natgillin/translations-raw huggingface dataset:
Co-administration of PREZISTA with 100 mg ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated.
Kontraindicirana je sočasna uporaba zdravila PREZISTA s 100 mg ritonavirja in učinkovin, pri katerih je očistek v veliki meri odvisen od CYP3A in pri katerih so povišane plazemske koncentracije povezane z resnimi in/ ali življenje ogrožujočimi dogodki.
These active substances include e.g. antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics [triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)] and HMG-CoA reductase inhibitors (simvastatin and lovastatin) (see section 4.5).
Med te učinkovine sodijo npr. antiaritmiki (amiodaron, bepridil, kinidin, sistemsko dani lidokain), antihistaminiki (astemizol, terfenadin), alkaloidi ergot (npr. dihidroergotamin, ergonovin, ergotamin in metilergonovin), učinkovine, ki vplivajo na motiliteto prebavnega trakta (cisaprid), nevroleptiki (pimozid, sertindol), sedativi/ hipnotiki [triazolam, midazolam apliciran peroralno (za opozorila pri parenteralni aplikaciji midazolama glejte poglavje 4. 5)] in inhibitorji HMG- CoA reduktaze (simvastatin in lovastatin) (glejte poglavje 4. 5).
Increasing the dose of ritonavir from that recommended in section 4.2 did not significantly affect darunavir concentrations and is not recommended.
25 Povečanje odmerka ritonavirja, nad vrednost priporočeno v poglavju 4. 2, ni pomembno vplivalo na koncentracijo darunavirja in zato ni priporočljivo.
24 Elderly:
Starostniki:
Darunavir binds predominantly to α1-acid glycoprotein.
Darunavir se veže predvsem na plazemski alfa- 1 kisli glikoprotein.
Therefore, protein displacement of medicinal products highly bound to α1-acid glycoprotein cannot be ruled out.
Zato ne moremo izključiti zamenjave z drugimi zdravili, ki se z veliko afiniteto vežejo na alfa- 1 kisli glikoprotein.
Severe skin rash, which may be accompanied with fever and/or elevations of transaminases, has occurred in 0.5% of patients treated with PREZISTA.
Pri 0, 5% bolnikov, ki so se zdravili z zdravilom PREZISTA, se je pojavil resen kožni izpuščaj, ki ga je lahko spremljala povišana telesna temperatura in/ ali povišane vrednosti transaminaz.
Erythema multiforme and Stevens-Johnson Syndrome have been rarely (< 0.1%) observed.
Redko (< 0, 1%) so poročali o multiformnem eritemu in Stevens- Johnsonovem sindromu.
Due to an increase in the unbound darunavir plasma concentrations, PREZIST A should be used with caution in patients with mild or moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Zaradi povišanja plazemske koncentracije nevezanega darunavirja, je treba pri bolnikih z blago do zmerno okvaro jeter zdravilo PREZISTA uporabljati previdno (glejte poglavja 4. 2, 4. 3 in 5. 2).
Diabetes mellitus/Hyperglycaemia New onset diabetes mellitus, hyperglycaemia, or exacerbation of existing diabetes mellitus has been reported in patients receiving antiretroviral therapy, including PIs.
Sladkorna bolezen/ hiperglikemija Pri bolnikih na protiretrovirusni terapiji, vključno z zaviralci proteaz, so poročali o primerih novonastale sladkorne bolezni, hiperglikemije ali poslabšanju obstoječe sladkorne bolezni.
25 Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
26 Pri bolnikih, okuženih s HIV, je bila kombinirana protiretrovirusna terapija povezana s prerazporeditvijo telesnega maščevja (lipodistrofijo).
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination antiretroviral therapy (CART).
Osteonekroza Kljub temu, da so ocenili, da je vzrokov več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, visokim indeksom telesne mase), so poročali o primerih osteonekroze, še posebej pri bolnikih z napredovalo boleznijo HIV in/ ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji (CART - Combination Antiretroviral Therapy).
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Sem sodijo citomegalovirusni retinitis, generalizirane in/ ali fokalne mikobakterijske okužbe in pljučnica, ki jo povzroča Pneumocystis jiroveci (prej znana kot Pneumocystis carinii).
PREZISTA co-administered with 100 mg ritonavir must not be combined with medicinal products that are highly dependent on CYP3A4 for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index).
Zdravila PREZISTA s 100 mg ritonavirja ne smete sočasno uporabljati z zdravili, katerih očistek je močno odvisen od CYP3A4 in pri katerih je povečana sistemska izpostavljenost povezana z resnimi in/ ali smrtno nevarnimi neželenimi učinki (majhna terapevtska širina).
These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, terfenadine, midazolam administered orally, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin and the ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (see section 4.3).
Med ta zdravila sodijo amiodaron, bepridil, kinidin, sistemsko dani lidokain, astemizol, terfenadin, midazolam apliciran peroralno, triazolam, cisaprid, pimozid, sertindol, simvastatin, lovastatin in alkaloidi ergot (npr. ergotamin, dihidroergotamin, ergonovin in metilergonovin) (glejte poglavje 4. 3).
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg b.i.d.
Skupni učinek farmakokinetične okrepitve z ritonavirjem je privedel do približno 14- kratnega povečanja sistemske izpostavljenosti darunavirju pri peroralni uporabi enkratnega odmerka 600 mg darunavirja v kombinaciji z ritonavirjem v odmerku 100 mg dvakrat na dan.
A clinical study utilising a cocktail of drugs that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6
27 Klinična študija v kateri so uporabljali mešanico zdravilnih učinkovin, ki se presnavljajo s citokromi CYP2C9, CYP2C19 in CYP2D6 je v prisotnosti zdravila PREZISTA/ rtv pokazala zvečanje aktivnosti CYP2C9 in CYP2C19 ter zmanjšanje aktivnosti CYP2D6, kar lahko pripišemo prisotnosti majhnega odmerka ritonavirja.
Medicinal products that affect darunavir/ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Zdravila, ki vplivajo na izpostavljenost darunavirju/ ritonavirju Darunavir in ritonavir se presnavljata z encimom CYP3A.
Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir (e.g. rifampicin, St John’s wort, lopinavir).
Pričakovano je, da zdravila, ki inducirajo aktivnost encima CYP3A, povečajo očistek darunavirja in ritonavirja in posledično znižajo plazemske koncentracije darunavirja in ritonavirja (npr. rifampicin, šentjanževka, lopinavir).
Interaction table Interactions between darunavir/ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not determined as “ND”, twice daily as “b.i.d.”, once daily as “q.d.” and once every other day as “q.o.d.”).
Preglednica medsebojnih delovanj z drugimi zdravili Interakcije med darunavirjem/ ritonavirjem in zaviralci proteaz, drugimi protiretrovirusnimi učinkovinami in ne- protiretrovirusnimi zdravili so navedene v spodnjih preglednicah (povečanje je prikazano z “ ↑ ”, zmanjšanje z “ ↓ ”, brez spremembe “ ↔ ”, ni podatka z “ ND ”, jemanje dvakrat na dan kot “ b. i. d. ”, enkrat na dan kot “ q. d. ” in jemanje vsak drugi dan kot “ q. o. d. ”).
Interactions – Darunavir/ritonavir with Protease Inhibitors The efficacy and safety of the use of PREZISTA with 100 mg ritonavir and any other PI (e.g.
Medsebojna delovanja- darunavir/ ritonavir z zaviralci proteaz (ZP) Učinkovitost in varnost uporabe zdravila PREZISTA s 100 mg ritonavirja in katerimkoli drugim ZP (npr.
Lopinavir/ritonavir 400/100 b.i.d.
1. 200/ 100 b. i. d.
Atazanavir
28 Atazanavir
Interactions – Darunavir/ritonavir with Antiretroviral Agents other than Protease Inhibitors
Medsebojna delovanja- darunavir/ ritonavir z drugimi protiretrovirusnimi učinkovinami
300/
300/ 100 b. i. d. #
Efavirenz decreases the plasma concentrations of darunavir as a result of CYP3A4 induction.
Zaradi indukcije CYP3A4 efavirenz zmanjša plazemske koncentracije darunavirja.
Etravirine
Kadar se zdravilo PREZISTA s 100 mg ritonavirja daje v kombinaciji z efavirenzem, bo zaradi povečane izpostavljenostu efavirenzu, morda potrebno klinično spremljanje zaradi možnosti pojava toksičnosti za osrednji živčni system.
600/
↓
Darunavir
etravirin darunavir
* dose used in drug-interaction study.
* odmerek uporabljen v študiji medsebojnih delovanj z drugimi zdravili.
Interactions – Darunavir/ritonavir with Non-antiretroviral co-administered Medicinal Products Co-administered
29 Medsebojna delovanja- darunavir/ ritonavir z ne- protiretrovirusnimi zdravili
Antiarrhythmics
Antiaritmiki ↑ 60% Digoksin
28
0, 4
600/100 b.
600/ 100 b. i. d.
Darunavir/ritonavir increases the plasma concentrations of clarithromycin as a result of CYP3A4 inhibition and possible Pgp inhibition.
Darunavir/ ritonavir poveča plazemske koncentracije klaritromicina, kar je posledica zaviranja CYP3A4 in verjetno tudi Pgp.
400/100 b.i.d.
Vorikonazola se ne sme sočasno uporabljati z zdravilom PREZISTA s 100 mg ritonavirja razen, če ocena razmerja med tveganjem in koristjo opravičuje uporabo vorikonazola.
Ketoconazole 200 b.i.d.
200 b. i. d.
400/100 b.i.d.# Ketoconazole
400/ 100 b. i. d. #
↑ 42%
↑ 212% ↑ 42%
↑ 73%
↑ 868% ↑ 73%
Itraconazole
30 Itrakonazol
29 Clotrimazole
Klotrimazol
HMG Co-A Reductase Inhibitors Lovastatin Simvastatin
Zaviralci HMG- CoA reduktaze Lovastatin Simvastatin
600/100 b
mg enkratni odmerek
Based on these results, PREZISTA co-administered with 100 mg ritonavir can be co-administered with proton pump inhibitors without dose adjustments.
31 Na podlagi teh izsledkov lahko zdravilo PREZISTA s 100 mg ritonavirja uporabljamo sočasno z zaviralci protonske črpalke, brez prilagajanja odmerka.
Opiods Methadone
Opiodi
55-150 q.d.
↓ 16%
600/100 b.i.d.
↓ 15%
R-methadone
Metadon
↓ 16%
55- 150 q. d.
↓ 15%
600/ 100 b. i. d.
(dosed for 7 days)
(7 dni)
30 Based on pharmacokinetic and clinical findings, no adjustment of methadone dosage is required when initiating co-administration with PREZISTA/ritonavir.
Na osnovi farmakokinetičnih in kliničnih podatkov prilagajanje odmerka metadona ob uvedbi sočasnega zdravljenja z zdravilom PREZISTA/ ritonavir ni potrebno.
PDE-5 inhibitors Sildenafil Vardenafil Tadalafil Rifamycines
Zaviralci PDE- 5 Sildenafil Vardenafil Tadalafil Rifamicini
Rifabutin* 1.6 ND times ↑ ↑ 53% Darunavir ↑ 68% * sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite) A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day [i.e. rifabutin 150 mg q.o.d.
* vsota aktivnih frakcij rifabutina (učinkovina + 25- O- deacetil presnovek) Pri bolnikih, ki jemljejo to kombinacijo je priporočljivo zmanjšanje običajnega odmerka 300 mg/ dan rifabutina za 75% [to je 150 mg rifabutina q. o. d.
(once daily) reference dose is lacking.
Sedativi/ hipnotiki
Parenteral midazolam
32 Parenteralno apliciran midazolam
Selective Serotonin Reuptake Inhibitors (SSRIs)
Selektivni zaviralci ponovnega privzema serotonina (SSRI) Paroksetin
400/100 b.i.
400/ 100 b. i. d. #
Steroids Fluticasone propionate Budesonide
Steroidi Flutikazon - Propionat Budezonid
Pregnancy There are no adequate and well controlled studies with darunavir in pregnant women.
33 Pri nosečnicah ni ustreznih in dobro kontroliranih preskušanj z darunavirjem.
Breast-feeding It is not known whether darunavir is excreted in human milk.
Dojenje Ni znano, ali se darunavir izloča v materino mleko.
Because of both the potential for HIV transmission and the potential for adverse reactions in breast-fed infants, mothers should be instructed not to breast-feed under any circumstances if they are receiving PREZISTA.
Zaradi obojega, možnosti za prenos okužbe HIV in možnosti za neželene učinke pri dojenčkih, je treba materam naročiti, naj v nobenem primeru ne dojijo, če jemljejo zdravilo PREZISTA.
There was no effect on mating or fertility with darunavir treatment in rats (see section 5.3).
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
4.7 Effects on ability to drive and use machines 32 No studies on the effects of PREZISTA in combination with ritonavir on the ability to drive and use machines have been performed.
Študij o vplivu zdravila PREZISTA v kombinaciji z ritonavirjem na sposobnost vožnje in upravljanja s stroji niso izvedli.
The adverse drug reactions are derived from Phase IIb and Phase III trials, in which a total of 1,968 treatment-experienced patients initiated therapy with the recommended dose of PREZISTA 600 mg with ritonavir 100 mg twice daily.Median exposure to PREZISTA/ritonavir in this group was 37.3 weeks.
Mediana vrednost izpostavljenosti kombinaciji PREZISTA/ ritonavir, v tej skupini, je bila 37, 3 tedne.
lipodystrophy (including lipohypertrophy, lipodystrophy, lipoatrophy), hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia
lipodistrofija (vključno z lipohipertrofijo, lipodistrofijo, lipoatrofijo), hipertrigliceridemija, hiperholesterolemija, hiperlipidemija 34
Nervous system disorders 33 common
pogosti
uncommon Eye disorders
občasni Očesne bolezni
uncommon Vascular disorders
občasni Žilne bolezni
Hepatobiliary disorders common
35 Bolezni jeter, žolčnika in žolčevodov pogosti
34 uncommon
občasni
generalised rash, allergic dermatitis, face oedema, urticaria, dermatitis, eczema, erythema, hyperhidrosis, night sweats, alopecia, acne, seborrhoeic dermatitis, skin lesion, xeroderma, dry skin, nail pigmentation
generaliziran izpuščaj, alergijski dermatitis, edem obraza, urtikarija, dermatitis, ekcem, eritem, hiperhidroza, nočno znojenje, alopecija, akne, seboroični dermatitis, razjede na koži, kseroderma, suha koža, obarvanje nohtov
generalised rash, allergic dermatitis, urticaria, pruritus, hyperhidrosis, night sweats, alopecia
generaliziran izpuščaj, alergijski dermatitis, urtikarija pruritus, hiperhidroza, nočno znojenje, alopecija
Musculoskeletal and connective tissue disorders uncommon
Bolezni mišično- skeletnega sistema in vezivnega tkiva občasni Bolezni sečil
myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness, arthritis, arthralgia, joint stiffness, pain in extremity, osteoporosis, increased blood creatine phosphokinase
mialgija, mišični krči, šibkost mišic, okorelost mišic, artritis, artralgija, okorelost sklepov, bolečine v udih, osteoporoza, povišanje kreatin fosfokinaze v krvi
myalgia, arthralgia, pain in extremity, osteoporosis, increased blood creatine phosphokinase
mialgija, artralgija, bolečine v udih, osteoporoza, povišanje kreatin fosfokinaze v krvi
Renal and urinary disorders uncommon
občasni
acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, decreased creatinine renal clearance, proteinuria, bilirubinuria, dysuria, nocturia, pollakiuria
akutna ledvična odpoved, ledvična odpoved, nefrolitiaza, povišan kreatinin v krvi, zmanjšan ledvični klirens kreatinina, proteinurija, bilirubinurija, disurija, nikturija, polakisurija
acute renal failure, renal failure, nephrolithiasis, increased blood creatinine, decreased creatinine renal clearance, proteinuria, bilirubinuria
akutna ledvična odpoved, ledvična odpoved, nefrolitiaza, povišan kreatinin v krvi, zmanjšan ledvični klirens kreatinina, proteinurija, bilirubinurija
Reproductive system and breast disorders uncommon
Motnje reprodukcije in dojk občasni
General disorders and administration site conditions common
Splošne težave in spremembe na mestu aplikacije Splošne težave in spremembe na mestu aplikacije
In clinical trials (n=1,968), rash (all grades, at least possibly related) occurred in 5.6% of patients treated with PREZISTA.
Večinoma je bil izpuščaj
Uncommon: hyperlipidaemia, vomiting, abdominal pain, increased aspartate aminotransferase, rash (including maculopapular rash), allergic dermatitis, pruritus.
Občasni: hiperlipidemija, bruhanje, bolečina v trebuhu, povečana koncentracija aspartat- aminotransferaze, izpuščaj (vključno z makulopapuloznim izpuščajem), alergijski dermatitis, pruritus.
Common: hypertriglyceridaemia, hypercholesterolaemia, anorexia, insomnia, headache, dizziness, dysgeusia, vomiting, abdominal pain, abdominal discomfort, abdominal distension, flatulence,
Pogosti: hipertrigliceridemija, hiperholesterolemija, anoreksija, nespečnost, glavobol, omotica, disgevzija, bruhanje, bolečina v trebuhu, napetost v trebuhu, napihnjen trebuh, flatulenca, povečana koncentracija alanin- aminotransferaze, izpuščaj (vključno z makulopapuloznim, papuloznim izpuščajem), alopecija, suha koža, pruritus, izčrpanost.
Combination antiretroviral therapy has also been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirana protiretrovirusna terapija je bila povezana tudi z motnjami presnove, na primer s hipertrigliceridemijo, hiperholesterolemijo, rezistenco na insulin, hiperglikemijo in hiperlaktatemijo (glejte poglavje 4. 4).
Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving PREZISTA co-administered with ritonavir 600/100 mg b.i.d., 236 patients were co-infected with hepatitis B or C.
37 Med 1. 968 bolniki, ki so že bili zdravljeni s protiretrovirusnimi zdravili in so prejemali zdravilo PREZISTA skupaj z ritonavirjem (600/ 100 mg dvakrat na dan), jih je bilo 236 okuženih tudi s hepatitisom B ali C.
Since darunavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Ker je darunavir v velikem odstotku vezan na beljakovine, je malo verjetno, da bi lahko s hemodializo odstranili pomembno večjo količino učinkovine.
36 Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10-12M).
Mehanizem delovanja Darunavir je zaviralec dimerizacije in katalitične aktivnosti proteaze HIV- 1 (KD 4, 5 x 10- 12 M).
The EC50 value of darunavir increases by a median factor of 5.4 in the presence of human serum.
V prisotnosti človeškega seruma se vrednost EC50 za darunavir poveča za faktor 5, 4 (mediana vrednost).
Viruses selected in these conditions and showing decreased susceptibility to darunavir (range:
23 do 50- krat),
23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
38 so imeli 2 do 4 substitucij aminokislin v genu za proteazo.
In the 48 week analysis of the ARTEMIS trial (see Clinical experience subsection ART-naïve patients), 9.9% virologic failures were observed in patients receiving PREZISTA/ritonavir 800/100 mg q.d.
Pri analizi podatkov po 48 tednih preskušanja ARTEMIS (glejte podpoglavje Bolniki, ki nimajo izkušenj z ART v poglavju Klinične izkušnje) so pri 9, 9% bolnikov, ki so prejemali zdravilo PREZISTA/ ritonavir 800/ 100 mg q. d opazili pojav rezistence.
In these virologic failures no developing PI RAMs were identified.
Pri teh bolnikih niso ugotovili PI RAMov.
In 1 virologic failure of the PREZISTA/ritonavir group, 1 developing NRTI RAM at position 184 was identified, which was associated with a decreased susceptibility to emtricitabine included in the background regimen.
Pri enem bolniku z rezistenco v skupini PREZISTA/ ritonavir so ugotovili razvoj enega NNRTI RAMa na mestu 184, ki so ga povezali z zmanjšano občutljivostjo za emtricitabin, ki je bil vključen v osnovno shemo zdravljenja.
In a pooled analysis of the POWER 1, 2 and 3 (see Clinical experience subsection ART-experienced patients) and DUET 1 and 2 (TMC125-C206 and TMC125-C216) trials the amino acid substitutions identified that developed on PREZISTA co-administered with ritonavir (600/100 mg b.i.d.) in ≥ 20% of the isolates from subjects who experienced virologic failure by rebound were V32I, I54L and L89V.
V analizi združenih podatkov preskušanj POWER 1, 2 in 3 (glejte podpoglavje Klinične izkušnje, Bolniki, ki imajo izkušenje z ART) ter preskušanj DUET 1 in 2 (TMC125- C206 in TMC125- C216) se je pri zdravilu PREZISTA z ritonavirjem (600/ 100 mg dvakrat na dan) pokazalo, da so se, pri ≥ 20% izolatov, pri bolnikih, ki so že na predhodno zdravljenje razvili rezistenco, razvile zamenjave aminokislin V32I, I54L in L89V.
Of the viruses isolated from patients experiencing virologic failure by rebound from the PREZISTA/rtv 600/100 mg b.i.d. group of the POWER and DUET trials, 85% of those susceptible to darunavir at baseline developed decreased susceptibility to darunavir during treatment.
V preskušanjih POWER in DUET je pri 85% virusov (izoliranih pri bolnikih iz skupine, ki je prejemala zdravilo PREZISTA/ rtv 600/ 100 mg dvakrat na dan, pri katerih se je razvila rezistenca na predhodno zdravljenje in so bili na začetku preskušanj občutljivi za darunavir) med zdravljenjem prišlo do zmanjšanja občutljivosti za darunavir.
In the same group of patients, 71% of viruses that were susceptible to tipranavir at baseline remained susceptible after treatment.
V isti skupini bolnikov je izmed virusov, ki so bili ob začetku preskušanj občutljivi za tipranavir, po zdravljenju nanj ostalo občutljivih 71%.
In the virologic failures of the ARTEMIS trial no cross-resistance with other PIs was observed.
Pri rezistencah, ki so se pojavile v preskušanju ARTEMIS, niso opazili nobene navzkrižne odpornosti z drugimi PI.
37 Clinical experience Efficacy of PREZISTA co-administered with 100 mg ritonavir in ART-naïve patients The evidence of efficacy of PREZISTA/ritonavir 800/100 mg q.d. is based on the analyses of 48 week data from the ongoing, randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing PREZISTA/ritonavir 800/100 mg q.d. with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Klinične izkušnje Učinkovitost zdravila PREZISTA s 100 mg ritonavirja, pri bolnikih, ki še nimajo izkušenj z ART Dokazi o učinkovitosti zdravila PREZISTA/ ritonavir 800/ 100 mg q. d. temeljijo na analizi podatkov po 48 tednih zdravljenja v randomiziranem, nadzorovanem, odprtem kliničnem preskušanju III. faze (preskušanje ARTEMIS), ki še poteka, pri bolnikih okuženih s HIV- 1, ki še niso prejemali antiretrovirusnega zdravljenja, v katerem so primerjali kombinaciji PREZISTA/ ritonavir 800/ 100 mg q. d. in lopinavir/ ritonavir 800/ 200 mg na dan (ki so ga dajali z režimom dvakrat na dan ali enkrat na dan).
Both arms used a fixed background regimen consisting of tenofovir disoproxil fumarate 300 mg q.d. and emtricitabine 200 mg q.d.
V obeh krakih preskušanja so uporabljali osnovno shemo zdravljenja, ki je bila sestavljena iz 300 mg q. d. tenofovirdizoproksil fumarata in 200 mg q. d. emtricitabina.
HIV-1 infected patients who were eligible for this trial had plasma HIV-1 RNA > 5,000 copies/ml.
Bolniki, okuženi s HIV- 1, ki so bili primerni za to preskušanje, so imeli v plazmi > 5. 000 kopij/ ml HIV- 1 RNA.
Randomisation was stratified by screening plasma viral load and screening CD4+ cell count.
Randomizacija je bila razslojena glede na virusno breme in število CD4+ celic pred vključitvijo v preskušanje.