natgillin/translations-raw huggingface dataset:
Although a limited number of subjects aged 65 years and over has been included (n=36), no clinically relevant differences in the pharmacokinetics of doravirine have been identified in subjects at least 65 years of age compared to subjects less than 65 years of age in a Phase 1 trial or in a population pharmacokinetic analysis. 
Iako je u ispitivanje faze 1 i populacijsku farmakokinetičku analizu bio uključen ograničen broj ispitanika u dobi od 65 ili više godina (n=36), nisu utvrđene klinički značajne razlike u farmakokinetici doravirina u ispitanika u dobi od najmanje 65 godina u usporedbi s onima mlađima od 65 godina.
How Pifeltro works 
Kako Pifeltro djeluje
3, 84 % were male, 27 % were non-white, 4 % had hepatitis B and/or C virus co-infection, 10 % had a history of AIDS, 20 % had HIV-1 RNA greater than 100,000 copies per mL, 13 % received ABC/3TC and 87 % received FTC/TDF; these characteristics were similar between treatment groups. 
84% bili su muškarci, 27% ispitanika nije bilo bijele rase, 4% istodobno je imalo infekciju virusom hepatitisa B i/ili C, 10% imalo je AIDS u anamnezi, 20% imalo je razinu HIV-1 RNK višu od 100 000 kopija/ml, 13% ih je primalo ABC/3TC, a 87% FTC/TDF; te su značajke bile slične u obje liječene skupine.
Antiviral activity in combination with other HIV antiviral medicinal products The antiviral activity of doravirine was not antagonistic when combined with the NNRTIs delavirdine, efavirenz, etravirine, nevirapine, or rilpivirine; the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir disoproxil, or zidovudine; the PIs darunavir or indinavir; the fusion inhibitor enfuvirtide; the CCR5 co-receptor antagonist maraviroc; or the integrase strand transfer inhibitor raltegravir. 
Antivirusna aktivnost kod primjene u kombinaciji s drugim antiviroticima za liječenje HIV infekcije Antivirusna aktivnost doravirina nije bila antagonistička kada se kombinirao s NNRTI-jima delavirdinom, efavirenzom, etravirinom, nevirapinom ili rilpivirinom; NRTI-jima abakavirom, didanozinom, emtricitabinom, lamivudinom, stavudinom, tenofovirdizoproksilom ili zidovudinom; inhibitorima proteaze darunavirom ili indinavirom; inhibitorom fuzije enfuvirtidom; antagonistom koreceptora CCR5 maravirokom; ili inhibitorom prijenosa lanca integrazom raltegravirom.
*NRTIs in DOR arm: FTC/TDF (333) or ABC/3TC (50); NRTIs in DRV+r arm: FTC/TDF (335) or ABC/3TC (48) **Subjects received FTC/TDF 
*NRTI-ji u skupini koja je primala doravirin (DOR): FTC/TDF (333) ili ABC/3TC (50); NRTI-ji u skupini koja je primala darunavir pojačan ritonavirom (DRV+r): FTC/TDF (335) ili ABC/3TC (48) **Ispitanici su primali FTC/TDF
P007 was a Phase 2b trial in antiretroviral treatment-naïve HIV-1 infected adult subjects (n = 340). 
P007 bilo je ispitivanje faze 2b provedeno u odraslih ispitanika s HIV-1 infekcijom koji prethodno nisu bili liječeni antiretroviroticima (n=340).
Mutagenesis Doravirine was not genotoxic in a battery of in vitro or in vivo assays. 
Doravirin nije bio genotoksičan u nizu testova in vitro ili in vivo.
Consistent results were seen for the comparison at study Week 24 in each treatment group. 
Rezultati liječenja prikazani su u Tablici 6. Prilikom usporedbe u 24. tjednu ispitivanja, primijećeni su dosljedni rezultati u obje liječene skupine.
In a study comparing 8 subjects with severe renal impairment to 8 subjects without renal impairment, the single dose exposure of doravirine was 31 % higher in subjects with severe renal impairment. 
