natgillin/translations-raw huggingface dataset:
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
V raziskavi interakcij med zdravili so se plazemske koncentracije karbamazepina
Effect of food: the administration of STOCRIN with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Pri zaužitju zdravila STOCRIN skupaj s hrano se lahko poveča izpostavitev efavirenzu (glejte poglavje 5. 2) in lahko pride do večje pogostosti neželenih učinkov (glejte poglavje 4. 8).
102 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Pri bolnikih, ki se zdravijo z drugimi zdravili, ki so toksična za jetra, prav tako priporočamo spremljanje jetrnih encimov.
103 Table 2:
107 Preglednica 2:
AUC: ↔ */ ** (↓ 10% to ↑ 26%) Cmax: ↔ */ ** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/ ** (↓ 16% to ↑ 49%) (CYP3A4 induction). * When compared to atazanavir 300 mg/ ritonavir 100 mg once daily in the evening without efavirenz.
(400 mg enkrat na dan/ 200 mg enkrat
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir. ** based on historical comparison
na dan/ 600 mg enkrat na dan, vse se vzame s hrano)
increase in the dose of both atazanavir and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
↑ 26%) Cmax: ↔ * / ** (↓ 5% do ↑ 26%) Cmin: ↑ 12% * / ** (↓ 16% do ↑ 49%) (indukcija CYP3A4) * v primerjavi z atazanavirom 300 mg/ ritonavirom 100 mg enkrat na dan zvečer brez efavirenza.
Indinavir/ Efavirenz (800 mg q8h/ 200 mg once daily)
indinavir/ efavirenz (800 mg q8h/ 200 mg enkrat na dan)
AUC: ↓ 31% (↓ 8 to ↓ 47) Cmin: ↓ 40% A similar reduction in indinavir exposures was observed when indinavir 1.000 mg q8h was given with efavirenz 600 mg daily.
AUC: ↓ 31% (↓ 8 do ↓ 47) Cmin: ↓ 40% Pri jemanju indinavira 1000 mg q8h z efavirenzem 600 mg na dan so opazili podobno zmanjšanje v izpostavljenosti indinaviru.
While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz and indinavir.
Kliničnega pomena zmanjšanih koncentracij indinavira niso ugotovili, vendar je treba stopnjo opažene farmakokinetične interakcije upoštevati pri izbiri režima zdravljenja, pri katerem se uporabljata oba – efavirenz in indinavir.
pharmacokinetic interaction
108
104 Medicinal product by therapeutic
Zdravilne učinkovine po
Effects on drug levels
Učinki na koncentracije
areas
terapevtskih področjih
efavirenz
Ni klinično pomembnih farmakokinetičnih interakcij.
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
Pri jemanju z indinavirom ali indinavir/ ritonavir/ efavirenz (800 mg dvakrat na dan/ 100 mg
AUC: ↓ 25% (↓ 16 to ↓ 32) b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b
Cmax: ↓ 17% (↓ 6 do ↓ 26) b
Efavirenz:
Cmin: ↓ 50% (↓ 40 do ↓ 59) b efavirenz:
105 Medicinal product by therapeutic
109
106 Medicinal product by therapeutic
110
108 Medicinal product by therapeutic
aluminijev hidroksidni- magnezijev hidroksidni- simetikonijev antacid/ efavirenz (enkratni odmerek 30 ml/ enkratni odmerek 400 mg) famotidin/ efavirenz (enkratni odmerek 40 mg/ enkratni odmerek 400 mg) ANKSIOLITIKI
AGENTS
113
109 Medicinal product by therapeutic
Zdravilne učinkovine po terapevtskih področjih
110 Medicinal product by therapeutic
verapamil, felodipin, nifedipin in Interakcij niso preučevali.
Effects on drug levels
115
Rosuvastatin/ Efavirenz
116
111
Priporočilo glede sočasne
4.6 Pregnancy and lactation
117 4. 6 Nosečnost in dojenje
112 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Ženske v rodni dobi: ženske, ki se zdravijo z efavirenzem, se morajo izogibati nosečnosti.
