natgillin/translations-raw huggingface dataset:
Two months after completion of INCIVO treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control. 
Dva meseca po zaključku zdravljenja z zdravilom INCIVO so hormonski kontraceptivi spet primerni kot ena od dveh zahtevanih učinkovitih kontracepcijskih metod.
When co-administration is required, high doses of itraconazole (> 200 mg/day) or ketoconazole (> 200 mg/day) are not recommended. 
Kadar je potrebna sočasna uporaba teh zdravil, veliki odmerki itrakonazola (> 200 mg/dan) ali ketokonazola (> 200 mg/dan), niso priporočljivi.
There are no data from the use of INCIVO in pregnant women. 
Ni podatkov o uporabi zdravila INCIVO pri nosečnicah.
However, when fed via milk from telaprevir-treated dams, body weight gain of rat pups was lower than normal (likely due to taste aversion). 
Če pa so jih hranili z mlekom samic, ki so prejemale telaprevir, je bilo pridobivanje telesne mase mladičev počasnejše kot je normalno (verjetno zaradi neprijetnega okusa mleka).
If you have both hepatitis C virus infection and human immunodeficiency virus infection, and are taking efavirenz, the recommended dose regimen is 3 tablets of INCIVO every 8 hours with food. 
Če imate okužbo z virusom hepatitisa C in virusom imunske pomankljivosti pri človeku in jemljete efavirenz, je priporočljivi odmerek zdravila INCIVO 3 tablete na vsakih 8 ur, s hrano.
Replicon variants generated from patient-derived sequences showed similar results. 
Tudi variante replikonov, dobljene iz sekvenc, odvzetih od bolnikov, so dale podobne rezultate.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use INCIVO are provided with a healthcare professional educational pack containing the following: 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo zdravniki, ki bodo predpisovali ali uporabljali zdravilo INCIVO prejeli izobraževalno gradivo, ki bo vsebovalo:
What INCIVO looks like and contents of the pack Film-coated tablet. 
Izgled zdravila INCIVO in vsebina pakiranja Filmsko obložena tableta.
These may be symptoms of anaemia (decrease in your red blood cells); 
To so lahko znaki anemije (zmanjšanja števila rdečih krvnih celic).
Patients should be instructed to swallow the tablets whole (e.g. patients should not chew, break or 
Bolnike je treba poučiti, naj tablete pogoltnejo cele (ne smejo jih žvečiti, zlomiti ali raztopiti).
Do not use INCIVO in combination with any of the following medicines as they may increase the risk of severe side effects, and/or affect the way INCIVO or the other medicine works: 
Ne jemljite zdravila INCIVO skupaj z naslednjimi zdravili, ker lahko povečajo tveganje za pojav hudih neželenih učinkov in/ali vplivajo na delovanje zdravila INCIVO ali drugih zdravil:
The effect of subject gender on telaprevir pharmacokinetics was evaluated using population pharmacokinetics of data from Phase 2 and 3 studies of INCIVO. 
Vpliv spola preiskovanca na farmakokinetiko telaprevirja so ovrednotili s pomočjo podatkov populacijske farmakokinetike iz študij zdravila INCIVO faze II in III.
Other enzymes are also involved in the metabolism such as aldo-ketoreductases and other proteolytic enzymes. 
V presnovo so lahko vključeni tudi drugi encimi, kot so aldo-ketoreduktaze in drugi proteolitični encimi.
Patients Co-infected with HIV-1 
Bolniki, sočasno okuženi z virusom HIV-1
INCIVO tablets should be stored in the original bottle. 
Tablete INCIVO shranjujte v originalni plastenki.
Transfusion rates over the whole study period were 4.6% and 1.6%, respectively. 
Stopnja transfuzije je bila 4,6% in 1,6% za vsako skupino v celotnem času trajanja študij.
Tell your doctor if you have an hepatitis B infection so that your doctor can decide if INCIVO 
Povejte svojemu zdravniku, če imate okužbo z virusom hepatitisa B, da se bo lahko odločil ali je zdravilo INCIVO primerno za vas.
The SVR rate for Black patients was 62% (45/73). 
Stopnja trajnega virološkega odziva pri bolnikih iz skupine črncev je bila 62% (45/73).
In vitro studies with recombinant UGT1A3 suggested that telaprevir may inhibit this enzyme. 
In vitro študije z rekombinantnim UGT1A3 kažejo na možnost, da telaprevir zavira ta encim.
The safety and efficacy of INCIVO in children aged < 18 years have not yet been established. 
Varnost in učinkovitost zdravila INCIVO pri otrocih, starih < 18 let, še nista ugotovljeni.
In clinical trials, the majority of patients were administered antihistamines and topical corticosteroids. 
V kliničnih preskušanjih so večini bolnikov predpisali antihistaminike in lokalne kortikosteroide.
An effect of telaprevir on UDP-glucuronyltransferases cannot be ruled out and may affect the plasma concentrations of abacavir or zidovudine. 
Učinka telaprevirja na UDP-glukuroniltransferaze ne moremo izključiti in lahko vpliva na plazemske koncentracije abakavirja ali zidovudina.
However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients. 
Kljub temu pa je priporočljivo klinično spremljanje, ker bo lahko pri nekaterih bolnikih potrebna prilagoditev odmerka metadona v času vzdrževalnega zdravljenja z njim.
The total treatment duration was determined based on the patients' individual on-treatment viral response. 
Celokupen čas zdravljenja je bil določen glede na virološki odziv posameznega bolnika.
Your doctor will decide on the appropriate dose regimen for you. 
Zdravnik vam bo predpisal režim jemanja zdravila, ki je primeren za vas.
This difference is likely due to the higher genetic barrier for the V36M and R155K substitutions for genotype 1b than genotype 1a. 
Ta razlika je bila verjetno posledica večje genetske ovire substituciji V36M in R155K pri genotipu 1b kot pri genotipu 1a.
The lower limit of the 95% CI (-4.9%) was greater than the pre-determined noninferiority margin of -11% and therefore the non inferiority of T12(b.i.d. 
Vrednost spodnje meje 95% IZ (-4,9%) je bila višja od vnaprej določene meje primerljivosti, ki je bila -11%, in zato je bila dokazana primerljivost režimov T12(b.i.d.
If you are taking INCIVO twice daily (morning and evening) If you notice the missed dose within 6 hours, you must take three tablets immediately. 
Če jemljete zdravilo INCIVO dvakrat na dan (zjutraj in zvečer) Če se na pozabljeni odmerek spomnite v roku 6 ur, morate takoj zaužiti tri tablete.
Clinical relevance unknown. 
Klinični pomen ni znan.
Caution should be used and dose reduction for amlodipine should be considered. 
Potrebna je previdnost in po potrebi tudi zmanjšanje odmerka amlodipina.
Voriconazole should not be administered to patients receiving telaprevir unless an assessment of the benefit/risk ratio justifies its use. 
Vorikonazola ne smete predpisovati bolnikom, ki prejemajo telaprevir, razen če njegovo uporabo opravičuje ocena razmerja med tveganjem in koristjo.
Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified. 
O smrtnih primerih so poročali pri bolnikih z napredujočim izpuščajem in sistemskimi simptomi, ki so prejemali kombinirano terapijo z zdravilom INCIVO tudi po pojavu hude kožne reakcije.
The rash reported during INCIVO combination treatment was assessed as a typically pruritic, eczematous rash, and involved less than 30% of body surface area. 
Izpuščaj, o katerem so poročali pri kombiniranem zdravljenju z zdravilom INCIVO, so ocenili kot značilno pruritičen, ekcematozen izpuščaj, ki je zajemal manj kot 30% telesne površine.
Plasma HCV RNA values were measured using the COBAS 
Plazemske vrednosti HCV RNK so merili s pomočjo testa COBAS
Signs and symptoms of dehydration include increased thirst, dry mouth, decreased urine frequency or volume, and dark coloured urine. 
Znaki in simptomi dehidracije obsegajo povečano žejo, suha usta, zmanjšano pogostnost uriniranja ali zmanjšano količino urina in temno obarvan urin.
Electrolyte disturbances (e.g., hypokalaemia, hypomagnesaemia and hypocalcaemia) should be monitored and corrected, if necessary, prior to initiation and during INCIVO therapy. 
Motnje elektrolitov (npr. hipokaliemija, hipomagneziemija in hipokalcemija) je treba spremljati in jih po potrebi odpraviti še pred uvedbo zdravila INCIVO oziroma med zdravljenjem.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Refer to sections 4.4 and 4.6. 
Glejte poglavji 4.4 in 4.6.
In INCIVO clinical experience, less than 0.1% of patients had Stevens-Johnson Syndrome (SJS). 
V okviru kliničnih izkušenj z zdravilom INCIVO se je Stevens-Johnsonov sindrom (SJS) pojavil pri manj kot 0,1% bolnikov.
Tell your doctor if you have had other problems with your liver such as liver failure. 
Povejte zdravniku, če ste imeli kdaj kakšne druge težave z jetri, kot je jetrna odpoved.
P < 0.001, T12/PR compared to Pbo/PR48. 
P < 0,001, T12/PR za primerjavo s Pbo/PR48.
A decrease in haemoglobin levels occurs during the first 4 weeks of treatment, with lowest values reached at the end of INCIVO dosing. 
Do zmanjšanja koncentracije hemoglobina pride v prvih 4 tednih zdravljenja, najnižje vrednosti pa so dosežene ob koncu jemanja zdravila INCIVO.
T12/PR All Patients 
T12/PR Vsi bolniki
Dosing of the animals did not result in any exposure-margin when compared to human exposure. 
Odmerki pri živalih niso dosegali meje izpostavljenosti v primerjavi z ljudmi.
Drug interactions need to be carefully taken into account, see sections 4.4 and 4.5. 
Skrbno je treba upoštevati interakcije z drugimi zdravili, glejte poglavji 4.4 in 4.5.
Atazanavir/ritonavir: this combination is associated with a high frequency of hyperbilirubinaemia/icterus. 
Atazanavir/ritonavir: to kombinacijo povezujejo z veliko pogostnostjo hiperbilirubinemije/zlatenice.
Important information about some of the ingredients of INCIVO This medicinal product contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet. 
Pomembne informacije o nekaterih sestavinah zdravila INCIVO To zdravilo vsebuje 2,3 mg natrija na tableto, kar je treba upoštevati pri bolnikih na dieti z
In case of overdose you may experience nausea, headache, diarrhoea, decreased appetite, abnormal 
V primeru prevelikega odmerka se lahko pojavi slabost, glavobol, driska, zmanjšan apetit, nenormalen
atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir to treat HIV infections (HIV-protease inhibitors) 
atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir za zdravljenje okužbe s HIV (zaviralci proteaze HIV)
It is not known whether telaprevir is excreted in human breast milk. 
Ni znano, ali se telaprevir pri človeku izloča v materino mleko.
Prescribers should ensure that patients are fully informed about the risk of severe rashes, and to consult with their prescriber immediately if they develop a new rash or worsening of an existing rash. 
Zdravnik mora zagotoviti, da so bolniki natančno poučeni o tveganju za pojav hudih izpuščajev in o tem, da se morajo ob pojavu izpuščaja ali ob poslabšanju obstoječega izpuščaja takoj posvetovati s svojim zdravnikom.
If you notice the missed dose within 4 hours, you must take two tablets immediately. 
Če se na pozabljeni odmerek spomnite v roku 4 ur, morate takoj zaužiti dve tableti.
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency. 
Bolnice, ki jemljejo estrogene v okviru hormonske nadomestne terapije, je treba klinično spremljati, da ugotovite znake pomanjkanja estrogena.
CYP3A4 is partly responsible for the metabolism of telaprevir. 
izoencim CYP3A4 je delno odgovoren za presnovo telaprevirja.
Telaprevir and its major metabolite are excreted in rat milk (see section 5.3). 
Telaprevir in njegov glavni presnovek se izločata v mleko pri podganah (glejte poglavje 5.3).
Syncope and retinopathy have been reported in some patients taking INCIVO and should be considered when assessing a patient's ability to drive or operate machines. 
Pri nekaterih bolnikih, ki so jemali zdravilo INCIVO, so poročali o sinkopi in retinopatiji, kar je treba upoštevati pri oceni bolnikove sposobnosti za vožnjo in upravljanje s stroji.
Marked immunosuppressant dose reductions with or without prolongation of the dosing intervals will be required. 
Potrebno bo bistveno zmanjšanje odmerka z ali brez podaljšanje razmika med odmerki imunosupresiva.
If you or your female partner become pregnant during INCIVO treatment or the months that follow, you must contact your doctor immediately (see section 'Pregnancy precautions for men and women' below). 
Če zanosite (oziroma če zanosi vaša partnerka) med zdravljenjem z zdravilom INCIVO ali v mesecih, ki sledijo temu zdravljenju, se nemudoma obrnite na svojega zdravnika (glejte poglavje Preprečevanje nosečnosti v nadaljevanju).
Co-administration with inducers may lead to lower exposure of telaprevir with risk of lower efficacy. 
Sočasna uporaba z induktorji lahko vodi do zmanjšanja izpostavljenosti telaprevirju in nevarnosti za manjšo učinkovitost.
ANTIFUNGALS ketoconazole* itraconazole posaconazole voriconazole 
ANTIMIKOTIKI ketokonazol* itrakonazol posakonazol vorikonazol
The contribution of unchanged 
Prispevek nespremenjenega, s C
• Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other treatment components. 
• merila za oceno in zdravljenje izpuščaja in hudih kožnih reakcij, še posebno kriterije za nadaljevanje ali prekinitev zdravljenja s telaprevirjem in drugimi zdravili
Telaprevir is primarily metabolised in the liver. 
Telaprevir se presnavlja predvsem v jetrih.
The mean elimination half-life after single-dose oral administration of telaprevir 750 mg typically ranged from about 4.0 to 4.7 hours. 
Srednja vrednost razpolovne dobe izločanja po peroralnem jemanju enkratnega 750 mg odmerka telaprevirja se je značilno gibala med približno 4,0 in 4,7 ure.
Table 4: Selected laboratory abnormalities (DAIDS 
Preglednica 4: izbrane laboratorijske nenormalnosti (stopnje ≥ 2 po DAIDS
Table 6: SVR rates for patient subgroups: Study C211 T12(b.i.d. 
Preglednica 6: stopnje SVR po podskupinah bolnikov: študija C211 T12(b.i.d.
Pregnancy precautions for men and women 
Kontracepcija pri moških in ženskah
Tell your doctor if you have heart failure, irregular heartbeat, slow heart rate, an abnormality shown in your heart tracing (ECG) called 'long QT syndrome', or a family history of a heart condition called 'congenital QT syndrome'. 
Povejte svojemu zdravniku, če imate srčno popuščanje, nereden srčni utrip, počasen srčni utrip, motnjo, ki se kaže na elektrokardiogramu (EKG) in se imenuje “sindrom dolgega intervala QT” ali imate v družini srčno bolezen, imenovano “kongenitalni sindrom QT”.
The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range. 
Smer puščice (↑ = povečanje, ↓ = zmanjšanje, ↔ = ni spremembe) za vsak farmakokinetični parameter temelji na 90% intervalu zaupanja za razmerje geometrične sredine, ki je v okviru razpona 80-125% (↔), ali pod (↓) oziroma nad (↑) njim.
Table 2: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS 
Preglednica 2: INTERAKCIJE IN PRIPOROČILA ZA ODMERJANJE Z DRUGIMI ZDRAVILI Zdravila po terapevtskih področjih
In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval. 
V dveh dvojno slepih, randomiziranih in s placebom ter aktivno učinkovino nadzorovanih študijah, ki sta bili opravljeni za ovrednotenje vpliva zdravila na interval QT, monoterapija s telaprevirjem v odmerku 750 mg na vsakih 8 ur ni bila povezana s klinično pomembnimi učinki na interval QTcF.
Hormonal contraceptives may be continued but may not be reliable during INCIVO dosing and for up to two months following cessation of INCIVO (see section 4.5). 
Med jemanjem zdravila INCIVO se uporaba hormonskih kontraceptivov lahko nadaljuje, vendar le-ti morda ne bodo zanesljivi še do dva meseca po ukinitvi zdravila INCIVO (glejte poglavje 4.5).
Medicinal products 
Zdravila
The Marketing Authorisation Holder shall agree to the format and content of the healthcare professional educational pack with the National Competent Authority prior to launch in the Member State. 
Imetnik dovoljenja za promet z zdravilom se bo za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce pred dajanjem zdravila na trg dogovoril s pristojnim nacionalnim organom države
All telaprevir-resistant variants studied remained fully sensitive to interferon-alfa, ribavirin, and representative HCV nucleoside and non-nucleoside polymerase inhibitors in the replicon system. 
Vse preučevane variante, ki so bile rezistentne za telaprevir, so ostale popolnoma občutljive za interferon-alfa, ribavirin in reprezentativne nukleozidne in nenukleozidne zaviralce polimeraze HCV v sistemu replikonov.
The most marked effects are expected on oral, nasal and buccal/sublingual fentanyl formulations. 
Najbolj izražene učinke pričakujemo pri peroralnih intranazalnih in bukalnih/sublingvalnih oblikah fentanila.
(7.0-8.9 g/dl or any decrease ≥ 4.5 g/dl) 
(70-89 g/l ali kakršnokoli zmanjšanje ≥ 45 g/l)
Unless your doctor tells you to stop, continue taking INCIVO in order to ensure that your medicine continues to work against the virus. 
Če vam zdravnik ne naroči, da prenehajte jemati zdravilo INCIVO, morate nadaljevati z njegovim jemanjem, saj s tem zagotovite, da še naprej deluje proti virusom.
Your doctor may evaluate how severe your liver disease is before deciding if you can take INCIVO. 
Zdravnik bo lahko tudi ocenil jetrno bolezen, preden se bo odločil, ali smete jemati zdravilo INCIVO.
Patients experiencing mild to moderate rash should be monitored for signs of progression; however, progression was infrequent (less than 10%). 
Bolnike z blagim do zmernim izpuščajem je treba spremljati glede morebitnih znakov napredovanja izpuščaja, čeprav se je to dogajalo le redko (v manj kot 10% primerov).
• Pictures of rash according to different grades 
• slike izpuščajev različnih stopenj
Population pharmacokinetic analysis of INCIVO in HCV-infected subjects indicated that the exposure to telaprevir was similar in Blacks/African-Americans and Caucasians. 
Analiza populacijske farmakokinetike zdravila INCIVO pri preiskovancih, okuženih s HCV, je pokazala podobno izpostavljenost telaprevirju pri črncih/afroameričanih in belcih.
For additional information, see sections 4.5 and 4.6. 
Za dodatne podatke glejte poglavji 4.5 in 4.6.
T12/PR All Patients N=540 
T12/PR Vsi bolniki N = 540
When administered to lactating rats, levels of telaprevir and its major metabolite were higher in milk compared to those observed in plasma. 
Pri podganah v fazi laktacije so bile koncentracije telaprevirja in njegovega glavnega presnovka v mleku višje od koncentracij v plazmi.
In vitro studies demonstrated that telaprevir is not an inhibitor of UGT1A9 or UGT2B7. 
In vitro študije so pokazale, da telaprevir ni zaviralec encimov UGT1A9 in UGT2B7.
SVR rates for patient subgroups: Study 108 
Preglednica 8: stopnje SVR za podskupine bolnikov: študija 108 Podskupina
Such patients should be closely monitored, including ECG assessments. 
Te bolnike je treba skrbno spremljati, vključno s snemanjem EKG.
Telaprevir has not been tested for its carcinogenic potential. 
Kancerogenosti telaprevirja niso testirali.
After oral administration, the typical apparent volume of distribution (Vd) was estimated to be 252 l, with an inter-individual variability of 72.2%. 
Po peroralni uporabi je znašal njegov ocenjeni značilni navidezni porazdelitveni volumen (Vd) 252 l, variabilnost med posamezniki pa je bila 72,2%.
No studies on the effects of INCIVO on the ability to drive and use machines have been performed. 
Študij učinkov zdravila INCIVO na sposobnost vožnje in upravljanja s stroji niso izvedli.
Dose reduction for parenterally administered midazolam should be considered, especially if more than a single dose of midazolam is administered. 
Po potrebi zmanjšajte odmerek parenteralno danega midazolama, še posebej, če ste bolniku predpisali več kot en odmerek midazolama.
The pharmacokinetics of telaprevir were assessed after administration of a single dose of 750 mg to HCV-negative subjects with severe renal impairment (CrCl < 30 ml/min). 
Farmakokinetiko telaprevirja so ocenili po zaužitju enkratnega 750 mg odmerka pri za HCV negativnih preiskovancih s hudo ledvično okvaro (CrCl < 30 ml/min).
During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception. 
V tem času morajo ženske v rodni dobi uporabljati dve učinkoviti ne-hormonski kontracepcijski metodi.
Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment and afterwards as recommended in the Summary of Product Characteristics for ribavirin, and as described below. 
Bolnice v rodni dobi in njihovi partnerji pa tudi moški bolniki in njihove partnerke morajo med zdravljenjem z zdravilom INCIVO, po zaključku pa skladno z navodili v Povzetku glavnih značilnosti zdravila ribavirin in kot je opisano v nadaljevanju, uporabljati 2 učinkoviti kontracepcijski metodi.
- Heart problems 
- Srčne bolezni
Co-administration of fluticasone or budesonide and telaprevir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. 
Sočasna uporaba flutikazona ali budezonida s telaprevirjem torej ni priporočljiva, razen če njegova morebitna korist za bolnika odtehta tveganja za sistemske neželene učinke kortikosteroidov.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin, therefore, extreme care must be taken to avoid pregnancy in female patients and 
Pri vseh živalskih vrstah, ki so bile izpostavljene ribavirinu, so dokazali pomembne teratogene in/ali embriocidne učinke, zato je potrebno izredno skrbno preprečevati nosečnost pri bolnicah in tudi pri
INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors'. 
Zdravilo INCIVO vsebuje snov telaprevir in sodi v skupino zdravil, ki jih imenujemo ‘zaviralci NS3-4A proteaze'.
Telaprevir is partly metabolised in the liver by CYP3A and is a P-glycoprotein (P-gp) substrate. 
Telaprevir se delno presnavlja v jetrih z izoencimom CYP3A in je substrat P-glikoproteina (P-gp).
INCIVO has no or negligible influence on the ability to drive and use machines. 
Zdravilo INCIVO nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
In both rats and dogs, AST/ALT elevations were observed in most studies, of which the increase in ALT in rats was not normalised after recovery. 
Pri podganah in pri psih so v večini študij opazili povečanje koncentracij AST/ALT, pri čemer se koncentracije ALT pri podganah po odtegnitvi zdravila niso normalizirale.
Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1). 
Ker je zelo malo verjetno, da bodo bolniki z nezadostnim virološkim odzivom dosegli trajni virološki odziv (SVR - sustained virologic response), je priporočljivo, da bolnikom, ki imajo v 4. ali 12. tednu koncentracije HCV RNK > 1.000 i.e./ml, zdravljenje ukinete (glejte preglednico 1).
• Incidence of rash and severe cutaneous reactions 
• pojavnost izpuščaja in hudih kožnih reakcij