natgillin/translations-raw huggingface dataset:
Hjertearytmier (primært supraventrikulære) responderer sædvanligvis på konventionel behandling, men kan kræve afbrydelse af ViraferonPeg behandling.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of ViraferonPeg therapy.
Som ved alle interferoner, afbryd behandling med ViraferonPeg hos patienter, der udvikler forlængede koagulationsmarkører, hvilket kan være tegn på leversvigt.
As with all interferons, discontinue treatment with ViraferonPeg in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Tilstrækkelig hydrering skal opretholdes hos patienter, der får ViraferonPeg behandling, da hypotension relateret til væskemangel har været set hos nogle patienter behandlet med alfa interferoner.
Adequate hydration must be maintained in patients undergoing ViraferonPeg therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Regelmæssige synsundersøgelser anbefales under ViraferonPeg behandling, især hos patienter med sygdomme, der kan være forbundet med retinopati, såsom diabetes mellitus eller hypertension.
Periodic visual examinations are recommended during ViraferonPeg therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Seponering af ViraferonPeg bør overvejes hos patienter, som udvikler nye eller forværrede oftalmologiske lidelser.
Discontinuation of ViraferonPeg should be considered in patients who develop new or worsening ophthalmological disorders.
Ved tilstedeværelse af nedsat thyreoideafunktion kan ViraferonPeg behandling fortsættes, hvis TSH værdier kan bibeholdes i normalområdet med medicinsk behandling.
In the presence of thyroid dysfunction, ViraferonPeg treatment may be continued if TSH levels can be maintained in the normal range by medication.
8 Samtidig infektion med HCV/ HIV Mitokondriel toksicitet og mælkesyre acidose:
HCV/ HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Forsigtighed bør udvises, når ViraferonPeg og ribavirin adderes til HAART terapi (se ribavirin SPC).
Caution should be used when adding ViraferonPeg and ribavirin to HAART therapy (see ribavirin SPC).
4. 5)
Patients treated with ViraferonPeg and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
For de antiretrovirale lægemidler, der skal tages samtidig med HCV- behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med ViraferonPeg og ribavirin.
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 ViraferonPeg and ribavirin.
Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af ViraferonPeg og ribavirin.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long- term treatment with the combination of ViraferonPeg and ribavirin.
Sikkerheden og effekten af ViraferonPeg alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever - eller andre organtransplantatmodtagere har ikke været undersøgt.
The safety and efficacy of ViraferonPeg alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
På grund af meddelelser om at interferon alfa kan forværre tilstedeværende psoriasissygdom og sarcoidosis, kan brug af ViraferonPeg til patienter med psoriasis eller sarcoidosis kun anbefales, hvis den potentielle gavnlige effekt retfærdiggør den mulige risiko.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of ViraferonPeg in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
9 Laboratorieundersøgelser:
Laboratory tests:
Acceptable udgangsværdier, som kan anvendes som retningslinie før påbegyndelse af ViraferonPeg behandling, er:
Acceptable baseline values that may be considered as a guideline prior to initiation of ViraferonPeg therapy are:
Vigtige oplysninger om visse af indholdsstofferne i ViraferonPeg:
Important information about some of the ingredients of ViraferonPeg:
Resultater fra en multidosis undersøgelse, som vurderede P450 substrater hos kroniske hepatitis C patienter, som modtog ViraferonPeg (1, 5 µg/ kg) en gang ugentligt i 4 uger, viste en øgning i aktiviteten af CYP2D6 og CYP2C8/ 9.
9 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Disse fund kan delvist være relaterede til forbedret metabolisk kapacitet, som følge af reduceret hepatisk inflammation hos patienter i behandling med ViraferonPeg.
These findings may partly relate to improved metabolic capacity due to reduced hepatic inflammation in patients undergoing treatment with ViraferonPeg.
Forsigtighed tilrådes derfor, når ViraferonPeg behandling mod kronisk hepatitis initieres hos patienter der behandles med lægemidler med et snævert terapeutisk vindue og følsomhed for mild metabolisk svækkelse af leveren.
Caution is therefore advised when ViraferonPeg treatment is initiated for chronic hepatitis in patients treated with medication with a narrow therapeutic window and sensitive to mild metabolic impairment of the liver.
15% (95% Cl for AUC ratio estimat 103 – 128%).
In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of ViraferonPeg subcutaneously for 4 weeks increased R-methadone AUC by approximately 15% (95% Cl for AUC ratio estimate 103 – 128%).
Det bør overvejes, hvorvidt zidovudin kan erstattes i en kombinationsbehandling
Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established.
