natgillin/translations-raw huggingface dataset:
Emotionelle sygdomme, ændringer i stemningslejet aggression, nervøsitet, nedsat libido
Emotional disorders, mood alteration Aggression, nervousness, libido decreased
Hovedpine, svimmelhed *, koncentrationsbesvær
Headache, dizziness*, concentration impaired
Hukommelsessvæk - kelse, besvimelse, svaghed, migræne, hypoæstesi, hyperæstesi, paræstesier, tremor, smagsforstyrrelser, mareridt, somnolens
Memory impairment, syncope, weakness, migraine, hypoaesthesia, hyperaesthesia, paraesthesia, tremor, taste disturbance, nightmares, somnolence
Koma, konvulsioner, facialisparese
Coma, convulsions,, facial palsy
Retinal blødning
Retinal hemorrhage
Optisk neuropati, Synstab papilødem, retinal vaskulær lidelse, retinopati, sår på cornea
Optic neuropathy, papilledema, retinal vascular disorder, retinopathy, corneal ulcer
Vertigo, øresmerter Takykardi, palpitationer, perifere ødemer
Vertigo, earache
Myokardie - infarkt, kongestiv hjertesygdom, angina, supraventrikulær takykardi, arytmier, atrieflimren, pericarditis, kardiomyopati
Myocardial infarction, congestive heart failure, angina, supraventricular tachycardia, arrhythmia, atrial fibrillation, pericarditis, cardiomyopathy
Hjerneblødning, vasculitis
Cerebral haemorrhage, vasculitis
Dyspnø under anstrengelser, epistaxis, nasopharyngitis, sinuskongestion, nasal kongestion, rhinitis, ondt i halsen
Dyspnoea exertional, epistaxis, nasopharyngitis, sinus congestion, nasal congestion, rhinitis, sore throat
Hiven efter vejret
Wheezing
Interstitiel pneumonitis inklusiv fatal udgang, lungeemboli
Interstitial pneumonitis including fatal outcome, pulmonary embolism
Mave- tarmkanalen
14 Body system
Diarré *, kvalme *, abdominalsmerter *
Very Common ≥ 1/ 10
Opkastning, dyspepsi, dysfagi, sår i munden, gingival blødning, glossitis, stomatitis, flatulens, mundtørhed
Common ≥ 1/ 100 to < 1/ 10
Gastrointestinal blødning
Uncommon ≥ 1/ 1000 to < 1/ 100
Mavesår, pancreatitis
Rare ≥ 1/ 10,000 to < 1/ 1000
14 System - organklasse
Very rare < 1/ 10,000
Meget almindelig ≥1/ 10
Gastrointestinal disorders
Almindelig ≥1/ 100 til < 1/ 10
Diarrhoea*, nausea*, abdominal pain*
Ikke almindelig ≥1/ 1. 000 til < 1/ 100
Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
Sjælden ≥1/ 10. 000 til < 1/ 1. 000
Gastrointestinal bleeding
Meget sjælden < 1/ 10. 000
Peptic ulcer, pancreatitis
Leverinsuffi - ciens, cholangitis, fedtlever
Hepatic failure, cholangitis, fatty liver
Udslæt, øget svedtendens psoriasis, urticaria, eksem, hudsygdomme, lysoverfølsomhedsreak - tioner, nattesved
Rash, sweating increased, psoriasis, urticaria, eczema, skin disorder, photosensitivity reaction, night sweats
Toksisk epidermal necrolyse, Stevens - Johnsons syndrom, angioødem, erythem multiforme
Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme
Knogler, led, muskler og bindevæv
Musculoskeletal Myalgia, connective tissue arthralgia and bone disorders
Rygsmerter, arthritis, muskelslaphed, knoglesmerter, nakkesmerter, smerter i muskler og skelet, muskelkramper
Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskeletal pain, muscle cramps
Myositis
Myositis
Almene symptomer Pyreksi, og reaktioner på kulderystelser *, administrationsstedet smerter *, asteni, træthed, reaktioner på injektionsstedet *, irritabilitet *
General disorders Pyrexia, and rigors*, administration pain*, site conditions asthenia, fatigue, injection site reaction*, irritability*
Undersøgelser Traumer og forgiftninger
Investigations Injury and poisoning
* Disse uønskede hændelser var almindelige (≥1/ 100 til < 1/ 10) hos patienter med kronisk hepatitis B, der bliver behandlet med Pegasys monoterapi
*These adverse reactions were common (≥ 1/ 100 to < 1/ 10) in CHB patients treated with Pegasys monotherapy
Uønskede hændelser efter markedsføring
Post marketing adverse events
Frekvens ukendt.
Cerebral ischemia: frequency unknown.
Øjne:
Eye Disorders:
Frekvens ukendt.
Serous retinal detachment: frequency unknown.
Ligesom for andre alfa- inteferoner har der med Pegasys været rapporteret alvorlig løsrivning af retina.
As with other alpha interferons, serous retinal detachment has been reported with Pegasys.
Knogler, led, muskler og bindevæv:
Musculoskeletal connective tissue and bone disorders:
Frekvens ukendt.
Rhabdomyolysis: frequency unknown.
Laboratorieværdier Behandling med Pegasys ledsagedes af abnorme laboratorieværdier:
15 Laboratory values Pegasys treatment was associated with abnormal laboratory values:
4. 4).
ALT increase, bilirubin increase, electrolyte disturbance (hypokalaemia, hypocalcaemia, hypophosphataemia), hyperglycaemia, hypoglycaemia and elevated triglycerides (see section 4.4.).
Både efter Pegasys monoterapi og efter kombineret behandling med ribavirin fik op til 2% af patienterne ALAT- stigninger, som medførte dosisjustering eller afbrydelse af behandlingen.
With both Pegasys monotherapy, and also the combined treatment with ribavirin, up to 2% of patients experienced increased ALT levels that led to dose modification or discontinuation of the treatment.
4. 2 og 4. 4).
Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
15 Moderat (absolut neutrofillocyttal:
Moderate (ANC:
24% (216/ 887) og 5% (41/ 887) af de patienter, som fik 180 mikrogram Pegasys og 1000/ 1200 milligram ribavirin i 48 uger.
0.749 - 0.5 x 109/ l) and severe (ANC: < 0.5 x 109/ l) neutropenia was observed respectively in 24% (216/ 887) and 5% (41/ 887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/ 1200 milligrams for 48 weeks.
Anti- interferon antistoffer 1- 5% af de patienter, som blev behandlet med Pegasys udviklede neutraliserende antistoffer.
Anti-interferon antibodies 1-5% of patients treated with Pegasys developed neutralising anti-interferon antibodies.
Som for andre interferoner blev der set en høj incidens af neutraliserende antistoffer ved kronisk hepatitis B; dette var imidlertidigt ikke korreleret med fravær af terapeutisk respons hos nogen af sygdommene.
However in neither disease was this correlated with lack of therapeutic response.
4. 4).
Thyroid function Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
De observerede hyppigheder (4, 9%) hos patienter, som fik Pegasys/ ribavirin (NV15801), var den samme, som observeret for andre interferoner.
The frequencies observed (4.9%) in patients receiving Pegasys/ ribavirin (NV15801) are similar to those observed with other interferons.
Laboratorieværdier hos hiv- HCV- co- inficerede patienter Selvom hæmatologisk toksicitet som neutropeni, trombocytopeni og anæmi indtraf hyppigere hos hiv - HCV- patienter, kunne størstedelen af patienterne håndteres ved hjælp af dosismodifikation og anvendelse af vækstfaktorer og kun mindre hyppigt var det nødvendigt med præmatur ophør af behandlingen.
Laboratory values for HIV-HCV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
13% og 11% af patienterne, som fik Pegasys - monoterapi eller kombinationsbehandling.
Decrease in ANC levels below 500 cells/ mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
10% og 8% af patienterne, som fik Pegasys- monoterapi eller kombinationsbehandling.
Decrease in platelets below 50,000/ mm3 was observed in 10% and 8% of patients receiving Pegasys monotherapy and combination therapy, respectively.
7% og 14% af patienterne, som fik Pegasys - monoterapi eller kombinationsbehandling.
Anaemia (haemoglobin < 10g/ dL) was reported in 7% and 14% of patients treated with Pegasys monotherapy or in combination therapy, respectively.
1260 mikrogram/ uge).
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for1 week (ie, 1260 micrograms/ week) have been reported.
Immunstimulerende middel/ cytokin, ATC- kode:
Immunostimulating Agent/ Cytokine, ATC code:
Ved konjugering af PEG- reagens (bis- monomethoxypolyethylenglycol) til interferon alfa- 2a dannes et pegyleret interferon alfa- 2a (Pegasys).
The conjugation of PEG reagent (bis-monomethoxypolyethylene glycol) to interferon alfa-2a forms a pegylated interferon alfa-2a (Pegasys).
In vitro har Pegasys de samme antivirale og antiproliferative virkninger, som er karakteristisk for interferon alfa- 2a.
Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.
20. 000.
16 Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/ mole of protein. The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000.
HCV- RNA- niveauet falder bifasisk hos responderende patienter med hepatitis C, som har fået behandling med 180 mikrogram Pegasys.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
Faldets første fase indtræffer indenfor 24 til 36 timer efter den første Pegasys- dosis, og efterfølges af anden fase, som fortsætter de næste 4 til 16 uger hos patienter med varigt respons.
The first phase of decline occurs 24 to 36 hours after the first dose of Pegasys and is followed by the second phase of decline which continues over the next 4 to 16 weeks in patients who achieve a sustained response.
Ribavirin havde ingen signifikant effekt på den initiale virale kinetik i de første 4 til 6 uger hos patienter, som behandledes med kombinationen af ribavirin og pegyleret interferon alfa- 2a eller med interferon alfa.
Ribavirin had no significant effect on the initial viral kinetics over the first 4 to 6 weeks in patients treated with the combination of ribavirin and pegylated interferon alfa-2a or interferon alfa.
16 Kronisk hepatitis B:
Chronic hepatitis B:
Resultater fra kliniske studier Alle kliniske studier rekrutterede patienter med kronisk hepatitis B med aktiv viral replikation bedømt ved HBV- DNA, forhøjede ALAT- niveauer og en leverbiopsi, som var konsistent med kronisk hepatitis.
Clinical trial results All clinical trials recruited patients with chronic hepatitis B who had active viral replication measured by HBV DNA, elevated levels of ALT and a liver biopsy consistent with chronic hepatitis.
Studie WY16240 rekrutterede patienter, som var HBeAg- positive, mens studie WV16241 rekrutterede patienter, som var HBeAg- negative og anti- HBe- positive.
Study WV16240 recruited patients who were positive for HBeAg, while study WV16241 recruited patients who were negative for HBeAg and positive for anti-HBe.
I begge studier varede behandlingen 48 uger med 24 ugers behandlingsfri follow- up.
In both studies the treatment duration was 48 weeks, with 24 weeks of treatment-free follow-up.
De to studiers responsrater ved afslutningen af follow- up- perioden fremgår af tabel 5.
Response rates at the end of follow-up for the two studies are presented in Table 5.
I studie WV16240 var primære endepunkter for effekt HBeAg- serokonversion og HBV- DNA under 105 kopier/ ml.
In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105 copies/ ml.
I studie WV16241 var primære endepunkter for effekt normalisering af ALAT og HBV - DNA under 2 x 104 kopier/ ml.
In study WV16241, the primary efficacy endpoints were ALT normalisation and HBV-DNA below 2 x 104 copies/ ml.
HBV- DNA blev målt med COBAS AMPLICORTM HBV MONITOR Assay (detektionsgrænse 200 kopier/ ml).
HBV-DNA was measured by the COBAS AMPLICOR™ HBV MONITOR Assay (limit of detection 200 copies/ ml).
I alt havde 283/ 1351 (21%) af patienterne fremskreden fibrose eller cirrose, 85/ 1351 (6%) havde cirrose.
A total of 283/ 1351 (21%) of patients had advanced fibrosis or cirrhosis, 85/ 1351 (6%) had cirrhosis.
Serologisk, virologisk og biokemisk respons ved kronisk hepatitis B
Serological, Virological and Biochemical Responses in Chronic Hepatitis B
Studie WV16240
HBeAg positive Study WV16240
Studie WV16241
HBeAg negative / anti-HBe positive Study WV16241
Respons - Parameter
Response Parameter
Pegasys 180 µg & Placebo
Pegasys 180 mcg & Placebo
Pegasys 180 µg & Lamivudin 100 mg
Pegasys 180 mcg & Lamivudine 100 mg
(N=177)
(N=177)
(N=179)
(N=179)
(N=181)
(N=181)
HBeAg- sero - konversion
HBeAg Sero- conversion
HBV- DNA respons *
HBV DNA response *
ALAT - normalisering
ALT Normal- isation
HBsAg- sero - konversion
HBsAg Sero- conversion
* For HBeAg- positive patienter:
* For HBeAg-positive patients:
HBV- DNA < 105 kopier/ ml For HBeAg- negative / anti- HBe- positive patienter:
HBV DNA < 105 copies/ ml For HBeAg-negative / anti-HBe-positive patients:
HBV- DNA < 2 x 104 kopier/ ml
HBV DNA < 2 x 104 copies/ ml
# p- værdi (vs. lamivudin) < 0, 01 (stratificeret Cochran- Mantel- Haenszel test)
# p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
Det histologiske respons var det samme for de tre behandlingsgrupper i hvert studie; der var dog signifikant flere patienter med bevaret respons 24 uger efter behandlingens afslutning, som også fik histologisk bedring.
17 Histological response was similar across the three treatment groups in each study; however, patients showing a sustained response 24 weeks after the end of treatment were significantly more likely to also show histological improvement.
Alle patienter, som fuldendte fase III- studierne, var egnede til at indgå i et langtids- follow- up- studie (WV16866).
All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866).
Blandt patienter fra studie WV16240, som fik Pegasys- monoterapi og indgik i langtids - follow- up- studiet, var raten af vedvarende HbeAg- serokonversion 12 måneder efter afslutningen af behandlingen 48% (73/ 153).
Among patients from study WV16240, who received Pegasys monotherapy and entered the long-term follow-up study, the rate of sustained HBeAg seroconversion 12 months after the end of therapy was 48% (73/ 153).
Hos patienter, der fik Pegasys- monoterapi i studie WV16241, var raten af HBV- DNA respons og ALAT- normalisering 12 måneder efter afslutning af behandling henholdsvis 42% (41/ 97) og 59% (58/ 99).
In patients receiving Pegasys monotherapy in study WV16241, the rate of HBV DNA response and ALT normalisation 12 months after end of treatment were 42% (41/ 97) and 59% (58/ 99), respectively.
17 Kronisk Hepatitis C:
Chronic hepatitis C
Responsets forudsigelighed Der henvises til 4. 2, tabel 2.
Predictability of response Please refer to section 4.2, in Table 2.
135 mikrogram og 180 mikrogram.
Dose-response in monotherapy In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
Bekræftende kliniske forsøg hos behandlingsnaive patienter I alle klinske forsøg indgik interferon naive patienter med kronisk hepatitis C, hvor diagnosen blev verificeret ved målbare niveauer af serum- HCV- RNA, forhøjede niveauer af ALAT (med undtagelse af studie NR16071) og en leverbiopsi, der korrelerer med kronisk hepatitis.
Confirmatory clinical trials in treatment-naïve patients All clinical trials recruited interferon-naïve patients with chronic hepatitis C confirmed by detectable levels of serum HCV RNA, elevated levels of ALT (with the exception of study NR16071) and a liver biopsy consistent with chronic hepatitis.
I det kliniske studie NV15495 blev der specielt rekrutteret patienter med histologisk diagnosticeret cirrose (omkring 80%) eller begyndende cirrose (omkring 20%).
Study NV15495 specifically recruited patients with a histological diagnosis of cirrhosis (about 80%) or transition to cirrhosis (about 20%).
Kun hiv- HCV- co- inficerede patienter blev inkluderet i studie NR15961 (se tabel 14).
Only HIV-HCV co-infected patients were included in the study NR15961 (see Table 14).
Disse patienter havde stabil hiv- sygdom og gennemsnittet af CD4 T - celle- tal var omkring 500 celler/ µl.
These patients had stable HIV disease and mean CD4 T-cell count was about 500 cells/ µL.
Se tabel 6, 7, 8 og 14 vedrørende hhv. behandlingsregimer, behandlingsvarighed og studieudfald for HCV- monoinficerede patienter og hiv- HCV- co- inficerede patienter.
For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 6, 7, 8 and Table 14, respectively.
(detektionsgrænse 100 kopier/ ml, lig med 50 internationale enheder/ ml) og vedvarende respons blev defineret som een negativ prøve omkring 6 måneder efter behandlingens ophør.
Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR™ HCV Test, version 2.0 (limit of detection 100 copies/ ml equivalent to 50 International Units/ ml) and sustained response as one negative sample approximately 6 months after end of therapy.
Tabel 6:
18 Table 6:
Virologisk respons hos HCV- patienter
Virological Response in HCV Patients
Pegasys monoterapi
Pegasys Monotherapy
Pegasys kombinationsterapi
Pegasys Combination Therapy
med og uden cirrose
non-
med cirrose
cirrhotic and cirrhotic cirrhotic
Pegasys Interferon 180 µg alfa- 2a 3 MIE
Pegasys 180 mcg
Pegasys Pegasys 180 µg 180 µg & & Ribavirin Ribavirin 1000/ 1200 1000/ 1200 mg mg
Ribavirin Ribavirin 1000/ 1200 1000/ 1200 mg mg
Interferon alfa- 2b 3 MIE & Ribavirin 1000/ 1200 mg
Ribavirin 1000/ 1200 mg
Respons
(N=701)
(N=701) 48 uger
(N=478)
(N=478) 48 uger
(N=87)
(N=87) (N=88) 48 uger 48 uger
(N=88)
(N=436) (N=453) 48 uger 48 uger
(N=436) (N=453)
(N=444) 48 uger
(N=444)
ved
48 weeks
55 – 69%
55 - 69%
22 – 28%
22 - 28%
44%
44% 14%
69% 22 – 28% 44% 14% 68% 69%
68% 69%
afslutning af behand - ling
Overall
Samlet vedvaren - de respons
Sustained Response
28 – 39%
28 - 39%
11 – 19%
11 - 19%
* 95% konfidensinterval for forskellighed:
* 95% CI for difference:
11% til 33% p- værdi (stratificeret Cochran- Mantel- Haenszel test) = 0, 001 ** 95% konfidensinterval for forskellighed:
3% to 16%
Det virologiske respons hos HCV- monoinficerede patienter, som behandledes med Pegasys monoterapi og med Pegasys og ribavirin kombinationsterapi, baseret på genotype og viral belastning
p-value (stratified Cochran-Mantel-Haenszel test) = 0.001 p-value (stratified Cochran-Mantel-Haenszel test)=0.003
18 ved baseline samt i relation til genotype, viral belastning ved baseline og hurtig virologisk respons ved uge 4, er opsummeret i hhv. tabel 7 og 8.
The virological responses of HCV monoinfected patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 7 and Table 8, respectively.
Resultaterne fra studie NV15942 udgør rationalet for at anbefale behandling baseret på genotype, viral belastning ved baseline og virologisk respons ved uge 4 (se tabel 1, 7 og 8).
The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 7 and 8).
Forskellen mellem behandlingsregimerne var generelt ikke påvirket af forekomst/ fravær af cirrose; derfor er behandlingsanbefalingerne for genotype 1, 2 og 3 uafhængige af denne baselinekarakteristika.
The difference between treatment regimens was in general not influenced by presence/ absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic.
Tabel 7:
19 Table 7:
Vedvarende virologisk respons baseret på genotype og viral belastning ved baseline efter behandling med Pegasys i kombination med ribavirin hos HCV- patienter
Sustained Virological Response Based on Genotype and Pre-treatment Viral Load after Pegasys Combination Therapy with Ribavirin in HCV Patients
Pegasys Pegasys Pegasys Pegasys Pegasys 180 µg 180 µg 180 µg 180 µg 180 µg
Pegasys Pegasys Pegasys Pegasys Pegasys 180 mcg 180 mcg 180 mcg 180 mcg 180 mcg
Interferon alfa- 2b 3 MIE
Interferon alfa-2b 3 MIU
24 uger
24 weeks 24 weeks
24 uger 48 uger 48 uger 48 uger
48 weeks 48 weeks 48 weeks
Genotype 1
Genotype 1 Low viral load High viral load
29% (29/ 101)
29% (29/ 101) 41% (21/ 51) 16% (8/ 50)
26% (12/ 47)
42% (49/ 118)* 52% (37/ 71) 26% (12/ 47)
36% (69/ 190)
41% (102/ 250)* 55% (33/ 60) 36% (69/ 190)
47% (87/ 186)
52% (142/ 271)* 65% (55/ 85) 47% (87/ 186)
40% (73/ 182)
45% (134/ 298) 53% (61/ 115) 40% (73/ 182)
33% (62/ 189)
36% (103/ 285) 44% (41/ 94) 33% (62/ 189)
Genotype 2/ 3
Genotype 2/ 3 Low viral load High viral load Genotype 4
84% (81/ 96)
84% (81/ 96) 85% (29/ 34) 84% (52/ 62) (0/ 5)
81% (117/ 144)
81% (117/ 144) 83% (39/ 47) 80% (78/ 97) (8/ 12)
79% (78/ 99)
79% (78/ 99) 88% (29/ 33) 74% (49/ 66) (5/ 8)
80% (123/ 153)
80% (123/ 153) 77% (37/ 48) 82% (86/ 105) (9/ 11)
71% (100/ 140)
71% (100/ 140) 76% (28/ 37) 70% (72/ 103) (10/ 13)
61% (88/ 145)
61% (88/ 145) 65% (34/ 52) 58% (54/ 93) (5/ 11)
Lav viral bel.
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL * Pegasys 180 mcg ribavirin 1000/ 1200 mg, 48 w vs.
77% (37/ 48)
Pegasys 180 mcg ribavirin 800 mg, 48 w:
Hav viral bel.
Pegasys 180 mcg ribavirin 1000/ 1200 mg, 24 w:
82% (86/ 105)
Odds Ratio (95% CI) = 2.12 (1.30 to 3.46)
Odds ratio (95% konfidensinterval) = 2, 12 (1, 30 til 3, 46), p- værdi (stratificeret Cochran- Mantel- Haenszel test) =0, 002.
P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
Det er blevet undersøgt, om behandlingsvarigheden muligvis kan forkortes til 24 uger hos patienter med genotype 1 og 4, baseret på den vedvarende virologiske respons- rate, der er observeret hos patienter med hurtig virologisk respons ved uge 4 i studierne NV15942 og ML17131 (se tabel 8).
The possibility to consider shortening treatment duration to 24 weeks in genotype 1 and 4 patients was examined based on a sustained rapid virological response observed in patients with rapid virological response at week 4 in studies NV15942 and ML17131 (see Table 8).
19 Tabel 8:
Table 8:
Vedvarende virologisk respons baseret på hurtig virologisk respons ved uge 4 for genotype 1 og 4 efter Pegasys kombinationsbehandling med ribavirin hos HCV- patienter
Sustained Virological Response Based on Rapid Viral Response at week 4 for Genotype 1 and 4 after Pegasys Combination Therapy with Ribavirin in HCV Patients
Pegasys 180 µg &
Pegasys 180 mcg &
1000/ 1200 mg 1000/ 1200 mg 24 uger 48 uger
1000/ 1200 mg 48 weeks
1000/ 1200 mg 24 uger
1000/ 1200 mg 24 weeks
Genotype 1 hurtig viral respons
Genotype 1 RVR Low viral load High viral load Genotype 1 non RVR Low viral load High viral load
90% (28/ 31) 92% (47/ 51)
90% (28/ 31) 93% (25/ 27) 75% (3/ 4) 24% (21/ 87) 27% (12/ 44) 21% (9/ 43)
93% (25/ 27) 96% (26/ 27) 75% (3/ 4) 88% (21/ 24) 24% (21/ 87) 43% (95/ 220)
92% (47/ 51) 96% (26/ 27) 88% (21/ 24) 43% (95/ 220) 50% (31/ 62) 41% (64/ 158)
80% (52/ 65) 58% (7/ 12) -
77% (59/ 77) 80% (52/ 65) 58% (7/ 12) - - -
Lav viral belastning Høj viral belastning Genotype 4 hurtig viral respons
Genotype 4 RVR
27% (12/ 44) 50% (31/ 62) 21% (9/ 43) 41% (64/ 158) (5/ 6) (5/ 5)
92% (22/ 24)
- - 92% (22/ 24)
Genotype 4 non RVR
Genotype 4 ikke - hurtig viral respons
(3/ 6)
Lav viral belastning = ≤ 800. 000 IE/ ml; Høj viral belastning = > 800. 000 IE/ ml Hurtig viral respons (HCV- RNA ikke- målelig) ved uge 4 og HCV- RNA ikke- målelig ved uge 24
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24