natgillin/translations-raw huggingface dataset:
Der findes ingen fyldestgørende, gennemkontrollerede studier, hvori der indgår gravide kvinder.
There are no adequate and well-controlled studies in pregnant women.
4. 4).
Caution should be exercised when prescribing VIRAMUNE to pregnant women (see section 4.4).
4. 4).
As hepatotoxicity is more frequent in women with CD4 cell counts above 250 cells/ mm3, these conditions should be taken in consideration on therapeutic decision (see section 4.4).
4. 4 og 4. 5).
Women of childbearing potential should not use oral contraceptives as the sole method for birth control, since nevirapine might lower the plasma concentrations of these medications (see sections 4.4 & 4.5).
Det anbefales, at HIV- smittede mødre ikke ammer deres børn for at undgå risiko for postnatal overførsel af HIV og at mødre bør afbryde amningen, hvis de behandles med VIRAMUNE.
It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving VIRAMUNE.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøjer eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
De hyppigst rapporterede bivirkninger relateret til VIRAMUNE behandling, på tværs af alle kliniske forsøg, var udslæt, allergiske reaktioner, hepatitis, leverfunktionstests uden for normalområdet, kvalme, opkastninger, diarré, abdominalsmerter, træthed, feber, hovedpine og myalgi.
The most frequently reported adverse reactions related to VIRAMUNE therapy, across all clinical trials, were rash, allergic reactions, hepatitis, abnormal liver function tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache and myalgia.
Postmarketing erfaring har vist, at de alvorligste bivirkninger er Stevens- Johnson syndrom og toksisk epidermal nekrolyse og alvorlig hepatitis/ leversvigt og overfølsomhedsreaktioner, karakteriseret ved udslæt med konstitutionelle symptomer, såsom feber, artralgi, myalgi, lympadenopati samt organpåvirkning, såsom hepatitis, eosinofili, granulocytopeni og nedsat nyrefunktion.
The postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome and toxic epidermal necrolysis and serious hepatitis/ hepatic failure and hypersensitivity reactions, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
4. 4).
The first 18 weeks of treatment is a critical period which requires close monitoring (see section 4.4).
Følgende bivirkninger, som kan være forårsaget af indgivelsen af VIRAMUNE, er blevet rappoteret.
The following adverse reactions which may be causally related to the administration of VIRAMUNE have been reported.
De estimerede frekvenser er baseret på poolede data fra de kliniske forsøg og omfatter hændelser, der er vurderet til at være relateret til VIRAMUNE behandling.
The frequencies estimated are based on pooled clinical trial data for events considered related to VIRAMUNE treatment.
Meget almindelig (≥1/ 10) Almindelig (≥1/ 100 til, < 1/ 10) Ikke almindelig (≥1/ 1. 000 til, < 1/ 100) Sjælden (≥1/ 10. 000 til, < 1/ 1. 000) Meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
Frequency is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Undersøgelser Almindelig:
Investigations Common
Leverfunktionstests uden for normalområdet
liver function tests abnormal
Blod - og lymfesystem Almindelig:
Blood and lymphatic system disorders Common Uncommon
Granulocyttopeni *
granulocytopenia* anaemia
Anæmi * I studie 1100. 1090 (n = 28), hvor de fleste af de rapporterede tilfælde kommer fra, forekom granulocytopeni hos flere patienter i placebogruppen (3, 3%) end i nevirapingruppen (2, 5%).
* In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine (2.5%).