ViraferonPeg anbefales kun til brug hos fertile kvinder, når de anvender effektiv antikonception under behandlingen.
ViraferonPeg is recommended for use in fertile women only when they are using effective contraception during the treatment.
Ribavirin forårsager alvorlige medfødte misdannelser ved indgivelse under graviditet.
Ribavirin therapy is
Ribavirin behandling er kontraindiceret hos kvinder, der er gravide.
10 contraindicated in women who are pregnant.
Den yderste forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter eller hos partnere af mandlige patienter, der får ViraferonPeg i kombination med ribavirin.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking ViraferonPeg in combination with ribavirin.
Patienter, der udvikler træthed, søvnighed eller forvirring under behandling med ViraferonPeg advares mod at køre bil og betjene maskiner.
Patients who develop fatigue, somnolence or confusion during treatment with ViraferonPeg are cautioned to avoid driving or operating machinery.
De hyppigste behandlingsrelaterede bivirkninger, der er rapporteret under kliniske undersøgelser med ViraferonPeg i kombination med ribavirin, og som er set hos mere end halvdelen af forsøgspersonerne, var hovedpine, træthed og reaktion på injektionsstedet.
The most common treatment-related adverse reactions reported during clinical trials with ViraferonPeg in combination with ribavirin, seen in more than half of the study subjects, were headache, fatigue, and injection site reaction.
Træthed, alopeci, kløe, kvalme, anoreksi, vægttab, irritabilitet og søvnløshed forekommer i en bemærkelsesværdig lavere frekvens hos patienter behandlet med ViraferonPeg monoterapi sammenlignet med dem, der behandledes med kombinationsbehandling (se Tabel 4).
Fatigue, alopecia, pruritus, nausea, anorexia, weight decrease, irritability and insomnia occur at a notably lower rate in patients treated with ViraferonPeg monotherapy compared to those treated with combination therapy (see Table 4).
Følgende behandlingsrelaterede bivirkninger blev rapporteret under behandling med ViraferonPeg.
The following treatment-related adverse reactions were reported during therapy with ViraferonPeg.
Bivirkninger, der er rapporteret i kliniske undersøgelser eller efter markedsføring hos patienter behandlet med interferon alfa- 2b, inklusive ViraferonPeg monoterapi eller ViraferonPeg + ribavirin.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
Meget almindelig:
Diabetes Metabolism and nutrition disorders Very common:
Sinuitis, bronkitis, dysfoni, næseblod, rhinitis, respiratorisk lidelse, forstoppet næse, rhinorrhea, tør hoste
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 12
Bivirkninger var almindelige (≥ 1/ 100 til < 1/ 10) i kliniske undersøgelser hos patienter behandlet med ViraferonPeg monoterapi.
These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with ViraferonPeg monotherapy.
Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med de anbefalede doser af ViraferonPeg i kombination med ribavirin (WHO grad 3:
There were some cases of more severe neutropenia in patients treated with the recommended doses of ViraferonPeg in combination with ribavirin (WHO grade 3:
I en klinisk undersøgelse rapporterede cirka 1, 2% af patienter behandlet med ViraferonPeg eller interferon alfa- 2b i kombination med ribavirin livstruende psykiatriske bivirkninger under behandling.
13 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Bivirkningerne, der har været rapporteret i undersøgelserne med en hyppighed > 5%, var oral candidiasis (14%), pådraget lipodystrofi (13%), nedsat CD4- lymfocytter (8%), nedsat appetit (8%), øget gamma - glutamyltransferase (9%), rygsmerte (5%), øget amylase i blodet (6%), øget mælkesyre i blodet (5%), cytolytisk hepatitis (6%), øget lipase (6%) og smerte i lemmerne (6%).
HCV/HIV co-infected patients For HCV/HIV co-infected patients receiving ViraferonPeg in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Hæmatologiske anomaliteter blev rapporteret mere hyppigt hos patienter, der modtog ViraferonPeg i kombination med ribavirin end hos patienter, der modtog interferon alfa- 2b i kombination med ribavirin.
Haematological abnormalities were more frequently reported in patients receiving ViraferonPeg in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Et fald i blodplader under 50. 000/ mm3 blev også observeret i 4% (8/ 194) af de patienter, der modtog ViraferonPeg i kombination med ribavirin.
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 ViraferonPeg in combination with ribavirin.
Hos 12% (23/ 194) af patienterne, der blev behandlet med ViraferonPeg i kombination med ribavirin, blev der rapporteret om anæmi (Hæmoglobin < 9, 4 g/ dl).
Anaemia (hemoglobin < 9.4g/dl) was reported in 12% (23/194) of patients treated with ViraferonPeg in combination with ribavirin.
