natgillin/translations-raw huggingface dataset:
Co- administration with Agenerase may substantially increase PDE5 inhibitor plasma concentrations and associated adverse events, including hypotension, visual changes and priapism (see section 4.4).
Zaradi sočasne uporabe zdravila Agenerase in zaviralcev PDE5 se lahko znatno povišajo plazemske koncentracije slednjih, kar lahko privede do neželenih dogodkov, vključno s hipotenzijo, motnjami vida in priapizmom (glejte poglavje 4. 4)..
9 Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82-89%).
Pri zdravih osebah, ki so med klinično študijo 7 dni sočasno prejemale ritonavir v obliki 100 mg kapsul dvakrat dnevno in flutikazonpropionat v odmerku 50 µg intranazalno (4- krat dnevno) so ugotovili, da so se vrednosti flutikazonpropionata v plazmi znatno povečale, intrinzične vrednosti kortizola pa zmanjšale za približno 86% (90% interval zaupanja; 82- 89%).
Systemic corticosteroid effects including Cushing’ s syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e. g. budesonide.
Pri bolnikih, ki so prejemali ritonavir in inhalacijske ali intranazalne oblike flutikazonpropionata, so poročali o pojavu sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo.
Consequently, concomitant administration of Agenerase with ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Omenjeni sistemski kortikosteroidni učinki se lahko pojavijo tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo s P450 3A, npr. budezonid, zato sočasne uporabe zdravila Agenerase v kombinaciji z ritonavirjem in tovrstnimi glukokortikoidi ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4. 4).
A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e. g. beclomethasone).
Razmisliti je treba o zmanjšanju odmerka glukokortikoida ob sočasnem skrbnem nadziranju lokalnih in sistemskih učinkov ali o zamenjavi z glukokortikoidom, ki ni substrat za CYP3A4 (npr. beklometazon).
HMG-CoA reductase inhibitors:
Zaviralci HMG- CoA reduktaze:
HMG-CoA reductase inhibitors which are highly dependent on CYP3A4 for metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with Agenerase.
Za zaviralce HMG- CoA reduktaze, kot sta lovastatin in simvastatin, ki so pri presnovi zelo odvisni od CYP3A4, se ob sočasni uporabi z zdravilom Agenerase pričakuje znatno povišanje njihovih plazemskih koncentracij.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with Agenerase is not recommended.
Ker zvišane plazemske koncentracije zaviralcev HMG- CoA lahko povzročijo miopatijo, vključno z rabdomiolizo, se kombinacija teh zdravil z zdravilom Agenerase ne priporoča.
When used with Agenerase, the lowest possible dose of atorvastatin should be administered.
Atorvastatin je pri presnovi sicer manj odvisen od CYP3A4, vendar je, pri sočasni uporabi z zdravilom Agenerase, potrebno uporabiti najnižji možni odmerek atorvastatina.
If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
V primeru indikacije za zdravljenje z zaviralci HMG- CoA reduktaze sta priporočena pravastatin in fluvastatin.
Immunosuppressants: frequent therapeutic concentration monitoring of immunosuppresant levels is recommended until levels have stabilised as plasma concentrations of cyclosporin, rapamycin and tacrolimus may be increased when co-administered with amprenavir (see section 4.4).
Priporočamo redno nadziranje terapevtskih koncentracij zdravil za zaviranje imunske odzivnosti (dokler se vrednosti ne ustalijo), saj se plazemske koncentracije ciklosporina, rapamicina in takrolimusa lahko povečajo, če se jih uporablja sočasno z amprenavirjem (glejte poglavje 4. 4).
Therefore Agenerase should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Agenerase and parenteral midazolam.
Zaradi tega naj se zdravilo Agenerase ne daje sočasno s peroralno apliciranim midazolamom (glejte poglavje 4. 3), ob sočasni parenteralni aplikaciji zdravila Agenerase in midazolama pa je potrebna previdnost.
Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Podatki o sočasni parenteralni uporabi midazolama in drugih zaviralcev proteaz nakazujejo možen 3 - do 4- kratni porast plazemskih ravni midazolama.
If Agenerase with or without ritonavir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/ or prolonged sedation.
Če je zdravilo Agenerase z ritonavirjem ali brez dano sočasno s parenteralno apliciranim midazolamom, naj se to zgodi na oddelku za intenzivno nego ali podobnem oddelku, ki omogoča skrbno klinično spremljanje bolnika in ustrezno ukrepanje v primeru respiratorne depresije in/ ali podaljšane sedacije.
