natgillin/translations-raw huggingface dataset:
Samtidig administration af PREZISTA, med 100 mg ritonavir, og aktive stoffer, der er meget afhængige af CYP3A for eliminering, og for hvilke forhøjede plasmakoncentrationer er forbundet med alvorlige og/ eller livstruende hændelser, er kontraindiceret.
Co-administration of PREZISTA with 100 mg ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated.
4. 5).
These active substances include e.g. antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics [triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)] and HMG-CoA reductase inhibitors (simvastatin and lovastatin) (see section 4.5).
PREZISTA bør kun anvendes i kombination med 100 mg ritonavir som en farmakokinetisk forstærker (se pkt.
PREZISTA should only be used in combination with 100 mg of ritonavir as a pharmacokinetic enhancer (see section 5.2).
Ældre:
24 Elderly:
Da der kun foreligger begrænsede oplysninger om brug af PREZISTA til patienter over 65 år, skal der udvises forsigtighed ved administration af PREZISTA til ældre patienter, for hvilke der skal
As limited information is available on the use of PREZISTA in patients aged 65 and over, caution should be exercised in the administration of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Darunavir binder sig hovedsageligt til α1- syre- glycoprotein.
Darunavir binds predominantly to α1-acid glycoprotein.
Derfor kan man ikke udelukke en proteinfortrængning af lægemidler, der i udstrakt grad binder sig til α1- syre- glycoprotein.
Therefore, protein displacement of medicinal products highly bound to α1-acid glycoprotein cannot be ruled out.
Alvorlige hududslæt, der kan ledsages af feber og/ eller forøgelser af transaminaser, er forekommet hos 0, 5% af PREZISTA- behandlede patienter.
Severe skin rash, which may be accompanied with fever and/or elevations of transaminases, has occurred in 0.5% of patients treated with PREZISTA.
Erythema multiforme og Stevens- Johnsons syndrom er sjældent (< 0, 1%) observeret.
Erythema multiforme and Stevens-Johnson Syndrome have been rarely (< 0.1%) observed.
4. 2, 4. 3 og 5. 2).
Due to an increase in the unbound darunavir plasma concentrations, PREZIST A should be used with caution in patients with mild or moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Diabetes mellitus/ hyperglykæmi Der er rapporter om nyligt opstået diabetes mellitus, hyperglykæmi eller forværring af eksisterende diabetes mellitus hos patienter, der får antiretroviral behandling, herunder PI' er.
Diabetes mellitus/Hyperglycaemia New onset diabetes mellitus, hyperglycaemia, or exacerbation of existing diabetes mellitus has been reported in patients receiving antiretroviral therapy, including PIs.
Omfordeling af fedt og metaboliske forstyrrelser Antiretroviral kombinationsbehandling er blevet forbundet med omfordeling af kropsfedt (lipodystrofi) hos HIV- inficerede patienter.
25 Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
26 hypotese om en forbindelse mellem visceral lipomatose og PI' er og lipoatrofi og NRTI' er.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
Osteonekrose Selvom ætiologien anses for at være multifaktoriel (herunder kortikosteroidbehandling, alkoholforbrug, alvorlig immunsuppression, højt BMI), er der rapporteret tilfælde af osteonekrose, især hos patienter med fremskreden HIV- sygdom og/ eller langvarig eksponering for antiretroviral kombinationsbehandling (CART).
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Relevante eksempler omfatter cytomegalovirus retinitis, generaliserede og/ eller fokale mykobakterielle infektioner og pneumoni forårsaget af Pneumocystis jiroveci (tidligere kendt som Pneumocystis carinii).
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
PREZISTA, co- administreret med 100 mg ritonavir, må ikke kombineres med lægemidler, der er meget afhængige af CYP3A4 i forbindelse med clearance, og for hvilke øget systemisk eksponering er forbundet med alvorlige og/ eller livstruende hændelser (snævert terapeutisk indeks).
PREZISTA co-administered with 100 mg ritonavir must not be combined with medicinal products that are highly dependent on CYP3A4 for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index).
4. 3).
These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, terfenadine, midazolam administered orally, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin and the ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (see section 4.3).
14- fold stigning i den systemiske eksponering for darunavir ved administration af en peroral enkeltdosis darunavir på 600 mg i kombination med ritonavir 100 mg x 2.
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg b.i.d.
Et klinisk studie, hvor man anvendte flere forskellige lægemidler, der metaboliseres af cytochrom CYP2C9, CYP2C19 og CYP2D6, viste en stigning i CYP2C9 - og CYP2C19- aktiviteten og en hæmning af CYP2D6- aktiviteten ved tilstedeværelse af PREZISTA/ rtv.
