natgillin/translations-raw huggingface dataset:
Vurderingen af de behandlingsrelaterede bivirkninger bygger på poolede data fra CCR5- tropisme HIV- 1 inficerede patienter, der fik den anbefalede dosis i to fase 3- forsøg (MOTIVATE- 1 og MOTIVATE- 2).
Assessment of treatment related adverse reactions is based on pooled data at the recommended dose from two Phase 3 studies (MOTIVATE 1 and MOTIVATE 2) in CCR5-tropic HIV-1 infected patients.
De hyppigst rapporterede bivirkninger, der ses i fase 3- forsøgene ved anbefalet dosis uanset hyppighed sammenlignet med optimal baggrundsbehandling (OB) alene, er diarré, kvalme og
The most frequently reported adverse reactions occurring in the Phase 3 studies at the recommended dose regardless of the incidence compared to OBT alone were diarrhoea, nausea and headache.
Disse bivirkninger var almindelige (≥ 1/ 100 til < 1/ 10).
These adverse reactions were common (≥ 1/ 100 to < 1/ 10).
De rapporterede frekvenser for disse bivirkninger samt seponeringsraten på grund af bivirkninger var den samme for de patienter, der fik CELSENTRI 300 mg 2 gange dagligt + optimal baggrundsbehandling (OB) sammenlignet med dem, der fik OB alene.
The reported frequencies for these events as well as the rates of discontinuation due to any adverse reactions were similar in patients receiving CELSENTRI 300 mg twice daily + OBT (Optimised Background Therapy) compared to those receiving OBT alone.
Frekvenserne er defineret som meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10) og ikke almindelig (≥1/ 1000 til < 1/ 100).
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1000 to < 1/ 100).
Bivirkningerne og laboratorieabnormaliteterne, der er anført nedenfor, er ikke justeret med hensyn til eksponering.
The adverse reactions and laboratory abnormalities presented below are not exposure adjusted.
Nedenstående tabel viser de bivirkninger, der forekommer med en numerisk højere rate blandt patienter, der får CELSENTRI 300 mg 2 gange dagligt + OB end patienter, der får OB alene med en hyppighed på ≥1%.
The following table presents adverse reactions occurring at a numerically higher rate among patients receiving CELSENTRI 300 mg twice daily + OBT than patients on OBT alone with an incidence of ≥ 1%.
Bivirkninger, der forekommer med en numerisk højere rate blandt patienter, der får CELSENTRI 300 mg 2 gange dagligt + OB end patienter, der får OB alene med en hyppighed på ≥1%.
Adverse reactions occurring at a numerically higher rate among patients receiving CELSENTRI 300 mg twice daily + OBT than patients on OBT alone with an incidence of ≥ 1%
Systemorganklasse Undersøgelser
System Organ Class Investigations
Bivirkninger stigning i alanin- aminotransferase, stigning i aspartat- aminotransferase, stigning i gamma- glutamyltransferase, vægttab
Adverse Reaction alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, weight decreased
Frekvens almindelige
Frequency common
svimmelhed, paræstesi, dysgeusi, søvnighed
dizziness, paraesthesia, dysgeusia, somnolence
almindelige
common
opkastning, abdominalsmerte, abdominal distension, dyspepsi, obstipation
vomiting, abdominal pain, abdominal distension, dyspepsia, constipation
udslæt, pruritus
rash, pruritus
muskelspasmer, rygsmerter
muscle spasms, back pain
asteni
Asthenia
søvnløshed
Insomnia
De klinisk betydende bivirkninger, som forekom hos under 1% af voksne patienter, der fik CELSENTRI, i fase 3- forsøgene er anført nedenfor.
Clinically important adverse reactions occurring in less than 1% of adult patients receiving CELSENTRI in Phase 3 studies are presented below.
