natgillin/translations-raw huggingface dataset:
With 50 mg twice daily, the exposure over 24 hours was approximately doubled compared to 50 mg once daily.
Kod primjene doze od 50 mg dvaput na dan, izloženost tijekom 24 sata približno se udvostručila u odnosu na primjenu doze od 50 mg jedanput na dan.
The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Srednja vrijednost IC50 za 3 izolata HIV-2 iznosila je 0,18 nM (raspon: 0,09-0,61).
Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
S obzirom na ograničene podatke o djeci i adolescentima (u dobi od 6 do manje od 18 godina i tjelesne težine od najmanje 15 kg), nisu primijećene dodatne vrste nuspojava u odnosu na one primijećene u odraslih bolesnika.
The bottles contain 30 or 90 film-coated tablets.
Boce sadrže 30 ili 90 filmom obloženih tableta.
Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 2).
Dolutegravir je i supstrat za UGT1A3, UGT1A9, CYP3A4, P-gp i BCRP; stoga lijekovi koji induciraju navedene enzime mogu smanjiti koncentracije dolutegravira u plazmi i tako oslabiti terapijski učinak dolutegravira (vidjeti
Dolutegravir ↔ (Not studied)
nelfinavir dolutegravir ↔ (interakcija nije ispitivana)
Interactions between dolutegravir and co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Interakcije između dolutegravira i istodobno primijenjenih lijekova navedene su u Tablici 2 (povećanje je označeno kao “↑”, smanjenje kao “↓”, stanje bez promjene kao “↔”, površina ispod krivulje koncentracija-vrijeme kao “AUC”, maksimalna zabilježena koncentracija kao “Cmax”, a koncentracija na kraju intervala doziranja kao “Cτ”).
How to take Tivicay
Kako uzimati Tivicay
30 to less than 40
30 do manje od 40
Dolutegravir had no pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Dolutegravir nije utjecao na farmakodinamiku luteinizirajućeg hormona (LH), folikulostimulirajućeg hormona (FSH)
Virologic non-response†
Izostanak virološkog odgovora†
If you take too many tablets of Tivicay, contact your doctor or pharmacist for advice.
Ako slučajno uzmete previše Tivicay tableta, obratite se svom liječniku ili ljekarniku za savjet.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Ovakve su se reakcije uobičajeno javljale unutar prvih nekoliko tjedana ili mjeseci nakon uvođenja kombinirane antiretrovirusne terapije.
4.6 Fertility, pregnancy and lactation Women of childbearing potential
4.6 Plodnost, trudnoća i dojenje
When excluding patients who stopped therapy for non-efficacy reasons, and those with major protocol deviations (incorrect dolutegravir dosing, intake of prohibited co-medication), namely, “the Virological Outcome (VO)-population)”, the corresponding response rates were 75% (120/161, week 24) and 69% (111/160, week 48).
Nakon isključivanja bolesnika koji su prekinuli terapiju zbog nedjelotvornosti te bolesnika u kojih je došlo do značajnih odstupanja u protokolu (netočno doziranje dolutegravira, primjena zabranjenih lijekova), odnosno “populacije s virološkim ishodom”, odgovarajuće stope odgovora iznosile su 75% (120/161, 24. tjedan) i 69% (111/160, 48. tjedan).
In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
In vitro dolutegravir nije pokazao ni izravnu ni slabu inhibiciju (IC50 > 50 μM) enzima citokroma P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridin difosfat glukuronoziltransferaze (UGT)1A1 ili UGT2B7 niti prijenosnika P-gp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 ili MRP4.
When using the lab-strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F, resulting in a maximal fold change in susceptibility of 4 (range 2-4).
Pri korištenju laboratorijskog soja HIV-1 IIIB za vrijeme pasaže tijekom 112 dana, odabrane mutacije pojavljivale su se polako, sa supstitucijama na položajima S153Y i F, što je za posljedicu imalo maksimalnu promjenu (engl. fold change, FC) u osjetljivosti od 4 (raspon: 2-4).
Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase experienced or infected with integrase resistant virus by transmission.
Od ta četiri ispitanika, dva su imala jedinstvenu supstituciju R263K na integrazi uz maksimalni FC od 1,93, jedan je imao polimorfnu supstituciju V151V/I na integrazi uz maksimalni FC od 0,92, a jedan je ispitanik imao otprije postojeće mutacije integraze te se pretpostavlja da je prethodno primao inhibitore integraze ili da je prijenosom bio zaražen virusom rezistentnim na inhibitore integraze.
The E92Q mutation has been selected in patients with pre-existing raltegravir resistance who were then treated with dolutegravir (listed as a secondary mutation for dolutegravir).
Mutacija E92Q izdvojena je u bolesnika s već postojećom rezistencijom na raltegravir koji su liječeni dolutegravirom (navodi se kao sekundarna mutacija za dolutegravir).
• calcium supplements, iron supplements and multivitamins.
• nadomjeske kalcija, nadomjeske željeza i multivitaminske pripravke.
As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Budući da se dolutegravir u velikoj mjeri veže za proteine u plazmi, nije vjerojatno da će se značajno ukloniti dijalizom.
This is supported by 96 week data from an open-label, randomized and activecontrolled study FLAMINGO (ING114915) and additional data from the open-label phase of SINGLE to 144 weeks.
Podupiru ih i podaci prikupljeni tijekom 96 tjedana u otvorenom, randomiziranom i aktivno kontroliranom ispitivanju FLAMINGO (ING114915) i dodatni podaci iz otvorene faze ispitivanja SINGLE do 144. tjedna.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release GLAXO WELLCOME, S.A., Avda.
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet GLAXO WELLCOME, S.A., Avda.
- This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po jediničnoj dozi, tj. zanemarive količine natrija.
Pharmacokinetic data for dolutegravir in subjects >65 years of age are limited.
Farmakokinetički podaci o primjeni dolutegravira u ispitanika starijih od 65 godina su ograničeni.
Dolutegravir is eliminated mainly through metabolism by UGT1A1.
Dolutegravir se uglavnom eliminira metabolizmom posredstvom UGT1A1.
The systemic exposure at this dose (based on AUC) to dolutegravir was ~17-20-fold higher than humans at the recommended pediatric exposure.
Sistemska izloženost dolutegraviru pri toj dozi (na temelju AUC-a) bila je ~17 - 20 puta veća od izloženosti u ljudi kod preporučene pedijatrijske izloženosti.
No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore dolutegravir should be used with caution in these patients (see section 5.2).
Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) pa se u tih bolesnika dolutegravir mora primjenjivati uz oprez (vidjeti dio 5.2).
Rare side effects These may affect up to 1 in 1000 people:
Rijetke nuspojave Mogu se javiti u do 1 na 1000 osoba:
In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
U štakorica u laktaciji koje su primile jednu peroralnu dozu od 50 mg/kg 10 dana postpartalno, dolutegravir je pronađen u mlijeku u koncentracijama koje su obično bile veće od onih u krvi.
In Phase I studies in healthy subjects, between-subject CVb% for AUC and Cmax ranged from ~20 to 40% and Cτ from 30 to 65% across studies.
U ispitivanjima faze I u zdravih ispitanika, interindividualna vrijednost CVb% za AUC i Cmax kretala se u rasponu od ~20 do 40%, a za Cτ od 30 do 65% u svim ispitivanjima.
Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Na temelju ovih podataka, ne očekuje se da će dolutegravir utjecati na farmakokinetiku lijekova koji su supstrati za glavne enzime ili prijenosnike (vidjeti dio 4.5).
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do njihove pojave je različito pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja (vidjeti dio 4.4).
Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with dolutegravir.
Metformin se izlučuje putem bubrega, stoga je važno nadzirati bubrežnu funkciju kada se istodobno primjenjuje s dolutegravirom.
In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
In vivo dolutegravir nije imao učinak na midazolam, probni supstrat za CYP3A4.
The effect of severe hepatic impairment on the pharmacokinetics of Tivicay has not been studied.
Utjecaj teškog oštećenja jetrene funkcije na farmakokinetiku lijeka Tivicay nije ispitivan.
The proportion of subjects with HIV RNA <50 copies/mL was 96/126 (76%) for No Q148 mutations, 22/41 (54%) for Q148+1 and 5/19 (26%) for Q148+≥2 secondary mutations.
