natgillin/translations-raw huggingface dataset:
4. 4).
Immune Reactivation Syndrome: 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).
Det vides ikke, om amprenavir kan fjernes ved peritoneal - dialyse eller hæmodialyse.
It is not known whether amprenavir can be removed by peritoneal dialysis or haemodialysis.
4. 8), og standard symptomatisk behandling iværksættes om nødvendigt.
If overdosage occurs, the patient should be monitored for evidence of toxicity (see section 4.8) and standard supportive treatment applied as necessary.
Antivirale midler; proteasehæmmer, ATC- kode:
Antivirals for systemic use, protease inhibitor, ATC Code:
Amprenavir er en kompetitiv hæmmer af HIV- 1- proteasen.
Amprenavir is a competitive inhibitor of the HIV-1 protease.
Amprenavir bindes til det aktive site på HIV- 1- proteasen og forebygger dermed spaltningen af viral gag og gag- pol polyprotein forstadier, og der dannes umodne, ikke- infektiøse viruspartikler.
Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
2 gange og plasma- Cτ, ss 4 til 6 gange, sammenlignet med registrerede værdier, når fosamprenavir administreres alene.
13 Co-administration of ritonavir with fosamprenavir increase plasma amprenavir AUC by approximately 2-fold and plasma C τ, ss by 4- to 6-fold, compared to values obtained when fosamprenavir is administered alone.
Administration af 700 mg fosamprenavir 2 gange daglig i kombination med 100 mg ritoavir 2 gange daglig resulterer i plasmakoncentrationer af amprenavir med proteinjusterede gennemsnitlige ratioer for Cmin/ IC50 og Cmin/ IC95 på henholdsvis 21, 7 (interval 1, 19- 240) og 3, 21 (interval 0, 26- 30, 0) (data fra studie APV30003 af patienter, der tidligere er behandlet med antiretrovirale midler).
Administration of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily results in plasma amprenavir concentrations (data from study APV30003 in antiretroviral experienced patients) which results in protein adjusted median ratios of Cmin/ IC50 and Cmin/ IC95 of 21.7 (range 1.19-240) and 3.21 (range 0.26-30.0), respectively.
13 Resistens
Resistance
Adskillige behandlingsregimer både med og uden samtidig administration af ritonavir er undersøgt i forbindelse med udviklingsprogrammet for amprenavir/ fosamprenavir.
a) ART-naïve or PI-naïve patients Various regimens have been assessed in the amprenavir/ fosamprenavir development programs with and without co-administration of ritonavir.
En resistensmutation forekom i alle 3 isolater: henholdsvis K20K/ R, I54I/ L og I93I/ L.
K20K/ R, I54I/ L and I93I/ L respectively
Den nuværende (Juli 2006) ANRS
The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/ V, or I50V, or at least four mutations among:
L10F/ I/ V, L33F, M36I, I54A/ L/ M/ S/ T/ V, I62V, V82A/ C/ F/ G, I84V og L90M.
L10F/ I/ V, L33F, M36I, I54A/ L/ M/ S/ T/ V, I62V, V82A/ C/ F/ G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
Nedsat følsomhed over for amprenavir var associeret med virus, som havde udviklet I50V, I84V, V32I+I47V eller I54M- mutationer.
Reduced susceptibility to amprenavir was associated with virus that had developed I50V or I84V or V32I+I47Vor I54M mutations.
Baseret på data fra 25 antiviral- naive patienter, der er blevet behandlet med et svigtende fosamaprenavirregime (hvoraf én udviste resistens over for lopinavir og saquinavir ved baseline og en anden over for tipranavir), frembringer resistensmønstret, som er forbundet med amprenavir, begrænset krydsresistens over for atazanavir/ ritonavir (tre ud af 25 isolater), darunavir/ ritonavir (fire ud af 25 isolater), indinavir/ ritonavir (en ud af 25 isolater), lopinavir/ ritonavir (tre ud af 24 isolater), saquinavir (tre ud af 24 isolater) og tipranavir/ ritonavir (fire ud af 24 isolater).
Based on data from twenty-five antiretroviral naïve patients failing a fosamprenavir containing regimen (one of whom showed Baseline resistance to lopinavir and saquinavir and another to tipranavir the resistance pathways associated with amprenavir produce limited cross-resistance to atazanavir/ ritonavir (three of 25 isolates), darunavir/ ritonavir (four of 25 isolates), indinavir/ ritonavir (one of 25 isolates), lopinavir/ ritonavir (three of 24 isolates, saquinavir (three of 24 isolates) and tipranavir/ ritonavir (four of 24 isolates).