U ispitivanju u kojem se 8 ispitanika s teškim oštećenjem funkcije bubrega uspoređivalo s 8 ispitanika bez oštećenja funkcije bubrega izloženost doravirinu nakon primjene jedne doze bila je 31% veća u ispitanika s teškim oštećenjem funkcije bubrega.
Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. 
Čuvati u originalnoj boci, a bocu držati čvrsto zatvorenom radi zaštite od vlage.
Exclusionary NNRTI substitutions were those listed above (DRIVE-FORWARD and DRIVE-AHEAD), with the exception of substitutions RT K103N, G190A and Y181C (accepted in DRIVE-SHIFT). 
Isključujuće supstitucije povezane s rezistencijom na NNRTI-je bile su one navedene gore (DRIVE-FORWARD i DRIVE-AHEAD), uz izuzetak supstitucija u reverznoj transkriptazi K103N, G190A i Y181C (prihvaćene u ispitivanju DRIVE-SHIFT).
Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccant. 
Jedno pakiranje sadrži bocu od polietilena visoke gustoće (HDPE) zatvorenu polipropilenskim zatvaračem sigurnim za djecu koja sadrži silika-gel kao sredstvo za sušenje.
The administration of a single doravirine tablet with a high-fat meal to healthy subjects resulted in a 16 % and 36 % increase in doravirine AUC and C24, respectively, while Cmax was not significantly affected. 
Utjecaj hrane na apsorpciju nakon peroralne primjene Primjena jedne tablete doravirina uz obrok s visokim udjelom masnoća u zdravih ispitanika povisila je AUC i C24 doravirina za 16% odnosno 36%, dok na Cmax nije značajno utjecala.
Pregnancy There are no or limited amount of data from the use of doravirine in pregnant women. 
Nema podataka ili su podaci o primjeni doravirina u trudnica ograničeni.
DRV + r + NRTIs* 
DRV + r + NRTI-ji*
No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine. 
Spol Nisu utvrđene klinički značajne razlike u farmakokinetici doravirina između muškaraca i žena.
Pifeltro contains the active substance doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI). 
Pifeltro sadrži djelatnu tvar doravirin - nenukleozidni inhibitor reverzne transkriptaze (engl. non-nucleoside reverse transcriptase inhibitor, NNRTI).
Subjects must have been virologically suppressed (HIV-1 RNA < 40 copies/mL) on their baseline regimen for at least 6 months prior to trial entry, with no history of virologic failure, and a documented absence of RT substitutions conferring resistance to doravirine, lamivudine and tenofovir (see section Resistance). 
Virološka supresija (HIV-1 RNK < 40 kopija/ml) morala je biti postignuta početnim režimom u ispitanika tijekom najmanje 6 mjeseci prije ulaska u ispitivanje, pri čemu u anamnezi nije zabilježen izostanak virološkog odgovora, uz dokumentiranu odsutnost supstitucija u reverznoj transkriptazi koje donose rezistenciju na doravirin, lamivudin ili tenofovir (vidjeti dio Rezistencija).
Expected:  doravirine sofosbuvir 
Očekivano: ↔ doravirin sofosbuvir
What Pifeltro is 
Što je Pifeltro
If your doctor decides you should take these medicines with Pifeltro, one tablet of doravirine should be taken twice daily (approximately 12 hours apart). 
Ako Vaš liječnik odluči da trebate uzimati te lijekove zajedno s lijekom Pifeltro, morat ćete uzimati jednu tabletu doravirina dvaput na dan (u razmaku od približno 12 sati).
Subsequently F227(L/C/V) or L234I emerged in addition to V106 substitution (double mutants yielding a fold change of > 100). 
Nakon toga se uz supstituciju V106 javila i mutacija F227(L/C/V) ili L234I (dvostruke mutacije koje su dovele do promjene > 100 puta u odnosu na početnu vrijednost).
If a patient misses a dose by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. 
Ako je od propuštene doze prošlo više od 12 sati, bolesnik ne smije uzeti propuštenu dozu, nego treba uzeti sljedeću predviđenu dozu prema uobičajenom rasporedu.
