natgillin/translations-raw huggingface dataset:
CYP3A4 - induktion; fald i efvirenz - koncentrationen:
CYP3A4 induction; decrease in efavirenz concentrations:
Steady- state AUC, Cmax og Cmin for den aktive carbamazepinepoxid - metabolit forblev uændret.
CYP3A4 and CYP2B6 induction) The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Dosisrekommandation kan ikke gives.
No dosage recommendation can be made.
Phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP450- isoenzymer
Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Plasmakoncentrationen for phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP450 - isoenzymer, kan eventuelt falde eller stige, når disse administreres samtidigt med efavirenz.
There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when co-administered with efavirenz.
Når efavirenz administreres sammen med et antikonvulsivum, som er et substrat for CYP450 - isoenzymer, bør regelmæssig monitorering af antikonvulsiva - koncentrationen foretages.
When efavirenz is co-administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
Valproinsyre/ efavirenz (250 mg to gange dagligt/ 600 mg én gang dagligt)
Valproic acid/ Efavirenz (250 mg twice daily/ 600 mg once daily)
Ingen klinisk signifikant effekt på efavirenz 'farmakokinetik.
No clinically significant effect on efavirenz pharmacokinetics.
Lægemidler i henhold til
12 Medicinal product by therapeutic
ANTIDEPRESSIVA Selektive serotonin genoptagelseshæmmere (SSRIer) Sertralin/ efavirenz (50 mg én gang dagligt/ 600 mg én gang dagligt)
ANTIDEPRESSANTS Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/ Efavirenz
AUC: ↓ 39% (↓ 27 til ↓ 50) Cmax: ↓ 29% (↓ 15 til ↓ 40) Cmin: ↓ 46% (↓ 31 til ↓ 58) Efavirenz:
(50 mg once daily/ 600 mg once daily) AUC: ↓ 39% (↓ 27 to ↓ 50) Cmax: ↓ 29% (↓ 15 to ↓ 40) Cmin: ↓ 46% (↓ 31 to ↓ 58) Efavirenz:
Øgning af sertralindosis bør være under vejledning af klinisk respons.
be guided by clinical response.
Paroxetin/ efavirenz (20 mg én gang dagligt/ 600 mg én gang dagligt)
Paroxetine/ Efavirenz No clinically significant (20 mg once daily/ 600 mg once daily) pharmacokinetic interaction
Ingen klinisk signifikant farmakokinetisk interaktion.
No dosage adjustment is necessary for either medicinal product.
Interaktion er ikke undersøgt.
Fluoxetine/ Efavirenz Interaction not studied.
Da fluoxetin har samme metaboliske profil som paroxetin, dvs. stærk CYP2D6- hæmmende virkning, forventes samme mangel på interaktion for fluoxetin.
ANTIHISTAMINES
Cetirizin:
Cetirizine/ Efavirenz Cetirizine:
AUC: ↔ Cmax: ↓ 24% (↓ 18 til ↓ 30) Disse ændringer anses ikke for at være klinisk signifikante.
(10 mg single dose/ 600 mg once AUC: ↔ daily) Cmax: ↓ 24% (↓ 18 to ↓ 30) These changes are not considered clinically significant.
15
No dosage adjustment is necessary for efavirenz.
Lægemidler i henhold til
13 Medicinal product by therapeutic
KARDIOVASKULÆRE LÆGEMIDLER Kalciumkanalblokkere Diltiazem/ efavirenz (240 mg én gang dagligt/ 600 mg én gang dagligt)
co-administration with
Diltiazem:
(dose)
Dosisjustering af diltiazem bør foretages ud fra klinisk respons (se SPC for diltiazem).
Cmax, Cmin with confidence intervals if availablea (mechanism)
Dosisjustering er ikke nødvendig for efavirenz.
efavirenz
Verapamil, felodipin, nifedipin og nicardipin LIPIDSÆNKENDE LÆGEMIDLER HMG Co- A reduktasehæmmere
Verapamil, Felodipine, Nifedipine and Nicardipine LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors
Atorvastatin/ efavirenz (10 mg én gang dagligt/ 600 mg én gang dagligt)
Atorvastatin/ Efavirenz (10 mg once daily/ 600 mg once daily)
AUC: ↓ 43% (↓ 34 til ↓ 50) Cmax: ↓ 12% (↓ 1 til ↓ 26) 2- hydroxy atorvastatin:
AUC: ↓ 43% (↓ 34 to ↓ 50) Cmax: ↓ 12% (↓ 1 to ↓ 26) 2-hydroxy atorvastatin:
AUC: ↓ 35% (↓ 13 til ↓ 40) Cmax: ↓ 13% (↓ 0 til ↓ 23) 4- hydroxy atorvastatin:
AUC: ↓ 35% (↓ 13 to ↓ 40) Cmax: ↓ 13% (↓ 0 to ↓ 23) 4-hydroxy atorvastatin:
AUC: ↓ 4% (↓ 0 til ↓ 31) Cmax: ↓ 47% (↓ 9 til ↓ 51) Totalt aktive HMG Co- A reduktasehæmmere:
AUC: ↓ 4% (↓ 0 to ↓ 31) Cmax: ↓ 47% (↓ 9 to ↓ 51) Total active HMG Co-A reductase inhibitors:
Dosisjustering af atorvastatin kan være påkrævet (se SPC for atorvastatin).
Dosage adjustments of atorvastatin may be required (refer to the Summary of Product Characteristics for the atorvastatin).
administration med efavirenz
Pravastatin/ Efavirenz (40 mg once daily/ 600 mg once daily)
Dosisjustering af pravastatin kan være påkrævet (se SPC for pravastatin).
Dosage adjustments of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin).
Simvastatin/ efavirenz (40 mg én gang dagligt/ 600 mg én gang dagligt)
Simvastatin/ Efavirenz (40 mg once daily/ 600 mg once daily)
AUC: ↓ 58% (↓ 39 til ↓ 68) Cmax: ↓ 51% (↓ 32 til ↓ 58) Totalt aktive HMG Co- A reduktasehæmmere:
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total active HMG Co-A reductase inhibitors:
AUC: ↓ 60% (↓ 52 til ↓ 68) Cmax: ↓ 62% (↓ 55 til ↓ 78) (CYP3A4- induktion) Samtidig administration af efavirenz og atorvastatin, pravastatin eller simvastatin påvirkede ikke efivarenz 'AUC - eller Cmax- værdier.
AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
Dosisjustering af simvastatin kan være påkrævet (se SPC for simvastatin).
Dosage adjustments of simvastatin may be required (refer to the Summary of Product Characteristics for simvastatin).
Rosuvastatin/ efavirenz ORALE KONTRACEPTIVA
Rosuvastatin/ Efavirenz
Interaktion er ikke undersøgt..
Interaction not studied.
17
14
administration med efavirenz
AUC: ↑ 37% (↑ 25 to ↑ 51) Cmax: ↔ Efavirenz:
IMMUNOSUPPRESSIVA Immunosuppressiva metaboliseres via CYP3A4 (fx cyclosporin, tac - rolimus, sirolimus) / efavirenz OPIOIDER
Immunosuppressants metabolized by CYP3A4 (e. g., cyclosporine, tacrolimus, sirolimus)/ Efavirenz OPIOIDS
Nedsat eksponering af det immunosuppressive lægemiddel kan forventes (CYP3A4- induktion).
Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction).
Disse immunosuppressiva forventes ikke at påvirke efavirenz 'eksponering.
These immunosuppressants are not anticipated to affect exposure of efavirenz.
Dosisjustering kan være nødvendig for det immunosuppressive lægemiddel.
Dose adjustments of the immunosuppressant may be required.
Tæt monitorering af de immunosuppressive koncentrationer anbefales i mindst 2 uger (indtil stabil koncentration er nået), når behandling med efavirenz igangsættes eller seponeres.
Close monitoring of immunosuppressant concentrations for at least 2 weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with efavirenz.
Methadon/ efavirenz (stabil vedligeholdelse, 35- 100 mg én gang dagligt/ 600 mg én gang dagligt)
Methadone/ Efavirenz (stable maintenance, 35-100 mg once daily/ 600 mg once daily)
I en undersøgelse med HIV - inficerede brugere af intravenøse stoffer resulterede samtidig administration af efavirenz og methadon i nedsat plasmakoncentration af methadon og abstinenssymptomer.
AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction) In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Buprenorphin/ naloxon/ efavirenz a
Buprenorphine/ naloxone/ Efavirenz
AUC: ↓ 50% Norbuprenorphin:
AUC: ↓ 50% Norbuprenorphine:
90% konfidensinterval med mindre andet er angivet. b 95% konfidensinterval.
a 90% confidence intervals unless otherwise noted. b 95% confidence intervals.
Efavirenz bør ikke anvendes under graviditet, medmindre der ikke er andre hensigtsmæssige behandlingsmuligheder.
Efavirenz should not be used during pregnancy unless there are no other appropriate treatment options.
Graviditet bør undgås hos kvinder, der er i behandling med efavirenz.
15 Women of childbearing potential: pregnancy should be avoided in women treated with efavirenz.
Barrierekontraception bør altid anvendes sammen med andre kontraceptiva (fx orale eller andre hormonkontraceptiva).
Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives).
Det anbefales at tage passende kontraceptive forholdsregler i 12 uger efter ophørt behandling med efavirenz, da efavirenz har en lang halveringstid.
Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of efavirenz is recommended.
Fødedygtige kvinder bør altid få foretaget graviditetstest før initiering af behandling med efavirenz.
Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz.
Mængden af data vedrørende anvendelse af efavirenz til gravide kvinder er begrænset.
Pregnancy: there are limited amount of data from the use of efavirenz in pregnant women.
Her blev der i første trimester behandlet med efavirenz som en del af et antiretroviralt kombinationsregime, uden specifikke deformationsmønstre.
In postmarketing experience through an antiretroviral pregnancy registry, more than 200 pregnancies with first-trimester exposure to efavirenz as part of a combination antiretroviral regimen have been reported with no specific malformation pattern.
5. 3).
Studies in animals have shown reproductive toxicity including marked teratogenic effects (see section 5.3).
Rotteundersøgelser har vist, at efavirenz udskilles i mælk i langt højere koncentrationer, end det er set i maternal plasma.
Lactation: studies in rats have demonstrated that efavirenz is excreted in milk reaching concentrations much higher than those in maternal plasma.
Det vides ikke, om efavirenz udskilles i human mælk.
It is not known whether efavirenz is excreted in human milk.
Da dyredata tyder på, at stoffet muligvis udskilles i modermælk, anbefales det, at mødre, der tager efavirenz, ikke ammer deres børn.
Since animal data suggest that the substance may be passed into breast milk, it is recommended that mothers taking efavirenz do not breast feed their infants.
Det anbefales, at HIV- smittede kvinder, for at undgå overførsel af HIV, ikke ammer deres børn under nogen omstændigheder.
It is recommended that HIV infected women do not breast feed their infants under any circumstances in order to avoid transmission of HIV.
Efavirenz kan forårsage svimmelhed, nedsat koncentrationsevne og/ eller somnolens.
Efavirenz may cause dizziness, impaired concentration, and/ or somnolence.
Patienterne skal instrueres i at undgå potentielt farlige opgaver som fx at føre motorkøretøj eller betjene maskiner, hvis de oplever disse symptomer.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Efavirenz er undersøgt hos mere end 9. 000 patienter.
Efavirenz has been studied in over 9,000 patients.
Udslæt (11, 6%), svimmelhed (8, 5%), kvalme (8, 0%), hovedpine (5, 7%) og træthed (5, 5%).
In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/ or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%).
4. 4).
The administration of STOCRIN with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Langtidssikkerhedsprofilen for regimer, der indeholder efavirenz blev evalueret i en kontrolleret undersøgelse (006), hvori patienter behandledes med enten efavirenz + zidovudin + lamivudin (n = 412, medianvarighed 180 uger), efavirenz + indinavir (n = 415, medianvarighed 102 uger) eller indinavir + zidovudin+lamivudin (n = 401, medianvarighed 76 uger).
The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
I kliniske undersøgelser oplevede 26% af de patienter, der blev behandlet med 600 mg efavirenz, hududslæt sammenlignet med 17% af de patienter, der blev behandlet i kontrolgrupperne.
Rash: in clinical studies, 26% of patients treated with 600 mg of efavirenz experienced skin rash compared with 17% of patients treated in control groups.
Hos de fleste patienter forsvinder
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
19 udslættet inden for 1 måned ved fortsat behandling med efavirenz.
In most patients rash resolves with continuing therapy with efavirenz within one month.
Erfaring med efavirenz hos patienter, som er ophørt med andre antiretrovirale lægemidler af NNRTI- gruppen, er begrænset.
16 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
9 af disse patienter udviklede mildt til moderat udslæt, mens de fik behandling med efavirenz, og 2 ophørte på grund af udslæt.
Nine of these patients developed mild-to-moderate rash while receiving therapy with efavirenz, and two discontinued because of rash.
Der er indberettet alvorlige psykiatriske bivirkninger hos patienter behandlet med efavirenz.
Psychiatric symptoms: serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
For kontrollerede undersøgelser med 1. 008 patienter, der blev behandlet med regimer, der indeholder efavirenz i gennemsnitligt 1, 6 år og 635 patienter behandlet med kontrolregimer i gennemsnitligt 1, 3 år, er hyppigheden af specifikke, alvorlige psykiatriske bivirkninger beskrevet i detaljer nedenfor:
In controlled trials of 1,008 patients treated with regimens containing efavirenz for an average of 1.6 years and 635 patients treated with control regimens for an average of 1.3 years, the frequency of specific serious psychiatric events are detailed hereafter:
Efavirenzregime
Efavirenz regimen
Kontrolregime
Control regimen
- Svær depression - Suicidale tanker - Ikke fatale selvmordsforsøg - Aggresiv opførsel - Paranoide reaktioner - Maniske reaktioner
- severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Patienter med psykiatriske lidelser i anamnesen synes at have større risiko for disse alvorlige, psykiatriske bivirkninger, hvor hyppigheden af hvert af de ovenstående tilfælde varierer fra 0, 3% for maniske reaktioner til 2, 0% for både svær depression og suicidaltanker.
Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies of each of the above events ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Der har ligeledes efter markedsføring været indberetninger om selvmord, vrangforestillinger og psykotisk opførsel.
There have also been post-marketing reports of death by suicide, delusions and psychosis-like behaviour.
I kliniske, kontrollerede undersøgelser med patienter, som fik 600 mg efavirenz sammen med andre antiretrovirale lægemidler, var de ofte rapporterede bivirkninger bl. a. følgende:
Nervous system symptoms: in clinical controlled trials, frequently reported adverse reactions in patients receiving 600 mg efavirenz with other antiretroviral agents included, but were not limited to: dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming.
Svimmelhed, søvnløshed, somnolens, nedsat koncentrationsevne og unormal drømmeaktivitet. 19, 4% af patienterne oplevede symptomer fra nervesystemet af moderat til svær intensitet sammenlignet med 9, 0% af de patienter, der fik kontrolregimer.
Nervous system symptoms of moderate-to-severe intensity were experienced by 19.4% of patients compared to 9.0% of patients receiving control regimens.
Disse symptomer var alvorlige hos 2, 0% af de patienter, der fik efavirenz 600 mg daglig, og hos 1, 3% af de patienter, der fik kontrolregimer.
These symptoms were severe in 2.0% of patients receiving efavirenz 600 mg daily and in 1.3% of patients receiving control regimens.
I en klinisk undersøgelse varierede den månedlige prevalens af symptomer af mindst moderat sværhedsgrad fra nervesystemet mellem uge 4 og 48, mellem 5 – 9% hos patienter i behandligsregimer med efavirenz og mellem 3 – 5% hos patienterne, som fik kontrolbehandling.
In one clinical study, the monthly prevalence of nervous system symptoms of at least moderate severity between weeks 4 and 48, ranged from 5% - 9% in patients treated with regimens containing efavirenz and 3% - 5% in patients treated with the control regimen.
I en undersøgelse af ikke- inficerede frivillige havde et repræsentativt symptom fra nervesystemet en mediantid indtil debut på 1 time efter dosering og en medianvarighed på 3 timer.
In a study of uninfected volunteers, a representative nervous system symptom had a median time to onset of 1 hour post-dose and a median duration of 3 hours.
Symptomer fra nervesystemet kan forekomme hyppigere, hvis efavirenz indtages sammen med et måltid, muligvis pga. øget plasmakoncentration for efavirenz (se pkt.
Nervous system symptoms may occur more frequently when efavirenz is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
4. 2).
Dosing at bedtime seems to improve the tolerability of these symptoms and can be recommended during the first weeks of therapy and in patients who continue to experience these symptoms (see section 4.2).
Dosisreduktion eller opdeling af daglig dosis er ikke påvist at være en fordel.
Dose reduction or splitting the daily dose has not been shown to provide benefit.
Analyse af langtidsdata fra undersøgelse 006 (median follow- up 180 uger, 102 uger og 76 uger for patienter, der blev behandlet med henholdsvis efavirenz + zidovudin + lamivudin, efavirenz + indinavir og indinavir + zidovudin + lamivudin) viste, at ud over 24 ugers behandling var frekvensen af nye symptomer fra nervesystemet blandt patienter, der blev behandlet med efavirenz generelt sammenlignelig med de symptomer, som sås i kontrolgruppen.
Analysis of long-term data from study 006 (median follow-up 180 weeks, 102 weeks, and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.
Frekvens
Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
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); Meget sjælden (< 1/ 10. 000) inklusive enkeltstående rapporter.
Frequency 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); very rare (< 1/ 10,000) including isolated reports.
Nervesystemet Almindelig
17 Nervous system disorders common
Opmærksomhedsforstyrrelse, svimmelhed, hovedpine, somnolens.
disturbance in attention, dizziness, headache, somnolence
Ophidselse, amnesi, ataxi, unormal koordination, kramper, abnorm tankevirksomhed.
agitation, amnesia, ataxia, coordination abnormal, convulsions, thinking abnormal
Øjne Ikke almindelig
Eye disorders uncommon
Sløret syn
vision blurred
Mave- tarmkanalen Almindelig
Gastrointestinal disorders common
Akut pankreatitis.
pancreatitis acute
Hud og subkutane væv Meget almindelig
Skin and subcutaneous tissue disorders very common
Udslæt
rash
Pruritus
pruritus
Erythema multiforme, Stevens- Johnsons syndrom
erythema multiforme, Stevens-Johnson syndrome
Lever og galdeveje Ikke almindelig
Hepatobiliary disorders uncommon
Abnorme drømme, angst, depression, søvnløshed.
abnormal dreams, anxiety, depression, insomnia
Affektlabilitet, aggression, konfus tilstand, eufori, hallucinationer, mani, paranoia, suicidalforsøg, suicidaltanker.
affect lability, aggression, confusional state, euphoric mood, hallucination, mania, paranoia, suicide attempt, suicide ideation
4. 4).
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Kombinationsbehandling med antiretrovirale lægemidler er hos patienter med HIV associeret med omfordeling af kropsfedt (lipodystrofi), herunder tab af sub -
Lipodystrophy and metabolic abnormalities: 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).
18 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Der sås forhøjelser af aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) til mere end 5 gange den øvre grænse for normalområdet (ULN) hos 3% af 1. 008 patienter, der blev behandlet med 600 mg efavirenz (5- 8% efter langtidsbehandling i Undersøgelse 006).
Liver enzymes: elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients treated with 600 mg of efavirenz (5-8% after long-term treatment in study 006).
Der sås forhøjelser af gamma- glutamyltransferase (GGT) til mere end fem gange ULN hos 4% af alle de patienter, der blev behandlet med 600 mg efavirenz og hos 1, 5- 2% af de patienter, der blev behandlet med kontrolregimerne (7% af de efavirenzbehandlede patienter og 3% patienter i kontrolgruppen efter langtidsbehandling).
Elevations of gamma-glutamyltransferase (GGT) to greater than five times ULN were observed in 4% of all patients treated with 600 mg of efavirenz and 1.5 - 2% of patients treated with control regimens (7% of efavirenz-treated patients and 3% of control-treated patients after long-term treatment).
I langtidsdata fra undersøgelse 006 var 137 patienter i regimer, der indeholder efavirenz (median behandlingsvarighed 68 uger) og 84 patienter i kontrolregimer (median behandlingsvarighed 56 uger) seropositive ved screening for hepatitis B (surface antigen positive) og/ eller C (hepatitis C antistof positive).
In the long-term data set from study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/ or C (hepatitis C antibody positive).
Blandt disse co- inficerede patienter udvikledes der forhøjelser af ASAT på mere end fem gange ULN hos 13% af patienterne i efavirenz- gruppen og hos 7% af patienterne i kontrolgruppen, samt forhøjelser af ALAT på mere end fem gange ULN hos 20% af patienterne i efavirenz- gruppen og hos 7% af patienterne i kontrolgruppen.
Among these co-infected patients, elevations in AST to greater than five times ULN developed in 13% of patients in the efavirenz arms and 7% of those in the control arm, and elevations in ALT to greater than five times ULN developed in 20% of patients in the efavirenz arms and 7% of the patients in the control arm.