natgillin/translations-raw huggingface dataset:
Forvirring, tremor, ataksi, neuralgi, svimmelhed, paræstesi, hypoæstesi, hyperæstesi, hypertoni, migræne, øget svedtendens
Confusion, tremor, ataxia, neuralgia, vertigo, paresthesia, hypoaesthesia, hyperaesthesia, hypertonia, migraine, increased sweating
Krampeanfald, perifer neuropati
Seizure, peripheral neuropathy
12 Hyppighed ikke kendt:
Frequency not known:
Ansigtslammelse, neuropatier, mononeuropatier
Facial palsy, neuropathies, mononeuropathies
Konjunktivitis, sløret syn, tårekirtellidelse, øjensmerte
Conjunctivitis, blurred vision, lacrimal gland disorder, eye pain
Nedsat visuel skarphed eller synsfelt, nethindehæmoragi, retinopati, nethindearterieokklusion, nethindeveneokklusion, optisk neuritis, papilødem, macular ødem, “ uldtotter ”
Loss of visual acuity or visual fields, retinal haemorrhage, retinopathy, retinal artery obstruction, retinal vein obstruction, optic neuritis, papilloedema, macular oedema, cotton wool spots Ear and labyrinth disorders Common:
Nedsat hørelse/ høretab, tinnitus
Hearing impairment/loss, tinnitus
Palpitation, takycardi
Palpitation, tachycardia
Arythmi
Arrhythmia
Kardiomyopati, perikardial effusion, perikarditis
Cardiomyopathy, pericardial effusion, pericarditis
Hypotension, hypertension, besvimelse, rødmen
Hypotension, hypertension, syncope, flushing
Dyspnø *, pharyngitis *, hoste *
Dyspnea*, pharyngitis*, coughing*
Sinuitis, bronkitis, dysfoni, næseblod, rhinitis, respiratorisk lidelse, forstoppet næse, rhinorrhea, tør hoste
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough
Interstitiel lungesygdom
Interstitial lung disease 12
Opkastning *, kvalme, mavesmerte, diaré, anoreksi
Vomiting*, nausea, abdominal pain, diarrhoea, anorexia
Dyspepsi, gastroøsofageal refluks, stomatitis, ulcerativ stomatitis, tandkødsblødning, løse afføringer, forstoppelse, flatulence, hæmorroider, tandkødsbetændelse, glossitis, dehydrering, smagsforstyrrelser
Dyspepsia, gastroesophageal reflux, stomatitis, ulcerative stomatitis, gingival bleeding, loose stools, constipation, flatulence, hemorrhoids, gingivitis, glossitis, dehydration, taste perversion
Iskæmisk colitis, ulcerøs colitis
Ischaemic colitis, ulcerative colitis
Hepatomegali, hyperbilirubinæmi
Hepatomegaly, hyperbilirubinemia
Alopeci, kløe *, tør hud *, udslæt *
Alopecia, pruritus*, skin dry*, rash*
Psoriasis, lysoverfølsomhedsreaktion, maculopapuløst udslæt, dermatitis, ansigts eller perifert ødem, erytematøst udslæt, eksem, acne, furunkulose, erythem, urticaria, unormal hårstruktur, neglelidelse
Psoriasis, photosensitivity reaction, maculopapular rash, dermatitis, face or peripheral oedema, erythematous rash, eczema, acne, furunculosis, erythema, urticaria, abnormal hair texture, nail disorder
Stevens- Johnsons syndrom, toksisk epidermal nekrolyse, nekrose på injektionsstedet, erythema multiforme
Stevens Johnson syndrome, toxic epidermal necrolysis, injection site necrosis, erythema multiforme
Myalgi, arthralgi, muskulo- skeletal smerte
Myalgia, arthralgia, musculoskeletal pain
Arthritis
Arthritis
13 Sjælden:
Rare:
Rhabdomyolyse, myositis
Rhabdomyolysis, myositis Renal and urinary disorders Common:
Ændret vandladningsfrekvens, abnorm urin
Micturition frequency, urine abnormal
Amenorrhea, impotens, brystsmerte, menorrhagi, menstruationsforstyrrelse, æggestoklidelse, vaginal lidelse, seksuel dysfunktion (ikke- specificeret), prostatitis
Amenorrhoea, impotence, breast pain, menorrhagia, menstrual disorder, ovarian disorder, vaginal disorder, sexual dysfunction (not specified), prostatitis
Inflammation på injektionsstedet, reaktion på injektionsstedet *, svimmelhed, træthed, rigor, feber, influenzalignende symptomer, asteni
Injection site inflammation, injection site reaction*, dizziness, fatigue, rigors, fever, flu-like symptoms, asthenia
Almindelig: *
Common: *
Brystsmerte, smerte i højre øvre kvadrant, utilpashed, smerte på injektionsstedet
Chest pain, RUQ pain, malaise, injection site pain
Bivirkninger var almindelige (≥ 1/ 100 til < 1/ 10) i kliniske undersøgelser hos patienter behandlet med PegIntron monoterapi.
These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with PegIntron monotherapy.
De fleste tilfælde af neutropeni og trombocytopeni var milde (WHO grad 1 eller 2).
Most cases of neutropaenia and thrombocytopaenia were mild (WHO grades 1 or 2).
Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med de anbefalede doser af PegIntron i kombination med ribavirin (WHO grad 3:
There were some cases of more severe neutropenia in patients treated with the recommended doses of PegIntron in combination with ribavirin (WHO grade 3:
39 af 186 [21%]; og WHO grad 4:
39 of 186 [21%]; and WHO grade 4:
13 af 186 [7%]).
13 of 186 [7%]).
I en klinisk undersøgelse rapporterede cirka 1, 2% af patienter behandlet med PegIntron eller interferon alfa- 2b i kombination med ribavirin livstruende psykiatriske bivirkninger under behandling.
In a clinical trial, approximately 1.2% of patients treated with PegIntron or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
4. 4).
These events included suicidal ideation and attempted suicide (see section 4.4).
4. 4).
13 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).
4. 4).
Ophthalmological disorders that have been reported rarely with alpha interferons include retinopathies (including macular oedema), retinal haemorrhages, retinal artery or vein obstruction, cotton wool spots, loss of visual acuity or visual field, optic neuritis, and papilloedema (see section 4.4).
4. 4, Autoimmun sygdom).
A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies and Vogt-Koyanagi-Harada syndrome (see also section 4.4, Autoimmune disorders).
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 PegIntron 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%).
4. 4).
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).
14 Laboratorieværdier for samtidig infektion med HCV/ HIV Selvom hæmatologisk toksicitet af neutropeni, thrombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af HCV/ HIV, kunne hovedparten afhjælpes med en modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
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 anomaliteter blev rapporteret mere hyppigt hos patienter, der modtog PegIntron 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 Peg Intron 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 PegIntron 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 PegIntron in combination with ribavirin.
Hos 12% (23/ 194) af patienterne, der blev behandlet med PegIntron 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 PegIntron in combination with ribavirin.
Fald i CD4 lymfocytter:
CD4 lymphocytes decrease:
Behandling med PegIntron 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 PegIntron 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.
Faldet i CD4+ - celletællinger var reversible efter dosisreduktion eller behandlingsophør.
The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Anvendelsen af PegIntron i kombination med ribavirin havde ingen observerbar negativ indvirkning på kontrollen af HIV- viræmi under behandling eller opfølgning.
The use of PegIntron in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
4. 4).
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 toksicitet, der er specifik for det enkelte produkt samt potentialet for overlappende toksiciteter med PegIntron 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 PegIntron in combination with ribavirin.
Der er set doser op til 10, 5 gange den tilsigtede dosis.
Doses up to 10.5 times the intended dose have been reported.
Den maksimale daglige dosis, der er set er 1. 200 mikrogram i én dag.
The maximum daily dose reported is 1,200 µg for one day.
Standardmetoder til at øge udskillelsen af lægemidlet, f. eks. dialyse, har ikke vist sig at være brugbare.
Standard methods to increase elimination of the medicinal product, e.g., dialysis, have not been shown to be useful.
Der findes ingen specifik antidot til PegIntron; i tilfælde af overdosering anbefales der derfor symptomatisk behandling og tæt observation af patienten.
No specific antidote for PegIntron is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Om nødvendigt, anbefales det at ordinerende læger kontakter forgiftningscentralen på H: S Bispebjerg Hospital.
If available, prescribers are advised to consult with a poison control centre (PCC).
Immunstimulerende midler, Cytokiner og immunmodulatorer, Interferoner, Peginterferon alfa- 2b, ATC- kode:
Immunostimulants, Cytokines and immunomodulators, Interferons, Peginterferon alfa-2b, ATC code:
Rekombinant interferon alfa- 2b er covalent konjugeret med monomethoxypolyethylenglycol med en gennemsnitlig substitutionsgrad på 1 mol polymer/ mol protein.
Recombinant interferon alfa-2b is covalently conjugated with monomethoxy polyethylene glycol at an average degree of substitution of 1 mole of polymer/mole of protein.
Den gennemsnitlige molekylevægt er omkring 31. 300 dalton af hvilken proteindelen udgør cirka 19. 300.
The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Interferon alfa- 2b In vitro og in vivo undersøgelser tyder på, at den biologiske aktivitet af PegIntron stammer fra dets interferon alfa- 2b del.
Interferon alfa-2b In vitro and in vivo studies suggest that the biological activity of PegIntron is derived from its interferon alfa-2b moiety.
Dog er visse abearter, som for eksempel Rhesusaber, følsomme overfor farmakodynamisk stimulering ved udsættelse for humane type 1 interferoner.
However, certain monkey species, e.g., Rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
15 Når først interferon er bundet til cellemembranen, så udløser det en kompleks række af intracellulære virkninger, som inkluderer induktion af visse enzymer.
Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Det formodes, at denne proces, i det mindste delvis, er ansvarlig for de forskellige cellulære reaktioner på interferon, inklusive hæmning af virusreplikation i virusinficerede celler, suppression af celledeling og sådanne immunmodulerende aktiviteter som øgning af den fagocytiske aktivitet af makrofager og øgning af den specifikke cytotoksicitet af lymfocytter på målcellerne.
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.
Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant interferon alfa- 2b er ukendt, synes det at ændre værtscellemetabolismen.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
PegIntron Farmakodynamikken af PegIntron 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.
PegIntron PegIntron 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 PegIntron mellem 0, 25 og 2, 0 mikrogram/ kg/ uge, blev serum neopterin koncentrationen øget på en dosisafhængig måde.
Following single doses of PegIntron 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 PegIntron.
Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of PegIntron.
PegIntron kliniske undersøgelser - Naive patienter To pivotale undersøgelser er blevet udført, en (C/ I97- 010) med PegIntron monoterapi; den anden (C/ I98- 580) med PegIntron i kombination med ribavirin.
PegIntron clinical trials – Naïve patients Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Mulige patienter til disse undersøgelser havde kronisk hepatitis C bekræftet ved en positiv HCV- RNA polymerase kædereaktionstest (PCR) (> 30 IU/ ml), en leverbiopsi i overensstemmelse med en histologisk diagnose på kronisk hepatitis uden anden årsag til den kroniske hepatitis, samt en abnorm serum ALT.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction (PCR) assay (> 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.
I PegIntron monoterapiundersøgelsen blev i alt 916 naive kroniske hepatitis C patienter behandlet med PegIntron (0, 5, 1, 0 eller 1, 5 mikrogram/ kg/ uge) i et år med en opfølgningsperiode på seks måneder.
In the PegIntron monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with PegIntron (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Herudover fik 303 patienter interferon alfa- 2b (3 millioner internationale enheder [MIE] tre gange om ugen [tre gange om ugen]) til sammenligning.
In addition, 303 patients received interferon alfa-2b (3 million International Units [MIU] three times a week) as a comparator.
Dette studie viste, at PegIntron var bedre end interferon alfa- 2b (Tabel 5).
This study showed that Peg Intron was superior to interferon alfa-2b (Table 5).
I PegIntron kombinationsundersøgelsen blev 1. 530 naive patienter behandlet i et år med et af følgende kombinationsregimen: • PegIntron (1, 5 mikrogram/ kg/ uge) + ribavirin (800 mg/ dag), (n = 511). • PegIntron (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).
15 following combination regimens: • Peg Intron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • PegIntron (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 PegIntron (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 PegIntron (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 PegIntron 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 Peg Intron or interferon alfa-2b.
Hos disse patienter, som fik > 10, 6 mg/ kg ribavirin (800 mg dosis for en typisk patient på 75 kg), uafhængigt af genotype eller virusmængde, var responsraten signifikant højere end hos de patienter, der fik ≤ 10, 6 mg/ kg ribavirin (Tabel 6), mens responsraten i patienter, der fik > 13, 2 mg/ kg ribavirin var endnu højere.
In those patients that received > 10.6 mg/kg ribavirin (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 ribavirin (Table 6), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Vedvarende virologisk
Sustained virological response (% patients HCV negative) PegIntron monotherapy
respons (% patienter HCV negative) PegIntron monoterapi PegIntron + ribavirin 16
PegIntron + ribavirin
Behandlingsregimen
Treatment regimen
P 1, 5
P 1.5
P 1, 0
P 1.0
P 0, 5
P 0.5
P 0, 5/ R
P 1.5/R P 0.5/R
315
315
Respons ved afsluttet behandling
Response at end of treatment
P 1, 5 PegIntron 1, 5 mikrogram/ kg P 1, 0 PegIntron 1, 0 mikrogram/ kg P 0, 5 PegIntron 0, 5 mikrogram/ kg I Interferon alfa- 2b 3 MIE P 1, 5/ R P 0, 5/ R I/ R * **
P 1.5 PegIntron 1.5 micrograms/kg P 1.0 PegIntron 1.0 microgram/kg P 0.5 PegIntron 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/R * **
PegIntron (1, 5 mikrogram/ kg) + ribavirin (800 mg) PegIntron (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 PegIntron + ribavirin (efter ribavirindosis, genotype og virusmængde)
Sustained response rates with PegIntron + ribavirin (by ribavirin dose, genotype and viral load)
Ribavirin dosis (mg/ kg)
Ribavirin dose (mg/kg)
Alle ≤ 10, 6 > 10, 6
All ≤ 10.6 > 10.6
Genotype 1 ≤ 600. 000 IU/ ml
Genotype 1 ≤ 600,000 IU/ml
Genotype 1 > 600. 000 IU/ ml
Genotype 1 > 600,000 IU/ml
Alle ≤ 10, 6 > 10, 6
All ≤ 10.6
PegIntron (1, 5 mikrogram/ kg) + ribavirin (800 mg) PegIntron (1, 5 til 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 MIE) + ribavirin (1. 000/ 1. 200 mg)
Peg Intron (1.5 micrograms/kg) + ribavirin (800 mg) PegIntron (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 PegIntron monoterapiundersøgelsen var livskvaliteten generelt mindre påvirket ved 0, 5 mikrogram/ kg PegIntron end ved enten 1, 0 mikrogram/ kg PegIntron en gang om ugen eller 3 MIE interferon alfa- 2b tre gange om ugen.
In the PegIntron monother apy study, the Quality of Life was generally less affected by 0.5 microgram/kg of PegIntron than by either 1.0 microgram/kg of PegIntron 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 PegIntron, 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 PegIntron, 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).
Fireogtyve% havde bridging fibrose eller cirrose (Knodell 3/ 4).
Twenty-four% had bridging fibrosis or cirrhosis (Knodell 3/4).
Virologisk respons ved afsluttet behandling, vedvarende virologisk respons og relaps efter HCV Genotype og virusmængde * PegIntron 1, 5 μg/ kg en gang ugentlig plus Ribavirin 800- 1. 400 mg/ dag
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* PegIntron 1.5 μg/kg once weekly plus Ribavirin 800-1,400 mg/day
Respons ved afsluttet Vedvarende virologisk respons
Sustained Virologic Response
17 behandling
All Subjects
Alle patienter
94
94% (211/ 224)
% (211/224)
(27/ 224) HCV 2 ≤ 600. 000 IU/ ml > 600. 000 IU/ ml
HCV 2 ≤ 600,000 IU/ml
100% (42/ 42) 100% (20/ 20) 100% (22/ 22)
100% (42/42) 100% (20/20)
93% (39/ 42) 95% (19/ 20) 91% (20/ 22)
93% (39/42) 95% (19/20)
7% (3/ 42) 5% (1/ 20) 9% (2/ 22)
100% (22/22)
(24/ 166) ≤ 600. 000 IU/ ml
≤ 600,000 IU/ml
> 600. 000 IU/ ml
> 600,000 IU/ml
* Enhver patient med et ikke målbart HCV- RNA niveau ved besøget i opfølgningsuge 12 og manglende resultater ved besøget i opfølgningsuge 24 blev betragtet som vedvarende responder.
* 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 susta ined responder.
Enhver patient med manglende resultater i og efter perioden omkring opfølgningsuge 12 blev betragtet som en non- responder ved 24 ugers opfølgning.
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.
Den 6 måneders behandlingsvarighed i denne undersøgelse blev tolereret bedre end et års behandling i den grundlæggende kombinationsundersøgelse; seponering hos 5% mod 14%, dosisjustering hos 18% mod 49%.
49%.