If you forget to take Pifeltro 
Ako prestanete uzimati Pifeltro
No dose adjustment of doravirine is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. 
Nije potrebno prilagođavati dozu doravirina u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
In the DRIVE-SHIFT clinical trial, no subjects developed genotypic or phenotypic resistance to DOR, 3TC, or TDF during the initial 48 weeks (immediate switch, N=447) or 24 weeks (delayed switch, N=209) of treatment with DOR/3TC/TDF. 
U kliničkom ispitivanju DRIVE-SHIFT, nijedan ispitanik nije razvio genotipsku ili fenotipsku rezistenciju na DOR, 3TC ili TDF uz liječenje DOR/3TC/TDF tijekom početnih 48 tjedana (prelazak bez odgode, N=447) ili tijekom 24 tjedna (odgođeni prelazak, N=209).
At baseline, the median age of subjects was 31 years (range 18-70 years), 85 % were male, 52 % were non-white, 3% had hepatitis B or C co-infection, 14 % had a history of AIDS, 21 % had HIV-1 RNA > 100,000 copies per mL, and 12 % had CD4 
Medijan dobi ispitanika na početku ispitivanja iznosio je 31 godinu (raspon: 18 - 70 godina), 85% bili su muškarci, 52% ispitanika nije bilo bijele rase, 3% istodobno je imalo infekciju virusom hepatitisa B ili C, 14% imalo je AIDS u anamnezi, 21% imalo je razinu HIV-1 RNK višu od 100 000 kopija/ml, a 12% ih je imalo broj CD4
In DRIVE-FORWARD, 766 subjects were randomised and received at least 1 dose of either doravirine 100 mg or darunavir + ritonavir 800+100 mg once daily, each in combination with emtricitabine/tenofovir disoproxil (FTC/TDF) or abacavir/lamivudine (ABC/3TC) selected by the investigator. 
U ispitivanju DRIVE-FORWARD randomizirano je 766 ispitanika, koji su primili najmanje 1 dozu doravirina od 100 mg ili darunavira + ritonavira od 800 + 100 mg jedanput na dan, svaki u kombinaciji s emtricitabinom/tenofovirdizoproksilom (FTC/TDF) ili abakavirom/lamivudinom (ABC/3TC), prema izboru ispitivača.
Package leaflet: Information for the user Pifeltro 100 mg film-coated tablets doravirine 
Uputa o lijeku: Informacije za korisnika Pifeltro 100 mg filmom obložene tablete doravirin
Rare blood creatine phosphokinase increased insomnia includes: insomnia, initial insomnia and sleep disorder depression includes: depression, depressed mood, major depression, and persistent depressive disorder anxiety includes: anxiety and generalised anxiety disorder abdominal pain includes: abdominal pain, and abdominal pain upper abdominal discomfort includes: abdominal discomfort, and epigastric discomfort faeces soft includes: faeces soft and abnormal faeces gastrointestinal motility disorder includes: gastrointestinal motility disorder, and frequent bowel movements rash includes: rash, rash macular, rash erythematous, rash generalised, rash maculo-papular, rash papular, and urticarial alanine aminotransferase increased includes: alanine aminotransferase increased and hepatocellular injury 
Pretrage često povišene vrijednosti alanin aminotransferaze manje često povišene vrijednosti lipaze, povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti amilaze, snižene vrijednosti hemoglobina rijetko povišene vrijednosti kreatin fosfokinaze u krvi nesanica uključuje: nesanicu, početnu nesanicu i poremećaj spavanja depresija uključuje: depresiju, depresivno raspoloženje, veliki depresivni poremećaj i perzistirajući depresivni poremećaj anksioznost uključuje: anksioznost i generalizirani anksiozni poremećaj bol u abdomenu uključuje: bol u abdomenu i bol u gornjem dijelu abdomena nelagoda u abdomenu uključuje: nelagodu u abdomenu i nelagodu u epigastriju mekana stolica uključuje: mekanu stolicu te abnormalnu stolicu poremećaj gastrointestinalnog motiliteta uključuje: poremećaj gastrointestinalnog motiliteta i učestala pražnjenja crijeva osip uključuje: osip, makularni osip, eritemski osip, generalizirani osip, makulopapularni osip, papularni osip i urtikariju povišene vrijednosti alanin aminotransferaze uključuju: povišene vrijednosti alanin aminotransferaze i hepatocelularnu ozljedu
If the patient misses a dose of Pifeltro within 12 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule. 
