natgillin/translations-raw huggingface dataset:
Sløret syn
Common
Øre og labyrint:
vision blurred vertigo
21 Efavirenz+emtricitabin+ tenofovirdisoproxilfumarat (n=257) Luftveje, thorax og mediastinum:
Respiratory, thoracic and mediastinal disorders:
Dyspnø
dyspnoea
Kvalme Diarré, opkastning, mavesmerter, flatulens, oppustethed, mundtørhed
nausea diarrhoea, vomiting, abdominal pain, flatulence, abdominal distension, dry mouth
Dyspepsi
dyspepsia
Udslæt Pruritus, hyperpigmentering af huden, dermatitis Urticaria, tør hud, eksem
rash pruritus, skin hyperpigmentation, dermatitis urticaria, dry skin, eczema
Nedsat appetit, øget appetit Hypertriglyceridæmi, anoreksi
decreased appetite, increased appetite hypertriglyceridaemia, anorexia
Almene symptomer og reaktioner på administrationsstedet:
20 Efavirenz+emtricitabine+tenofovir disoproxil fumarate (n=257) General disorders and administration site conditions:
Asteni, føle sig beruset
fatigue, fever asthenia, feeling drunk
Abnorme drømme Mareridt, depression, søvnmangel, søvnforstyrrelser, eufori
abnormal dreams nightmares, depression, insomnia, sleep disorder, euphoric mood
Paranoia, psykomotorisk agitation, vrangforestillinger, forvirring, angst, aggressivitet, nervøsitet, desorientering
paranoia, psychomotor agitation, delusion, confusional state, anxiety, aggression, nervousness, disorientation
Unormale laboratorieprøver:
Laboratory test abnormalities:
I en 144- ugers klinisk undersøgelse (GS- 01- 934) blev der rapporteret om forhøjet aspartataminotransferase (ASAT > 5 gange ULN (øvre normalgrænse)) og forhøjet alaninaminotransferase (ALAT > 5 gange ULN) hos henholdsvis 3% og 2% af de patienter, der blev behandlet med efavirenz, emtricitabin og tenofovirdisoproxilfumarat (n=257) samt henholdsvis 3% og 3% af patienter, behandlet med efavirenz og fast- dosis zidovudin/ lamivudin (n=254).
Liver enzymes: in a 144-week clinical study (GS-01-934), elevations of aspartate aminotransferase (AST > 5 times ULN (upper limit of normal)) and of alanine aminotransferase (ALT > 5 times ULN) were reported in 3% and 2% of patients treated with efavirenz, emtricitabine, and tenofovir disoproxil fumarate (n=257) and 3% and 3% of patients treated with efavirenz and fixed-dose zidovudine/ lamivudine (n=254), respectively.
Bivirkninger forbundet med de individuelle Atripla- komponenter I tabel 4 nedenfor ses bivirkningerne fra kliniske undersøgelser samt erfaring efter markedsføringen med de individuelle Atripla- komponenter inddelt i legemssystemorganklasse og frekvens.
Adverse reactions associated with the individual components of Atripla The adverse reactions from clinical study and post-marketing experience with the individual components of Atripla in antiretroviral combination therapy are listed in Table 4 below by body system organ class and frequency.
De væsentligste bivirkninger rapporteret i kliniske undersøgelser af efavirenz er udslæt og symptomer fra nervesystemet.
The most notable adverse reactions that have been reported in clinical studies with efavirenz are rash and nervous system symptoms.
4. 4).
The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Efter markedsføringen har der i forbindelse med tenofovirdisoproxilfumarat været rapporter om nyre - eller urinvejssygdomme inklusive nyresvigt, proksimal tubulopati (inklusive Fanconis syndrom), akut tubulær nekrose og nefrogen diabetes insipidus.
There have been post-marketing reports in association with tenofovir disoproxil fumarate of renal and urinary disorders including renal failure, proximal tubulopathy (including Fanconi syndrome), acute tubular necrosis and nephrogenic diabetes insipidus.
22 Tabel 4:
Table 4:
Bivirkninger som er forbundet med Atriplas individuelle komponenter og baseret på erfaring fra klinisk undersøgelse samt erfaring efter markedsføring.
Adverse reactions associated with the individual components of Atripla based on clinical study and post-marketing safety experience
Tenofovirdisoproxil - fumarat
Tenofovir disoproxil fumarate
Almindelig Ikke almindelig Nervesystemet:
Common Uncommon Nervous system disorders:
Neutropeni Anæmi
neutropenia anaemia
Meget almindelig Almindelig
Uncommon vertigo
Hovedpine Svimmelhed
headache dizziness
Ikke almindelig
21
Ukendt * Øjne:
Efavirenz
Sløret syn
Emtricitabine
Ikke almindelig
Tenofovir disoproxil fumarate
Ukendt * Mave- tarm- kanalen:
Not known* Gastrointestinal disorders:
Diarré, kvalme
diarrhoea, nausea
Diarré, opkastning, kvalme
diarrhoea, vomiting, nausea
Diarré, opkastning, mavesmerter, kvalme
Common diarrhoea, vomiting, abdominal pain, nausea Uncommon pancreatitis acute
Forhøjet amylase herunder forhøjet pankreatisk amylase, forhøjet serum- lipase, opkastning, mavesmerter, dyspepsi
elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia
Flatulens
flatulence
Ikke almindelig Ukendt * Nyrer og urinveje:
Not known* Renal and urinary disorders:
Pankreatitis
pancreatitis
23 Hud og subkutane væv:
Not known* Skin and subcutaneous tissue disorders:
Udslæt 18%)
Very common rash (all grades, 18%)
(alle grader,
renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy including Fanconi syndrome, nephritis, acute interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria
Almindelig
Common pruritus Uncommon Stevens-Johnson syndrome, erythema multiforme, severe rash (< 1%)
Pruritus
allergic reaction, vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)
Allergisk reaktion, vesikuløst udslæt, pustuløst udslæt, makulopapuløst udslæt, udslæt, pruritus, urticaria, misfarvning af huden (øget pigmentering)
Not known* photoallergic dermatitis Musculoskeletal and connective tissue disorders:
Ikke almindelig
rash
Stevens- Johnsons syndrom, erythema multiforme, svært udslæt (< 1%)
Very common Not known* Metabolism and nutrition disorders:
Ikke kendt * Knogler, led, muskler Meget almindelig
elevated creatine kinase
Photodermatitis og bindevæv:
Very common Common
Forhøjet kreatininkinase
hyperglycaemia, hypertriglyceridaemia
Udslæt
hypophosphataemia
Ikke kendt *
Not known*
Meget almindelig Almindelig
lactic acidosis, hypokalaemia
Hyperglykæmi, hypertriglyceridæmi
22
Hypofosfatæmi
Efavirenz
Ikke kendt *
Emtricitabine
Laktatacidose, hypokalæmi
Tenofovir disoproxil fumarate
Almindelig Ikke kendt * Immunsystemet:
Common Not known*
Udmattelse
fatigue
Asteni
asthenia
Ikke almindelig Lever og galdeveje:
Uncommon
Hypersensitivitet
hypersensitivity
Forhøjet serumaspartatamino - transferase (ASAT) og/ eller forhøjet serumalaninaminotrans - ferase (ALAT), hyperbilirubinæmi
elevated serum aspartate aminotransferase (AST) and/ or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia
Leversvigt
hepatic failure
Hepatitis, forhøjede transaminaser, steatosis hepatis
hepatitis, increased transaminases, hepatic steatosis
Ikke almindelig
Uncommon Psychiatric disorders:
Gynækomasti
gynaecomastia
Efavirenz
Common
Depression (svær hos 1, 6%), angst, abnorme drømme, søvnløshed
depression (severe in 1.6%), anxiety, abnormal dreams, insomnia
Suicidalforsøg, suicidaltanker, mani, paranoia, hallucinationer, eufori, affektlabilitet, forvirret tilstand, agitation
suicide attempt, suicide ideation, mania, paranoia, hallucination, euphoric mood, affect lability, confusional state, aggression
Fuldført selvmord, psykose, vrangforestillinger, neuroser
completed suicide, psychosis, delusion, neurosis
* Disse bivirkninger er blevet identificeret via kontrol efter markedsføring, og frekvensen er ukendt.
* These adverse reactions have been identified through post-marketing safety surveillance and the frequency is not known.
Følgende bivirkninger, som er opført under systemorganklasserne ovenfor, kan forekomme som følge af proksimal renal tubulopati: rabdomyolyse, osteomalaci (manifesteret som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer), hypokalæmi, muskelsvækkelse, myopati og hypofosfatæmi.
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, myopathy and hypophosphataemia.
Hvis der ikke er proksimal renal tubulopati, betragtes disse hændelser ikke som årsagsmæssigt forbundet med behandlingen med tenofovirdisoproxilfumarat.
These events are not considered to be causally associated with tenofovir disoproxil fumarate therapy in the absence of proximal renal tubulopathy.
Udslættene er for det meste milde til moderate, makulopapuløse huderuptioner, der optræder inden for de første 2 uger efter påbegyndelse af efavirenzbehandling.
Rash with efavirenz: rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
I kliniske undersøgelser ophørte 1, 7% med efavirenzbehandlingen på grund af udslæt.
In clinical studies, 1.7% of patients treated with efavirenz discontinued therapy because of rash.
Anvendelse af passende antihistaminer og/ eller kortikosteroider anbefales, når efavirenzbehandling genoptages.
Use of appropriate antihistamines and/ or corticosteroids is recommended when efavirenz is restarted.
Erfaring med efavirenz hos patienter, som er ophørt med andre antiretrovirale lægemidler af NNRTI- gruppen, er begrænset.
Experience with efavirenz in patients who discontinued other antiretroviral agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class is limited.
19 patienter, der ophørte med nevirapin på grund af udslæt, er blevet behandlet med efavirenz.
Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz.
9 af disse patienter udviklede mildt til moderat udslæt, mens de fik behandling med efavirenz, og 2 ophørte på grund af udslæt.
23 developed mild-to-moderate rash while receiving therapy with efavirenz, and two discontinued because of rash.
Patienter med psykiske forstyrrelser i anamnesen synes at have større risiko for de alvorlige psykiske bivirkninger, som nævnt i efavirenzkolonnen i tabel 4 med en hyppighed fra 0, 3% for maniske reaktioner til 2, 0% for både svær depression og suicidaltanker.
Psychiatric symptoms with efavirenz: patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 4 with the frequency of events ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
I kliniske, kontrollerede undersøgelser oplevede 19, 4% af patienterne symptomer fra nervesystemet i moderat til svær grad sammenlignet med 9, 0% af de patienter, der fik kontrolregimer.
Nervous system symptoms with efavirenz: in clinical controlled studies, 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 dagligt, 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 kliniske undersøgelser ophørte 2, 1% af de patienter, der blev behandlet med 600 mg efavirenz med behandlingen på grund af symptomer fra nervesystemet.
In clinical studies 2.1% of patients treated with 600 mg of efavirenz discontinued therapy because of nervous system symptoms.
Symptomer fra nervesystemet debuterer sædvanligvis i løbet af de første 1 - 2 behandlingsdage og forsvinder i reglen efter de første 2 - 4 uger.
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first two to four weeks.
Symptomer fra nervesystemet kan forekomme hyppigere, hvis efavirenz indtages sammen med et måltid, muligvis p. g. a. 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 (see section 4.2).
Analyse af langtidsdata fra klinisk undersøgelse (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
Analysis of long-term data from a clinical study (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.
4. 4).
Lactic acidosis: lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues (see section 4.4).
Patienter som samtidigt er inficerede med HIV/ HBV eller HCV:
HIV/ HBV or HCV co-infected patients:
Det var kun et begrænset antal patienter, som samtidigt var inficerede med HBV (n=13) eller HCV (n=26) i undersøgelse GS- 01- 934.
Only a limited number of patients were co-infected with HBV (n=13) or HCV (n=26) in study GS-01-934.
