natgillin/translations-raw huggingface dataset:
Fuzeon er i kombination med andre antiretrovirale lægemidler indiceret til behandling af hiv- 1 - smittede patienter, som er behandlet med og som ikke har responderet på mindst et lægemiddel fra en af følgende antiretrovirale lægemiddelgrupper; Proteasehæmmere, non- nukleosid reverse transkriptasehæmmere og nucleosid reverse transkriptasehæmmere, eller som ikke har tolereret tidligere antiretrovirale regimer.
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non- nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
5. 1)
(see section 5.1)
Om muligt kan det være hensigtsmæssig med resistenstestning.
Where available, resistance testing may be appropriate.
5. 1)
(See sections 4.4 and 5.1)
Voksne og unge ≥ 16 år:
Adults and adolescents ≥ 16 years:
Den anbefalede dosis er 90 mg Fuzeon to gange daglig, injiceret subkutant i overarmen, på lårets forside eller i abdomen.
The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen.
Der er ingen erfaringer hos patienter > 65 år.
There is no experience in patients > 65 years old.
Børn over ≥ 6 år og unge:
Children ≥ 6 years and adolescents:
5. 2).
The experience in children is limited (See section 5.2).
I kliniske forsøg blev doseringsregimet, som er anvist i tabel 1 nedenfor, anvendt:
In clinical trials the dosage regimen in table 1 below was used:
2 Tabel 1:
2 Table 1:
Dosering til børn
Paediatric Dosing
Dosis pr. injektion, som
Weight (kg)
Injektionsvolumen
Dose per bid injection
Vægt (kg)
Injection volume
to gange daglig (mg/ dosis)
(mg/ dose)
(90 mg
(90 mg enfuvirtide per ml)
11, 0 til 15, 5 15, 6 til 20, 0 20, 1 til 24, 5 24, 6 til 29, 0 29, 1 til 33, 5 33, 6 til 38, 0 38, 1 til 42, 5 ≥ 42, 6
11.0 to 15.5 15.6 to 20.0 20.1 to 24.5 24.6 to 29.0 29.1 to 33.5 33.6 to 38.0 38.1 to 42.5 ≥ 42.6
5. 2).
Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).
Dosisjustering er ikke nødvendig hos patienter med nyreinsufficiens inklusive dialysepatienter.
No dose adjustment is required for patients with renal impairment including those receiving dialysis.
4. 4 og 5. 2).
(See sections 4.4 and 5.2).
Der foreligger ingen data til bestemmelse af dosisanbefalinger til patienter med leverinsufficiens.
No data are available to establish a dose recommendation for patients with hepatic impairment.
Som ved andre antiretrovirale midler bør enfuvirtid optimalt kombineres med andre antiretrovirale midler, som patientens virus er følsom overfor.
As with other antiretrovirals, enfuvirtide should optimally be combined with other antiretrovirals to which the patient’ s virus is sensitive.
5. 1)
(See section 5.1)
Patienterne skal oplyses om, at det ikke er bevist, at antiretrovirale behandlinger, inklusive enfuvirtid, forebygger risikoen for overførsel af hiv til andre gennem seksuel kontakt eller blodkontaminering.
Patients must be advised that antiretroviral therapies including enfuvirtide have not been proved to prevent the risk of transmission to HIV to others through sexual contact or blood contamination.
De skal fortsætte med at anvende passende forsigtighedsregler.
They must continue to use appropriate precautions.
Patienter skal også informeres om, at Fuzeon ikke kan helbrede en hiv- 1- infektion.
Patients should also be informed that Fuzeon is not a cure for HIV-1 infection.
Forsøg med dyr har vist, at enfuvirtid måske kan nedsætte nogle af immunsystemets funktioner (se pkt.
Animal studies have shown that enfuvirtide may impair some immune functions (see section 5.3).
En forøget hyppighed af visse bakterielle infektioner, især øget forekomst af pneumoni, er blevet set hos patienter, som behandles med Fuzeon.