De klinisk betydende bivirkninger, som forekom hos under 1% af voksne patienter, der fik CELSENTRI, i fase 3- forsøgene Systemorganklasser
Clinically important adverse reactions occurring in less than 1% of adult patients receiving CELSENTRI in Phase 3 studies
myokardieinfarkt, myokardieiskæmi
System Organ Class Cardiac disorders
ikke almindelige
Adverse Reaction myocardial infarction, myocardial
Blod - og lymfesystem
Frequency uncommon
ikke almindelige
9 ischaemia
10 lymfadenopati Nervesystemet
Blood and lymphatic system disorders
ikke almindelige
pancytopenia, neutropenia, lymphadenopathy
Luftveje, thorax og mediastinum
uncommon
respirationsbesvær, bronkospasmer
Nervous system disorders
ikke almindelige
loss of consciousness, epilepsy, petit mal epilepsy, convulsion, facial palsy, polyneuropathy, areflexia
Mave- tarmkanalen
uncommon
ikke almindelige
Respiratory, thoracic and Mediastinal disorders
ikke almindelige
respiratory distress, bronchospasm
myositis
uncommon
Infektioner og parasitære sygdomme
Gastrointestinal disorders Renal and urinary disorders Musculoskeletal and connective tissue disorders
ikke almindelig
pancreatitis, rectal haemorrhage renal failure, polyuria Myositis
hepatisk cirrhose
uncommon uncommon uncommon
Psykiske forstyrrelser
Infections and infestations Hepatobiliary disorders Psychiatric disorders
hallucinationer
Pneumonia hepatic cirrhosis Hallucination
ikke almindelig
uncommon uncommon uncommon
4. 4).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Laboratorieabnormaliteter Tabel 5 viser hyppigheden ≥1% af grad 3- 4 abnormaliteter (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 abnormiteter (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)
OB
OBT
2 gange dagligt + OB
twice daily + OBT
alene
alone
N=421 * (%)
=421* (%)
N=207 * (%)
=207* (%)
Aspartataminotransferase Alaninaminotransferase Total bilirubin Amylase Lipase Absolut neutrofiltal ULN:
Aspartate aminotransferase Alanine aminotransferase Total bilirubin Amylase Lipase Absolute neutrophil count ULN:
Den øvre referenceværdi
Upper Limit of Normal
> 5, 0 x ULN > 5, 0 x ULN > 5, 0 x ULN > 2, 0 x ULN > 2, 0 x ULN < 750/ mm3
> 5.0x ULN > 5.0x ULN > 5.0x ULN > 2.0x ULN > 2.0x ULN < 750/ mm3
* Procent baseret på total antal patienter evalueret for hver laboratorieparameter
* Percentages based on total patients evaluated for each laboratory parameter
Der er rapporteret tilfælde af osteonekrose især hos patienter med bekræftede risikofaktorer, avanceret HIV- sygdom eller langtidsbehandling med antiretroviral kombinationsbehandling (CART).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
1200 mg var den højeste dosis, som blev givet i kliniske forsøg.
The highest dose administered in clinical studies was 1200 mg.
11 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 300 mg 2 gange dagligt.
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.
Heller ikke i det specifikke farmakokinetiske forsøg, hvor CELSENTRIs potentiale til at forlænge QT- intervallet blev vurderet, blev der set klinisk signifikant QT- forlængelse.
However, no clinically significant QT prolongation compared to OBT alone was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of CELSENTRI to prolong the QT interval.
Der er ingen specifik antidot for overdosering med CELSENTRI.
10 There is no specific antidote for overdose with CELSENTRI.
Hvis nødvendigt bør ikke- absorberet aktivt maraviroc elimineres ved opkastning eller ventrikelskylning.
If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage.
Administration af aktivt kul kan også anvendes til at fjerne ikke- absorberet aktivt stof.
Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
ATC - kode:
Antivirals for systemic use, Other Antivirals ATC code:
Maraviroc tilhører en terapeutisk gruppe, som kaldes CCR5- antagonister.
Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Maraviroc bindes selektivt til human kemokin- receptor CCR5, idet den forhindrer CCR5- tropisme HIV- 1 i at komme ind i cellerne.
Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
In vitro har maraviroc ingen aktivitet mod virus, der bruger CXCR4 som deres indtrædende co - receptor (dual- tropisme eller CXCR4- tropisme, der tilsammen benævnes CXCR4- using virus, se nedenfor).
Maraviroc has no antiviral activity in vitro against viruses which can use CXCR4 as their entry co- receptor (dual-tropic or CXCR4-tropic viruses, collectively termed ‘ CXCR4-using’ virus below).
Den serum- justerede EC90- værdi hos 43 primære HIV- 1 kliniske isolater var 0, 57 (0, 06 - 10, 7) ng/ ml uden signifikante ændringer mellem forskellige undersøgte undertyper.
The serum adjusted EC90 value in 43 primary HIV-1 clinical isolates was 0.57 (0.06 – 10.7) ng/ mL without significant changes between different subtypes tested.
Den antivirale aktivitet af maraviroc mod HIV- 2 er ikke vurderet.
The antiviral activity of maraviroc against HIV-2 has not been evaluated.
For yderligere information henvises til http: // www. emea. europa. eu/ htms/ human/ epar/ eparintro.
For details please refer to http: / /www. emea. europa. eu/ htms/ human/ epar/ eparintro.
I cellekultur var kombinationen af maraviroc og andre antiretrovirale lægemidler ikke antagonistisk med en række NRTI, NNRTI, proteasehæmmere eller HIV- fusionshæmmeren enfuvirtid.
When used with other antiretroviral medicinal products in cell culture, the combination of maraviroc was not antagonistic with a range of NRTIs, NNRTIs, PIs or the HIV fusion inhibitor enfuvirtide.
Viral flugt fra maraviroc kan ske via 2 veje: selektering af virus, som anvender CXCR4 som deres co - receptor (CXCR4- using virus), eller selektering af virus, der fortsætter med udelukkende at bruge CCR5 (CCR5- tropisme virus).
Viral escape from maraviroc can occur via 2 routes: the selection of virus which can use CXCR4 as its entry co-receptor (CXCR4-using virus) or the selection of virus that continues to use exclusively CCR5 (CCR5-tropic virus).
HIV- 1- varianter med nedsat følsomhed over for maraviroc er udvalgt in vitro efter seriepassage af to CCR5- tropisme virus (0 laboratoriestammer, 2 kliniske isolater).
HIV-1 variants with reduced susceptibility to maraviroc have been selected in vitro, following serial passage of two CCR5-tropic viruses (0 laboratory strains, 2 clinical isolates).
Maraviroc- resistent virus forbliver CCR5- tropisme, og der er ingen konversion fra CCR5- tropisme virus til CXCR4- using virus.
The maraviroc-resistant viruses remained CCR5-tropic and there was no conversion from a CCR5-tropic virus to a CXCR4- using virus.
Koncentrationsresponskurver for maraviroc- resistent virus er fænotypisk karakteriseret ved kurver, der ikke når 100% hæmning ved analyser, når der anvendes fortyndingsserier af maraviroc.
Phenotypic resistance: concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc.
Traditionel IC50/ IC90 gange ændring er ikke en nyttig parameter til at måle fænotypisk resistens, da disse værdier nogle gange er uændret til trods for signifikant reduceret følsomhed.
Traditional IC50/ IC90 fold-change was not a useful parameter to measure phenotypic resistance, as those values were sometimes unchanged despite significantly reduced sensitivity.
Mutationer ser ud til at akkumulere i gp120- kappe- glycoprotein (viralt protein som bindes til CCR5 co- receptor).
Genotypic resistance: mutations were found to accumulate in the gp120 envelope glycoprotein (the viral protein that binds to the CCR5 co-receptor).
Relevansen af disse mutationer over for maraviroc- følsomhed i andre virus er ikke kendt.
Hence, the relevance of these mutations to maraviroc susceptibility in other viruses is not known.
HIV- 1 kliniske isolater, der er resistente over for nucleosid- analog reverse transcriptase- hæmmere (NRTI), non- nucleosid- analog reverse transcriptase- hæmmere (NNRTI), proteasehæmmere (PI) og enfuvirtid var alle følsomme over for maraviroc i cellekulturer.
