natgillin/translations-raw huggingface dataset:
Non- nukleosidanaloge reverse transcriptasehæmmere (NNRTI) Efavirenz 600 mg en gang daglig
Non-nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD
Der behøves ingen dosisjustering
No dosage adjustment needed
Delavirdine 400 mg 3 gange daglig
Delavirdine 400 mg TID Nevirapine
Sikkerhed af kombinationen er ikke fastslået; kombinationen anbefales ikke.
Safety of combination not established; combination not recommended.
Metaboliske enzyminducere Rifabutin 300 mg en gang daglig
Metabolic enzyme inducers Rifabutin 300 mg QD
Rifabutin 150 mg en gang daglig Rifabutin 150 mg en gang daglig
Rifabutin 150 mg QD
750 mg 3 gange daglig 1250 mg 2 gange daglig
750 mg TID
↓ 23% ↔
↓ 23%
gange daglig eller 1250 mg 2 gange daglig og rifabutin er co- administreret.
1250 mg BID and rifabutin are co-administered.
↑ Indikerer stigning, ↓ indikerer fald, ↔ indikerer minimal ændring (< 10%).
↑ Indicates increase, ↓ indicates decrease, ↔ indicates minimal change (< 10%)
Der er ikke set behandlingsrelaterede bivirkninger i reproduktions- toksikologiske undersøgelser på rotter i doser, som medfører systemisk eksponering for lægemidlet svarende til den kliniske dosis.
No treatment-related adverse reactions were seen in animal reproductive toxicity studies in rats at doses providing systemic exposure comparable to that observed with the clinical dose.
For at undgå overførelse af hiv, anbefales det at hiv- smittede kvinder ikke under nogen omstændigheder ammer deres spædbørn.
It is recommended that HIV-infected women must not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Sikkerheden af VIRACEPT 250 mg tabletter blev undersøgt i kontrollerede kliniske studier, som omfattede mere end 1300 patienter. De fleste patienter fik enten 750 mg tre gange daglig alene eller i kombination med nukleosidanaloger eller 1250 mg to gange daglig i kombination med nukleosidanaloger.
The majority of patients in these studies received either 750 mg TID either alone or in combination with nucleoside analogues or 1250 mg BID in combination with nucleoside analogues.
Følgende uønskede hændelser, der i det mindste har en mulig sammenhæng med nelfinavir (dvs. bivirkninger) og som rapporteredes hyppigst var: diaré, kvalme og udslæt.
The following adverse events with an at least possible relationship to nelfinavir (i.e. adverse reactions) were reported most frequently: diarrhoea, nausea, and rash.
Bivirkninger fra kliniske studier er anført i tabel 3.
Adverse reactions in clinical studies are summarised in Table 3.
Listen indeholder også tydelige laboratorie abnormaliteter, som har været observeret med nelfinavir (ved 48 uger).
The list also includes marked laboratory abnormalities that have been observed with nelfinavir (at 48 weeks).
10 Tabel 3:
Table 3:
Forekomst af bivirkninger og tydelige laboratorie abnormaliteter fra fase II og III studier.
Incidences of Adverse Reactions and marked laboratory abnormalities from the phase II and phase III studies.
(Meget almindelige (≥ 10%); almindelige (≥ 1% og < 10%)) Organklasser Bivirkningsfrekvens
(Very common (≥ 10%); common (≥ 1% and < 10%) Body System Frequency of Reaction
Grad 3 & 4
Grades 3 & 4
Diaré Kvalme, flatulens
Diarrhoea Nausea, flatulence,
Almindelig Undersøgelser
Skin and subcutaneous tissue disorders Common Investigations
Øget alanin- aminotransferase, øget aspartat- aminotransferase, neutropeni, øget blod keratin- phosphokinase, nedsat neutrofil antal.
Increased alanine aminotransferase, increased aspartate aminotransferase, neutropenia, blood creatinine phosphokinase increased, neutrophil count decreased
Et samlet antal på cirka 400 patienter fik nelfinavir i pædiatriske behandlingsforsøg (studie 524, 556, PACTG377/ 725 og PENTA- 7) i op til 96 uger.
A total of approximately 400 patients received nelfinavir in paediatric treatment trials (Studies 524, 556, PACTG 377/725, and PENTA-7) for up to 96 weeks.
Neutropeni/ leukopeni var den mest observerede laboratorie abnormalitet.
Neutropenia/leukopenia was the most frequently observed laboratory abnormality.
Under disse forsøg var der færre end 13% af alle patienterne, som afbrød behandlingen på grund af uønskede hændelser.
During these trials less than 13% of patients in total discontinued treatment due to adverse events.
4. 8, og for hvilke en kausal sammenhæng med nelfinavir ikke kan udelukkes.
Post-marketing experience with nelfinavir Serious and non-serious adverse reactions from post-marketing spontaneous reports (where nelfinavir was taken as the sole protease inhibitor or in combination with other antiretroviral therapy), not mentioned previously in section 4.8, for which a causal relationship to nelfinavir cannot be excluded, are summarised below.
Ikke almindelig (≥ 0, 1% - ≤ 1%): overfølsomhed inklusive bronkospasme, pyreksi, kløe, ansigtsødem og udslæt (makulopapulær eller bulløs).
Uncommon (≥ 0.1% - ≤ 1%): hypersensitivity including bronchospasm, pyrexia, pruritus, facial oedema and rash (maculopapular or bullous).
Sjælden (≥ 0, 01% - ≤ 0, 1%): ny diabetes mellitus eller eksacerbation af eksisterende diabetes mellitus.
Rare (≥ 0.01% - ≤ 0.1%): new onset diabetes mellitus, or exacerbation of existing diabetes mellitus.
Ikke almindelig – sjælden (≥ 0, 01% - ≤ 1%): antiretroviral kombinationsbehandling er, hos patienter med hiv, associeret med omfordeling af kropsfedt (lipodystrofi), inklusive tab af perifert subkutant fedt og subkutant fedt i ansigtet, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervikal fedtakkumulering (bøffel- pukkel).
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).
Sjælden (≥ 0, 01% - ≤ 0, 1%): øget spontan blødning hos patienter med hæmofili.
Rare (≥ 0.01% - ≤ 0.1%): increased spontaneous bleeding in patients with haemophilia.
Ikke almindelig (≥ 0, 1% - ≤ 1%): opkastning; pancreatitis/ forhøjet blodamylase.
Rare (≥ 0.01% - ≤ 0.1%): abdominal distension, Uncommon (≥ 0.1% - ≤ 1%): vomiting, pancreatitis/blood amylase increased.
Sjælden (≥ 0, 01% - ≤ 0, 1%: hepatitis, abnorme leverenzymer og ikterus, når nelfinavir er anvendt i kombination med andre antiretrovirale stoffer.
Rare (≥ 0.01% - ≤ 0.1%): hepatitis, abnormal liver enzymes and jaundice when nelfinavir is used in combination with other antiretroviral agents.
Meget sjælden (≤ 0, 01%), herunder enkeltstående indberetninger: erythema multiforme.
Erythema multiforme.
11 Knogler, led, muskler og bindevæv:
Musculoskeletal and connective tissue disorders:
Sjælden (≥ 0, 01% - ≤ 0, 1%):
Rare (≥ 0.01% - ≤ 0.1%):
Forhøjet blod- kreatinfosfokinase, myalgi, myositis og rhabdomyolyse er rapporteret med PI, specielt i kombination med nukleosidanaloger.
Blood creatine phosphokinase increased, myalgia, myositis and rhabdomyolysis have been reported with PIs, particularly in combination with nucleoside analogues.
Frekvenserne for bivirkningerne er ukendte, da disse data kommer fra det spontane rapporteringssystem: hypertriglyceridæmi, anæmi, forhøjet mælkesyre i blodet og pneumoni.
As these data come from the spontaneous reporting system, the frequency of the adverse reactions is unknown: hypertriglyceridemia, anaemia, blood lactic acid increased, and pneumonia.
Der er rapporteret om tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv- sygdom eller langvarig kombinationsbehandling med antiretroviral 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).
Antiretroviral kombinationsbehandling er blevet associeret med metaboliske abnormaliteter så som hypertriglyceridæmi, hyperkolesterolæmi, insulinresistens, hyperglykæmi og hyperlaktæmi.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactaemia.
Hos hiv- inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
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.
5. 3).
Overdoses of nelfinavir could theoretically be associated with prolongation of the QT-interval of the ECG (see also section 5.3).
Farmakoterapeutisk klassifikation: direkte virkende antivirale lægemidler, ATC kode:
Pharmacotherapeutic group:direct acting antivirals, ATC code:
J05 A E04.
J05AE04.
Virkningsmekanisme:
12 Mechanism of action:
Hiv protease er et enzym, som er nødvendigt for den proteolytiske spaltning af virus polyprotein prækursorer til de individuelle proteiner, som findes i smitsom hiv.
HIV protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors to the individual proteins found in infectious HIV.
Spaltningen af disse virus polyproteiner er essentiel for modning af en smitsom virus.
The cleavage of these viral polyproteins is essential for the maturation of infectious virus.
Nelfinavir bindes reversibelt til den aktive del af hiv protease og forebygger spaltning af polyproteiner, hvilket medfører dannelsen af umodne, ikke- smittende viruspartikler.
Nelfinavir reversibly binds to the active site of HIV protease and prevents cleavage of the polyproteins resulting in the formation of immature non-infectious viral particles.
Nelfinavirs antivirale aktivitet in vitro er demonstreret i både akutte og kroniske hiv infektioner i lymfoblastoide cellelinjer, perifere blodlymfocyter og monocyter/ makrofager.
Antiviral activity in vitro: the antiviral activity of nelfinavir in vitro has been demonstrated in both HIV acute and chronic infections in lymphoblastoid cell lines, peripheral blood lymphocytes and monocytes/macrophages.
Nelfinavir viste sig at være aktiv over for en lang række laboratoriestammer og kliniske rendyrkninger af hiv- 1 og hiv- 2 stammen ROD.
Nelfinavir was found to be active against a broad range of laboratory strains and clinical isolates of HIV-1 and the HIV-2 strain ROD.
EC95 (95% effektiv koncentration) for nelfinavir var fra 7 til 111 nM (middelværdi på 58 nM).
The EC95 (95% effective concentration) of nelfinavir ranged from 7 to 111 nM (mean of 58 nM).
Nelfinavir demonstrerede additive til synergistiske virkninger over for hiv i kombination med de reverse transcriptasehæmmere zidovudin (ZDV), lamivudin (3TC), didanosin (ddI), zalcitabin (ddC) og stavudin (d4T) uden øget cytotoksicitet.
Nelfinavir demonstrated additive to synergistic effects against HIV in combination with reverse transcriptase inhibitors zidovudine (ZDV), lamivudine (3TC), didanosine (ddI), zalcitabine (ddC) and stavudine (d4T) without enhanced cytotoxicity.
Lægemiddelresistens:
Drug Resistance:
Hiv- isolater med reduceret følsomhed over for nelfinavir er blevet isoleret in vitro.
HIV isolates with reduced susceptibility to nelfinavir have been selected in vitro.
Der blev opdaget
HIV isolates from selected patients treated with nelfinavir alone or in combination with reverse transcriptase inhibitors were monitored for phenotypic (n=19) and genotypic (n=195, 157 of which were assessable) changes in clinical trials over a period of 2 to 82 weeks.
12 en eller flere virale proteasemutationer ved aminosyrepositionerne 30, 35, 36, 46, 71, 77 og 88 hos > 10% af patienterne med vurderbare isolater.
One or more viral protease mutations at amino acid positions 30, 35, 36, 46, 71, 77 and 88 were detected in > 10% of patients with assessable isolates.
Hos patienter, der får nelfinavir monoterapi eller nelfinavir i kombination med zidovudin og lamivudin eller stavudin, var den overordnede hyppighed af D30N mutationer i den virale protease hos vurderbare isolater (n=157) 54, 8%.
The overall incidence of the D30N mutation in the viral protease of assessable isolates (n=157) from patients receiving nelfinavir monotherapy or nelfinavir in combination with zidovudine and lamivudine or stavudine was 54.8%.
Den overordnede hyppighed af andre mutationer relateret til primær PI resistens var 9, 6% for L90M substitution, mens substitutioner ikke blev set ved positionerne 48, 82 og 84.
The overall incidence of other mutations associated with primary PI resistance was 9.6% for the L90M substitution where as substitutions at 48, 82 and 84 were not observed.
Krydsresistens:
Cross resistance:
Hiv- isolater fra 5 patienter i behandling med nelfinavir viste nedsættelse (med en faktor 5 til 93) af følsomheden overfor nelfinavir in vitro sammenlignet med matchede isolater ved baseline, men ingen tilsvarende nedsættelse af følsomheden overfor indinavir, ritonavir, saquinavir eller amprenavir in vitro.
HIV isolates obtained from 5 patients during nelfinavir therapy showed a 5- to 93-fold decrease in nelfinavir susceptibility in vitro when compared to matched baseline isolates but did not demonstrate a concordant decrease in susceptibility to indinavir, ritonavir, saquinavir or amprenavir in vitro.
Et hiv- isolat fra en patient, som fik saquinavir, viste nedsat følsomhed overfor saquinavir (med en faktor 7), men ingen tilsvarende nedsættelse af følsomheden overfor nelfinavir.
An HIV isolate obtained from a patient receiving saquinavir therapy showed decreased susceptibility to saquinavir (7- fold) but did not demonstrate a concordant decrease in susceptibility to nelfinavir.
Krydsresistens mellem nelfinavir og reverse transcriptasehæmmere er usandsynlig på grund af de forskellige involverede enzymers angrebspunkt.
Cross-resistance between nelfinavir and reverse transcriptase inhibitors is unlikely because different enzyme targets are involved.
Det er dokumenteret, at behandling med nelfinavir alene eller i kombination med andre antiretrovirus midler nedsætter virusbelastningen og øger CD4- celletællingen hos hiv- 1 seropositive patienter.
Clinical pharmacodynamic data: treatment with nelfinavir alone or in combination with other antiretroviral agents has been documented to reduce viral load and increase CD4 cell counts in HIV-1 seropositive patients.
Fald i hiv RNA observeret med nelfinavir monoterapi var mindre udpræget og af kortere varighed.
Decreases in HIV RNA observed with nelfinavir monotherapy were less pronounced and of shorter duration.
Nelfinavirs virkning (alene eller kombineret med andre antiretrovirale midler) på biologiske markører, CD4- celletal g virus RNA blev evalueret i adskillige undersøgelser af hiv- 1 smittede patienter.
The effects of nelfinavir (alone or combined with other antiretroviral agents) on biological markers of disease activity, CD4 cell count and viral RNA, were evaluated in several studies involving HIV-1 infected patients.
Effekten af BID- regimet er evalueret overfor TID- regimet med VIRACEPT 250 mg tabletter, hovedsageligt hos PI- naive patienter.
The efficacy of the BID regimen has been evaluated versus the TID regimen with VIRACEPT 250 mg tablets primarily in patients naïve to PIs.
En åben, randomiseret undersøgelse sammenlignede suppression af hiv RNA efter hhv. nelfinavir 1250 mg BID og nelfinavir 750 mg TID hos PI- naive patienter, som også fik stavudin (30- 40 mg BID) og lamivudin (150 mg BID).
A randomised open-label study compared the HIV RNA suppression of nelfinavir 1250 mg BID versus nelfinavir 750 mg TID in PI naïve patients also receiving stavudine (30-40 mg BID) and lamivudine (150 mg BID).
Antal patienter med hiv RNA under LOQ (sensitive og ultrasensitive assays) ved uge 48 Assay
13 Proportion of patients with HIV RNA below LOQ (sensitive and ultrasensitive assays) at Week 48 Assay
Analyse Observerede data
Analysis Observed data
Viracept BID (%) 135/ 164 (82%)
Viracept BID (%) 135/164 (82%)
Viracept TID (%) 146/ 169 (86%)
Viracept TID (%) 146/169 (86%)
LOCF ITT (NC = F) Observerede data
LOCF ITT (NC = F) Observed data
145/ 200 (73%) 135/ 200 (68%) 114/ 164 (70%)
145/200 (73%) 135/200 (68%) 114/164 (70%)
161/ 206 (78%) 146/ 206 (71%) 125/ 169 (74%)
161/206 (78%) 146/206 (71%) 125/169 (74%)
(- 14, +3) (- 12, +6) (- 14, +5)
(-14, +3) (-12, +6) (-14, +5)
Ultrasensitiv
Ultrasensitive LOCF= Last observation
LOCF= Last observation carried forward ITT = Intention to Treat NC = F: non- completers = behandlingssvigt
ITT = Intention to Treat NC = F: non-completers = failures
BID regimet viste statistisk signifikante højere peak nelfinavir plasma værdier versus TID regimet.
The BID regimen produced statistically significantly higher peak nelfinavir plasma levels versus the TID regimen.
Små, ikke statistisk signifikante forskelle blev observeret for andre farmakokinetiske parametre uden tendens til at farvorisere det ene regime frem for det andet.
Small, non-statistically significant differences were observed in other pharmacokinetic parameters with no trend favouring one regimen over the other.
I et studie af 297 hiv- 1 seropositive patienter som fik zidovudin og lamivudin sammen med nelfinavir (i to forskellige doser) eller zidovudin eller lamivudin alene, var gennemsnits baseline CD4 celletallet
In a study of 297 HIV-1 seropositive patients receiving zidovudine and lamivudine plus nelfinavir (2 different doses) or zidovudine and lamivudine alone, the mean baseline CD4 cell count was 288 cells/mm3 and the mean baseline plasma HIV RNA was 5.21 log10 copies/ml (160,394 copies/ml).
Gennemsnitsreduktion i plasma hiv RNA ved anvendelse af PCR assay (< 400 kopier/ ml) ved 24 uger var 2, 33 log10 i patienter, der fik kombinationsterapi med nelfinavir 750 mg tre gange daglig sammenlignet med 1, 34 log10 hos patienter, der alene fik zidovudin og lamivudin.
The mean decrease in plasma HIV RNA using a PCR assay (< 400 copies/ml) at 24 weeks was 2.33 log10 in patients receiving combination therapy with nelfinavir 750 mg TID, compared to 1.34 log10 in patients receiving zidovudine and lamivudine alone.
Efter 24 uger var der 81% og 8% af patienterne, hvis plasma- hiv RNA var faldet til under prøvens detektionsgrænse (< 400 kopier/ ml) i hhv. gruppen, der fik 750 mg nelfinavir 3 gange daglig sammen med zidovudin og lamivudin, og gruppen der fik zidovudin og lamivudin.
At 24 weeks, the percentage of patients whose plasma HIV RNA levels had decreased to below the limit of detection of the assay (< 400 copies/ml) were 81% and 8% for the groups treated with nelfinavir 750 mg TID plus zidovudine and lamivudine or zidovudine and lamivudine, respectively.
Middel- CD4 - celletallet efter 24 uger steg med hhv. 150 og 95 celler/ mm3i gruppen, der fik 750 mg nelfinavir tre gange daglig sammen med zidovudin og lamivudin sammenlignet med gruppen, der fik zidovudin og lamivudin.
Mean CD4 cell counts at 24 weeks were increased by 150 and 95 cells/mm3 for the groups treated with nelfinavir 750 mg TID plus zidovudine and lamivudine or zidovudine and lamivudine, respectively.
I denne gruppe steg CD4- celletallet med mere end 198 celler/ mm3 efter 48 uger.
At 48 weeks, approximately 75% of the patients treated with nelfinavir 750 mg TID plus zidovudine and lamivudine remained below the level of detection of the assay (< 400 copies/ml); mean increase in CD4 cell counts was 198 cells/mm3 at 48 weeks in this group.
Procentvis var der i begge arme lige mange patienter med bivirkninger, uanset sværhedsgrad og uanset sammenhæng med forsøgsmedicinen.
No important differences in safety or tolerability were observed between the BID and TID dosing groups, with the same proportion of patients in each arm experiencing adverse events of any intensity, irrespective of relationship to trial medication.
Plasmakoncentrationerne af visse hiv- 1 proteasehæmmere, som overvejende metaboliseres af CYP3A4, kan øges ved samtidig administration af lavdosis ritonavir, som hæmmer denne metabolisering.
Plasma levels of certain HIV-1 protease inhibitors, which are metabolised predominantly by CYP3A4, can be increased by the co-administration of low-dose ritonavir, which is an inhibitor of this metabolism.
Behandlingsregimerne for flere proteasehæmmere, som er subjekt for denne interaktion, kræver samtidig administration af lavdosis ritonavir (“ boosting ”) for at øge plasmakoncentrationerne og optimere den antivirale virkning.
Treatment paradigms for several protease inhibitors, which are subject to this interaction, require the co-administration of low-dose ritonavir (‘boosting’) in order to enhance plasma levels and optimise antiviral efficacy.
Plasmakoncentrationerne af nelfinavir, som fortrinsvis metaboliseres af CYP2C19 og kun delvis af CYP3A4, øges kun lidt ved samtidig administration af ritonavir, derfor synes samtidig administration af nelfinavir med lavdosis ritonavir ikke at være fordelagtigt.
Plasma levels of nelfinavir, which is metabolised predominantly by CYP2C19 and only partially by CYP3A4, are not greatly increased by co-administration with ritonavir, and therefore co-administration of nelfinavir with low-dose ritonavir does not appear to be beneficial.
To studier har sammenlignet sikkerhed og effekt af nelfinavir (ikke- boostet) med ritonavir- boostede proteasehæmmere, begge i kombination med andre antiretrovirale stoffer.
Two studies have compared the safety and efficacy of nelfinavir (unboosted) with ritonavir- boosted protease inhibitors, each in combination with other antiretroviral agents.
Studie M98- 863 er en randomiseret, dobbeltblindet undersøgelse med 653 antiretroviral - behandlingsnaive patienter, hvor lopinavir/ ritonavir (400/ 100 mg to gange daglig n=326) blev sammenlignet med nelfinavir (750 mg tre gange daglig, n=327), begge i kombination med lamivudin (150 mg to gange daglig) og stavudin (40 mg to gange daglig).
Study M98-863 is a randomised, double blind trial of 653 antiretroviral-naïve patients investigating lopinavir/ritonavir (400/100 mg BID n=326) compared to nelfinavir (750 mg TID n=327), each in combination with lamivudine (150 mg twice daily) and stavudine (40 mg twice daily).
4, 98 log10 kopier/ ml og 5, 01 log10 kopier/ ml i henholdsvis nelfinavir - og lopinavir/ ritonavirgrupperne.
Median baseline HIV-1 RNA was 4.98 log10 copies/ml and 5.01 log10 copies/ml in the nelfinavir and lopinavir/ritonavir treatment groups respectively.
Det mediane baseline CD4+ celletal var 232 celler/ mm3 i begge grupper.
Median baseline CD4+ cell count was 232 cells/mm3 in both groups.
Efter 48 uger havde 63% af nelfinavirpatienterne og 75% af lopinavir/ ritonavirpatienterne < 400 kopier/ ml hiv- 1 RNA, hvorimod 52% af nelfinavirpatienterne og 67% af lopinavir/ ritonavirpatienterne havde < 50 kopier/ ml hiv- 1 RNA (intent- to- treat, manglende = svigt).
At week 48, 63% nelfinavir and 75% lopinavir/ritonavir patients had HIV-1 RNA < 400 copies/ml, whereas 52% nelfinavir and 67% lopinavir/ritonavir patients had HIV-1 RNA < 50 copies/ml (intent-to-treat, missing = failure).
Den gennemsnitlige stigning fra baseline i CD4+ celletallet efter 48 uger var henholdsvis 195 celler/ mm3 og 207 celler/ mm3 i nelfinavir - og lopinavir/ ritonavirgrupperne.
The mean increase from baseline in CD4+ cell count at week 48 was 195 cells/mm3 and 207 cells/mm3 in the nelfinavir and lopinavir/ritonavir groups
Efter 48 ugers behandling havde en statistisk signifikant større del af patienterne i lopinavir/ ritonavir armen < 50 kopier/ ml hiv- 1 RNA sammenlignet med nelfinavir armen.
Through 48 weeks of therapy, a statistically significantly higher proportion of patients in the lopinavir/ritonavir arm had HIV-1 RNA < 50 copies/ml compared to the nelfinavir arm.