An increased rate of some bacterial infections, most notably a higher rate of pneumonia, has been seen in patients treated with Fuzeon.
Patienter skal nøje kontrolleres for kliniske fund og symptomer på pneumoni.
Patients should be monitored closely for signs and symptoms of pneumonia.
4. 8)
(See section 4.8)
Hypersensitivitetsreaktioner er lejlighedsvis blevet relateret til behandlingen med enfuvirtid, og i sjældne tilfælde er hypersensitivitetsreaktionerne dukket op igen ved provokationsforsøg.
Hypersensitivity reactions have occasionally been associated with therapy with enfuvirtide and in rare cases hypersensitivity reactions have recurred on rechallenge.
De omfatter udslæt, feber, kvalme og opkastning, kulderystelser, stivhed, lavt blodtryk og forhøjede serum- levertransaminaser i forskellige kombinationer og muligvis primært immunkompleksreaktioner, respirationsbesvær og glomerulonefritis.
Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
Patienter, som udvikler kliniske fund/ symptomer på en systemisk hypersensitivitetsreaktion skal straks stoppe behandlingen med enfuvirtid og søge læge.
Patients developing signs/ symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately.
Leversygdomme:
Liver disease:
Sikkerheden og effekten af behandling med enfuvirtid hos patienter med underliggende leversygdomme, er ikke specifikt blevet undersøgt.
The safety and efficacy of enfuvirtide has not been specifically studied in patients with significant underlying liver disorders.
Patienter med kronisk hepatitis B
Patients with chronic hepatitis B and C and treated with
3 og C, som behandles med antiretroviral terapi har en forhøjet risiko for alvorlige og potentielt dødelige leverbivirkninger.
3 antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
I de kliniske fase III- forsøg var få patienter co- inficeret med hepatitis B/ C.
Few patients included in the phase III trials were co-infected with hepatitis B/ C.
Administration af Fuzeon til non- hiv- 1- smittede personer kan inducere anti- enfuvirtid antistoffer, som krydsreagerer med hiv- gp41.
Administration of Fuzeon to non-HIV-1 infected individuals may induce anti-enfuvirtide antibodies that cross-react with HIV gp41.
Det kan resultere i en falsk positiv hiv- test med anti- hiv ELISA testen.
This may result in a false positive HIV test with the anti-HIV ELISA test.
Fuzeon skal anvendes med forsigtighed til disse populationer.
Fuzeon should be used with caution in these populations.
4. 2 og 5. 2).
(See sections 4.2 and 5.2)
Hos hiv- smittede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
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 CART.
Interaktionsundersøgelser er kun udført på voksne.
Interactions studies have only been performed in adults.
Der forventes ingen klinisk signifikante farmakokinetiske interaktioner mellem enfuvirtid og samtidigt indgivne lægemidler, som metaboliseres af CYP450- enzymer.
No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes.
Enfuvirtids indvirkning på metabolismen af samtidigt indgivne lægemidler:
Influence of enfuvirtide on metabolism of concomitant medicinal products:
I et humant in- vivo - metabolismestudie hæmmede enfuvirtid ved den anbefalede dosis på 90 mg to gange daglig ikke metabolismen af lægemidler, som er substrater for CYP3A4 (dapson), CYP2D6 (debrisoquin), CYP1A2 (koffein), CYP2C19 (mefenytoin) og CYP2E1 (chlorzoxazon).
In an in-vivo human metabolism study enfuvirtide, at the recommended dose of 90 mg twice daily, did not inhibit the metabolism of substrates by CYP3A4 (dapsone), CYP2D6 (debrisoquine), CYP1A2 (caffeine), CYP2C19 (mephenytoin), and CYP2E1 (chlorzoxazone).
Indvirkning af samtidigt indgivne lægemidler på enfuvirtids metabolisme:
Influence of concomitant medicinal products on enfuvirtide metabolism:
I separate farmakokinetiske interaktionsstudier medførte samtidig administration af ritonavir (potent CYP3A4- hæmmer) eller saquinavir i kombination med en støddosis af ritonavir eller rifampicin (potent CYP3A4- induktor) ingen klinisk signifikante ændringer af enfuvirtids farmakokinetik.