HIV-1 clinical isolates resistant to nucleoside analogue reverse transcriptase inhibitors (NRTI), non- nucleoside analogue reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI) and enfuvirtide
Maraviroc- resistente virus, der opstår in vitro forbliver følsomme over for fusionshæmmeren enfuvirtid og proteasehæmmeren saquinavir.
Maraviroc-resistant viruses that emerged in vitro remained sensitive to the fusion inhibitor enfuvirtide and the protease inhibitor saquinavir.
Behandlings- naive patienter Resistensprofilen hos behandlings- naive patienter er ikke karakteriseret.
Treatment naïve patients The resistance profile in treatment-naïve patients has not been characterized.
Behandlingserfarne patienter I de pivotale forsøg (MOTIVATE- 1 og MOTIVATE- 2) fik 7, 6% af patienterne ændring i tropismeresultatet fra CCR5- tropisme til CXCR4- tropisme eller dual/ mixed- tropisme mellem screening og baseline (en periode på 4- 6 uger).
Treatment experienced patients In the pivotal studies (MOTIVATE 1 and MOTIVATE 2), 7.6% of patients had a change in tropism result from CCR5-tropic to CXCR4-tropic or dual/ mixed-tropic between screening and baseline (a period of 4-6 weeks).
Ved behandlingssvigt blev CXCR4- using virus påvist hos ca.
Failure with CXCR4-using virus:
60% af forsøgspersonerne, som havde behandlingssvigt med CELSENTRI, sammenlignet med 6% af forsøgspersonerne, som havde behandlingssvigt i OB- gruppen alene.
CXCR4-using virus was detected at failure in approximately 60% of subjects who failed treatment on CELSENTRI, as compared to 6% of subjects who experienced treatment failure in the OBT alone arm.
For at undersøge den sandsynlige oprindelse af på- behandling CXCR4- using virus blev en detaljeret klonal- analyse udført på virus hos 20 repræsentative forsøgspersoner (16 forsøgspersoner fra CELSENTRI- gruppen og 4 forsøgspersoner fra OB- gruppen).
To investigate the likely origin of the on-treatment CXCR4-using virus, a detailed clonal analysis was conducted on virus from 20 representative subjects (16 subjects from the CELSENTRI arms and 4 subjects from the OBT alone arm) in whom CXCR4-using virus was detected at treatment failure.
Denne analyse tyder på, at CXCR4- virus opstår fra et præ- eksisterende CXCR4- using reservoir, som ikke blev påvist ved baseline, snarere end fra en mutation af CCR5- tropisme virus, som var til stede ved baseline.
This analysis indicated that CXCR4-virus emerged from a pre-existing CXCR4-using reservoir not detected at baseline, rather than from mutation of CCR5-tropic virus present at baseline.
En analyse af tropisme efter behandlingssvigt med CELSENTRI med CXCR4- using virus viste, at viruspopulationen vendte tilbage til CCR5- tropisme hos størstedelen af patienterne ved opfølgning af patienterne efter afbrydelse af CELSENTRI.
An analysis of tropism following failure of CELSENTRI therapy with CXCR4 -using virus, demonstrated that the virus population reverted back to CCR5 tropism in the majority of patients during follow up after discontinuation of CELSENTRI.
14 patienter fortsatte med at have detekterbar CXCR4- using virus.
Out of 44 patients studied, the virus population in 30 reverted back to exclusively CCR5-tropism during a median follow-up of 203 days; 14 patients continued to have detectable CXCR4 -using virus.
Opfølgningsperioden hos disse patienter var imidlertid kortere (median 16 dage).
However, the follow-up period in these patients were shorter (median 16 days).
Baseret på tilgængelige data for tidspunkt for behandlingssvigt med CXCR4- using virus, viser resistensmønsteret for andre antiretrovirale præparater at være det samme som for CCR5- tropisme populationen ved baseline.
