natgillin/translations-raw huggingface dataset:
Similarly for patients with cirrhosis or transition to cirrhosis, the frequencies of withdrawal from Pegasys treatment and ribavirin treatment were higher in the 72-week treatment arms (13% and 15%) than in the 48-week arms (6% and 6%).
Podobno je bila pri bolnikih s cirozo ali prehodu v cirozo prekinitev zdravljenja z zdravilom Pegasys in ribavirinom pogostejša v skupini, ki se je zdravila 72 tednov (13% zaradi neželenih učinkov in 15% zaradi laboratorijskih nenormalnosti), kot v skupini, ki se je zdravila 48 tednov (6% zaradi neželenih učinkov in 6% zaradi laboratorijskih nenormalnosti).
Patients who withdrew from previous therapy with pegylated interferon alfa-2b/ ribavirin because of hematological toxicity were excluded from enrolling in this trial.
Bolniki, ki so prejšnje zdravljenje s pegiliranim interferonom alfa- 2b/ ribavirinom prekinili zaradi hematoloških toksičnosti niso bili vključeni v to preskušanje.
In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000/ mm3 were treated for 48 weeks.
V drugem kliničnem preskušanju so neodzivne bolnike z napredovalo fibrozo ali cirozo (stopnja 3 do 6 po Ishaku) in izhodiščno koncentracijo trombocitov tudi tako nizko kot je 50. 000/ mm3 zdravili 48 tednov.
Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anemia (26% of patients experienced a hemoglobin level of < 10 g/ dL), neutropenia (30% experienced an ANC < 750/ mm3), and thrombocytopenia (13% experienced a platelet count < 50,000/ mm3) (see section 4.4).
Hematološke laboratorijske nenormalnosti, ki so jih opazili prvih 20 tednov preskušanja so vključevale anemijo (26% bolnikov je imelo hemoglobin < 10 g/ dl), nevtropenijo (30% je imelo ANC < 750/ mm3) in trombocitopenijo (13% je imelo število trombocitov < 50. 000/ mm3) (glejte poglavje 4. 4).
In HIV-HCV co-infected patients, the clinical adverse event profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients For HIV- HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/ lactic acidosis, influenza, pneumonia, affect lability, apathy, tinnitus, pharyngolaryngeal pain, cheilitis, acquired lipodystrophy and chromaturia.
Pri bolnikih, ki so okuženi s HIV in HCV in prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali tudi o drugih neželenih učinkih pri ≥ 1% do ≤ 2% bolnikov: hiperlaktacidemija/ laktacidoza, gripa, pljučnica, čustvena labilnost, apatičnost, tinitus, bolečina v žrelu in grlu, heilitis, pridobljena lipodistrofija in kromaturija.
Pegasys treatment was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Zdravljenje z zdravilom Pegasys je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih zdravljenja, odstotek celic
Limited safety data (N= 51) are available in co- infected patients with CD4+ cell counts < 200/ µl.
Podatki o varnosti pri bolnikih okuženih z obema virusoma in s številom celic CD4+ manjšim od 200/ μl so omejeni (n = 51).
Table 4 summarises the undesirable effects reported with Pegasys monotherapy in CHB or CHC patients and with Pegasys in combination with ribavirin in CHC patients.
Preglednica 4 povzema neželene učinke, o katerih so poročali pri samostojnem zdravljenju z zdravilom Pegasys pri bolnikih s kroničnim hepatitisom B ali C ter pri bolnikih s kroničnim hepatitisom C, ki so prejemali zdravilo Pegasys v kombinaciji z ribavirinom.
Undesirable Effects Reported with Pegasys Monotherapy for HBV or HCV or In Combination with Ribavirin for HCV Patients Body system
Organski sistem Zelo pogosti
Very Common ≥ 1/ 10
Pogosti
Common ≥ 1/ 100 to < 1/ 10
Zelo redki
Uncommon ≥ 1/ 1000 to < 1/ 100
≥ 1/ 100 do < 1/ 10 ≥ 1/ 1. 000 do < 1/ 100
Rare ≥ 1/ 10,000 to < 1/ 1000
≥ 1/ 10. 000 do < 1/ 1. 000
Very rare < 1/ 10,000
< 1/ 10. 000
Upper respiratory infection, bronchitis, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
okužba zgornjih pljučnica, dihal, bronhitis, okužba kože kandidaza v ustih, herpes simpleks, glivične, virusne in bakterijske okužbe
Pneumonia, skin infection
endokarditis, vnetje zunanjega ušesa
Endocarditis, otitis externa
Benigne in maligne neoplazme
Neoplasms benign and malignant
maligne jetrne novotvorbe
Thrombocytopenia, anaemia, lymphadenopathy
trombocitopenija, anemija, limfadenopatija
Aplastic anemia
aplastična anemija
Sarcoidosis, thyroiditis
sarkoidoza, tiroiditis
Anaphylaxis, systemic lupus erythematosus, rheumatoid arthritis
anafilaksa, sistemski eritematozni lupus, revmatoidni artritis
Idiopathic or thrombotic thrombocytopenic purpura
idiopatična ali trombotična trombocitopenična purpura
Diabetic ketoacidosis
Psihiatrične motnje
13 Body system Metabolism and Nutrition Disorders
samomor, psihotične motnje
Very Common ≥ 1/ 10 Anorexia
Zelo pogosti ≥ 1/ 10
Common ≥ 1/ 100 to < 1/ 10
Pogosti ≥ 1/ 100 do < 1/ 10
Uncommon ≥ 1/ 1000 to < 1/ 100 Dehydration
Občasni ≥ 1/ 1. 000 do < 1/ 100
Very rare < 1/ 10,000
Zelo redki < 1/ 10. 000
Psychiatric disorders
Očesne bolezni
Depression*, anxiety, insomnia*
zamegljen vid, bolečina v očesu, vnetje očesa, kseroftalmija
Emotional disorders, mood alteration Aggression, nervousness, libido decreased
očesna nevropatija, edem papile, okvara žil mrežnice, retinopatija, razjeda na roženici
Suicidal ideation, hallucinations
Ušesne bolezni, vključno z motnjami labirinta
Suicide, psychotic disorder
vrtoglavica, bolečina v ušesu
Nervous system disorders
Srčne bolezni
Headache, dizziness*, concentration impaired
tahikardija, palpitacije, periferni edem
Memory impairment, syncope, weakness, migraine, hypoaesthesia, hyperaesthesia, paraesthesia, tremor, taste disturbance, nightmares, somnolence
miokardni infarkt, kongestivno srčno popuščanje, angina pektoris, supraventrikularna tahikardija,
Peripheral neuropathy
aritmija, fibrilacija atrijev, perikarditis, kardiomiopatija
Coma, convulsions,, facial palsy
Žilne bolezni
Eye disorders
rdečica
Vision blurred, eye pain, eye inflammation, xerophthalmia
hipertenzija
Retinal hemorrhage
krvavitve v možganih, vaskulitis
Optic neuropathy, papilledema, retinal vascular disorder, retinopathy, corneal ulcer
Bolezni dihal, prsnega koša in mediastinalnega prostora
Vision loss,
dispneja, kašelj
Ear and labyrinth disorders
dispneja po naporu, epistaksa, nazofaringitis, zamašitev sinusov, zamašitev nosu, rinitis, vneto grlo
Vertigo, earache
težko dihanje
Hearing loss
intersticijski pnevmonitis, vključno s smrtnim izidom, pljučna embolija
Tachycardia, palpitations, oedema peripheral
driska *, navzea *, bolečina v trebuhu *
Myocardial infarction, congestive heart failure, angina, supraventricular tachycardia, arrhythmia, atrial fibrillation, pericarditis, cardiomyopathy
bruhanje, dispepsija, disfagija, razjeda v ustih, krvavitev dlesni, glositis, stomatitis, flatulenca suha usta
Vascular disorders
krvavitev v prebavilih
Flushing
želodčni čir, pankreatitis
Hypertension
motnja jetrnega delovanja
Cerebral haemorrhage, vasculitis
jetrna odpoved, holangitis, zamaščenost jeter
Dyspnoea, cough
alopecija, dermatitis, pruritus, suha koža
Dyspnoea exertional, epistaxis, nasopharyngitis, sinus congestion, nasal congestion, rhinitis, sore throat
kožni izpuščaj, povečano znojenje, psoriaza, urtikarija, ekcem, motnje na koži, fotosenzitivnostna reakcija, nočno znojenje
Wheezing
Pogosti
Interstitial pneumonitis including fatal outcome, pulmonary embolism
Občasni
14 Body system
Redki
Very Common ≥ 1/ 10
Zelo redki
Common ≥ 1/ 100 to < 1/ 10
≥ 1/ 10
Gastrointestinal disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Diarrhoea*, nausea*, abdominal pain*
mialgija, artralgija
Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
bolečina v hrbtu, artritis, mišična oslabelost, bolečina v kosteh, bolečina v vratu, mišičnoskeletna bolečina, mišični krči
Gastrointestinal bleeding
miozitis
Peptic ulcer, pancreatitis
Bolezni sečil
Hepato-biliary disorders
ledvična insuficienca
Hepatic dysfunction
Motnje reprodukcije in dojk
Hepatic failure, cholangitis, fatty liver
impotenca
Alopecia, dermatitis, pruritis, dry skin
pireksija, rigorji *,
Musculoskeletal Myalgia, connective tissue arthralgia and bone disorders
bolečina v prsih, bolezen podobna
Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskeletal pain, muscle cramps
mestu aplikacije bolečina *, astenija, utrujenost, reakcija na mestu injiciranja *, razdražljivost *
Renal and urinary disorders Reproductive system and breast disorders
influenci, občutek neugodja, letargija, vročinski valovi, žeja
Impotence
Preiskave
Renal insufficiency
zmanjšanje telesne mase
Chest pain, influenza like illness, malaise, lethargy, hot flushes, thirst
Poškodbe in zastrupitve in zapleti pri posegih
Investigations Injury and poisoning
preveliko odmerjanje učinkovine
*These adverse reactions were common (≥ 1/ 100 to < 1/ 10) in CHB patients treated with Pegasys monotherapy
* Ti neželeni učinki so bili pogosti (≥ 1/ 100 do < 1/ 10) pri bolnikih, ki so imeli kronični hepatitis B in so bili zdravljeni le z zdravilom Pegasys.
Post marketing adverse events
Neželeni dogodki po prihodu zdravila na trg
Cerebral ischemia: frequency unknown.
Bolezni živčevja Cerebralna ishemija: pogostnost ni znana.
Serous retinal detachment: frequency unknown.
Očesne bolezni Serozni odstop mrežnice: pogostnost ni znana.
As with other alpha interferons, serous retinal detachment has been reported with Pegasys.
Kot pri zdravljenju z drugimi interferoni alfa, so tudi pri zdravljenju z zdravilom Pegasys poročali o seroznem odstopu mrežnice.
Rhabdomyolysis: frequency unknown.
Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza: pogostnost ni znana.
ALT increase, bilirubin increase, electrolyte disturbance (hypokalaemia, hypocalcaemia, hypophosphataemia), hyperglycaemia, hypoglycaemia and elevated triglycerides (see section 4.4.).
Laboratorijske vrednosti Zdravljenje z zdravilom Pegasys je bilo povezano s patološkimi laboratorijskimi vrednostmi: zvišane koncentracije ALT, zvišan bilirubin, motnje elektrolitov (hipokaliemija, hipokalciemija, hipofosfatemija), hiperglikemija, hipoglikemija in zvišani trigliceridi (glejte poglavje 4. 4).
With both Pegasys monotherapy, and also the combined treatment with ribavirin, up to 2% of patients experienced increased ALT levels that led to dose modification or discontinuation of the treatment.
Pri samostojnem in kombiniranem zdravljenju zdravila Pegasys z ribavirinom so se pri do 2% bolnikov pojavile zvišane koncentracije ALT, zaradi katerih so odmerek spremenili ali pa so zdravljenje prekinili.
Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
Pri zdravljenju z zdravilom Pegasys se je pojavilo zmanjšanje hematoloških vrednosti (levkopenija, nevtropenija, limfopenija, trombocitopenija in hemoglobin), ki se je v večini primerov popravilo s
Moderate (ANC:
Zmerna nevtropenija (absolutno število nevtrofilcev:
0.749 - 0.5 x 109/ l) and severe (ANC: < 0.5 x 109/ l) neutropenia was observed respectively in 24% (216/ 887) and 5% (41/ 887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/ 1200 milligrams for 48 weeks.
0, 749 do 0, 5 x 109/ l) se je pojavila pri 24% bolnikov (216/ 887), huda nevtropenija (absolutno število nevtrofilcev: < 0, 5 x 109/ l) pa pri 5% (41/ 887) bolnikov, ki so prejemali zdravilo Pegasys v odmerku 180 mikrogramov in ribavirin v odmerku 1. 000/ 1. 200 miligramov 48 tednov.
Anti-interferon antibodies 1-5% of patients treated with Pegasys developed neutralising anti-interferon antibodies.
Protitelesa proti interferonu Pri 1 do 5% bolnikov, ki so se zdravili z zdravilom Pegasys, so se pojavila nevtralizirajoča protitelesa proti interferonu.
As with other interferons, a higher incidence of neutralising antibodies was seen in chronic hepatitis B.
Kot pri drugih interferonih so pri kroničnem hepatitisu B opazili višjo incidenco nevtralizirajočih protiteles.
Thyroid function Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
Delovanje ščitnice Pri zdravljenju z zdravilom Pegasys so laboratorijske preiskave pokazale klinično značilne bolezenske spremembe ščitnice, ki so zahtevale klinično intervencijo (glejte poglavje 4. 4).
The frequencies observed (4.9%) in patients receiving Pegasys/ ribavirin (NV15801) are similar to those observed with other interferons.
Pogostnost pri bolnikih, ki so prejemali zdravilo Pegasys in ribavirin (NV15801), je bila podobna kot pri zdravljenjih z drugimi interferoni (4, 9%).
Laboratory values for HIV-HCV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Laboratorijske vrednosti za bolnike sočasno okužene s HIV in HCV Čeprav so se hematološke toksičnosti nevtropenija, trombocitopenija in anemija pri bolnikih okuženih s HIV in HCV pojavile pogosteje, so večino lahko uravnali s spremembo odmerka in uporabo rastnih dejavnikov, predčasna prekinitev zdravljenja je bila potrebna zelo redko.
Decrease in ANC levels below 500 cells/ mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/ mm3 so opazili pri 13% bolnikih, ki so jemali zdravilo Pegasys samostojno in pri 11% bolnikov, ki so jemali zdravilo Pegasys v kombinaciji.
Decrease in platelets below 50,000/ mm3 was observed in 10% and 8% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Zmanjšanje števila trombocitov pod 50. 000/ mm3 so opazili pri 10% bolnikov, ki so jemali zdravilo Pegasys samostojno in pri 8% bolnikov, ki so prejemali kombinirano zdravljenje.
Anaemia (haemoglobin < 10g/ dL) was reported in 7% and 14% of patients treated with Pegasys monotherapy or in combination therapy, respectively.
O anemiji (hemoglobin < 10 g/ dl) so poročali pri 7% bolnikov, ki so se zdravili le z zdravilom Pegasys in pri 14% bolnikov, ki so prejemali kombinirano zdravljenje.
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for1 week (ie, 1260 micrograms/ week) have been reported.
Poročali so o prevelikih odmerjanjih, ki so se pojavila med dvema injekcijama v zaporednih dnevih (namesto tedenskega intervala) in pri dnevnih injekcijah do 1 tedna (to je 1260 mikrogramov na teden).
Immunostimulating Agent/ Cytokine, ATC code:
Farmakoterapevtska skupina: citokini in imunomodulatorji, oznaka ATC:
The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
S konjugacijo reagenta PEG (bis- monometoksipolietilenglikol) z interferonom alfa- 2a dobimo pegiliran interferon alfa- 2a (zdravilo Pegasys).
Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.
Zdravilo Pegasys ima enake protivirusne in protiproliferativne značilnosti in vitro kot interferon alfa- 2a.
16 Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/ mole of protein. The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000.
Povprečna molekulska masa je približno 60. 000, od tega predstavlja beljakovinski del približno 20. 000.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
17 Pri odzivnih bolnikih s hepatitisom C, ki so prejeli zdravljenje s 180 mikrogrami zdravila Pegasys, se koncentracije HCV RNA zmanjšajo v dveh fazah.
Ribavirin had no significant effect on the initial viral kinetics over the first 4 to 6 weeks in patients treated with the combination of ribavirin and pegylated interferon alfa-2a or interferon alfa.
Ribavirin pri bolnikih, ki prejemajo kombinacijo ribavirina in pegiliranega interferona alfa- 2a ali interferona alfa, na začetno kinetiko virusa med prvimi 4 do 6 tedni značilno ne vpliva.
Clinical trial results All clinical trials recruited patients with chronic hepatitis B who had active viral replication measured by HBV DNA, elevated levels of ALT and a liver biopsy consistent with chronic hepatitis.
Podatki kliničnih preskušanj Vsi bolniki s kroničnim hepatitisom B, ki so bili vključeni v klinična preskušanja, so imeli aktivno virusno replikacijo izmerjeno s HBV DNA, zvišane vrednosti ALT in jetrno biopsijo v skladu s kroničnim hepatitisom.
Study WV16240 recruited patients who were positive for HBeAg, while study WV16241 recruited patients who were negative for HBeAg and positive for anti-HBe.
V študijo WV16240 so bili vključeni bolniki, ki so bili HBeAg pozitivni, v študijo WV16241 pa so bili vključeni HBeAg negativni in anti- HBe pozitivni bolniki.
In both studies the treatment duration was 48 weeks, with 24 weeks of treatment-free follow-up.
V obeh študijah je zdravljenje potekalo 48 tednov, ki jim je sledilo 24- tedensko obdobje sledenja bolnikom brez jemanja zdravil.
Response rates at the end of follow-up for the two studies are presented in Table 5.
Deleži odzivov po koncu obdobja sledenja bolnikom za ti dve študiji so predstavljeni v preglednici 5.
In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ ml.
V študiji WV16240 sta bila primarna cilja raziskave HBeAg serokonverzija in število HBV DNA pod 105 kopij/ ml.
In study WV16241, the primary efficacy endpoints were ALT normalisation and HBV-DNA below 2 x 104 copies/ ml.
V študiji WV16241 sta bila primarna cilja raziskave normalizacija ALT in število HBV DNA pod 2 x 104 kopij/ ml.
HBV-DNA was measured by the COBAS AMPLICOR™ HBV MONITOR Assay (limit of detection 200 copies/ ml).
HBV DNA so merili s testom COBAS AMPLICOR HBV MONITOR (meja detekcije 200 kopij/ ml).
A total of 283/ 1351 (21%) of patients had advanced fibrosis or cirrhosis, 85/ 1351 (6%) had cirrhosis.
Skupno 283 od 1351 bolnikov (21%) je imelo napredovalo fibrozo ali cirozo, 85 od 1351 bolnikov (6%) pa je imelo cirozo.
Table 5:
Preglednica 5.
Serological, Virological and Biochemical Responses in Chronic Hepatitis B
Serološki, virološki in biokemični odzivi pri kroničnem hepatitisu B.
HBeAg negative / anti-HBe positive Study WV16241
HBeAg negativni / anti- HBe pozitivni študija WV16241
Pegasys 180 mcg & Placebo
Pegasys 180 μg
Pegasys 180 mcg & Lamivudine 100 mg
Pegasys 180 μg
Pegasys 180 mcg & Placebo
Pegasys Pegasys lamivudin 180 μg 180 μg 100 mg
Pegasys 180 mcg & Lamivudine 100 mg
in placebo
Lamivudine 100 mg
in lamivudin 100 mg
(N=271)
(n = 272)
(N=271)
in in placebo lamivudin 100 mg (n = 181)
(N=272)
(n = 271) (n = 271) 32% #
(N=177)
(n
(N=179)
= 177)
(N=181)
(n = 179)
HBeAg Sero- conversion
HBeAg sero - konverzija
HBsAg Sero- conversion
3% # HBsAg sero - konverzija
0%
0% 3%
* For HBeAg-positive patients:
* za HBeAg- pozitivne bolnike:
HBV DNA < 105 copies/ ml For HBeAg-negative / anti-HBe-positive patients:
HBV DNA < 105 kopij/ ml za HBeAg- negativne / anti- HBe- pozitivne bolnike:
HBV DNA < 2 x 104 copies/ ml
HBV DNA < 2 x 104 kopij/ ml # p- vrednost (v primerjavi z lamivudinom) < 0. 01 (stratificiran Cochran- Mantel- Haenszel test)
# p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
Histološki odziv je bil v vseh treh zdravljenih skupinah podoben v vseh študijah.
17 Histological response was similar across the three treatment groups in each study; however, patients showing a sustained response 24 weeks after the end of treatment were significantly more likely to also show histological improvement.
Histološko izboljšanje pa se je značilno pojavilo z večjo verjetnostjo pri bolnikih, ki so po 24 tednih po zaključku zdravljenja pokazali trajen odziv.
All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866).
18 Vsi bolniki, ki so zaključili fazo III študij, so bili primerni za vključitev v dolgotrajno študijo sledenja (WV16866).
Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/ 153).
Med bolniki iz študije WV16240, ki so prejemali le zdravilo Pegasys in so bili vključeni v dolgotrajno študijo sledenja, je delež trajne HBeAg serokonverzije 12 mesecev po zaključku zdravljenja znašal 48% (73/ 153).
In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/ 97) and 59% (58/ 99), respectively.
Pri bolnikih, ki so v študiji WV16241 prejemali le zdravilo Pegasys, je 12 mesecev po koncu zdravljenja delež HBV DNA odziva znašal 42% (41/ 97), normalizacija ALT pa 59% (58/ 99).
Predictability of response Please refer to section 4.2, in Table 2.
Predvidljivost odziva Prosimo, glejte poglavje 4. 2, preglednica 2.
Dose-response in monotherapy In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
V raziskavi bolnikov brez ciroze so bili rezultati podobni pri obeh odmerkih, tako pri 135 mikrogramskem kot pri 180 mikrogramskem odmerku.
Confirmatory clinical trials in treatment-naïve patients All clinical trials recruited interferon-naïve patients with chronic hepatitis C confirmed by detectable levels of serum HCV RNA, elevated levels of ALT (with the exception of study NR16071) and a liver biopsy consistent with chronic hepatitis.
Potrdilna klinična preskušanja pri bolnikih, ki se še niso zdravili Vsa klinična preskušanja so vključevala bolnike, ki se še niso zdravili z interferoni in so imeli kronični hepatitis C potrjen z merljivimi koncentracijami serumske HCV RNA, zvišane koncentracije ALT (z izjemo študije NR16071) in biopsijo jeter, ki ustreza kroničnemu hepatitisu.
Study NV15495 specifically recruited patients with a histological diagnosis of cirrhosis (about 80%) or transition to cirrhosis (about 20%).
Študija NV15495 je specifično vključevala bolnike s histološko diagnozo ciroze (okoli 80%) ali prehoda v cirozo (okoli 20%).
Only HIV-HCV co-infected patients were included in the study NR15961 (see Table 14).
V študijo NR15961 so bili vključeni le bolniki, okuženi s HIV in HCV (glejte preglednico 14).
These patients had stable HIV disease and mean CD4 T-cell count was about 500 cells/ µL.
Ti bolniki so imeli stabilno bolezen HIV, srednje število celic CD4+ pa je bilo približno 500 celic/ μl.
For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 6, 7, 8 and Table 14, respectively.
Sheme zdravljenja, trajanje zdravljenja in ugotovitve študij za bolnike, ki so okuženi le s HCV in za bolnike, ki so sočasno okuženi s HIV in HCV najdete v preglednicah 6, 7, 8 in 14.
Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR™ HCV Test, version 2.0 (limit of detection 100 copies/ ml equivalent to 50 International Units/ ml) and sustained response as one negative sample approximately 6 months after end of therapy.
Trajni odziv pa je bil definiran kot en negativni vzorec približno 6 mesecev po končanem zdravljenju.
18 Table 6:
Preglednica 6.
Virological Response in HCV Patients
Virološki odziv pri bolnikih s HCV.
Pegasys Monotherapy
Samostojno zdravljenje z zdravilom Pegasys
Pegasys Combination Therapy
Kombinirano zdravljenje z zdravilom Pegasys