FrancophonIA/ELRC3.0 huggingface dataset:
English: Pifeltro is used to treat HIV (‘human immunodeficiency virus') infection.
Maltese: Pifeltro jintuża għat-trattament ta' infezzjoni tal-HIV (‘human immunodeficiency virus', virus talimmunodefiċjenza umana).
English: Rare hypomagnesaemia
Maltese: Rari ipomagnesimja
English: Film-coating Carnauba wax (E903) Hypromellose (E464) Lactose monohydrate Titanium dioxide (E171)
Maltese: Carnauba wax (E903) Hypromellose (E464) Lactose monohydrate Titanium dioxide (E171) Triacetin (E1518)
English: 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.
Maltese: Attività antivirali meta jingħata flimkien ma' prodotti mediċinali antivirali oħra għall-HIV L-attività antivirali ta' doravirine ma kinitx antagonistika meta ngħata flimkien mal-NNRTIs delavirdine, efavirenz, etravirine, nevirapine, jew rilpivirine; mal-NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir disoproxil, jew zidovudine; il-PIs darunavir jew indinavir; l-inibitur tal-fużjoni enfuvirtide; l-antagonist tal-koriċettur CCR5 maraviroc; jew l-inibitur tat-trasferiment tal-fila ta' integrase raltegravir.
English: Expected: ↔ doravirine ↔ tenofovir alafenamide
Maltese: ↔ doravirine ↔ tenofovir alafenamide
English: P007 was a Phase 2b trial in antiretroviral treatment-naïve HIV-1 infected adult subjects (n = 340).
Maltese: P007 kienet prova ta' Fażi 2b f'individwi adulti infettati b'HIV-1 (n = 340) li qatt ma kienu ħadu trattament antiretrovirali qabel.
English: Table 6: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study
Maltese: Tabella 6: Rispons ta' effikaċja (approċ Snapshot) fl-studju DRIVE-SHIFT
English: Expected:  doravirine (CYP3A inhibition) ↔ elvitegravir
Maltese: ↑ doravirine (Inibizzjoni ta' CYP3A) ↔ elvitegravir
English: Doravirine exhibited an EC50 value of 12.0±4.4 nM against wild-type laboratory strains of HIV-1 when tested in the presence of 100 % normal human serum using MT4-GFP reporter cells.
Maltese: Doravirine wera valur EC50 ta' 12.0±4.4 nM kontra rażeż ta' HIV-1 tal-laboratorju li jinsabu fin-natura meta ġie ttestjat fil-preżenza ta' serum 100 % normali tal-bniedem bl-użu ta' ċelluli rapportaturi MT4-GFP.
English: Antineoplastics mitotane
Maltese: Antineoplastiċi
English: White, oval-shaped, tablet of dimensions 19.00 mm x 9.50 mm, debossed with the corporate logo and 700 on one side and plain on the other side.
Maltese: Pillola bajda, ta' għamla ovali, b'daqs ta' 19.00 mm x 9.50 mm, imnaqqxa bil-logo tal-kumpanija u 700 fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: • The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; and silica, colloidal anhydrous E551.
Maltese: • Is-sustanza(i) l-oħra huma croscarmellose sodium E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; u silica, colloidal anhydrous E551.
English: GM: Geometric mean, % CV: Geometric coefficient of variation
Maltese: GM: Medja ġeometrika, % CV: koeffiċjent ġeometriku ta' varjazzjoni
English: Note: Both doravirine and efavirenz were administered with emtricitabine/tenofovir disoproxil (FTC/TDF).
Maltese: Nota: Kemm doravirine kif ukoll efavirenz ingħataw ma' emtricitabine/tenofovir disoproxil (FTC/TDF).
English: Rare musculoskeletal pain
Maltese: Rari uġigħ muskoluskeletriku
English: Steady state was generally achieved by Day 2 of once daily dosing, with accumulation ratios of 1.2 to 1.4 for AUC0-24, Cmax, and C24.
Maltese: L-istat fiss ġeneralment inkiseb ma' Jum 2 ta' għoti ta' dożi darba kuljum, bi proporzjonijiet ta' akkumulazzjoni ta' 1.2 sa 1.4 għal AUC0-24, Cmax, u C24.
English: Nucleoside Reverse Transcriptase Inhibitors tenofovir disoproxil (245 mg QD, doravirine 100 mg SD)
Maltese: Inibituri Nucleoside ta' Reverse Transcriptase tenofovir disoproxil (245 mg QD, doravirine 100 mg SD)
English: Expected: ↔ doravirine ↔ maraviroc
Maltese: ↔ doravirine ↔ maraviroc
English: Expected: ↔ canagliflozin ↔ liraglutide ↔ sitagliptin
Maltese: ↔ canagliflozin ↔ liraglutide
English: 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.
Maltese: esklużoni: 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.
English: Common NNRTI-resistant mutations (K103N, Y181C) were not selected in the in vitro study.
Maltese: Mutazzjonijiet komuni reżistenti għal NNRTI (K103N, Y181C) ma ntagħżlux fl-istudju in vitro.
English: DRV + r + 2 NRTIs (383)
Maltese: DOR + 2 NRTIs (383) DRV + r + 2 NRTIs
English: Doravirine is primarily metabolized and eliminated by the liver.
Maltese: Doravirine huwa metabolizzat u eliminat primarjament mill-fwied.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna, (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa < 1/1,000).
English: In a population pharmacokinetic analysis, which included subjects with CrCl between 17 and 317 mL/min, renal function did not have a clinically relevant effect on doravirine pharmacokinetics.
Maltese: F'analiżi farmakokinetika ta' popolazzjoni, li kienet tinkludi individwi bi CrCl bejn 17 u 317 mL/min, il-funzjoni tal-kliewi ma kelliex effett rilevanti b'mod kliniku fuq il-farmakokinetika ta' doravirine.
English: In a pooled analysis combining data from two treatment-naïve trials (P007 and DRIVE-AHEAD), a lower proportion of subjects who discontinued due to an adverse event by week 48 was seen for the combined doravirine (100 mg) treatment groups (2.8 %) compared with the combined EFV treatment group (6.1 %) (treatment difference -3.4 %, p-value 0.012).
Maltese: F'analiżi kollettiva li ġabret data minn żewġ provi fejn l-individwi qatt ma kienu ħadu trattament qabel (P007 u DRIVE-AHEAD), proporzjon inqas ta' individwi li waqfu minħabba avveniment avvers sa ġimgħa 48 deher għall-gruppi ta' trattament ikkombinat b'doravirine (100 mg) (2.8 %) meta mqabbla mal-grupp ta' trattament ikkombinat b'EFV (6.1 %) (differenza fit-trattament -3.4 %, valur p 0.
English: Investigations Common alanine aminotransferase increased
Maltese: Komuni żieda fl-alanine aminotransferase9
English: See “Other medicines and Pifeltro” section for a list of medicines.
Maltese: Ara s-sezzjoni “Mediċini oħra u Pifeltro” għal lista ta' mediċini.
English: At baseline, the median age of subjects was 43 years, 16 % were female, and 24 % were non-white.
Maltese: Fil-linja bażi, l-età medjana tal-individwi kienet 43 sena, 16 % kienu nisa, u 24 % kienu mhux bojod.
English: Based on administration of an IV microdose, the volume of distribution of doravirine is 60.5 L. Doravirine is approximately 76 % bound to plasma proteins.
Maltese: Abbażi ta' għoti ta' mikrodoża fil-vini, il-volum ta' distribuzzjoni ta' doravirine huwa 60.5 L. Madwar 76 % ta' doravirine jintrabat mal-proteini tal-plażma.
English: 20-200 mg QD individualised dose, doravirine 100 mg QD
Maltese: 20-200 mg QD doża individwalizzata, doravirine 100 mg QD
English: Excipient with known effect Each film-coated tablet contains 222 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 222 mg lactose (bħala monohydrate).
English: Week 48 and 96 outcomes for DRIVE-FORWARD and DRIVE-AHEAD are provided in Table 4.
Maltese: Ir-riżultati ta' Ġimgħa 48 u 96 għal DRIVE-FORWARD u DRIVE-AHEAD huma pprovduti f'Tabella 4.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza totali ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Hepatitis C Antiviral Agents elbasvir + grazoprevir (50 mg elbasvir QD + 200 mg grazoprevir QD, doravirine 100 mg QD)
Maltese: Rakkomandazzjoni Dwar l-Għoti Flimkien ma' doravirine elbasvir + grazoprevir (50 mg elbasvir QD + 200 mg grazoprevir QD, doravirine 100 mg QD)
English: In DRIVE-AHEAD, 728 subjects were randomized and received at least 1 dose of either doravirine/lamivudine/tenofovir disoproxil 100/300/245 mg (DOR/3TC/TDF) or efavirenz/emtricitabine/tenofovir disoproxil (EFV/FTC/TDF) once daily.
Maltese: Fi DRIVE-AHEAD, 728 individwu ntagħżlu b'mod arbitrarju u rċivew mill-inqas doża 1 ta' doravirine/lamivudine/tenofovir disoproxil 100/300/245 mg (DOR/3TC/TDF) jew efavirenz/emtricitabine//tenofovir disoproxil (EFV/FTC/TDF) darba kuljum.
English: Doravirine has been evaluated in a limited number of patients with NNRTI resistance (K103N n=7, G190A n=1); all patients were suppressed to < 40 copies/mL at week 48.
Maltese: Doravirine ġie evalwat f'numru limitat ta' pazjenti b'reżistenza għal NNRTI (K103N n=7, G190A n=1); il-pazjenti kollha ġew soppressi għal < 40 kopja/mL f'ġimgħa 48.
English: 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 (see section 5.1).
Maltese: Ma ġiex stabbilit punt li ogħla minnu jkunx hemm tnaqqis fis suxxettibbiltà, li rriżulta minn diversi sostituzzjonijiet ta' NNRTI, li huwa assoċjat ma' tnaqqis fleffikaċja klinika (ara sezzjoni 5.1).
English: Expected:  doravirine daclatasvir
Maltese: ↔ doravirine daclatasvir
English: Observed emergent amino acid substitutions in RT included: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L, and Y318F.
Maltese: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L u Y318F.
English: As a precautionary measure, it is preferable to avoid the use of doravirine during pregnancy.
Maltese: Bħala prekawzjoni, hu preferribli li jiġi evitat l-użu ta' doravirine waqt it-tqala.
English: • decreased levels of phosphate
Maltese: • tnaqqis fil-livelli tal-phosphate
English: Biotransformation Based on in vitro data, doravirine is primarily metabolized by CYP3A.
Maltese: Bijotrasformazzjoni Abbażi ta' data in vitro, doravirine jiġi metabolizzat primarjament minn CYP3A.
English:  doravirine AUC 3.54 (3.04, 4.11) Cmax 1.31 (1.17, 1.46) C24 2.91 (2.33, 3.62) (Inhibition of CYP3A)
Maltese: ↑ doravirine AUC 3.54 (3.04, 4.11) Cmax 1.31 (1.17, 1.46) C24 2.91 (2.33, 3.62) (Inibizzjoni ta' CYP3A)
English: • nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
Maltese: • ħmar il-lejl, depressjoni, ansjetà, irritabilità konfużjoni, ħsibijiet ta' suwiċidju
English: 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.
Maltese: Is-CIs ta' 95 % ġew ikkalkulati bl-użu tal-metodu ta' Miettinen u Nurminen bil-piżijet fi proporzjon għad-daqs ta' kull stratum (RNA ta' HBV-1 tal-iscreening > 100,000 kopja/mL jew ≤ 100,000 kopja/mL. **Approċ għall-immaniġġjar ta' data nieqsa: Approċ Falliment Osservat (OF, Observed Failure).
English: Metabolism and nutrition disorders Uncommon hypophosphataemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux Komuni ipofosfatimja
English:  dolutegravir AUC 1.36 (1.15, 1.62) Cmax 1.43 (1.20, 1.71) C24 1.27 (1.06, 1.53) (Inhibition of BCRP)
Maltese: ↑dolutegravir AUC 1.36 (1.15, 1.62) Cmax 1.43 (1.20, 1.71) C24 1.27 (1.06, 1.53) (Inibizzjoni ta' BCRP)
English: 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).
Maltese: Pifeltro huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għat-trattament ta' adulti infettati b'HIV-1 mingħajr xhieda fil-passat jew fil-preżent ta' reżistenza għall-klassi ta' NNRTI (ara sezzjonijiet 4.4 u 5.1).
English: Uncommon lipase increased, aspartate aminotransferase increased, amylase increased, haemoglobin decreased
Maltese: Mhux komuni żieda fil-lipase, żieda fl-aspartate aminotransferase, żieda fl-amylase, tnaqqis flemoglobina
English: • telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome)
Maltese: • telotristat ethyl (mediċina biex tittratta dijarea f'persuni b'sindrome karċinojd)
English: Table 2: Tabulated summary of adverse reactions associated with doravirine used in combination with other antiretrovirals
Maltese: Tabella 2: Sommarju ta' reazzjonijiet avversi miġbura f'tabella assoċjati ma' doravirine użat flimkien ma' antiretrovirali oħra
English: 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
Maltese: Fil-linja bażi, l-età medjana tal-individwi kienet ta' 31 sena (firxa 18-70 sena), 85 % kienu rġiel, 52 % ma kinux bojod, 3% kellhom infezzjoni tal-epatite B jew Ċ fl-istess waqt, 14 % kellhom storja ta' AIDS, 21 % kellhom RNA ta' HIV-1 > 100,000 kopja f'kull mL, u 12% kellhom għadd ta' ċelluli T CD4+ < 200 ċellula f'kull mm3; dawn il-karatteristiċi kienu jixxiebhu bejn il-gruppi ta' trattament.
English: Expected: ↔ doravirine ↔ raltegravir ritonavir †-boosted elvitegravir
Maltese: ↔ doravirine ↔ raltegravir elvitegravir imsaħħaħ b'ritonavir†
English: Safety and efficacy of doravirine have not been established in patients younger than 18 years of age.
Maltese: Is-sigurtà u l-effikaċja ta' doravirine ma ġewx determinati f'pazjenti iżgħar minn 18-il sena.
English: Therefore caution should be used when co-administering doravirine with medicinal products that are sensitive CYP3A substrates that also have a narrow therapeutic window (e.g., tacrolimus and sirolimus).
Maltese: prodotti mediċinali li huma sustrati sensittivi ta' CYP3A li għandhom ukoll medda terapewtika stretta (eż., tacrolimus u sirolimus).
English: One subject developed RT M184M/I mutation and phenotypic resistance to 3TC and FTC during treatment with their baseline regimen.
Maltese: Individwu wieħed żviluppa mutazzjoni M184M/I f'RT u reżistenza fenotipika għal 3TC u FTC matul it-trattament bl-iskeda ta' trattament tagħhom fillinja bażi.
English: Doravirine steady state pharmacokinetics following administration of 100 mg once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis, are provided below.
Maltese: Il-farmakokinetika ta' doravirine fi stat fiss wara għoti ta' 100 mg darba kuljum lill-individwi infettati b'HIV-1, abbażi ta' analiżi farmakokinetika ta' popolazzjoni hija pprovduta taħt.
English: 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).
Maltese: L-għoti flimkien ma' prodotti mediċinali li huma indutturi qawwija tal-enzima taċ-ċitokrom P450 CYP3A huwa kontraindikat minħabba li huwa mistenni li jseħħ tnaqqis sinifikanti filkonċentrazzjonijiet ta' doravirine fil-plażma, li jista' jnaqqas l-effikaċja ta' Pifeltro (ara sezzjonijiet 4.4 u 4.5).
English: 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.
Maltese: Il-pilloli huma miksija b'rita b'materjal tal-kisi li fih is-sustanzi li ġejjin: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171; u triacetin E1518.
English: 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.
Maltese: Fi DRIVE-FORWARD, 766 individwu ntagħżlu b'mod arbitrarju u rċivew mill-inqas doża 1 ta' doravirine 100 mg jew inkella darunavir + ritonavir 800+100 mg darba kuljum, kull wieħed flimkien ma' emtricitabine/tenofovir disoproxil (FTC/TDF) jew abacavir/lamivudine (ABC/3TC) magħżula mill-investigatur.
English: 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
Maltese: 4uġigħ fl-addome jinkludi: uġigħ fl-addome, u uġigħ fin-naħa ta' fuq tal-addome 5skumdità fl-addome tinkludi: skumdità fl-addome u skumdità epigastrika 6ippurgar maħlul jinkludi: ippurgar maħlul u ippurgar mhux normali 7disturb fil-motilità gastrointestinali jinkludi: disturb fil-motilità gastrointestinali, u ppurgar frekwenti 8raxx jinkludi: raxx, raxx makulari, raxx eritematuż, raxx mifrux, raxx makulopapulari, raxx papulari, u urtikarja 9żieda fl-alanine aminotransferase tinkludi: żieda fl-alanine aminotransferase u ħsara epatoċellulari
English: Rare dermatitis allergic, rosacea
Maltese: Rari dermatite allerġika, rosaċea Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: 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.
Maltese: L-Iskeda ta' Trattament fil-Linja Bażi = PI imsaħħaħ b'ritonavir jew b'cobicistat (b'mod speċifiku atazanavir, darunavir, jew lopinavir), jew elvitegravir imsaħħaħ b'cobicistat, jew NNRTI (b'mod speċifiku efavirenz, nevirapine, jew rilpivirine), kull wieħed minnhom mogħti flimkien ma' żewġ NRTIs.
English: 5, abdominal distension, dyspepsia, faeces soft gastrointestinal motility disorder
Maltese: Mhux komuni stitikezza, skumdità fl-addome5, nefħa fladdome, dispepsja, ippurgar maħlul6, disturb filmotilità gastrointestinali7
English: 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).
Maltese: Sostituzzjonijiet ta' NNRTI li jeskludu kienu dawk elenkati fuq (DRIVE-FORWARD u DRIVEAHEAD), ħlief għas-sostituzzjonijiet K103N, G190A u Y181C f'RT (aċċettati fi DRIVE-SHIFT).
English: The clinical relevance of a 5-10 fold reduction in susceptibility is unknown.
Maltese: Ir-rilevanza klinika ta' tnaqqis ta' 5-10 darbiet aktar fissuxxettibbiltà mhijiex magħrufa.
English: The efficacy of doravirine is based on the analyses of 96-week data from two randomised, multicentre, double-blind, active controlled Phase 3 trials, (DRIVE-FORWARD and DRIVE-AHEAD) in antiretroviral treatment-naïve, HIV-1 infected subjects (n = 1494).
Maltese: L-effikaċja ta' doravirine hija bbażata fuq l-analiżi ta' data ta' 96 ġimgħa minn żewġ provi arbitrarji, b'ħafna ċentri, ikkontrollat b'mod attiv, ta' Fażi 3, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża (DRIVE-FORWARD u DRIVE-AHEAD), f'individwi infettati b'HIV-1 li qatt ma kienu ħadu trattament antiretrovirali qabel (n = 1,494).
English: Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AG06
Maltese: Antivirali għal użu sistemiku, Kodiċi ATC:
English: • thioridazine (a medicine to treat psychiatric conditions such as schizophrenia)
Maltese: • thioridazine (mediċina biex tittratta kondizzjonijiet psikjatriċi bħal skizofrenja)
English: Refer to Resistance section for NNRTI substitutions that were part of exclusion criteria.
Maltese: Irreferi għas-sezzjoni dwar Rezistenza għas-sostituzzjonijiet ta' NNRTI li kienu parti mill-kriterji ta' esklużjoni.
English: Expected:  doravirine (Inhibition of CYP3A4)
Maltese: ↑ doravirine (Inibizzjoni ta' CYP3A4)
English: Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Maltese: Mhux komuni disturb fl-attenzjoni, indeboliment fil-memorja, parestesija, ipertonja, irqad ta' kwalità fqira
English: Other medicines and Pifeltro
Maltese: Mediċini oħra u Pifeltro
English: Antigout and Uricosuric Agents lesinurad
Maltese: Sustanzi kontra l-Gotta u Urikosuriċi lesinurad
English: ↔ boosted PIs
Maltese: TA' EĊĊIPJENTI
English:  metformin AUC 0.94 (0.88, 1.00) Cmax 0.94 (0.86, 1.03)
Maltese: AUC 0.94 (0.88 , 1.00) Cmax 0.94 (0.86 , 1.03)
English: No dose adjustment of doravirine is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' doravirine f'pazjenti b'indeboliment ħafif (Klassi A ta' Child-Pugh) jew moderat (Klassi B ta' Child-Pugh) tal-fwied.
English: 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.
Maltese: Fil-prova klinika DRIVE-SHIFT, l-ebda individwu ma żviluppa reżistenza ġenotipika jew fenotipika għal DOR, 3TC, jew TDF matul l-ewwel 48 ġimgħa (bidla immedjata, N=447) jew 24 ġimgħa (bidla ttradjata, N=209) ta' trattament b'DOR/3TC/TDF.
English: 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.
Maltese: Għalkemm ġie inkluż numru limitat ta' individwi li kellhom 65 sena jew aktar (n=36), ma ġew identifikati l-ebda differenzi rilevanti b'mod kliniku fil-farmakokinetika ta' doravirine f'individwi li kellhom mill-inqas 65 sena meta mqabbla ma' individwi li kellhom inqas minn 65 sena fi prova ta' Fażi 1 jew f'analiżi farmakokinetika ta' popolazzjoni.
English: Mean CD4 change from baseline (cells/mm
Maltese: Bidla medja f'CD4 mil-linja bażi (ċelluli/mm3)**
English: 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).
Maltese: L-individwi riedu jkunu soppressi b'mod viroloġiku (RNA ta' HIV-1 < 40 kopja/mL) bl-iskeda ta' trattament tagħhom tal-linja bażi għal millinqas 6 xhur qabel ma ddaħħlu fl-istudju, mingħajr l-ebda storja ta' falliment viroloġiku, u nuqqas dokumentat ta' sostituzzjonijiet f'RT li jagħtu reżistenza għal doravirine, lamivudine u tenofovir (ara s-sezzjoni Reżistenza).
English: HIV Antiviral Agents Fusion and Entry Inhibitors enfuvirtide
Maltese: Sustanzi Antivirali għall-HIV Inibituri tal-Fużjoni u tad-Dħul enfuvirtide