Behandling med ViraferonPeg i kombination med ribavirin, blev associeret med et fald i absolut CD4+ - celletælling inden for de 4 første uger uden en reduktion i CD4+- celleprocenten.
Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Anvendelsen af ViraferonPeg i kombination med ribavirin havde ingen observerbar negativ indvirkning på kontrollen af HIV- viræmi under behandling eller opfølgning.
The use of ViraferonPeg in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
For de antiretrovirale lægemidler, der skal tages samtidig med HCV- behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med ViraferonPeg i kombination med ribavirin.
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 ViraferonPeg in combination with ribavirin.
Generelt er bivirkninger, der er set ved tilfælde af overdosering, hvor ViraferonPeg er involveret, i overensstemmelse med den kendte sikkerhedsprofil for ViraferonPeg; sværhedsgraden af tilfældene kan imidlertid øges.
In general, the adverse events seen in overdose cases involving ViraferonPeg are
Der findes ingen specifik antidot til ViraferonPeg; i tilfælde af overdosering anbefales der derfor symptomatisk behandling og tæt observation af patienten.
No specific antidote for ViraferonPeg is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Interferon alfa- 2b In vitro og in vivo undersøgelser tyder på, at den biologiske aktivitet af ViraferonPeg stammer fra dets interferon alfa- 2b del.
Interferon alfa-2b In vitro and in vivo studies suggest that the biological activity of ViraferonPeg is derived from its interferon alfa-2b moiety.
ViraferonPeg Farmakodynamikken af ViraferonPeg blev undersøgt i en undersøgelse med stigende enkeltdoser i raske forsøgspersoner ved at undersøge ændringer i mundtemperatur, koncentrationer af effektorproteiner såsom serum neopterin og 2’ 5 ’ - oligoadenylat syntetase (2’ 5 ’ - OAS), og ligeledes antal hvide blodlegemer og neutrofile.
ViraferonPeg ViraferonPeg pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2’5’-oligoadenylate synthetase (2’5’-OAS), as well as white cell and neutrophil counts.
Efter enkeltdoser af ViraferonPeg mellem 0, 25 og 2, 0 mikrogram/ kg/ uge, blev serum neopterin koncentrationen øget på en dosisafhængig måde.
Following single doses of ViraferonPeg between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Reduktion af antallet af neutrofile og hvide blodlegemer ved slutningen af uge 4 svarede til dosis af ViraferonPeg.
Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of ViraferonPeg.
ViraferonPeg kliniske undersøgelser - Naive patienter To pivotale undersøgelser er blevet udført, en (C/ I97- 010) med ViraferonPeg monoterapi; den anden (C/ I98- 580) med ViraferonPeg i kombination med ribavirin.
ViraferonPeg clinical trials – Naïve patients Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
I ViraferonPeg monoterapiundersøgelsen blev i alt 916 naive kroniske hepatitis C patienter behandlet med ViraferonPeg (0, 5, 1, 0 eller 1, 5 mikrogram/ kg/ uge) i et år med en opfølgningsperiode på seks måneder.
15 In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Dette studie viste, at ViraferonPeg var bedre end interferon alfa- 2b (Tabel 5).
This study showed that ViraferonPeg was superior to interferon alfa-2b (Table 5).
I ViraferonPeg kombinationsundersøgelsen blev 1. 530 naive patienter behandlet i et år med et af følgende kombinationsregimen: • ViraferonPeg (1, 5 mikrogram/ kg/ uge) + ribavirin (800 mg/ dag), (n = 511). • ViraferonPeg (1, 5 mikrogram/ kg/ uge i en måned efterfulgt af 0, 5 mikrogram/ kg/ uge i 11 måneder) + ribavirin (1. 000/ 1. 200 mg/ dag), (n = 514). • Interferon alfa- 2b (3 MIE tre gange om ugen) + ribavirin (1. 000/ 1. 200 mg/ dag) (n = 505).
In the ViraferonPeg combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • ViraferonPeg (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • ViraferonPeg (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
I denne undersøgelse var kombinationen af ViraferonPeg (1, 5 mikrogram/ kg/ uge) og ribavirin signifikant mere effektivt end kombinationen af interferon alfa- 2b og ribavirin (Tabel 5), især hos patienter inficeret med genotype 1 (Tabel 6).
In this trial, the combination of ViraferonPeg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 5), particularly in patients infected with Genotype 1 (Table 6).
Responsraterne i denne undersøgelse blev imidlertid vist også at være afhængige af dosen af ribavirin indgivet i kombination med ViraferonPeg eller interferon alfa- 2b.
However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with ViraferonPeg or interferon alfa-2b.
16 Tabel 5
Table 5
Vedvarende virologisk respons (% patienter HCV negative) ViraferonPeg monoterapi ViraferonPeg + ribavirin
Sustained virological response (% patients HCV negative) ViraferonPeg monotherapy ViraferonPeg + ribavirin
P 1, 5 ViraferonPeg 1, 5 mikrogram/ kg P 1, 0 ViraferonPeg 1, 0 mikrogram/ kg P 0, 5 ViraferonPeg 0, 5 mikrogram/ kg I Interferon alfa- 2b 3 MIE P 1, 5/ R P 0, 5/ R I/ R * **
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/R * **
ViraferonPeg (1, 5 mikrogram/ kg) + ribavirin (800 mg) ViraferonPeg (1, 5 til 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 MIE) + ribavirin (1. 000/ 1. 200 mg) p < 0, 001 P 1, 5 mod I = 0, 0143 P 1, 5/ R mod I/ R
I/R
Vedvarende responsrater med ViraferonPeg + ribavirin (efter ribavirindosis, genotype og virusmængde)
Sustained response rates with ViraferonPeg + ribavirin (by ribavirin dose, genotype and viral load)
Genotype 1 ≤ 600. 000 IU/ ml
≤ 600,000 IU/ml
Alle ≤ 10, 6 > 10, 6
≤ 10.6 > 10.6
Alle ≤ 10, 6 > 10, 6
All
ViraferonPeg (1, 5 mikrogram/ kg) + ribavirin (800 mg) ViraferonPeg (1, 5 til 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 MIE) + ribavirin (1. 000/ 1. 200 mg)
ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg)
I ViraferonPeg monoterapiundersøgelsen var livskvaliteten generelt mindre påvirket ved 0, 5 mikrogram/ kg ViraferonPeg end ved enten 1, 0 mikrogram/ kg ViraferonPeg en gang om ugen eller 3 MIE interferon alfa- 2b tre gange om ugen.
In the Vir aferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
I en separat undersøgelse fik 224 patienter med genotype 2 eller 3 ViraferonPeg, 1, 5 mikrogram/ kg subkutant en gang ugentlig, i kombination med ribavirin 800 mg – 1. 400 mg p. o. i 6 måneder (baseret på kropsvægt, kun tre patienter, der vejede > 105 kg, fik 1. 400 mg dosen) (Tabel 7).
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 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).
Virologisk respons ved afsluttet behandling, vedvarende virologisk respons og relaps efter HCV Genotype og virusmængde *
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* ViraferonPeg 1.5 μg/kg once weekly plus Ribavirin 800-1,400 mg/day
17 ViraferonPeg 1, 5 μg/ kg en gang ugentlig plus Ribavirin 800 - 1. 400 mg/ dag
of Treatment Response
Respons ved afsluttet Vedvarende virologisk respons behandling
Sustained Virologic Response
94% (211/ 224) 81% (182/ 224)
81% (182/224)
12%
12% (27/224)
(27/ 224) HCV 2 ≤ 600. 000 IU/ ml > 600. 000 IU/ ml HCV 3
HCV 2 ≤ 600,000 IU/ml
≤ 600. 000 IU/ ml
≤ 600,000 IU/ml
I et ikke- sammenlignende studie fik 235 patienter med genotype 1 og lav virusmængde (< 600. 000 IU/ ml) ViraferonPeg 1, 5 mikrogram/ kg subkutant en gang ugentlig i kombination med vægtjusteret ribavarin.
17 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Behandling ViraferonPeg 1, 5
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 +
18 Den negative prædiktive værdi for vedvarende respons hos patienter behandlet med ViraferonPeg i monoterapi var 98%.
The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98%.
Samtidig infektion med HCV/ HIV Der har været udført to undersøgelser hos patienter med samtidig infektion af HCV og HIV.
HCV/HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
Patienterne blev randomiseret til enten at modtage ViraferonPeg (1, 5 μg/ kg/ uge) plus ribavirin (800 mg/ dag) eller interferon alfa- 2b (3 MIE TIW) plus ribavirin (800 mg/ dag) i 48 uger med en opfølgningsperiode på 6 måneder.
Patients were randomized to receive either ViraferonPeg (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Patienterne blev randomiseret til enten at modtage ViraferonPeg (100 eller 150 μg/ uge baseret på vægt) plus ribavirin (800- 1. 200 mg/ dag baseret på vægt) eller interferon alfa- 2b (3 MIE TIW) plus ribavirin (800- 1. 200 mg/ dag baseret på vægt).
Patients were randomized to receive either ViraferonPeg (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).