A clinical study utilising a cocktail of drugs that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6
27 plasmakoncentration af disse lægemidler, hvilket kan øge eller forlænge deres terapeutiske effekt og bivirkninger.
Co-administration of darunavir and ritonavir and medicinal products which are primarily metabolised by CYP2D6 (such as flecainide, propafenone, metoprolol) may result in increased plasma concentrations of these medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Lægemidler, der påvirker eksponeringen for darunavir/ ritonavir Darunavir og ritonavir metaboliseres via CYP3A.
Medicinal products that affect darunavir/ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Lægemidler, der inducerer CYP3A- aktivitet, ville forventes at øge clearance af darunavir og ritonavir, hvilket medfører en lavere plasmakoncentration af darunavir og ritonavir (f. eks. rifampicin, perikon, lopinavir).
Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir (e.g. rifampicin, St John’s wort, lopinavir).
Co- administration af darunavir og ritonavir og andre lægemidler, der hæmmer CYP3A, kan nedsætte clearance af darunavir og ritonavir og kan medføre øgede plasmakoncentrationer af darunavir og ritonavir (f. eks. indinavir, systemiske azoler som ketoconazol og clotrimazol).
Co-administration of darunavir and ritonavir and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and ritonavir and may result in increased plasma concentrations of darunavir and ritonavir (e.g. indinavir, systemic azoles like ketoconazole and clotrimazole).
Interaktionstabel Interaktioner mellem darunavir/ ritonavir og proteasehæmmere, andre antiretrovirale midler end proteasehæmmere og andre non- antiretrovirale midler er opført i tabellen nedenfor (stigning er angivet som “ ↑ ”, reduktion er angivet som “ ↓ ”, ingen ændring som “ ↔ ”, ikke fastsat (not determined) som ” ND ”, to gange daglig som “ x 2 ”, en gang daglig som “ x 1 ” og en gang hver anden dag som ” x 1 hver anden dag ”).
Interaction table Interactions between darunavir/ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not determined as “ND”, twice daily as “b.i.d.”, once daily as “q.d.” and once every other day as “q.o.d.”).
Interaktioner – Darunavir/ ritonavir med proteasehæmmere Man har ikke fastslået virkningen og sikkerheden af PREZISTA, med 100 mg ritonavir, og andre PI’ er (f. eks.
Interactions – Darunavir/ritonavir with Protease Inhibitors The efficacy and safety of the use of PREZISTA with 100 mg ritonavir and any other PI (e.g.
darunavir/ ritonavir
darunavir/ritonavir
Lopinavir/ ritonavir
Assessed
400/ 100 x 2 533/ 133, 3 x 2
Lopinavir/ritonavir
1. 200/ 100 x 2 1. 200 x 2
400/100 b.i.d.
400/ 100 x
4
28 Atazanavir
Atazanavir
Interaktioner – Darunavir/ ritonavir med andre antiretrovirale midler end proteasehæmmere Co- administreret
Interactions – Darunavir/ritonavir with Antiretroviral Agents other than Protease Inhibitors
300/ 100 x 2 #
300/
Efavirenz Darunavir
Efavirenz 600 q.d.
Efavirenz nedsætter plasmakoncentrationerne af darunavir som følge af CYP3A4 - inducering.
Efavirenz decreases the plasma concentrations of darunavir as a result of CYP3A4 induction.
600/ 100 x
600/
400/ 100 x
Nevirapine 200 b.i.d.
400 x 1 600/ 100 x 2 Didanosin Darunavir Didanosin blev administreret på tom mave 2 timer før administration af darunavir/ ritonavir.
Didanosine ↔ NA Darunavir ↔ ↔ Didanosine was administered on an empty stomach 2 hours prior to administration of darunavir/ritonavir.
600/ 100
600/100 b.i.d.
Maraviroc 150 x 2 600/ 100 x 2 Maraviroc
Maraviroc ↑ 305% ND Darunavir ↔ ND The maraviroc dose should be 150 mg twice daily when co-administered with PREZISTA with low dose ritonavir.
Maraviroc- dosis skal være 150 mg to gange daglig, når det co- administreres med PREZISTA med lave doser ritonavir.
Darunavir/ritonavir concentrations were consistent with historical data.
29 Interaktioner – Darunavir/ ritonavir med non- antiretrovirale co- administrerede lægemidler Co- administreret
Interactions – Darunavir/ritonavir with Non-antiretroviral co-administered Medicinal Products Co-administered
Antiarytmika
Assessed
mg, med mindre andet er anført)
28
400 /
400/100 b.i.d.#
Darunavir/ ritonavir øger plasmakoncentrationerne af clarithromycin som følge af CYP3A4- hæmning og mulig Pgp- hæmning (P- glykoprotein).
Darunavir/ritonavir increases the plasma concentrations of clarithromycin as a result of CYP3A4 inhibition and possible Pgp inhibition.
400 /
400/100 b.i.d.
30 Itraconazol
Itraconazole
Clotrimazol
29 Clotrimazole
HMG Co- A- reduktasehæmmere Lovastatin Simvastatin
HMG Co-A Reductase Inhibitors Lovastatin Simvastatin
600/ 100 x
600/100 b
Kalciumkanalblokkere
Opiods Methadone
31 Felodipin Nicardipin Nifedipin Opioder
55-150 q.d.
Dog kan det
↓ 16%
være nødvendigt at øge dosis af methadon, ved samtidig administration over en længere periode, på grund af ritonavirs induktion af metabolisme.
However, increased methadone dose may be necessary when concomitantly administered for a longer period of time due to induction of metabolism by ritonavir.
4. 3).
The combination of rifampicin and PREZISTA with concomitant low dose ritonavir is contraindicated (see section 4.3).
Rifabutin Sedativa/ hypnotika
Rifabutin Sedatives/Hypnotics
32 Parenteral midazolam
Parenteral midazolam
Selektive serotonin genoptagshæmmere (SSRI’ er) Paroxetin
31 Paroxetine
400/ 100 x
400/100 b.i.
Sertralin 50 x 1 400/ 100 x 2 # Sertralin
400/100 b.i.d.# Sertraline
Derudover skal patienter, som får en stabil dosis sertralin eller paroxetin, og som påbegynder behandling med PREZISTA co- administreret med 100 mg ritonavir, monitoreres for respons på det antidepressive middel.
In addition, patients on a stable dose of sertraline or paroxetine who start treatment with PREZISTA co-administered with 100 mg ritonavir should be monitored for antidepressant response.
Steroider Fluticason - propionat Budesonid
Steroids Fluticasone propionate Budesonide
33 Der er ikke udført tilstrækkelige og velkontrollerede forsøg med darunavir hos gravide kvinder.
Pregnancy There are no adequate and well controlled studies with darunavir in pregnant women.
Amning Det vides ikke, om darunavir udskilles i brystmælk hos mennesker.
Breast-feeding It is not known whether darunavir is excreted in human milk.
Både på grund af risiko for overførsel af HIV og risiko for bivirkninger hos de ammende spædbørn, skal mødre instrueres i, at de under ingen omstændigheder må amme, hvis de behandles med PREZISTA.
Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving PREZISTA.
Fertilitet Der foreligger ingen data om virkningen af darunavir på fertilitet hos mennesker.
Fertility No human data on the effect of darunavir on fertility are available.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines 32 No studies on the effects of PREZISTA in combination with ritonavir on the ability to drive and use machines have been performed.
Medianeksponeringen for PREZISTA/ ritonavir hos denne gruppe patienter var 37, 3 uger.
The adverse drug reactions are derived from Phase IIb and Phase III trials, in which a total of 1,968 treatment-experienced patients initiated therapy with the recommended dose of PREZISTA 600 mg with ritonavir 100 mg twice daily.Median exposure to PREZISTA/ritonavir in this group was 37.3 weeks.
34 Metabolisme og ernæring almindelig
Metabolism and nutrition disorders common
ikke almindelig Psykiske forstyrrelser
uncommon
almindelig
Psychiatric disorders common
almindelig
Nervous system disorders 33 common
ikke almindelig Øre og labyrint
uncommon
ikke almindelig Vaskulære sygdomme
uncommon Vascular disorders
35 ikke almindelig Lever og galdeveje
uncommon
ikke almindelig Hud og subkutane væv
uncommon
ikke almindelig
34 uncommon
36 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.
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 sammenlignes med lopinavir/ ritonavir 800/ 200 mg pr. dag.
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.
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,
4. 4).
Combination antiretroviral therapy has also been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
37 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.
Virkningsmekanisme Darunavir er en hæmmer af dimer- dannelsen og den katalytiske aktivitet af HIV- 1 proteasen (KD på 4, 5 x 10- 12M).
36 Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10-12M).
EC50værdien for darunavir stiger med en median faktor på 5, 4 ved tilstedeværelse af humant serum.
The EC50 value of darunavir increases by a median factor of 5.4 in the presence of human serum.
38 I 48- ugers- analysen fra ARTEMIS- forsøget (se underafsnit om klinisk erfaring med ART - behandlingsnaive patienter) blev der observeret virologisk svigt hos 9, 9% af patienterne, der fik PREZISTA/ ritonavir 800/ 100 x 1.
In the 48 week analysis of the ARTEMIS trial (see Clinical experience subsection ART-naïve patients), 9.9% virologic failures were observed in patients receiving PREZISTA/ritonavir 800/100 mg q.d.
Der blev ikke identificeret nogen PI RAMer i udvikling ved disse virologiske svigt.
In these virologic failures no developing PI RAMs were identified.
Ved et virologisk svigt i PREZISTA/ ritonavir- gruppen blev der identificeret 1 NRTI RAM i udvikling ved position 184, der var forbundet med nedsat følsomhed over for emtricitabin, som var inkluderet i baggrundsregimet.
In 1 virologic failure of the PREZISTA/ritonavir group, 1 developing NRTI RAM at position 184 was identified, which was associated with a decreased susceptibility to emtricitabine included in the background regimen.
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 med ART- behandlingserfarne patienter) 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 ART-experienced patients) 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.
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.
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.
Der blev ikke observeret nogen krydsresistens med andre PI’ er i de virologiske svigt fra ARTEMIS - forsøget.
In the virologic failures of the ARTEMIS trial no cross-resistance with other PIs was observed.
Forsøget sammenligner behandling med PREZISTA/ ritonavir 800/ 100 mg x 1 med lopinavir/ ritonavir 800/ 200 mg pr. dag (givet enten to gange dagligt eller én gang dagligt).
37 Clinical experience Efficacy of PREZISTA co-administered with 100 mg ritonavir in ART-naïve patients The evidence of efficacy of PREZISTA/ritonavir 800/100 mg q.d. is based on the analyses of 48 week data from the ongoing, randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing PREZISTA/ritonavir 800/100 mg q.d. with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Begge behandlingsarme brugte et fast baggrundsregime bestående af tenofovirdisoproxilfumarat 300 mg x 1 og emtricitabin 200 mg x 1.
Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg q.d. and emtricitabine 200 mg q.d.
De HIV- 1- patienter, der var egnede til dette forsøg, havde plasma HIV- 1- RNA > 5. 000 kopier/ ml.
HIV-1 infected patients who were eligible for this trial had plasma HIV-1 RNA > 5,000 copies/ml.
Randomiseringen var stratificeret for virusbelastningen i plasma og CD4+ celletal ved screening.
Randomisation was stratified by screening plasma viral load and screening CD4+ cell count.
Den gennemsnitlige baseline plasma HIV- 1 RNA var 4, 86 log10 kopier/ ml, og medianen af baseline CD4+ celletal var 228 x 106 celler/ l (spændvidde 4 – 750 x 106 celler/ l).
The mean baseline plasma HIV-1 RNA was 4.86 log10 copies/ml and the median baseline CD4+ cell count was 228 x 106 cells/l (range 4–750 x 106 cells/l).
Tabellen nedenfor viser effektdata af 48 ugers- analysen fra ARTEMIS- forsøget.
The table below shows the efficacy data of the 48 week analyses from the ARTEMIS trial:
ARTEMIS Resultat
ARTEMIS Outcomes
PREZISTA/ ritonavir 800/ 100 mg x 1 N=343
N=343
lopinavir/ ritonavir 800/ 200 mg pr. dag N=346
lopinavir/rtv 800/200 mg per day N=346
Behandlingsdifference (95% CI af forskel)
treatment difference (95% CI of difference)
HIV- 1- RNA < 50 kopier/ mla HIV- 1- RNA < 400 kopier/ mla Gennemsnitlig HIV- 1- RNA log - ændring fra baseline (log10 kopier/ ml) c
HIV-1 RNA < 50 copies/mla HIV-1 RNA < 400 copies/mla
287 (83, 7%) 301 (87, 8%) - 2, 77
287 (83.7%) 301 (87.8%)
271 (78, 3%) 295 (85, 3%) - 2, 65
271 (78.3%) 295 (85.3%)
5, 3 (- 0, 5; 11, 2) b 2, 5 (- 2, 6; 7, 6) b - 0, 11d (- 0, 30; 0, 07) b
mean HIV-1 RNA log change from baseline (log10 copies/ml)c
39 median CD4+ celletalændring fra baseline (x 106/ l) c a I overensstemmelse med 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 Patienter, der stoppede behandlingen for tidligt, tillægges en ændring lig 0 d Forskelle i gennemsnit
Imputations according to the TLOVR algorithm b Based on normal approximation to the difference in% response c Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0 d Difference in means
I 48 ugers- analysen var det virologiske respons (HIV- 1 RNA < 50 kopier/ ml) 83, 7% for PREZISTA/ ritonavir - og 78, 3% for lopinavir/ ritonavir- behandlingsarmen.
In the 48 week analysis, the virologic response (HIV-1 RNA < 50 copies/ml) for the PREZISTA/ritonavir arm was 83.7% and for the lopinavir/rtv arm 78.3%.
Non- inferiøritet i virologisk respons, defineret som procentdelen af patienter med plasma HIV- 1 RNA niveau < 50 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 < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat and On Protocol populations.