natgillin/translations-raw huggingface dataset:
13 of 186 [7%]); WHO grade 3 leukopenia was also reported in 7% of this treatment group.
13 od 186 [7%]) med bolniki, zdravljenimi z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b; pri 7% bolnikov iz te terapevtske skupine so poročali tudi o levkopeniji 3. stopnje po WHO (SZO).
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Pri nekaterih bolnikih, ki so bili zdravljeni z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b v kliničnih preskušanjih, so opažali povečanje vrednosti sečne kisline in indirektnega bilirubina v povezavi s hemolizo, vendar so se te vrednosti povrnile na začetne vrednosti do konca četrtega tedna po koncu terapije.
For HCV/HIV co-infected patients receiving Rebetol in combination with peginterferon alfa-2b, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%),
Bolniki, ki so bili sočasno okuženi s HCV in HIV in so prejemali zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b, so imeli naslednje dodatne neželene učinke, ki jih niso opažali pri bolnikih s samo eno okužbo, v študijah pa so jih prijavljali s pogostnostjo > 5%: peroralna kandidiaza (14%), pridobljena lipodistrofija (13%), zmanjšano število limfocitov CD4 (8%), zmanjšan tek (8%), zvišana vrednost gama glutamiltransferaze (9%), bolečine v hrbtu (5%), zvišana vrednost amilaze v krvi (6%), zvišana koncentracija mlečne kisline v krvi (5%), citolitični hepatitis (6%), zvišana vrednost lipaze (6%) in bolečine v udih (6%).
Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection (see section 4.4).
Pri HIV- pozitivnih bolnikih, ki so prejemali shemo NRTI skupaj z ribavirinom zaradi sočasne okužbe s HCV, so poročali o toksičnosti za mitohondrije in o laktacidozi (glejte poglavje 4. 4).
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Četudi se je hematološka toksičnost v obliki nevtropenije, trombocitopenije in anemije pogosteje pojavljala pri bolnikih, ki so bili sočasno okuženi s HCV in HIV, so lahko pri večini teh bolnikov toksične učinke odpravili s prilagoditvijo odmerka in je bila zaradi njih le redko potrebna predčasna ukinitev zdravila (glejte poglavje 4. 4).
Haematological abnormalities were more frequently reported in patients receiving Rebetol in combination with peginterferon alfa-2b when compared to patients receiving Rebetol in combination with interferon alfa-2b.
O hematoloških motnjah so poročali pogosteje pri bolnikih, ki so prejemali zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b, kot pri tistih, ki so prejemali Rebetol v kombinaciji z interferonom alfa- 2b.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4% (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4% (8/194) of patients receiving Rebetol in combination with peginterferon alfa-2b.
V študiji 1 (glejte poglavje 5. 1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/ mm3 pri 4% (8/ 194) bolnikov in zmanjšanje števila trombocitov pod 50. 000/ mm3 pri 4% (8/ 194) bolnikov, ki so prejemali zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b.
Anaemia (haemoglobin < 9.4 g/dl) was reported in 12% (23/194) of patients treated with Rebetol in combination with peginterferon alfa-2b.
O anemiji (hemoglobin < 9, 4 g/ dl) so poročali pri 12% (23/ 194) bolnikov, zdravljenih z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b.
Treatment with Rebetol in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Zdravljenje z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
The use of Rebetol in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Uporaba zdravila Rebetol v kombinaciji s peginterferonom alfa- 2b ni imela opaznega negativnega vpliva na nadzor viremije HIV med samim zdravljenjem ali pozneje, med spremljanjem bolnikov.
Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Za sočasno okužene bolnike s številom celic CD4+ < 200/ µl so na voljo le omejeni podatki o varnosti zdravila (N = 25) (glejte poglavje 4. 4).
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Rebetol in combination with peginterferon alfa-2b.
Preberite si tudi ustrezne Povzetke glavnih značilnosti zdravila za protiretrovirusna zdravila, ki jih bo bolnik jemal skupaj s terapijo za HCV, da bi se bolj zavedali in bi lahko zdravili toksične učinke vsakega od teh zdravil ter da bi se zavedali potencialnega prekrivanja njihovih toksičnih učinkov z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b.
Children and adolescents:
14 Otroci in mladostniki:
In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
V kliničnih preskušanjih pri 118 otrocih in mladostnikih, starih od 3 do 16 let, so pri 6% ukinili terapijo zaradi neželenih dogodkov.
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
Na splošno je bil profil neželenih dogodkov v omejeni pediatrični populaciji, ki je bila vključena v študije, podoben profilu pri odraslih, čeprav se je pri njih pojavila dodatna skrb glede zaviranja rasti, saj so med zdravljenjem opažali zmanjšanje percentila telesne višine (srednje percentilno zmanjšanje hitrosti rasti za 9%) in telesne mase (srednje percentilno zmanjšanje za 13%) (glejte poglavje 4. 4).
Reported adverse reactions listed in Table 5 are based on experience from paediatric clinical trials.
Prijavljeni neželeni učinki, ki so navedeni v Preglednici 5, temeljijo na izkušnjah iz pediatričnih kliničnih preskušanj.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to < 1/10).
Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥1/ 10); pogosti (od ≥1/ 100 do < 1/ 10).
Table 5
Preglednica 5 Neželeni učinki, ki so jih zelo pogosto ali pogosto prijavljali med kliničnimi preskušanji zdravila Rebetol z interferonom alfa- 2b za injiciranje pri pediatričnih bolnikih
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection,
Virusne okužbe, faringitis Glivične okužbe, bakterijske okužbe, pljučne okužbe, otitis media, zobni absces, herpes simpleks, okužbe sečil, vaginitis, gastroenteritis
14
Pogosti:
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy
Anemija, nevtropenija Trombocitopenija, limfadenopatija
Hypothyroidism Hyperthyroidism, virilism
Hipotiroidizem Hipertiroidizem, virilizem
Anorexia Hypertriglyceridemia, hyperuricemia, increased appetite
Anoreksija Hipertrigliceridemija, hiperurikemija, povečan tek
Depression, insomnia, emotional lability Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
Depresija, nespečnost, čustvena nestabilnost Samomorilne misli, agresivno odzivanje, zmedenost, vedenjske motnje, vznemirjenost, somnambulizem, tesnoba, živčnost, motnje spanja, nenormalne sanje, apatičnost
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Glavobol, omotica Hiperkinezija, tremor, disfonija, parestezije, hipoestezija, Hiperestezija, motnje koncentracije, somnolenca
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Konjunktivitis, očesne bolečine, motnje vida, bolezni solzne žleze
Raynaud’s disease, flushing, pallor
Raynaudova bolezen, pordelost, bledica
Respiratory, thoracic and mediastinal disorders Common:
Pogosti:
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Dispneja, tahipneja, epistaksa, kašelj, kongestija nosne sluznice, draženje nosne sluznice, rinoreja, kihanje
Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder
Driska, bruhanje, slabost, trebušne bolečine Razjede v ustih, ulcerozni stomatitis, stomatitis, bolečine v zgornjem desnem kvadrantu trebuha, dispepsija, glositis, gastroezofagealni refluks, bolezni danke, bolezni prebavil, zaprtje, mehko blato, zobobol, zobne bolezni
Common:
Bolezni jeter, žolčnika in žolčevodov Pogosti:
Hepatic function abnormal
Motnje delovanja jeter
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
Alopecija, izpuščaj Preobčutljivostne reakcije na svetlobo, makulopapulozni izpuščaj, ekcem, akne, kožne bolezni, bolezni nohtov, obarvanje kože, pruritus, suha koža, eritem, podplutbe, povečano potenje
Musculoskeletal and connective tissue disorders Very common:
Zelo pogosti:
Arthralgia, myalgia, musculoskeletal pain
Artralgija, mialgija, mišično- skeletne bolečine
Enuresis, micturition disorder, urinary incontinence
Enureza, motnje uriniranja, inkontinenca seča
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Ženske: amenoreja, menoragija, menstrualne motnje, bolezni nožnice Moški: bolečine v testisih
General disorders and administration site Very common:
Zelo pogosti:
conditions Injection site inflammation, injection site reaction, fatigue, rigors, fever, influenza-like symptoms, malaise, irritability
Vnetje na mestu injiciranja, reakcija na mestu injiciranja, utrujenost, mrzlica, zvišana telesna temperatura, gripi podobni simptomi, bolehnost, razdražljivost
Chest pain, asthenia, oedema, injection site pain 15
Bolečine v prsih, astenija, edem, bolečine na mestu injiciranja
Growth rate decrease (height and/or weight decrease for age)
Zmanjšana hitrost rasti (zmanjšana telesna višina in/ ali telesna masa glede na starost)
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih Pogosti:
Common:
Laceracije kože
Skin laceration
4. 9 Preveliko odmerjanje
In clinical trials with Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (50 x 200 mg capsules) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
V kliničnih preskušanjih zdravila Rebetol v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b je bilo največje preveliko odmerjanje skupni odmerek 10 g zdravila Rebetol (50 x 200 mg kapsul) in 39 mio i. e. interferona alfa- 2b (13 subkutanih injekcij po 3 mio i. e. vsaka), ki ga je v enem dnevu vzel bolnik v poskusu samomora.
The patient was observed for two days in the emergency room, during which time no adverse event from the overdose was noted.
Bolnika so opazovali dva dni na urgentnem oddelku in v tem času niso ugotovili nobenega neželenega dogodka zaradi prevelikega odmerka.
Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code:
Zdravila z direktnim delovanjem na viruse, nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC:
J05A B04.
J05A B04
Ribavirin (Rebetol) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
16 Ribavirin (Rebetol) je sintetični nukleozidni analog, ki je pokazal aktivnost proti nekaterim RNA in DNA virusom in vitro.
The mechanism by which Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b exerts its effects against HCV is unknown.
Mehanizem delovanja, prek katerega zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b deluje proti HCV, ni znan.
Oral formulations of Rebetol monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Peroralne pripravke zdravila Rebetol v monoterapiji so proučevali v večih kliničnih preskušanjih kot možnost zdravljenja kroničnega hepatitisa C.
Results of these investigations showed that Rebetol monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after six to 12 months of therapy and six months of follow-up.
Izsledki teh raziskav so pokazali, da monoterapija z zdravilom Rebetol ni imela nobenega učinka na uničenje virusa hepatitisa (HCV- RNA) ali na izboljšanje jetrnega histološkega izvida po šestih do dvanajstih mesecih terapije in nadaljnjih šestih mesecih spremljanja bolnikov.
Rebetol clinical trials in adults The use of Rebetol in combination treatment with peginterferon alfa-2b or interferon alfa-2b was evaluated in a number of clinical trials.
Klinična preskušanja zdravila Rebetol na odraslih Uporabo zdravila Rebetol v kombinirani terapiji s peginterferonom alfa- 2b ali interferonom alfa- 2b so ovrednotili v številnih kliničnih preskušanjih.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 30 IU/ml), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
V te klinične raziskave so vključili bolnike s kroničnim hepatitisom C, potrjenim s pozitivnim izvidom testa polimerazne verižne reakcije (PCR) na HCV - RNK (> 30 i. e. / ml), izvid jetrne biopsije pa je bil v skladu s histološko diagnozo kroničnega hepatitisa brez drugih vzrokov za kronični hepatitis, poleg tega pa so imeli bolniki tudi nenormalne serumske vrednosti ALT.
Naïve patients Three trials examined the use of interferon in naïve patients, two with Rebetol + interferon alfa-2b (C95-132 and I95-143) and one with Rebetol + peginterferon alfa-2b (C/I98-580).
Predhodno nezdravljeni bolniki V treh preskušanjih so raziskovali uporabo interferona pri predhodno nezdravljenih bolnikih in sicer v dveh z zdravilom Rebetol + interferonom alfa- 2b (C95- 132 in I95- 143) in v eni z zdravilom Rebetol + peginterferonom alfa- 2b (C/ I98- 580).
The sustained response at the end of follow-up was significantly increased by the addition of Rebetol to interferon alfa-2b (41% vs 16%, p < 0.001).
Trajni odziv na koncu spremljanja bolnikov je bil bistveno večji (41% proti 16%, p < 0, 001) zaradi dodatka zdravila Rebetol interferonu alfa- 2b.
In clinical trials C95-132 and I95-143, Rebetol + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
V kliničnih preskušanjih C95- 132 in I95- 143 se je kombinirana terapija z zdravilom Rebetol in interferonom alfa- 2b izkazala za statistično značilno bolj učinkovito od monoterapije z interferonom alfa- 2b (podvojen trajni odziv).
This was true for all HCV genotypes, particularly Genotype 1, in which the relapse rate was reduced by 30% compared with interferon alfa-2b monotherapy.
To je veljalo za vse HCV genotipe, a še posebej za genotip 1, kjer se je delež ponovitev zmanjšal za 30% v primerjavi z monoterapijo z interferonom alfa- 2b.
In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens: • Rebetol (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511). • Rebetol (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n = 514). • Rebetol (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
V kliničnem preskušanju C/ I98- 580 je 1. 530 predhodno nezdravljenih bolnikov leto dni prejemalo enega od naslednjih kombiniranih režimov zdravljenja: • Rebetol (800 mg/ dan) + peginterferon alfa- 2b (1, 5 mikrogramov/ kg na teden) (n = 511). • Rebetol (1. 000/ 1. 200 mg/ dan) + peginterferon alfa- 2b (1, 5 mikrogramov/ kg na teden en mesec, potem pa 0, 5 mikrogramov/ kg na teden 11 mesecev) (n = 514). • Rebetol (1. 000/ 1. 200 mg/ dan) + interferon alfa- 2b (3 mio i. e. trikrat na teden) (n = 505).
16 In this trial, the combination of Rebetol and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of Rebetol and interferon alfa-2b, particularly in patients infected with Genotype 1.
V tem preskušanju je bila kombinacija zdravila Rebetol in peginterferona alfa- 2b (1, 5 mikrogramov/ kg na teden) bistveno bolj učinkovita od kombinacije zdravila Rebetol in interferona alfa- 2b, še posebej pri bolnikih, okuženih z genotipom 1.
However, response rates in this trial were shown to be dependent also on the dose of Rebetol administered in combination with peginterferon alfa-2b or interferon alfa-2b.
Vendar pa je bil odziv v tej raziskavi odvisen tudi od odmerka zdravila Rebetol, ki so ga dajali v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b.
In those patients that received > 10.6 mg/kg Rebetol (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg Rebetol (Table 6), while response rates in patients that received > 13.2 mg/kg Rebetol were even higher.
Pri bolnikih, ki so prejeli > 10, 6 mg/ kg zdravila Rebetol (800 mg odmerek pri značilnem 75 kg težkem bolniku, je bil delež odziva bistveno višji kot pri tistih, ki so prejeli ≤ 10, 6 mg/ kg zdravila Rebetol, ne glede na genotip ali virusno obremenitev (Preglednica 6), delež odziva pri tistih, ki so prejeli > 13, 2 mg/ kg zdravila Rebetol, pa je bil še višji.
Table 6
Preglednica 6 HCV genotip
Sustained response rates with Rebetol + peginterferon alfa-2b (by Rebetol dose [mg/kg], genotype and viral load)
Trajni virološki odziv pri uporabi zdravila Rebetol + peginterferon alfa- 2b (po odmerku zdravila Rebetol [mg/ kg], genotipu in virusni obremenitvi) Odmerek P 1, 5/ R P 0, 5/ R I/ R Rebetola (mg/ kg)
HCV Genotype
Vsi genotipi
Rebetol dose (mg/kg)
vsi 54% 47% 47% ≤ 10, 6 50% 41% 27%
P 1.5/R
17
P 0.5/R
> 10, 6 61% 48%
I/R
47%
All Genotypes Genotype 1 Genotype 1
Genotip 1
All 10.6 10.6 All 10.6 10.6 All
vsi 42% 34% ≤ 10, 6 38% 25% > 10, 6 48% 34%
≤ 600,000 IU/ml Genotype 1
Genotip 1 ≤ 600. 000 i. e. / ml
≤ >
vsi 73% 51% ≤ 10, 6 74% 25% > 10, 6 71% 52%
74% 71% 30%
Genotip 1
25% 52% 27%
vsi 30% 27% ≤ 10, 6
> 600,000 IU/ml Genotype 2/3
> 600. 000 i. e. / ml
10.6 10.6 All 10.6 10.6
27% 25% > 10, 6 37% 27%
Rebetol (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) Rebetol (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) Rebetol (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Rebetol (800 mg) + peginterferon alfa- 2b (1, 5 mikrogramov/ kg) Rebetol (1. 000/ 1. 200 mg) + peginterferon alfa- 2b (1, 5 do 0, 5 mikrogramov/ kg) Rebetol (1. 000/ 1. 200 mg) + interferon alfa- 2b (3 mio i. e.)
In a separate trial, 224 patients with genotype 2 or 3 received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo peginterferon alfa- 2b v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z zdravilom Rebetol v odmerku od 800 mg do 1. 400 mg peroralno, v času 6 mesecev (glede na telesno maso - 1. 400 mg za bolnike s telesno maso > 105 kg; vključeni so bili le 3 bolniki) (Preglednica 7).
Twenty-four% had bridging fibrosis or cirrhosis (Knodell 3/4).
24% bolnikov je imelo mostno fibrozo ali cirozo (Knodell 3/ 4).
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* Rebetol 800-1,400 mg/day Plus peginterferon alfa-2b 1.5 μg/kg Once Weekly
Virološki odziv ob koncu zdravljenja, trajni virološki odziv in ponovitev bolezni po HCV genotipih in virusni obremenitvi *
End
Peginterferon alfa- 2b v odmerku 1, 5 μg/ kg enkrat na teden plus Rebetol v odmerku 800 do 1. 400 mg na dan
of Treatment Response
odziv ob koncu zdravljenja
81% (182/224)
ponovitev bolezni
HCV 2 ≤ 600,000 IU/ml
Vsi preiskovanci HCV 2 ≤ 600. 000 i. e. / ml > 600. 000 i. e. / ml HCV 3 ≤ 600. 000 i. e. / ml > 600. 000 i. e. / ml
* Any subject with an undetectable HCV-RNA level at the Follow-Up Week 12 visit and missing data at the Follow- Up Week 24 visit was considered a sustained responder.
* Vsakega preiskovanca z nemerljivo koncentracijo HCV- RNA ob obisku v 12. tednu spremljanja bolnikov ali z manjkajočimi podatki ob obisku v 24. tednu spremljanja bolnikov so šteli med bolnike s stalnim virološkim odzivom.
Any subject with missing data in and after the Follow-Up Week 12 window was considered to be a non-responder at Week 24 of follow-up.
Vsakega preiskovanca z manjkajočimi podatki v časovnem obdobju 12. tedna spremljanja bolnikov in po njem pa so ob obisku v 24. tednu spremljanja bolnikov šteli med bolnike brez virološkega odziva.
The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5% vs.
Kar zadeva dolžino zdravljenja, so bolniki v tem osrednjem kombiniranem preskušanju bolje prenašali 6- mesečno terapijo kot enoletno terapijo.
49%.
Za prekinitev zdravljenja so bile vrednosti 5% in 14%, za prilagoditev odmerka pa 18% in 49%.
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo peginterferon alfa- 2b v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z zdravilom Rebetol v odmerku, izračunanem glede na telesno maso.
The overall sustained response rate after a 24-week treatment duration was 50%.
Skupna stopnja stalnega virološkega odziva po 24- tedenskem zdravljenju je bila 50%.
Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at Week 4 and Week 24 of therapy.
41% preiskovancev (97/ 235) ni imelo merljivih koncentracij HCV- RNA v plazmi v 4. in 24. tednu zdravljenja.
In this subgroup, there was a 92% (89/97) sustained virological response rate.
V tej podskupini bolnikov je bila stopnja stalnega virološkega odziva 92% (89/ 97).