In separate pharmacokinetic interaction studies, co-administration of ritonavir (potent CYP3A4 inhibitor) or saquinavir in combination with a booster dose of ritonavir or rifampicin (potent CYP34A inducer) did not result in clinically significant changes of the pharmacokinetics of enfuvirtide.
Der foreligger ikke tilstrækkelige data eller vel- kontrollerede studier hos gravide kvinder.
There are no adequate and well-controlled studies in pregnant women.
Dyreforsøg viser ikke skadelige virkninger på fosterudviklingen.
Animal studies do not indicate harmful effects with respect to foetal development.
Det vides ikke, om enfuvirtid udskilles i modermælk.
It is not known whether enfuvirtide is secreted in human milk.
På grund af risikoen for overførsel af hiv og for eventuelle bivirkninger hos de diende børn, skal mødre frarådes at amme, hvis de får enfuviritid.
Mothers should be instructed not to breast-feed if they are receiving enfuvirtide because of the potential for HIV transmission and any possible undesirable effects in breast-fed infants.
4 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4 4.7 Effects on ability to drive and use machines
Det er ikke bevist at enfuvirtid påvirker evnen til at føre motorkøretøj eller betjene maskiner, men enfuvirtids bivirkningsprofil skal dog tages i betragtning.
There is no evidence that enfuvirtide may alter the patient’ s ability to drive and use machines, however, the adverse event profile of enfuvirtide should be taken into account.
5. 1).
Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1).
100 patienteksponeringsår (bortset fra reaktioner på injektionsstedet).
Safety results are expressed as the number of patients with an adverse reaction per 100 patient- years of exposure (except for injection site reactions).
Reaktioner på injektionsstedet (ISR) var de hyppigst rapporterede bivirkninger, og de indtraf hos 98% patienterne (tabel 2).
Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 2).
De fleste lokale reaktioner på injektionsstedet indtraf inden for den første uge efter administration af Fuzeon, og de ledsagedes af let til moderat smerte eller ubehag på injektionsstedet uden indskrænkning af sædvanlige aktiviteter.
The vast majority of ISRs occurred within the first week of Fuzeon administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities.
Sværhedsgrad af smerte og ubehag steg ikke med behandlingsvarigheden.
The severity of the pain and discomfort did not increase with treatment duration.
De kliniske fund og symptomerne varede almindeligvis i højst 7 dage.
The signs and symptoms generally lasted equal to or less than 7 days.
Infektioner på injektionsstedet (inklusive absces og cellulitis) indtraf hos 1, 5% af patienterne.
Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.
Sammenfatning af individuelle kliniske fund og symptomer på lokale reaktioner på injektionsstedet kombineret fra TORO 1 - og TORO 2- studierne (% patienter) n=663
Summary of individual signs/ symptoms characterising local injection site reactions in studies TORO 1 and TORO 2 combined (% of patients) n=663
Seponering pga. reaktioner på injektionsstedet
Withdrawal Rate due to ISRs
4
4%
Symptom
Event Category
Fuzeon + OBa
Fuzeon
Hændelser
% of Event
(optimal
+Optimised
inklusive grad 3 -
comprising
inklusive grad 4 -
comprising
baggrund)
Pain / discomfort
reaktioner,%
backgrounda 96.1%
reaktioner,%
4 reactions 0%b
Smerte / ubehag Erytem Induration Knuder og cyster Pruritus Ecchymoser a Uanset sværhedsgrad. b
Erythema Induration Nodules and cysts Pruritus Ecchymosis a Any severity grade. b
96, 1 90, 8 90, 2 80, 4 65, 2 51, 9
90.8% 90.2% 80.4% 65.2% 51.9%
11, 0b 23, 8c 43, 5d 29, 1e 3, 9f 8, 7g
23.8%c 43.5%d 29.1%e 3.9%f 8.7%g
0b 10, 5c 19, 4d 0, 2e NA 4, 7g
10.5%c 19.4%d 0.2%e NA 4.7%g
Grad 3 = svære smerter, som kræver analgetika (eller opioidanalgetika ≤ 72 timer) og/ eller begrænser almindelige aktiviteter; grad 4 =svære smerter, som kræver indlæggelse eller forlænget indlæggelse, resulterende i dødsfald eller vedvarende eller betydeligt handicap/ uarbejdsdygtighed, eller er livstruende eller medicinsk betydende. c Grad 3 = ≥ 50 mm, men < 85 mm i middeldiameter; grad 4 = ≥ 85 mm i middeldiameter. d Grad 3 = ≥ 25 mm, men < 50 mm i middeldiameter; grad 4 = ≥ 50 mm i middeldiameter. e Grad 3 = ≥ 3 cm; grad 4 = hvis der anlægges dræn. f Grad 3 = refraktær overfor lokal behandling eller krævende oral eller parenteral behandling; grad 4 = ikke defineret. g Grad 3 = > 3 cm, men ≤ 5 cm; grad 4 = > 5 cm.
