natgillin/translations-raw huggingface dataset:
Genoptages behandlingen med Trizivir eller ethvert andet lægemiddel med abacavir efter en overfølsomhedsreaktion, vender symptomerne omgående tilbage inden for timer.
Restarting Trizivir, or any other medicinal product containing abacavir, following a hypersensitivity reaction would result in a prompt return of symptoms within hours.
Denne tilbagevenden af overfølsomhedsreaktionen er som regel mere alvorlig end den initiale reaktion og kan omfatte livstruende hypotension og død.
This recurrence of the hypersensitivity reaction was usually more severe than on initial presentation and may include life- threatening hypotension and death.
Hos patienter, der har udviklet denne overfølsomhedsreaktion, skal behandlingen seponeres og må aldrig genoptages, hverken med Trizivir eller ethvert andet lægemiddel med abacavir (dvs.
Patients who develop this hypersensitivity reaction must discontinue Trizivir and must never be rechallenged with Trizivir, or any other medicinal product containing abacavir (i. e.
For at undgå forsinkelse af diagnosen og for at mindske risikoen for en livstruende overfølsomhedsreaktion, skal Trizivir seponeres permanent, hvis overfølsomhed ikke kan udelukkes, selv når andre diagnoser er mulige (luftvejssygdomme, influenzalignende sygdom, gastroenteritis eller overfølsomhed over for andre lægemidler).
To avoid a delay in diagnosis and minimise the risk of a life-threatening hypersensitivity reaction, Trizivir must be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory disease, flu-like illness, gastroenteritis or reactions to other medications).
Derudover blev der i meget sjældne tilfælde rapporteret overfølsomhedsreaktioner hos patienter, der har genoptaget behandlingen, og som ikke havde haft nogen forudgående symptomer på en overfølsomhedsreaktion.
Moreover, on very rare occasions hypersensitivity reactions have been reported in patients who have restarted therapy and who had no preceding symptoms of a hypersensitivity reaction.
I begge tilfælde, såfremt det besluttes at genoptage Trizivir, skal dette foregå under omstændigheder, hvor muligheden for hurtig medicinsk indgriben er tilgængelig.
In both cases if a decision is made to restart Trizivir this must be done in a setting where medical assistance is readily available.
11 Tabel 1:
Table 1:
Opsummering af tegn og symptomer som associeres med overfølsomhed over for abacavir (Tegn og symptomer rapporteret hos mindst 10% af patienterne med en overfølsomhedsreaktion over for abacavir er markeret med fed skrift).
Summary of signs and symptoms associated with hypersensitivity to abacavir (Signs and symptoms reported in at least 10% of patients with a hypersensitivity reaction to abacavir are in bold text).
Organsystem Mavetarmkanalen
Gastrointestinal tract
Bivirkninger Kvalme, opkastning, diarré, abdominalsmerter, ulcerationer i munden
Nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Neurologiske/ psykiatriske
Neurological/ psychiatry
Åndenød, ondt i halsen, hoste, ARDS (adult respiratory distress syndrome), respirationssvigt
Dyspnoea, sore throat, cough, adult respiratory distress syndrome, respiratory failure
Hud Udslæt (sædvanligvis makulopapuløst eller urtikarielt)
Rash (usually maculopapular or urticarial)
Feber, svær udmatning, utilpashed, ødem, hævede lymfeknuder, hypotension, konjunktivitis, anafylaksi
Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Bivirkninger rapporteret for de enkelte stoffer Bivirkningerne som er rapporteret for abacavir, lamivudin og zidovudin er vist i tabel 2.
11 Undesirable effects reported with the individual substances The adverse reactions reported with abacavir, lamivudine and zidovudine are presented in Table 2.