113 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Pri bolnikih, ki so prenehali jemati druga protiretrovirusna zdravila iz razreda NNRTI- jev, so izkušnje z efavirenzem omejene.
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
119 Spodaj so našteti neželeni učinki zmerne ali hujše resnosti, katerih vzročna povezava z zdravljenjem je bila (s strani raziskovalca) ocenjena najmanj kot mogoča in so jih poročali iz kliničnih raziskav efavirenza pri priporočenem odmerku v kombiniranem zdravljenju (n = 1. 008).
114 Nervous system disorders common
Bolezni živčevja pogosti
gynaecomastia
ginekomastija
Lipodystrophy and metabolic abnormalities: 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).
Prerazporeditev maščevja (lipodistrofija) pri bolnikih s HIV, vključno z izgubo perifernega in obraznega podkožnega maščevja, povečano intraabdominalno in
115 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 so povezali s pojavom metabolnih motenj, kot so hipertrigliceridemija, hiperholesterolemija, odpornost proti insulinu, hiperglikemija in povišana vrednost laktata v krvi (glejte poglavje 4. 4).
Osteonecrosis: 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).
Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
Postmarketing experience with efavirenz has shown the following additional adverse reactions to occur in association with efavirenz-containing antiretroviral treatment regimens: cerebellar coordination and balance disturbances, delusion, hepatic failure, neurosis, photoallergic dermatitis, psychosis and completed suicide.
121 Izkušnje z efavirenzem na tržišču so pokazale še sledeče dodatne neželene učinke, ki se lahko pojavijo pri protiretrovirusnem zdravljenju, ki vključuje efevirenz: motnje cerebelarne koordinacije in ravnotežja, privid, odpoved jeter, nevroza, fotoalergični dematitis, psihoza in samomor.
116 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Opazili so tudi substitucije na RT na položajih 98, 100, 101, 108, 138, 188, 190 ali 225, vendar redkeje in pogosto le v kombinaciji s
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained
Dva od treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna na efavirenz in sta vsebovala substitucijo K103N.
Efficacy results for study 006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 3.
Rezultate učinkovitosti raziskave 006 pri podskupini 614 bolnikov vključenih vsaj 48 tednov, prikazuje preglednica 3.
Table 3:
123 Preglednica 3:
Dose related increases in Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional
Od odmerka odvisna zvišanja Cmax in AUC so opazili pri odmerkih do 1. 600 mg.
119 suggesting diminished absorption at higher doses.
Ta zvišanja so bila manj kot sorazmerna, kar nakazuje zmanjšano absorpcijo zdravila pri višjih odmerkih.
Effect of food: the AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI:
Vpliv hrane: pri neokuženih prostovoljcih sta bila AUC in Cmax po enkratnem odmerku 600 mg filmsko obložene tablete efavirenza ob obroku z veliko maščobami povečana za 28% (90%, CI:
22 – 33%) and 79% (90% CI:58 – 102%), respectively, when given with a high fat meal relative to when given under fasted conditions (see section 4.4).
58 - 102%) v primerjavi z vrednostima na tešče (glejte poglavje 4. 4).
Elimination: efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40 - 55 hours after multiple doses.
Izločanje: efavirenz ima relativno dolg terminalni razpolovni čas: vsaj 52 ur po enkratnem odmerku in 40 do 55 ur po večkratnih odmerkih.
Paediatric pharmacokinetics: in 49 paediatric patients receiving the equivalent of a 600 mg dose of efavirenz (dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.
125 Pediatrična farmakokinetika: pri 49 pediatričnih bolnikih, ki so dobivali odmerek, ekvivalenten 600 mg odmerku efavirenza (odmerek je bil prilagojen velikosti telesa, izračunan glede na telesno težo), je bila Cmax v stanju ravnotežja 14, 1 μM, Cmin v stanju ravnotežja 5, 6 μM in AUC 216 μM· h.