Grade 3= severe pain requiring analgesics (or narcotic analgesics for ≤ 72 hours) and/ or limiting usual activities; Grade 4= severe pain requiring hospitalisation or prolongation of hospitalisation, resulting in death, or persistent or significant disability/ incapacity, or life- threatening, or medically significant. c Grade 3= ≥ 50 mm but < 85 mm average diameter; Grade 4= ≥ 85 mm average diameter. d Grade 3= ≥ 25 mm but< 50 mm average diameter; Grade 4= ≥ 50 mm average diameter. e Grade 3= ≥ 3 cm; Grade 4= If draining. f Grade 3= refractory to topical treatment or requiring oral or parenteral treatment; Grade 4= not defined. g Grade 3= > 3 cm but ≤ 5 cm; Grade 4= > 5 cm.
Tilføjelse af Fuzeon til antiretroviral baggrundsbehandling forøgede i almindelighed ikke hyppigheden eller sværhedsgraden af de fleste bivirkninger.
The addition of Fuzeon to background antiretroviral therapy generally did not increase the frequency or severity of most adverse reactions.
100 patientår for Fuzeon + OB versus OB).
The most frequently reported events occurring in the TORO 1 and TORO 2 studies were diarrhoea (38 versus 73 patients with event per 100 patient years for Fuzeon + OB versus OB) and nausea (27 versus 50 patients with event per 100 patient years for Fuzeon + OB versus OB).
100 patientår.
The following list presents events seen at a higher rate among patients receiving Fuzeon+OB regimen than among patients on the OB alone regimen with an exposure adjusted increase of at least 2 patients with event per 100 patient-years.
Disse bivirkninger er derfor frekvensestimerede (“ meget almindelig ” (≥1/ 10) eller “ almindelig ” (≥1/ 100, < 1/ 10).
These events are then designated frequency estimation (“ very common” (≥ 1/ 10), or “ common” (≥ 1/ 100, < 1/ 10)).
5 Infektioner og parasitære sygdomme Almindelig: - sinuitis, hudpapillom, influenza, pneumoni, øreinfektion.
Infections and Infestations Common: - sinusitis, skin papilloma, influenza, pneumonia, ear infection.
Blod og lymfesystem Almindelig: - lymfadenopati.
5 Blood and Lymphatic System Disorders Common: - lymphadenopathy.
Metabolisme og ernæring Almindelig: - nedsat appetit, anoreksi, hypertriglyceridæmi, diabetes mellitus.
Metabolism and Nutrition Disorders Common: - appetite decreased, anorexia, hypertriglyceridaemia, diabetes mellitus.
Psykiske forstyrrelser Almindelig: - angst, mareridt, irritabilitet.
Psychiatric Disorders Common: - anxiety, nightmare, irritability.
Nervesystemet Meget almindelig: - perifer neuropati.
Nervous System Disorders Very Common: - peripheral neuropathy.