12 Tabel 2:
Table 2:
Bivirkninger, som er rapporteret for de individuelle bestanddele af Trizivir
Adverse reactions reported with the individual components of Trizivir
Se beskrivelsen i den indrammede tekst og tabel 1 ovenfor vedrørende oplysninger om overfølsomhed over for abacavir Blod - og lymfesystem
IMPORTANT: for information on abacavir hypersensitivity, see the description above in the boxed information and Table 1
Ikke almindelig:
Blood and lymphatic system disorders
Ren erytrocyt aplasi.
Uncommon: neutropenia, anaemia (both occasionally severe), thrombocytopenia Very rare: pure red cell aplasia
Aplasisk anæmi.
Common: anaemia, neutropenia and leucopenia Uncommon: thrombocytopenia and pancytopenia with marrow hypoplasia Rare: pure red cell aplasia Very rare: aplastic anaemia
Overfølsomhed.
Common: hypersensitivity
Sjælden:
Common: anorexia
Anoreksi. uden samtidig hypoxæmi..
Rare: anorexia, lactic acidosis in the absence of hypoxaemia
Angst og depression.
Rare: anxiety, depression
Hovedpine.
Nervous system disorders Common: headache
Hovedpine og
Common: headache, insomnia
Hovedpine.
Very common: headache
Perifer neuropati (paræstesi).
Very rare: peripheral neuropathy (paraesthesiae)
Søvnløshed, paræstesi, somnolens, mental sløring, kramper.
Common: dizziness Rare: insomnia, paraesthesia, somnolence, loss of mental acuity, convulsions
Kardiomyopati.
Rare: cardiomyopathy
Hoste og symptomer fra næsen.
Common: cough, nasal symptoms
Sjælden:
Uncommon: dyspnoea Rare: cough
Almindelig:
Common: nausea, vomiting, Common: nausea, vomiting,
Sjælden:
Very common:
Pancreatitis.
Nausea
Sjælden:
diarrhoea Rare: pancreatitis
Opkast, abdominalsmerter og diarré.
abdominal pain, diarrhoea Rare: rises in serum amylase, pancreatitis
Pigmentering af mundslimhinden, smags - forstyrrelser, dyspepsi, pancreatitis.
Common: vomiting, abdominal pain, and diarrhoea Uncommon: flatulence Rare: oral mucosa pigmentation, taste disturbance dyspepsia, pancreatitis
Hepatitis.
Uncommon: transient rises in liver enzymes (AST, ALT) Rare: hepatitis
Leversygdomme såsom svær hepatomegali med steatosis.
Common: raised blood levels of liver enzymes and bilirubin Rare: liver disorders such as severe hepatomegaly with steatosis,
Erythema multiforme, Stevens- Johnson syndrom og toksisk epidermal nekrolyse
Common: rash (without systemic symptoms) Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Udslæt og hårtab.
Common: rash, alopecia
Pigmentering af negle og hud, nældefeber og øget svedtendens.
Uncommon: rash and pruritus Rare: nail and skin pigmentation, urticaria and sweating
Sjælden:
Common: arthralgia, muscle disorders Rare: rhabdomyolysis
Muskelsmerter.
Common: myalgia Uncommon: myopathy
Hyppig vandladning.
Rare: urinary frequency
Gynækomasti.
Rare: gynaecomastia
Feber, sløvhed og træthed.
Common: fever, lethargy, fatigue
Træthed, utilpashed og feber.
Common: fatigue, malaise, fever
Almindelig:
Common: malaise Uncommon: fever, generalised pain and asthenia Rare: chills, chest pain, and influenza-like syndrome
Ikke almindelig:
Adverse reactions associated with
Sjælden:
abacavir:
14 Bivirkninger ved abacavir En del af de bivirkninger, der er nævnt ovenfor, optræder almindeligvis (kvalme, opkastning, diarré, feber, svær udmatning, udslæt) hos patienter med overfølsomhed over for abacavir.
13 Many of the adverse reactions listed above occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Hvis behandling med Trizivir tidligere er blevet afbrudt hos patienter, der har oplevet nogen af disse symptomer, og det besluttes at starte patienten op igen på behandling med abacavir, skal dette foregå under omstændigheder, hvor muligheden for hurtig medicinsk indgriben er tilgængelig (se afsnit 4. 4).