Nervesystemet Almindelig:
14 Nervous system disorders Common
Mave- tarmkanalen
Gastrointestinal Common
Opkastning, diarré, abdominalsmerter, kvalme
disorders vomiting, diarrhoea, abdominal pain, nausea
Steven Johnsons syndrom / toksisk epidermal nekrolyse (0, 1%), angioneurotisk ødem, urticaria
Skin and subcutaneous tissue disorders Very common Uncommon oedema, urticaria
Ikke almindelig:
rash (13.6%) Stevens Johnson Syndrome/ toxic epidermal necrolysis (0.1%), angioneurotic
Myalgi Ledsmerte
Musculoskeletal and connective tissue disorders Common Uncommon
Almene symptomer
myalgia arthralgia
og reaktioner på administrationsstedet
General disorders and administration site conditions Common
Feber, træthed
fever, fatigue
Ikke kendt:
Immune system disorders Common Not known
Hypersensitivitet Medicinsk udslæt med eosinofili og systemiske symptomer, anafylaksi
hypersensitivity drug rash with eosinophilia and systemic symptoms, anaphylaxis
Sjælden:
Hepatobiliary disorders Common Uncommon Rare
Hepatitis (1, 4%) Gulsot Fulminant hepatitis
hepatitis (1.4%) jaundice hepatitis fulminant
Antiretroviral kombinationsbehandling er hos patienter med HIV associeret med omfordeling af kropsfedt (lipodystrofi) herunder tab af subkutant fedt perifert og i ansigtet, øget intraabdominal og visceral fedt, bryst hypertrofi og dorsocervical fedt ophobning (“ buffalo hump ”).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients including the loss of peripheral and facial subcutaneous fat, increased intra- abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Pancreatitis, perifer neuropati og trombocytopeni.
The following events have also been reported when VIRAMUNE has been used in combination with other anti-retroviral agents: pancreatitis, peripheral neuropathy and thrombocytopaenia.
Disse tilfælde er ofte forbundet med andre antiretrovirale midler og vil muligvis forventes at opstå, når VIRAMUNE anvendes i kombination med disse midler.
These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however it is unlikely that these events are due to VIRAMUNE treatment.
Det er dog usandsynligt at sådanne tilfælde skyldes behandlingen med VIRAMUNE Hepatorenale syndromer har i sjældne tilfælde været rapporteret.
Hepatic-renal failure syndromes have been reported rarely.
Især hos patienter med generelt anerkendte risikofaktorer er der rapporteret om tilfælde af osteonekrose, fremskreden HIV- sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Den mest almindelige kliniske toksisitet ved VIRAMUNE er udslæt, idet VIRAMUNE var årsag til udslæt hos 13, 6% af patienterne i kombinationsregimer i kontrollede studier.
The most common clinical toxicity of VIRAMUNE is rash, with VIRAMUNE attributable rash occurring in 13.6% of patients in combination regimens in controlled studies.
Udslæt er ofte milde til moderate, maculopapulære erytematøse hududslæt med eller uden kløe, lokaliseret til truncus, ansigt og ekstremiteterne.
Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or
Allergiske reaktioner (anafylaksi, angioødem og nældefeber) er blevet rapporteret.
Allergic reactions (anaphylaxis, angioedema and urticaria) have been reported.
Udslæt opstår selvstændigt eller i sammenhæng med overfølsomhedsreaktioner, karakteriseret ved udslæt med konstitutionelle symptomer, såsom feber, ledsmerter, muskelsmerter og lymfeknudesvulster sammen organpåvirkning, såsom hepatitis, eosinofili, granulocytopeni og nyredysfunktion.
Rashes occur alone or in the context of hypersensitivity reactions, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lympadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Nogle patienter, som blev behandlet med VIRAMUNE, udviklede alvorlige og livstruende hudreaktioner, herunder Stevens- Johnson syndrom (SJS) og toksisk epidermal nekrolyse (TEN).
Severe and life-threatening skin reactions have occurred in patients treated with VIRAMUNE, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Der er rapporteret fatale tilfælde af SJS, TEN og overfølsomhedsreaktioner.
Fatal cases of SJS, TEN and hypersensitivity reactions have been reported.
4. 4.).
The majority of severe rashes occurred within the first 6 weeks of treatment and some required hospitalisation, with one patient requiring surgical intervention (see section 4.4).
ALAT, ASAT, GGT, total bilirubin og alkalisk fosfatase.