Almindelig: - hypoaesthesi, nedsat opmærksomhed, tremor.
Common: -hypoaesthesia, disturbance in attention, tremor.
Øjne Almindelig: - konjunktivitis.
Eye Disorders Common: - conjunctivitis.
Øre og labyrint Almindelig: - vertigo.
Ear and Labyrinth disorders Common: - vertigo.
Luftveje, thorax og mediastinum Almindelig: - næsetilstopning.
Respiratory, Thoracic and Mediastinal Disorders Common: - nasal congestion.
Mave- tarmkanalen Almindelig: - pankreatitis, gastroøsofageal refluks.
Gastrointestinal Disorders Common: - pancreatitis, gastro-oesophageal reflux disease.
Hud og subkutane væv Almindelig: - tør hud, seborroisk eksem, erytem, acne.
Skin and Subcutaneous Tissue Disorders Common: - dry skin, eczema seborrhoeic, erythema, acne.
Knogler, led, muskler og bindevæv Almindelig: - myalgier.
Musculoskeletal, Connective Tissue and Bone Disorders Common: - myalgia.
Nyrer og urinveje Almindelig: - nyresten.
Renal and Urinary Disorders Common: - Calculus renal.
Almene symptomer og reaktioner på administrationsstedet Almindelig: - influenzalignende sygdom, slaphed.
General Disorders and Administration Site Conditions Common: - influenza like illness, weakness.
Almindelig: - forhøjede triglycerider i blodet, hæmaturi.
Investigations Very Common: - weight decreased Common: - blood triglycerides increased, haematuria present.
I nogle tilfælde er der forekommet recidiv efter provokation.
In addition there have been a small number of hypersensitivity reactions attributed to enfuvirtide and in some cases recurrence has occurred upon re-challenge.
4. 4)
(See section 4.4)
Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv- sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART) er der rapporteret om tilfælde af osteonekrose.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
6 Laboratorieanomalier
Laboratory abnormalities
Bortset fra de laboratorieparametre, som er nævnt i tabel 3, ændredes toksicitetsgraden i laboratorieparametrene sig ikke under studiet hos de fleste patienter.
The majority of patients had no change in the toxicity grade of any laboratory parameter during the study except for those listed in Table 3.
I uge 48 optrådte eosinofili [højere end øvre normalgrænse (ULN) dvs. > 0, 7 x 109/ l] hyppigere hos patienter i gruppen, som fik Fuzeon (12, 4 patienter pr.
Through week 48, eosinophilia [greater than the Upper Limit
Ved anvendelse af en højere grænseværdi for eosinofili (> 1, 4 x 109/ l) var den patienteksponeringsjusterede hyppighed af eosinofili den samme i begge grupper (1, 8 patienter med uønskede hændelser pr.
6 of Normal of > 0.7 x 109/ l] occurred at a higher rate amongst patients in the Fuzeon containing group (12.4 patients with event per 100 patient-years) compared with OB alone regimen (5.6 patients with event per 100 patient-years).
100 patientår).
When using a higher threshold for eosinophilia (> 1.4 x 109/ l), the patient exposure adjusted rate of eosinophilia is equal in both groups (1.8 patients with event per 100 patient- years).
100 patientår
Exposure adjusted Grade 3 & 4 laboratory abnormalities among patients on Fuzeon+OB and OB alone regimens, reported at more than 2 patients with event per 100 patient years
Laboratorieparameter
Laboratory Parameters
Fuzeon + OB
Fuzeon+OB regimen
OB alene
OB alone regimen
Graduering n (Total patienteksponeringsår) ALAT
Grading n (Total Exposure patient years) ALAT
100 patientår 663 (557, 0)
Per 100 patient years 663 (557.0)
100 patientår 334 (162, 1)
Per 100 patient years 334 (162.1)
Gr.
Gr.
3 (> 5- 10 x ULN) Gr.
3 (> 5-10 x ULN) Gr.
4 (> 10 x ULN) Hæmoglobin
4 (> 10 x ULN) Haemoglobin
3 (6, 5- 7, 9 g/ dl) Gr.
3 (6.5-7.9 g/ dL) Gr.
4 (< 6, 5 g/ dl) Kreatininphosphokinase
4 (< 6.5 g/ dL) Creatinine phosphokinase
Den højeste dosis, som blev givet til 12 patienter i et klinisk studie, var en enkelt subkutan dosis på 180 mg subkutant.
The highest dose administered to 12 patients in a clinical trial was 180 mg as a single dose subcutaneously.
I et Early Access Program- studie fik en patient administreret 180 mg Fuzeon som enkeltdosis ved en enkelt lejlighed.
In an Early Access Program study, one patient administered 180 mg of Fuzeon as a single dose on one occasion.
Andre antivirale lægemidler, ATC kode:
Other antivirals, ATC code:
Virkningsmekanisme:
Mechanism of Action:
Enfuvirtid tilhører en terapeutisk gruppe, som kaldes fusionshæmmere.
Enfuvirtide is a member of the therapeutic class called fusion inhibitors.
Det er en hæmmer af den strukturelle ændring af hiv- 1- gp41 og virker ved specifikt at binde sig ekstracellulært til dette virusprotein, hvilket blokerer fusionen af virus - og målcelle- cellemembranerne og hindrer dermed virus i at komme ind i cellen.
It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell.
Den geometriske middel EC50 for følsomheden af 612 hiv- rekombinanter indeholdende env- gener fra hiv- RNA- prøver taget ved baseline fra patienter i fase III- studier var 0, 259 μg/ ml (geometrisk middeltal + 2SD = 1, 96 μg/ ml) i et rekombinant fænotype hiv- assay.
The susceptibility to enfuvirtide of 612 HIV recombinants containing the env genes from HIV RNA samples taken at baseline from patients in Phase III studies gave a geometric mean EC 50 of 0.259 μ g/ ml (geometric mean + 2SD = 1.96 μ g/ ml) in a recombinant phenotype HIV entry assay.
Enfuvirtid hæmmede også hiv- 1- viruspartiklers celle- celle medierede fusion.
Enfuvirtide also inhibited HIV-1 envelope mediated cell-cell fusion.
Der er ikke påvist sammenhæng mellem følsomhed af hiv- 1 over for enfuvirtid in vitro og hæmning af hiv- 1 - replikation hos mennesker.
The relationship between the in vitro susceptibility of HIV-1 to enfuvirtide and inhibition of HIV-1 replication in humans has not been established.
7 Antiretroviral lægemiddelresistens:
Antiretroviral drug resistance:
Ufuldstændig viral suppression kan medføre udvikling af lægemiddelresistens over for en eller flere behandlingskomponenter.
Incomplete viral suppression may lead to the development of drug resistance to one or more components of the regimen.
In vitro- resistens overfor enfuvirtid:
7 In Vitro resistance to enfuvirtide:
Disse isolater har aminosyresubstitutionerne 36- 38 i gp41 ektodomænet.
HIV-1 isolates with reduced susceptibility to enfuvirtide have been selected in vitro which harbour substitutions in amino acids (aa) 36-38 of the gp41 ectodomain.
Substitutionerne blev korreleret med forskellige niveauer af nedsat enfuvirtid følsomhed hos specifikke hiv site- directed mutanter.
These substitutions were correlated with varying levels of reduced enfuvirtide susceptibility in HIV site- directed mutants.
In vivo- resistens overfor enfuvirtid:
In Vivo resistance to enfuvirtide:
I kliniske fase III- studier viste hiv- rekombinanter, indeholdende env- gener fra hiv- RNA- prøver taget op til uge 24 fra 187 patienter, > 4 gange nedsat følsomhed overfor enfuvirtid sammenlignet med tilsvarende prøver taget før behandlingen.
In phase III clinical studies HIV recombinants containing the env genes from HIV RNA samples taken up to week 24 from 187 patients showed > 4 fold reduced susceptibility to enfuvirtide compared with the corresponding pre-treatment samples.