At time of failure with CXCR4-using virus, the resistance pattern to other antiretrovirals appears similar to that of the CCR5-tropic population at baseline, based on available data.
Ved selektering af behandlingsregimer bør det derfor antages, at virus, som er en del af den hidtil ikke- detekterede del af CXCR4- using populationen (dvs. lav viralpopulation), har samme resistensmønster som CCR5- tropisme population.
Hence, in the selection of a treatment regimen, it should be assumed that viruses forming part of the previously undetected CXCR4 -using population (i. e. minor viral population) harbours the same resistance pattern as the CCR5-tropic population.
Fænotypisk resistens:
Failure with CCR5-tropic virus:
Hos patienter med CCR5- tropismevirus på tidspunktet for behandlingssvigt med CELSENTRI havde 22 ud af 58 patienter virus med reduceret følsomhed over for maraviroc.
Phenotypic resistance: in patients with CCR5-tropic virus at time of treatment failure with CELSENTRI, 22 out of 58 patients had virus with reduced sensitivity to maraviroc.
Den sidste gruppe havde markører svarende til lav compliance (lave og variable lægemiddelkoncentrationer og ofte en beregnet høj OBT- score for residualfølsomhed).
The latter group had markers correlating to low compliance (low and variable drug levels and often a calculated high residual sensitivity score of the OBT).
Hos de patienter, der kun havde behandlingssvigt med R5 - virus, kan maraviroc måske stadig betragtes som aktiv, hvis den maksimale procent- hæmningsværdi (MPI) er ≥ 95% (Phenosense Entry assay).
In patients failing therapy with R5-virus only, maraviroc might be considered still active if the maximal percentage inhibition (MPI) value is ≥ 95% (Phenosense Entry assay).
Residualaktiviteten for virus med MPI- værdier < 95% er ikke bestemt in vivo.
Residual activity in vivo for viruses with MPI-values < 95% has not been determined.
Genotypisk resistens:
Genotypic resistance:
Nøglemutationer (V3- loop) kan på nuværende tidspunkt ikke foreslås pga. den høje variabilitet af V3- sekvensen og det lave antal af analyserede prøver.
Key mutations (V3-loop) can presently not be suggested due to the high variability of the V3-sequence, and the low number of samples analysed.
13 Kliniske resultater
Clinical Results
Forsøg med behandlingserfarne patienter med CCR5- tropisme:
Studies in CCR5-tropic Treatment-Experienced Patients:
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.
De patienter, der kunne indgå i forsøget, skulle være behandlet med mindst 3 antiretrovirale lægemiddelklasser [≥1 nucleosid reverse transcriptase- hæmmer (NRTI), ≥1 non- nucleosid reverse transcriptase- hæmmer (NNRTI), ≥2 proteasehæmmere (PI), og/ eller enfurvirtid] eller dokumenteret resistens over for mindst én i hver klasse.
Patients who were eligible for these studies had prior exposure to at least 3 antiretroviral medicinal product classes [≥ 1 nucleoside reverse transcriptase inhibitors (NRTI), ≥ 1 non-nucleoside reverse transcriptase inhibitors (NNRTI), ≥ 2 protease inhibitors (PI), and/ or enfurvirtide] or documented
Patienterne blev randomiseret i forholdet 2: 2: 1, således at de enten fik CELSENTRI 300 mg (dosisækvivalens) 1 gang dagligt, CELSENTRI 300 mg 2 gange dagligt eller placebo i kombination med en optimal baggrundsbehandling (OB), der omfattede 3 til 6 antiretrovirale lægemidler (undtagen lavdosis ritonavir).
Patients were randomised in a 2:2:1 ratio to CELSENTRI 300 mg (dose equivalence) once daily, twice daily or placebo in combination with an optimized background consisting of 3 to 6 antiretroviral medicinal products (excluding low-dose ritonavir).
OB var valgt ud fra patienternes tidligere behandlingsanamnese og genotypisk og fænotypisk viral resistensbestemmelse ved baseline.
The OBT was selected on the basis of the subject’ s prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
Demografiske og baseline karakteristika hos patienter i forsøgene MOTIVATE- 1 og MOTIVATE- 2 (poolede analyser)
Demographic and baseline characteristics of patients in studies MOTIVATE 1 and MOTIVATE 2 (Pooled Analysis)
300 mg 2
300 mg twice daily + OBT
gange dagligt + OB
Age (years)
alene
= 426 46.3
N=426
N
N=209
= 209 45.7
Alder (år) (interval, år) Køn, mænd
(Range, years) Male Sex
46, 3 21- 73 89, 7%
21-73 89.7%
45, 7 29- 72 88, 5%
29-72 88.5%
Race (hvide, sorte, andre) Gennemsnit baseline HIV- 1 RNA (log10 kopier/ ml)
Race (White/ Black/ Other) Mean Baseline HIV-1 RNA (log10 copies/ mL) Median Baseline CD4+ Cell Count (cells/ mm3)
85, 2
85.2% /
% / 12% / 2, 8 4, 85
12% / 2.8% 4.85 166.8
85, 2% / 12, 4% / 2, 4% 4, 86
85.2% /
Median baseline CD4+- celletal
12.4% / 2.4% 4.86 171.3
(celler/ mm3) (interval, celler/ mm3)
(range, cells/ mm3)
(2, 0- 820, 0)
(2.0-820.0)
(1, 0- 675, 0)
(1.0-675.0)
Screening, viralbelastning > 100, 000 kopier/ ml
Screening Viral Load > 100,000 copies/ mL
Baseline CD4+- celletal ≤200 celler/ mm3 Antal patienter (i procent) med GSS- score:
Baseline CD4+ Cell Count ≤ 200 cells/ mm3 Number (Percentage) of patients with GSS score:
0 1 2 ≥3 GeneSeq resistensanalyse
0 1 2 ≥ 3
Der er et begrænset antal patienter af anden etnisk oprindelse end hvide inkluderet i de pivotale forsøg, hvorfor kun begrænsede data er tilgængelig i disse patientpopulationer.
Limited numbers of patients from ethnicities other than Caucasian were included in the pivotal clinical studies, therefore very limited data are available in these patient populations.
Den gennemsnitlige stigning i CD4+- celletal ved baseline hos patienter, som havde manglende effekt af behandlingen og med en ændring i tropismeresultat til dual/ mixed tropisme eller CXCR4 var højere i gruppen, der fik CELSENTRI 300 mg 2 gange dagligt + (OB) (+56 celler/ mm3) end hos de patienter, der havde behandlingssvigt med OB alene (+13, 8 celler/ mm3) uanset tropisme.
The mean increase in CD4+ cell count from baseline in patients who failed with a change in tropism result to dual/ mixed tropic or CXCR4, in the CELSENTRI 300 mg twice daily + OBT (+56 cells/ mm3) group was greater than that seen in patients failing OBT alone (+13.8 cells/ mm3) regardless of tropism.
14 Tabel 7.
Table 7.
Resultater ved 48 ugers randomiseret behandling (poolede data fra forsøgene MOTIVATE- 1 og MOTIVATE- 2)
Outcomes of randomised treatment at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2)
Resultater
HIV-1 RNA
CELSENTRI
Outcomes
alene
OBT alone N=209
2 gange dagligt + OB HIV- 1 RNA
Treatment Difference1 (Confidence Interval2)
- 1, 05
-1.05
(log10 kopier/ ml)
(log10 copies/ mL)
(- 1, 33; - 0, 78)
(-1.33, -0.78)
Andel af patienter med HIV- RNA < 400 kopier/ ml
Proportion of patients with HIV RNA < 400 copies/ ml
Odds ratio:
Odds ratio:
4, 76 (3, 24; 7, 00)
4.76 (3.24, 7.00)
Andel af patienter med HIV- RNA < 50 kopier/ ml CD4+- celletal
Proportion of patients with HIV RNA < 50 copies/ ml CD4+ cell count
4, 49 (2, 96; 6, 83)
4.49 (2.96, 6.83)