Ako je bolesnik propustio uzeti dozu lijeka Pifeltro, a od propuštene doze je prošlo manje od 12 sati, treba je uzeti što je prije moguće i zatim nastaviti s primjenom prema uobičajenom rasporedu.
Expected:  doravirine glecaprevir, pibrentasvir 
Očekivano: ↔ doravirin glekaprevir, pibrentasvir
Baseline Regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each administered with two NRTIs. 
Početni režim = inhibitor proteaze pojačan ritonavirom ili kobicistatom (posebno atazanavir, darunavir ili lopinavir), ili elvitegravir pojačan kobicistatom, ili NNRTI (posebno efavirenz, nevirapin ili rilpivirin), svaki primijenjen s dva NRTI-ja.
+ T'. 
+T stanice“.
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class (see sections 4.4 and 5.1). 
Pifeltro je u kombinaciji s drugim antiretrovirusnim lijekovima indiciran za liječenje odraslih osoba s infekcijom virusom humane imunodeficijencije tipa 1 (HIV-1) bez prethodnih ili trenutačnih dokaza rezistencije na lijekove iz skupine nenukleozidnih inhibitora reverzne transkriptaze (engl. non-nucleoside reverse transcriptase inhibitors, NNRTI) (vidjeti dijelove 4.4 i 5.1).
If co-administration cannot be avoided, one tablet of doravirine should be taken twice daily (approximately 12 hours apart). 
Ako se istodobna primjena ne može izbjeći, treba uzimati jednu tabletu doravirina dvaput na dan (u razmaku od približno 12 sati).
Therefore, caution is advised when doravirine is administered to patients with severe hepatic impairment (see section 5.2). 
Stoga se preporučuje oprez kada se doravirin primjenjuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
30 months After first opening of the bottle use within 35 days. 
Primijeniti unutar 35 dana nakon prvog otvaranja boce.
In both parts of the trial, doravirine and EFV were administered as blinded-therapy and FTC/TDF was administered open-label. 
U oba su se dijela ispitivanja doravirin i EFV primjenjivali kao slijepa terapija, dok se kombinacija FTC/TDF primjenjivala otvoreno.
If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart). 
Ako se istodobna primjena s drugim umjerenim induktorima CYP3A (npr., dabrafenib, lesinurad, bosentan, tioridazin, nafcilin, modafinil, etiltelotristat) ne može izbjeći, potrebno je uzimati jednu tabletu lijeka Pifeltro od 100 mg dvaput na dan (u razmaku od približno 12 sati).
What Pifeltro looks like and contents of the pack Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side. 
Pifeltro je bijela, ovalna, filmom obložena tableta s utisnutim logotipom proizvođača i oznakom „700“ na jednoj strani i bez oznake na drugoj strani.
Do not take Pifeltro if the above applies to you. 
Pifeltro ako se nešto od navedenog odnosi na Vas.
Clinical isolates containing the Y188L substitution or V106 substitutions in combination with A98G, H221Y, P225H, F227C or Y318F showed a greater than 100-fold reduced susceptibility to doravirine. 
Klinički izolati koji su sadržavali supstituciju Y188L ili supstitucije V106 u kombinaciji s mutacijama A98G, H221Y, P225H, F227C ili Y318F pokazivali su više od 100 puta smanjenu osjetljivost na doravirin.
The Phase 3 studies, DRIVE-FORWARD and DRIVE-AHEAD, included previously untreated patients (n = 747) where the following NNRTI substitutions were part of exclusion criteria: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, M230I, M230L, P225H, F227C, F227L, F227V. 
U ispitivanjima faze 3, DRIVE-FORWARD i DRIVE-AHEAD, sudjelovali su prethodno neliječeni bolesnici (n=747), a sljedeće supstitucije povezane s rezistencijom na NNRTI-je bile su dio isključnih kriterija: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C,Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, M230I, M230L, P225H, F227C, F227L, F227V.
Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of Pifeltro (see sections 4.4 and 4.5). 
Istodobna primjena s lijekovima koji su snažni induktori enzima citokroma P450 CYP3A kontraindicirana je jer se očekuju značajna sniženja koncentracija doravirina u plazmi, koja mogu smanjiti učinkovitost lijeka Pifeltro (vidjeti dijelove 4.4 i 4.5).
Nervous system disorders Common headache, dizziness, somnolence 
Poremećaji živčanog sustava često glavobolja, omaglica, somnolencija
Other established NNRTI substitutions yielded a fold change of 5-10 (G190S (5.7), K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)). 
Uz ostale utvrđene supstitucije povezane s rezistencijom na NNRTI-je zabilježena je promjena za 5 - 10 puta (G190S [5,7 puta], K103N/P225H [7,9 puta], V108I/Y181C [6,9 puta], Y181V [5,1 put]).
Recommendation Concerning Co-administration with doravirine dasabuvir 
Preporuka za istodobnu primjenu s doravirinom dasabuvir
Pifeltro 100 mg film-coated tablets. 
Pifeltro 100 mg filmom obložene tablete.
• telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome) 
• etiltelotristat (lijek za liječenje proljeva u osoba s karcinoidnim sindromom)
In the DRIVE-SHIFT trial, an immediate switch to DOR/3TC/TDF was demonstrated to be noninferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the proportion of subjects with HIV-1 RNA < 40 copies/mL. 
U ispitivanju DRIVE-SHIFT, prelazak na DOR/3TC/TDF bez odgode pokazao se neinferiornim u 48. tjednu u usporedbi s nastavkom početnog režima u 24. tjednu, što je procijenjeno prema omjeru ispitanika s HIV-1 RNK < 40 kopija/ml.
Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep 
Nuspojave manje često poremećaj pažnje, poremećaj pamćenja, parestezija, hipertonija, loša kvaliteta sna
• 1 bottle with 30 film-coated tablets. 
• 1 boca s 30 filmom obloženih tableta.
How to take Pifeltro 
Kako uzimati Pifeltro
The 95 % CIs were calculated using Miettinen and Nurminen's method with weights proportional to the size of each stratum (screening HBV-1 RNA > 100,000 copies/mL or ≤ 100,000 copies/mL. 
Intervali pouzdanosti od 95% (95% CI) izračunati su Miettinenovom i Nurminenovom metodom, uz pondere proporcionalne veličini svakog stratuma (HBV-1 RNK pri probiru > 100 000 kopija/ml ili ≤ 100 000 kopija/ml) Pristup za postupanje s podacima koji nedostaju: Pristup utemeljen na opaženom neuspjehu liječenja (OF).
If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2). 
Ako se istodobna primjena s drugim umjerenim induktorima CYP3A (npr., dabrafenibom, lesinuradom, bosentanom, tioridazinom, nafcilinom, modafinilom, etiltelotristatom) ne može izbjeći, potrebno je povećati dozu doravirina na 100 mg dvaput na dan (doze je potrebno uzeti u razmaku od približno 12 sati (vidjeti dio 4.2).
In Part I, subjects were randomized to receive one of 4 doses of doravirine or EFV, each in combination with FTC/TDF. 
U prvom su dijelu ispitivanja (Part I) ispitanici bili randomizirani za primanje jedne od 4 doze doravirina ili EFV-a, oba u kombinaciji s FTC-om/TDF-om.
• The active substance is doravirine 100 mg. 
• Djelatna tvar je doravirin u dozi od 100 mg.
Doravirine should not be coadministered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine (see sections 4.3 and 5.2). 
Doravirin se ne smije primjenjivati istodobno s lijekovima koji su snažni induktori enzima CYP3A jer se očekuju značajna sniženja koncentracija doravirina u plazmi, koja mogu smanjiti učinkovitost doravirina (vidjeti dijelove 4.3 i 5.2).
