natgillin/translations-raw huggingface dataset:
The SVR rate was 62.5% (40/64) in subjects treated with Victrelis in combination with PR and 29.4% (10/34) in subjects treated with PR alone (see Table 6).
Stopa SVR-a iznosila je 62,5% (40/64) u ispitanika liječenih lijekom Victrelis u kombinaciji s PR-om te 29,4% (10/34) u ispitanika liječenih samo PR-om (vidjeti Tablicu 6).
The IC50 and IC90 values for boceprevir against different genotype 1b replicons ranged from 200 to 600 nM and 400 to 900 nM, respectively, in a 72-hour cell culture assay.
Vrijednosti IC50 boceprevira protiv različitih replikona genotipa 1b kretale su se u rasponu od 200 do 600 nM, a vrijednosti IC90 od 400 do 900 nM, u 72-satnom testu na kulturi stanica.
Caution should be exercised when boceprevir is combined with ketoconazole or azole antifungals (itraconazole, posaconazole, voriconazole).
Potreban je oprez kad se boceprevir kombinira s ketokonazolom ili azolnim antimikoticima (itrakonazolom, posakonazolom, vorikonazolom).
Patients receiving digoxin should be monitored appropriately.
Bolesnike koji primaju digoksin treba nadzirati na odgovarajući način.
Tachycardia*, arrhythmia, cardiovascular disorder
tahikardija*, aritmija, kardiovaskularni poremećaj
No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
Spol U ispitivanjima faze III nisu opažene farmakokinetičke razlike s obzirom na spol u odraslih bolesnika.
The subjects included 62% (104/168) genotype 1a and 38% (63/168) genotype 1b.
Među ispitanicima je njih 62% (104/168) bilo zaraženo virusom genotipa 1a, a njih 38% (63/168) virusom genotipa 1b.
The median time for all RAVs to become undetectable was 1.17 years for genotype 1a.
Medijan vremena potrebnog da svi RAV-ovi postanu nemjerljivi iznosio je 1,17 godina za genotip 1a.
Population pharmacokinetic analysis of Victrelis indicated that race had no apparent effect on exposure.
Populacijska farmakokinetička analiza lijeka Victrelis ukazala je da rasa nema vidljivog učinka na izloženost lijeku.
Sustained Virologic Response (SVR) to treatment was defined as undetectable
Trajan virološki odgovor (SVR) na liječenje definiran je kao nemjerljiva razina
Victrelis 200 mg hard capsules
Victrelis 200 mg tvrde kapsule
At Treatment Week 24
U 24. tjednu liječenja
Decreases in neutrophil counts may require dose reduction of peginterferon alfa or discontinuation of therapy.
Smanjenje broja neutrofila može zahtijevati smanjenje doze peginterferona alfa ili prekid liječenja.
Concomitant administration of Victrelis and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma.
Istodobna primjena lijeka Victrelis i kvetiapina može povisiti koncentracije kvetiapina u plazmi što može dovesti do toksičnosti povezane s kvetiapinom, uključujući komu.
It is not known whether boceprevir is excreted in human breast milk.
Nije poznato izlučuje li se boceprevir u majčino mlijeko u ljudi.
This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Istodobna primjena ovih lijekova može se razmotriti u pojedinačnim slučajevima ako se smatra neophodnom, i to u bolesnika koji imaju smanjeno virusno opterećenje HIV-om i zaraženi su sojem HIV-a koji bez ikakve sumnje nije rezistentan na režim liječenja HIV-a.
• intravenous sedatives - benzodiazepines (e.g., alprazolam, midazolam, triazolam)
• intravenski primijenjene sedative - benzodiazepine (npr. alprazolam, midazolam, triazolam)
Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Bolesnici muškog spola ili njihove partnerice moraju primjenjivati djelotvornu kontracepciju tijekom liječenja i 7 mjeseci po njegovu završetku.
IL28B rs12979860 was genotyped in 653 of 1,048 (62%) subjects in SPRINT-2 (previously untreated) and 259 of 394 (66%) subjects in RESPOND-2 (previous treatment failure) [see section 5.1 for the clinical trial descriptions].
Genotip varijante IL28B rs12979860 određen je u 653 od 1048 ispitanika (62%) u ispitivanju SPRINT-2 (prethodno nisu bili liječeni) te u 259 od 394 ispitanika (66%) u ispitivanju RESPOND-2 (prethodno liječenje bez odgovora) [vidjeti dio 5.1 za opise kliničkih ispitivanja].
The concomitant use of Victrelis with doxazosin or tamsulosin may increase plasma concentrations of these medicines.
Istodobna primjena lijeka Victrelis s doksazozinom i tamsulozinom može povećati koncentracije tih lijekova u plazmi.
The median time for all RAVs to become undetectable was 1.04 years for genotype 1b.
Medijan vremena potrebnog da svi RAV-ovi postanu nemjerljivi iznosio je 1,04 godine za genotip 1b.
The use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events including pulmonary embolism, acute myocardial infarction, cerebrovascular accident, and
Primjena lijekova koji stimuliraju eritropoezu bila je povezana s povećanim rizikom od tromboembolijskih događaja, uključujući plućnu emboliju, akutni infarkt miokarda, cerebrovaskularni incident i duboku vensku trombozu.
Croscarmellose sodium Pre-gelatinized starch Magnesium stearate
škrob, prethodno geliran magnezijev stearat
Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA (< 800,000 IU/mL vs. ≥ 800,000 IU/mL).
Ispitanici su randomizirani u omjeru 2:1 i stratificirani na temelju ciroze/fibroze i početne vrijednosti HCV-RNK (< 800 000 IU/ml naspram ≥ 800 000 IU/ml).
SVR rates with “missing=failure” approach were similar to those in the table: 69.9% (174/249) for subjects randomized to receive ribavirin dose reduction; 68.5% (172/251) for subjects randomized to receive
Stope SVR-a uz pristup "nedostaje = nije odgovorio" bile su slične onima u tablici: 69,9% (174/249) za ispitanike randomizirane za snižavanje doze ribavirina: 68,5% (172/251) za ispitanike randomizirane za primanje
The combination of boceprevir with these medicines is not recommended (see section 4.4).
Kombinacija boceprevira s tim lijekovima se ne preporučuje (vidjeti dio 4.4).
In both studies, the addition of Victrelis to the current standard of care (peginterferon alfa and ribavirin) significantly increased sustained virologic response (SVR) rates compared to the current standard of care alone.
U oba je ispitivanja dodavanje lijeka Victrelis današnjoj standardnoj terapiji (peginterferonu alfa i ribavirinu) značajno povećalo stope trajnog virološkog odgovora (SVR) u usporedbi s primjenom samo standardne terapije.
No clinical paediatric exposure data is available (see section 4.2).
Nisu dostupni klinički podaci o izloženosti pedijatrijskih bolesnika (vidjeti dio 4.2).
Co-administration of Victrelis with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure to Victrelis (see section 4.4).
Primjena lijeka Victrelis istodobno s lijekovima koji induciraju ili inhibiraju CYP3A4/5 može povećati, odnosno smanjiti izloženost lijeku Victrelis (vidjeti dio 4.4).
• antiarrhythmic medicines- amiodarone, quinidine
• lijekove protiv aritmije - amiodaron, kinidin
Please refer to the Summary of Product Characteristics for peginterferon alfa for the contraindication in patients with decompensated liver disease.
Molimo pročitajte Sažetak opisa svojstava lijeka za peginterferon alfa za kontraindikaciju u bolesnika s dekompenziranom bolešću jetre.
Follow-up analysis of boceprevir-treated subjects who did not achieve SVR showed that the population of wild-type virus increased and the majority of boceprevir-resistant variants became undetectable over time after the end of boceprevir treatment.
Naknadna analiza ispitanika liječenih boceprevirom koji nisu postigli trajan virološki odgovor (SVR) pokazala je da se po završetku liječenja boceprevirom populacija virusa divljega tipa povećala i da je većina varijanti rezistentnih na boceprevir s vremenom postala nemjerljiva.
Administer peginterferon alfa and ribavirin and finish through TW 48.
Primijenite peginterferon alfa i ribavirin i završite tijekom TL 48.
This should be discussed
Razgovarajte o tome sa svojim
Plasma concentrations of calcium channel blockers may increase when administered with Victrelis.
Koncentracije blokatora kalcijevih kanala u plazmi mogu se povisiti kad se primjenjuju s lijekom Victrelis.
Combined use with peginterferon alfa-2a see specific section in section 4.4.
Za primjenu s peginterferonom alfa-2a vidjeti odgovarajući odjeljak u dijelu 4.4.
The absolute bioavailability of Victrelis has not been studied.
Nije ispitivana apsolutna bioraspoloživost lijeka Victrelis.
Boceprevir has a mean total body clearance (CL/F) of approximately 161 l/hr.
Srednji ukupni klirens iz organizma (CL/F) boceprevira iznosi približno 161 l/hr.
The frequency of severe or life threatening infections tends to be higher in boceprevir-containing arms than the control arm.
Učestalost teških ili po život opasnih infekcija veća je u skupinama koje su primale boceprevir nego u kontrolnoj skupini.
• warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
• varfarin i druge slične lijekove pod nazivom antagonisti vitamina
Victrelis was associated with an additional decrease of approximately 1 g/dL in haemoglobin concentration (see section 4.4).
Victrelis je povezan s dodatnim sniženjem koncentracije hemoglobina od približno 1 g/dl (vidjeti dio 4.4).
No dose adjustment of Victrelis is required for patients with mild, moderate or severe hepatic impairment.
Nije potrebno prilagođavati dozu lijeka Victrelis u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije jetre.
The most frequently reported adverse reactions were fatigue, anaemia (see section 4.4), nausea,
Najčešće prijavljene nuspojave bile su umor, anemija (vidjeti dio 4.4), mučnina, glavobolja i
The mean decreases in haemoglobin values from baseline were larger in previously treated patients compared to patients who had never received prior therapy.
Srednje vrijednosti sniženja koncentracije hemoglobina u usporedbi s početnim vrijednostima bile su veće u bolesnika koji su prethodno bili liječeni u usporedbi s onima koji prethodno nisu bili liječeni.
For additional information on use of Victrelis in patients with advanced liver disease, see section 4.4.
Za dodatne informacije o primjeni lijeka Victrelis u bolesnika s uznapredovalom bolešću jetre, vidjeti dio 4.4.
Treatment with Victrelis should be initiated and monitored by a physician experienced in the
Liječenje lijekom Victrelis treba započeti i nadzirati liječnik s iskustvom u liječenju kroničnog
No human data on the effect of Victrelis on fertility are available.
Nisu dostupni podaci o učinku lijeka Victrelis na plodnost u ljudi.
Table 10 Sustained Virologic Response (SVR) rates by IL28B rs12979860 genotype
Tablica 10 Stope trajnog virološkog odgovora (SVR) prema genotipu IL28B rs12979860
There is no specific antidote for overdose with Victrelis.
Nema specifičnog protulijeka za predoziranje lijekom Victrelis.
Studies in vitro indicate that boceprevir primarily undergoes metabolism through the aldoketoreductase (AKR)-mediated pathway to ketone-reduced metabolites that are inactive against HCV.
Ispitivanja in vitro ukazuju da se boceprevir prvenstveno metabolizira putem posredovanim aldoketoreduktazom (AKR) u metabolite s reduciranim ketonima koji nisu aktivni protiv HCV-a.
• Store in a refrigerator (2C - 8C) until expiry.
Čuvati u hladnjaku (2°C - 8°C).
Use in patients having HCV genotypes other than genotype 1
Primjena u bolesnika s HCV infekcijom drugog genotipa osim genotipa 1
If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced.
Ako bolesnik ima ozbiljnu nuspojavu koja može biti povezana s peginterferonom alfa i/ili ribavirinom, treba smanjiti dozu peginterferona alfa i/ili ribavirina.
The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of combination therapy with HIV antiretroviral medicines, which also affect the pharmacokinetics of etravirine and/or boceprevir, has not been directly assessed.
Nije izravno ispitan klinički značaj smanjenja farmakokinetičkih parametara etravirina i Cmin boceprevira u uvjetima kombinirane terapije antiretrovirusnim lijekovima za liječenje HIV-a koji također utječu na farmakokinetiku etravirina i/ili boceprevira.
Ketoconazole* (ketoconazole 400 mg two times daily +
Ketokonazol* (ketokonazol 400 mg dvaput na dan +
C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4 fold greater than that of boceprevir.
C-boceprevira, u cirkulaciji je najzastupljenija bila dijastereoizomerska smjesa metabolita s reduciranim ketonima, s oko 4 puta većom srednjom izloženošću od boceprevira.
Prompt evaluation and treatment of infections is recommended.
Preporučuje se odmah procijeniti infekciju i započeti s liječenjem.
However, the combination therapy of Victrelis, peginterferon alfa and ribavirin may make you feel tired, faint, a sensation of your head spinning, changes in blood pressure, confused or difficulty seeing clearly.
Međutim, kombinirano liječenje lijekom Victrelis, peginterferonom alfa i ribavirinom može izazvati umor, nesvjesticu, osjećaj vrtnje u glavi, promjene krvnog tlaka, zbunjenost i poteškoće s vidom.
In both treatment arms, patients with cirrhosis were at a higher risk to experience Grade 3-4 thrombocytopenia compared with non
U obje su ispitivane skupine bolesnici s cirozom imali veći rizik da dobiju trombocitopeniju stupnja 3-4 u usporedbi s bolesnicima bez ciroze.
rilpivirine AUC ↑ 39% rilpivirine Cmax ↑ 15% rilpivirine Cmin ↑ 51%
rilpivirin AUC ↑ 39% rilpivirin Cmax ↑ 15% rilpivirin Cmin ↑ 51%
In a genotype 1a replicon, the IC50 and IC90 values for boceprevir were 900 nM and 1,400 nM, respectively.
U jednom replikonu genotipa 1a, vrijednost IC50 boceprevira iznosila je 900 nM, a vrijednost IC90 1400 nM.
Effects of food on oral absorption
Učinci hrane na apsorpciju nakon peroralne primjene
Due to the combined treatment with peginterferon alfa and ribavirin, extreme care must be taken to avoid pregnancy in female patients or in female partners of male patients.
Zbog kombiniranog liječenja peginterferonom alfa i ribavirinom neophodan je izniman oprez kako bi se izbjegla trudnoća u bolesnica ili partnerica bolesnika.
Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Victrelis se u kombinaciji s peginterferonom alfa i ribavirinom koristi za liječenje kronične infekcije virusom hepatitisa C u odraslih osoba (naziva se i HCV infekcija).
Of 314 treatment-naïve and previously treated subjects who did not achieve SVR from Phase 2/3 studies (P03523, P03659, P05216, and P05101) in whom boceprevir-resistant variants had emerged during treatment, 73% (228/314) of subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing within 3 years post-therapy.
Među 314 ispitanika (od kojih su neki prethodno primili liječenje, a neki ne) iz ispitivanja faze II/III (P03523, P03659, P05216 i P05101) koji nisu postigli SVR i u kojih su se tijekom liječenja pojavile varijante rezistentne na boceprevir, u njih 73% (228/314) sekvenciranjem populacije unutar 3 godine nakon liječenja više nisu otkriveni RAV-ovi na lokusima povezanima s rezistencijom na boceprevir.
Heart or circulation: heart attack; stopping breathing; blood clot in the leg or arm; decreased blood flow to parts of the brain (e.g., dizziness, double vision, or weakness on both sides of the
Krv ili cirkulacija: srčani udar; prestanak disanja, krvni ugrušak u nozi ili ruci, smanjen dotok krvi u dijelove mozga (npr. omaglica, dvostruke slike ili slabost na obje strane tijela)
Shellac Red iron oxide (E172)
šelak željezov oksid, crveni (E172)
Victrelis 400 mg single dose)
Victrelis pojedinačna doza od 400 mg)
If there is no such value, the FW 12 value was carried forward.
Ako takva vrijednost ne postoji, i dalje se uzima vrijednost iz 12. tjedna praćenja.
In repeat-dose toxicity studies boceprevir showed testicular degeneration in rats at systemic exposures lower than those in humans at the recommended human therapeutic dose.
Istraživanja toksičnosti ponovljenih doza boceprevira pokazala su degeneraciju testisa u štakora pri sistemskoj izloženosti nižoj od izloženosti u ljudi pri preporučenim terapijskim dozama.
Each hard capsule contains 200 mg boceprevir.
Jedna tvrda kapsula sadrži 200 mg boceprevira.
Chest: being short of breath when lying flat; serious lung infection like pneumonia; sharp chest pains which are worse when breathing; pain behind breast bone which can spread to neck and
Prsni koš: nedostatak zraka pri ležanju na ravnom; teška infekcija pluća poput upale pluća; oštra bol u prsnom košu koja se pogoršava pri disanju; bol iza prsne kosti koja se može širiti u
Caution should be exercised in patients taking drospirenone-containing medicines with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics.
Potreban je oprez u bolesnika koji uzimaju lijekove koji sadrže drospirenon i imaju tegobe zbog kojih postoji predispozicija za razvoj hiperkalijemije kao i u bolesnika koji uzimaju diuretike koji štede kalij.
Victrelis contains lactose
Victrelis sadrži laktozu
Combination therapy of Victrelis, peginterferon alfa and ribavirin may influence some patients' ability to drive and use machines.
Liječenje kombinacijom lijeka Victrelis, peginterferona alfa i ribavirina može u nekih bolesnika utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
• have low blood potassium (hypokalaemia)
• ako imate nisku razinu kalija u krvi (hipokalijemiju).
Victrelis 200 mg hard capsules boceprevir
Victrelis 200 mg tvrde kapsule boceprevir
• CYP3A4 inducer medicines (such as antibiotic medicine - rifampicin, and anticonvulsant medicines - carbamazepine, phenobarbital, phenytoin)
• lijekove koji su induktori enzima CYP3A4 (kao što su antibiotici - rifampicin i lijekovi protiv napadaja - karbamazepin, fenobarbital, fenitoin)
All patients in this treatment arm were limited to 32 weeks of Victrelis.
Svim bolesnicima u ovoj terapijskoj skupini liječenje lijekom Victrelis bilo je ograničeno na 32 tjedna.
† Rates for patients who are previously untreated
Bolesnici koji prethodno nisu bili liječeni
HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current
Bolesnici istodobno zaraženi HBV-om/HCV-om izloženi su riziku od reaktivacije HBV-a te ih stoga treba pratiti i liječiti sukladno važećim kliničkim smjernicama.
The TW 4 response was a stronger predictor of SVR compared to response to previous treatment and allowed the determination of the subject's on-treatment interferon
Odgovor u 4. tjednu liječenja bio je jači pretkazatelj SVR nego odgovor na prethodno liječenje i omogućavao je određivanje odgovora ispitanika na interferon tijekom liječenja.
drospirenone AUC ↑ 99% drospirenone Cmax ↑ 57%
drospirenon AUC ↑ 99% drospirenon Cmax ↑ 57%
Population pharmacokinetic analysis of Victrelis indicated that age had no apparent effect on exposure.
Populacijska farmakokinetička analiza lijeka Victrelis ukazala je da dob nema vidljivog učinka na izloženost lijeku.
The race distribution of subjects was as follows: 77% White, 19% Black, and 4% others.
Raspodjela ispitanika po rasama bila je kako slijedi: 77% bijelaca, 19% crnaca i 4% ostalih.
The ovulation suppression activity of oral contraceptives containing lower doses of norethindrone/ethinyl estradiol and of other forms of hormonal contraception during coadministration with Victrelis has not been established.
Nije utvrđeno djelovanje oralnih kontraceptiva koji sadrže niže doze noretindrona/etinilestradiola i drugih oblika hormonske kontracepcije na supresiju ovulacije tijekom istodobne primjene s lijekom Victrelis.
Patients receiving prednisone and Victrelis should be monitored appropriately.
Bolesnike koji primaju prednizon i Victrelis treba nadzirati na odgovarajući način.
• Peginterferon alfa-2b + ribavirin for 48 weeks (PR48).
• Peginterferon alfa-2b + ribavirin tijekom 48 tjedana (PR48).
If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine
Ako bolesnik ima potvrđenu mjerljivu HCV-RNK u TL 24; tada prekinite trojnu terapiju.
Pack sizes: carton of 84 hard capsules and multipack containing 336 (4 packs of 84) hard capsules.
Veličine pakiranja: kutija s 84 tvrde kapsule i višestruko pakiranje koje sadrži 336 tvrdih kapsula
Seven percent of subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin had neutrophil counts of < 0.5 x 10
Sedam posto ispitanika koji su primali kombinaciju lijeka Victrelis s peginterferonom alfa-2b i ribavirinom imalo je < 0,5 x 10
The antiviral activity of boceprevir was evaluated in a biochemical assay for slow binding inhibitors of NS3 protease and in the genotype 1a and 1b HCV replicon system.
Protuvirusno djelovanje boceprevira ocijenjeno je biokemijskim testom za sporovezujuće inhibitore NS3 proteaze kao i sustavom replikona HCV-a genotipa 1a i 1b.
Neuropathy peripheral*, cognitive disorder, hyperaesthesia, lethargy, loss of consciousness, mental impairment, neuralgia, presyncope
periferna neuropatija*, kognitivni poremećaj, hiperestezija, letargija, gubitak svijesti, mentalni poremećaj, neuralgija,
Subjects randomized to receive erythropoietin (N=251)
Ispitanici randomizirani da primaju eritropoetin (N=251)
SVR rates with “missing=failure” approach were 17/80 [21.3%] for PR48, 94/162 [58.0%] for Victrelis-RGT,
Stope SVR-a uz pristup "nedostaje = nije odgovorio" bile su 17/80 [21,3%] za PR48, 94/162 [58,0%] za Victrelis-RGT, 106/161 [65,8%] za
Boceprevir is an inhibitor of the HCV NS3 protease.
Boceprevir je inhibitor NS3 proteaze virusa hepatitisa C (HCV).
If the patient has hepatitis C virus ribonucleic acid (HCV-RNA) results greater than or equal to 1,000 IU/mL at TW 8; then discontinue three-medicine regimen.
Ako bolesnik ima nalaz ribonukleinske kiseline virusa hepatitisa C (HCV-RNK) veći ili jednak 1000 IU/ml u TL 8; tada prekinite trojnu terapiju.
If other HCV-RNA values were available after FW 24, the last available value in the period after FW 24 was used.
Ako su nakon 24. tjedna praćenja bile dostupne i druge vrijednosti HCV-RNK, korištena je posljednja dostupna vrijednost nakon 24. tjedna praćenja.
Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro.
Pokazalo se da je boceprevir in vitro supstrat za p-glikoprotein (P-gp) i protein koji uzrokuje rezistenciju raka dojke na lijekove (engl.
Victrelis 800 mg three times daily)
Victrelis 800 mg triput na dan)
Whether on treatment early viral response and/or IL28B genotype could reliably identify those patients who are unlikely to retrieve significant benefit of boceprevir (higher SVR rates or short course treatment duration) on top of the bitherapy is currently under investigation.
Još se ispituje mogu li se na temelju ranog virološkog odgovora i/ili genotipa IL28B pouzdano otkriti oni bolesnici koji vjerojatno neće imati značajne koristi od dodavanja boceprevira dvojnoj terapiji (više stope SVR ili kraće trajanje liječenja).
Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Boceprevir u kombinaciji s peginterferonom alfa i ribavirinom procijenjen je u ukupno 98 bolesnika (64 ih je primalo boceprevir) koji su istodobno bili zaraženi virusom humane imunodeficijencije (HIV) i HCV-om genotipa 1 i koji prethodno nisu bili liječeni zbog kronične HCV infekcije (vidjeti dijelove 4.8 i 5.1).