Methadone and opiate derivatives: co-administration of methadone with amprenavir resulted in a decrease in the Cmax and AUC of the active methadone enantiomer (R-enantiomer) of 25% and 13% respectively, whilst the Cmax, AUC and Cmin of the inactive methadone enantiomer (S-enantiomer) were decreased by 48%, 40% and 23% respectively.
Sočasna uporaba metadona in amprenavirja je imela za posledico zmanjšanje Cmax in AUC aktivnega metadonovega enantiomera (R- enantiomer), in sicer Cmax za 25%
As compared to a non-matched historical control group, co-administration of methadone and amprenavir resulted in a 30%, 27% and 25% decrease in serum amprenavir AUC, Cmax and Cmin respectively.
AUC za 30%, Cmax za 27% in Cmin za 25%.
10 Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Agenerase with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect (see section 4.4).
Priporočamo poostreno nadziranje internacionalnega normaliziranega razmerja, če se zdravilo Agenerase uporablja skupaj z varfarinom ali drugimi peroralnimi antitrombotiki, zaradi možnega zmanjšanja ali povečanja njihovega antitrombotičnega učinka (glejte poglavje 4. 4).
Steroids: oestrogens and progestogens may interact with amprenavir.
Estrogeni in progestogeni lahko medsebojno učinkujejo z amprenavirjem, vendar trenutno dostopni podatki ne zadostujejo za opredelitev narave interakcij.
However, the information currently available is not sufficient for determining the nature of the interaction.
Sočasna uporaba 0, 035 mg etinilestradiola in 1, 0 mg noretindrona je imela za posledico zmanjšanje AUC in Cmin amprenavirja:
Co-administration of 0.035 mg ethinyl estradiol plus 1.0 mg norethindrone resulted in a decrease of the amprenavir AUC and Cmin of 22% and 20% respectively, Cmax being unchanged.
AUC za 22% in Cmin za 20%, Cmax amprenavirja pa je ostala nespremenjena.
The Cmin of ethinyl estradiol was increased by 32%, whilst the AUC and Cmin of norethindrone were increased by 18% and 45% respectively.
AUC za 18% in Cmin za 45%.
Tricyclic antidepressants: careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they (for example desipramine and nortriptyline) are concomitantly administered with Agenerase (see section 4.4).
Pri sočasnem zdravljenju z zdravilom Agenerase in tricikličnimi antidepresivi (npr. dezipramin, nortriptilin) priporočamo skrbno nadziranje terapevtskih učinkov in neželenih reakcij tricikličnih antidepresivov (glejte poglavje 4. 4).
Other substances: plasma concentrations of other substances may be increased by amprenavir.
Druge učinkovine:
These include substances such as: clozapine, cimetidine, dapsone and loratadine.
Amprenavir lahko zviša plazemske koncentracije drugih zdravilnih učinkovin, kot so: klozapin, cimetidin, dapson in loratadin.
Some substances (e. g. lidocaine (by systemic route) and halofantrine) given with Agenerase may cause serious adverse reactions.
Nekatere učinkovine (npr. lidokain (sistemska uporaba) in halofantrin) lahko pri sočasni uporabi z zdravilom Agenerase povzročijo resne neželene reakcije.
Concomitant use is not recommended (see section 4.4).
Sočasne uporabe ne priporočamo (glejte poglavje 4. 4).
Pregnancy: there are no adequate data from the use of amprenavir in pregnant women.
Ni zadostnih podatkov o uporabi amprenavirja pri nosečnicah.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Lactation: amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
V podganjem mleku so zasledili amprenavirju sorodne snovi, vendar ni znano, ali se amprenavir izloča v človeško mleko.
4.7 Effects on ability to drive and use machines
11 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
No studies on the effects on ability to drive and use machines have been performed (see section 4.8).
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene (glejte poglavje 4. 8).
Adverse events considered associated with the use of Agenerase are gastro-intestinal symptoms, rash and oral/ peri-oral paraesthesia.
Neželeni učinki, za katere se predpostavlja, da so povezani z uporabo zdravila Agenerase, so gastrointestinalni simptomi, eksantem in oralna/ perioralna parestezija.
11 In children, the nature of the safety profile is similar to that seen in adults.
Pri otrocih je narava varnostnega profila podobna tistemu pri odraslih.
