natgillin/translations-raw huggingface dataset:
is Disse bivirkninger er også rapporteret med Viraferon alene.
These undesirable effects have also been reported with Viraferon alone.
tor Kardiovaskulære (CV) bivirkninger, specielt arytmi, syntes for det meste at være indbyrdes forbundet med tidligere CV sygdom og tidligere behandling med kardiotoksiske stoffer (se pkt.
s ori Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre- existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Kardiomyopati, som
Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior
4. 4).
uth evidence of cardiac disease (see section 4.4).
ere
A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons
4. 4). ng
ra including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
omfatter reduktion i antal af granulocytter og hvide blodlegemer, nedsat hæmoglobinniveau og trombocyttal, øgning i basisk fosfatase, LDH, serum- kreatinin og serum- urinstof.
ge Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and lon platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Forøgelse i serum ALAT/ ASAT (SGPT/ SGOT) - koncentrationer er blevet observeret som en abnormitet hos nogle non - hepatitis personer samt hos nogle patienter med kronisk hepatitis B samtidig med udskillelse af viral ke
Increase in serum ALT/ AST (SGPT/ SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp. no
DNAp.
Paediatric population
4. 4. r ik
Children and adolescents – Chronic Hepatitis C t
Børn og unge - kronisk hepatitis C I kliniske undersøgelser med 118 børn og unge i alderen 3 til 16 år afbrød 6% behandling på grund af bivirkninger.
In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse uc
population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, da en procentvis formindsket højde (gennemsnitlig procentvis nedgang i væksthastighed på 9%) og vægt (gennemsnitlig procentvis nedgang på 13%) blev observeret under mi
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%) rod
4. 4).
percentile were observed during treatment (see section 4.4).
Som hos voksne patienter oplevede børn og unge også andre ge
As in adult patients, children and adolescents also experienced other psychiatric lp
psykiatriske bivirkninger (såsom depression, emotionel labilitet og søvnighed) (se pkt.
adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
Derudover forekom lidelser på injektionsstedet, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos Læ
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Dosisjusteringer var nødvendige hos 30% af patienterne, mest almindeligt for anæmi og neutropeni.
commonly for anaemia and neutropaenia.
De bivirkninger, der er listet i Tabel 2, er baseret på erfaringer fra kliniske undersøgelser med børn.
The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials. i dic
Følgende kategorier er anvendt: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
alg Tabel 2.
Me
s Systemorganklasser Infektioner og parasitære
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials Very common (≥ 1/ 10) - Common (≥ 1/ 100, < 1/ 10) System Organ Class Infection and infestations
til sygdomme Meget almindelig:
Very common:
Virusinfektion, pharyngitis Svampeinfektion, bakteriel infektion, pulmonal infektion, otitis
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection,
t ere media, tand absces, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis Benigne, maligne og uspecificerede tumorer (inkl.
91 vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
is cyster og polypper) Almindelig:
Blood and lymphatic system disorders
tor Blod og lymfesystem Meget almindelig:
ed Very common:
au Det endokrine system Meget almindelig:
s Very common:
Almindelig:
ori Common:
Hypothyroidisme§, Hyperthyroidisme§, virilisering ere
Hyperthyroidism§, virilism
Meget almindelig:
uth disorders Very common:
Almindelig: §
Common:
Anoreksi Hypertriglyceridæmi§, hyperurikæmi, øget appetit ng
Anorexia Hypertriglyceridemia§, hyperuricemia, increased appetite
Depression, emotionel ustabilitet, søvnløshed Selvmordstanker, aggressiv reaktion, forvirring, læ
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep
adfærdsforstyrrelser, agitation, søvngængeri, angst, nervøsitet, søvnforstyrrelser, unormale drømme, apati Nervesystemet§ Meget almindelig:
ge disorder, abnormal dreaming, apathy Nervous system disorders§ Very common:
Hovedpine, svimmelhed,
Headache, dizziness lon
r ik
Eye disorders
Øjne Almindelig:
Common:
Konjunktivitis, øjensmerte, unormalt syn, tårekirtelproblemer
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder no
Almindelig: te
Common:
Raynauds syndrome, rødmen, bleghed
Raynaud’ s disease, flushing, pallor t
Luftveje, thorax og mediastinum dle
mediastinal disorders uc
Mave- tarmkanalen
rod
Meget almindelig: mi
Gastrointestinal disorders Very common:
Mundsår, ulcerativ stomatitis, stomatitis, smerte i øvre højre kvadrant, dyspepsi, glossitis, gastroøsofageal refluks, rektale
Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal
forstyrrelser, gastrointestinale forstyrrelser, forstoppelse, løs afføring, tandpine, tandproblemer Lever og galdeveje Læ
disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder na
Almindelig:
Hepatobiliary disorders Common:
Hud og subkutane væv
Skin and subcutaneous tissue i
Alopeci, udslæt Fotosensitivitets reaktioner, makulopapulært udslæt, eksem, akne, hudlidelse, neglelidelse, pigmentforandringer, pruritus, tør hud,
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin,
88 erythem, blå mærker, øget svedtendens
erythema, bruise, sweating increased Musculoskeletal and connective tissue disorders Very common:
Meget almindelig:
Renal and urinary disorders
alg Nyrer og urinveje Almindelig:
Common:
s mammae Almindelig:
92 Common:
Kvinder: amenorré, menoragi, menstruations forstyrrelser, vaginale
General disorders and administration site conditions
til problemer Mænd: testikelsmerter
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder Male: testicular pain
ere reaktioner på administartionsstedet Meget almindelig:
Very common:
Inflammation på injektionsstedet, reaktion på injektionsstedet, træthed, stivhed, feber§, influenzalignende symptomer§, utilpashed,
Injection site inflammation, injection site reaction, fatigue, rigors,
is irritabilitet Almindelig:
ed fever§, influenza-like symptoms§, malaise, irritability Common:
tor Undersøgelser Meget almindelig:
s Very common:
Fald i væksthastighed (højde og/ eller vægtfald i forhold til alder) §
Growth rate decrease (height and/ or weight decrease for age)§
au Traumer, forgiftninger og behandlingskomplikationer Almindelig: § Se pkt.
ori Injury and poisoning Common: §
ng
uth See section 4.4
ere
4.9 Overdose
Der er ingen meddelelser om tilfælde af overdosering, der har medført akutte kliniske symptomer.
ra No case of overdose has been reported that has led to acute clinical manifestations.
Som for ethvert farmakologisk aktivt stof er symptomatisk behandling med hyppig monitorering af vitale tegn og tæt observation af patienten dog indiceret. læ
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
FARMAKOLOGISKE EGENSKABER ke
PHARMACOLOGICAL PROPERTIES ge lon 5.1 Pharmacodynamic properties
Immunstimulerende midler, cytokiner og immunmodulatorer, interferoner, interferon alfa- 2b, ATC- kode:
Immunostimulants, cytokines and immunomodulators, interferons, interferon no
Viraferon er en steril, stabil, formulering af højt oprenset interferon alfa- 2b produceret ved rekombinant te
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA t
DNA- teknik.
techniques.
Rekombinant interferon alfa- 2b er et vandopløseligt protein med en molekylvægt på cirka 19. 300 daltons.
Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of uc
med et interferon alfa- 2b gen fra humane leukocytter.
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes. rod
Aktiviteten af Viraferon udtrykkes i IE, med 1 mg af rekombinant interferon alfa- 2b protein svarende til 2, 6 x 108 IE.
The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon mi
International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte lp
alfa- 2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af verdenssundhedsorganisationen WHO. ge
interferon established by the World Health Organisation.
Interferoner er en familie af små proteinmolekyler med molekylevægte på cirka 15. 000- 21. 000 daltons.
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to na
substanser.
21,000 daltons.
Tre væsentlige klasser af interferon er blevet identificeret:
They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Disse tre hovedklasser er i sig selv ikke homogene og kan indeholde forskellige molekyletyper af interferon.
These three main classes are themselves not homogeneous and may contain several different molecular i dic
Viraferon er blevet klassificeret som rekombinant interferon alfa- 2b.
Me
89 Interferoner udøver deres cellulære aktiviteter ved at binde sig til specifikke membranreceptorer på celleoverfladen.
Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
alg visse abearter, såsom rhesus aber, modtagelige for farmakodynamisk stimulation ved udsættelse for human type 1 interferoner.
However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Det formodes, at
93 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
til denne proces, i det mindste delvis, er ansvarlig for de forskellige cellulære reaktioner på interferon, inklusiv hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af den fagocytære aktivitet af makrofager og øgning af den
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Rekombinant interferon alfa- 2b har vist antiproliferative effekter i undersøgelser under anvendelse af både
ed Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.
tor Rekombinant interferon alfa- 2b hæmmer også viral replikation in vitro og in vivo.
s ori Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant alfa- 2b er ukendt, synes det at ændre
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
au værtscellemetabolismen.
uth Chronic hepatitis B:
Nuværende kliniske erfaringer med patienter, som forbliver i interferon alfa- 2b behandling i 4 til 6 måneder, viser, at behandlingen kan give elimination af serum HBV- DNA.
Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that
Forbedring i leverhistologien er set.
ra therapy can produce clearance of serum HBV-DNA.
Hos voksne patienter med nedsættelse af HbeAg og HBV- DNA er set en ng
An improvement in liver histology has been observed.
signifikant reduktion i morbiditet og mortalitet.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Interferon alfa- 2b (6 MIE/ m2 3 gange om ugen i 6 måneder) er blevet givet til børn med kronisk aktiv læ
ge Interferon alfa-2b (6 MIU/ m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B.
Herudover fik børn behandlet med interferon alfa- 2b en nedsat væksthastighed og nogle tilfælde af depression sås. ke
Moreover children treated lon with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Hos voksne patienter, som modtager interferon i kombination med ribavirin, er den opnåede vedvarende respons rate 47%.
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is no
interferon med ribavirin (vedvarende respons rate 61% opnået i en undersøgelse udført hos naive patienter med en ribavirin dosis > 10, 6 mg/ kg, p < 0, 01). te
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61% achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/ kg, p < 0.01). t uc
Undersøgelserne sammenlignede effekten af Viraferon anvendt alene eller i kombination dle
The trials compared the efficacy of Viraferon used alone or in combination with ribavirin.
Effekt blev defineret som vedvarende virologisk respons 6 måneder efter afsluttet behandling.
Efficacy was defined as sustained virologic response, rod
overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, og abnorm serum ALAT. ge
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT. lp
Viraferon blev indgivet i en dosis på 3 MIE 3 gange om ugen som monoterapi eller i kombination med ribavirin.
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with na
Alle patienter blev fulgt i yderligere 6 måneder efter afsluttet behandling for bestemmelse af vedvarende virologisk Læ
All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response.
Vedvarende virologiske responsrater for behandlingsgrupper behandlet i et år med Viraferon alene eller i kombination med ribavirin (fra to undersøgelser) er vist i Tabel 3.
combination with ribavirin (from two studies) are shown in Table 3.
HCV genotype og baseline virusmængde er 90 prognostiske faktorer, som er kendt for at kunne påvirke responsrater.
HCV genotype and baseline virus load are prognostic Me
Den relative gavn af kombinationsbehandling med Viraferon + ribavirin er særlig signifikant i de undergrupper af patienter, der er vanskeligst at behandle (genotype 1 og høj virusmængde)
The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Uafhængigt af genotype havde patienter, som
Regardless of genotype, patients who received Viraferon in combination with ribavirin and received ≥ 80% of their treatment had a higher sustained
s fik Viraferon i kombination med ribavirin og fik ≥ 80% af deres behandling, et højere vedvarende respons 6 måneder efter 1 års behandling end dem, der anvendte < 80% af deres behandling (56%
94 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
til mod 32% i undersøgelse C/ I98- 580).
32% in trial C/ I98-580).
Vedvarende virologiske responsrater med Viraferon + ribavirin (et års
Sustained virologic response rates with Viraferon + ribavirin (one year of treatment) by genotype and viral load
tor Alle genotyper
s All Genotypes
au Genotype 1
ori Genotype 1
ere
33%
≤ 2 millioner kopier/ ml Genotype 1
uth Genotype 1 ≤ 2 million
> 2 millioner kopier/ ml
ra copies/ ml Genotype 1 > 2 million
I/ R Viraferon (3 MIE 3 gange om ugen) + ribavirin (1. 000/ 1. 200 mg/ dag) ke
I Viraferon (3 MIU 3 times a week) I/ R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/ 1,200 mg/ day) no
Samtidig infektion med HCV/ HIV r ik
HCV/ HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
I begge undersøgelser var patienter, der fik Viraferon plus ribavirin overordnet mindre tilbøjelige til at respondere end patienter, der fik pegyleret interferon alfa- 2b med ribavirin.
interferon alfa-2b with ribavirin.
Respons på behandlingen i begge disse undersøgelser er vist i Tabel 4.
The response to treatment in both of these trials is presented in Table 4. uc
multicenterundersøgelse, der inkluderede 412 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med HIV.
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Patienterne blev randomiseret til enten at få pegyleret dle
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/ kg/ week) plus ribavirin (800 mg/ day) or Viraferon (3 MIU TIW) rod
interferon alfa 2b (1, 5 µg/ kg/ uge) plus ribavirin (800 mg/ dag) eller Viraferon (3 MIE TIW) plus ribavirin (800 mg/ dag) i 48 uger med en opfølgningsperiode på 6 måneder.
plus ribavirin (800 mg/ day) for 48 weeks with a follow-up period of 6 months.
Patienterne blev randomiseret mi
Patients were randomized to receive either pegylated interferon alfa-2b (100 lp
til at få enten pegyleret interferon alfa- 2b (100 eller 150 µg / uge baseret på vægt) plus ribavirin (800 - 1. 200 mg/ dag baseret på vægt) eller Viraferon (3 MIE TIW) plus ribavirin (800- 1. 200 mg/ dag baseret ge
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load na
Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af de patienter, der var inficeret med genotype 2 og 3 og viral load < 800. 000 IE/ ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder.
< 800,000 IU/ ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period. i
Læ
Table 4
91 Tabel 4
dic
Vedvarende virologisk respons baseret på genotype efter Viraferon i kombination med ribavirin versus pegyleret interferon alfa- 2b i kombination med ribavirin hos patienter med samtidig infektion af HCV/ HIV
ribavirin versus pegylated interferon alfa-2b in combination with ribavirin in HCV/ HIV co-infected patients
alg
Me
pegyleret
Study 22
Undersøgelse 22
pegylated
(3
(3
MIE TIW) +
MIU TIW) +
+ ribavirin
ribavirin
værdia
value a
1. 200 mg) d 1. 200 mg) d
1,200 mg)
værdib
d
Alle
1,200 mg)
27% (56/ 205) 20% (41/ 205) 0, 047 44% (23/ 52)
d
21% (9/ 43)
valueb
0, 017
95 All Genotype 1, 4
Genotype 1, 17% (21/ 125)
27% (56/ 205) 17% (21/ 125)
0, 006 38% (12/ 32)
44% (23/ 52) 38% (12/ 32)
is 4
Genotype 2, 3
tor Genotype 2, 44% (35/ 80) 3
44% (35/ 80)
au a: p værdi baseret på Cochran- Mantel Haenszel Chi kvadrat- test. b: p værdi baseret på chi- kvadrat- test. c: forsøgspersoner < 75 kg fik 100 µg/ uge pegyleret interferon alfa- 2b og forsøgspersoner ≥ 75 kg fik 150 µg/ uge pegyleret interferon alfa- 2b. d: ribavirin dosering var 800 mg for patienter < 60 kg, 1. 000 mg for patienter 60- 75 kg og 1. 200 mg for patienter > 75 kg. ere 1 Carrat F, Bani- Sadr F, Pol S et al.
ed a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/ week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/ week pegylated interferon alfa-2b.
F27- F36. ng
F27-F36.
Relaps patienter:
uth Relapse patients:
I alt 345interferon alfa relaps patienter blev behandlet i to kliniske undersøgelser læ
A total of 345 interferon alpha relapse patients were treated in two clinical trials with Viraferon monotherapy or in combination with ribavirin.
Denne forøgelse af effekten omfattede tab af serum HCV (< 100 kopier/ ml ved PCR), forbedring i leverinflammation og normalisering af ALAT, og var ke
This enhancement in efficacy included loss of serum HCV (< 100 copies/ ml by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when
opretholdt ved måling 6 måneder efter afsluttet behandling.
ge measured 6 months after the end of treatment.
I en stor undersøgelse, blev 1. 071 patienter inkluderet efter behandling i en tidligere ikke pegyleret interferon alfa- 2b eller ikke pegyleret interferon alfa- 2b/ ribavirin undersøgelse for at evaluere varigheden af vedvarende virologisk respons og bestemme virkningen af fortsat viral negativitet på te
Long-Term efficacy data lon In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b or non pegylated interferon alfa-2b/ ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
446 patienter fuldendte mindst 5 års langtidsopfølgning og kun 12 vedvarende responders ud af 492 fik tilbagefald under denne undersøgelse.
462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study. no
konfidensinterval på [95%, 99%].
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97% with a 95% Confidence Interval of [95%, 99%].
SVR efter behandling af kronisk HCV med ikke pegyleret interferon alfa- 2b (med eller uden ribavirin) resulterer i langtidsclearance af virus hvilket medfører resolution af den hepatiske infektion og klinisk mi
SVR after treatment of chronic HCV with non pegylated interferon alfa-2b (with or without ribavirin) results t
'helbredelse' af kronisk HCV.
chronic HCV.