natgillin/translations-raw huggingface dataset:
Det kan være, at din dosis af Telzir skal ændres, hvis du tager • etravirin (mod hiv-infektion).
Your dose of Telzir may need to be changed if you are taking • etravirine (used to treat HIV infection)
ANTINEOPLASTISKE MIDLER METABOLISERET AF CYP3A
ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A
Telzir findes i plastflasker med 225 ml oral suspension.
Telzir is supplied in plastic bottles containing 225 ml oral suspension.
Risiko for alvorlige og/eller livstruende reaktioner såsom akut ergotamintoksicitet karakteriseret ved perifere vasospasmer og iskæmi i ekstremiteterne og andre væv.
Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
TRICYKLISKE ANTIDEPRESSIVA
TRICYCLIC ANTIDEPRESSANTS
• dasatinib, nilotinib, ibrutinib, vinblastin og everolimus (til behandling af flere typer af kræft).
• dasatinib, nilotinib, ibrutinib, vinblastine and everolimus (used to treat several types of cancer)
Sæt sprøjten fast i adaptoren.
Insert the syringe firmly into the adapter.
Antiretroviral naive voksne patienter
Antiretroviral Naïve Adult Patients
Ved behandling af hiv-infektion er det ikke altid muligt at afgøre, om nogen af de bivirkninger, der opstår, skyldes Telzir, andre lægemidler taget samtidigt eller hiv-sygdommen.
When treating HIV, it can be hard to tell whether side effects are caused by Telzir, by other medicines taken at the same time or by the HIV disease itself.
Det anbefales at dosistitrere paroxetin ud fra en klinisk vurdering af det antidepressive respons.
Dose titration of paroxetine based on a clinical assessment of antidepressant response is recommended.
• desipramin, nortriptylin, paroxetin og lignende medicin (mod depression)
• desipramine, nortriptyline, paroxetine and similar medicines (used to treat depression)
Lægen beregner den rigtige dosis ud fra kropsvægt.
Your doctor will work out the right dose based on your weight.
På grund af Telzirs hæmning af CYP3A forventes det, at koncentrationen af quetiapin vil stige.
Due to CYP3A inhibition by Telzir, concentrations of quetiapine are expected to increase.
Effektresultatet er beskrevet i tabellen nedenfor.
Efficacy outcomes are described in the table below.
Pravastatin eller fluvastatin anbefales, fordi deres metabolisme er uafhængig af CYP3A4, og der forventes ikke interaktioner med proteasehæmmere.
Pravastatin or fluvastatin are recommended because their metabolism is not dependent on CYP 3A4 and interactions are not expected with protease inhibitors.
Patienter, der er på en stabil dosis af paroxetin, og som påbegynder behandling med Telzir og ritonavir, bør overvåges for antidepressivt respons.
Patients on stable dose of paroxetine who start treatment with Telzir and ritonavir should be monitored for antidepressant response.
Amprenavirs antivirale in vitro-aktivitet blev evalueret over for hiv-1-IIIB i både akut og kronisk inficerede lymfoblastiske cellelinjer (MT-4, CEM-CCRF, H9) og perifere blodlymfocytter.
The in vitro antiviral activity of amprenavir was evaluated against HIV-1 IIIB in both acutely and chronically infected lymphoblastic cell lines (MT-4, CEM-CCRF, H9) and in peripheral blood lymphocytes.
Personer med hepatitis B eller C, der får kombinationsbehandling, har større risiko for at få alvorlige leverproblemer
People with hepatitis B or C taking combination therapy are at increased risk of getting severe liver problems.
Ryst flasken 20 sekunder før første anvendelse.
Shake the bottle for 20 seconds before the first use.
Non-nukleoside revers transkriptasehæmmere:
Non-nucleoside reverse transcriptase inhibitors:
Ryst flasken kraftigt før brug.
Shake the bottle vigorously before use.
6-17 år ≥ 39 kg Tabletter eller oral suspension 700 mg (1 tablet eller 14 ml suspension)
6-17 years >39 kg Tablet or Oral suspension 700 mg (1 tablet or 14 ml suspension)
Det vides ikke, om amprenavir kan fjernes ved peritonealdialyse eller hæmodialyse.
It is not known whether amprenavir can be removed by peritoneal dialysis or haemodialysis.
Du skal derfor tage Telzir oral suspension.
You must take Telzir oral suspension.
Hos hunrotterne, der fik den høje doseis, var vægten af den drægtige livmoder nedsat (0-16 %), formentlig på grund af, at antallet af ovarie corpora lutea og livmoderimplantationssteder var reduceret.