The most frequently observed laboratory test abnormalities are elevations in liver function tests (LFTs), including ALAT, ASAT, GGT, total bilirubin and alkaline phosphatase.
Asymptomatisk elevation af GGT - niveau er de hyppigste.
Asymptomatic elevations of GGT levels are the most frequent.
Tilfælde af hepatitis (alvorlig og livstruende hepatoksicitet, inkl. fatal fulminant hepatitis) er blevet rapporteret for patienter behandlet med VIRAMUNE.
Cases of hepatitis (severe and life-threatening hepatoxicity, including fatal fulminant hepatitis) have been reported in patients treated with VIRAMUNE.
Den bedste forudsigelse for et alvorligt levertilfælde var 0eleverede baseline leverfunktionstests.
The best predictor of a serious hepatic event was elevated baseline liver function tests.
15 Pædiatriske patienter
Paediatric population
På baggrund af erfaring fra kliniske forsøg med 361 pædiatriske patienter, hvor hovedparten fik kombinationsbehandling med ZDV og/ eller ddl, er de bivirkninger, som hyppigst er relateret til VIRAMUNE tilsvarende dem, som er observeret hos voksne.
Based on clinical trial experience of 361 paediatric patients the majority of which received combination treatment with ZDV or/ and ddI, the most frequently reported adverse events related to VIRAMUNE were similar to those observed in adults.
I et åbent, klinisk forsøg (ACTG 180) blev granulocytopeni vurderet som lægemiddelrelateret hos 5/ 37 (13, 5%) af patienterne.
In an open-label clinical trial (ACTG 180) granulocytopenia assessed as drug- related occurred in 5/ 37 (13.5%) of patients.
I ACTG 245, et dobbeltblindt, placebokontrolleret forsøg, var forekomsten af alvorlig, lægemiddelrelateret granulocytopeni 5/ 305 (1, 6%).
In ACTG 245, a double-blind placebo controlled study, the frequency of serious drug-related granulocytopenia was 5/ 305 (1.6%).
Isolerede tilfælde af Stevens- Johnson syndrom eller Stevens- Johnson/ toksisk epidermal nekrolyse overgangssyndrom er blevet rapporteret hos denne befolkningsgruppe.
Isolated cases of Stevens- Johnson syndrome or Stevens-Johnson/ toxic epidermal necrolysis transition syndrome have been reported in this population.
Der findes ingen kendt antidot i tilfælde af overdosering af VIRAMUNE.
There is no known antidote for VIRAMUNE overdosage.
Tilfælde af VIRAMUNEoverdosering efter indtagelse af doser mellem 800- 6000 mg/ dag i op til 15 dage har været rapporteret.
Cases of VIRAMUNE overdose at doses ranging from 800 to 6000 mg per day for up to 15 days have been reported.
Alle disse hændelser fortog sig efter ophør af VIRAMUNE.
All of these effects subsided following discontinuation of VIRAMUNE.
NNRTI (non- nukleotid- reverse- transcriptase- hæmmer), ATC kode J 05 AG 01.
NNRTI (non-nucleoside reverse transcriptase inhibitors), ATC code J05AG01.
Virkningsmekanisme Nevirapin er en ikke- nukleosid reverse transcriptase hæmmer (NNRTI) af HIV- 1.
Mechanism of Action Nevirapine is a NNRTI of HIV-1.
Nevirapin bindes direkte til reverse transcriptase og blokerer den RNA- afhængige og DNA- afhængige DNA polymeraseaktivitet ved at forårsage en afbrydelse af enzymets katalytiske sted.
Nevirapine binds directly to reverse transcriptase and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.
Aktiviteten af nevirapin konkurrerer ikke med template eller nukleoside trifosfater.
The activity of nevirapine does not compete with template or nucleoside triphosphates.
HIV- 2 reverse transcriptase og eukaryotisk DNA polymeraser (såsom human DNA polymeraserne α, ß, γ, eller δ) hæmmes ikke af nevirapin.