Udio ispitanika s HIV RNK <50 kopija/ml bio je 96/126 (76%) za ispitanike bez Q148 mutacije, 22/41 (54%) za Q148+1 i 5/19 (26%) za Q148+≥2 sekundarne mutacije.
The response was lower when the Q148-mutation was present at baseline, and in particular in the presence of ≥2 secondary mutations, Table 8.
Odgovor je bio niži kada je mutacija Q148 bila prisutna na početku ispitivanja, osobito ako su uz nju bile prisutne i ≥ 2 sekundarne mutacije; Tablica 8.
AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
AUC je u sjemenu iznosio 7%, a u rektalnome tkivu 17% odgovarajuće vrijednosti u plazmi u stanju dinamičke ravnoteže.
Thirty-two percent of the total oral dose is excreted in the urine, represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Trideset i dva posto ukupne peroralne doze izlučuje se u mokraću u obliku eter-glukuronida dolutegravira (18,9% ukupne doze), metabolita dobivenog N-dealkilacijom (3,6% ukupne doze) i metabolita koji nastaje oksidacijom na benzilnom atomu ugljika (3,0% ukupne doze).
In a combined analysis of VIKING-3 and VIKING-4 (n=186, VO population), the proportion of subjects with HIV RNA <50 copies/mL at Week 48 was 123/186 (66%).
U združenoj analizi ispitivanja VIKING-3 i VIKING-4 (n=186, populacija s virološkim ishodom (VO)), udio ispitanika s HIV RNK <50 kopija/ml u 48. tjednu bio je 123/186 (66%).
G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Mutacija G118R smanjuje osjetljivost izolata s ciljanom mutagenezom (engl. site directed mutants) na dolutegravir (FC 10), ali nije pronađena u bolesnika koji su primali dolutegravir u programu ispitivanja faze III.
In SINGLE, the median time to viral suppression was shorter in the dolutegravir treated patients (28 vs 84 days, (p<0.0001, analysis pre-specified and adjusted for multiplicity).
U ispitivanju SINGLE, medijan vremena do virusne supresije bio je kraći u bolesnika liječenih dolutegravirom (28 naspram 84 dana [p<0,0001; analiza je bila unaprijed određena i prilagođena za multiplicitet]).
20 to less than 30
20 do manje od 30
The pharmacokinetics of dolutegravir following single dose oral administration to Japanese subjects appear similar to observed parameters in Western (US) subjects.
Farmakokinetika dolutegravira nakon peroralne primjene jedne doze u ispitanika japanskoga podrijetla čini se sličnom parametrima primijećenima u ispitanika sa zapada (SAD).
In serial passage with strain NL432, starting with site directed mutants harbouring N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
U serijskoj pasaži sa sojem NL432, koja je započela s izolatima s ciljanom mutagenezom i mutacijom N155H ili E92Q, nije primijećena daljnja selekcija rezistencije (FC od približno 1 ostao je nepromijenjen).
In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2).
U slučaju rezistencije na skupinu inhibitora integraze, Tivicay je poželjno uzimati s hranom radi pospješivanja izloženosti (osobito u bolesnika s mutacijama Q148) (vidjeti dio 5.2).
No dose adjustment of oral contraceptives is necessary when co-administered with dolutegravir.
Nije potrebno prilagođavati dozu oralnih kontraceptiva pri njihovoj istodobnoj primjeni s dolutegravirom.
Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Iako se smatra da postoji više uzroka (uključujući primjenu kortikosteroida, bifosfonate, konzumiranje alkohola, jaku imunosupresiju, viši indeks tjelesne mase), slučajevi osteonekroze prijavljeni su u bolesnika s uznapredovalom HIV bolešću i/ili u bolesnika dugotrajno izloženih kombiniranoj antiretrovirusnoj terapiji.
Common Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) elevations Common Creatine phosphokinase (CPK) elevations
Pretrage često povišene vrijednosti alanin aminotransferaze (ALT) i/ili aspartat aminotransferaze (AST)
The exposure to dolutegravir was decreased by approximately 40% in subjects with severe renal impairment.
Izloženost dolutegraviru smanjila se za približno 40% u ispitanika s teškim oštećenjem bubrežne funkcije.
• difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Kako postaje snažniji, imunološki sustav u rijetkim slučajevima može napadati i zdravo tkivo u tijelu (autoimuni poremećaji).