In females, at the high dose, there was a reduction in the weight of gravid uterus (0 to 16%) probably due to a reduction of the number of ovarian corporea lutea and implantations.
Telzir-tabletter kan tages uden hensyn til fødeindtagelse.
Telzir tablets may be taken without regard to food intake.
Der er nogle typer af medicin, som du ikke må tage sammen med Telzir.
There are some medicines that must not be taken with Telzir.
Hvis Telzir/ritonavir gives i kombination med parenteral midazolam, skal det gøres på en intensivafdeling eller under tilsvarende forhold, som sikrer tæt klinisk monitorering og hensigtsmæssig behandling i tilfælde af respirationsdepression og/eller forlænget sedation.
If Telzir/ritonavir is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Hertfordshire SG12 ODJ Storbritannien
Hertfordshire SG12 0DJ United Kingdom
Tabel 5 Baseline karakteristika og effektresultat ved uge 48 i APV29005 ITT(E) population
Table 5 Baseline Characteristics and Efficacy Outcomes at Week 48 in APV29005 ITT(E) Population
Telzir anvendes til behandling af hiv (humant immundefekt)-infektion.
Telzir is used to treat HIV (human immunodeficiency virus) infection.
Lægemidler mod hepatitis C-virus Simeprevir
Anti-hepatitis C virus medicinal products
Amprenavirs (APV) farmakokinetik blev undersøgt hos gravide kvinder, der fik FPV/RTV 700/100 mg to gange dagligt i andet trimester (n=6) eller tredje trimester (n=9) og post partum.
Amprenavir (APV) pharmacokinetics were studied in pregnant women receiving FPV/RTV 700/100 mg twice daily during the second trimester (n=6) or third trimester (n=9) and postpartum.
Effektresultat opdelt i undergrupper er beskrevet i tabellen nedenfor.
Efficacy outcomes by subgroups are described in the table below.
Den primære metaboliseringsvej er via cytokrom P450 3A4-enzymet.
The primary route of metabolism is via the cytochrome P450 3A4 enzyme.
Clarithromycin: moderat  forventet
Clarithromycin: moderate ↑ expected
• udslæt (rødt, hævet eller kløende) - hvis udslættet er alvorligt, kan det være, at du skal stoppe med at tage Telzir.
• Skin rashes (red, raised or itchy) - if the skin rash is severe, you may have to stop taking this medicine
Ritonavir hæmmer også CYP2D6, men i mindre udstrækning end CYP3A4.
Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4.
ANTIRETROVIRALE LÆGEMIDLER
ANTIRETROVIRAL MEDICINAL PRODUCTS
Dosis kan ikke justeres med Telzir-tabletter.
This dose adjustment cannot be made with Telzir tablets.
Hos voksne, der tidligere er blevet behandlet med antiretrovirale midler, har Telzir i kombination med en lav dosis ritonavir ikke vist sig så effektivt som lopinavir/ritonavir.
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
Hvis du har glemt at tage Telzir
If you forget to take Telzir
Se nedenstående tabel for doseringsanbefalinger til pædiatriske patienter.
Please refer to the table below for the dosing recommendations in paediatric patients.
Alvorlige og livstruende hudreaktioner, herunder Stevens-Johnsons syndrom, er sjældne.
Severe or life-threatening cases of rash, including Stevens-Johnson syndrome are rare.
Den 50 % hæmmende koncentration (IC50) for amprenavir varierede fra 0,012 til 0,08 M i akut inficerede celler og var 0,41 M i kronisk inficerede celler (1 M = 0,50 g/ml).
The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ml).
Efter oral administration bliver fosamprenavir hurtigt og næsten fuldstændigt hydrolyseret til amprenavir og uorganisk phosphat før det når kredsløbet.
After oral administration, fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation.
(R-) methadon: Cmax 
(R-) methadone: Cmax ↓
Dosisadskillelse og dosisjustering er ikke nødvendig (se ”Antacida”).
No dose separation or dosage adjustment necessary (see Antacids).
Den gennemsnitlige ændring i AAUCMB (Log10 kopier/ml) i ITT(E) populationen (observeret analyse) ved uge 48 (det primære endepunkt) og andre effektresultater opdelt i undergrupper er beskrevet i tabellen nedenfor:
The mean AAUCMBs (log10 c/ml) in the ITT (E) population (Observed analysis) at 48 weeks (primary end-point) and other efficacy outcomes by subgroup are described in the tables below:
Ungernes overlevelse var nedsat.
Pup survival was decreased.
Relevansen af de uterin endometriale adenocarcinomaer for mennesker er ukendt, men der er ingen kliniske studier eller postmarketingsdata, der tyder på, at disse fund har klinisk betydning.
The relevance of the uterine endometrial adenocarcinomas for humans is uncertain; however there is no evidence from clinical trials or marketed use to suggest that these findings are of clinical significance.
Ranitidin 300 mg enkelt dosis
Ranitidine 300 mg single dose
Telzir findes også som en oral suspension til patienter, der ikke kan synke tabletter.
Telzir is also available as an oral suspension for those patients unable to swallow the tablets.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer):
Very common side effects These may affect more than 1 in 10 people:
Vær ekstra forsigtig med at tage Telzir Kontakt lægen eller apoteket, før du tager Telzir:
Take special care with Telzir Talk to your doctor or pharmacist before taking Telzir:
Udslættene vil normalt forsvinde spontant uden nødvendig seponering af behandlingen med fosamprenavir og ritonavir.
The rash generally will resolve spontaneously without the necessity of discontinuing treatment with the fosamprenavir with ritonavir.
Farmakoterapeutisk klassifikation: Antivirale midler; proteasehæmmer, ATC-kode: J05AE07.
Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor, ATC Code: J05AE07 Mechanism of action
Ved at hindre protease i at virke, kan Telzir forhindre hiv i at formere sig og inficere flere CD4-celler.
By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells.
Telzir fås også i en flydende udgave (oral suspension) til personer, der ikke kan sluge tabletter.
Telzir is also available as a liquid (oral suspension) for people who are unable to swallow tablets.
Glaxo Operations UK Ltd. (registreret som GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, Storbritannien eller
Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom or
Tabel 4 AAUCMB ved uge 48 ved genotypisk sensitivitetsscore i OBT og baseline resistens overfor FPV/RTV
Table 4 AAUCMB at Week 48 by genotypic sensitivity score in OBT and baseline resistance to FPV/RTV
De fleste bivirkninger i forbindelse med kombinationsbehandling med fosamprenavir/ritonavir var milde til moderate, tidligt indsættende og sjældent begrænsende for behandlingen.
Most adverse reactions associated with fosamprenavir/ritonavir combination therapies were mild to moderate in severity, early in onset and rarely treatment limiting.
MedDRA-systemorganklasser og absolut frekvens.
Adverse reactions are listed by MedDRA system organ class and absolute frequency.
Ved behandlingsophør med glukokortikoider skal nedtrapningen ske gradvist over en længere periode (se pkt.
In case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period (see section 4.4).
Hvis du har taget for meget Telzir Hvis du har taget mere end den ordinerede dosis af Telzir:  Kontakt straks lægen eller apoteket for rådgivning.
If you have taken more than the prescribed dose of Telzir: →Contact your doctor or pharmacist immediately for advice.
Udslæt/hudreaktioner: Erytematøse eller makulopapulære kutane eruptioner med eller uden pruritus kan forekomme under behandlingen.
Rash / cutaneous reactions: erythematous or maculopapular cutaneous eruptions, with or without pruritus, may occur during therapy.
ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Irland
ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Patienter med > 1 log10 ændring fra baseline i plasma-hiv-1RNA
Subjects with >1 log10 change from baseline in plasma HIV1 RNA
Se afsnittet ”Brug af anden medicin sammen med Telzir”.
See section ‘Other medicines and Telzir'.
Ritonavir dosis (2 GANGE DAGLIG)
Ritonavir dose (TWICE DAILY)
Amprenavir kan findes inde i sæd, men koncentrationen fundet i sæd er lavere end koncentrationen i plasma.
Amprenavir appears to penetrate into semen, though semen concentrations are lower than plasma concentrations.
Det er derfor vigtigt, at du også omhyggeligt læser indlægssedlen til al anden medicin, du får.
It is therefore important that you carefully read the package leaflet provided with these medicines.
Pakningen indeholder desuden en adapter af polyethylen samt en 10 ml doseringssprøjte bestående af en cylinder af polypropylen (med angivelse af ml) og et stempel af polyethylen.
The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
• carbamazepin, phenobarbital, phenytoin (mod epilepsi)
• carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
Hovedpine, svimmelhed, oral paræstesi
Headache, dizziness, oral paraesthesia
Enkeltdosis (30 ml) af antacidasuspension (ækvivalent med 3,6 gram aluminiumhydroxid og 1,8 gram magnesiumhydroxid)
Single 30 ml dose of antacid suspension (equivalent to 3.6 grams aluminium hydroxide and 1.8 grams magnesium hydroxide
Samtidig administration af fosamprenavir/ ritonavir med lurasidon er kontraindiceret på grund af risikoen for alvorlige og/eller livstruende reaktioner relateret til lurasidon (se pkt.