Bivirkningsprofilen for efavirenz, emtricitabin og tenofovirdisoproxilfumarat hos patienter, som samtidigt var inficerede med HIV/ HBV eller HIV/ HCV lignede den, der observeredes hos patienter, som kun var inficerede med HIV.
The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil fumarate in patients co-infected with HIV/ HBV or HIV/ HCV was similar to that observed in patients infected with HIV without co-infection.
Som det kunne forventes for denne patientpopulation, forekom forhøjelserne af ASAT og ALAT imidlertid hyppigere end hos den generelle HIV- inficerede population.
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
I kliniske undersøgelser blev der set asymptomatiske stigninger i serumamylasekoncentrationen, til > 1, 5 gange ULN hos 10% af de patienter, der blev behandlet med efavirenz og 6% af de patienter, der blev behandlet med kontrolregimer.
Amylase: in clinical studies, asymptomatic increases in serum amylase levels > 1.5 times the ULN were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Den kliniske signifikans af asymptomatiske stigninger af serumamylase kendes ikke.
The clinical significance of asymptomatic increases in serum amylase is unknown.
4. 4).
Lipids, lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin-resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
4. 4).
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) (see section 4.4).
4. 4).
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Interaktion med cannabinoid- test:
Cannabinoid test interaction: efavirenz does not bind to cannabinoid receptors.
Efavirenz binder sig ikke til cannabinoidreceptorer.
False positive urine cannabinoid test results have been reported in uninfected volunteers who received efavirenz.
Der er rapporteret falsk positive resultater af urinprøver for cannabinoid hos ikke- inficerede frivillige, som fik efavirenz.
False positive test results have only been observed with the CEDIA DAU Multi-Level THC assay, which is
Falsk positive prøveresultater sås kun med CEDIA DAU Multi- Level THC test, som anvendes til screening, og er ikke set med andre anvendte cannabinoid- tests inklusive tests anvendt til bekræftelse af positive resultater.
24 used for screening, and have not been observed with other cannabinoid assays tested including tests used for confirmation of positive results.
Særligt hos patienter med generelt anerkendte risikofaktorer, fremskreden HIV- sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART) er der rapporteret om tilfælde af osteonekrose.
Osteonecrosis: 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).
4. 8), og standardmæssig, støttende behandling anvendes efter behov.
If overdose occurs, the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Administration af aktivt kul kan anvendes for at understøtte fjernelse af ikke- absorberet efavirenz.
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
10% af tenofovirdosis kan fjernes ved hæmodialyse.
Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Det vides ikke, om emtricitabin eller tenofovir kan fjernes ved peritoneal dialyse.
It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
ATC- kode:
Antivirals for treatment of HIV infections, combinations, ATC code:
Efavirenz er en NNRTI af HIV- 1.
Mechanism of action: efavirenz is an NNRTI of HIV-1.
Efavirenz er en nonkompetitiv hæmmer af HIV- 1 revers transkriptase (RT) og hæmmer ikke signifikant human immundeficient virus- 2 (HIV- 2) RT eller cellulære deoxyribonukleinsyre (DNA) polymeraser (α, β, γ eller δ).
Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Undersøgelser in vitro har vist, at både emtricitabin og tenofovir kan fosforyleres fuldstændigt, når de kombineres i celler.
In vitro studies have shown that both emtricitabine and tenofovir can be fully phosphorylated when combined together in cells.
Emtricitabintriphosphat og tenofovirdiphosphat hæmmer kompetitivt HIV- 1 revers transkriptase, hvilket resulterer i DNA - kædeblokering.
Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Både emtricitabintriphosphat og tenofovirdiphosphat er svage hæmmere af mammale DNA - polymeraser, og der var intet tegn på toksicitet over for mitokondrier in vitro eller in vivo.
Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Efavirenz udviste antiviral aktivitet mod de fleste nongruppe- B isolater (undergrupper A, AE, AG, C, D, F, G, J og N) men havde reduceret antiviral aktivitet mod gruppe- O vira.
Antiviral activity in vitro: efavirenz demonstrated antiviral activity against most non-clade B isolates (subtypes A, AE, AG, C, D, F, G, J, and N) but had reduced antiviral activity against group O viruses.
