTIVATE- 1 og MOTIVATE- 2, n=1076) hos patienter inficeret med CCR5- tropisme HIV- 1 virus, bestemt ved Monogram Trofile- assay.
The clinical efficacy of CELSENTRI (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal ongoing, randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
N=426
Age (years)
N=209
N
Alder (år)
= 426 46.3
45, 7
N = 209 45.7
(interval, år)
(Range, years)
85, 2% / 12% / 2, 8 4, 85
12% / 2.8% 4.85 166.8
Median baseline CD4+- celletal (celler/ mm3) (interval, celler/ mm3) Screening, viralbelastning > 100, 000 kopier/ ml
Screening Viral Load > 100,000 copies/ mL
166, 8 (2, 0- 820, 0) 179 (42, 0%)
179 (42.0%)
171, 3 (1, 0- 675, 0) 84 (40, 2%)
84 (40.2%)
alene
OBT alone
(konfidens- interval2)
Treatment Difference1 (Confidence Interval2)
HIV- 1 RNA
HIV-1 RNA
Ændring fra baseline (celler/ mm3) 1 p- værdi < 0, 0001 2
Change from baseline (cells/ mm3) 1 p-values < 0.0001 2
For alle effektendepunkter var konfidensintervallet 95%, undtagen for HIV- 1 RNA, hvor ændring fra baseline var 97, 5%
For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline which was 97.5%
CELSENTRI 300 mg 2 gange dagligt + OB var bedre end OB alene i alle undergrupper af patientanalyser (se tabel 8).
29 CELSENTRI 300 mg twice daily + OBT was superior to OBT alone across all subgroups of patients analysed (see Table 8).
Antal aktive ARV i OBT:
Number of active ARVs in OBT1,2:
Forsøg A4001029 er et eksplorativt forsøg med patienter inficeret med dual/ mixed eller CXCR4 - tropisme HIV- 1 med et lignende design som forsøgene MOTIVATE- 1 og MOTIVATE - 2.
Study A4001029 was an exploratory study in patients infected with dual/ mixed or CXCR4 tropic HIV-1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Der blev hverken vist forbedring eller non- inferioritet til OB alene i dette forsøg, skønt der ikke var negativt resultat af viralbelastning eller CD4+- celletal.
In this study, neither superiority nor non-inferiority to OBT alone were demonstrated although there was no adverse outcome on viral load or CD4+ cell count
33 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties