natgillin/translations-raw huggingface dataset:
Antiretroviral kombinationsterapi har været forbundet med omfordeling af kropsfedt (lypodystrophy) hos HIV - patienter inklusiv tab af subkutant fedtlag i ansigtet, forøget fedtlag på mave og de indre maveorganer, forøgelse af brystfedtlag og akkumulering af ryggens fedtdepoter (tyrenakke).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
4. 4).
11 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Bivirkninger:
Adverse reactions:
Følgende bivirkninger af moderat til svær grad med en mulig eller sandsynlig relation til Kaletra er blevet rapporteret.
The following adverse reactions of moderate to severe intensity with possible or probable relationship to Kaletra have been reported.
De mest alvorlige anføres først: meget almindelig > 1/ 10), almindelig (> 1/ 100, < 1/ 10, usædvanlig > 1/ 1000, < 1/ 100.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common > 1/ 10, common > 1/ 100 ,< 1/10, uncommon > 1/ 1000, < 1/ 100.
12 Bivirkninger i kliniske studier for voksne Infektiøse og parasitære sygdomme
Undesirable effects in clinical studies in adult patients Infections and infestations
Mellemørebetændelse, bronkititis, sinitus, furunculus, bakterieinfektion, virusinfektion
Otitis media, bronchitis, sinusitis, furunculosis, bacterial infection, viral infections
Godartede, ondartede og uspecificerede svulster (herunder cyster og polypper)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Hudtumorer godartede, cyster
Skin benign neoplasm, cyst
Anæmi, leukopeni og lympfadenopat
Anaemia, leucopenia and lymphadenopathy
Hypogonadisme, Cushings syndrom, hypothyreodisme
Hypogonadism male, Cushing syndrome, hypothyroidism
Stofskiftesygdomme og ernæringsbetingede sygdomme
Metabolic and nutritional disorders
A- vitaminosis, dehydrering ødemer, øget appetit, laktose acidose, fedme, anoreksi, diabetes mellitus, hyperglykæmi, hypocholesteræmi
Avitaminosis, dehydration, oedema, increased appetite, lactic acidosis, obesity, anorexia, diabetes, mellitus, hyperglycaemia, hypocholesteremia
Psykiske lidelser
Psychiatric disorder
Abnorme drømme, agitation, vrede, forvirring, depression, ufrivillige bevægelser, nedsat libido, nervøsitet, unormal tankevirksomhed
Abnormal dreams, agitation, anxiety, confusion, depression, dyskenesia, emotional liability, decreased libido, nervousness, abnormal thinking
Hovedpine, paræstesi
Headache, parathesia
Svimmelhed, hukommelsestab, ataksi, lidelser i hjernen, ansigtslammelser, forhøjet blodtryk, nervelammelser, somnolens, perifer nervebetændelse,, smagsforstyrrelser, migræne, ekstrapyramidal symdrom
Dizziness, amnesia, ataxia, encephalopathy, facial paralysis, hypertonia, neuropathy, peripheral neuritis, somnolence, tremor, taste perversion, migraine, extrapyramidal syndrome
Øjensygdomme Sygdomme i det ydre og det indre øre
Eye disorders Ear and labyrinth disorders Cardiac disorders Vascular disorders
Usædvanlig Usædvanlig
Uncommon Uncommon Uncommon Uncommon
Hypertension, tromboflebitis, vaskulitis og åreknuder, dyb thromboflebitis, karforstyrrelser
Abnormal vision, eye disorder Tinnitus Palpitation, lung oedema, myocardial infarct1 Hypertension, thrombophebitis, vasculitis, varicose vein, deep thrombophlebitis, vascular disorder
Sygdomme i ånddrætsorganer, brysthule og mediastinum
Respiratory, thoracic and mediastinal disorders
Dyspnø og rhinit, forøget hoste
Dyspnoea, rhinitis, cough increased
Gastrointestinale sygdomme
12 Gastrointestinal disorders
Diarrè Kvalme, opkastning, mavesmerter, unormal
Diarrhoea
afføring, halsbrand, luft i maven, almindelig mavebesvær
Nausea, vomiting, abdominal pain, abnormal stools, dyspepsia, flatulence, gastrointestinal disorder
synkebesvær, tarmkatar, sure opstød, betændelse i spiserøret, fækal inkontinens, gastritis, gatroenteritis, blodig colitis, sår mavemunden, pankreatit2, betændelse i spytgangene, stomatitis, stomatitis med ulceration, periodonitis
Abdomen enlarged, constipation, dry mouth, dysphagia, enterocolitis, eructation, oesophagitis, faecal incontinence, gastritis, gastroenteritis, haemorrhagic colitis, mouth ulcerations, pancreatitis2, sialadenitis, stomatitis, ulcerative stomatitis, periodontitis
Betændelse i galdeblæren, hepatitis, hepatomegali, aflejring af fedt på leveren, leverømhed
Cholecystitis, hepatitis, hepatomegaly, liver fatty deposit, liver tenderness
Sygdomme i hudog subkutane væv
Skin and subcutaneous tissue disorders
Rødme, lipodystrofi, akne
Rash, lipodystrophy, acne
Hårtab, tør hud, eksem, afskalning af hud, plettet hud, negleproblemer, pruritis, seborrhae, misfarvet hud, hudsår, ansigtsødem, svendtendens, hudstriber
Alopecia, dry skin, eczema, exfoliative dermatitis, maculopapular rash, nail disorder, pruritis, seborrhoea, skin discoloration, skin ulcer, face oedema, sweating, skin striae
Sygdomme i bevægeapparatet og bindevæv
Musculoskeletal and connective tissue disorder
Artralgi, artrosis, myalgi, nakkesmerter, led forstyrrelser
Arthralgia, arthrosis, myalgia, back pain, joint disorder
Nyresten, unormale urinprøver, albuminuria, hyperkalkuri, hyperurikæmi
Kidney calculus, urine abnormality, albuminuria, hypercalcinuria, hyperuricemia
Unormal ejakulation, bryst forstørrelse, gynækomasti, impotens, menorrhagia
Abnormal ejaculation, breast enlargement, gynecomastia, impotence, menorrhagia
Træthed, smerter
Asthenia, pain
Brystsmerter, kulderystelser, feber, infuenzasymtomer, utilpashedsfornemmelse, perifert ødem, lægemiddelinteraktioner
Chest pain, chest pain substernal, chills, fever, flu syndrome, malaise, peripheral oedema, drug interactions
Meget almindelig (grad 3 eller 4)
Very common (Grade 3 or 4)
Forhøjede triglycerider, forhøjet total kolesterol, forhøjet GGT Forhøjet glukose, forhøjet amylase, forhøjet
Increased triglycerides, increased total cholesterol, increased GGT
Almindelig (grad 3 eller 4)
Common (Grade 3 or 4)
SGOT/ AST, forhøjet SGPT/ ALT, abonorme leverfunktionstests
Increased glucose, increased amylase, increased SGOT/ AST, increased SGPT/ ALT, liver function tests abnormal
Sænket glukosetolerance, vægtforøgelse,
1 2
1
This event had a fatal outcome
vægttab, forhøjet bilirubin, ændret hormonniveau, abnorme laboratorietests
Decreased glucose tolerance, weigh gain, weight loss, increased bilirubin, hormone level altered, lab test abnormal
2 Se pkt 4. 4: pankreatitis og lipider
See Section 4.4 pancreatitis and lipids
14 Børn
13 Paediatric patients
For børn på 2 år og derover er bivirkningsmønsteret som for voksne.
In children 2 years of age and older, the nature of the safety profile is similar to that seen in adults.
Bivirkninger i kliniske studier for børn Infektiøse og parasitære sygdomme
Undesirable effects in clinical studies in paediatric patients Infections and infestations
Virusinfektioner
Viral infection
Sydomme i nervesystemet
Nervous system disorders
Smagsforstyrrelser
Taste perversion
Gastrointestinale sygdomme
Gastrointestinal disorders Hepatobiliary disorders Skin and subcutaneous tissue disorders
Almindelig
Common Common Common
Forstoppelse, opkastning og pankeatitis *
Constipation, vomiting, pancreatitis Hepatomegaly Rash, Dry skin
Almindelig (Grad 3 eller 4)
Common (Grade 3 or 4)
Forhøjet trombocyttid, lav hæmaglobin, lav blodpladeværdi, forhøjet natrium, forhøjet kalium, forhøjet calcium, forhøjet bilirubin, forhøjet SGPT/ ALT, forhøjet SGOT/ AST, forhøjet totalkolesterol, forhøjet amylase, forhøjet urinsyre, lav natrium, lav kalium, lav calcium, lav neutrofilværdi
Increased activated partial thromboplastin time, decreased haemoglobin, decreased platelets, increased sodium, increased potassium, increased calcium, increased bilirubin, increased SGPT/ ALT, increased SGOT/ AST, increased total cholesterol, increased amylase, increased uric acid, decreased sodium, decreased potassium, decreased calcium, decreased neutrophils
* se pkt 4. 4: pankreatitis og lipider
*see section 4.4: pancreatitis and lipids
Post marketing erfaring
Post marketing experience
Der er rappporteret om hepatitis, og sjældent gulsot, hos patienter, både med og uden identificerbare riskofaktorer for hepatitis, i behandling med Kaletra.
Hepatitis, and rarely jaundice, have been reported in patients on Kaletra therapy in the presence or absence of identifiable risk factors for hepatitis.
Der er rapporteret om Steven- Johnson syndrom og erythema multiforme.
Stevens-Johnson syndrome and erythema multiforme have been reported.
Der er rapporteret om tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskreden HIV- sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
De kliniske bivirkninger observeret i hunde inkluderer spytafsondring, emesis, og diarré/ unormal afføring.
The adverse clinical signs observed in dogs included salivation, emesis and diarrhoea/ abnormal stool.
Hvis påkrævet kan eliminering af ikke- absorberede aktivt stof opnås ved emesis eller maveskylning.
If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage.
Ligeledes kan administration af aktivt kul anvendes for at lette fjernelsen af ikke - absorberet aktivt stof.
Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance.
Farmakoterapeutisk klassifikation: proteasehæmmer, ATC- kode:
Pharmaco-therapeutic group: protease inhibitor, ATC code:
Lopinavir hæmmer HIV- 1 og HIV- 2 proteasen.
Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases.
Hæmning af HIV protease forhindrer spaltningen af gag- pol polyproteinet, hvilket resulterer i dannelsen af umodne, ikke- infektiøse virus.
Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Effekter på elektrokardiogram:
Effects on the electrocardiogram:
QTcF- intervallet blev evalueret i et randomiseret, placebo og aktiv (moxifloxacin 400 mg en gang daglig) kontrolleret overkrydsnings- forsøg hos 39 raske voksne, med 10 målinger over 12 timer på dag 3.
QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 39 healthy adults, with 10 measurements over 12 hours on Day 3.
De maksimale gennemsnitlige (95% øvre konfidensgrænse) forskelle i QTcF fra placebo var henholdsvis 3, 6 (6, 3) og 13, 1( 15, 8) for 400/ 100 mg to gange daglig og supraterapeutisk 800/ 200 mg to gange daglig LPV/ r.
The maximum mean (95% upper confidence bound) differences in QTcF from placebo were 3.6 (6.3) and 13.1(15.8) for 400/ 100 mg twice daily and supratherapeutic 800/ 200 mg twice daily LPV/ r, respectively.
Den inducerede QRS- interval- forlængelse fra 6 ms til 9, 5 ms med høj- dosis lopinavir/ ritonavir (henholdsvis 800/ 200 mg to gange daglig) medvirker til QT- forlængelse.
The induced QRS interval prolongation from 6 ms to 9.5 ms with high dose lopinavir/ ritonavir (800/ 200 mg twice daily) contributes to QT prolongation.
Ved steady state resulterede de to regimer i ekspositioner på dag 3, som var tilnærmelsesvis 1, 5 og 3- gange højere end dem, som blev set med den anbefalede LPV/ r dosis en gang daglig eller to gange daglig.
The two regimens resulted in exposures on Day 3 which were approximately 1.5 and 3-fold higher than those observed with recommended once daily or twice daily LPV/ r doses at steady state.
Ingen individer oplevede en stigning i QTcF på ≥ 60 msek fra baseline eller et QTcF- interval, som oversteg den potentielt kliniske relevante grænse på 500 msek.
No subject experienced an increase in QTcF of ≥ 60 msec from baseline or a QTcF interval exceeding the potentially clinically relevant threshold of 500 msec.
På dag 3 blev også set beskeden forlængelse af PR- intervallet hos individer, som fik lopinavir/ ritonavir i det samme forsøg.
Modest prolongation of the PR interval was also noted in subjects receiving lopinavir/ ritonavir in the same study on Day 3.
De gennemsnitlige ændringer i PR- interval fra baseline strækker sig fra 11, 6 ms til 24, 4 ms i et interval på 12 timer efter dosen.
The mean changes from baseline in PR interval ranged from 11.6 ms to 24.4 ms in the 12 hour interval post dose.
Det maksimale PR- interval var 286 msek og der blev ikke observeret nogen anden eller tredie grads hjerte- blokade (se punkt 4. 4).
Maximum PR interval was 286 msec and no second or third degree heart block was observed (see section 4.4).
Lopinavirs antivirale effekt mod laboratorie og kliniske HIV- stammer in vitro er undersøgt i henholdsvis akut inficerede lymfoblast cellelinjer og periferale blod lymfocytter.
Antiviral activity in vitro: the in vitro antiviral activity of lopinavir against laboratory and clinical HIV strains was evaluated in acutely infected lymphoblastic cell lines and peripheral blood lymphocytes, respectively.
Den gennemsnitlige EC50 for lopinavir mod 5 forskellige HIV- 1 laboratoriestammer var 19 nM i fravær af humant serum.
In the absence of human serum, the mean IC50 of lopinavir against five different HIV-1 laboratory strains was 19 nM.
Den gennemsnitlige EC50 for lopinavir mod HIV- 1IIIB i MT4 celler var 17 nM og 102 nM ved henholdsvis fravær eller tilstedeværelse af 50% humant serum.
In the absence and presence of 50% human serum, the mean IC50 of lopinavir against HIV-1IIIB in MT4 cells was 17 nM and 102 nM, respectively.
Den gennemsnitlige EC50 for lopinavir mod flere kliniske HIV- 1 isolater var 6. 5 nM i fravær af humant serum.
In the absence of human serum, the mean IC50 of lopinavir was 6.5 nM against several HIV-1 clinical isolates.
Bedømmelse af In- vitro resistens:
In vitro selection of resistance:
HIV- 1 isolater med nedsat følsomhed overfor lopinavir er blevet udvalgt in vitro.
HIV-1 isolates with reduced susceptibility to lopinavir have been selected in vitro.
HIV- 1 blev inkuberet in vitro med lopinavir alene og med lopinavir plus ritonavir i koncentrationer, der svarer til de forskellige plasmakoncentrationer, der ses under behandling med Kaletra.
HIV-1 has been passaged in vitro with lopinavir alone and with lopinavir plus ritonavir at concentration ratios representing the range of plasma concentration ratios observed during Kaletra therapy.
Genotypiske og fænotypiske analyser af udvalgte virus fra disse inkubationer indikerer at tilstedeværelsen af ritonavir, i de anvendte koncentrationer, ikke påvirker selektionen af lopinavir- resistente virus målbart.
Genotypic and phenotypic analysis of viruses selected in these passages suggest that the presence of ritonavir, at these concentration ratios, does not measurably influence the selection of lopinavir-resistant viruses.
Analyse af resistens hos ARV- naive patienter:
Analysis of resistance in ARV-naïve patients:
I et fase II- forsøg (M97 – 720) med 204 ugers behandling, blev der udført en succesfuld genotype - analyse af virale isolater i 11 ud af 16 patienter med bekræftet HIV RNA 400 kopier/ ml og ingen primære - eller aktiv- stedmutationer i protease (amino - syrer på position 8, 30, 32, 46, 47, 48, 50, 82, 84 og 90) eller protease- hæmmer- fænotype- resistens blev afsløret.
In a Phase II study (M97-720) through 204 weeks of treatment, genotypic analysis of viral isolates was successfully conducted in 11 of 16 patients with confirmed HIV RNA above 400 copies/ ml revealed no primary or active site mutations in protease (amino acids at positions 8, 30, 32, 46, 47, 48, 50, 82, 84 and 90) or protease inhibitor phenotypic resistance.
I et fase III- forsøg (M98- 863) med 653 patienter randomiseret til at modtage stavudin og lamivudin med enten lopinavir/ ritonavir eller nelfinavir, havde 113 nelfinavir- behandlede forsøgspersoner og 74 lopinavir/ ritonavir- behandlede forsøgspersoner en HIV RNA over 400 kopier/ ml under behandling fra uge 24 til uge 96.
In a Phase III study (M98-863) of 653 patients randomised to receive stavudine plus lamivudine with either lopinavir/ ritonavir or nelfinavir, 113 nelfinavir-treated subjects and 74 lopinavir/ ritonavir- treated subjects had an HIV RNA above 400 copies/ ml while on treatment from Week 24 through Week 96.
Af disse kunne isolater fra 96 nelfinavir- behandlede forsøgspersoner og 51
Of these, isolates from 96 nelfinavir-treated subject and 51 lopinavir/ ritonavir-treated
16 lopinavir/ ritonavir- behandlede forsøgspersoner udvides med resistens- måling.
15 subjects could be amplified for resistance testing.
Resistens mod nelfinavir, defineret som tilstedeværelse af D30N eller L90M mutation i protease, blev observeret hos 41/ 96 (43%) forsøgspersoner.
Resistance to nelfinavir, defined as the presence of the D30N or L90M mutation in protease, was observed in 41/ 96 (43%) subjects.
Resistens mod lopinavir, defineret som tilstedeværelse af enhver primær eller aktiv sted- mutation i protease (se ovenfor), blev observeret hos 0/ 51 (0%) forsøgspersoner.
Resistance to lopinavir, defined as the presence of any primary or active site mutations in protease (see above), was observed in 0/ 51 (0%) subjects.
Mangel på resistens mod lopinavir blev bekræftet med fænotype- analyse.
Lack of resistance to lopinavir was confirmed by phenotypic analysis.
Analyse af resistens hos PI - erfarne patienter:
Analysis of resistance in PI-experienced patients:
The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was Bedømmelse af resistens mod lopinavir hos patienter, hvor tidligere behandling med protease - hæmmere var mislykkedes, var karakteriseret ved analyse af isolater fra længderetningen fra 19 protease hæmmer- erfarne forsøgspersoner i 2 fase II - og et fase III- forsøg, som enten oplevede ufuldstændig virologisk undertrykkelse eller viral rebound efter initial respons på Kaletra, og som udviste trinvis voksende in- vitro- resistens mellem baseline og rebound (defineret som tilsynekomst af nye mutationer eller 2- gange ændring i fænotype- følsomhed for lopinavir).
The selection of resistance to lopinavir in patients having failed prior protease inhibitor therapy was characterised by analysing the longitudinal isolates from 19 protease inhibitor-experienced subjects in 2 Phase II and one Phase III studies who either experienced incomplete virologic suppression or viral rebound subsequent to initial response to Kaletra and who demonstrated incremental in vitro resistance between baseline and rebound (defined as emergence of new mutations or 2-fold change in phenotypic susceptibility to lopinavir).
Forøgelse af resistens var mest almindelig i forsøgspersoner, hvis baseline- isolater havde adskillige protease- hæmmere - associerede mutationer, men < 40- gange formindsket følsomhed for lopinavir ved baseline.
Incremental resistance was most common in subjects whose baseline isolates had several protease inhibitor-associated mutations, but < 40-fold reduced susceptibility to lopinavir at baseline.
Mutation L33F, I50V og V32I kombineret med I47V/ A blev også observeret.
Mutations L33F, I50V and V32I combined with I47V/ A were also observed.
De 19 isolater demonstrerede en 4. 3- gange stigning i IC50 sammenlignet med baseline- isolater (fra 6. 2 - til 43- gange, sammenlignet med vild- type virus).
The 19 isolates demonstrated a 4.3-fold increase in IC50 compared to baseline isolates (from 6.2- to 43-fold, compared to wild-type virus).
I denne gruppe var følgende mutationer i HIV protease forbundet med nedsat følsomhed overfor lopinavir in vitro:
Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir:
L10F/ I/ R/ V, K20M/ R, L24I, M46I/ L, F53L, I54L/ T/ V, L63P, A71I/ L/ T/ V, V82A/ F/ T, I84V og L90M.
L10F/ I/ R/ V, K20M/ R, L24I, M46I/ L, F53L, I54L/ T/ V, L63P, A71I/ L/ T/ V, V82A/ F/ T, I84V and L90M.
Middeltallet for EC50 for lopinavir mod isolater med 0 - 3, 4- 5, 6- 7 og 8- 10 mutationer i de aminosyre codons, der er beskrevet ovenfor, var henholdsvis 0, 8, 2, 7, 13, 5 og 44, 0 gange højere end EC50 mod vildtype HIV.
The median EC50 of lopinavir against isolates with 0 − 3, 4 − 5, 6 − 7 and 8 − 10 mutations at the above amino acid positions was 0.8, 2.7 13.5 and 44.0-fold higher than the EC50 against wild type HIV, respectively.
De 16 virus, der udviste > 20 gange forskel i følsomhed havde alle mutationer ved codon 10, 54, 63 og 82 og/ eller 84.
The 16 viruses that displayed > 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/ or 84.
I tillæg til mutationerne beskrevet ovenfor, har mutation V32I og I47A været observeret i rebound- isolater med nedsat lopinavir- følsomhed hos protease- hæmmer- erfarne- patienter, som modtog Kaletra- behandling.
In addition to the mutations described above, mutations V32I and I47A have been observed in rebound isolates with reduced lopinavir susceptibility from protease inhibitor experienced patients receiving Kaletra therapy.
Antiviral aktivitet af Kaletra hos patienter, hvor behandling med proteasehæmmere ikke virker: Den kliniske relevans af nedsat følsomhed af lopinavir in vitro er blevet undersøgt ved at bestemme det virologiske respons for Kaletra terapi, med hensyn til basal viral genotype og fænotype, i 56 patienter, der tidligere var blevet behandlet med proteasehæmmere uden effekt.
Antiviral activity of Kaletra in patients failing protease inhibitor therapy: the clinical relevance of reduced in vitro susceptibility to lopinavir has been examined by assessing the virologic response to Kaletra therapy, with respect to baseline viral genotype and phenotype, in 56 patients previous failing therapy with multiple protease inhibitors.
EC50 af lopinavir mod de 56 virale basalisolater var fra 0, 6 til 96 gange højere end EC50 mod vildtype HIV.
The EC50 of lopinavir against the 56 baseline viral isolates ranged from 0.6 to 96-fold higher than the EC50 against wild type HIV.
Efter 48 ugers behandling med Kaletra, efavirenz og nukleosid revers transkriptasehæmmere, blev plasma HIV RNA ≤ 400 kopier/ ml observeret i 93% (25/ 27), 73% (11/ 15), og 25% (2/ 8) of af patienterne med en basal følsomhed, der var henholdsvis < 10 gange, 10- 40 gange,, og > 40 gange nedsat overfor lopinavir.
After 48 weeks of treatment with Kaletra, efavirenz and nucleoside reverse transcriptase inhibitors, plasma HIV RNA ≤ 400 copies/ ml was observed in 93% (25/ 27), 73% (11/ 15), and 25% (2/ 8) of patients with< 10-fold, 10 to 40-fold, and > 40-fold reduced susceptibility to lopinavir at baseline, respectively.
Desuden blev et virologisk respons observeret i 91% (21/ 23), 71% (15/ 21), og 33% (2/ 6) patienter med henholdsvis 0- 5, 6- 7 og 8- 10 mutationer af de mutationer i HIV protease, der er nævnt ovenfor, som relaterer til nedsat følsomhed til lopinavir in vitro.
In addition, virologic response was observed in 91% (21/ 23), 71% (15/ 21) and 33% (2/ 6) patients with 0 − 5, 6 − 7, and 8 − 10 mutations of the above mutations in HIV protease associated with reduced in vitro susceptibility to lopinavir.
Da disse patienter ikke tidligere har været udsat for hverken Kaletra eller efavirenz, kan en del af dette respons skyldes efavirenz ’ antivirale aktivitet, især hos patienter der er inficeret med stærkt lopinavir- resistente virus.
Since these patients had not previously been exposed to either Kaletra or efavirenz, part of the response may be attributed to the antiviral activity of efavirenz, particularly in patients harbouring highly lopinavir resistant virus.
17 Krydsresistens:
Cross-resistance:
Aktivitet af andre protease- hæmmere for isolater, som udviklede voksende resistens mod lopinavir efter behandling med Kaletra hos protease- hæmmer- erfarne- patienter:
Activity of other protease inhibitors against isolates that developed incremental resistance to lopinavir after Kaletra therapy in protease inhibitor experienced patients: