natgillin/translations-raw huggingface dataset:
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 Rebetol i kombination med peginterferon alfa- 2b (WHO grad 3:
There were some cases of more severe neutropenia in patients treated with Rebetol in combination with peginterferon alfa-2b (WHO grade 3:
39 af 186 [21%)] og WHO grad 4:
39 of 186 [21%]; and WHO grade 4:
13 af 186 [7%]); WHO grad 3 leukopeni blev også rapporteret hos 7% af denne behandlingsgruppe.
13 of 186 [7%]); WHO grade 3 leukopenia was also reported in 7% of this treatment group.
En stigning i urinsyre og indirekte bilirubin værdier forbundet med hæmolyse blev set hos nogle patienter behandlet med Rebetol anvendt i kombination med peginterferon alfa- 2b eller interferon alfa- 2b i kliniske undersøgelser, men værdierne vendte tilbage til baseline niveau fire uger efter afsluttet behandling.
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Rebetol 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.
Patienter med samtidig infektion med HCV/ HIV 13 For HCV/ HIV co- inficerede patienter, der modtog Rebetol i kombination med peginterferon alfa- 2b, har der været rapporteret andre bivirkninger (som ikke blev rapporteret hos mono- inficerede patienter).
For HCV/HIV co-infected patients receiving Rebetol 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%),
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%).
13 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).
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 Rebetol i kombination med peginterferon alfa- 2b sammenlignet med patienter, der modtog Rebetol i kombination med interferon alfa- 2b.
Haematological abnormalities were more frequently reported in patients receiving Rebetol in combination with peginterferon alfa-2b when compared to patients receiving Rebetol 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 i 4% (8/ 194) af de patienter, der modtog Rebetol i kombination med peginterferon alfa- 2b.
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 Rebetol in combination with peginterferon alfa-2b.
Anæmi (hæmoglobin < 9, 4 g/ dl) blev rapporteret i 12% (23/ 194) af patienterne, der blev behandlet med Rebetol i kombination med peginterferon alfa- 2b.
Anaemia (haemoglobin < 9.4 g/dl) was reported in 12% (23/194) of patients treated with Rebetol in combination with peginterferon alfa-2b.
Fald i CD4- lymfocytter:
CD4 lymphocytes decrease:
Behandling med Rebetol 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 Rebetol 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 Rebetol i kombination med peginterferon alfa- 2b havde ingen observerbar negativ indvirkning på kontrollen af HIV- viræmi under behandling eller opfølgning.
The use of Rebetol in combination with peginterferon alfa-2b 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 specifikke for det enkelte produkt samt potentialet for overlappende toksiciteter med Rebetol 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 Rebetol in combination with peginterferon alfa-2b.
I kliniske undersøgelser med 118 børn og unge i alderen 3 til 16 år afbrød 6% behandling på grund af bivirkninger.
In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
4. 4).
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).
Rapporterede bivirkninger i Tabel 5 er baseret på erfaring fra pædiatriske kliniske undersøgelser.
Reported adverse reactions listed in Table 5 are based on experience from paediatric clinical trials.
Indenfor 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 Rebetol med interferon alfa- 2b injektion i pædiatriske patienter
Adverse reactions very commonly and commonly reported during clinical trials of Rebetol with interferon alfa-2b injection in paediatric patients
14 Systemorganklasse Bivirkninger
Adverse Reactions
Infektioner og parasitære sygdomme Meget almindelig Almindelig
Common:
Virusinfektion, pharyngitis Svampeinfektion, bakterieinfektion, pulmonær infektion, otitis media, tandbylder, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection,
Meget almindelig Almindelig Det endokrine system
Endocrine disorders
Anæmi, neutropeni Thrombocytopeni, lymfadenopati,
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy
Meget almindelig Almindelig Metabolisme og ernæring
Metabolism and nutrition disorders
Hypothyreoidisme Hyperthyreoidisme, virilisering
Hypothyroidism Hyperthyroidism, virilism
Meget almindelig Almindelig Psykiske forstyrrelser
Psychiatric disorders
Anoreksi Hypertriglyceridæmi, hyperuricæmi, øget appetit
Anorexia Hypertriglyceridemia, hyperuricemia, increased appetite
Meget almindelig Almindelig Nervesystemet
Nervous system disorders
Depression, søvnløshed, emotionel labilitet Selvmordstanker, aggresiv opførsel, forvirring, unormal opførsel, uro, søvngængeri, angst, nervøsitet, søvnforstyrrelser, abnorme drømme, apati
Depression, insomnia, emotional lability Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
Meget almindelig Almindelig Øjne
Eye disorders
Hovedpine, svimmelhed Hyperkinesi, tremor, dysfoni, paræstesi, hypoæstesi, hyperæstesi, nedsat koncentration, somnolens
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Almindelig Vaskulære sygdomme
Vascular disorders
Almindelig Luftveje, thorax og mediastinum
Common:
Raynauds syndrom, rødme, bleghed
Raynaud’s disease, flushing, pallor
Almindelig Mave- tarm- kanalen
Gastro-intestinal disorders
Dyspnø, tachypnoea, næseblod, hoste, næsetæthed, næseirritation, næseflåd, nysen
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Meget almindelig Almindelig Lever og galdeveje
Hepatobiliary disorders
Diarre, opkastning, kvalme, abdominal smerte Mundsår, ulcerøs stomatitis, stomatitis, smerte i højre øvre kvadrant, dyspepsi, glossitis, gastro - øsofageal reflux, rektal lidelse, gastrointestinal lidelse, forstoppelse, løse afføringer, tandpine, tandlidelse
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
Almindelig Hud og subkutane væv
Skin and subcutaneous tissue disorders
Meget almindelig Almindelig Knogler, led, muskler og bindevæv
Common:
Alopeci, udslæt Lysoverfølsomhedsreaktion, maculopapuløst udslæt, eksem, akne, hudlidelse, neglelidelse, hudmisfarvning, pruritus, tør hud, erythem, blå mærker, øget svedtendens
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
Meget almindelig Nyrer og urinveje
Musculoskeletal and connective tissue disorders Very common:
Almindelig Det reproduktive system og mammae
Reproductive system and breast disorders
Ufrivillig vandladning, ændret 15 vandladningsfrekvens, urininkontinens
Enuresis, micturition disorder, urinary incontinence
Amenorrhea, menorrhagi, menstruationsforstyrrelser, vaginallidelse, Mænd: testikulær smerte
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Almene symptomer og reaktioner på administrationsstedet Meget almindelig
General disorders and administration site Very common:
Inflammation på injektionsstedet, reaktion på injektionsstedet, træthed, rigor, feber, influenzalignende symptomer, utilpashed, irritabilitet
conditions Injection site inflammation, injection site reaction, fatigue, rigors, fever, influenza-like symptoms, malaise, irritability
Almindelig Undersøgelser
Investigations
Brystsmerter, asteni, ødem, smerte på injektionsstedet
Chest pain, asthenia, oedema, injection site pain 15
Nedsat voksehastighed (højde - og/ eller vægtfald i forhold til alder)
Growth rate decrease (height and/or weight decrease for age)
Traumer, forgiftninger og behandlingskomplikationer Almindelig
Injury, poisoning and procedural complications
Hudrifter
Common:
4. 9 Overdosering
Skin laceration
I kliniske undersøgelser med Rebetol anvendt i kombination med peginterferon alfa- 2b eller interferon alfa- 2b var den højeste rapporterede overdosering en total dosis på 10 g Rebetol (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 Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (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.
Patienten blev observeret i to dage på skadestue, og i denne periode blev der ikke noteret nogen bivirkning fra overdoseringen.
The patient was observed for two days in the emergency room, during which time no adverse event from the overdose was noted.
Direkte virkende antivirale stoffer, nukleosider og nukleotider (eksklusiv reverse transcriptase- hæmmere), ATC- kode:
Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code:
Mekanismen ved hvilken Rebetol i kombination med peginterferon alfa- 2b eller interferon alfa- 2b udøver sine virkninger mod HCV er ukendt.
The mechanism by which Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b exerts its effects against HCV is unknown.
Resultater fra disse undersøgelser viste, at Rebetol 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 Rebetol 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.
Rebetol kliniske undersøgelser hos voksne Anvendelsen af Rebetol i kombinationsbehandling med peginterferon alfa- 2b eller interferon alfa- 2b blev vurderet i en række kliniske undersøgelser.
Rebetol clinical trials in adults The use of Rebetol 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 polymerase kædereaktionstest (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 ALT.
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 Rebetol + interferon alfa- 2b (C95- 132 og I95- 143) og en med Rebetol + peginterferon alfa- 2b (C/ I98 - 580).
Naïve patients Three trials examined the use of interferon in naïve patients, two with Rebetol + interferon alfa-2b (C95-132 and I95-143) and one with Rebetol + peginterferon alfa-2b (C/I98-580).
16 fordobling i vedvarende respons).
The sustained response at the end of follow-up was significantly increased by the addition of Rebetol to interferon alfa-2b (41% vs 16%, p < 0.001).
Dette var tilfældet for alle HCV genotyper, især genotype 1, i hvilken relapsraten 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: • Rebetol (800 mg/ dag) + peginterferon alfa- 2b (1, 5 mikrogram/ kg/ uge) (n = 511). • Rebetol (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). • Rebetol (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: • Rebetol (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511). • Rebetol (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). • Rebetol (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
I denne undersøgelse var kombinationen af Rebetol og peginterferon alfa- 2b (1, 5 mikrogram/ kg/ uge) signifikant mere effektiv end kombinationen af Rebetol og interferon alfa- 2b, især hos patienter inficeret med genotype 1.
16 In this trial, the combination of Rebetol and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of Rebetol and interferon alfa-2b, particularly in patients infected with Genotype 1.
Responsrater i denne undersøgelse blev imidlertid vist også at være afhængige af dosis af Rebetol 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 Rebetol administered in combination with peginterferon alfa-2b or interferon alfa-2b.
For de patienter, som fik > 10, 6 mg/ kg Rebetol (800 mg dosis i en typisk patient på 75 kg), uafhængigt af genotype eller virusmængde, var responsrater signifikant højere end for de patienter, der fik ≤ 10, 6 mg/ kg Rebetol (Tabel 6), mens responsrater for patienter, der fik > 13, 2 mg/ kg Rebetol, var endnu højere.
In those patients that received > 10.6 mg/kg Rebetol (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 Rebetol (Table 6), while response rates in patients that received > 13.2 mg/kg Rebetol were even higher.
Vedvarende responsrater med Rebetol + peginterferon alfa- 2b (efter Rebetol dosis [mg/ kg], genotype og virusmængde)
Sustained response rates with Rebetol + peginterferon alfa-2b (by Rebetol dose [mg/kg], genotype and viral load)
Rebetol dosis (mg/ kg)
Rebetol dose (mg/kg)
Alle genotyper
All Genotypes Genotype 1 Genotype 1
Alle ≤ 10, 6 > 10, 6
≤ > ≤ >
Alle ≤ 10, 6 > 10, 6
All 10.6 10.6 All 10.6 10.6 All
Genotype 1 ≤ 600. 000 IE/ ml
≤ 600,000 IU/ml Genotype 1
Alle ≤ 10, 6 > 10, 6
10.6 10.6 All
Genotype 1 > 600. 000 IE/ ml
> 600,000 IU/ml Genotype 2/3
Alle ≤ 10, 6 > 10, 6
10.6 10.6 All 10.6 10.6
Rebetol (800 mg) + peginterferon alfa- 2b (1, 5 mikrogram/ kg) Rebetol (1. 000/ 1. 200 mg) + peginterferon alfa- 2b (1, 5 til 0, 5 mikrogram/ kg) Rebetol (1. 000/ 1. 200 mg) + interferon alfa- 2b (3 MIE)
Rebetol (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) Rebetol (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) Rebetol (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
I en separat undersøgelse fik 224 patienter med genotype 2 eller 3 peginterferon alfa- 2b, 1, 5 mikrogram/ kg subkutant en gang ugentligt i kombination med Rebetol 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 peginterferon alfa-2b, 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* Rebetol 800-1,400 mg/day Plus peginterferon alfa-2b 1.5 μg/kg Once Weekly
17
End
Respons ved afsluttet behandling
of Treatment Response
(27/ 224) HCV 2 ≤ 600. 000 IE/ ml
HCV 2 ≤ 600,000 IU/ml
> 600. 000 IE/ ml
> 600,000 IU/ml
(24/ 166) ≤ 600. 000 IE/ ml
≤ 600,000 IU/ml
I et ikke- sammenlignende studie fik 235 patienter med genotype 1 og lav virusmængde (< 600. 000 IE/ ml) peginterferon alfa- 2b 1, 5 mikrogram/ kg subkutant en gang ugentlig i kombination med vægtjusteret Rebetol.
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Forudsigelighed med hensyn til vedvarende virologisk respons hos naive patienter Virologisk repons ved uge 12, defineret som en 2- log reduktion af virusmængden eller ikke påviselige værdier for HCV RNA, er vist som værende prædiktiv for vedvarende respons (se Tabel 8).
Predictability of sustained virological response in naïve patients Virological response by week 12, defined as a 2-log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (Table 8).
til vedvarende respons efter viralt respons ved uge 12
Predictability of sustained response by viral response at week 12 and genotype*
Genotype
Treatment
Viralt respons ved Vedvarende respons Negativ uge 12 prædiktiv værdi
Genotype Viral response at Sustained response Negative week 12 predictive value
(> 10, 6 mg/ kg) + peginterferon alfa- 2b 1, 5 48- ugers behandling Rebetol 800 –
1.5 48-week treatment
1
No 25% (28/110)
Ja 75% (82/ 110) 71% (58/ 82) ---- Nej 25% (28/ 110) 0% (0/ 28) 100%
0% (0/28)
1. 400 mg + peginterferon alfa- 2b 1, 5 24- ugers behandling
Rebetol 800-1400 mg 2 and 3 +peginterferon alfa-2b
2 og 3
(177/213)
Ja 99% (213/ 215) 83% (177/ 213) ---- Nej 1% (2/ 215) 50% (1/ 2) 50%
----
* viser patienter med 12 ugers resultat tilgængeligt
1.5 24-week treatment *reflects patients with 12 week data available
Samtidig infektion med HCV/ HIV
No 1% (2/215)
18 Der har været udført to undersøgelser af 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.
Respons på behandlingen i begge af disse undersøgelser er vist i Tabel 9.
The response to treatment in both of these trials is presented in Table 9.
Patienterne blev randomiseret til enten at modtage Rebetol (800 mg/ dag) plus peginterferon alfa- 2b (1, 5 μg/ kg/ uge) eller Rebetol (800 mg/ dag) plus interferon alfa- 2b (3- MIE TIW) i 48 uger med en opfølgningsperiode på 6 måneder.
Patients were randomized to receive either Rebetol (800 mg/day) plus peginterferon alfa-2b (1.5 µg/kg/week) or Rebetol (800 mg/day) plus interferon alfa-2b (3 MIU TIW) for 48 weeks with a follow-up period of 6 months.
Patienterne blev randomiseret til enten at modtage Rebetol (800- 1. 200 mg/ dag baseret på vægt) plus peginterferon alfa- 2b (100 eller 150 μg/ uge baseret på vægt) eller Rebetol (800- 1. 200 mg/ dag baseret på vægt) plus interferon alfa- 2b (3 MIE TIW).
Patients were randomized to receive either Rebetol (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or Rebetol (800- 1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Behandlingsvarigheden var 48- uger med en opfølgningsperiode på 6 måneder med undtagelse af patienter, der var inficeret med genotype 2 eller 3 og viral load < 800. 000 IE/ ml (Amplicor), som blev behandlet i 24 uger med en 6 måneders opfølgningsperiode.
The duration of therapy was 18 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Tabel 9
Table 9 Sustained virological response based on genotype after Rebetol in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Vedvarende virologisk respons baseret på genotype efter Rebetol i kombination med peginterferon alfa- 2b hos patienter med samtidig infektion af HCV/ HIV Undersøgelse 11 Undersøgelse 22 Rebetol (800 - Rebetol 1. 200 mg/ dag) d (800 mg) Rebetol + + (800 mg) + peginterferon Rebetol (800 - Peginterferon Interferon alfa- 2b (100 1. 200 mg) d + alfa- 2b alfa- 2b or Interferon (1, 5 µg/ kg / (3 MIE TIW) p - 150c µg/ uge) alfa- 2b p - uge) værdia (3 MIE TIW) værdi
p
Alle Genotype 1, 4
All Genotype 1, 17 4
27% (56/ 205) 20% 17% (21/ 125)
27% (56/205) 20%% (21/125)
(41/ 205) 0, 047 44% (23/ 52) 6% (8/ 129) 0, 006 38% (12/ 32)
44% (23/52) 0.006 38% (12/32)
Genotype 2, 3
Genotype 2, 44% (35/80) 3