FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Estonian: HCV infektsiooniga täiskasvanud patsientide sofosbuviiri ja ribaviriini ohutusprofiil enne maksasiirdamist oli sarnane III faasi kliinilistes uuringutes sofosbuviiri ja ribaviriiniga ravitud patsientide omaga (vt lõik 5.1).
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Estonian: ↑ AUC 4,53 (3,26; 6,30)
English: Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Estonian: Ravitulemuste ülevaade raviskeemide ja ravi kestuse põhjal, võrdlus HCV 4., 5. ja 6. genotüüpide infektsiooni uuringute lõikes
English: Table 6: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Estonian: Kõrvaltoimed sofosbuviiri kasutamisel kombinatsioonravis koos ribaviriini või alfapeginterferooni ja ribaviriiniga
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Estonian: IDA Business & Technology Park Carrigtohill
English: Psychiatric disorders: Very common insomnia insomnia
Estonian: Psühhiaatrilised häired Väga sage unetus unetus
English: Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Estonian: Sovaldi koosmanustamine rifapentiiniga vähendab eeldatavalt sofosbuviiri kontsentratsiooni, tingides seega Sovaldi ravitoime nõrgenemist.
English: PEG+RBV 24 weeks (n = 243)
Estonian: PEG + RBV 24 nädalat (n = 243)
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Estonian: Samaaegse HCV/HIV-infektsiooniga täiskasvanud patsientide sofosbuviiri ja ribaviriini ohutusprofiil oli sarnane III faasi kliinilistes uuringutes sofosbuviiri ja ribaviriiniga ravitud HCV monoinfektsiooniga patsientide omaga (vt lõik 5.1).
English: Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Estonian: Muuc a. Efektiivsusuuringusse kaasati 3 patsienti rekombinantse HCV infektsiooni 2./1.
English: No dose adjustment of Sovaldi is required when concomitantly used with rifabutin.
Estonian: Manustamisel koos rifabutiiniga ei ole Sovaldi annust vaja kohandada.
English: Kidney problems
Estonian: Neeruprobleemid
English: Yes a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Estonian: Jah a. Efektiivsusuuringusse kaasati 3 patsienti rekombinantse HCV infektsiooni 2./1.
English: Otherb a. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Estonian: Muub a. Retsidiiv määratletakse patsientide arvu põhjal, kelle HCV RNA on viimase raviaegse hinnangu ajal < LLOQ.
English: No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly.
Estonian: Sofosbuviiri ja tenofoviirdisoproksiili kooskasutamisel ei ole vaja ei sofosbuviiri ega tenofoviirdisoproksiili annuseid kohandada.
English: Sovaldi is contraindicated with rifampicin (see section 4.3).
Estonian: Sovaldi on vastunäidustatud rifampitsiiniga (vt lõik 4.3).
English: • low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
Estonian: • väikest punavereliblede arvu (aneemia), mille nähud on muuhulgas väsimustunne, peavalud,
English: No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Estonian: Sofosbuviiri ja norgestimaadi/etinüülöstradiooli kooskasutamisel ei ole vaja norgestimaadi/etinüülöstradiooli annuseid kohandada.
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Estonian: Sofosbuviir on nukleotiidi eelravim, mis läbib farmakoloogiliselt aktiivse uridiini analoogtrifosfaadi (GS-461203) moodustamiseks intratsellulaarse metabolismi.
English: No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly.
Estonian: Sofosbuviiri ja rilpiviriini kooskasutamisel ei ole vaja ei sofosbuviiri ega rilpiviriini annuseid kohandada.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Estonian: Sofosbuviiri sisaldavate raviskeemide kasutamisel kombinatsioonis amiodarooni ning koos südame löögisagedust vähendavate teiste ravimitega või ilma, esines raske bradükardia ja südameblokaadi juhtumeid.
English: SOF+RBV 24 weeks
Estonian: SOF+RBV 24 nädalat
English: Genotype 4, 5 or 6 Cirrhosis
Estonian: 4., 5. või 6.
English: Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection.
Estonian: Kroonilise C-hepatiidi 2. ja 3. genotüübiga patsientidel tehtud kliinilised uuringud Varem ravi mittesaanud täiskasvanud - FISSION (uuring 1231) FISSION oli randomiseeritud avatud aktiivse kontrollrühmaga uuring, kus hinnati 12-nädalast sofosbuviiri kombinatsioonravi ribaviriiniga võrrelduna 24-nädalase sofosbuviiri, alfa-2apeginterferooni ja ribaviriini kombinatsioonraviga varem ravi mittesaanud HCV-infektsiooni 2. või 3. genotüübiga patsientidel.
English: Treated patients (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the patients were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
Estonian: Ravitud patsientide (n = 419) vanuse mediaan oli 51 aastat (vahemik 19…74); 60% patsientidest olid meessoost; mediaan kehamassi indeks oli 25 kg/m2 (vahemik 17…44 kg/m2); keskmine ravieelne HCV RNA oli 6,4 log10 RÜ/ml; 21%-l oli tsirroos; 78%-l oli HCV 3. genotüüp; 65%-l olid eelnevad retsidiivid.
English: Gastrointestinal disorders: Very common nausea diarrhoea, nausea, vomiting
Estonian: Seedetrakti häired Väga sage iiveldus kõhulahtisus, iiveldus, oksendamine
English: SOF+RBV 12 weeks (n = 256)a
Estonian: SOF + RBV 12 nädalat (n = 256)a
English: Renal impairment
Estonian: Sage aneemia
English: SOF+RBV 16 weeks (n = 98)a
Estonian: SOF + RBV 16 nädalat (n = 98)a
English: Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007.
Estonian: Peamise ringleva metaboliidi GS-331007 saab tõhusalt (ekstraktsiooni määr 53%) eemaldada hemodialüüsiga.
English: The exposure to GS-331007 was not altered in the presence of a high-fat meal.
Estonian: Suure rasvasisaldusega eine ei mõjutanud GS-331007 ekspositsiooni.
English: Of the 50 treated patients, the median age was 15 years (range: 12 to 17); 42% of the patients were female; 90% were White, 4% were Black, and 2% were Asian; 4% were Hispanic/Latino; mean body mass index was 22 kg/m2 (range: 16 to 32 kg/m2); 18% were treatment experienced; 66% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 74% of patients had non-CC IL28B alleles (CT or TT); and no patients had known cirrhosis.
Estonian: 50 ravitud patsiendi mediaanne vanus oli 15 aastat (vahemik 12…17); 42% patsientidest olid naissoost; 90% valgenahalised, 4% mustanahalised ja 2% Aasia päritolu; 4% Hispaania või ladina päritolu; keskmine kehamassi indeks oli 22 kg/m2 (vahemik 16…32 kg/m2); 18% oli eelnevalt ravi saanud; 66%-l oli ravieelne HCV RNA võrdne või suurem kui 800 000 RÜ/ml; 74%-l oli mitte-C/C IL28B alleelid (CT või TT); ühelgi patsiendil ei olnud teadaolevalt tsirroosi.
English: • shortness of breath, cough
Estonian: • õhupuudus, köha
English: SOF+RBV 16 weeks
Estonian: SOF+RBV 16 nädalat
English: No dose adjustment of sofosbuvir or darunavir (ritonavir boosted) is required when sofosbuvir and darunavir are used concomitantly.
Estonian: Sofosbuviiri ja darunaviiri (ritonaviiri abil võimendatud) kooskasutamisel ei ole vaja ei sofosbuviiri ega darunaviiri annuseid kohandada.
English: Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑
Estonian: Sofosbuviir 1,6-kordne↑ 2,1-kordne↑ 2,7-kordne↑ 1,3
English: SOF+RBV 12 weeks (n = 183)
Estonian: SOF + RBV 12 nädalat (n = 183)
English: No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly.
Estonian: Sofosbuviiri ja emtritsitabiini kooskasutamisel ei ole vaja ei sofosbuviiri ega emtritsitabiini annuseid kohandada.
English: Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114)
Estonian: 1. genotüüp varem ravi mittesaanud SOF+RBV 24 nädalat (n = 114)
English: The starting dose of ribavirin was 400 mg given in a divided daily dose.
Estonian: 400 mg, mida anti jagatud ööpäevase annusena.
English: No dose adjustment of sofosbuvir or ciclosporin is required at initiation of co-administration.
Estonian: Sofosbuviiri ja tsüklosporiini kooskasutamise alustamisel ei ole vaja annuseid kohandada.
English: Common weight decreased
Estonian: Sage kehakaalu vähenemine
English: Sovaldi is contraindicated with carbamazepine (see section 4.3).
Estonian: Sovaldi on vastunäidustatud karbamasepiiniga (vt lõik 4.3).
English: Antiviral activity
Estonian: Viirusevastane toime
English: SOF+RBV 12 weeks (n = 207)
Estonian: SOF + RBV 12 nädalat (n = 207)
English: PEG+RBV 24 weeks (n = 67)
Estonian: PEG + RBV 24 nädalat (n = 67)
English: FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 2 or 3 HCV infection.
Estonian: NEUTRINO oli avatud ühe ravirühmaga uuring, kus hinnati 12-nädalast sofosbuviiri kombinatsioonravi alfa-2a-peginterferooni ja ribaviriiniga varem ravi mittesaanud HCV-infektsiooni 1., 4., 5. või 6. genotüübiga patsientidel.
English: and <50 mL/min/1.73 m2)
Estonian: Mõõdukas NK (eGFR ≥30 ja <50 mk/min/1.73 m2)
English: Skin and subcutaneous tissue disorders: Very common rash, pruritus
Estonian: Naha ja nahaaluskoe kahjustused Väga sage lööve, sügelus
English: Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Estonian: Sofosbuviiri manustati avatud uuringus (uuring 0154) fikseeritud annustes koos ledipasviiriga 12 nädalat 18-le raske neerufunktsiooni kahjustusega genotüüp 1 CHC-ga patsiendile.
English: Overall No cirrhosis Cirrhosis
Estonian: Kokkua Tsirroositaa Tsirroosigaa
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA)
Estonian: Sofosbuviir ↓ Cmax 0,23 (0,19; 0,29)
English: No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly.
Estonian: Sofosbuviiri ja raltegraviiri kooskasutamisel ei ole vaja ei sofosbuviiri ega raltegraviiri annuseid kohandada.
English: Baseline NS5B sequences were obtained for 47 patients in the Phase 2 study.
Estonian: 47-l II faasi uuringus osalenud patsiendil määrati NS5B järjestuste algväärtused.
English: Treated patients (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the patients were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL; 16% had cirrhosis; 49% had HCV genotype 3.
Estonian: Ravitud patsientide (n = 278) vanuse mediaan oli 54 aastat (vahemik 21...75); 54% patsientidest olid meessoost; 91% valgenahalised, 5% mustanahalised, 11% Hispaania või ladina päritolu; keskmine kehamassi indeks oli 28 kg/m2 (vahemik 18...53 kg/m2); 70%-l oli ravieelne HCV RNA suurem kui 6 log10 RÜ/ml; 16%-l oli tsirroos; 49%-l oli HCV 3. genotüüp.
English: The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study.
Estonian: Ühel patsiendil, kes sai II faasi uuringus Sovaldi monoteraapiat, tuvastati S282T asendus NS5B-s.
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
Estonian: Sofosbuviir ↓ Cmax 0,52 (0,43; 0,62)
English: Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Estonian: Sovaldi koosmanustamine modafiniiliga vähendab eeldatavalt sofosbuviiri kontsentratsiooni, tingides seega Sovaldi ravitoime nõrgenemist.
English: Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi.
Estonian: Enne Sovaldiga ravi alustamist tuleb tutvuda koosmääratud ravimite ravimi omaduste kokkuvõtetega.
English: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Estonian: ja ravieelse HCV RNA taseme (6 log10 RÜ/ml vs ≥ 6 log10 RÜ/ml) alusel.
English: Treated patients (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the patients were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Estonian: Ravitud patsientide (n = 327) vanuse mediaan oli 54 aastat (vahemik 19...70); 64% patsientidest olid meessoost; 79% valgenahalised, 17% mustanahalised, 14% Hispaania või ladina päritolu; keskmine kehamassi indeks oli 29 kg/m2 (vahemik 18...56 kg/m2); 78%-l oli ravieelne HCV RNA suurem kui 6 log10 RÜ/ml; 17%-l oli tsirroos; 89%-l oli HCV 1. genotüüp ja 11 protsendil oli 4., 5. või 6. genotüüp.
English: Regimen/Duration
Estonian: Raviskeem/kestus
English: SOF+RBV 12 weeks (n = 73)a
Estonian: SOF + RBV 12 nädalat (n = 73)a
English: Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Estonian: Sovaldi koosmanustamine okskarbasepiiniga vähendab eeldatavalt sofosbuviiri kontsentratsiooni, tingides seega Sovaldi ravitoime nõrgenemist.
English: Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, 1.69) Cmin (NA)
Estonian: Sofosbuviir ↓ Cmax 0,95c (0,68; 1,33)
English: SOF+RBV 12 weeks (n = 103)a
Estonian: SOF + RBV 12 nädalat (n = 103)a
English: • diarrhoea, feeling sick (nausea), being sick (vomiting)
Estonian: • kõhulahtisus, iiveldus, oksendamine
English: Cirrhosis
Estonian: Tsirroosiga
English: GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
Estonian: GS-331007 ↓ Cmax 0,77 (0,70; 0,84)
English: Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible patients were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
Estonian: Sofosbuviiri uuriti avatud kliinilises uuringus, kus hinnati sofosbuviiri ja ribaviriini 24-nädalase kombinatsioonravi ohutust ja efektiivsust kroonilise C-hepatiidiga maksasiirdamise retsipientidel.
English: ESRD Requirin g
Estonian: Kehakaal kg
English: SOF+RBV 16 weeks (n = 35)
Estonian: SOF + RBV 16 nädalat (n = 35)
English: Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling.
Estonian: POSITRON oli randomiseeritud topeltpime platseebokontrolliga uuring, kus hinnati 12-nädalast sofosbuviiri ja ribaviriini kombinatsioonravi (n = 207) võrreldes platseeboga (n = 71) patsientidel, kellel oli interferooni talumatus või kes ei vastanud uuringu tingimustele või ei soovinud uuringus osaleda.
English: No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration.
Estonian: Sofosbuviiri ja takroliimuse kooskasutamise alustamisel ei ole vaja annuseid kohandada.
English: 20% had cirrhosis; 72% had HCV genotype 3.
Estonian: 6 log10 RÜ/ml; 34%-l oli tsirroos; 63%-l oli HCV 3. genotüüp; 75%-l olid eelnevad retsidiivid.
English: S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
Estonian: ↔ Cmin 0,94 (0,77; 1,14) S-metadoon ↔ Cmax 0,95 (0,79; 1,13)
English: • rash, itchy skin
Estonian: • lööve, sügelev nahk
English: SOF+RBV 12 weeks (n = 64)
Estonian: SOF + RBV 12 nädalat (n = 64)
English: SOF+RBV 12 weeks
Estonian: SOF + RBV 12 nädalat
English: Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
Estonian: Sage artralgia, seljavalu, lihaskrambid, müalgia seljavalu, lihaskrambid
English: SOF+RBV 16 weeks (n = 63)
Estonian: SOF + RBV 16 nädalat (n = 63)
English: Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68)
Estonian: genotüüp varem ravi mittesaanud SOF+RBV 12 nädalat (n = 68)
English: Effects on drug levels.
Estonian: Toime ravimi sisaldusele.
English: Treated patients (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the patients were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Estonian: Ravitud patsientide (n = 499) vanuse mediaan oli 50 aastat (vahemik 19...77); 66% patsientidest olid meessoost; 87% valgenahalised, 3% mustanahalised, 14% Hispaania või ladina päritolu; keskmine kehamassi indeks oli 28 kg/m2 (vahemik 17...52 kg/m2); 57%-l oli ravieelne HCV RNA suurem kui 6 log10 RÜ/ml; 20%-l oli tsirroos; 72%-l oli HCV 3. genotüüp.
English: Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Estonian: Ravitulemuste ülevaade raviskeemide ja ravi kestuse põhjal, võrdlus HCV 1. genotüübi infektsiooni uuringute lõikes
English: The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Estonian: Sofosbuviiri ja peamise ringleva metaboliidi GS-331007 farmakokineetilisi omadusi on hinnatud tervetel täiskasvanutel ja kroonilise C-hepatiidiga patsientidel.
English: Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Estonian: Ravitulemuste ülevaade raviskeemide ja ravi kestuse põhjal, võrdlus HCV 2. genotüübi infektsiooni uuringute lõikes
English: No dose adjustment of sofosbuvir is recommended for patients with mild, moderate and severe hepatic impairment (see section 4.2).
Estonian: Kerge, mõõduka või raske maksafunktsiooni kahjustusega patsientidel ei ole tarvis sofosbuviiri annust muuta (vt lõik 4.2).
English: SOF+RBV 12 weeks (n = 39)
Estonian: SOF + RBV 12 nädalat (n = 39)
English: Respiratory, thoracic and mediastinal disorders: Very common dyspnoea, cough
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Väga sage düspnoe, köha
English: Gilead Sciences Ireland UC Tel: + 353 (0) 214 825999
Estonian: Tel: + 353 (0) 214 825999
English: Table 12: SVR12 rates for selected subgroups by genotype in POSITRON
Estonian: SVR12 määrad valitud alarühmades genotüüpide lõikes uuringus POSITRON
English: GS-331007 ↓ Cmax 0.73c (0.65, 0.83) ↔ AUC 1.04c (0.89, 1.22) Cmin (NA)
Estonian: GS-331007 ↓ Cmax 0,73c (0,65; 0,83)
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.20) ↔ AUC 1.03 (0.97, 1.08) Cmin (NA)
Estonian: GS-331007 ↔ Cmax 1,09 (0,99; 1,20)
English: GS-331007 ↔ Cmax 1.06 (0.99, 1.14) ↔ AUC 1.01 (0.97, 1.04) Cmin (NA)
Estonian: GS-331007 ↔ Cmax 1,06 (0,99; 1,14)
English: SOF+RBV 24 weeks (n = 250)
Estonian: 3. genotüüp SOF+RBV 24 nädalat (n = 250)
English: Table 22: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Estonian: Ravitulemuste ülevaade raviskeemide ja ravi kestuse põhjal, võrdlus HCV 3. genotüübi infektsiooni uuringute lõikes
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA)
Estonian: GS-331007 ↔ Cmax 0,97 (0,83; 1,14)
English: No dose adjustment of sofosbuvir or efavirenz is required when sofosbuvir and efavirenz are used concomitantly.
Estonian: Sofosbuviiri ja efaviirensi kooskasutamisel ei ole vaja ei sofosbuviiri ega efaviirensi annuseid kohandada.
English: Treated patients (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the patients were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers.
Estonian: Ravitud patsientide (n = 201) vanuse mediaan oli 56 aastat (vahemik 24...70); 70% patsientidest olid meessoost; 87% valgenahalised, 3% mustanahalised, 9% Hispaania või ladina päritolu; keskmine kehamassi indeks oli 29 kg/m2 (vahemik 19...44 kg/m2); 73%-l oli ravieelne HCV RNA suurem kui
English: Sovaldi is contraindicated with St. John's wort (see section 4.3).
Estonian: Sovaldi on vastunäidustatud naistepunaga (vt lõik 4.3).
English: SOF+RBV 24 weeks TE (n = 13)
Estonian: SOF+RBV 24 nädalat VR (n = 13)
English: • weight loss
Estonian: • kehakaalu vähenemine
English: Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, 1.27) Cmin (NA)
Estonian: ↔ Cmin 0,99 (0,94; 1,04) Sofosbuviir ↑ Cmax 1,21 (0,90; 1,62)
English: Treatment-naïve (NEUTRINO)
Estonian: (NEUTRINO)
English: Overall No cirrhosis
Estonian: Kokku Tsirroosita Tsirroosiga
English: Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA)
Estonian: ↔ Cmin 0,95 (0,81; 1,12) Sofosbuviir ↔ Cmax 0,87 (0,71; 1,08)
English: • back pain, muscle spasms
Estonian: • seljavalu, lihaskrambid
English: 130 mg/daily])
Estonian: 15 mg/kg ööpäevas
English: • light-headedness
Estonian: • lihasvalud, liigestevalud
English: SOF+RBV 24 weeks TE (n = 15)
Estonian: SOF+RBV 24 nädalat VR (n = 15)
English: Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Estonian: Annusevahemikus 200...400 mg on sofosbuviiri ja GS-331007 AUCd praktiliselt proportsionaalsed.
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
Estonian: Sofosbuviir ↓ Cmax 0,97 (0,65; 1,43)
English: SOF+RBV 12 weeks TN (n = 42)
Estonian: SOF+RBV 12 nädalat VRM (n = 42)
English: Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11)
Estonian: ↔ Cmin 1,04 (0,98; 1,11) Sofosbuviir ↓ Cmax 0,81 (0,60; 1,10)
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69) ↔ AUC 1.04 (0.90, 1.20) Cmin (NA)
Estonian: GS-331007 ↓ Cmax 0,60 (0,53; 0,69)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA)
Estonian: GS-331007 ↔ Cmax 0,97 (0,90; 1,05)
English: No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Estonian: Sofosbuviiri ega GS-331007 puhul ei täheldatud soost või rassist sõltuvaid kliiniliselt olulisi farmakokineetilisi erinevusi.