≥ 1 in 10 ≥ 1 in 100 and < 1 in 10 ≥ 1 in 1,000 and < 1 in 100 ≥ 1 in 10,000 and < 1 in 1,000
≥ 1/ 10 ≥ 1/ 100 in < 1/ 10 ≥ 1/ 1. 000 in < 1/ 100 ≥ 1/ 10. 000 in < 1/ 1. 000
Most of the adverse events below come from two clinical trials (PROAB3001, PROAB3006) involving PI naïve subjects receiving Agenerase 1200mg twice daily.
Večina navedenih neželenih učinkov izhaja iz dveh kliničnih študij (PROAB3001, PROAB3006), ki sta vključevali osebe, ki so prejemale zdravilo Agenerase v odmerku 1200 mg dvakrat dnevno in s PI - ji predhodno še niso bile zdravljene.
Events (grade 2-4) reported by study investigators as attributable to study medication and occurring in > 1% of patients, are included as well as grade 3-4 treatment emergent laboratory abnormalities.
Vključeni so tako neželeni učinki (stopnje 2– 4), ki so se pojavili pri > 1% bolnikov in so jih raziskovalci, ki so o njih poročali, pripisali preučevanemu zdravilu, kot tudi laboratorijska odstopanja stopnje 3– 4, ki so bila povezana z zdravljenjem.
Elevated triglycerides, elevated amylase, abnormal fat redistribution, anorexia Hyperglycaemia, hypercholesterolaemia
hiperglikemija, hiperholesterolemija
Elevated triglycerides, elevated amylase and hyperglycaemia (grade 3-4) were reported primarily in patients with abnormal values at baseline.
O zvišanih vrednostih trigliceridov, zvišanih vrednostih amilaze in o hiperglikemiji (stopnja 3– 4) so poročali predvsem pri bolnikih z nenormalnimi osnovnimi vrednostmi.
Elevations in cholesterol were of grade 3-4 intensity.
Zvišanje vrednosti holesterola je bilo stopnje 3– 4.
Only one case (a buffalo hump) was reported in 113 (< 1%) antiretroviral naive subjects treated with amprenavir in combination with lamivudine/ zidovudine for a median duration of 36 weeks.
Med 113 bolniki, ki predhodno še niso bili zdravljeni s protiretrovirusnimi zdravili in so 36 tednov (srednji čas zdravljenja) prejemali amprenavir v kombinaciji z lamivudinom/ zidovudinom, so poročali le o enem primeru (bivolja grba; < 1%).
In study PROAB3006, seven cases (3%) were reported in 245 NRTI-experienced subjects treated with amprenavir and in 27 (11%) of 241 subjects treated with indinavir, in combination with various NRTIs for a median duration of 56 weeks (p < 0.001).
12 ki so se zdravile z amprenavirjem, in o 27 primerih (11%) pri 241 osebah, ki so se 56 tednov (srednji čas zdravljenja, p < 0, 001) zdravile z indinavirjem v kombinaciji z različnimi NRTI- ji.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirano protiretrovirusno zdravljenje je bilo povezano s presnovnimi motnjami, kot so hipertrigliceridemija, hiperholesterolemija, insulinska rezistenca, hiperglikemija in hiperlaktatemija (glejte poglavje 4. 4).
Mood disorders, depressive disorders
razpoloženjske motnje, depresivne motnje
Headache Oral/ perioral paraesthesia, tremors, sleep disorders
glavobol oralna/ perioralna parestezija, tremor, motnje spanja
Diarrhoea, nausea, flatulence, vomiting Abdominal pain, abdominal discomfort, dyspeptic symptoms, loose stools
driska, navzea, flatulenca, bruhanje abdominalna bolečina, nelagoden občutek v trebuhu, simptomi dispepsije, neredna stolica
12 Hepatobiliary disorders
Bolezni jeter, žolčnika in žolčevodov
Elevated transaminases Hyperbilirubinaemia
zvišanje vrednosti transaminaz hiperbilirubinemija
Elevated transaminases and hyperbilirubinaemia (grade 3-4) were reported primarily in patients with abnormal values at baseline.
O zvišanih vrednostih transaminaz in hiperbilirubinemiji (stopnja 3– 4) so poročali predvsem pri bolnikih z nenormalnimi osnovnimi vrednostmi.
Rash Angioedema Stevens Johnson syndrome
eksantem angioedem Stevens- Johnsonov sindrom
Severe or life-threatening skin reactions have also occurred in patients treated with amprenavir (see section 4.4).
Pri bolnikih, ki so se zdravili z amprenavirjem, pa so se pojavile tudi hude ali življenjsko usodne kožne reakcije (glejte poglavje 4. 4).
Increased CPK, myalgia, myositis, and rarely rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
V povezavi z zaviralci proteaz, zlasti v kombinaciji z nukleozidnimi analogi, so poročali o zvišanih vrednostih CPK (kreatin- fosfokinaze), mialgiji, miozitisu in redkeje o rabdomiolizi.
The frequency of this is unknown (see section 4.4).
Pogostnost tega ni znana (glejte poglavje 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).
13 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
In PI experienced patients receiving Agenerase capsules 600 mg twice daily and low dose ritonavir, 100 mg twice daily, the nature and frequency of adverse events (grade 2-4) and Grade 3/ 4 laboratory abnormalities were similar to those observed with Agenerase alone, with the exception of elevated triglyceride levels, and elevated CPK levels which were very common in patients receiving Agenerase and low dose ritonavir.
Izjema je bilo le zelo pogosto zvišanje vrednosti trigliceridov in zelo pogosto zvišanje vrednosti CPK pri bolnikih, ki so prejemali zdravilo Agenerase skupaj z nizkim odmerkom ritonavirja.
If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8) and standard supportive treatment provided as necessary.
V primeru prevelikega odmerjanja je potrebno bolnika nadzirati glede znakov toksičnosti (glejte poglavje 4. 8) in po potrebi zagotoviti običajno podporno terapijo.
13 Pharmacotherapeutic group; protease inhibitor; ATC Code:
Zaviralci proteaz, Oznaka ATC:
Amprenavir is a competitive inhibitor of HIV-1 protease.
Amprenavir je kompetitivni zaviralec proteaze virusa HIV- 1.
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.
Amprenavir se veže na aktivno mesto proteaze virusa HIV- 1 in tako prepreči nastajanje virusnih gag in gag- pol poliproteinskih predhodnikov, kar ima za posledico tvorbo nezrelih in nekužnih virusnih delcev.
The in vitro antiviral activity of amprenavir was evaluated against HIV-1 IIIB in both acutely and chronically infected lymphoblastic cell lines (MT-4, CEM-CCRF, H9) and in peripheral blood lymphocytes.
Protivirusna aktivnost amprenavirja proti HIV- 1 IIIB in vitro je bila vrednotena na akutno in kronično okuženih limfoblastnih celičnih linijah (MT- 4, CEM- CCRF, H9) in na limfocitih iz periferne krvi.
The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ ml).
Pri akutno okuženih celicah se je 50% inhibitorna koncentracija (IC50) amprenavirja gibala med 0, 012 in 0, 08 μM, pri kronično okuženih celicah pa je bila 0, 41 μM; (1 μM = 0, 50 μg/ ml).
The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Povezava med proti - HIV- 1 aktivnostjo amprenavirja in vitro in inhibicijo replikacije HIV- 1 pri človeku ni bila določena.
HIV-1 isolates with decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments.
Med serijskimi pasažami in vitro so izolirali izolate virusa HIV- 1 z zmanjšano občutljivostjo za amprenavir.
a) ART-naïve or PI-naïve patients
a) Bolniki, ki se še niso zdravili s protiretrovirusnimi zdravili ali z zaviralci proteaz
(Note:
(Opozorilo:
Agenerase is not approved in ART-naive or PI-naive patients).
Zdravilo Agenerase ni odobreno za zdravljenje bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili ali z zaviralci proteaz).
Various regimens have been assessed in the amprenavir/ fosamprenavir development programs with and without co-administration of ritonavir.
V razvojnem programu uporabe amprenavirja/ fosamprenavirja s sočasno uporabo ritonavirja ali brez so bili ovrednoteni različni režimi zdravljenja.
Analysis of the virological failure samples across these regimens defined four main resistance pathways:
Analize primerov virusnega neodziva v teh režimih so
V32I+I47V, I50V, I54L/ M and I84V.
V32I+I47V, I50V, I54L/ M in I84V.
Additional mutations observed which may contribute to resistance were:
Dodatne mutacije, ki so jih opazili in lahko pripomorejo k odpornosti, so:
L10V/ F/ R, I13V, K20R/ T, L33F/ V, M36I, M46I/ L, I47V/ L Q58E, I62V, L63P, V77I, I85V, and I93L.
L10V/ F/ R, I13V, K20R/ T, L33F/ V, M36I, M46I/ L, I47V/ L Q58E, I62V, L63P, V77I, I85V in I93L.
When ART naïve patients were treated with the currently approved doses of fosamprenavir/ ritonavir, as for other ritonavir boosted PI regimens, the mutations described were infrequently observed.
Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, so se pri zdravljenju s trenutno priporočenimi odmerki fosamprenavirja/ ritonavirja opisane mutacije pojavile redko, podobno kot pri drugih režimih zdravljenja z zaviralci proteaz z okrepitvijo z ritonavirjem.
Sixteen of 434 ART-naïve patients who received fosamprenavir 700mg/ ritonavir 100mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
V študiji ESS100732 se je pri zdravljenju s fosamprenavirjem 700 mg/ ritonavirjem 100 mg dvakrat na dan v 48. tednu virusni neodziv pojavil pri 16 od 434 bolnikov, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, pri čemer so določili genotip 14 izolatov.
One resistance mutation was observed in each of 3 isolates:
Pri vsakem od 3 izolatov so poročali o eni rezistenčni mutaciji:
K20K/ R, I54I/ L and I93I/ L respectively.
K20K/ R, I54I/ L ali I93I/ L.
b) PI-experienced patients
b) Bolniki, ki so se že zdravili z zaviralci proteaz
14 In the studies of PI-experienced patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure:
V študijah bolnikov, ki so že bili zdravljeni z zaviralci proteaz, PRO30017 (amprenavir 600 mg / ritonavir 100 mg dvakrat na dan in podštudijah A in B, v katere je bilo vključenih 80 oziroma 37 bolnikov), so se pri bolnikih z virusnim neodzivom pojavile naslednje mutacije:
L10F/ I/ V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/ L, I47V, G48V, I50V, I54L/ M/ T/ V, Q58E, D60E, I62V, A71V, V77I, V82A/ I, I84V, I85V, L90M and I93L/ M.
L10F/ I/ V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/ L, I47V, G48V, I50V, I54L/ M/ T/ V, Q58E, D60E, I62V, A71V, V77I, V82A/ I, I84V, I85V, L90M in I93L/ M.
In the studies of PI-experienced patients, APV30003 and its extension, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg twice daily: n=107), the following mutations emerged in patients experiencing virological failure through 96 weeks:
V študijah bolnikov, ki so že bili zdravljeni z zaviralci proteaz, APV30003 in njenem podaljšku, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg dvakrat na dan: n=107), so se pri bolnikih z virusnim neodzivom med 96 tedni zdravljenja pojavile naslednje mutacije:
L10F/ I, L24I, V32I, L33F, M36I, M46I/ L, I47V, I50V, I54L/ M/ S, A71I/ T/ V, G73S, V82A, I84V, and L90M.
L10F/ I, L24I, V32I, L33F, M36I, M46I/ L, I47V, I50V, I54L/ M/ S, A71I/ T/ V, G73S, V82A, I84V in L90M.
In the paediatric studies APV20003 and APV29005, 67 PI-experienced patients were treated with fosamprenavir / ritonavir and of 22 virological failure isolates genotyped, nine patients were found with treatment-emergent protease mutations.
Genotipsko je bilo določenih 22 izolatov virusa z neodzivom na zdravljenje.
Genotypic interpretation systems may be used to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in subjects with PI-resistant isolates.
Analize na osnovi genotipskega testiranja rezistence Za ocenjevanje delovanja amprenavirja / ritonavirja ali fosamprenavirja / ritonavirja pri osebah z izolati, odpornimi na zaviralce proteaz, se lahko uporabijo genotipski interpretacijski sistemi.
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:
Trenutni (julij 2006) ANRS AC- 11 algoritem za fosamprenavir / ritonavir opredeljuje rezistenco kot prisotnost mutacij V32I+I47A/ V ali I50V ali vsaj štirih mutacij izmed:
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).
L10F/ I/ V, L33F, M36I, I54A/ L/ M/ S/ T/ V, I62V, V82A/ C/ F/ G, I84V in L90M ter je povezan tako s povečano fenotipsko odpornostjo na fosamprenavir z ritonavirjem kot tudi z zmanjšano verjetnostjo virusnega odziva (rezistence).