natgillin/translations-raw huggingface dataset:
Some patients taking combination antiretroviral medicines such as Biktarvy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Neki bolesnici koji uzimaju kombinirane antiretrovirusne lijekove kao što je Biktarvy mogu razviti bolest kostiju koja se zove osteonekroza (odumiranje koštanog tkiva prouzrokovano gubitkom prokrvljenosti kosti).
Increases in serum creatinine occurred by Week 4 of treatment and remained stable through Week 96.
Serumski kreatinin povisio se do 4. tjedna liječenja i ostao stabilan do
Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Tenofoviralafenamid i tenofovir imaju medijan poluvremena u plazmi od 0,51 odnosno 32,37 sati.
- azithromycin, clarithromycin, rifabutin or rifapentine
- azitromicin, klaritromicin, rifabutin ili rifapentin
However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Ipak, tenofovirdizoproksilfumarat smanjio je indeks preživljenja i težinu mladunčadi u perinatalnim i postnatalnim ispitivanjima toksičnosti pri dozama toksičnim za majku.
Other effects that may be seen during HIV treatment
Druge nuspojave koje se mogu javiti tijekom liječenja protiv HIV-a
• If you have liver problems or a history of liver disease, including hepatitis.
• ako imate tegobe s jetrom ili ste prethodno bolovali od bolesti jetre uključujući hepatitis.
 If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.
Ako opazite ove ili bilo kakve druge simptome upale ili infekcije, odmah o tome obavijestite svog liječnika.
Of these, all single and double mutant isolates lacking Q148H/K/R and 10 of 24 isolates with Q148H/K/R with additional INSTI resistance associated substitutions had ≤ 2.5-fold reduced susceptibility to bictegravir; > 2.5-fold reduced susceptibility to bictegravir was found for 14 of the 24 isolates that contained G140A/C/S and Q148H/R/K substitutions in integrase.
Među njima, svi jednostruki i dvostruki mutanti bez Q148H/K/R i 10 od 24 izolata s Q148H/K/R s dodatnim supstitucijama povezanima s rezistencijom na INSTI imali su ≤ 2,5 puta smanjenu osjetljivost na biktegravir; > 2,5 puta smanjena rezistencija na biktegravir opažena je kod 14 od 24 izolata koji su sadržavali supstitucije G140A/C/S i Q148H/R/K u integrazi.
This is because some of the active substances in this medicine pass into human breast milk.
Neke djelatne tvari iz ovoga lijeka prelaze u majčino mlijeko.
Adults: one tablet each day with or without food Do not chew, crush or split the tablet.
Odrasli: jedna tableta svaki dan, s hranom ili bez nje.
Mean systemic emtricitabine exposure was higher in patients with severe renal impairment (CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
Srednja vrijednost sistemske izloženosti emtricitabinu bila je viša u bolesnika s teškim oštećenjem funkcije bubrega (CrCl < 30 ml/min) (33,7 µg•h/ml) nego u ispitanika s normalnom funkcijom bubrega (11,8 µg•h/ml).
Biktarvy and calcium-containing supplements can be taken together, without regard to food.
Biktarvy i dodaci prehrani koji sadrže kalcij smiju se uzimati zajedno, bez obzira na hranu.
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Neklinički podaci o emtricitabinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
Do not breast-feed during treatment with Biktarvy.
Nemojte dojiti tijekom liječenja lijekom Biktarvy.
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
Biotransformacija emtricitabina uključuje oksidaciju tiolne skupine molekule, pri čemu nastaju 3'-sulfoksid diastereomeri (~9% doze), i konjugaciju s glukuronskom kiselinom, pri čemu nastaje 2'-O-glukuronid (~4% doze).
Co-administration of Biktarvy with the OCT2 and MATE1 substrate metformin did not result in a clinically significant increase in metformin exposure.
Istodobna primjena lijeka Biktarvy sa supstratom OCT2 i MATE1, metforminom, nije rezultirala klinički značajnim povećanjem izloženosti metforminu.
• sleep disorders
• poremećaji spavanja
Co-administration with rifampicin and St. John's wort (Hypericum perforatum) (see section 4.5).
Istodobna primjena rifampicina i gospine trave (Hypericum perforatum) (vidjeti dio 4.5).
If you feel dizzy when taking Biktarvy, do not drive and do not use any tools or machines.
Ako tijekom uzimanja lijeka Biktarvy imate omaglicu, nemojte upravljati vozilom niti raditi s alatima ili na strojevima.
g Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
g Obuhvaća bolesnike koji su prekinuli liječenje zbog štetnih događaja ili smrti u bilo kojem trenutku od 1. dana do završetka vremenskog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
Table 1: Interactions between Biktarvy or its individual component(s) and other medicinal products
Tablica 1: Interakcije između lijeka Biktarvy ili njegovih pojedinih komponenti s drugim lijekovima
Each bottle contains silica gel desiccant and polyester coil.
Svaka boca sadrži sredstvo za sušenje (silika gel) i poliestersku vaticu.
If you forget to take Biktarvy
Ako ste zaboravili uzeti lijek Biktarvy
In animal studies, bictegravir was detected in the plasma of nursing rat pups likely due to the presence of bictegravir in milk, without effects on nursing pups.
U ispitivanjima na životinjama, biktegravir je bio otkriven u plazmi mladunčadi štakora koja sišu majčino mlijeko, vjerojatno zbog prisutnosti biktegravira u mlijeku, ali nije imao učinke na ovu mladunčad.
Initiation of Biktarvy is not recommended in patients with estimated CrCl below 30 mL/min, as there are insufficient data available regarding the use of Biktarvy in this population (see section 5.2).
Uvođenje lijeka Biktarvy se ne preporučuje u bolesnika s procijenjenim CrCl ispod 30 ml/min jer nema dovoljno dostupnih podataka o primjeni lijeka Biktarvy u ovoj populaciji (vidjeti dio 5.2).
In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
In vitro i klinička farmakokinetička ispitivanja interakcija lijekova pokazala su da je mogućnost interakcija posredovanih CYP-sustavom za emtricitabin s drugim lijekovima mala.
Biktarvy reduces the amount of HIV in your body.
Biktarvy smanjuje količinu HIV-a u Vašem tijelu.
Biktarvy may interact with other medicines.
Biktarvy može ući u interakciju s drugim lijekovima.
 Get advice from your doctor or pharmacist before taking Biktarvy if you are taking any of these medicines.
Potražite savjet svog liječnika ili ljekarnika prije nego uzmete lijek Biktarvy ako uzimate neke od ovih lijekova.
• mineral supplements or vitamins containing magnesium or iron
• vitaminske ili mineralne dodatke prehrani koji sadrže magnezij ili željezo
The mean baseline plasma HIV-1 RNA was 4.4 log10 copies/mL (range 1.3-6.6).
Srednja početna vrijednost HIV-1 RNK u plazmi bila je 4,4 log10 kopija/ml (raspon 1,3-6,6).
This modest change is not considered clinically meaningful and B/F/TAF can be administered with or without food.
Ta se mala promjena ne smatra klinički značajnom pa se stoga B/F/TAF može davati s hranom ili bez nje.
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Postoje izvješća o poremećaju funkcije mitohondrija kod HIV-negativne dojenčadi koja je bila in utero i/ili postnatalno izložena analozima nukleozida; ova su se izvješća pretežno odnosila na liječenje režimima koji su sadržavali zidovudin.
Emtricitabine systemic exposure was unaffected when emtricitabine was administered with food and B/F/TAF can be administered with or without food.
Primjena emtricitabina s hranom nije utjecala na sistemsku izloženost emtricitabinu pa se B/F/TAF može davati s hranom ili bez nje.
Bictegravir inhibits organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1) in vitro.
Biktegravir inhibira prijenosnik organskih kationa 2 (engl. organic cation transporter 2, OCT2) i prijenosnik za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion transporter 1, MATE1) in vitro.
Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Relevantni primjeri obuhvaćaju citomegalovirusni retinitis, generalizirane i/ili žarišne mikobakterijske infekcije, te upalu pluća uzrokovanu Pneumocystis jirovecii.
Sucralfate (Chelation with polyvalent cations)
Sukralfat (kelacija s polivalentnim kationima)
In vitro drug resistance selection studies with tenofovir alafenamide have shown no development of high-level resistance after extended culture.
In vitro ispitivanja rezistencije na lijek s tenofoviralafenamidom pokazala su da ne dolazi do razvoja visoke rezistencije nakon produljene kultivacije.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bocu s 30 filmom obloženih tableta i kutije koje sadrže 90 (3 boce od 30) filmom obloženih tableta.
Bictegravir was not carcinogenic in a 6-month rasH2 transgenic mouse study (at doses of up to 100 mg/kg/day in males and 300 mg/kg/day in females, which resulted in exposures of approximately 15 and 23 times, in males and females, respectively, the exposure in humans at the recommended human dose) nor in a 2-year rat study (at doses of up to 300 mg/kg/day, which resulted in exposures of approximately 31 times the exposure in humans).
Biktegravir nije bio kancerogen u 6-mjesečnom ispitivanju na rasH2 transgeničnim miševima (pri dozama do 100 mg/kg/dan kod mužjaka i 300 mg/kg/dan kod ženki, što je rezultiralo izloženošću približno 15 puta većom kod mužjaka odnosno 23 puta većom kod ženki od izloženosti u ljudi pri preporučenoj dozi za ljude) niti u dvogodišnjem ispitivanju na štakorima (s dozama do 300 mg/kg/dan), što je rezultiralo izloženošću otprilike 31 puta većom od izloženosti u ljudi).
Following administration of [14C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (~86%) and faeces (~14%).
Nakon primjene [14C]-emtricitabina, cijela doza emtricitabina izolirana je u mokraći (~86%) i stolici (~14%).
Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, and region.
Ishodi liječenja u liječenih skupina bili su slični u podskupinama prema dobi, spolu, etničkoj pripadnosti i području.
Sofosbuvir metabolite GS-331007: AUC: ↔
Metabolit sofosbuvira GS331007: AUC: ↔
Pharmacokinetics of bictegravir, emtricitabine, and tenofovir have not been fully evaluated in the elderly (≥ 65 years of age).
Farmakokinetika biktegravira, emtricitabina i tenofovira nije u potpunosti procijenjena kod starijih bolesnika (u dobi ≥ 65 godina).
(11%) and Grade 2 (4%) (≥1.0 to 2.5 x Upper Limit of Normal [ULN]), and were not associated with hepatic adverse reactions or other liver related laboratory abnormalities.
Povećanja su prvenstveno bila 1. stupnja (11%) i 2. stupnja (4%) (≥1,0 - 2,5 puta iznad gornje granice normale [GGN]) i nisu bila povezana s jetrenim nuspojavama ili drugim laboratorijskim abnormalnostima jetrenih nalaza.
Thirteen percent of the dose was recovered in the urine as three putative metabolites.
Trinaest posto doze emtricitabina izolirano je u mokraći u obliku tri putativna metabolita.
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).
Film ovojnica poli(vinil alkohol), titanijev dioksid (E171), makrogol, talk, crveni željezov oksid (E172), crni željezov oksid (E172).
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).
Zabilježeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, zabilježeno vrijeme do njihova nastupa poremećaja prilično je raznoliko i ti se događaji mogu pojaviti mnogo mjeseci nakon početka liječenja (vidjeti dio 4.4).
The number of patients co-infected with HIV and HBV treated with B/F/TAF is limited.
Broj bolesnika istodobno zaraženih HIV-om i HBV-om liječenih B/F/TAF-om ograničen je.
Co-administration is not recommended due to the expected decrease of tenofovir alafenamide.
Istodobna primjena se ne preporučuje zbog očekivanog smanjenja tenofoviralafenamida.
Other medicines and Biktarvy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Interactions between Biktarvy or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”; all No
Interakcije lijeka Biktarvy ili njegovih pojedinih komponenti i istodobno primijenjenih lijekova navedene su u tablici 1 (povećanje je označeno kao “↑”, smanjenje kao “↓”, bez promjene kao “↔”; svi su rasponi bez učinka 70% - 143%).
vomiting, abdominal pain, dyspepsia, flatulence
povraćanje, bol u abdomenu, dispepsija, flatulencija
In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
U djece čije su majke tijekom trudnoće uzimale NRTI-jeve prevagnula je korist od zaštite protiv HIV-a u odnosu na rizike od nuspojava.
The use of Biktarvy in children and adolescents under 18 years of age has not yet been studied.
Primjena lijeka Biktarvy u djece u i adolescenata mlađih od 18 godina nije još ispitana.
Patients must have been stably suppressed on their baseline regimen for at least 6 months and must not have been previously treated with any INSTI.
U bolesnika je HIV-1 morao biti stabilno suprimiran početnim režimom najmanje 6 mjeseci i oni nisu smjeli biti prethodno liječeni pomoću INSTI.
Biktarvy contains tenofovir alafenamide, which is active against hepatitis B virus (HBV).
Biktarvy sadrži tenofoviralafenamid, koji djeluje protiv virusa hepatitisa B (HBV).
Studies of bictegravir in monkeys revealed the liver as the primary target organ of toxicity.
Ispitivanja biktegravira na majmunima pokazala su da je jetra primarni ciljni organ toksičnog djelovanja.
Biktarvy should not be co-administered with other antiretroviral medicinal products.
Biktarvy se ne smije primjenjivati istodobno s drugim antiretrovirusnim lijekovima.
Following a single dose oral administration of [14C]-bictegravir, ~60% of the dose from faeces included unchanged parent, desfluoro-hydroxy-BIC-cysteine-conjugate, and other minor oxidative metabolites.
Nakon peroralne primjene jedne doze [14C]-biktegravira, ~60% doze iz stolice uključilo je nepromijenjeni izvorni lijek, konjugat desfluoro-hidroksi-BIC-cisteina i druge manje oksidativne metabolite.
No human data on the effect of Biktarvy on fertility are available.
Nisu dostupni podaci o učinku lijeka Biktarvy na plodnost u ljudi.
The K65R and K70E mutations result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Mutacije K65R i K70E dovode do smanjene osjetljivosti na abakavir, didanozin, lamivudin, emtricitabin i tenofovir, ali zadržavaju osjetljivost na zidovudin.
Although kidney problems have not been observed with Biktarvy, there is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time.
Iako uz Biktarvy nisu opažene tegobe s bubrezima, postoji mogućnost da Vam se jave tegobe s bubrezima ako uzimate Biktarvy tijekom dugog vremenskog razdoblja.
In patients with moderate renal impairment, close monitoring should be considered when starting co-administration of bictegravir with metformin, due to the increased risk for lactic acidosis in these patients.
U bolesnika s umjerenim oštećenjem funkcije bubrega, potrebno je razmotriti pomno praćenje kada se počinje s istodobnom primjenom biktegravira i metformina, zbog povećanog rizika od laktacidoze u ovih bolesnika.
At screening, 15% of patients were receiving abacavir/lamivudine plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) and 85% of patients were receiving emtricitabine/tenofovir disoproxil fumarate plus atazanavir or darunavir (boosted by either cobicistat or ritonavir).
Na probiru, 15% bolesnika primalo je abakavir/lamivudin plus atazanavir ili darunavir (pojačane kobicistatom ili ritonavirom), a 85% bolesnika primalo je emtricitabin/tenofovirdizoproksilfumarat plus atazanavir ili darunavir (pojačan kobicistatom ili ritonavirom).
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Te nalaze treba uzeti u obzir u svakog djeteta koje je in utero bilo izloženo analozima nukleozida/nukleotida, a koje je imalo tešku kliničku sliku nepoznate etiologije, osobito neurološke nalaze.
• If you notice 18 hours or more after the time you usually take Biktarvy, then do not take the missed dose.
• Ako to primijetite kada je prošlo 18 sati ili više od vremena kad obično uzimate lijek Biktarvy, onda nemojte uzeti propuštenu dozu.
(Inhibition of P-gp/BCRP)
(inhibicija P-gp/BCRP)
In vitro binding of bictegravir to human plasma proteins was > 99% (free fraction ~0.25%).
In vitro vezanje biktegravira za proteine ljudske plazme bilo je > 99% (slobodna frakcija ~0,25%).
Changes in bilirubin
Promjene bilirubina
Based on drug interaction studies conducted with Biktarvy or the components of Biktarvy, no clinically significant drug interactions are expected with: amlodipine, atorvastatin, buprenorphine, drospirenone, famciclovir, famotidine, fluticasone, methadone, naloxone, norbuprenorphine, omeprazole or rosuvastatin.
Na temelju ispitivanja interakcija lijekova provedenih s lijekom Biktarvy ili komponentama lijeka Biktarvy, ne očekuju se klinički značajne interakcije s: amlodipinom, atorvastatinom, buprenorfinom, drospirenonom, famciklovirom, famotidinom, flutikazonom, metadonom, naloksonom, norbuprenorfinom, omeprazolom ili rosuvastatinom.
Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.
Istodobna primjena emtricitabina s lijekovima koji se eliminiraju aktivnom tubularnom sekrecijom može povećati koncentracije emtricitabina i/ili istodobno primijenjenog lijeka.
Stopping Biktarvy can seriously affect how future treatment works.
Prestanak uzimanja lijeka Biktarvy može ozbiljno utjecati na djelovanje budućeg liječenja.
Studies in animals with bictegravir have shown no evidence of teratogenicity or an effect on reproductive function.
Ispitivanja biktegravira na životinjama nisu pokazala znakove tetragenosti ili djelovanja na reproduktivnu funkciju.
ABC = abacavir
ABC = abakavir
While you are taking Biktarvy
Dok uzimate lijek Biktarvy
In human clinical studies, a 25 mg oral dose of tenofovir alafenamide resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 300 mg oral dose of tenofovir disoproxil fumarate.
U kliničkim ispitivanjima u ljudi, peroralna doza od 25 mg tenofoviralafenamida rezultirala je koncentracijama tenofovirdifosfata > 4 puta većima u PBMC-ovima i > 90% manjim koncentracijama tenofovira u plazmi u usporedbi s 300 mg peroralne doze tenofovirdizoproksilfumarata.
- adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir disoproxil
- adefovirdipivoksil, atazanavir, biktegravir, emtricitabin, lamivudin, tenofoviralafenamid ili tenofovirdizoproksil
No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Nije potrebna prilagodba doze lijeka Biktarvy u bolesnika s procijenjenim klirensom kreatinina (CrCl) ≥ 30 ml/min.
Renal excretion of intact bictegravir is a minor pathway (~1% of dose).
Bubrežna ekskrecija nepromijenjenog biktegravira predstavlja put izlučivanja koji je od malog značaja (~1% doze).
2 This adverse reaction was not observed in the clinical studies of emtricitabine + tenofovir alafenamide-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
2 Ova nuspojava nije opažena u kliničkim ispitivanjima lijekova koji sadrže emtricitabin + tenofoviralafenamid, ali je prepoznata u kliničkim ispitivanjima emtricitabina i nakon njegova stavljanja u promet kad se primjenjivao s drugim antiretrovirusnim lijekovima.
In Studies GS-US-380-1489 and GS-US-380-1490, the mean age was 35 years (range 18-77), 89% were male, 58% were White, 33% were Black, and 3% were Asian.
U ispitivanjima GS-US-380-1489 i GS-US-380-1490, srednja vrijednost dobi bila je 35 godina (raspon 18-77), bilo je 89% muškaraca, 58% bili su bijelci, 33% crnci i 3% azijati.
Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Neklinička ispitivanja tenofoviralafenamida na štakorima i psima otkrila su da su kost i bubreg primarni ciljni organi toksičnog djelovanja.
Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 5.1).
Lijek Biktarvy indiciran je za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) bez dokaza o sadašnjoj ili prošloj rezistenciji virusa na skupinu inhibitora integraze, emtricitabin ili tenofovir (vidjeti dio 5.1).
Four patients had missing HBV DNA data at Week 96 (one lost to follow-up from Week 48, 1 lost to follow-up after Week 72, 1 with missing HBV data but HIV-1 RNA < 50 copies/mL, and 1 with missing data in Week 96 window).
Za četiri bolesnika nedostajali su podaci za HBV DNK u 96. tjednu (jedan je bio izgubljen iz praćenja od 48. tjedna, drugi je bio izgubljen iz praćenja nakon 72. tjedna, za trećeg su nedostajali podaci za HBV, ali imao je HIV-1 RNK < 50 kopija/ml, a za četvrtog su nedostajali podaci u okviru 96. tjedna).
Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Virusi rezistentni na emtricitabin sa supstitucijom M184V/I bili su križno rezistentni na lamivudin, ali su zadržali osjetljivost na didanozin, stavudin, tenofovir i zidovudin.
Medicinal products that induce P-gp activity (e.g. rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Biktarvy and development of resistance.
Očekuje se da će lijekovi koji induciraju aktivnost P-gp-a (npr. rifabutin, karbamazepin, fenobarbital) smanjiti apsorpciju tenofoviralafenamida, što uzrokuje smanjenje koncentracije tenofoviralafenamida u plazmi, koje može dovesti do gubitka terapijskog učinka lijeka Biktarvy i razvoja rezistencije.