Emtricitabin viste antiviral aktivitet mod HIV- 1 grupperne A, B, C, D, E, F og G.
Emtricitabine displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, and G.
Tenofovir viste antiviral aktivitet mod HIV- 1 grupperne A, B, C, D, E, F, G og O.
Tenofovir displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, G, and O.
Både emtricitabin og tenofovir viste stammespecifik aktivitet mod HIV- 2 og antiviral aktivitet mod HBV.
Both emtricitabine and tenofovir showed strain specific activity against HIV-2 and antiviral activity against HBV.
Additiv til synergistiske virkninger blev observeret i kombinationsundersøgelser til vurdering af efavirenz 'og emtricitabins samlede antivirale aktivitet in vitro samt emtricitabins og tenofovirs samlede antivirale aktivitet.
In combination studies evaluating the in vitro antiviral activity of efavirenz and emtricitabine together, efavirenz and tenofovir together, and emtricitabine and tenofovir together, additive to synergistic antiviral effects were observed.
Resistens over for efavirenz kan selekteres in vitro og resulterede i enkle eller multiple aminosyresubstitutioner i HIV- 1 RT, herunder L100I, V108I, V179D og Y181C.
25 Resistance: resistance to efavirenz can be selected in vitro and resulted in single or multiple amino acid substitutions in HIV-1 RT, including L100I, V108I, V179D, and Y181C.
K103N var den hyppigst observerede RT- substitution i virale isolater fra patienter, som oplevede rebound viræmi under de kliniske undersøgelser med efavirenz.
K103N was the most frequently observed RT substitution in viral isolates from patients who experienced rebound in viral load during clinical studies of efavirenz.
Substitutioner på RT- positionerne 98, 100, 101, 108, 138, 188, 190 eller 225 var allerede observeret men i lavere frekvens og ofte i kombination med K103N.
Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Krydsresistensprofilerne for efavirenz, neviparin og delavirdin in vitro har vist, at K103N - substitutionen medfører et tab af følsomhed over for alle tre NNRTIer.
Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Der er observeret resistens over for emtricitabin og tenofovir in vitro og hos nogle HIV- 1- inficerede patienter på grund af udvikling af M184V - eller M184I- substitution i RT med emtricitabin eller K65R- substitution i RT med tenofovir.
Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of an M184V or M184I substitution in RT with emtricitabine or a K65R substitution in RT with tenofovir.
Der er ikke identificeret andre resistensveje over for emtricitabin eller tenofovir.
No other pathways of resistance to emtricitabine or tenofovir have been identified.
Emtricitabinresistente vira med M184V/ I- mutationen var krydsresistente over for lamivudin, men beholdt følsomhed over for didanosin, stavudin, tenofovir og zidovudin.
Emtricitabine-resistant viruses with the M184V/ I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
K65R- mutationen kan desuden selekteres ved hjælp af abacavir eller didanosin og forårsager nedsat følsomhed over for disse stoffer samt lamivudin, emtricitabin og tenofovir.
The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Tenofovirdisoproxilfumarat bør undgås hos patienter med HIV- 1 med stammer, som har
Tenofovir disoproxil fumarate should be avoided in patients with HIV-1 harbouring the K65R mutation.
Både K65R og M184V/ I mutationer forbliver fuldt ud følsomme over for efavirenz.
Both the K65R and M184V/ I mutation remain fully susceptible to efavirenz.
Patienter, hvis HIV- 1 udtrykte 3 eller flere tymidinanalog- forbundne mutationer (TAMer), som omfattede enten en M41L - eller en L210W- substitution i RT, udviste reduceret følsomhed over for tenofovirdisoproxilfumarat.
Patients with HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either an M41L or an L210W substitution in RT showed reduced susceptibility to tenofovir disoproxil fumarate.
Der er på nuværende tidspunkt yderst begrænsede resistensdata fra patienter behandlet med Atripla.
In vivo resistance (antiretroviral-naïve patients): extremely limited resistance data from patients treated with Atripla are currently available.