natgillin/translations-raw huggingface dataset:
Dosisjustering af midazolam bør overvejes, specielt hvis der administreres mere end én dosis midazolam.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Der foreligger ikke tilstrækkelige data om brugen af atazanavir hos gravide kvinder.
There are no adequate data from the use of atazanavir in pregnant women.
5. 3).
Studies in animals have not shown evidence of selective developmental toxicity or effects on reproductive function and fertility (see section 5.3).
REYATAZ bør kun anvendes under graviditet, hvis den potentielle effekt opvejer den potentielle risiko.
REYATAZ should be used during pregnancy only if the potential benefit justifies the potential risk.
I præpartum- perioden bør yderligere monitorering og alternativ behandling til REYATAZ overvejes.
In the prepartum period, additional monitoring and alternative therapy to REYATAZ should be considered.
Det vides ikke, om atazanavir udskilles i modermælk.
It is not known whether atazanavir is excreted in human milk.
Undersøgelser med rotter har vist, at atazanavir udskilles i mælken.
Studies in rats have demonstrated that atazanavir is excreted in the milk.
Mødre bør derfor ikke amme deres spædbørn, når de er i behandling med REYATAZ.
It is therefore recommended that mothers being treated with REYATAZ not breast-feed their infants.
For at undgå overførsel af HIV bør HIV- inficerede mødre som en generel regel ikke amme deres spædbørn.
As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV.
4. 8).
Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ (see section 4.8).
REYATAZ er i kontrollerede kliniske undersøgelser evalueret for sikkerhed i kombinationsbehandling med andre antiretrovirale lægemidler hos 1. 806 voksne patienter behandlet med REYATAZ 400 mg, én gang dagligt (1. 151 patienter, 52 ugers middelvarighed og 152 ugers maksimal varighed) eller REYATAZ 300 mg med ritonavir 100 mg én gang dagligt (655 patienter, 48 ugers middelvarighed og 101 ugers maksimal varighed).
REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 48 weeks median duration and 101 weeks maximum duration).
12 Bivirkninger var ensartede mellem patienter, der fik 400 mg REYATAZ én gang dagligt, og patienter, der fik 300 mg REYATAZ med ritonavir 100 mg én gang dagligt, med undtagelse af, at der hyppigere indberettedes gulsot og forhøjede niveauer af totalbilirubin ved REYATAZ plus ritonavir.
Adverse reactions were consistent between patients who received REYATAZ 400 mg once daily and patients who received REYATAZ 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with REYATAZ plus ritonavir.
Blandt patienter, der fik REYATAZ 400 mg, én gang dagligt, eller REYATAZ 300 mg med 100 mg ritonavir, én gang dagligt, var de eneste meget almindelige bivirkninger, af nogen sværhedsgrad og med mindst en mulig forbindelse til regimer indeholdende REYATAZ og én eller flere NRTIer: kvalme (20%), diarré (10%) og gulsot (12%).
Among patients who received REYATAZ 400 mg once daily or REYATAZ 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (12%).
Blandt patienter, der fik 300 mg REYATAZ med 100 mg ritonavir, var frekvensen af gulsot 17%.
Among patients receiving REYATAZ 300 mg with ritonavir
4. 4).
In the majority of cases, jaundice was reported within a few days to a few months after the initiation of treatment (see section 4.4).
Antiretroviral kombinationsbehandling er forbundet med omfordeling af legemsfedt (lipodystrofi) hos HIV- patienter, omfattende tab af perifert og facialt subkutant fedt, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervical fedtakkumulering (tyrenakke).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy, and dorsocervical fat accumulation (buffalo hump).
4. 4 og 5. 1).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, and hyperlactataemia (see sections 4.4 and 5.1).
Voksne patienter Følgende bivirkninger af moderat intensitet eller højere, med mindst en mulig forbindelse til regimer indeholdende REYATAZ og én eller flere NRTIer er ligeledes indberettet.
Adult patients The following adverse reactions of moderate intensity or greater with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs have also been reported.
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100), sjælden (≥1/ 10. 000 til < 1/ 1. 000) eller meget sjælden (< 1/ 10. 000).
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), or very rare (< 1/ 10,000).
sjældne: ødem, palpitation
rare: oedema, palpitation
almindelige: hovedpine ikke almindelige: perifer neuropati, synkope, amnesi, svimmelhed, somnolens, dysgeusia
common: headache; uncommon: peripheral neuropathy, syncope, amnesia, dizziness, somnolence, dysgeusia
almindelige: okulær icterus
common: ocular icterus
ikke almindelige: dyspnø
uncommon: dyspnoea
almindelige: opkastning, diarré, abdominalsmerter, kvalme, dyspepsi; ikke almindelige: pankreatitis, gastritis, abdominal udspiling, aphtøs stomatitis, flatulens, tør mund
common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth
ikke almindelige: nephrolithiasis, hæmaturi, proteinuri, pollakiuri; sjælden: nyresmerter
uncommon: nephrolithiasis, hematuria, proteinuria, pollakiuria; rare: kidney pain
almindelige: udslæt ikke almindelige: urticaria, alopeci, pruritus sjældne: vesiculobulløst udslæt, eksem, vasodilatation
common: rash; uncommon: urticaria, alopecia, pruritus; rare: vesiculobullous rash, eczema, vasodilatation
ikke almindelige: muskelatrofi, artralgi, myalgi; sjælden: myopati
uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy
ikke almindelige: vægttab, vægtstigning, anoreksi, øget appetit
uncommon: weight decreased, weight gain, anorexia, appetite increased
ikke almindelige: hypertension
uncommon: hypertension
almindelige: lipodystrofisk syndrom, træthed ikke almindelige: brystsmerter, ubehag, pyreksi, asteni; sjælden: gangforstyrrelser
common: lipodystrophy syndrome, fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance
ikke almindelig: hypersensitivitet
uncommon: hypersensitivity
almindelig: gulsot ikke almindelig: hepatitis sjælden: hepatosplenomegali
common: jaundice; uncommon: hepatitis; rare: hepatosplenomegaly
uncommon: gynaecomastia
uncommon: gynaecomastia
ikke almindelige: depression, desorientering, ængstelse, søvnløshed, søvnforstyrrelser, abnorme drømme
uncommon: depression, disorientation, anxiety, insomnia, sleep disorder, abnormal dream
Laboratoriemæssige abnormaliteter Den oftest rapporterede laboratoriemæssige anormalitet hos patienter, der fik regimer indeholdende REYATAZ og én eller flere NRTIer, var forhøjet total bilirubin, primært indberettet som indirekte forhøjet [ukonjugeret] bilirubin (84% grad 1, 2, 3 eller 4).
Laboratory abnormalities The most frequently reported laboratory abnormality in patients receiving regimens containing REYATAZ and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (84% Grade 1, 2, 3, or 4).
Grad 3 eller 4 forhøjelse af total bilirubin blev noteret hos 35% (5% grad 4).
Grade 3 or 4 elevation of total bilirubin was noted in 35% (5% Grade 4).
Blandt behandlingserfarne patienter som fik REYATAZ 300 mg én gang dagligt med 100 mg ritonavir én gang dagligt i gennemsnitligt 95 uger, havde 53% grad 3- 4 forhøjelse af total bilirubin.
Among experienced patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
4. 4).
Among naive patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 48 weeks, 39% had Grade 3-4 total bilirubin elevations (see section 4.4).
Andre markante, kliniske laboratoriemæssige abnormaliteter (grad 3 eller 4) rapporteret hos ≥2% af patienterne, der fik regimer indeholdende REYATAZ og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/ serum- glutamin- pyrudrue transaminase (ALAT/ SGPT) (4%), lav neutrofiltælling (4%), forhøjet aspartataminotransferase/ serum- glutamin - oxalsyretransaminase (ASAT/ SGOT) (3%) og forhøjet lipase (2%).
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing REYATAZ and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/ SGPT) (4%), low neutrophils (4%), elevated aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase (AST/ SGOT) (3%), and elevated lipase (2%).
Én procent af patienterne behandlet med REYATAZ oplevede samtidig grad 3- 4 ALAT/ ASAT og grad 3- 4 forhøjelser af total bilirubin.
One percent of patients treated with REYATAZ experienced concurrent Grade 3-4 ALT/ AST and Grade 3-4 total bilirubin elevations.
Patienter med samtidig hepatitis B - og/ eller hepatitis C- virusinfektion Blandt 1. 151 patienter, der fik 400 mg atazanavir én gang dagligt, var 177 patienter samtidig inficeret med kronisk hepatitis B eller C, og blandt 655 patienter, der fik 300 mg atazanavir én gang dagligt med 100 mg ritonavir én gang dagligt, var 97 patienter samtidig inficeret med kronisk hepatitis B eller C.
Patients co-infected with hepatitis B and/ or hepatitis C virus Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C.
Samtidigt inficerede patienter havde større sandsynlighed for forhøjede levertransaminaser ved baseline end de, der ikke havde kronisk viral hepatitis.
Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
4. 4).
The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between REYATAZ and comparator regimens (see section 4.4).
Hyppigheden er ukendt.
Postmarketing experience There have been postmarketing reports of unknown frequency for torsades de pointes, QTc prolongation, diabetes mellitus, hyperglycaemia, nephrolithiasis, and gallbladder disorders including cholelithiasis, cholecystitis, and cholestasis.
Raske frivillige har indtaget enkeltdoser på op til 1. 200 mg uden symptomatisk negativ effekt.
Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects.
4. 4 og 4. 8).
14 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Behandling af overdosering med REYATAZ bør bestå af generelt understøttende tiltag, inklusive monitorering af vitale tegn og elektrokardiogram (EKG) samt observation af patientens kliniske status.
Treatment of overdose with REYATAZ should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Proteasehæmmer, ATC- kode:
Pharmacotherapeutic group: protease inhibitor, ATC code:
Atazanavir er en azapeptid HIV- 1- proteasehæmmer (PI).
Mechanism of action: atazanavir is an azapeptide HIV-1 protease inhibitor (PI).
Stoffet blokerer bearbejdningen af virale gag- pol- proteiner i HIV- 1 inficerede celler og hindrer dermed dannelsen af modne virioner og infektion af andre celler.
The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Atazanavir udviser i fravær af humant serum anti- HIV- 1- aktivitet (EC50 af 2 til 5 nM) mod en række laboratorie - og kliniske HIV- isolater.
Antiviral activity in vitro: atazanavir exhibits anti-HIV-1 activity (EC50 of 2 to 5 nM) in the absence of human serum against a variety of laboratory and clinical HIV isolates.
Atazanavir er aktivt mod HIV- 1 Gruppe M subtype- virus A -, B -, C -, D -, AE -, AG -, F -, G - og J- isolater i cellekulturer.
Atazanavir has activity against HIV-1 Group M subtype viruses A, B, C, D, AE, AG, F, G, and J isolates in cell culture.
Atazanavir er aktivt mod HIV- 2 isolater (EC50 af 1, 9 til 32 nM).
Atazanavir has activity against HIV-2 isolates (EC50 of 1.9 to 32 nM).
Kombinationer af atazanavir med stavudin, didanosin, lamivudin, zidovudin, nelfinavir, indinavir, ritonavir, saquinavir, amprenavir medførte ikke antagonistisk anti- HIV- aktivitet eller forstærket cytotoksisk effekt ved de højeste koncentrationer anvendt til antiviral evaluering.
Combinations of atazanavir with stavudine, didanosine, lamivudine, zidovudine, nelfinavir, indinavir, ritonavir, saquinavir, amprenavir, did not result in antagonistic anti-HIV activity or enhanced cytotoxic effects at the highest concentrations used for antiviral evaluation.
Resistens Patienter der ikke tidligere har været i antiretroviral behandling Hos patienter, der ikke tidligere har modtaget antiretroviral behandling er I50L- substitutionen, nogle gange i kombination med A71V- ændring, den kendetegnende resistenssubstitution for atazanavir.
Resistance Antiretroviral treatment naive patients In antiretroviral treatment naive patients, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
En atazanavir resistensfænotype udtrykkes i alle gensplejsede virale kloner indeholdende I50L - substitutionen, i en lang række genetiske baggrunde.
An atazanavir resistance phenotype is expressed in all recombinant viral clones containing the I50L substitution in a variety of genetic backgrounds.
Resistensniveauerne strakte sig fra 3, 5 til 29 gange.
Resistance levels ranged from 3.5- to 29-fold.
Der var ingen tegn på krydsresistens mellem atazanavir og amprenavir, med tilstedeværelse af I50L - og I50V- substitutioner, som gav selektiv resistens over for henholdsvis atazanavir og amprenavir.
There was no evidence of cross-resistance between atazanavir and amprenavir, with the presence of the I50L and I50V substitutions yielding selective resistance to atazanavir and amprenavir, respectively.
N88S- substitutionen er i sjældne tilfælde set hos patienter med virologisk svigt ved atazanavirbehandling.
The N88S substitution has been rarely observed in patients with virologic failure on atazanavir treatment.
Mens det kan bidrage til nedsat følsomhed over for atazanavir, når det forekommer med andre proteasesubstitutioner, har N88S i kliniske undersøgelser for sig selv ikke medført fænotyperesistens over for atazanavir eller konsekvent påvirket den kliniske effekt.
While it may contribute to decreased susceptibility to atazanavir when it occurs with other protease substitutions, in clinical studies N88S by itself does not lead to phenotypic resistance to atazanavir or have a consistent impact on clinical efficacy.
Patienter der tidligere har været i antiretroviral behandling Hos antiretroviralt behandlingserfarne patienter blev 100 isolater fra patienter angivet som virologisk svigt under behandling, der omfattede enten atazanavir, atazanavir + ritonavir eller atazanavir + saquinavir og blev fastsat til at have udviklet resistens over for atazanavir,.
Antiretroviral treatment experienced patients In antiretroviral treatment experienced patients, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Ud af de 60 isolater fra patienter behandlet med enten atazanavir eller atazanavir + ritonavir viste 18 (30%) I50L- fænotypen
Of the 60 isolates from patients treated with either atazanavir or atazanavir + ritonavir, 18 (30%) displayed the I50L phenotype previously described in naive patients.
Resistensen hos antiretroviralt behandlingserfarne patienter forekommer hovedsageligt ved akkumulering af de primære og sekundære resistenssubstitutioner beskrevet tidligere som værende involverede i proteasehæmmerresistens.
The resistance in antiretroviral treatment experienced patients mainly occurs by accumulation of the primary and secondary resistance substitutions described previously to be involved in protease inhibitor resistance.
Disse isolater udviklede højere niveauer af resistens over for de andre proteasehæmmere.
These isolates developed higher levels of resistance to the other protease inhibitors.
Krydsresistens in vitro for vira, der er resistente over for andre proteasehæmmere Følsomhed over for atazanavir er evalueret i 943 kliniske isolater fra patienter, der ikke tidligere havde været behandlet med atazanavir og som viste en lang række genotype - og fænotypemønstre.
Cross-resistance in vitro in viruses resistant to other protease inhibitors Atazanavir susceptibility was evaluated in 943 clinical isolates from patients without prior atazanavir exposure and exhibited a wide array of genotypic and phenotypic patterns.
In vitro sås tydelig tendens til nedsat følsomhed over for atazanavir, da isolaterne viste høje resistensniveauer over for flere proteasehæmmere.
In vitro, there was a clear trend toward decreased susceptibility to atazanavir as isolates exhibited high resistance levels to
Generelt bevaredes følsomheden over for atazanavir (83% af isolaterne viste ændring i EC50på < 2, 5) i isolater, der var resistente over for maksimalt 2 proteasehæmmere.
In general, susceptibility to atazanavir was retained (83% of isolates displayed < 2.5 fold change in EC50) among isolates resistant to no more than 2 protease inhibitors.
Atten procent af isolaterne havde 4 eller mere af følgende 6 substitutioner, som anses for kritiske substitutioner for proteasehæmmere: position L10, M46, I54, V82, I84 og L90.
Eighteen percent of isolates had 4 or more of the following 6 substitutions considered critical substitutions for protease inhibitors: positions L10, M46, I54, V82, I84, and L90.
Disse isolater viste middel gange ændring i EC50 i forhold til en wildtype på 12. 0 for atazanavir.
These isolates expressed a median fold change in EC50 relative to wildtype of 12.0 for atazanavir.
Virale isolater med mindst 4 af disse specifikke mutationer anses derfor som resistente over for atazanavir.
Therefore, viral isolates having at least 4 of these specific mutations would be considered resistant for atazanavir.
Kliniske resultater Patienter der ikke tidligere har været i antiretroviral behandling Studie 138 er et internationalt, randomiseret, åbent, prospektivt multicenter- forsøg med 883 ikke tidligere antiretroviralt behandlede patienter, der sammenligner REYATAZ/ ritonavir (300 mg/ 100 mg én gang dagligt) med lopinavir/ ritonavir (400 mg/ 100 mg 2 gange dagligt), hver i kombination med en fast dosis tenofovir/ emtricitabin (300 mg/ 200 mg tabletter én gang dagligt).
Clinical results In antiretroviral naive patients Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naïve patients comparing REYATAZ/ ritonavir (300 mg/ 100 mg once daily) to lopinavir/ ritonavir (400 mg/ 100 mg twice daily), each in combination with fixed dose tenofovir/ emtricitabine (300 mg/ 200 mg tablets once daily).
Gennemsnitligt CD4 - celletal ved baseline var 214 celler/ mm3 (spænd:
The mean baseline CD4 cell count was 214 cells/ mm3 (range:
2- 810 celler/ mm3) og gennemsnitlig HIV- 1- RNA i plasma ved baseline var 4, 94 log10 kopier/ ml (spænd:
2 to 810 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ ml (range:
2, 6 til 5, 88 log10 kopier/ ml).
2.6 to 5.88 log10 copies/ ml).
REYATAZ/ ritonavir- armen har antiviral effekt svarende til lopinavir/ ritonavir- armen (non- inferiør) vurderet ved andelen af patienter med HIV- RNA < 50 kopier/ ml ved uge 48:
The REYATAZ/ ritonavir arm has similar (non-inferior) antiviral efficacy compared to the lopinavir/ ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ ml at week 48:
78% af patienterne behandlet med REYATAZ/ ritonavir sammenlignet med 76% af patienterne behandlet med lopinavir/ ritonavir (en estimeret forskel for ATV/ RTV- LPV/ RTV:
78% of patients on REYATAZ/ ritonavir compared to 76% on lopinavir/ ritonavir (difference estimate of ATV/ RTV-LPV/ RTV:
1, 7% [95% KI, - 3, 8%, 7, 1%] i henhold til CVR (Confirmed Virologic Response) NC = F (Non- Completion = Failure) definitionen på respons.
1.7% [95% CI, -3.8%, 7.1%] according to the Confirmed Virologic Response (CVR) Non-Completer = Failure (NC = F) definition of response.
I en per- protokolanalyse som udelukkede patienter, der ikke gennemførte (dvs. patienter som udgik inden HIV- RNA- vurdering ved uge 48) og patienter med større protokolafvigelser, var andelen af patienter med HIV- RNA < 50 kopier/ ml ved uge 48 86% (338/ 392) for REYATAZ/ ritonavir og 89% (332/ 372) for lopinavir/ ritonavir (estimeret forskel for ATV/ RTV- LPV/ RTV: - 3% [95% KI, - 7, 6%, 1, 5%].
In a per protocol analysis which excluded non-completers (i. e. patients who discontinued before the week 48 HIV RNA assessment) and patients with major protocol deviations, the proportion of patients with HIV RNA < 50 copies/ ml at week 48 was 86% (338/ 392) for REYATAZ/ ritonavir and 89% (332/ 372) for lopinavir/ ritonavir (difference estimate of ATV/ RTV-LPV/ RTV: -3% [95% CI, -7.6%, 1.5%].
16 Tabel 2:
Table 2:
Effektresultater ved Uge 48 (Studie 138) for CVR (NC=F) analysen
Efficacy Outcomes at Week 48 (Study 138) for the CVR (NC=F) REYATAZ/ ritonavira (300 mg/ 100 mg once daily)
REYATAZ/ ritonavira lopinavir/ ritonavirb (300 mg/ 100 mg (400 mg/ 100 mg én gang dagligt) 2 gange dagligt)
analysis lopinavir/ ritonavirb (400 mg/ 100 mg twice daily)
n=440 n=443
n=443
HIV- RNA < 50 kopier/ ml,% c Alle patienter Baseline- karakteristika HIV RNA
HIV RNA < 50 copies/ ml,% c All patients Baseline Characteristics HIV RNA
< 100. 000 kopier/ ml ≥100. 000 kopier/ ml
< 100,000 copies/ ml ≥ 100,000 copies/ ml
CD4- tal
16 CD4 count
< 50 celler/ mm3 50 til < 100 celler/ mm3
< 50 cells/ mm3 50 to < 100 cells/ mm3
100 til < 200 celler/ mm3 ≥200 celler/ mm3
100 to < 200 cells/ mm3 ≥ 200 cells/ mm3
Gennemsnitlig ændring i HIV- RNA fra baseline, log10 kopier/ ml
HIV RNA Mean Change from Baseline, log10 copies/ ml
Gennemsnitlig ændring i CD4- tal fra baseline, celler/ mm3 Alle patienter Baseline- karakteristika HIV- RNA
CD4 Mean Change from Baseline, cells/ mm3 All patients Baseline Characteristics HIV RNA
< 100. 000 kopier/ ml ≥100. 000 kopier/ ml a
< 100,000 copies/ ml ≥ 100,000 copies/ ml a