There are limited data available on the use of dolutegravir in patients aged 65 years and over.
Malobrojni su podaci o primjeni dolutegravira u bolesnika u dobi od 65 ili više godina.
Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Dolutegravir se nakon peroralne primjene brzo apsorbira, pri čemu se medijan Tmax postiže 2 do 3 sata nakon primjene doze u obliku tablete.
The bottle contains a desiccant to reduce moisture.
Boca sadrži sredstvo za sušenje koje smanjuje količinu vlage.
Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
Sveukupno je sigurnosni profil u bolesnika s istodobnom infekcijom hepatitisom B i/ili C bio sličan onomu primijećenom u bolesnika koji nisu imali istodobnu infekciju hepatitisom B ili C, premda su u svim liječenim skupinama stope odstupanja u vrijednostima AST-a i ALT-a bile nešto više u podskupini bolesnika s istodobnom infekcijom hepatitisom B i/ili C.
It should not be taken as five 10 mg tablets.
Ne smije se primijeniti kao pet tableta od 10 mg.
EXPIRY DATE EXP {MM/YYYY}
EXP {MM/GGGG}
There is currently limited experience with overdosage in dolutegravir.
Trenutno iskustvo s predoziranjem dolutegravirom je ograničeno.
• St. John's wort (Hypericum perforatum), a herbal remedy to treat depression
• gospinu travu (Hypericum perforatum), biljni lijek za liječenje depresije.
• If you are taking certain other medicines, the dose is one 50 mg tablet twice a day.
• Ako uzimate i neke druge lijekove, doza je jedna tableta od 50 mg dvaput na dan.
In a meta-analysis using pharmacogenomics samples collected in clinical studies in healthy subjects, subjects with UGT1A1 (n=7) genotypes conferring poor dolutegravir metabolism had a 32% lower clearance of dolutegravir and 46% higher AUC compared with subjects with genotypes associated with normal metabolism via UGT1A1 (n=41).
U meta-analizi farmakogenomskih uzoraka prikupljenih u kliničkim ispitivanjima u zdravih dobrovoljaca, ispitanici s UGT1A1 (n=7) genotipovima i slabim metabolizmom dolutegravira imali su 32% niži klirens dolutegravira i 46% viši AUC u usporedbi s ispitanicima s genotipovima povezanima s normalnim metabolizmom putem UGT1A1 (n=41).
The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern (see section 5.1).
Odluku o primjeni dolutegravira u tih bolesnika treba temeljiti po uzorku rezistencije integraze (vidjeti dio 5.1).
Warnings and precautions Look out for important symptoms
Pripazite na važne simptome
PK/PD modelling using pooled data from clinical studies in integrase resistant patients suggest that increasing the dose from 50 mg twice daily to 100 mg twice daily may increase the effectiveness of dolutegravir in patients with integrase resistance and limited treatment options due to advanced multi class resistance.
Farmakokinetičko/farmakodinamičko modeliranje, koje koristi združene podatke iz kliničkih ispitivanja u bolesnika rezistentnih na inhibitore integraze, sugerira da povišenje doze s 50 mg dvaput na dan na 100 mg dvaput na dan može povećati učinkovitost dolutegravira u bolesnika s rezistencijom na inhibitore integraze i ograničenim mogućnostima liječenja zbog uznapredovale rezistencije na više skupina lijekova.
The between-subject PK variability of dolutegravir was higher in HIV-infected subjects than healthy subjects.
Interindividualna farmakokinetička varijabilnost dolutegravira bila je veća u ispitanika s HIV infekcijom nego u zdravih ispitanika.
Some medicines can affect how Tivicay works, or make it more likely that you will have side effects.
Neki lijekovi mogu utjecati na način djelovanja lijeka Tivicay ili povećati vjerojatnost pojave nuspojava.
• The usual dose is one 50 mg tablet once a day.
• Uobičajena doza je jedna tableta od 50 mg jedanput na dan.
Q148+1 secondary mutationb
Q148+1 sekundarna mutacijab
When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to these primary mutations in experiments with site directed mutants, dolutegravir susceptibility is still unchanged (FC <2 vs wild type virus), except in the case of Q148-mutations, where a FC of 5-10 or higher is seen with combinations of certain secondary mutations.