Gender, race, elderly: although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Spol, rasa, starejši bolniki: čeprav omejeni podatki, ki so za sedaj na voljo, kažejo, da je lahko tako pri ženskah kot pri bolnikih iz Azije ali s Pacifiških otokov izpostavitev efavirenzu večja, ti nimajo nižje tolerance za zdravilo.
120 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Tablet core Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Jedro tablete premrežen natrijev karmelozat mikrokristalna celuloza natrijev lavrilsulfat hidroksipropil celuloza laktoza monohidrat magnezijev stearat
Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Yellow iron oxide (E172) Carnauba wax
Filmska obloga hipromeloza (E464) titanov dioksid (E171) makrogol 400 rumeni železov oksid (E172) karnauba vosek.
Not applicable.
126 Navedba smiselno ni potrebna.
121 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Packs of 30 x 1 film-coated tablets in aluminium perforated unit dose blisters.
Zloženke z 30 x 1 filmsko obloženimi tabletami v aluminijevih perforiranih pretisnih omotih za enkratne odmerke.
Not all pack sizes may be marketed.
Vsa pakiranja niso nujno na tržišču.
EU/ 1/ 99/ 111/ 008 – bottle EU/ 1/ 99/ 111/ 009 – blister
EU/ 1/ 99/ 111/ 008 - plastenka EU/ 1/ 99/ 111/ 009 - pretisni omot
Excipient: each film-coated tablet contains 20.8 mg of lactose monohydrate.
Pomožne snovi: ena filmsko obložena tableta vsebuje 20, 8 mg laktoze monohidrata.
Yellow, round, debossed with “ 113 ” on one side.
Rumena, okrogla, z oznako » 113 « na eni strani
Therapy should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje mora začeti zdravnik, ki ima izkušnje z zdravljenjem okužbe s HIV.
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
V kombinaciji z ZP in/ ali NRTI- ji je priporočeni odmerek zdravila STOCRIN za bolnike, stare 3 do 17 let, naveden v Preglednici 1.
STOCRIN is not
Tablete STOCRIN smemo dati le otrokom, ki so tablete zmožni pogoltniti.
123 recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
Zdravila STOCRIN za otroke, stare manj kot 3 leta ali lažje od 13 kg, zaradi pomanjkanja podatkov o varnosti in učinkovitosti za to starostno skupino ne priporočamo (glejte poglavji 5. 1 in 5. 2).
Patients should be monitored carefully for dose-related adversereactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Bolnike je treba pozorno spremljati zaradi možnih od odmerka odvisnih neželenih učinkov, še posebej tistih, ki so povezani z živčnim sistemom (glejte poglavji 4. 3 in 4. 4).
124 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Če se efavirenz uporablja kot monoterapija, se tako kot pri vseh drugih nenukleozidnih zaviralcih reverzne transkriptaze (NNRTI) lahko hitro pojavi rezistentni virus.
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
129 Sočasne uporabe efavirenza in tablete s fiksno kombinacijo, ki vsebuje efavirenz, emtricitabin in tenofovirdizoproksilfumarat, ne priporočamo.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Pri bolnikih, ki so jim zaradi izpuščaja ukinili zdravljenje z drugimi NNRTI, je možno večje tveganje za pojav izpuščaja pri zdravljenju z efavirenzem.
125 Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Pri bolnikih, ki se zdravijo z efavirenzem, so opazili krče, običajno pri tistih z napadi krčev v anamnezi.
126 In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Pri bolnikih, ki se zdravijo z drugimi zdravili, ki so toksična za jetra, prav tako priporočamo spremljanje jetrnih encimov.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Efavirenz filmsko obložene tablete niso primerne za uporabo pri sicer redkih bolnikih s prirojenimi motnjami galaktozamije ali z malabsorpcijskim sindromom za glukozo/ galaktozo.
127 Table 2:
132 Preglednica 2:
(CYP3A4 induction) Efavirenz:
(indukcija CYP3A4)
128 Medicinal product by therapeutic
133
indinavir/ ritonavir.
potrebna.
129 Medicinal product by therapeutic
134
130 Medicinal product by therapeutic
135
When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i. e., to 300 mg
Ko je zdravljenje z vorikonazolom
AUC: ↓ 7% (↓ 23 to ↑ 13) * Cmax: ↑ 23% (↓ 1 to ↑ 53) * Efavirenz:
Cmax: ↑ 23% (↓ 1 do ↑ 53) *
AUC: ↑ 17% (↑ 6 to ↑ 29) ** Cmax: ↔ ** *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (competitive inhibition of oxidative metabolism)
(400 mg dvakrat na dan/ 300 mg enkrat na dan)
once daily.
efavirenz:
132 Medicinal product by therapeutic
aluminijev hidroksidni- magnezijev hidroksidni- simetikonijev antacid/ efavirenz (enkratni odmerek 30 ml/ enkratni odmerek 400 mg) famotidin/ efavirenz (enkratni odmerek 40 mg/ enkratni odmerek 400 mg) ANKSIOLITIKI
AGENTS
138
133 Medicinal product by therapeutic
Zdravilne učinkovine po terapevtskih področjih
134 Medicinal product by therapeutic
verapamil, felodipin, nifedipin in Interakcij niso preučevali.
Effects on drug levels
140
Simvastatin/ Efavirenz (40 mg once daily/ 600 mg once daily)
simvastatin/ efavirenz (40 mg enkrat na dan/ 600 mg enkrat na dan)
AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
AUC: ↓ 60% (↓ 52 do ↓ 68) Cmax: ↓ 62% (↓ 55 do ↓ 78)
Dosage adjustments of simvastatin may be required (refer to the Summary of Product Characteristics for simvastatin).
Morda je treba prilagoditi odmerek simvastatina (glejte Povzetek glavnih značilnosti zdravila za simvastatin).
Rosuvastatin/ Efavirenz
(indukcija CYP3A4) Sočasna uporaba efavirenza z atorvastatinom, pravastatinom ali simvastatinom ni vplivala na vrednosti AUC ali Cmax efavirenza.
135
Priporočilo glede sočasne
Dose adjustment of buprenorphine or efavirenz may not be necessary when co- administered.
Pri sočasni uporabi prilagoditev odmerka buprenorfina ali efavirenza lahko ni potrebna.
4.6 Pregnancy and lactation
142 4. 6 Nosečnost in dojenje
136 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Ženske v rodni dobi: ženske, ki se zdravijo z efavirenzem, se morajo izogibati nosečnosti.
In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/ or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%).
V podskupini 1. 008 odraslih bolnikov, ki so v kontroliranih kliničnih raziskavah prejemali dnevno 600 mg efavirenza v kombinaciji z ZP in/ ali NRTI- ji, so bili najpogostejši neželeni učinki, ki so bili vsaj zmerne jakosti in so o njih poročali pri vsaj 5% bolnikov: izpuščaj (11, 6%), omotica (8, 5%), navzeja (8, 0%), glavobol (5, 7%) in utrujenost (5, 5%).
The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
Dolgoročni profil varnosti zdravljenja s kombinacijami zdravil, ki so vključevale efavirenz, so ocenjevali v kontrolirani raziskavi (006), v kateri so bolniki prejemali efavirenz + zidovudin + lamivudin (n = 412, povprečno trajanje 180 tednov), efavirenz + indinavir (n = 415, povprečno trajanje 102 tedna) ali indinavir + zidovudin +lamivudin (n = 401, povprečno trajanje 76 tednov).
137 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Pri bolnikih, ki so prenehali jemati druga protiretrovirusna zdravila iz razreda NNRTI, so izkušnje z efavirenzem omejene.
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Pogostnost je
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) including isolated reports.
144 definirana z uporabo sledečega dogovora: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000) vključno s posameznimi primeri.
138 Nervous system disorders common
Bolezni živčevja pogosti
139 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
145 Kombinirano protiretrovirusno zdravljenje so povezali s pojavom metabolnih motenj, kot so hipertrigliceridemija, hiperholesterolemija, odpornost proti insulinu, hiperglikemija in povišana vrednost laktata v krvi (glejte poglavje 4. 4).
140 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
ATC code:
Nenukleozidni zaviralci reverzne transkriptaze, oznaka ATC:
Cross resistance: cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Profili navzkrižne rezistence na efavirenz, nevirapin in delavirdin v celičnih kulturah so pokazali, da substitucija K103N povzroči izgubo občutljivosti na vse tri NNRTI.
Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained
Dva od treh kliničnih izolatov, rezistentnih na delavirdin, ki so jih preučevali, sta bila navzkrižno rezistentna
141 the K103N substitution.
147 na efavirenz in sta vsebovala substitucijo K103N.
Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Pri virusnih izolatih, ki so jih dobili od PBMC- jev bolnikov, ki so sodelovali v kliničnih raziskavah efavirenza in pri katerih je bilo zdravljenje neuspešno (povratek virusnega bremena), so določili občutljivost na NNRTI.
Five of these NNRTI-resistant isolates were found to have K103N or a valine-to-isoleucine substitution at position 108 (V108I) in RT.
Pri petih od teh na NNRTI rezistentnih izolatov so našli substitucijo K103N ali substitucijo valin- v- izolevcin na položaju 108 (V108I) na RT.
Study 006, a randomized, open-label trial, compared efavirenz + zidovudine + lamivudine or efavirenz + indinavir with indinavir + zidovudine + lamivudine in 1,266 patients who were required to be efavirenz-, lamivudine-, NNRTI-, and PI-naive at study entry.
Raziskava 006, randomizirana, odprta raziskava, je primerjala efavirenz + zidovudin + lamivudin ali efavirenz + indinavir z indinavirjem + zidovudinom + lamivudinom pri 1. 266 bolnikih, ki se pred vstopom v raziskavo še niso smeli zdraviti z efavirenzem, lamivudinom, NNRTI- jem ali ZP.
The mean baseline CD4 cell count was 341 cells/ mm3 and the mean baseline HIV-RNA level was 60,250 copies/ ml.
Povprečno izhodiščno število CD4 ob vstopu je bilo 341 celic/ mm3, povprečna izhodiščna raven HIV - RNA je bila 60. 250 kopij/ ml.
In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ ml at the missing time points.
Pri analizi deležev bolnikov, ki so se odzvali na zdravljenje (bolnik, ki raziskave ni končal, pomeni napako analize; NK = NA), so privzeli, da imajo bolniki, ki so raziskavo iz kakršnegakoli razloga predčasno prekinili ali so izpustili eno merjenje HIV - RNA vrednosti (vrednost pred ali za njo pa je bila nad mejo določitve testa), v manjkajočih časovnih točkah HIV- RNA vrednost izpuščene meritve nad 50 ali nad 400 kopij/ ml.
Table 3:
148 Preglednica 3:
Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV-RNA < 400 copies/ ml, HIV-RNA < 50 copies/ ml and in terms of mean change from baseline CD4 cell count.
Dolgoročni rezultati po 168 tednih raziskave 006 (raziskavo je zaključilo 160 bolnikov, zdravljenih z EFV + IDV, 196 bolnikov z EFV + ZDV + 3TC in 127 bolnikov z IDV + ZDV + 3TC) kažejo na dolgotrajnost odziva glede na deleže bolnikov s HIV RNA < 400 kopij/ ml, HIV RNA < 50 kopij/ ml in glede na povprečno spremembo od izhodiščnega števila celic CD4.
Study ACTG 364 enrolled 196 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Raziskava ACTG 364 je vključevala 196 bolnikov, ki so bili zdravljeni z NRTI, ne pa z ZP ali NNRTI.
Study 020 enrolled 327 patients who had been treated with NRTIs but not with PIs or NNRTIs.
V raziskavi ACTG 020 je sodelovalo 327 bolnikov, ki so bili zdravljeni z NRTI, ne pa z ZP ali NNRTI.
143 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti