natgillin/translations-raw huggingface dataset:
Children and adolescents weighing at least 40 kg can take the adult dose of one tablet (50 mg), once a day. 
Otroci in mladostniki, ki tehtajo vsaj 40 kg, lahko jemljejo odmerek za odrasle, to je eno tableto (50 mg) enkrat na dan.
If you take more Tivicay than you should 
Če ste vzeli večji odmerek zdravila Tivicay, kot bi smeli
Some people taking combination therapy for HIV develop a condition called osteonecrosis. 
Pri nekaterih osebah, ki jemljejo kombinacijo zdravil za HIV, se lahko pojavi stanje, imenovano osteonekroza.
Cohort IIA (6 to <12 years) (n=23) 
Kohorta IIA (od 6 do < 12 let) (n = 23)
What Tivicay is and what it is used for 
Kaj je zdravilo Tivicay in za kaj ga uporabljamo
Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q and T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations. 
Primarne mutacije za raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) ne vplivajo na dovzetnost dolutegravirja in vitro kot posamezne mutacije.
Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2). 
Na podlagi in vivo in/ali in vitro podatkov ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati glavnih encimov ali prenašalci, kot so CYP3A4, CYP2C9 in P-gp (za več informacij glejte poglavje 5.2).
15 to less than 20 
15 do manj kot 20
There is currently limited experience with overdosage in dolutegravir. 
Trenutno je le malo izkušenj s prevelikim odmerjanjem pri dolutegravirju.
Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose). 
Dolutegravir je prevladujoča snov, ki kroži v plazmi; izločanje nespremenjene učinkovine preko ledvic je majhno (< 1 % odmerka).
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. 
Pomembni primeri so citomegalovirusni retinitis, generalizirane in/ali fokalne okužbe z mikobakterijami in pljučnica zaradi Pneumocystis jirovecii.
Don't stop unless your doctor advises you to. 
Ne prenehajte z jemanjem, razen če vam tega ne priporoča zdravnik.
If possible, show them the Tivicay pack. 
Po možnosti jima pokažite ovojnino zdravila Tivicay.
The linearity of dolutegravir pharmacokinetics is dependent on dose and formulation. 
Linearnost farmakokinetike dolutegravirja je odvisna od odmerka in oblike.
Tivicay should be prescribed by physicians experienced in the management of HIV infection. 
Zdravilo Tivicay smejo predpisovati zdravniki, ki imajo izkušnje z zdravljenjem okužb z virusom HIV.
With this condition, parts of the bone tissue die because of reduced blood supply to the bone. 
Pri tej bolezni deli kostnega tkiva odmrejo zaradi zmanjšane prekrvitve kosti.
If you forget to take Tivicay 
Če ste pozabili vzeti zdravilo Tivicay
Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. 
Dolutegravir zavira integrazo HIV z vezavo na aktivno mesto integraze in preprečuje prenos zapisa pri vgradnji retrovirusne deoksiribonukleinske kisline (DNK), ki je bistvenega pomena za replikacijski ciklus HIV.
4.6 Fertility, pregnancy and lactation Women of childbearing potential 
4.6 Plodnost, nosečnost in dojenje
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. 
Čeprav so vzroki za osteonekrozo različni (vključujoč uporabo kortikosteroidov, difosfonatov, uživanje alkohola, hudo imunosupresijo in višji indeks telesne mase), so o primerih osteonekroze poročali predvsem pri bolnikih z napredovalo okužbo s HIV-boleznijo in/ali dolgotrajno izpostavljenostjo CART.
The overall susceptibility score (OSS) of the optimised background regimen (OBR) was not associated with Week 24 response, nor with the week 48 response. 
Skupna ocena dovzetnosti (OSS) optimizirane osnovne sheme (OBR) ni bila povezana z odzivom po 24., niti po 48. tednih.
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. 
G118R zmanjša dovzetnost za dolutegravir pri točkovnih mutantih (FC 10), vendar ga niso opazili pri bolnikih, ki so prejemali dolutegravir v programu III. faze.
The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61). 
Povprečna IC50 za 3 izolate HIV-2 je bila 0,18 nM (razpon: od 0,09 do 0,61).
Primary mutation other than Q148H/K/R2 
Druga primarna mutacija razen Q148H/K/R2
Some medicines can affect how Tivicay works, or make it more likely that you will have side effects. 
Nekatera zdravila lahko vplivajo na delovanje zdravila Tivicay ali povečajo verjetnost, da se pri vas pojavijo neželeni učinki.
Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir. 
Ledvični očistek nespremenjene učinkovine je manj pomembna pot izločanja dolutegravirja.
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). 
112 dni uporablja laboratorijski sev HIV-1 IIIB, se izbrane mutacije pojavljajo počasi, z substitucijami na mestih S153Y in F, kar ima za posledico maksimalno spremembo zavoja pri občutljivosti 4 (razpon 2-4).
35 mg once daily (Taken as one 25 mg and one 10 mg tablet) 
35 mg enkrat na dan (Uporabljen kot ena 25 mg in ena 10 mg tableta)
• If you are taking certain other medicines, the dose is one 50 mg tablet twice a day. 
• Če jemljete nekatera druga zdravila, je odmerek ena 50 mg tableta dvakrat na dan.
There is no clinical data on the safety or efficacy of the 100 mg twice daily dose. 
O varnosti in učinkovitosti odmerka 100 mg dvakrat na dan ni kliničnih podatkov.
Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children over 6 years old, who weigh at least 15 kg. 
Zdravilo Tivicay se uporablja za zdravljenje okužbe z virusom HIV (virus humane imunske pomanjkljivosti) pri odraslih, mladostnikih in otrocih, starejših od 6 let, ki tehtajo vsaj 15 kg.
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. 
Ko se mutacije, navedene kot sekundarne mutacije, povezane z zaviralci integraze (za raltegravir/elvitegravir), v poskusih s točkovnimi mutanti dodajo tem primarnim mutacijam, dovzetnost za dolutegravir ostaja še naprej nespremenjena (FC <2 proti virusu divjega tipa), razen v primeru mutacij Q148, kjer je opaziti FC 5 -10 ali več v kombinacijah z določenimi sekundarnimi mutacijami.
• stomach pain (abdominal pain) 
• bolečine v trebuhu (abdominalne bolečine)
These mutations were not selected in patients treated with dolutegravir in the clinical studies. 
Te mutacije pri bolnikih, zdravljenih z dolutegravirjem, v kliničnih študijah niso bile izbrane.
Delay in stopping treatment with dolutegravir or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction. 
Odlašanje z ukinitvijo zdravljenja z dolutegravirjem ali drugimi zadevnimi učinkovinami ob pojavu preobčutljivosti ima lahko za posledico življenjsko nevarno alergijsko reakcijo.
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. 
Pri doječih podganah, ki so prejele enkratni peroralni odmerek 50 mg/kg 10. dan po kotitvi, so bile ugotovljene koncentracije dolutegravirja v mleku značilno višje od tistih v krvi.
† Includes subjects who changed BR to new class or changed BR not permitted per protocol or due to lack of efficacy prior to Week 48 (for SPRING-2 only), subjects who discontinued prior to Week 48 for lack or loss of efficacy and subjects who are ≥50 copies in the 48 week window. 
† Vključuje osebe s spremembo klasifikacije osnovne sheme v nov razred ali po protokolu nedopustno spremembo BR ali spremembo zaradi neučinkovitosti pred 48. tednom (samo za SPRING-2), osebe, ki so odstopile pred 48. tednom zaradi pomanjkanja oz. izgube učinkovitosti ter osebe s ≥ 50 kopijami v 48
Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14). 
Podobne IC50 so opažali pri kliničnih izolatih, brez posebnih razlik med podvrstami; v panelu 24 izolatov HIV-1 podtipov A, B, C, D, E, F in G ter skupine O je bila povprečna IC50 0,2 nM
There is no specific treatment for an overdose of dolutegravir. 