Antallet af mutationer, der har betydning for PI- resistens, øges væsentligt, jo længere et regime med svigtende proteasehæmmere fortsættes.
The number of key PI-resistance mutations increases markedly the longer a failing PI-containing regimen is continued.
Krydsresistens mellem amprenavir og revers transkriptasehæmmere er usandsynlig, da angrebspunktet på enzymet er forskellig.
Cross-resistance between amprenavir and reverse transcriptase inhibitors is unlikely to occur because the enzyme targets are different.
Telzir frarådes som monoterapi på grund af hurtig forekomst af resistente virus.
Telzir is not recommended for use as monotherapy, due to the rapid emergence of resistant virus.
Klinisk erfaring
15 Clinical experience
Den kliniske erfaring med fosamprenavir boosted med ritonavir er hovedsageligt baseret på tre åbne studier.
Clinical experience with fosamprenavir boosted with ritonavir is mainly based on three open label studies.
To studier udført hos antiretroviral- naive patienter; et i sammenligning med nelfinavir (studie APV30002) og et i sammenligning med lopinavir/ ritonavir (studie ESS100732), samt et studie hos antiretroviral- experienced patienter i sammenligning med lopinavir/ ritonavir (studie APV30003).
Two studies performed in antiretroviral naïve patients, one in comparison to nelfinavir (study APV30002) and one in comparison to lopinavir / ritonavir (study ESS100732), and one study in antiretroviral experienced patients, in comparison to lopinavir / ritonavir (study APV30003).
Antiretroviralnaive voksne patienter
Antiretroviral Naïve Adult Patients
Over 48 uger viste behand - lingen effekt sammenlignelig med nelfinavir (1250 mg) administreret 2 gange daglig i kombination med abacavir og lamivudin (300 og 150 mg 2 gange daglig).
In antiretroviral naïve patients in APV30002, fosamprenavir (1400 mg) given once daily in combination with low dose ritonavir (200 mg) as part of a triple regimen including abacavir (300 mg twice daily) and lamivudine (150 mg twice daily) showed similar efficacy over 48 weeks compared to nelfinavir (1250 mg) given twice daily in combination with abacavir with lamivudine (300 and 150 mg twice daily).
15 Der blev vist ligeværdighed mellem fosamprenavir i kombination med ritonavir og nelfinavir baseret på den del af patienterne som opnåede HIV- 1 RNA niveauer i plasma større end 400 kopier/ ml ved uge 48 (primære end- point).
Non-inferiority was demonstrated between fosamprenavir with ritonavir and nelfinavir based on the proportions of patients achieving plasma HIV-1 RNA levels < 400 copies/ ml at 48 weeks (primary endpoint).
I ITT (Rebound or Discontinuation = failure) analysen fik 69% (221/ 322) af de patienter som fik fosamprenavir i kombination med ritonavir mere end 400 kopier / ml sammenlignet med 68% (221/ 327) af de patienter som fik nelfinavir.
In the ITT (Rebound or Discontinuation = Failure) analysis, 69% (221 / 322) of patients receiving fosamprenavir with ritonavir achieved < 400 copies/ ml compared to 68% (221 / 327) of patients receiving nelfinavir.
Median plasma HIV- 1 RNA var ved uge 48 faldet med 3, 1 log10 kopier/ ml og 3, 0 log10 kopier/ ml for henholdsvis armen med fosamprenavir i kombination med ritonavir og armen med nelfinavir.
The median plasma HIV-1 RNA had decreased by 3.1 log10 copies/ ml and 3.0 log10 copies/ ml at Week 48 in the fosamprenavir with ritonavir and nelfinavir arms respectively.
Det mediane CD4- celletal var lavt ved baseline (170 celler/ mm3totalt) for begge grupper.
The median baseline CD4 cell count was low (170 cells/ mm3 overall) in both groups.
Medianstigningen over baseline ved uge 48 var på henholdsvis +203 og +207 celler/ mm3.
CD4 + cell counts increased in both the fosamprenavir with ritonavir and nelfinavir groups, with median increases above baseline being similar in magnitude at Week 48 (+ 203 and + 207 cells/ mm3, respectively).
Disse data viser, at fosamprenavir i kombination med ritonavir (henholdsvis 1400 og 200 mg OD) 1 gang daglig hos antiretroviralnaive patienter har samme virkning som nelfinavir administreret 2 gange daglig.
The data presented above demonstrates that the once daily regimen of fosamprenavir with ritonavir (1400 / 200 mg OD) in antiretroviral naïve patients showed similar efficacy compared to nelfinavir given twice daily.
På grund af studiets design (åben versus nelfinavir) blev der ikke demonstreret tilstrækkelig effekt hos antiretrovirale naive patienter til at støtte et én gang daglig regime af fosamprenavir med ritonavir.
This study in view of its design (open label versus nelfinavir) did not provide a sufficiently robust efficacy demonstration in antiretroviral naïve patients to support the once daily regimen of fosamprenavir with ritonavir.
4. 2).
As a conservative approach, based on enhanced amprenavir Ctrough levels, the twice daily dosing regimen of fosamprenavir with ritonavir was recommended for optimal therapeutic management of this population (see section 4.2).
I et efterfølgende randomiseret åbent studie (ESS100732) hos antiretroviral- naive patienter, viste fosamprenavir (700 mg) med samtidig administration med en lav- dosis ritonavir (100 mg) 2 gange daglig og en fast- dosis kombinationstablet af abacavir/ lamivudin (600 mg/ 300 mg) en gang daglig, at have sammenlignelig effekt over 48 uger med lopinavir/ ritonavir (400 mg/ 100 mg) givet 2 gange daglig i kombination med abacavir/ lamivudin (600 mg/ 300 mg en gang daglig).
In a subsequent randomised open-label study (ESS100732) in antiretroviral naïve patients, fosamprenavir (700 mg) co-administered with low dose ritonavir (100 mg) in a twice daily regimen including abacavir / lamivudine (600 mg / 300 mg) fixed dose combination tablet once daily showed comparable efficacy over 48 weeks to lopinavir / ritonavir (400 mg / 100 mg) given twice daily in combination with abacavir / lamivudine (600 mg / 300 mg once daily).
Ikke- inferioritet blev demonstreret mellem fosamprenavir sammen med ritonavir og lopinavir/ ritonavir baseret på den andel af patienter, der opnåede plasma HIV- 1 RNA niveauer < 400 kopier/ ml ved 48 uger (primær endpoint).
Non-inferiority was demonstrated between fosamprenavir co-administered with ritonavir and lopinavir / ritonavir based on the proportions of patients achieving plasma HIV-1 RNA levels < 400 copies/ ml at 48 weeks (primary endpoint).
Ved tiden til tab af virologisk respons (TLOVR) analyse af ITT( E) gruppen, var andelen af patienter der opnåede < 400 kopier/ ml 73% (315/ 434) i fosamprenavir med ritonavir gruppen, sammenlignet med 71% (317/ 444) hos patienterne der modtog lopinavir/ ritonavir, med et 95% konfidensinterval med en forskel på [- 4, 84%; 7, 05%].
In the Time to loss of virological response (TLOVR) analysis for the ITT(E) population, the proportion of patients achieving < 400 copies/ ml was 73% (315 / 434) in the fosamprenavir with ritonavir group compared to 71% (317 / 444) of patients receiving lopinavir / ritonavir, with a 95% confidence interval of the difference of [-4,84%; 7; 05%].
Median plasma HIV- 1 RNA faldt med 3, 34 log10 kopier/ ml og 3, 33 log10 kopier/ ml ved uge 48 i henholdsvis fosamprenavir med ritonavir og lopinavir/ ritonavir armene.
The median plasma HIV-1 RNA had decreased by 3.34 log10 copies/ ml and 3.33 log10 copies/ ml at Week 48 in the fosamprenavir with ritonavir and lopinavir / ritonavir arms respectively.
Medianforøgelsen i CD4- celletal var 176 celler/ mm3 i fosamprenavir med ritonavir armen og 191 celler/ mm3 i lopinavir/ ritonavir armen ved uge 48.
16 Median increase in CD4 cell count was 176 cells/ mm3 in the fosamprenavir with ritonavir arm and 191 cells/ mm3 in the lopinavir / ritonavir arm respectively by Week 48.
I et randomiseret åbent studie (APV30003) med proteasehæmmer- experienced patienter, som havde virologisk svigt (< 2 PI’ er) viste kombinationen med fosamprenavir og ritonavir (700/ 100 mg 2 gange daglig eller 1400/ 200 mg 1 gang daglig) ikke non- inferioritet over for lopinavir/ ritonavir med hensyn til viral suppression målt ved det gennemsnitlige areal under kurven minus baseline (AAUCMB) for plasma HIV- 1 RNA over 48 uger (det primære end- point).
In a randomised open-label study (APV30003) in protease inhibitor experienced patients with virological failure (less than or equal to two PIs) the fosamprenavir with ritonavir combination (700 / 100 mg twice daily or 1400 / 200 mg once daily) did not demonstrate non-inferiority to lopinavir / ritonavir with regard to viral suppression as measured by the average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA over 48 weeks (the primary end point).
Resultatet var til fordel for lopinavir/ ritonavir armen som vist nedenfor.
Results were in favour of the lopinavir / ritonavir arm as detailed below.
Alle patienter i dette studie havde tidligere oplevet behandlingssvigt på et proteasehæmmerregime (defineret som plasma HIV- 1 RNA som aldrig kom under 1. 000 kopier/ ml efter mindst 12 konsekutive ugers terapi, eller som initial suppression af HIV- 1 RNA med efterfølgende rebound til ≥ 1. 000 kopier/ ml).
All patients in this study had failed treatment with a previous protease inhibitor regimen (defined as plasma HIV-1 RNA that never went below 1,000 copies/ ml after at least 12 consecutive weeks of therapy, or initial suppression of HIV-1 RNA which subsequently rebounded to ≥ 1,000 copies/ ml).
Imidlertid fik kun 65% af patienterne PI- baseret behandling ved studiets start.
However, only 65% of patients were receiving a PI based regimen at study entry.
Den indrullerede patientgruppe bestod for hovedparten af moderat antiretroviral- experienced patienter.
The population enrolled mainly consisted of moderately antiretroviral experienced patients.
Varigheden (median) af tidligere behandling med NRTI’ er var 257 uger for patienter, som fik fosamprenavir og ritonavir 2 gange daglig (79% havde tidligere fået ≥ 3 NRTI’ er), og 210 uger for patienter, som fik lopinavir/ ritonavir (64% havde tidligere fået ≥ 3 NRTI’ er).
The median durations of prior exposure to NRTIs were 257 weeks for patients receiving fosamprenavir with ritonavir twice daily (79% had ≥ 3 prior NRTIs) and 210 weeks for patients receiving lopinavir/ ritonavir (64% had ≥ 3 prior NRTIs).
16 ritonavir 2 gange daglig (49% havde tidligere fået ≥ 2 PI’ er), og 130 uger for patienter, som fik lopi - navir/ ritonavir (40% havde tidligere fået ≥ 2 PI’ er).
The median durations of prior exposure to protease inhibitors were 149 weeks for patients receiving fosamprenavir with ritonavir twice daily (49% received ≥ 2 prior PIs) and 130 weeks for patients receiving lopinavir/ ritonavir (40% received ≥ 2 prior PIs).
Den gennemsnitlige ændring i AAUCMB (Log10 kopier/ ml) i ITT( E) populationen (observeret analyse) ved uge 48 er beskrevet i tabellen nedenfor:
The mean AAUCMBs (log10 c/ ml) in the ITT (E) population (Observed analysis) at 48 weeks are described in the table below:
Plasma HIV- 1 RNA gennemsnit areal under kurven minus baseline (AAUCMB) (log10 kopier/ ml) ved uge 48 i APV30003, ITT (E) (observeret analyse)
Plasma HIV-1 RNA Average Area Under the Curve Minus Baseline (AAUCMB) Values (log10 copies/ ml) at week 48 by Randomisation Strata in APV30003 ITT (E) Population (Observed Analysis)
Observeret analyse LPV/ RTV BID
Observed analysis Observed analysis FPV/ RTV BID LPV/ RTV BID
Observeret analyse Differens
Observed analysis Mean Diff.
Plasma HIV- 1 RNA
Plasma HIV-1 RNA stratum 1000 – 10,000
N = 103 Middelværdi (n)
N=107 N=103 Mean (n) Mean (n)
(97, 5% CI) FPV/ RTV BID vs LPV/ RTV BID
(97.5% CI) FPV/ RTV BID vs LPV/ RTV BID
1000 – 10. 000 kopier / ml > 10. 000 – 100. 000
copies/ ml > 10,000 – 100,000
- 0, 104 (- 0, 550; 0, 342)
-0.104 (-0.550, 0.342)
kopier/ ml
copies/ ml
0, 216 (- 0, 213; 0, 664)
0.216 (-0.213, 0.664)
> 100. 000 kopier/ ml
> 100,000 copies/ ml
1, 232 (0, 512; 1, 952)
1.232 (0.512, 1.952)
Total population
Total population
- 1, 76 (103)
-1.53 (105) -1.76 (103)
0, 244 (- 0, 047; 0, 536)
0.244 (-0.047, 0.536)
FPV/ RTV BID – Fosamprenavir og ritonavir 2 gange daglig, LPV/ RTV BID – Lopinavir / ritonavir 2 gange daglig
FPV/ RTV BID – Fosamprenavir with ritonavir twice daily, LPV/ RTV BID – Lopinavir / ritonavir twice daily
Patienter med et ikke målbart viralt indhold i gruppen behandlet 2 gange daglig med fosamprenavir i kombination med ritonavir og gruppen behandlet med lopinavir/ ritonavir viste resultater til fordel for lopinavir/ ritonavir:
When considering the proportion of patients with undetectable viral load in the fosamprenavir with ritonavir twice daily dosing regimens and lopinavir / ritonavir arms respectively, results showed a trend in favour of the lopinavir / ritonavir arms:
58% kontra 61% (plasma HIV- 1 RNA < 400 kopier/ ml) – eller 46% kontra 50% (plasma HIV- 1 RNA < 50 kopier/ ml) ved uge 48 (sekundært efficacy end- point) i ” intent to treat ” (RD = F) - analysen.
58% versus 61% (plasma HIV-1 RNA < 400 copies/ ml) or 46% versus 50% (plasma HIV-1 RNA < 50 copies/ ml) at Week 48 (secondary efficacy endpoint) in the intent to treat (RD=F) analysis.
For patienter med højt viralt indhold ved baseline (> 100. 000 kopier/ ml) havde 7/ 14 (50%) af de patienter som fik lopinavir/ ritonavir og 6/ 19 (32%) af de patienter som fik fosamprenavir i kombination med ritonavir plasmakoncentrationer af HIV- 1 RNA < 400 kopier/ ml.
17 In patients with high viral load at baseline (> 100,000 copies/ ml) 7/ 14 (50%) patients in the lopinavir / ritonavir group and 6/ 19 (32%) patients in the fosamprenavir with ritonavir group had plasma HIV-1 RNA < 400 copies/ ml.
Dette blev målt via den mediane ændring fra baseline i CD4- celletal (fosamprenavir og ritonavir 2 gange daglig:
The fosamprenavir with ritonavir twice daily regimen and the lopinavir / ritonavir twice daily regimen showed similar immunological improvements through 48 weeks of treatment as measured by median change from baseline in CD4 + cell count (fosamprenavir with ritonavir twice daily:
81 celler / mm3; lopinavir/ ritonavir 2 gange daglig:
81 cells/ mm3: lopinavir / ritonavir twice daily:
91 celler/ mm3).
91 cells/ mm3).
Der foreligger ikke tilstrækkelige data til at anbefale behandling med fosamprenavir og ritonavir til svært behandlings- experienced patienter.
There are insufficient data to recommend the use of fosamprenavir with ritonavir in heavily pre-treated patients.
Fosamprenavir tabletter og oral suspension i kombination med ritonavir og sammen med andre NRTI’ er er blevet evalueret hos proteasehæmmernaive børn og unge, samt hos børn og unge, der tidligere er behandlet med proteasehæmmere.
Fosamprenavir tablets and oral suspension with ritonavir in combination with NRTIs have been evaluated in protease inhibitor naïve and experienced children and adolescent patients.
Både patienter, der tidligere er behandlet med proteasehæmmere, og proteasehæmmernaive patienter indgår i studiet.
The benefit in this age group has mainly been derived from the ongoing study, APV29005, an open label 48 week study evaluating the pharmacokinetic profiles, safety, and antiviral activity of fosamprenavir with ritonavir administered twice daily to HIV 1 protease inhibitor experienced and naive patients 2 to 18 years of age.
Resultaterne fra de første 24 ugers behandling er angivet nedenfor.
Results through 24 weeks of treatment are provided below.
APV29005 involverer 25 patienter mellem 6 og 11 år (hvoraf de fleste behandles med 18 mg fosamprenavir/ kg og 3 mg ritonavir/ kg 2 gange daglig eller voksendoseringen) og 29 patienter mellem 12 og 18 år (hvoraf de fleste behandles med voksendoseringen).
APV29005 enrolled 25 patients aged 6 to 11 (the majority of whom were treated with fosamprenavir / ritonavir 18/ 3 mg/ kg twice daily or the adult tablet regimen), and 29 patients aged 12 to 18 (the majority of whom were treated with the adult tablet regimen).
27 (50%) af patienterne var PI- naive, hvoraf 9 var ART- naive, og 27 (50%) af patienterne var tidligere behandlet med PI’ er.
Overall, 27 (50%) were PI-naïve, 9 of whom were ART naïve, and 27 (50%) were PI-experienced.
Alle patienterne var tidligere behandlet massivt med NRTI’ er; medianbehandlingstiden med NRTI’ er var henholdsvis 421 uger for de PI- naive patienter og 389 uger for patienterne, der tidligere var behandlet med PI’ er.
Prior NRTI exposure was extensive, with median durations of 421 and 389 weeks for the PI naïve and experienced patients respectively.
Mediantiden for den tidligere behandling med PI’ er var 239 uger.
The median duration of prior PI exposure was 239 weeks.
Samlet set indgik patienterne i studiet med en median HIV- 1- RNA log10 på 4, 6 kopier/ ml (hvoraf 33% havde > 100. 000 kopier/ ml ved baseline) og et median CD4+- celletal på 18% (hvoraf 37% havde CD4+ - celletal på < 15% ved baseline).
Overall, patients enrolled with a median 4.6 HIV-1 RNA log10 copies/ ml (33% of whom had > 100,000 copies/ ml at baseline) and a median% CD4+ cell of 18% (37% of whom had% CD4+ of < 15% at baseline).
Efter 24 ugers behandling havde 70% (19/ 27) af de PI- naive patienter og 56% (15/ 27) af patienterne, der tidligere var behandlet med PI’ er opnået og vedligeholdt et plasma HIV- 1- RNA på < 400 kopier/ ml (ITT( E), TLOVR).
Through 24 weeks of therapy, 70% (19/ 27) of protease inhibitor naive and 56% (15/ 27) of protease inhibitor experienced patients achieved and maintained a plasma HIV 1 RNA < 400 copies/ ml (ITT(E), TLOVR).
I ITT( E) - populationen (observeret analyse) var median CD4+- celletallet forøget med henholdsvis 8% hos de PI- naive patienter og med 4% hos patienterne, der tidligere er behandlet med PI’ er.
In the ITT(E) population (Observed analysis) at Week 24 the median% CD4+ cell counts increased by 8% in the PI-naïve subjects and 4% in the PI-experienced subjects.
Efter peroral administration bliver fosamprenavir hurtigt og næsten fuldstændigt hydrolyseret til amprenavir og uorganisk fosfat før det når kredsløbet.
After oral administration, fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation.
Ingen væsentlig forskel blev observeret mellem disse to grupper.
The pharmacokinetic properties of amprenavir following co-administration of Telzir with ritonavir have been evaluated in healthy adult subjects and HIV-infected patients and no substantial differences were observed between these two groups.
Den orale suspension havde 14% højere plasma amprenavir Cmax sammenlignet med tabletterne.
Telzir tablet and oral suspension formulations, both given fasted, delivered equivalent plasma amprenavir AUC∞ values and the Telzir oral suspension formulation delivered a 14% higher plasma amprenavir Cmax as compared to the oral tablet formulation.
2 timer efter administrationen.
18 After single dose administration of fosamprenavir, amprenavir peak plasma concentrations are observed approximately 2 hours after administration.
AUC værdierne for fosamprenavir er generelt mindre end 1% af værdierne observeret for amprenavir.
Fosamprenavir AUC values are, in general, less than 1% of those observed for amprenavir.
28% højere.
After multiple dose oral administration of equivalent fosamprenavir and amprenavir doses, comparable amprenavir AUC values were observed; however, Cmax values were approximately 30% lower and Cmin values were approximately 28% higher with fosamprenavir.