If Trizivir has been discontinued in patients due to experiencing any one of these symptoms and a decision is made to restart a medicinal product containing abacavir, this must be done in a setting where medical assistance is readily available (see Section 4.4).
Der er meget sjældne rapporter om erythema multiforme, Stevens- Johnsons syndrom og toksisk epidermal nekrolyse, hvor overfølsomhed over for abacavir ikke kunne udelukkes.
Very rarely cases of erythema multiforme, Stevens Johnson syndrome or toxic epidermal necrolysis have been reported where abacavir hypersensitivity could not be ruled out.
Hæmatologiske bivirkninger ved zidovudin Anæmi, neutropeni og leukopeni forekom hyppigere ved højere doser (1200- 1500 mg/ dag) og hos patienter med fremskreden HIV- infektion (specielt ved ringe knoglemarvsreserve forud for behandlingen), og især hos patienter med CD4- celletal under 100/ mm3.
Anaemia, neutropenia and leucopenia occurred more frequently at higher dosages (1200-1500 mg/ day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment) and particularly in patients with CD4 cell counts less than 100/ mm3.
Dosisreduktion eller seponering af behandling kan blive nødvendig (se afsnit 4. 4).
Dosage reduction or cessation of therapy may become necessary (see section 4.4).
Lactacidose Behandling med nukleosidanaloger har været forbundet med tilfælde af lactacidose, undertiden fatal, i forbindelse med svær hepatomegali med fedtinfiltration (se afsnit 4. 4).
Treatment with nucleoside analogues has been associated with cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, (see section 4.4).
Lipodystrofi/ metaboliske abnormaliteter Antiretroviral kombinationsbehandling er hos patienter med HIV forbundet med en omfordeling af legemsfedt (lipodystrofi), herunder tab af subkutant fedt perifert og i ansigtet, øget intraabdominalt og visceralt fedt, bryst hypertrofi og dorso- cervikal fedtophobning (buffalo hump).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Immunreaktiveringssyndrom Hos HIV- inficerede patienter med svær immuninsufficiens kan der ved påbegyndelseaf antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner (se afsnit 4. 4).
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Osteonekrose 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 combination antiretroviral therapy (CART).
Der er givet enkeltdoser op til 1200 mg og døgndoser op til 1800 mg abacavir til patienter i kliniske undersøgelser.
Single doses up to 1200 mg and daily doses up to 1800 mg of abacavir have been administered to patients in clinical studies.
Hvis overdosering finder sted, bør patienten overvåges for tegn på forgiftning (se afsnit 4. 8), og symptomatisk behandling iværksættes om nødvendigt.
14 If overdose occurs the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Hæmodialyse og peritonealdialyse synes at have begrænset effekt på udskillelsen af zidovudin, men
Haemodialysis and peritoneal dialysis appear to have a limited effect on elimination of zidovudine, but enhance the elimination of the glucuronide metabolite.
Alle tre lægemidler metaboliseres sekventielt af intracellulære kinaser til det respektive 5 ′ - trifosfat (TF).
Mechanism of action: Abacavir, lamivudine and zidovudine are all NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2. All three medicinal products are metabolised sequentially by intracellular kinases to the respective 5′ -triphosphate (TP).
Lamivudin- TF, carbovir- TF (den aktive trifosfatform af abacavir) og zidovudin- TF er substrater for og kompetitive hæmmere af HIV revers transkriptase (RT).
Lamivudine-TP, carbovir-TP (the active triphosphate form of abacavir) and zidovudine-TP are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Imidlertid udøves den væsentligste antivirale aktivitet gennem inkorporering af monofosfatformen i den virale DNA- kæde, hvorved kædedannelsen afsluttes.
However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Abacavir -, lamivudin - og zidovudin- trifosfat har signifikant mindre affinitet til værtscelle DNA- polymeraser.
Abacavir, lamivudine and zidovudine triphosphates show significantly less affinity for host cell DNA polymerases.
Lamivudin er påvist at virke stærkt synergistisk med zidovudin i hæmning af replikationen af HIV i cellekulturer.
Lamivudine has been shown to be highly synergistic with zidovudine, inhibiting the replication of HIV in cell culture.
Abacavir udviser synergi in vitro i kombination med nevirapin og zidovudin.
Abacavir shows synergy in vitro in combination with nevirapine and zidovudine.
Det er vist at være additivt i kombination med didanosin, stavudin og lamivudin.
It has been shown to be additive in combination with didanosine,, stavudine and lamivudine.
In vitro- resistens:
In vitro resistance:
In vivo- resistens (behandlingsnaive patienter):
In vivo resistance (Therapy naïve patients):
M184V - og M1841- varianterne opstår hos HIV- 1 - positive patienter, der behandles med lamivudin- holdige antiretroviraler.
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
De fleste patienter, som oplever virologisk svigt under en abacavir- behandling i et pivotalt klinisk forsøg med Combivir (fastdosiskombination med lamivudin og zidovudin), viste enten ingen NRTI- relaterede ændringer i forhold til baseline (15%) eller kun M184V - eller M1841- mutationer (78%).
Most patients experiencing virological failure with a regimen containing abacavir in a pivotal clinical trial with Combivir (fixed dose combination of lamivudine and zidovudine) showed either no NRTI-related changes from baseline (15%) or only M184V or M184I selection (78%).
Den generelle forekomst af M184V eller M1841 var høj (85%), mens L74V -, K65R - og Y115F- mutationerne ikke blev påvist (se tabel).
The overall selection frequency for M184V or M184I was high (85%), and selection of L74V, K65R and Y115F was not observed (see Table).
Thymidinanaloge mutationer (TAM’ er), som ses med zidovudin, blev også påvist (8%).
Thymidine analogue mutations (TAMs) which are selected by zidovudine (ZDV) were also found (8%).
Abacavir + Combivir
Abacavir + Combivir
forsøgspersoner
Number of Subjects
1.
40 (100%)
Antal genotyper i behandling K65R L74V Y115F M184V/ I TAM’ er1 Antal forsøgspersoner med ≥1 TAM
Number of subjects with ≥ 1 TAM.
Når behandlingen blev suppleret med ZDV blev forekomsten af L74V og K65R reduceret (K65R: uden ZDV:
In addition, the selection of L74V and K65R was reduced when co-administered with ZDV (K65R: without ZDV:
13/ 127, 10%; med ZDV:
13/ 127, 10%; with ZDV:
1/ 86, 1%; 1, 74V; uden ZDV:
1/ 86, 1%; L74V: without ZDV:
51/ 127, 40%; med ZDV:
51/ 127, 40%; with ZDV:
16 In vivo- resistens (tidligere behandlede patienter):
In vivo resistance (Therapy experienced patients):
M184V - eller M1841- varianterne opstår hos HIV- 1 - positive patienter, der er behandlet med lamivudin- holdige antiretroviraler og giver høj resistens over for lamivudin.
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confers high-level resistance to lamivudine.
På samme måde som tilstedeværelsen af TAM’ er giver resistens over for ZDV.
Similarly, the presence of TAMs gives rise to resistance to ZDV.
123 (74%) ud af de 166 forsøgspersoner havde M184V/ I, 50 (30%) havde T215Y/ F, 45 (27%) havde M4IL, 30 (18%) havde K70R og 25 (15%) havde D67N.
In a meta-analysis of five clinical trials where abacavir was added to intensify therapy, of 166 subjects, 123 (74%) had M184V/ I, 50 (30%) had T215Y/ F, 45 (27%) had M41L, 30 (18%) had K70R and 25 (15%) had D67N.
Den logistiske regressionsmodel for den prædiktive værdi af genotype (justeret for baseline- plasma HIV- 1- RNA [vRNA], CD4+- celletal, antal og varighed af tidligere antiretrovirale behandlinger) viste, at tilstedeværelsen af 3 eller flere NRTI - resistens- forbundne mutationer var forbundet med nedsat respons i uge 4 (p = 0, 015) eller 4 eller flere mutationer ved median uge 24 (p ≤ 0, 012).
Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1 RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies) showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤ 0.012).
Ydermere kan 69- indsættelseskomplekset eller Q151M - mutationen, sædvanligvis fundet i kombination med A62V, V751, F77L og F116Y, forårsage et højt niveau af resistens over for abacavir.
In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V, V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Uge 4
16 Week 4
mutatio
Mutatio
En To
-0.72
NRTI- mutation NRTI- forbundne mutationer
associated mutations Any three NRTI-
Zidovudin, didanosin, stavudin og tenofovir fastholder deres antiretrovirale aktiviteter mod sådanne HIV- 1- varianter.
Zidovudine, didanosine, stavudine and tenofovir maintain their antiretroviral activities against such HIV-1 variants.
Ligeledes kan tilstedeværelsen af M184V sammen med L74V være årsag til krydsresistens mellem abacavir, didanosin og lamivudin.
The presence of M184V with K65R does give rise to cross-resistance between abacavir, tenofovir, didanosine and lamivudine, and M184V with L74V gives rise to cross-resistance between abacavir, didanosine and lamivudine.
Krydsresistens mellem abacavir, lamivudin eller zidovudin og antiretroviraler fra andre grupper, f. eks.
Cross-resistance between abacavir, lamivudine or zidovudine and antiretrovirals from other classes e. g.
Klinisk erfaring Kombinationen af abacavir, lamivudin og zidovudin er i én randomiseret, dobbelblind, placebokontrolleret klinisk undersøgelse sammenlignet med kombinationen af indinavir, lamivudin og zidovudin hos tidligere ubehandlede patienter.
One randomised, double blind, placebo controlled clinical study has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine in treatment naive patients.
Skønt en
Due to the high proportion of premature discontinuation (42% of patients discontinued randomised treatment by week 48), no definitive conclusion can be drawn regarding the equivalence between the treatment regimens at week 48.
17 lignende antiviral effekt fandtes mellem regimerne med abacavir og indinavir, hvad angår andelen af patienter med udetekterbar virusbyrde (≤400 kopier/ ml; ” intention to treat ” - analyse (ITT) på 47% versus 49%; analyse af behandlede (AB) på 86% versus 94% for kombinationerne med henholdsvis abacavir og indinavir), var resultaterne til fordel for kombinationen med indinavir, særligt hos undergruppen af patienter med høj virusbyrde (udgangsværdi > 100. 000 kopier/ ml; ITT på 46% versus 55%; AB på 84% versus 93% for henholdsvis abacavir og indinavir).
Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (≤ 400 copies/ ml; intention to treat analysis (ITT), 47% versus 49%; as treated analysis (AT), 86% versus 94% for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load (> 100,000 copies/ ml at baseline; ITT, 46% versus 55%; AT, 84% versus 93% for abacavir and indinavir respectively).
ACTG5095 var en randomiseret (1: 1: 1), dobbelt- blindet, placebo- kontrolleret undersøgelse med 1147 antiretrovirale naive HIV- 1 inficerede voksne, som sammenlignede tre behandlingsregimer: zidovudin (ZDV), lamivudin (3TC), abacavir (ABC) og efavirenz (EFV) versus ZDV/ 3TC/ EFV versus ZDV/ 3TC/ ABC.
ACTG5095 was a randomised (1:1:1), double-blind, placebo-controlled trial performed in 1147 antiretroviral naïve HIV-1 infected adults, comparing 3 regimens: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) vs ZDV/ 3TC/ EFV vs ZDV/ 3TC/ ABC.
Hos 26% af patienterne, der fik ZDV/ 3TC/ ABC- kombinationen, var der manglende virologisk effekt (HIV RNA > 200 kopier/ ml), mens det tilsvarende var 16% for ZDV/ 3TC/ EFV og 13% for 4- stofkombinationen.
After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/ 3TC/ ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26% of subjects on the ZDV/3TC/ABC arm, 16% on the ZDV/3TC/EFV arm and 13% on the 4 drug arm categorised as having virological failure (HIV RNA > 200 copies/ml).
Ved uge 48 var andelen af patienter med HIV RNA < 50 kopier/ ml 63%, 80% og 86% for henholdsvis ZDV/ 3TC/ ABC, ZDV/ 3TC/ EFV og ZDV/ 3TC/ ABC/ EFV.
At week 48 the proportion of subjects with HIV RNA < 50 copies/ ml were 63%, 80% and 86% for the ZDV/ 3TC/ ABC, ZDV/ 3TC/ EFV and ZDV/ 3TC/ ABC/ EFV arms, respectively.
Data - og sikkerhedsmonitoreringskomitéen for studiet stoppede behandlingsarmen med ZDV/ 3TC/ ABC baseret på den højere andel af patienter med virologiske svigt.
The study Data Safety Monitoring Board stopped the ZDV/ 3TC/ ABC arm at this time based on the higher proportion of patients with virologic failure.
Ved en middelvurdering efter 144 uger blev 25% af patienterne i behandling med ZDV/ 3TC/ ABC/ EFV og 26% af patienterne i behandling med ZDV/ 3TC/ EFV kategoriseret som havende virologisk svigt.
There was no significant
Der var ingen signifikant forskel i tiden indtil første virologiske svigt (p=0, 73; log - rank test) mellem de to arme.
17 difference in the time to first virologic failure (p=0.73, log-rank test) between the 2 arms.
Tilføjelsen af ABC til ZDV/ 3TC/ EFV forbedrede ikke signifikant effekten i dette studie.
In this study, addition of ABC to ZDV/ 3TC/ EFV did not significantly improve efficacy.
Virologisk svigt (HIV 32 uger RNA > 200 kopier/ ml) 144 uger Virologisk succes (48 ugers HIV RNA < 50 kopier/ ml)
Virologic failure (HIV 32 weeks RNA > 200 copies/ ml) 144 weeks Virologic success (48 weeks HIV RNA < 50 copies/ ml)
26% - 63%
26% - 63%
16% 26% 80%
16% 26% 80%
13% 25% 86%
13% 25% 86%
I en igangværende klinisk undersøgelse over 16 uger hos tidligere ubehandlede patienter svarede den antivirale effekt af kombinationen af abacavir, lamivudin og zidovudin til kombinationen af nelfinavir, lamivudin og zidovudin.
In an ongoing clinical study over 16 weeks in treatment-naive patients, the combination of abacavir, lamivudine and zidovudine showed a similar antiviral effect to the combination with nelfinavir, lamivudine and zidovudine.
Tripelkombinationen af abacavir, lamivudin og zidovudin overgik lamivudin og zidovudin hos tidligere ubehandlede patienter med hensyn til varighed af effekten på virusbyrden over 48 uger.
In antiretroviral-naïve patients the triple combination of abacavir, lamivudine and zidovudine was superior in terms of durability of viral load response over 48 weeks to lamivudine and zidovudine.
70% af patienterne.
In a similar patient population durability of antiviral response over 120 weeks was demonstrated in approximately 70% of subjects.
90%, heraf 80% med < 50 kopier/ ml efter 24 ugers behandling.
In antiretroviral-naive patients treated with a combination of abacavir, lamivudine, zidovudine and efavirenz in a small, ongoing, open label pilot study, the proportion of patients with undetectable viral load (< 400 copies/ ml) was approximately 90% with 80% having < 50 copies/ ml after 24 weeks of treatment.