Specifičnega zdravljenja pri prevelikem odmerjanju dolutegravirja ni.
In patients without a primary mutation detected at baseline (N=60) (i.e. RAL/EVG not part of current failing therapy) there was a 1.63 log10 reduction in viral load at day 8. 
Pri bolnikih brez primarne mutacije ob izhodišču (N = 60) (tj. RAL/EVG ni del trenutne neuspešne terapije) je bilo zmanjšanje virusnega bremena na 8. dan 1,63 log10.
Table 8 Response by baseline Resistance, VIKING-3. 
Preglednica 8: Odziv glede na izhodiščno odpornost, VIKING-3.
Baseline parameters 
Izhodiščni parametri
RAL 400 mg Twice Daily + BR N=361§ 
RAL 400 mg dvakrat na dan + BR N=361§
Tivicay has not been studied in patients on dialysis. 
Zdravilo Tivicay ni raziskano pri bolnikih na dializi.
Currently available data are described in section 4.8, 5.1 and 5.2, but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in
Warnings and precautions Look out for important symptoms 
Bodite pozorni na pomembne simptome
There are no data available on the use of dolutegravir plus lamivudine as a two-drug regimen in paediatric patients. 
Podatki o uporabi kombinacije dolutegravirja in lamivudina kot sheme z dvema učinkovinama pri pediatričnih bolnikih niso na voljo.
A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls. 
Študijo farmakokinetike dolutegravirja so izvedli pri preiskovancih s hudo okvaro ledvic (Clcr < 30 ml/min) in je bila primerljiva z zdravimi kontrolnimi osebami.
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 med dolutegravirjem in sočasno uporabljenimi zdravili so navedene v Preglednici 2 (zvečanje je označeno kot “↑”, zmanjšanje kot “↓”, brez spremembe kot “↔”, površina pod koncentracijsko krivuljo v odvisnosti od časa kot “AUC”, maksimalna zabeležena koncentracija kot “Cmax”, koncentracija na koncu odmernega intervala pa kot “Cτ”).
Baseline CD4+ (cells/ mm3) 200 to <350 NRTI backbone ABC/3TC 
CD4+ (celic/mm3) 200 do < 350 NRTI ABC/3TC
30 to less than 40 
30 do manj kot 40
Median Change from Baseline, cells/mm3 
Mediana sprememba od izhodišča, celic/mm3
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). 
Z izključenimi bolniki, ki so končali zdravljenje zaradi neučinkovitosti ali so imeli večje kršitve protokola (nepravilno odmerjanje dolutegravirja, sočasno jemanje prepovedanih zdravil), "populacija z virološkim odzivom (VO)", sta bila ustrezna deleža odziva 75 % (120/161, 24. teden) in 69 % (111/160, 48. teden).
In animal reproductive toxicity studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3). 
V študijah toksičnosti za razmnoževanje pri živalih niso bili ugotovljeni negativni učinki na razvoj, vključno z okvarami nevralne cevi (glejte poglavje 5.3).
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). 
UGT1A9, CYP 3A4, Pgp in BCRP, zato lahko zdravila, ki inducirajo te encime, znižajo plazemske koncentracije dolutegravirja in zmanjšajo njegov terapevtski učinek (glejte Preglednico 2).
If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. 
Če je čas do naslednjega odmerka do 4 ure, bolnik ne sme vzeti pozabljenega odmerka, ampak preprosto nadaljuje z jemanjem po ustaljenem urniku.
But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. 
Če pa je čas do naslednjega odmerka do 4 ure, izpustite pozabljeni odmerek in vzemite naslednjega ob običajnem času.
The absolute bioavailability of dolutegravir has not been established. 
Absolutna biološka uporabnost dolutegravirja ni ugotovljena.
• The usual dose is one 50 mg tablet once a day. 
• Običajni odmerek je ena 50 mg tableta enkrat na dan.
Symptoms usually include fever, plus some of the following: 
Simptomi običajno vključujejo povišano telesno temperaturo in še katerega od naslednjih: • glavobol
Pharmacokinetic data for dolutegravir in subjects >65 years of age are limited. 
Farmakokinetičnih podatki o dolutegravirju pri osebah starejših od 65 let so omejeni.
Like all medicines, this medicine can cause side effects, but not everybody gets them. 
Možni neželeni učinki Kot vsa zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
HDPE (high density polyethylene) bottles closed with child resistant polypropylene screw closures, with a polyethylene faced induction heat seal liner. 
Vsebniki iz HDPE (polietilena visoke gostote) zaprti z za otroke varnimi polipropilenskimi pokrovčki z navojem, zapečateni s polietilensko folijo s pomočjo toplotne indukcije.
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 ni pokazal neposrednega ali šibkega zaviralnega učinka (IC50 > 50 μM) na encime citokrom P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridin difosfat glukuronozil transferazo (UGT)1A1 ali UGT2B7, ali na prenašalce Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 ali MRP4.
Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects. 
Farmakokinetika dolutegravirja je podobna pri zdravih osebah in osebah, okuženih z virusom HIV.
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 podlagi teh podatkov ni pričakovati, da bi dolutegravir vplival na farmakokinetiko zdravil, ki so substrati glavnih encimov ali prenašalci (glejte poglavje 4.5).
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). 
Najresnejši neželeni učinek, ki je bil opažen pri posameznem bolniku, je bila preobčutljivostna reakcija z izpuščajem in hudo prizadetostjo jeter (glejte poglavje 4.4).
In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN). 
V študijah faze III so bolniki s sočasno okužbo z virusom hepatitisa B in/ali C smeli biti vključeni v raziskavo pod pogojem, da njihove izhodiščne vrednosti jetrnih testov niso presegle petkratne zgornje meje normale (ULN - upper limit of normal).
Five further subjects experienced PDVF between weeks 24 and 48, and 2 of these 5 had treatment emergent mutations. 
Petim dodatnim preiskovancem se je po protokolu opredeljen virološki neuspeh pojavil od 24. do 48. tedna; 2 od teh 5 bolnikov sta imela mutacije, ki so se pojavile med zdravljenjem.
The response was lower when the Q148-mutation was present at baseline, and in particular in the presence of ≥2 secondary mutations, Table 8. 
Odziv je bil manjši, kadar je bila ob izhodišču prisotna mutacija Q148, še posebej ob prisotnosti ≥
Dolutegravir has a less than or equal to 10 FC against 94% of the 705 clinical isolates. 
Dolutegravir ima ≤10 FC proti 94% 705 kliničnih izolatov.
Then continue your treatment as before. 
Nadaljujte z zdravljenjem tako,
In a juvenile toxicity study in rats, dolutegravir administration resulted in two preweanling deaths at 75 mg/kg/day. 
V študiji juvenilne toksičnosti pri podganah je smrt dveh mladičev pred odstavitvijo povzročila uporaba dolutegravirja v odmerku 75 mg/kg/dan.
• difficulty moving. 
• oteženo gibanje
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji,
20 to less than 30 
20 do manj kot 30
Other medicines and Tivicay Tell your doctor if you are taking, have recently taken or are planning to take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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. 
Farmakokinetično/farmakodinamično modeliranje z uporabo skupnih podatkov kliničnih študij pri bolnikih, odpornih na zaviralce integraze, kaže, da lahko povečanje odmerka s 50 mg dvakrat na dan na 100 mg dvakrat na dan poveča učinkovitost dolutegravirja pri bolnikih z odpornostjo proti zaviralcem integraze in omejenimi možnostmi zdravljenja zaradi napredovale odpornosti proti več skupinam.
The results of the pooled analysis were in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at week 48 based on the Snapshot algorithm) was met. 
Rezultati združene analize so bili v skladu z rezultati vsake posamezne študije, za katere je bil primarni cilj (razlika v deležu < 50 kopij/mL HIV-1 RNA v plazmi po 48 tednih glede na “snapshot” algoritem) dosežen.
The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency. 
Neželeni učinki, ki bi lahko bili vsaj domnevno povezani z dolutegravirjem, so navedeni glede na prizadeti organski sistem in pogostnost.
Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3). 
Sočasna uporaba dolutegravirja in dofetilida je kontraindicirana zaradi možne življenjsko nevarne toksičnosti, ki jo povzroča visoka koncentracija dofetilida (glejte poglavje 4.3).
In the rat pre/post-natal development study, decreased body weight of the developing offspring was observed during lactation at a maternally toxic dose (approximately 27 times human exposure at the maximum recommended human dose). 
V študiji pre- in postnatalnega razvoja pri podganah so opažali zmanjšanje telesne mase razvijajočih se mladičev v obdobju dojenja med uporabo odmerka, toksičnega za samice-matere (približno 27-kratna izpostavljenost pri človeku med uporabo največjega priporočenega odmerka za človeka).
If the patient misses a dose of Tivicay, the patient should take Tivicay as soon as possible, providing the next dose is not due within 4 hours. 
Izpuščeni odmerki Če bolnik izpusti odmerek zdravila Tivicay, ga mora vzeti čim prej, pod pogojem, da do naslednjega odmerka ni manj kot 4 ure.
No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population (see section 5.2). 
Za bolnike, ki se zdravijo z dializo, ni podatkov, vendar pri tej populaciji ni pričakovati razlik v farmakokinetiki (glejte poglavje 5.2).
What Tivicay looks like and contents of the pack 
Izgled zdravila Tivicay in vsebina pakiranja
The efficacy of dolutegravir in HIV-infected, therapy naïve subjects is based on the analyses of 96-week data from two randomized, international, double-blind, active-controlled trials, SPRING-2 (ING113086) and SINGLE (ING114467). 
Učinkovitost dolutegravirja pri predhodno nezdravljenih osebah, okuženih z virusom HIV, temelji na analizi 96-tedenskih podatkov iz dveh randomiziranih, mednarodnih, dvojno slepih, aktivno nadzorovanih študij: SPRING-2 (ING113086) in SINGLE (ING114467).
The efficacy of dolutegravir in combination with lamivudine in adults is supported by 48-week primary endpoint data from two identical 148-week, randomised, multicentre, double-blind, non-inferiority studies GEMINI-1 (204861) and GEMINI-2 (205543). 
Učinkovitost dolutegravirja v kombinaciji z lamivudinom pri odraslih osebah temelji na 48 tedenskih podatkih o primarnih izidih iz dveh identičnih 148 tednov trajajočih randomiziranih, multicentričnih, dvojno slepih, neinferiornih študij GEMINI-1 (204861) in GEMINI-2 (205543).
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
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%). 
V kombinirani analizi študij VIKING-3 in VIKING-4 (n = 186, populacija z VO) je bil delež preiskovancev s HIV RNA < 50 kopij/ml v 48. tednu 123/186 (66 %).
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age. 
Zdravilo Tivicay je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, mladostnikov in otrok, starejših od 6 let, okuženih z virusom humane imunske pomanjkljivosti (HIV).
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. 
Delež preiskovancev s HIV RNA < 50 kopij/ml je bil 96/126 (76 %) za tiste brez mutacij Q148, 22/41 (54 %) za tiste s Q148+1 in 5/19 (26 %) za tiste s Q148+≥ 2 sekundarnima mutacijama.
For the comparator arms, the same lack of treatment emergent resistance was also the case for patients treated with darunavir/r in FLAMINGO. 
V primerjalnih skupinah prav tako ni bilo primerov med zdravljenjem nastale odpornosti pri bolnikih, zdravljenih s kombinacijo darunavir/r v študiji FLAMINGO.