Concomitant administration of fosamprenavir /ritonavir with lurasidone is contraindicated due to the potential for serious and/or life-threatening reactions related to lurasidone (see section 4.3)
Den orale suspension bør tages med mad
Oral suspension should be taken with food
Nyrernes udskillelse af ritonavir er ligeledes forsvindende lille, og derfor vurderes betydningen af nedsat nyrefunktion på eliminationen af amprenavir og ritonavir til at være minimal.
Renal clearance of ritonavir is also negligible, therefore the impact of renal impairment on amprenavir and ritonavir elimination should be minimal
ITT-E observeret analyse
ITT-E observed analysis
Der foreligger ikke tilstrækkelige data til at anbefale behandling med fosamprenavir og ritonavir til svært behandlingserfarne patienter.
There are insufficient data to recommend the use of fosamprenavir with ritonavir in heavily pre-treated patients.
Telzir tabletter kan tages med eller uden mad.
Telzir tablets can be taken with or without food.
I reproduktive toksikologiske studier af fosamprenavir i rotter var fertiliteten hos hanrotterne upåvirket.
In reproductive toxicity studies with fosamprenavir in rats, male fertility was not affected.
Eksempler på antineoplastiske midler: dasatinib nilotinib ibrutinib vinblastin everolimus
Examples of antineoplastic agents: dasatinib nilotinib ibrutinib vinblastine everolimus
ITT-E population TLOVR analyse
ITT-E Population TLOVR analysis
Der er set tilfælde af muskelsmerter, ømhed eller svækkelse, især ved antiretroviral behandling med både proteasehæmmere og nukleosidanaloger.
There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
• hvis man også tager medicin af typen kortikosteroider mod betændelseslignende tilstande
• if they are also taking anti-inflammatory medicines called corticosteroids
Der er rapporteret om øget blødningstendens, herunder spontane hudhæmatomer og hæmarthroner, hos hæmofilipatienter type A og B, som blev behandlet med proteasehæmmere (PI'er).
There have been reports of increased bleeding including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors (PIs).
ANTIHISTAMINER (HISTAMIN H1ANTAGONISTER) Astemizol
ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Astemizole Terfenadine
Den orale suspension bør tages uden mad
Oral suspension should be taken without food
Fluticasonpropionat 50 µg intranasalt 4 gange daglig i 7 dage
Fluticasone propionate 50 µg intranasal 4 times daily) for 7 days
• simeprevir, daclatasvir (mod hepatitis C-virusinfektion)
• , , simeprevir, daclatasvir (used to treat hepatitis C virus infection)
 Før kun motorkøretøj og betjen kun maskiner, hvis du har det godt.
→ Don't drive or operate machinery unless you're feeling well.
Hiv-infektion spredes ved seksuel kontakt med en smittet person eller ved overførsel af inficeret blod (f.eks. ved at dele injektionsnåle med andre).
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Hos kaniner var den systemiske eksponering af den højeste dosis kun 0,3 gange den dosis for human eksponering ved maksimum klinisk dosis og derfor er den udviklingsrelaterede toksicitet af fosamprenavir ikke klarlagt.
In rabbits, systemic exposure at the high dose level was only 0.3 times human exposure at the maximum clinical dose and thus the development toxicity of fosamprenavir has not been fully determined.
Telzir suspension administreres oralt.
Telzir suspension is administered orally.
Da der kan være øget risiko for levertransaminase stigninger og niveauet af hormoner kan være ændret ved samtidig administration af fosamprenavir, ritonavir og orale præventionsmidler, anbefales alternative ikke-hormonale præventionsmidler til fertile kvinder (se pkt.
Because there may be an increased risk of hepatic transaminase elevations and hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative nonhormonal methods of contraception are recommended for women of childbearing potential (see section 4.5).
Atorvastatin 10 mg én gang daglig i 4 dage
Atorvastatin 10 mg once daily for 4 days
Der foreligger ingen data for samtidig administration af fosamprenavir og ritonavir med østrogen og/eller progesteron, når disse anvendes som erstatningsterapi.
No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/or progestogens when used as hormonal replacement therapies.
Studier med rotter, der fik gentagne doser af fosamprenavir, viste påvirkninger forenelig med enzyminduktion i leveren, hvilket prædisponerer rotter for thyroide neoplasmaer.
Repeat dose studies with fosamprenavir in rats produced effects consistent with hepatic enzyme induction, which predisposes rats to thyroid neoplasms.
I tilfælde af samtidig administration med antineoplastiske midler, der metaboliseres af CYP3A, henvises til de relevante produktresuméer for disse lægemidler.
In case of concomitant administration with antineoplastic agents metabolized by CYP3A, please refer to the relevant product information for these medications.
I sjældne tilfælde kan udslættet blive voldsomt og alvorligt (Stevens-Johnsons syndrom).
Rarely, the skin rash can be severe and serious (Stevens Johnson syndrome).
Der forventes ikke klinisk signifikant interaktion.
No clinically significant interaction is expected.
Hvis du får muskelproblemer:  Fortæl det til lægen.
If you notice any muscle problems: →Tell your doctor.
Børn fra 6 år, som vejer mindst 25 kg Børn skal tage Telzir oral suspension sammen med mad.
Children from 6 years of age and weighing at least 25 kg Children should take the Telzir oral suspension with food.
Suspensionens farve er hvid til off-white.
The suspension is white to off-white in colour.
For at undgå overførsel af hiv anbefales det, at hiv-inficerede kvinder under ingen omstændigheder ammer deres børn.
It is recommended that HIV-infected women must not breast-feed under any circumstances to avoid transmission of HIV.
Telzir kræver ikke andre særlige forholdsregler vedrørende opbevaringen.
Telzir does not require any other special storage conditions.
Amprenavir bindes til det aktive site på hiv-1-proteasen og forebygger dermed spaltningen af viral gag og gag-pol polyprotein forstadier, så der dannes umodne, ikke-infektiøse viruspartikler.
Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
• hvis du har sukkersyge.
• If you have diabetes.
Der henvises til de relevante produktresuméer for disse lægemidler (se pkt.
Please refer to the relevant product information for these medications (see section 4.5).
ITT (Ext) Observeret analyse
ITT (Ext) Observed analysis
Samtidig administration af paritaprevir og fosamprenavir/ritonavir (FPV/RTV) er kontraindiceret pga. den forventede stigning i eksponeringen for paritaprevir og manglen på kliniske data til vurdering af størrelsen af denne stigning (se pkt.
Co-administration of paritaprevir and fosamprenavir/ritonavir (FPV/RTV) is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase (see section 4.5).
• ketoconazol og itraconazol doser på mere end 200 mg om dagen (mod svampeinfektioner)
• doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections)
En 75 % reduktion af rifabutinstandarddosis anbefales (dvs. til 150 mg hver anden dag), Yderligere dosisreduktion kan være nødvendig (se pkt.
A 75 % reduction of the standard rifabutin dose (i.e. to 150 mg every other day) is recommended.
Oral suspension Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Tyskland.
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany or
Når tidsfristen for fremsendelse af en periodisk, opdateret sikkerhedsindberetning (PSUR) er sammenfaldende med tidsfristen for opdatering af en RMP, skal de fremsendes samtidig.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Omdannelsen af fosamprenavir til amprenavir syntes primært at foregå i tarmens epitel.
The conversion of fosamprenavir to amprenavir appears to primarily occur in the gut epithelium.
Telzir i kombination med ritonavir bør ikke anvendes til børn under 6 år pga. utilstrækkelige data om farmakokinetik, sikkerhed og antiviralt respons (se pkt.
Telzir with ritonavir is not recommended in children below 6 years due to insufficient data on pharmacokinetics, safety and antiviral response (see section 5.2).
Vigtig information om nogle af de øvrige indholdsstoffer i Telzir oral suspension Telzir oral suspension indeholder propyl- og metylparahydroxybenzoat.
Important information about ingredients of Telzir oral suspension Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Ved tiden til tab af virologisk respons (TLOVR) analyse af ITT(E) gruppen, var andelen af patienter der opnåede < 400 kopier/ml 73 % (315/434) i fosamprenavir med ritonavir gruppen, sammenlignet med 71 % (317/444) hos patienterne der modtog lopinavir/ritonavir, med et 95 % konfidensinterval med en forskel på [-4,84 %; 7,05 %].
In the Time to loss of virological response (TLOVR) analysis for the ITT(E) population, the proportion of patients achieving <400 copies/ml was 73 % (315 / 434) in the fosamprenavir with ritonavir group compared to 71 % (317 / 444) of patients receiving lopinavir / ritonavir, with a 95 % confidence interval of the difference of [-4,84%; 7;05%].