natgillin/translations-raw huggingface dataset:
Ribavirin - behandling må ikke initieres før et negativt resultat fra en graviditetstest er opnået umiddelbart før behandlingsstart.
Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Den yderste forsigtighed skal udvises for at undgå graviditet hos partnere til mandlige patienter, der tager Ribavirin (se pkt.
Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin (see sections 4.3, 4.4 and 5.3).
Det er uvist, om ribavirin optaget i sædvæske vil udøve de potentielle teratogene eller genotoksiske virkninger på det humane embryo/ foster.
It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/ foetus.
Mænd, hvis partnere er gravide, skal underrettes om at anvende kondom for at mindske overførsel af ribavirin til partneren.
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment with Ribavirin and for seven months after treatment Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
10 4.7 Effects on ability to drive and use machines
Ribavirin har ingen eller ubetydelig indflydelse på evnen til at føre bil og betjene maskiner; peginterferon alfa- 2b eller interferon alfa- 2b anvendt i kombination kan imidlertid have en virkning.
Ribavirin has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
10 Patienter, der udvikler træthed, søvnighed eller forvirring under behandling, skal således advares mod at køre bil eller betjene maskiner.
Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Sikkerheden ved Ribavirin- kapsler er vurderet på basis af data fra tre kliniske undersøgelser hos patienter uden tidligere eksponering for interferon (interferon- naive patienter): to undersøgelser vurderede Ribavirin i kombination med interferon alfa- 2b, en undersøgelse vurderede Ribavirin i kombination med peginterferon alfa- 2b.
The safety of Ribavirin capsules is evaluated from data from three clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Ribavirin in combination with interferon alfa-2b, one trial studied Ribavirin in combination with peginterferon alfa-2b.
Patienter, som behandles med interferon alfa- 2b og ribavirin efter tidligere tilbagefald efter interferon - behandling, eller som behandles i en kortere periode, har sandsynligvis en bedre sikkerhedsprofil end den nedenfor beskrevne.
Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Et givet antal bivirkninger tilskrevet interferonbehandling, men som har været rapporteret i sammenhæng med hepatitis C- behandling (i kombination med ribavirin) er også anført i Tabel 4.
A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 4.
Desuden refererer SPC' et for peginterferon alfa - 2b og interferon alfa- 2b til bivirkninger, der kan tilskrives interferonmonoterapi.
Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferon monotherapy.
Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt.
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); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known.
Bivirkninger set i kliniske undersøgelser og efter markedsføring af ribavirin med pegyleret interferon alfa- 2b - eller interferon alfa- 2b- injektion
Adverse reactions reported during clinical trials or following the marketing use of ribavirin with pegylated interferon alfa-2b or interferon alfa-2b injection
Systemorganklasse
Infections
Infektioner og parasitære sygdomme Meget almindelig:
Very common:
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Almindelig:
Blood and lymphatic system disorders
Hyperglykæmi, hyperuricæmi, hypokalcæmi, dehydrering, øget appetit, tørst
Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite, thirst
Ataksi, tremor, paræstesi, dysfoni, tab af smagssans, hypoæstesi, hyperæstesi, somnolens, migræne, hypertoni, smagsforstyrrelser
Headache, dizziness, dry mouth, concentration impaired Ataxia, tremor, paresthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, somnolence, migraine, hypertonia, dysgeusia
Kramper‫, ٭ ‬perifer neuropati‫٭ ‬ Cerebrovaskulær blødning‫, ٭ ‬cerebrovaskulær iskæmi‫ ٭ ‬encefalopati‫, ٭ ‬polyneuropati‫٭ ‬
Seizure (convulsion)*, peripheral neuropathy* Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Vertigo, nedsat hørelse/ høretab, tinnitus, ørepine
Vertigo, hearing impairment/ loss, tinnitus, earache
Hjertebanken, takykardi Kardiomyopati‫, ٭ ‬arytmi‫٭ ‬ Hjerteinfarkt‫, ٭ ‬iskæmisk hjertesygdom‫٭ ‬
Palpitation, tachycardia Cardiomyopathy*, arrhythmia* Myocardial infarction*, cardiac ischaemia*
Diarre, opkastning, kvalme, abdominal smerte Ulcerøs stomatitis, stomatitis, colitis, smerte i højre øvre kvadrant, dyspepsi, gastro- øsofageal refluks‫, ٭ ‬glossitis, tandkødsblødning,
Diarrhoea, vomiting, nausea, abdominal pain Ulcerative stomatitis, stomatitis, colitis, upper right quadrant pain, dyspepsia, gastroesophogeal reflux*, glossitis, gingival bleeding, gingivitis, loose stools, constipation, flatulence
12 tandkødsbetændelse, løse afføringer, forstoppelse, flatulens
12 Very rare:
Pancreatitis‫٭ ‬ Iskæmisk colitis‫, ٭ ‬colitis ulcerosa‫٭ ‬ Rodbetændelse, tandlidelse
Ischaemic colitus*, ulcerative colitus* Periodontal disorder, dental disorder
Leverforstørrelse, gulsot, hyperbilirubinæmi‫٭ ‬ Hepatoksicitet (herunder dødelig) ‫٭ ‬
Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)*
Meget almindelig:
Musculoskeletal and connective tissue disorders Very common:
Almindelig:
Reproductive system and breast disorders Common:
Impotens, prostatitis Seksuel dysfunktion (ikke specificeret) ‫٭ ‬
Male: impotence, prostatitis Sexual dysfunction (not specified)*
Nekrose på injektionsstedet‫٭ ‬
Injection site necrosis
Almindelig: ‫ ٭ ‬Ovenstående frekvenser er fra
Common:
Vægtfald Hjertemislyd, unormal urin kliniske forsøg med ribavirin i kombination med interferon alfa- 2b (pegyleret eller nonpegyleret),
Weight decrease Cardiac murmur, urine abnormal
da ribavirin altid udskrives samtidig med et alfa- interferonprodukt, og de listede bivirkninger, som inkluderede reflekterende erfaring efter markedsføring, ikke tillader præcis kvantificering af frekvens.
* Since ribavirin is always prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
Et fald i hæmoglobinkoncentration på > 4 g/ dl blev set hos 30% af patienter behandlet med Ribavirin og peginterferon alfa- 2b og 37% af patienter behandlet med Ribavirin + interferon alfa- 2b.
A reduction in haemoglobin concentrations by > 4 g/ dl was observed in 30% of patients treated with Ribavirin and peginterferon alfa-2b and 37% of patients treated with Ribavirin + interferon alfa-2b.
Hæmoglobinværdierne faldt til under 10 g/ dl hos op til 14% voksne patienter og 7% børn og unge behandlet med Ribavirin i kombination med enten peginterferon alfa- 2b (kun voksne) eller interferon alfa- 2b.
Haemoglobin levels dropped below 10 g/ dl in up to 14% of adult patients and 7% of children and adolescents treated with Ribavirin in combination with either peginterferon alfa-2b (adults only) or interferon alfa-2b.
13 De fleste tilfælde af anæmi, neutropeni og trombocytopeni var milde (WHO grad 1 eller 2).
Most cases of anaemia, neutropaenia, and thrombocytopaenia were mild (WHO grades 1 or 2).
Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med Ribavirin i kombination med peginterferon alfa- 2b (WHO grad 3:
There were some cases of more severe neutropenia in patients treated with Ribavirin in combination with 13 peginterferon alfa-2b (WHO grade 3:
39 af 186 [21%] og WHO grad 4:
39 of 186 [21%]; and WHO grade 4:
En stigning i urinsyre og indirekte bilirubinværdier forbundet med hæmolyse blev set hos nogle patienter behandlet med Ribavirin anvendt i kombination med peginterferon alfa- 2b eller interferon alfa- 2b i kliniske undersøgelser, men værdierne vendte tilbage til baselineniveau fire uger efter afsluttet behandling.
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Ribavirin 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.
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 gammaglutamyltransferase (9%), rygsmerte (5%), øget amylase i blodet (6%), øget mælkesyre i blodet (5%), cytolytisk hepatitis (6%), øget lipase (6%) og smerte i lemmerne (6%).
For HCV/ HIV co-infected patients receiving Ribavirin 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%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Laboratorieværdier for samtidig infektion med HCV/ hiv:
Laboratory values for HCV/ HIV co-infected patients:
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).
Hæmatologiske unormaliteter blev rapporteret mere hyppigt hos patienter, der modtog Ribavirin i kombination med peginterferon alfa- 2b sammenlignet med patienter, der modtog Ribavirin i kombination med interferon alfa- 2b.
Haematological abnormalities were more frequently reported in patients receiving Ribavirin in combination with peginterferon alfa- 2b when compared to patients receiving Ribavirin in combination with interferon alfa-2b.
5. 1) blev fald i niveau af absolut neutrofiltælling under 500 celler/ mm3 observeret hos 4% (8/ 194) af patienterne, og fald i blodplader under 50. 000/ mm3 blev observeret hos 4% (8/ 194) af de patienter, der modtog Ribavirin i kombination med peginterferon alfa- 2b.
In Study 1 3 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/ mm was observed in 3 4% (8/ 194) of patients and decrease in platelets below 50,000/ mm was observed in 4% (8/ 194) of patients receiving Ribavirin in combination with peginterferon alfa-2b.
Anæmi (hæmoglobin < 9, 4 g/ dl) blev rapporteret i 12% (23/ 194) af patienterne, der blev behandlet med Ribavirin i kombination med peginterferon alfa- 2b.
Anaemia (haemoglobin < 9.4 g/ dl) was reported in 12% (23/ 194) of patients treated with Ribavirin in combination with peginterferon alfa-2b.
Behandling med Ribavirin i kombination med peginterferon alfa- 2b blev associeret med fald i absolut CD4+ celletælling inden for de 4 første uger uden en reduktion i CD4+ celleprocenten.
Treatment with Ribavirin 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.
Anvendelsen af Ribavirin i kombination med peginterferon alfa- 2b havde ingen observerbar negativ indvirkning på kontrollen af hiv- viræmi under behandling eller opfølgning.
The use of Ribavirin in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Begrænsede sikkerhedsdata er tilgængelige (N = 25) hos co- inficerede patienter med CD4+ celletællinger < 200/ µl (se pkt.
Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/ µl (see section 4.4).
For de antiretrovirale lægemidler, der skal tages samtidig med HCV- behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksiciteter, der er specifikke for det enkelte produkt samt potentialet for overlappende toksiciteter med Ribavirin i kombination med peginterferon alfa- 2b.
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 Ribavirin in combination with peginterferon alfa-2b.
Derudover blev selvmordstanker eller - forsøg rapporteret hyppigere
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).
14 sammenlignet med voksne patienter (2, 4% mod 1%) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
4. 4).
As in adult patients, children and adolescents also experienced other psychiatric 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 børn og unge sammenlignet med voksne patienter.
14 anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 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 to < 1/ 10).
Meget almindelige og almindelige bivirkninger rapporteret i kliniske undersøgelser af
Adverse reactions very commonly and commonly reported during clinical trials of
ribavirin med interferon alfa- 2b- injektion i pædiatriske patienter
ribavirin with interferon alfa-2b injection in paediatric patients
Benigne, maligne og uspecificerede tumorer Almindelig:
Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
(inkl. cyster og polypper) Uspecificerede svulster
Neoplasm unspecified
Anæmi, neutropeni Thrombocytopeni, lymfadenopati
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy
Raynauds syndrom, rødme, bleghed
Raynaud’ s disease, flushing, pallor
Almindelig:
Respiratory, thoracic and mediastinal disorders Common:
Diarre, opkastning, kvalme, abdominal smerte Mundsår, ulcerøs stomatitis, stomatitis, smerte i højre øvre kvadrant, dyspepsi, glossitis, gastroøsofageal
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
Lever og galdeveje
Hepatic function abnormal
15 reflux, rektal lidelse, gastrointestinal lidelse, forstoppelse, løse afføringer, tandpine, tandlidelse
15
Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
General disorders and administration site Very common:
Nedsat voksehastighed (højde - og/ eller vægtfald i forhold til alder)
Growth rate decrease (height and/ or weight decrease for age)
I kliniske undersøgelser med Ribavirin anvendt i kombination med peginterferon alfa- 2b eller interferon alfa- 2b var den højeste rapporterede overdosering en total dosis på 10 g Ribavirin (50 x 200 mg kapsler) og 39 MIE interferon alfa- 2b (13 subkutane injektioner med 3 MIE hver) anvendt på en dag af en patient i forsøg på selvmord.
In clinical trials with Ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Ribavirin (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.
Direkte virkende antivirale stoffer, nukleosider og nukleotider (eksklusive reverse transcriptase- hæmmere), ATC- kode:
Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code:
Ribavirin er en syntetisk nukleosidanalog, der har vist in vitro- aktivitet mod nogle RNA - og DNA- virus.
Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Mekanismen ved hvilken ribavirin i kombination med peginterferon alfa- 2b eller interferon alfa- 2b udøver sine virkninger mod HCV er ukendt.
The mechanism by which ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b exerts its effects against HCV is unknown.
Orale former for Ribavirin- monoterapi er blevet undersøgt til behandling af kronisk hepatitis C i flere kliniske undersøgelser.
Oral formulations of Ribavirin monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Resultater fra disse undersøgelser viste, at Ribavirin- monoterapi ikke havde nogen effekt på at fjerne hepatitis virus (HCV- RNA) eller forbedre leverhistologien efter seks til 12 måneders behandling og seks måneders opfølgning.
Results of these investigations showed that Ribavirin 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.
16 Ribavirin kliniske undersøgelser hos voksne Anvendelsen af Ribavirin i kombinationsbehandling med peginterferon alfa- 2b eller interferon alfa- 2b blev vurderet i en række kliniske undersøgelser.
Ribavirin clinical trials in adults The use of Ribavirin in combination treatment with peginterferon alfa-2b or interferon alfa-2b was evaluated in a number of clinical trials.
Mulige patienter til disse undersøgelser havde kronisk hepatitis C bekræftet ved en positiv HCV - RNA- polymerasekædereaktionstest (PCR) (> 30 IE/ ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, samt en abnorm serum ALAT.
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.
Naive patienter Tre undersøgelser vurderede anvendelsen af interferon hos naive patienter, to med Ribavirin + interferon alfa- 2b (C95- 132 og I95- 143) og en med Ribavirin + peginterferon alfa- 2b (C/ I98- 580).
Naïve patients Three trials examined the use of interferon in naïve patients, two with Ribavirin + interferon alfa-2b (C95-132 and I95-143) and one with Ribavirin + peginterferon alfa-2b (C/ I98-580).
I alle tilfælde varede behandlingen et år med en opfølgning på seks måneder.
The sustained response at the end of
Det vedvarende respons ved slutningen af opfølgningen var signifikant forhøjet ved tilføjelsen af Ribavirin til interferon alfa - 2b (41% mod 16%, p < 0, 001).
16 follow-up was significantly increased by the addition of Ribavirin to interferon alfa-2b (41% vs 16%, p < 0.001).
I kliniske undersøgelser C95- 132 og I95- 143 viste Ribavirin + interferon alfa- 2b - kombinationsbehandling sig at være signifikant mere effektiv end interferon alfa- 2b monoterapi (en fordobling i vedvarende respons).
In clinical trials C95-132 and I95-143, Ribavirin + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Dette var tilfældet for alle HCV- genotyper, især genotype 1, i hvilken tilbagefaldsraten blev reduceret med 30% sammenlignet med interferon alfa- 2b- monoterapi.
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.
I klinisk undersøgelse C/ I98- 580 blev 1. 530 naive patienter behandlet i et år med et af følgende kombinationsregimen: • Ribavirin (800 mg/ dag) + peginterferon alfa- 2b (1, 5 mikrogram/ kg/ uge) (n = 511). • Ribavirin (1. 000/ 1. 200 mg/ dag) + peginterferon alfa- 2b (1, 5 mikrogram/ kg/ uge i en måned efterfulgt af 0, 5 mikrogram/ kg/ uge i 11 måneder) (n = 514). • Ribavirin (1. 000/ 1. 200 mg/ dag) + interferon alfa- 2b (3 MIE tre gange om ugen) (n = 505).
In clinical trial C/ I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens: • Ribavirin (800 mg/ day) + peginterferon alfa-2b (1.5 micrograms/ kg/ week) (n = 511). • Ribavirin (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). • Ribavirin (1,000/ 1,200 mg/ day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
I denne undersøgelse var kombinationen af Ribavirin og peginterferon alfa- 2b (1, 5 mikrogram/ kg/ uge) signifikant mere effektiv end kombinationen af Ribavirin og interferon alfa- 2b, især hos patienter inficeret med genotype 1.
In this trial, the combination of Ribavirin and peginterferon alfa-2b (1.5 micrograms/ kg/ week) was significantly more effective than the combination of Ribavirin and interferon alfa-2b, particularly in patients infected with Genotype 1.
HCV- genotype og baselinevirusmængde er prognostiske faktorer, som er kendt for at påvirke responsrater.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Responsrater i denne undersøgelse blev imidlertid vist også at være afhængige af dosis af Ribavirin givet i kombination med peginterferon alfa- 2b 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 peginterferon alfa-2b or interferon alfa-2b.