HIV-2 reverse transcriptase and eukaryotic DNA polymerases (such as human DNA polymerases α, β, γ, or δ) are not inhibited by nevirapine.
In vitro HIV- følsomhed Nevirapins antivirale aktivitet er blevet målt in vitro i forskellige cellerækker, herunder perifere mononuklear blodceller, monocytderiverede makrofager og lymfoblastoide cellerækker.
The in vitro antiviral activity of nevirapine has been measured in a variety of cell lines including peripheral blood mononuclear cells, monocyte derived macrophages, and lymphoblastoid cell lines.
I nyere studier, hvor der er anvendt humane navlestrengsblodlymfocytter og human- embryonale nyre 293 - celler, er der fundet EC50- værdier (koncentration for 50% hæmmet) fra 14- 302 nM mod laboratorium og klinisk isolerede HIV- 1.
In recent studies using human cord blood lymphocytes and human embryonic kidney 293 cells, EC50 values (50% inhibitory concentration) ranged from 14-302 nM against laboratory and clinical isolates of HIV-1.
Nevirapin viste antiviral aktivitet in vitro mod gruppe M HIV- 1- isolater fra typerne A, B, C, D, F, G og H, og de cirkulerende rekombinante former (CRF), CRF01_ AE, CRF02_ AG og CRF12_ BF (median EC50 værdi på 63 nM).
Nevirapine exhibited antiviral activity in vitro against group M HIV-1 isolates from clades A, B, C, D, F, G, and H, and circulating recombinant forms (CRF), CRF01_AE, CRF02_AG and CRF12_BF (median EC50 value of 63 nM).
Nevirapin havde ingen antiviral aktivitet in vitro mod isolater fra gruppe O HIV- 1 og HIV- 2.
Nevirapine had no antiviral activity in vitro against isolates from group O HIV-1 and HIV-2.
Nevirapin viste additiv synergistisk anti- HIV- 1- aktivitet i kombination med proteasehæmmerne amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir og tipranavir og NRTIerne abacavir, didanosin, emtricitabin, lamivudin, stavudin, tenofovir og zidovudin.
Nevirapine in combination with efavirenz exhibited a strong antagonistic anti-HIV-1 activity in vitro (see section 4.5) and was additive to antagonistic with the protease inhibitor ritonavir or the fusion inhibitor enfuvirtide. Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
Nevirapins anti- HIV- 1- aktivitet blev in vitro hæmmet af anti- HBV- midlet adefovir og af anti- HCV- midlet ribavirin
The anti-HIV-1 activity of nevirapine was antagonized by the anti-HBV drug adefovir and by the anti-HCV drug ribavirin in vitro.
Resistens HIV- isolater med reduceret følsomhed (100- 250 gange) overfor nevirapin forekommer in vitro.
Resistance HIV isolates with reduced susceptibility (100 to 250-fold) to nevirapine emerge in vitro.
I uge 8 i monoterapi med
Phenotypic and genotypic changes occur in HIV isolates from patients treated with VIRAMUNE or VIRAMUNE + zidovudine over one to 12 weeks.
16 VIRAMUNE havde 100% af de testede patienter HIV- isolater med en > 100 gange mindre følsomhed overfor nevirapin uanset dosis.
By week 8 of VIRAMUNE monotherapy, 100% of the patients tested had HIV isolates with a > 100-fold decrease in susceptibility to nevirapine, regardless of dose.
Kombinationsbehandlingen VIRAMUNE + zidovudin ændrede ikke frekvensen af forekomst af nevirapinresistente virus.
VIRAMUNE + zidovudine combination therapy did not alter the emergence rate of nevirapine- resistant virus.
Genotypisk og fænotypisk resistens blev undersøgt hos patienter som modtog VIRAMUNE i triple og dobbelt behandling i stofkombinationsbehandling, og i den ikke - VIRAMUNE sammenligningsgruppe fra INCAS- studiet.
Genotypic and phenotypic resistance was examined for patients receiving VIRAMUNE in triple and double therapy drug combination therapy, and in the non-VIRAMUNE comparative group from the INCAS study.
Antiretrovirale naive emner med CD4 celletælling på 200- 600/ mm3 blev behandlet med enten VIRAMUNE + ZDV (n=46), ZDV + ddl (n=51) eller VIRAMUNE + ZDV + ddl (n=51) og fulgt i 52 uger eller længere med behandling.
Antiretroviral naive subjects with CD4 cells counts of 200-600/ mm3 were treated with either VIRAMUNE + zidovudine (n = 46), zidovudine + didanosine (n = 51) or VIRAMUNE + zidovudine + didanosine (n = 51) and followed for 52 weeks or longer on therapy.
Virologiske evaluationer blev udført ved baseline, 6 eller 12 måneder.
Virologic evaluations were performed at baseline, six months and 12 months.
Den udførte fænotypiske resistenstest krævede et minimum på 1. 000 kopier/ ml HIV RNA for at kunne behandles virussen.
The phenotypic resistance test performed required a minimum of 1000 copies/ ml HIV RNA in order to be able to amplify the virus.
I de tre studier, havde respektivt 16, 19 og 28 patienter evaluerbare baseline isolater og blev derfor i studiet i mindst 24 måneder.
Of the three study groups, 16, 19 and 28 patients respectively had evaluable baseline isolates and subsequently remained in the study for at least 24 weeks.
Ved baseline var der 5 sager med fænotypisk resistens til nevirapin; IC50værdierne var 5- 6, 5 gange stigende i 3 og > 100 gange i 2.
At baseline, there were five cases of phenotypic resistance to nevirapine; the IC50 values were 5 to 6.5-fold increased in three and > 100 fold in two.
Efter 24 uger, var alle tilgængelige helbredelige isolater hos patienter som modtog nevirapin modstandsdygtige over denne agent, mens 18/ 21 (86%) patienter bar på sådanne isolater i 30- 60 uger.
At 24 weeks, all available isolates recoverable from patients receiving nevirapine were resistant to this agent, while 18/ 21 (86%) patients carried such isolates at 30-60 weeks.
I 16 emner var viral undertrykkelse under grænser for påvisning (< 20 kopier/ ml = 14, < 400 kopier/ ml = 2).
In 16 subjects viral suppression was below the limits of detection (< 20 copies/ ml = 14, < 400 copies/ ml = 2).
Forudsat at undertrykkelse < 20 kopier/ ml medfører nevirapin - modtagelighed af virussen, havde 45% (17/ 38) af patienterne virus målt til eller tilskrevet at være modtagelige overfor nevirapin.
Assuming that suppression below < 20 copies/ ml implies nevirapine susceptibility of the virus, 45% (17/ 38) of patients had virus measured or imputed to be susceptible to nevirapine.
Alle 11 emner som modtog VIRAMUNE + ZDV, som blev testet for fænotypisk resistens, var resistente overfor nevirapin i 6 måneder.
All 11 subjects receiving VIRAMUNE + zidovudine who were tested for phenotypic resistance were resistant to nevirapine by six months.
I hele observationsperioden blev der set et tilfælde af ddl- resistens.
Over the entire period of observation, one case of didanosine resistance was seen.
Zidovudin- resistens opstod som mere hyppig efter 30- 60 uger, specielt hos patienter som modtog dobbelt kombinationsbehandling.
Zidovudine resistance emerged as more frequent after 30 – 60 weeks, especially in patients receiving double combination therapy.
Baseret på stigningen i IC50 forekom ZDV- resistens lavere i VIRAMUNE + ZDV + ddl- gruppen end i de andre behandlingsgrupper.
Based on the increase in IC50, zidovudine resistance appeared lower in the VIRAMUNE + zidovudine + didanosine group than the other treatment groups.
Med respekt overfor NVP- resistens, bar alle isolater som var i rækkefølge mindst en mutation associeret med resistens, den mest almindelige enkelt ændring er K103N og Y181C.
With respect to nevirapine resistance, all isolates that were sequenced carried at least one mutation associated with resistance, the most common single changes being K103N and Y181C.
Kombinationer af mutationer blev fundet i 9 ud af de 12 observerede patienter.
Combinations of mutations were found in nine of the 12 patients observed.
Disse data fra INCAS illustrerer at brugen af meget aktive stofbehandlinger er associeret med en forsinkning i udviklingen af antiretroviral stofresistens.
These data from INCAS illustrate that the use of highly active drug therapies is associated with a delay in the development of antiretroviral drug resistance.
Den kliniske relevans af fænotypiske og genotypiske ændringer i forbindelse med behandling med VIRAMUNE er ikke etableret.
The clinical relevance of phenotypic and genotypic changes associated with VIRAMUNE therapy has not been established.
Foruden ovenstående data eksisterer der risiko for hurtig udvikling resistens overfor NNRTIer i tilfælde af virologisk svigt.
17 In addition to the data presented above, there exists a risk of rapid emergence of resistance to NNRTIs in case of virological failure.
Krydsresistens Hurtig udvikling af HIV- stammer, som er krydsresistente over for NNRTIs er observeret in vitro.
Cross-resistance Rapid emergence of HIV strains which are cross-resistant to NNRTIs has been observed in vitro.
Data angående krydsresistens mellem NNRTI nevirapin og nukleoside analoge reverse transcriptase hæmmere er meget begrænsede.
Data on cross-resistance between the NNRTI nevirapine and NRTIs are very limited.
Hos fire patienter med zidovudinresistente isolater in vitro, bevaredes modtageligheden for nevirapin og hos 6 patienter med nevirapinresistente isolater, bevaredes modtageligheden for zidovudin og didanosin.
In four patients, zidovudine-resistant isolates tested in vitro retained susceptibility to nevirapine and in six patients, nevirapine-resistant isolates were susceptible to zidovudine and didanosine.
Krydsresistens mellem nevirapin og HIV proteasehæmmere er usandsynlig fordi de involverede enzymmål er forskellige.
Cross-resistance between nevirapine and HIV PIs is unlikely because the enzyme targets involved are different.
Krydsresistens mellem de for tiden registrerede NNRTI’ er er bred.
Cross-resistance among the currently registered NNRTIs is broad.
Nogle genotypisk resistens data indikerer, at hos de fleste patienter resistente for NNRTI, findes virale anlæg for kryds- resistens til de andre NNRTI’ er.
Some genotypic resistance data indicate that in most patients failing NNRTI, viral strains express cross-resistance to the other NNRTIs.
De i dag tilgængelige data understøtter ikke sekventiel brug af NNRTI’ er.
The currently available data do not support sequential use of NNRTIs.
Farmakodynamiske virkninger VIRAMUNE er blevet evalueret i både behandlingsnaive og tidligere behandlede patienter.
Pharmacodynamic Effects VIRAMUNE has been evaluated in both treatment naive and treatment experienced patients.
Resultater fra et forsøg (ACTG 241) evaluerede triple behandling med VIRAMUNE, zidovudin og didanosin sammenlignet med zidovudin + didanosin, hos 398 HIV- 1 smittede patienter (gennemsnitlig 153 CD4+ celler mm3; plasma HIV- 1 RNA 4, 59 log10 kopier/ ml) som havde modtaget mindst 6 måneders behandling af nukleosid analog behandling forud for indkluderingen (gennemsnitlig 115 uger).
Results from a trial (ACTG 241) evaluated triple therapy with VIRAMUNE, zidovudine and didanosine compared to zidovudine + didanosine, in 398 HIV-1 infected patients (mean baseline 153 CD4+ cells/ mm3; plasma HIV1 RNA 4.59 log10 copies/ ml), who had received at least 6 months of NRTI therapy prior to enrolment (median 115 weeks).