natgillin/translations-raw huggingface dataset:
In clinical trials, HCV-RNA in plasma was measured with the Roche COBAS Taqman 2.0 assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
U kliničkim ispitivanjima, HCV-RNK u plazmi određivala se testom Roche COBAS Taqman 2.0, s granicom detekcije od 9,3 IU/ml i granicom kvantifikacije od 25 IU/ml.
Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassiumsparing diuretics (see section 4.4).
Potreban je oprez u bolesnika koji imaju tegobe zbog kojih postoji predispozicija za razvoj hiperkalijemije ili u bolesnika koji uzimaju diuretike koji štede kalij (vidjeti dio 4.4).
Treatment of overdose with Victrelis should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status.
Liječenje predoziranja lijekom Victrelis treba obuhvatiti opće suportivne mjere, uključujući nadzor vitalnih znakova i praćenje
If you are breast-feeding, your doctor will advise you to discontinue breast-feeding or to discontinue Victrelis while breast-feeding.
Ako dojite, liječnik će Vam savjetovati da prestanete dojiti ili da prekinete uzimati Victrelis dok dojite.
• have another liver problem in addition to hepatitis C infection • have HIV (human immunodeficiency virus) or have ever had any other problems with your
• ako ste zaraženi virusom HIV-a (virusom humane imunodeficijencije) ili ste nekad imali drugih problema s imunološkim sustavom
If therapy is initiated, a very close monitoring for signs of infections and worsening liver function is warranted.
Ako se terapija uvede, neophodan je vrlo poman nadzor kako bi se uočili eventualni znakovi infekcija ili
Victrelis must not be used by itself.
Victrelis se ne smije koristiti kao jedini lijek.
Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and offwhite, opaque body with the code "314" imprinted in red ink.
Kapsula ima žućkasto-smeđu neprozirnu kapicu s logotipom "MSD" otisnutim crvenom tintom i bjelkasto neprozirno tijelo s oznakom "314" otisnutom crvenom tintom.
If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose
Ako bolesnik propusti dozu, a do sljedeće je doze ostalo manje od 2 sata, propuštenu dozu treba
Mean age of subjects randomized was 43.6 years.
Srednja dob randomiziranih ispitanika bila je 43,6 godina.
No data are available; therefore, the combination of boceprevir with these medicines is not-recommended (see section 4.4).
Podaci nisu dostupni te se ne preporučuje kombinacija boceprevira s tim lijekovima (vidjeti dio 4.4).
Mean age of subjects randomized was 49.1 years.
Srednja dob randomiziranih ispitanika bila je 49,1 godina.
In a study comparing the use of ribavirin dose reduction and erythropoesis stimulating agents in the management of treatment-emergent anaemia, the use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events (see section 5.1).
U ispitivanju u kojem se uspoređivalo sniženje doze ribavirina u odnosu na primjenu lijekova koji stimuliraju eritropoezu za liječenje anemije koja se javlja pri liječenju, primjena lijekova koji stimuliraju eritropoezu bila je povezana s povećanim rizikom od tromboembolijskih događaja (vidjeti
Plasma trough concentrations of Victrelis were decreased when administered with efavirenz.
Najniže koncentracije lijeka Victrelis u plazmi snižene su kad se primjenjuje istodobno s efavirenzom.
The addition of boceprevir to peginterferon alfa and ribavirin is associated with an additional decrease in haemoglobin concentrations of approximately 1 g/dL by Treatment Week 8 compared to standard of care (see section 4.8).
Dodavanje boceprevira peginterferonu alfa i ribavirinu povezano je s dodatnim sniženjem koncentracije hemoglobina od približno 1 g/dl do 8. tjedna liječenja u usporedbi sa standardnim liječenjem (vidjeti dio 4.8).
9/L) was higher in boceprevir-treated patients (29%) than in placebo-treated patients (17%), in combination with peginterferon alfa-2b and ribavirin.
9/l) bio je veći u skupinama liječenima boceprevirom (29%) nego u bolesnika koji su primali placebo (17%) u kombinaciji s peginterferonom alfa-2b i ribavirinom.
(CYP3A inhibition and/or P-gp
(inhibicija CYP3A i/ili inhibicija P-gp-a)
In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
U kliničkim ispitivanjima HCV-RNK u plazmi određivala se testom Roche COBAS Taqman, s granicom detekcije od 9,3 IU/ml i granicom kvantifikacije od 25 IU/ml.
HIV Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Nukleozidni inhibitor HIV reverzne transkriptaze (NRTI)
The concomitant use of Victrelis with potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, phenytoin) is not recommended (see section 4.5).
Ne preporučuje se istodobna primjena lijeka Victrelis sa snažnim induktorima CYP3A4 (rifampicinom, karbamazepinom, fenobarbitalom, fenitoinom) (vidjeti dio 4.5).
All subjects with detectable HCV-RNA in plasma at TW 12 were discontinued from treatment.
Svi ispitanici s mjerljivom HCV-RNK u plazmi u 12. tjednu isključeni su iz liječenja.
Fifty-seven percent (208/368) of subjects in the Victrelis-RGT arm and 56% (204/366) of subjects in the Victrelis-PR48 arm had undetectable HCV-RNA at TW 8 compared with 17% (60/363) of
U 57% ispitanika (208/368) u skupini Victrelis-RGT i 56% ispitanika (204/366) u skupini Victrelis-PR48 razine HCV-RNK u 8. tjednu liječenja nisu bile mjerljive, u usporedbi sa 17% ispitanika (60/363) u skupini PR.
Skin and hair: reddening of the skin; bacterial skin infection Stomach and gut: problems digesting food; vomiting blood; vomiting, diarrhoea, and severe right upper corner stomach (abdominal) pain
Koža i kosa: crvenilo kože; bakterijska infekcija kože Želudac i crijeva: poteškoće pri probavljanju hrane; povraćanje krvi; povraćanje; proljev i jaka bol u gornjem desnom dijelu trbuha (abdomena)
Acute myocardial infarction*, atrial fibrillation*, coronary artery disease*, pericarditis*, pericardial
akutni infarkt miokarda*, fibrilacija atrija*, bolest koronarnih arterija*, perikarditis*, perikardijalna efuzija
No dose adjustment is required in these patients and in patients with any degree of renal impairment.
Nije potrebno prilagođavati dozu u tih bolesnika kao ni u bolesnika s bilo kojim stupnjem oštećenja funkcije bubrega.
3 and/or serum albumin < 35 g/L and/or signs of coagulopathy (International Normalized Ratio (INR) > 1.7) at baseline.
3 i/ili vrijednost albumina u serumu < 35 g/l i/ili znakove koagulopatije (INR (engl.
* The Full Analysis Set (FAS) consisted of all subjects who became anaemic (serum haemoglobin of approximately ≤10 g/dL within the treatment period) and were randomized to using either ribavirin dose reduction or erythropoietin (N=500).
* Cijeli set analiza (FAS) obuhvaćao je sve ispitanike koji su postali anemični (hemoglobin u serumu približno ≤ 10 g/dl tijekom razdoblja liječenja) te su randomizirani da primaju ili sniženu dozu ribavirina ili eritropoetin (N=500).
The concomitant use of Victrelis with doxazosin and tamsulosin is not recommended (see section 4.5).
Istodobna primjena lijeka Victrelis s doksazozinom i tamsulozinom se ne preporučuje (vidjeti dio 4.5).
Victrelis contains lactose.
Victrelis sadrži laktozu.
Patients receiving dabigatran should be monitored appropriately.
Bolesnike koji uzimaju dabigatran treba odgovarajuće nadzirati.
The degree of added value of Victrelis on top of the bitherapy in C/C patients will depend on the likelihood of achieving SVR with the bitherapy only.
Stupanj dodane vrijednosti lijeka Victrelis povrh dvojne terapije u bolesnika s genotipom C/C ovisi o vjerojatnosti da postignu SVR samo s dvojnom terapijom.
Among the variants, 91% of V36M, 98% of T54A, 71% of T54S, 78% of V55A, 76% of R155K, 92% of A156S, 96% of I/V170A, 77% of R155K+T54S and 95% of R155K+V36M were undetectable by population sequencing.
Od svih varijanti, sekvenciranjem populacije nije otkriveno 91% V36M, 98% T54A, 71% T54S, 78% V55A, 76% R155K, 92% A156S, 96% I/V170A, 77% R155K+T54S i 95% R155K+V36M.
Medicines metabolized primarily by CYP3A4/5 may have increased exposure when administered with Victrelis, which could increase or prolong their therapeutic and adverse reactions (see Table 2).
Može se povećati izloženost lijekovima koji se primarno metaboliziraju putem CYP3A4/5 kad se primjenjuju zajedno s lijekom Victrelis, što može pojačati ili produljiti njihovo terapijsko djelovanje i nuspojave (vidjeti Tablicu 2).
Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy (see sections 4.4 and 5.1).
Victrelis je indiciran za liječenje kronične infekcije virusom hepatitisa C (CHC) genotipa 1 u kombinaciji s peginterferonom alfa i ribavirinom u odraslih bolesnika s kompenziranom bolešću jetre koji prethodno nisu bili liječeni ili nisu odgovorili na prethodnu terapiju (vidjeti dijelove 4.4 i 5.1).
Subjects who enrolled in PROVIDE within 2 weeks after the last dose of PR in the parent study received Victrelis 800 mg three times daily + PR for 44 weeks.
Ispitanici koji su uključeni u ispitivanje PROVIDE unutar 2 tjedna nakon posljednje doze PR-a u izvornom ispitivanju, primali su Victrelis u dozi od 800 mg triput na dan + PR tijekom 44 tjedna.
The safety profile represented by approximately 1,500 patients for the combination of Victrelis with peginterferon alfa-2b and ribavirin was based on pooled safety data in two clinical trials: one in patients who were previously untreated, and one in patients who had failed prior therapy (see
Sigurnosni profil kombinacije lijeka Victrelis s peginterferonom alfa-2b i ribavirinom, kojeg predstavlja oko 1500 bolesnika, temelji se na zbirnim podacima o sigurnosti primjene iz dva klinička ispitivanja: jednog u bolesnika koji prethodno nisu bili liječeni i jednog u bolesnika koji nisu odgovorili na prethodnu terapiju (vidjeti dio 5.1).
If there were no such values at and after FW 24, the FW 12 value was used.
Ako takve vrijednosti nisu postojale u i nakon 24. tjedna praćenja, koristila se vrijednost iz 12. tjedna praćenja.
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for baseline, ontreatment and post-treatment laboratory testing recommendations including haematology, biochemistry (including hepatic function tests), and pregnancy testing.
Molimo pročitajte Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin za preporuke o laboratorijskim pretragama na početku, tijekom i nakon liječenja, uključujući hematološke i biokemijske pretrage (uključujući testove jetrene funkcije) te testiranje na trudnoću.
• HIV non-nucleoside reverse transcriptase inhibitor - efavirenz, etravirine
• nenukleozidni inhibitor reverzne transkriptaze HIV-a - efavirenz, etravirin
Victrelis is partly metabolized by CYP3A4/5.
Victrelis se dijelom metabolizira putem CYP3A4/5.
The majority of subjects (87%; 85/98) were taking a ritonavir-boosted HIV protease inhibitor (PI) combined with HIV nucleoside reverse transcriptase inhibitors (NRTIs).
85/98) uzimala neki inhibitor HIV proteaze pojačan ritonavirom u kombinaciji s nukleozidnim inhibitorima HIV reverzne transkriptaze (NRTI).
Boceprevir/medicine derived material was shown to be transferred into the milk of lactating rats.
Pokazalo se da se boceprevir odnosno materijal koji potječe od lijeka izlučuje u mlijeko štakorica.
Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com dpoc_czechslovak@merck.com
Subjects who were not able to enrol in this study within 2 weeks received PR for 4 weeks followed by Victrelis 800 mg three times daily + PR for 44 weeks.
Ispitanici koji nisu mogli biti uključeni u ovo ispitivanje unutar ta 2 tjedna, primali su PR tijekom 4 tjedna, a zatim Victrelis u dozi od 800 mg + PR tijekom 44 tjedna.
Blood: low red blood cell count (anaemia), drop in the number of red blood cells - the signs may include feeling tired, headaches, being short of breath when exercising; low neutrophil count (neutropenia), low number of white blood cells - the signs may include getting more infections than usual - including fever, severe chills, a sore throat or mouth ulcers
Krv: nizak broj crvenih krvnih stanica (anemija), pad broja crvenih krvnih stanica - znakovi mogu obuhvaćati umor, glavobolje, nedostatak zraka u naporu; nizak broj neutrofila (neutropenija); mali broj bijelih krvnih stanica - znakovi mogu obuhvaćati češće infekcije nego obično - uključujući vrućicu, jaku zimicu, grlobolju ili vrijedove u ustima.
Therefore, female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Stoga bolesnice reproduktivne dobi moraju primjenjivati djelotvornu kontracepciju tijekom liječenja i 4 mjeseca po njegovu završetku.
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Pročitajte Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin za dodatne informacije o tome na koji način sniziti dozu i/ili prekinuti primjenu peginterferona alfa i/ili ribavirina.
• tyrosine kinase inhibitors - used as anti-cancer medicines
• inhibitore tirozin kinaze - za liječenje karcinoma.
A limited number of subjects (n=12) received ≤ 200mg/day of ribavirin for at least
Mali broj ispitanika (n=12) primao je dozu ribavirina ≤ 200 mg na dan tijekom najmanje 14 dana.
HCV-RNA levels should be monitored at Treatment Weeks 8, 12, and 24, and for other time points as
Razine HCV-RNK potrebno je kontrolirati u 8., 12. i 24. tjednu liječenja, a u drugim vremenskim točkama prema kliničkoj potrebi.
Dizziness*, headache*
kašalj*, dispneja*
• have ever had a blood problem such as pancytopenia (a combination of low platelet, red and
• ako ste nekada imali probleme s krvlju, kao što je pancitopenija (kombinacija premalog broja krvnih pločica, crvenih krvnih stanica i bijelih krvnih stanica)
Achievement of SVR was associated with the subject's response to peginterferon alfa-2b and ribavirin therapy, whether defined by classification of response to previous treatment, or by a decrease in HCVRNA at TW 4 (see Table 7).
Postizanje SVR povezano je s ispitanikovim odgovorom na liječenje peginterferonom alfa-2b i ribavirinom, definiranim ili prema klasifikaciji odgovora na prethodno liječenje, ili kao smanjenje razine HCV-RNK u 4. tjednu liječenja (vidjeti Tablicu 7).
Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.
Preporučuje se pojačan klinički i laboratorijski nadzor radi praćenja supresije HIV-a i HVC-a.
• However, if it is less than 2 hours before your next dose is due, skip the missed dose.
- Međutim, ako je do sljedeće doze ostalo manje od 2 sata, preskočite propuštenu dozu.
As a conservative measure in view of limitations of the data, in treatment experienced patients early responders, the total treatment duration is recommended to be prolonged to 48 weeks as compared to the tested 36 weeks total treatment duration (tested RGT), with a 12 weeks of peginterferon ribavirin consolidation phase after the end of the tritherapy at week 36.
Kao konzervativna mjera obzirom na ograničene podatke preporučuje se u već liječenih bolesnika s ranim odgovorom na liječenje produljiti ukupno trajanje liječenja na 48 tjedana, u usporedbi s ukupno 36 tjedana liječenja u kliničkim ispitivanjima (ispitivana RGT), tako da se nakon završetka trojne terapije u 36. tjednu liječenja nastavi s još 12 tjedana konsolidacije peginterferonom i ribavirinom.
The transfusion rate was 4% (10/249) in subjects randomized to receive ribavirin dose reduction and 2% (5/251) in subjects randomized to receive erythropoietin.
Stopa transfuzije iznosila je 4% (10/249) u ispitanika randomiziranih za snižavanje doze ribavirina te 2% (5/251) u ispitanika randomiziranih za primanje eritropoetina.
As a conservative measure in view of the limitations of the data, in treatment naïve patients-late responders, the treatment duration of the tritherapy is recommended to be prolonged to 32 weeks as compared to the tested 24 weeks duration of the tritherapy, for a total treatment duration of 48 weeks.
Kao konzervativna mjera obzirom na ograničene podatke preporučuje se u bolesnika koji prethodno nisu bili liječeni, s kasnim odgovorom na liječenje, produljiti trajanje trojne terapije na 32 tjedna, u usporedbi s 24 tjedna liječenja u ispitivanjima, čime bi cjelokupno liječenje trajalo 48 tjedana.
All subjects with detectable HCV-RNA in plasma at TW 24 were discontinued from treatment.
Svi ispitanici s mjerljivom HCV-RNK u plazmi u 24. tjednu liječenja isključeni su iz liječenja.
All patients in this treatment arm were limited to 24 weeks of therapy with Victrelis.
Svim bolesnicima u ovoj terapijskoj skupini liječenje lijekom Victrelis bilo je ograničeno na 24 tjedna.
In clinical trials with the combination of Victrelis, peginterferon alfa-2b and ribavirin compared to peginterferon alfa-2b and ribavirin alone, the median time from the initiation of therapy to onset of haemoglobin less than 10 g/dL was similar (71 days with a range of 15-337 days, and 71 days with a range of 8-337 days, respectively).
U kliničkim ispitivanjima u kojima se uspoređivala kombinacija lijeka Victrelis, peginterferona alfa-2b i ribavirina s primjenom samo peginterferona alfa-2b i ribavirina, medijan vremena od početka terapije do pada vrijednosti hemoglobina na manje od 10 g/dl bio je podjednak (71 dan uz raspon od 15-337 dana, odnosno 71 dan uz raspon od 8-337 dana).
Eleven subjects were missing TW 4 assessment (HCV-RNA) and were not included in the Lead-In
Za 11 ispitanika nedostajala je procjena nakon 4. tjedna liječenja (razina HCV-RNK) i oni nisu uključeni u rezultate odgovora na uvodno liječenje.
Rilpivirine* (rilpivirine 25 mg every 24 hours + Victrelis 800 mg three times daily)
Rilpivirin* (rilpivirin 25 mg svaka 24 sata + Victrelis 800 mg triput na dan)
The efficacy of Victrelis as a treatment for chronic hepatitis C genotype 1 infection was assessed in approximately 1,500 adult subjects who were previously untreated (SPRINT-2) or who had failed previous therapy (RESPOND-2) in Phase III clinical studies.
Djelotvornost lijeka Victrelis u liječenju kroničnog hepatitisa C genotipa 1 ispitana je u kliničkim ispitivanjima faze III u približno 1500 odraslih ispitanika koji prethodno nisu bili liječeni (SPRINT-2) ili nisu odgovorili na prethodnu terapiju (RESPOND-2).
Some cases have also been reported in patients coinfected with hepatitis B and C viruses treated with interferon (refer to the Summary of Product Characteristics for peginterferon alfa for more information on HBV reactivation in patients coinfected with HBV and HCV treated with interferon).
Neki slučajevi su prijavljeni i u bolesnika istodobno zaraženih virusom hepatitisa B i C liječenih interferonom (za više informacija o reaktivaciji HBV-a u bolesnika istodobno zaraženih HBV-om i HCV-om liječenih interferonom, pročitajte sažetak opisa svojstava lijeka za peginterferon alfa).
Table 1 Duration of therapy using Response-Guided Therapy (RGT) guidelines in patients without cirrhosis who are previously untreated or who have failed previous therapy to interferon and ribavirin therapy
Response-Guided Therapy, RGT) u bolesnika bez ciroze koji prethodno nisu bili liječeni ili nisu odgovorili na prethodnu terapiju interferonom i ribavirinom
You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment.
Vi i Vaša partnerica morate koristiti djelotvornu kontracepciju tijekom liječenja ribavirinom i 7 mjeseci po njegovu završetku.
Safety and efficacy of Victrelis, in combination with peginterferon alfa and ribavirin, have not been studied in patients with decompensated cirrhosis.
Sigurnost i djelotvornost lijeka Victrelis, u kombinaciji s peginterferonom alfa i ribavirinom, nisu ispitivane u bolesnika s dekompenziranom cirozom.
In clinical trials, the proportion of subjects who received erythropoietin for the management of anaemia was 43% (667/1,548) of subjects in the Victrelis-containing arms compared to 24% (131/547) of subjects receiving peginterferon alfa-2b and ribavirin alone.
U kliničkim je ispitivanjima udio bolesnika koji su primili eritropoetin za liječenje anemije bio 43% (667/1548) u skupinama ispitanika koji su primali Victrelis, a 24% (131/547) u skupinama koje su primale samo peginterferon alfa-2b i ribavirin.
9/L (Grade 4 neutropenia) compared to 4% of subjects receiving only peginterferon alfa-2b and ribavirin.
9/l neutrofila (neutropeniju stupnja 4), u usporedbi s 4% ispitanika koji su primali samo peginterferon alfa-2b i ribavirin.
Other clinical experience has not identified differences in responses between the older and younger patients (see section 5.2).
Ostalo kliničko iskustvo nije pokazalo razlike u odgovoru na liječenje između starijih i mlađih bolesnika
• Store in a refrigerator until expiry.
• Čuvati u hladnjaku do isteka roka valjanosti.
C-boceprevir, approximately 79% and 9% of the dose was excreted in faeces and urine, respectively, with approximately 8% and 3% of the dosed radiocarbon eliminated as boceprevir in faeces and urine.
Nakon jednokratne peroralne doze od 800 mg C-boceprevira, oko 79% doze izluči se stolicom, a oko 9% mokraćom, dok se oko 8% primijenjenog radiougljika eliminira kao boceprevir stolicom, a oko 3% mokraćom.
The subjects were then continued on different regimens based on Treatment Week (TW) 8 response-guided therapy (Victrelis-RGT).
Ispitanici su nakon toga nastavili liječenje različitim režimima ovisno o odgovoru u 8. tjednu liječenja prema smjernicama "liječenja prema odgovoru" (Victrelis-RGT).
The treatment discontinuation rate due to anaemia was 2% (5/249) in subjects randomized to receive ribavirin dose reduction and 2% (6/251) in subjects randomized to receive erythropoietin.
Stopa prekida liječenja zbog anemije iznosila je 2% (5/249) u ispitanika randomiziranih za snižavanje doze ribavirina te 2% (6/251) u ispitanika randomiziranih za primanje eritropoetina.
938/non-Black and Cohort 2 /Black N=159) and stratified by HCV genotype (1a or 1b) and by HCVRNA viral load (≤ 400,000 IU/mL vs. > 400,000 IU/mL) to one of the following three treatment arms:
Ispitanici su podijeljeni u dvije kohorte (kohorta 1 N= 938/sve rase osim crne i kohorta 2/crnci N= 159) i stratificirani prema genotipu HCV-a (1a ili 1b) i prema virusnom opterećenju HCV-RNK (≤ 400 000 IU/ml naspram > 400 000 IU/ml) te randomizirani u omjeru 1:1:1 u jednu od sljedeće tri
Table 5 presents sustained virologic response per treatment arm in previously untreated patients who were early responders and late responders and that received similar therapy up to treatment week 28.
Tablici 5 prikazan je trajan virološki odgovor po terapijskim skupinama u bolesnika koji prethodno nisu bili liječeni s ranim ili kasnim odgovorom na liječenje koji su primali sličnu terapiju do 28. tjedna liječenja.
Lopinavir/Ritonavir* (lopinavir 400 mg / ritonavir 100 mg two times daily + Victrelis 800 mg three times daily)
Lopinavir/ritonavir* (lopinavir 400 mg/ritonavir 100 mg dvaput na dan + Victrelis 800 mg triput na dan)
Victrelis does not inhibit or induce the other enzymes
Victrelis ne inhibira niti inducira druge enzime citokroma CYP450.
Each capsule contains 56 mg of lactose monohydrate.
Pomoćna tvar s poznatim učinkom Jedna kapsula sadrži 56 mg laktoze hidrata.
Mean age of subjects randomized was 49 years.
Srednja dob randomiziranih ispitanika bila je 49 godina.
The following double amino acid substitutions conferred more than 10-fold reduced sensitivity to boceprevir: V55A+I170V, T54S+R155K, R155K+D168N, R155T+D168N and
Sljedeće dvostruke aminokiselinske supstitucije smanjile su osjetljivost na boceprevir više od 10 puta: V55A+I170V, T54S+R155K, R155K+D168N, R155T+D168N i V36M+R155K.