Kada se u pokusima na izolatima s ciljanom mutagenezom primarnim mutacijama dodaju mutacije navedene kao sekundarne mutacije povezane s inhibitorima integraze (raltegravirom/elvitegravirom), osjetljivost na dolutegravir ostaje nepromijenjena (FC < 2 u odnosu na virus divljeg tipa), osim u slučaju mutacija Q148, gdje je u kombinacijama s određenim sekundarnim mutacijama zabilježen FC od 5-10 ili više.
In the presence of documented resistance that includes Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance (see section 5.2).
U slučaju dokumentirane rezistencije koja uključuje Q148 + ≥2 sekundarne mutacije G140A/C/S, E138A/K/T, L74I, modeliranje upućuje da se može razmotriti povišenje doze u bolesnika s ograničenim mogućnostima liječenja (manje od 2 aktivna lijeka) zbog uznapredovale rezistencije na više skupina lijekova (vidjeti dio 5.2).
- The other ingredients are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E171), macrogol, talc and for 25 and 50 mg tablets, iron oxide yellow (E172).
Drugi sastojci su manitol (E421), mikrokristalična celuloza, povidon (K29/32), natrijev škroboglikolat, natrijev stearilfumarat, djelomično hidroliziran poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk i za 25 mg i 50 mg tablete, žuti željezov oksid (E172).
Co-administration of dolutegravir and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 2).
Istodobna primjena dolutegravira i drugih lijekova koji inhibiraju spomenute enzime može povećati koncentracije dolutegravira u plazmi (vidjeti Tablicu 2).
Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3).
Istodobna primjena dolutegravira i dofetilida je kontraindicirana zbog moguće po život opasne toksičnosti uzrokovane visokom koncentracijom dofetilida (vidjeti dio 4.3).
The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Sažetak sigurnosnog profila Najteža nuspojava, primijećena u samo jednog bolesnika, bila je reakcija preosjetljivosti, koja je uključivala osip i teške jetrene nuspojave (vidjeti dio 4.4).
Some people taking medicines for HIV infection develop other conditions, which can be serious.
U nekih osoba koje uzimaju lijekove za liječenje HIV infekcije mogu se razviti i neka druga stanja,
NRTI, 75% ≥1 NNRTI, and 71% ≥2 PI major mutations; 62% had non-R5 virus.
je imalo ≥2 NRTI, 73% ≥1 NNRTI, i 67% ≥2 IP značajne mutacije; 83% imalo je virus koji nije bio R5.
Tivicay contains the active ingredient dolutegravir.
Tivicay sadrži djelatnu tvar dolutegravir.
Sixteen of 30 subjects (53%) harboured Q148 virus at baseline.
Šesnaest od 30 ispitanika (53%) imalo je virus s mutacijom Q148 na početku ispitivanja.
Q148 +≥2 secondary mutations 3
Q148 + ≥ 2 sekundarne mutacije3
Etravirine without boosted protease inhibitors decreased plasma dolutegravir concentration.
Etravirin bez pojačanih inhibitora proteaze smanjuje koncentraciju dolutegravira u plazmi.
HIV-1 RNA <50 copies/mL at 24 weeks, n (%) HIV-1 RNA <50 copies/mL at 48 weeks, n (%) HIV-1 RNA <400 copies/mL at 24 weeks, n (%) HIV-1 RNA <400 copies/mL at 48 weeks, n (%) Virologic non response
HIV-1 RNK < 50 kopija/ml u 24. tjednu, n (%) HIV-1 RNK < 50 kopija/ml u 48. tjednu, n (%) HIV-1 RNK < 400 kopija/ml u 24. tjednu, n (%) HIV-1 RNK < 400 kopija/ml u 48. tjednu, n (%) Izostanak virološkog odgovora Broj CD4 + stanica
Although these simulated results have not been confirmed in clinical trials, this high dose may be considered in the presence of the Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I in patients with overall limited treatment options due to advanced multi class resistance.
Iako ovi simulirani rezultati nisu potvrđeni u kliničkim ispitivanjima, ova viša doza može se razmotriti u prisustvu Q148 + ≥2 sekundarne mutacije: G140A/C/S, E138A/K/T, L74I u bolesnika sa sveukupno ograničenim terapijskim mogućnostima zbog uznapredovale rezistencije na više skupina lijekova.