natgillin/translations-raw huggingface dataset:
akut nyresvigt, nyresvigt, nephrolitiasis, forhøjet kreatinin i blodet, nedsat kreatininclearance i nyrerne, proteinuri, bilirubinuri
acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, decreased creatinine renal clearance, proteinuria, bilirubinuria
Det reproduktive system og mammae ikke almindelig
Reproductive system and breast disorders uncommon
Almene symptomer og reaktioner på administrationsstedet almindelig
General disorders and administration site conditions common
pyrexi, brystsmerter, perifert ødem, utilpashed, kulderystelse, unormal følelse, varme følelse, irritabel, smerte, tørhed
pyrexia, chest pain, peripheral oedema, malaise, chills, abnormal feeling, feeling hot, irritability, pain, xerosis
pyrexi, brystsmerter, asteni, perifert ødem, utilpashed
pyrexia, chest pain, asthenia, peripheral oedema, malaise
* Bivirkninger der forekommer hos mere end 1 patient samt, og som vurderes som muligvis relaterede til behandlingen med PREZISTA co- administreret med lavdosis ritonavir.
* Adverse events, considered at least possibly related by the investigator to PREZISTA co-administered with low dose ritonavir, occurring in more than 1 patient.
** Bivirkninger med mindst sværhedsgrad 2 der forekommer hos mere end 1 patient, og som vurderes som muligvis relaterede til behandlingen med PREZISTA co - administreret med lavdosis ritonavir.
** Adverse events, at least grade 2 in severity and considered at least possibly related by the investigator to PREZISTA co-administered with low dose ritonavir, occurring in more than 1 patient.
I kliniske forsøg (n=1. 968) forekom udslæt (alle sværhedsgrader og muligt relateret til behandlingen) hos 5, 6% af patienterne, som blev behandlet med PREZISTA.
In clinical trials (n=1,968), rash (all grades, at least possibly related) occurred in 5.6% of patients treated with PREZISTA.
Udslættet var oftest mildt til moderat og ofte forekommende inden for de første fire uger af behandlingen og forsvandt ved fortsat behandling.
Rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing.
Udslæt af sværhedsgrad 2- 4 blev rapporteret hos 2, 9% af patienterne.
Grade 2-4 rash was reported in 2.9% of patients.
0, 5% af de patienter, der fik PREZISTA co- administreret med 100 mg ritonavir, stoppede behandlingen på grund af udslæt.
The discontinuation rate due to rash in patients using PREZISTA co-administered with 100 mg ritonavir was 0.5%.
Der har været rapporter om alvorlige tilfælde af hududslæt, herunder erythema multiforme og Stevens - Johnson syndrom (begge sjældne), i igangværende kliniske forsøg med PREZISTA, co- administreret med 100 mg ritonavir.
Severe cases of skin rash, including erythema multiforme and Stevens-Johnson Syndrome (both rare) have been reported in ongoing clinical trials with PREZISTA co-administered with 100 mg ritonavir.
Sikkerhedsvurderingen af antiretrovirale behandlingsnaive voksne patienter (n=343) er baseret på alle sikkerhedsdata fra fase III- forsøget ARTEMIS, hvor PREZISTA/ ritonavir 800/ 100 mg x 1
The safety assessment in antiretroviral treatment-naïve adult patients (n=343) is based on all safety data from the Phase III trial ARTEMIS comparing PREZISTA/rtv 800/100 mg q.d. versus lopinavir/ritonavir 800/200 mg per day.
Medianeksponeringen hos den gruppe, der fik PREZISTA/ ritonavir, var 56, 3 uger.
Median exposure in the PREZISTA/ritonavir group was 56.3 weeks.
0, 6% af patienterne stoppede behandlingen på grund af bivirkninger.
0.6% of the patients discontinued treatment due to adverse drug reactions.
De følgende bivirkninger blev identificeret hos disse behandlingsnaive patienter:
In these treatment naïve-patients, the following adverse drug reactions were identified:
Bivirkninger rapporteret for mere end én patient og af mindst moderat intensitet Almindelig: hypertriglyceridæmi, hyperkolesterolæmi, hovedpine, diarré, kvalme, forhøjet alanin - aminotranferase.