If you take more Pifeltro than you should Do not take more than the recommended dose. 
Nemojte uzeti više od preporučene doze.
• feeling weak, general feeling of being unwell 
• slabost, opće loše osjećanje.
There were no effects on fertility, mating performance or early embryonic development when doravirine was administered to rats up to 7 times the exposure in humans at the RHD. 
Nije bilo učinaka na plodnost, sposobnost parenja ni rani razvoj zametka kada se doravirin primjenjivao štakorima u dozama pri kojima su postignute razine izloženosti do 7 puta veće od onih koje se postižu u ljudi kod primjene preporučene doze za ljude.
HIV-1 RNA < 40 copies/mL 32 (80) Treatment differences (95 % CI) 
HIV-1 RNK < 40 kopija/ml Razlike između liječenja (95% CI)
A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established. 
Nije utvrđena granična vrijednost za smanjenje osjetljivosti, uzrokovano različitim supstitucijama koje dovode do rezistencije na NNRTI-je, a koje bi bilo povezano sa smanjenjem kliničke djelotvornosti.
Table 6: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study 
Snapshot approach) u ispitivanju DRIVE-SHIFT.
Expected:  norgestimate/ethinyl oestradiol 
Očekivano:  norgestimat/etinilestradiol
Protease Inhibitors ritonavir 
↔ pojačani inhibitori proteaze
Expected: ↔ lisinopril 
Očekivano: ↔ lizinopril
• constipation, stomach discomfort, swollen or bloated stomach (abdominal distension), 
• zatvor, nelagoda u trbuhu, natečen ili nadut trbuh (distenzija abdomena), probavne smetnje,
The tablets are film-coated with a coating material containing the following ingredients: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171; and triacetin E1518. 
Tablete su obložene film ovojnicom koja sadrži sljedeće sastojke: karnauba vosak (E903), hipromelozu (E464), laktozu hidrat, titanijev dioksid (E171) i triacetin (E1518).
If you stop taking Pifeltro Do not run out of this medicine. 
Ako ste zaboravili uzeti Pifeltro • Važno je da ne propuštate ili preskačete doze ovog lijeka.
The following de novo resistance was seen in the resistance analysis subset (subjects with HIV-1 RNA greater than 400 copies per mL at virologic failure or early study discontinuation and having resistance data). 
U podskupini u kojoj je provedena analiza rezistencije (ispitanici kojima je razina HIV-1 RNK bila veća od 400 kopija/ml u trenutku izostanka virološkog odgovora ili prijevremenog povlačenja iz ispitivanja i za koje su postojali podaci o rezistenciji) opažena je sljedeća de novo rezistencija.
If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine. 
Pifeltro tablete sadrže laktozu Ako Vam je liječnik rekao da ne podnosite laktozu, obratite se liječniku prije uzimanja ovog lijeka.
Expected: ↔ doravirine ↔ enfuviritide maraviroc 
Očekivano: ↔ doravirin ↔ enfuviritid maravirok
Respiratory, thoracic and mediastinal disorders Rare dyspnoea, tonsillar hypertrophy 
Poremećaji dišnog sustava, prsišta i sredoprsja rijetko dispneja, hipertrofija krajnika
ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD) 
ledipasvir + sofosbuvir (ledipasvir 90 mg SD + sofosbuvir 400 mg SD, doravirin 100 mg SD)
The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1 infected subjects. 
Farmakokinetika doravirina ispitivala se u zdravih ispitanika i ispitanika s HIV-1 infekcijom.
Biotransformation Based on in vitro data, doravirine is primarily metabolized by CYP3A. 
Prema podacima in vitro, doravirin se primarno metabolizira putem enzima CYP3A.
• decreased levels of phosphate 
• snižene razine fosfata
Expected: ↔ doravirine ↔ raltegravir ritonavir †-boosted elvitegravir 
Očekivano: ↔ doravirin ↔ raltegravir elvitegravir pojačan ritonavirom