ADRs of at least moderate intensity and reported in more than one patient Common: hypertriglyceridaemia, hypercholesterolaemia, headache, diarrhoea, nausea, increased alanine aminotransferase.
Ikke almindelig: hyperlipidæmi, opkastning, abdominale smerter, forhøjet aspartat- aminotranferase, udslæt (herunder makulopapuløst udslæt), allergisk dermatitis, kløe.
Uncommon: hyperlipidaemia, vomiting, abdominal pain, increased aspartate aminotransferase, rash (including maculopapular rash), allergic dermatitis, pruritus.
Bivirkninger rapporteret for mere end én patient og af alle sværhedsgrader Meget almindelig: diarré, kvalme.
ADRs of all severity grades and reported in more than one patient Very common: diarrhoea, nausea.
Almindelig: hypertriglyceridæmi, hyperkolesterolæmi, anoreksi, søvnløshed, hovedpine, svimmelhed, dysgeusi, opkastning, abdominale smerter, mavebesvær, abdominal distention, flatulens, forhøjet alanin- aminotranferase, udslæt (herunder makulopapuløst og papuløst udslæt), alopeci, tør hud, kløe, træthed.
Common: hypertriglyceridaemia, hypercholesterolaemia, anorexia, insomnia, headache, dizziness, dysgeusia, vomiting, abdominal pain, abdominal discomfort, abdominal distension, flatulence, increased alanine aminotransferase, rash (including maculopapular, papular rash), alopecia, dry skin, pruritus, fatigue.
Ikke almindelig: infektion i den øvre del af trachea, diabetes mellitus, hyperlipidæmi, unormale drømme, hypoæstesi, opmærksomhedsforstyrrelser, somnolens, dyspepsi, ræben, forhøjet aspartat - aminotranferase, allergisk dermatitis, nældefeber, dermatitis, nattesved, myalgi, muskelspasmer, asteni.
Uncommon: upper respiratory tract infection, diabetes mellitus, hyperlipidaemia, abnormal dreams, hypoaesthesia, disturbance in attention, somnolence, dyspepsia, eructation, increased aspartate aminotransferase, allergic dermatitis, urticaria, dermatitis, night sweats, myalgia, muscle spasms, asthenia.
4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
4. 4).
14 Combination antiretroviral therapy has also been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Der har været rapporter om forhøjet CPK (kreatinkinase), myalgi, myositis og, i sjældne tilfælde, rhabdomyolysis i forbindelse med brug af proteasehæmmere, især i kombination med NRTI’ er.
Increased CPK, myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of protease inhibitors, particularly in combination with NRTIs.
Der er rapporteret tilfælde af osteonekrose, især hos patienter med generelt erkendte risikofaktorer, fremskreden HIV- sygdom eller langtidseksponering for 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).
4. 4).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
4. 4).
There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Patienter co- inficeret med hepatitis B - og/ eller hepatitis C- virus Blandt 1. 968 behandlingserfarne patienter, der fik PREZISTA, co- administreret med ritonavir 600/ 100 mg x 2, havde 236 patienter også hepatitis B eller C.
Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving PREZISTA co-administered with ritonavir 600/100 mg b.i.d., 236 patients were co-infected with hepatitis B or C.
4. 4).
Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Der er kun begrænset erfaring med akut overdosering af PREZISTA, co- administreret med 100 mg ritonavir, hos mennesker.
Human experience of acute overdose with PREZISTA co-administered with 100 mg ritonavir is limited.
Enkeltdoser op til 3. 200 mg darunavir som oral opløsning alene og op til 1. 600 mg som tabletformulering af darunavir i kombination med ritonavir er blevet givet til raske, frivillige forsøgspersoner uden nogen utilsigtede, symptomatiske virkninger.
Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
15 Der findes ingen specifik antidot mod PREZISTA.
There is no specific antidote for overdose with PREZISTA.
Hvis det findes indiceret, kan fjernelse af ikke- absorberet aktivt stof opnås ved at inducere opkastning eller ved ventrikelskylning.
If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage.
Administration af aktivt kul kan også anvendes til at hjælpe med at fjerne ikke- absorberet aktivt stof.
Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Antiviralt stof til systemisk brug, ATC- kode:
Antiviral for systemic use, ATC code:
Virkningsmekanisme Darunavir er en hæmmer af dimer- dannelsen og den katalytiske aktivitet af HIV- 1 proteasen (KD på 4, 5 x 10- 12M).
Mechanism of action Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10-12M).
Det er en selektiv hæmmer af spaltningen af HIV- kodede Gag- Pol polyproteiner i virusinficerede celler, hvorved dannelsen af modne, infektiøse viruspartikler forhindres.
It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Antiviral aktivitet in vitro Darunavir udviser aktivitet mod laboratoriestammer og kliniske isolater af HIV- 1 og laboratoriestammer af HIV- 2 i akut inficerede T- cellelinjer, monocytter fra perifert humant blod og humane monocytter/ makrofager med mediane EC50 værdier fra 1, 2 til 8, 5 nM (0, 7 til 5, 0 ng/ ml).
Antiviral activity in vitro Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/ml).
Darunavir udviser antiviral aktivitet in vitro mod en bred række af HIV- 1 gruppe M (A, B, C, D, E, F, G) og gruppe O primære isolater med EC50- værdier fra < 0, 1 til 4, 3 nM.
Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Disse EC50- værdier ligger et godt stykke under 50% af koncentrationsområdet for cellulær toksicitet på 87 µM til > 100 µM.
These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
EC50værdien for darunavir stiger med en median faktor på 5, 4 ved tilstedeværelse af humant serum.
15 The EC50 value of darunavir increases by a median factor of 5.4 in the presence of human serum.
Darunavir viste synergistisk antiviral aktivitet, når det blev undersøgt i kombination med proteasehæmmerne ritonavir, nelfinavir eller amprenavir og additiv antiviral aktivitet, når det blev undersøgt i kombination med proteasehæmmerne indinavir, saquinavir, lopinavir, atazanavir eller tipranavir, N( t) RTI' erne zidovudin, lamivudin, zalcitabin, didanosin, stavudin, abacavir, emtricitabin eller tenofovir, NNRTI' erne nevirapin, delavirdin eller efavirenz og fusionshæmmeren enfuvirtid.
Darunavir showed synergistic antiviral activity when studied in combination with the protease inhibitors ritonavir, nelfinavir, or amprenavir and additive antiviral activity when studied in combination with the protease inhibitors indinavir, saquinavir, lopinavir, atazanavir, or tipranavir, the N(t)RTIs zidovudine, lamivudine, zalcitabine, didanosine, stavudine, abacavir, emtricitabine, or tenofovir, the NNRTIs nevirapine, delavirdine, or efavirenz and the fusion inhibitor enfuvirtide.
Der blev ikke observeret nogen antagonisme mellem darunavir og nogen af disse antiretrovirale stoffer.
No antagonism was observed between darunavir and any of those antiretrovirals.
Resistens In vitro- selektion af darunavirresistent virus fra vildtype HIV- 1 tog lang tid (> 3 år).
Resistance In vitro selection of darunavir-resistant virus from wild type HIV-1 was lengthy (> 3 years).
De selekterede vira kunne ikke vokse ved tilstedeværelse af darunavir- koncentrationer over 400 nM.
The selected viruses were unable to grow in the presence of darunavir concentrations above 400 nM.
Vira, der blev selekteret under disse betingelser, og som viste reduceret følsomhed over for darunavir (område:
Viruses selected in these conditions and showing decreased susceptibility to darunavir (range:
23 - 50- fold), indeholdt 2 til 4 aminosyresubstitutioner i proteasegenet.
23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Identifikation af determinanter med reduceret følsomhed over for darunavir i disse vira bliver i øjeblikket undersøgt.
Identification of determinants of decreased susceptibility to darunavir in those viruses is under investigation.
In vitro- selektion af darunavirresistent HIV- 1 (område:
In vitro selection of darunavir resistant HIV-1 (range:
53- 641- fold ændring i EC50- værdier [FC]) fra 9 HIV- 1 stammer, der indeholdt multiple PI- resistensassocierede mutationer (RAM) viste, at der krævedes mindst 8 darunavirmutationer, der blev selekteret in vitro, i HIV- 1 proteasen for at gøre en virus resistent (FC > 10) over for darunavir.
53-641-fold change in EC50 values [FC]) from 9 HIV-1 strains harbouring multiple PI Resistance-Associated Mutations (RAMs) showed that a minimum of 8 darunavir in vitro selected mutations were required in the HIV-1 protease to render a virus resistant (FC > 10) to darunavir.
De aminosyresubstitutioner, der udvikledes ved PREZISTA, co- administreret med ritonavir (600/ 100 mg x 2), i ≥ 20% af isolaterne fra forsøgspersoner, der oplevede virologisk svigt ved tilbagefald, blev i den poolede analyse af POWER 1, 2 og 3 (se underafsnit om klinisk erfaring) samt DUET 1 - og 2- forsøgene (TMC125- C206 og TMC125- C216) identificeret til, at være V32I, I54L og L89V.
In a pooled analysis of the POWER 1, 2 and 3 (see Clinical experience subsection) and DUET 1 and 2 (TMC125-C206 and TMC125-C216) trials the amino acid substitutions identified that developed on PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in ≥ 20% of the isolates from subjects who experienced virologic failure by rebound were V32I, I54L and L89V.
Aminosyresubstitutioner, der udvikledes i 10- 20% af isolaterne, var V11I, I13V, L33F, I50V og F53L.
Amino acid substitutions that developed in 10 to 20% of the isolates were V11I, I13V, L33F, I50V and F53L.
Aminosyresubstitutioner, der udvikledes i 5- 10% af isolaterne, var L10F, I15V, M36L, K43T, M46I, I47V, A71I, G73S, T74P, L76V, V82I og I84V.
Amino acid substitutions that developed in 5 to 10% of isolates were L10F, I15V, M36L, K43T, M46I, I47V, A71I, G73S, T74P, L76V, V82I and I84V.
I løbet af behandlingen blev der observeret en udvikling i faldende følsomhed over for darunavir.
Of the viruses isolated from patients experiencing virologic failure by rebound from the PREZISTA/ rtv 600/ 100 mg b. i. d. group of the POWER and DUET trials, 85% of those susceptible to darunavir at baseline developed decreased susceptibility to darunavir during treatment.
16 I den samme gruppe af patienter blev det observeret, at 71% of vira, der var følsomme over for tipranavir ved baseline, forblev følsomme efter behandling.
In the same group of patients, 71% of viruses that were susceptible to tipranavir at baseline remained susceptible after treatment.
Dette viser, at vira, der er resistente over for de fleste PI' er, forbliver følsomme over for darunavir. "
Cross-resistance Darunavir has a < 10-fold decreased susceptibility against 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
Klinisk erfaring Virkning af PREZISTA co- administreret med 100 mg ritonavir hos behandlingsnaive patienter Der foreligger ingen data om virkningen af darunavir, co- administreret med 100 mg ritonavir, hos behandlingsnaive HIV- 1 inficerede patienter.
Clinical experience Efficacy of PREZISTA co-administered with 100 mg ritonavir in treatment-naïve patients There are no data on the efficacy of darunavir co-administered with 100 mg ritonavir in treatment-naïve HIV-1 infected patients.
Virkning af PREZISTA co- administreret med 100 mg ritonavir hos behandlingserfarne patienter Dokumentationen for virkningen af PREZISTA co- administreret med ritonavir (600/ 100 mg x 2), hos behandlingserfarne patienter er baseret på 48 ugers- analysen af fase III- forsøget TITAN hos behandlingserfarne lopinavir- naive patienter og på analysen af 96 ugers data fra fase IIb- forsøgene POWER 1, 2 og 3 hos patienter med høj grad af PI- resistens.
Efficacy of PREZISTA co-administered with 100 mg ritonavir in treatment-experienced patients The evidence of efficacy of PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in treatment-experienced patients is based on the 48 weeks analysis of the Phase III trial TITAN in treatment-experienced lopinavir naïve patients and on the analyses of 96 weeks data from the Phase IIb trials POWER 1, 2 and 3 in patients with high level of PI resistance.
TITAN er et fortløbende randomiseret, kontrollet, åbent fase III- forsøg, der sammenligner PREZISTA co- administeret med ritonavir (600/ 100 mg x 2) med lopinavir/ ritonavir (400/ 100 mg x 2) hos behandlingserfarne, lopinavir- naive voksne patienter HIV- 1 patienter.
TITAN is an ongoing randomised, controlled, open-label Phase III trial comparing PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) versus lopinavir/ritonavir (400/100 mg b.i.d) in treatment-experienced, lopinavir naïve HIV-1 infected adult patients.
Begge behandlingsarme brugte et optimeret baggrundsregime (OBR) bestående af mindst 2 antiretrovirale midler (NRTI’ er med eller uden NNRTI’ er).
Both arms used an Optimised Background Regimen (OBR) consisting of at least 2 antiretrovirals (NRTIs with or without NNRTIs).
Den gennemsnitlige baseline plasma HIV- 1 RNA var 4. 33 log10 kopier/ ml og medianen af baseline CD4+ celletal var 235 x 106 celler/ l (spændvidde 3 – 831 x 106 celler/ l) i PREZISTA/ ritonavir- behandlingsarmen.
The mean baseline plasma HIV-1 RNA was 4.33 log10 copies/ml and the median baseline CD4+ cell count was 235 x 106 cells/l (range 3 – 831 x 106 cells/l) in the PREZISTA/ritonavir arm.
Tabellen nedenfor viser effektdata af 48 ugers- analysen fra TITAN- forsøget.
The table below shows the efficacy data of the 48 week analysis from the TITAN trial.
TITAN Resultat
TITAN
PREZISTA/ ritonavir 600/ 100 mg x 2 + OBR N=298
PREZISTA/rtv 600/100 mg b.i.d. + OBR N=298
lopinavir/ ritonavir Behandlingsdifference 400/ 100 mg x 2 + (95% CI af forskel) OBR N=297
lopinavir/rtv 400/100 mg b.i.d. + OBR N=297
HIV- 1 RNA < 400 kopier/ mla
HIV-1 RNA < 400 copies/mla
199 (67, 0%) 9, 5% (2, 3; 16, 7) b
199 (67.0%)
HIV- 1 RNA < 50 kopier/ mla
HIV-1 RNA < 50 copies/mla
179 (60, 3%) 10, 5% (2, 9; 18, 1) b
179 (60.3%)
HIV- 1 RNA log gennemsnitlig ændring fra baseline (log10 kopier/ ml) c
mean HIV-1 RNA log change from baseline (log10 copies/ml)c
- 1, 95
-1.72
- 1, 72 - 0, 23d (- 0, 44; - 0, 02) b
-0.23d (-0.44; -0.02)b
median CD4+ celletalændring fra baseline (x 106/ l) c a Pålagt ifølge TLOVR- algoritmen b
median CD4+ cell count change from baseline (x 106/l)c a
Baseret på en normal approximation af forskellen i% respons c NC=F d Forskelle i gennemsnit
Imputations according to the TLOVR algorithm b Based on a normal approximation of the difference in% response c NC=F d Difference in means
Non- inferiøritet i virologisk respons, defineret som procentdelen af patienter med plasma HIV- 1 RNA niveau < 400 kopier/ ml, blev påvist (ved den valgte 12% non- inferiøritet grænse) på begge populationer (” Intent- To- Treat ” og ” On Protocol ”).
Non-inferiority in virologic response, defined as the percentage of subjects with plasma HIV-1 RNA level < 400 copies/ml, was demonstrated (at the chosen 12% non-inferiority margin) for both Intent-To-Treat and On Protocol populations.
POWER 1 og POWER 2 er randomiserede, kontrollerede forsøg, der består af: en initial periode til dosisfinding samt en længerevarende periode, hvor alle patienter, der blev randomiseret til PREZISTA co- administreret med 100 mg ritonavir, fik den anbefalede dosis på 600/ 100 mg x 2.
POWER 1 and POWER 2 are randomised, controlled trials consisting of an initial dose-finding part and a second long-term part in which all patients randomised to PREZISTA co-administered with 100 mg ritonavir received the recommended dose of 600/100 mg b.i.d.
PREZISTA co- administreret med 100 mg ritonavir plus et optimeret baggrundsbehandlingsregime (OBR) blev sammenlignet med en kontrolgruppe, der fik et PI- regime valgt af investigator plus et OBR.
HIV-1 infected patients who were eligible for these trials had previously failed more than 1 PI containing regimen.PREZISTA co-administered with 100 mg ritonavir plus an optimised background regimen (OBR) was compared to a control group receiving an investigator-selected PI(s) regimen plus an OBR.
POWER 3:
The OBR consisted of at least 2 NRTIs with or without enfuvirtide (ENF).
Yderligere indsamling af data om virkningen af PREZISTA co- administreret med ritonavir 600/ 100 mg x 2 med OBR hos lignende behandlingserfarne patienter, der deltog i det ikke - randomiserede forsøg TMC114- C215.
POWER 3: additional data on the efficacy of PREZISTA co-administered with ritonavir 600/100 mg b.i.d. with OBR have been obtained in similar treatment-experienced patients participating in the non-randomised trial TMC114-C215.
Også baseline- karakteristika var sammenlignelige med dem i POWER 1 og POWER 2.
Entry criteria were the same as and baseline characteristics were comparable to those of POWER 1 and POWER 2.
Tabellen nedenfor viser virkningsdataene fra 48- ugers- analyserne for den anbefalede 600 mg dosis PREZISTA co- administreret med 100 mg ritonavir x 2 fra de samlede POWER 1 - og POWER 2- forsøg samt fra POWER 3- forsøget.
The table below shows the efficacy data of the 48-week analyses on the recommended 600 mg dose of PREZISTA co-administered with 100 mg ritonavir b.i.d. from the pooled POWER 1 and POWER 2 trials as well as from the POWER 3 trial.
Baseline - karakteristika
Baseline characteristics
Samlede data fra POWER 1 og POWER 2 Resultat efter 48 uger
POWER 1 and POWER 2 pooled data Outcomes at 48 weeks
Gennemsnitlig plasma HIV- 1 RNA Median CD4+ celletal
Median CD4+ cell count
4, 61 log10 kopier/ ml (PREZISTA/ ritonavir) 4, 49 log10 kopier/ ml (kontrol) 153 x 106 celler/ l (PREZISTA/ ritonavir) 163 x 106 celler/ l (kontrol)
153 x 106 cells/l (PREZISTA/ritonavir) 163 x 106 cells/l (control)
4, 58 log10 kopier/ m l 120 x 106 celler/ l
120 x 106 cells/l
PREZISTA/ ritonavir Kontrol Behandlings - 600/ 100 mg x 2. n=124 difference n=131
PREZISTA/ritonavir Control Treatment 600/100 mg b.i.d. n=124 difference n=131
PREZISTA/ ritonavir 600/ 100 mg x 2 n=334
PREZISTA/ritonavir 600/100 mg b.i.d. n=334
HIV- 1 RNA log10 gennemsnitlig ændring fra baseline (log10 kopier/ ml) a
HIV-1 RNA log10 mean change from baseline (log10 copies/ml)a
CD4+ celletalgennem snitlig ændring fra baseline (x 106/ l) b
CD4+ cell count mean change from baseline (x 106/l)b
103 17
103 17 86 (57; 114)d
HIV RNA > 1 log10 under baselinec
HIV RNA > 1 log10 below baselinec
81 (61, 8%) 20 (16, 1%)
81 (61.8%) 20 (16.1%) 45.7% (35.0%; 56.4%)d 17
HIV RNA < 400 kopier/ mlc
HIV RNA