natgillin/translations-raw huggingface dataset:
Long-term use of efavirenz in this study was not associated with any new safety concerns.
Dolgotrajna uporaba efavirenza v tej raziskavi ni bila povezana s kakršnimikoli novimi pomisleki glede varnosti.
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.
V kliničnih raziskavah se je kožni izpuščaj pojavil pri 26% bolnikov, zdravljenih s 600 mg efavirenza, v primerjavi s 17% bolnikov iz kontrolne skupine.
Skin rash was considered treatment related in 18% of patients treated with efavirenz.
Pri 18% bolnikov, zdravljenih z efavirenzem, so pojav izpuščaja povezovali z zdravilom.
Severe rash occurred in less than 1% of patients treated with efavirenz, and 1.7% discontinued therapy because of rash.
1, 7% jih je zaradi izpuščaja zdravljenje prekinilo.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Izpuščaji so navadno blage do zmerne makulopapularne kožne lezije, ki se pojavijo v prvih dveh tednih po začetku zdravljenja z efavirenzem.
In most patients rash resolves with continuing therapy with efavirenz within one month.
Pri večini bolnikov se izpuščaj popravi v 1 mesecu nadaljnjega zdravljenja z efavirenzem.
Efavirenz can be reinitiated in patients interrupting therapy because of rash.
Pri bolnikih, ki so zaradi izpuščaja zdravljenje prekinili, lahko
Use of appropriate antihistamines and/ or corticosteroids is recommended when efavirenz is restarted.
Pri ponovni uvedbi zdravljenja z efavirenzem pa priporočamo uporabo ustreznih antihistaminikov in/ ali kortikosteroidov.
16 Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Pri bolnikih, ki so prenehali jemati druga protiretrovirusna zdravila iz razreda NNRTI- jev, so izkušnje z efavirenzem omejene.
Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz.
Devetnajst bolnikov, ki so zaradi izpuščaja prenehali jemati nevirapin, so potem zdravili z efavirenzem.
Nine of these patients developed mild-to-moderate rash while receiving therapy with efavirenz, and two discontinued because of rash.
Pri devetih od teh bolnikov se je med jemanjem efavirenza pojavil blag do zmeren izpuščaj, dva pa sta zaradi izpuščaja zdravljenje prekinila.
Psychiatric symptoms: serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
Pri bolnikih, ki so se zdravili z efavirenzem, so poročali o resnih psihiatričnih neželenih učinkih.
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:
V kontroliranih raziskavah, v katere je bilo vključenih 1. 008 bolnikov, ki so bili povprečno 1, 6 let zdravljeni z režimi, ki so vključevali efavirenz, in 635 bolnikov v kontrolnih skupinah, ki so bili povprečno zdravljeni 1, 3 leta, je bila pogostnost posameznih resnih duševnih motenj sledeča:
- severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
- huda oblika depresije - misel na samomor - samomorilni poskusi - agresivno vedenje - paranoidne reakcije - manične reakcije
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.
Kaže, da obstaja pri ljudeh, ki so v preteklosti že imeli duševne motnje, večje tveganje za resne psihiatrične neželene učinke s pogostnostjo vsakega od zgoraj naštetih simptomov od 0, 3% za manične reakcije do 2, 0% za hudo obliko depresije in misel na samomor.
There have also been post-marketing reports of death by suicide, delusions and psychosis-like behaviour.
Neželeni učinki, o katerih so poročali ob spremljanju zdravila na tržišču, so vključevali tudi smrt zaradi samomora, blodnjave motnje in vedenje podobno psihozi.
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.
V kontroliranih kliničnih raziskavah so bili pogosto poročani neželeni učinki pri bolnikih, ki so prejemali 600 mg efavirenza skupaj z drugimi protiretrovirusnimi učinkovinami: omotica, nespečnost, zaspanost, motena koncentracija in nenormalne sanje.
Nervous system symptoms of moderate-to-severe intensity were experienced by 19.4% of patients compared to 9.0% of patients receiving control regimens.
Zmerni do hudi simptomi živčnega sistema so se pojavili pri 19, 4% bolnikov, v primerjavi z 9, 0% bolnikov, ki so bili zdravljeni s kontrolnim režimom.
These symptoms were severe in 2.0% of patients receiving efavirenz 600 mg daily and in 1.3% of patients receiving control regimens.
Ti simptomi so bili hudi pri 2, 0% bolnikov, ki so dobivali 600 mg efavirenza dnevno, in pri 1, 3% bolnikov, ki so bili zdravljeni s kontrolnim režimom.
In clinical studies 2.1% of patients treated with 600 mg of efavirenz discontinued therapy because of nervous system symptoms.
V kliničnih raziskavah je 2, 1% bolnikov, zdravljenih s 600 mg efavirenza, prenehalo z zdravljenjem zaradi simptomov živčnega sistema.
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks.
Simptomi živčnega sistema se običajno pojavijo že prvi dan ali v prvih dveh dneh zdravljenja in običajno izginejo v 2 - 4 tednih.
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.
V klinični raziskavi je bila med 4. in 48. tednom mesečna prevalenca simptomov živčnega sistema, ki so bili vsaj zmerne jakosti, pri bolnikih, zdravljenih z efavirenzem, v območju od 5% - 9%, pri bolnikih v kontrolni skupini pa od 3% - 5%.
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.
V raziskavi, v katero so bili vključeni neokuženi prostovoljci, se je značilen simptom živčnega sistema pojavil v povprečju 1 uro po odmerku in je trajal v povprečju 3 ure.
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).
Simptomi živčnega sistema se lahko pojavijo pogosteje, kadar se efavirenz jemlje skupaj s hrano, verjetno zaradi povečane koncentracije efavirenza v plazmi (glejte poglavje 5. 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).
Kaže, da odmerjanje pred spanjem izboljša prenašanje teh simptomov in ga lahko priporočamo v prvih tednih zdravljenja ter pri bolnikih, pri katerih se ti simptomi nadaljujejo (glejte poglavje 4. 2).
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.
Analiza dolgoročnih podatkov iz raziskave 006 (povprečno spremljanje 180 tednov pri bolnikih, zdravljenih z efavirenzem + zidovudinom + lamivudinom, 102 tedna pri bolnikih, zdravljenih z efavirenzem + indinavirjem ter 76 tednov pri bolnikih, zdravljenih z indinavirjem + zidovudinom + lamivudinom) je pokazala, da je bila pojavnost simptomov živčnega sistema po 24 tednih zdravljenja pri bolnikih, zdravljenih z efavirenzem, na splošno podobna kot v kontrolnem kraku.
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.
Spodaj so našteti neželeni učinki zmerne ali hujše resnosti, katerih vzročna povezava z zdravljenjem je bila (s strani raziskovalca) ocenjena najmanj kot mogoča, in so jih poročali iz kliničnih raziskav
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.
Pogostnost je definirana z uporabo sledečega dogovora: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000) vključno s posameznimi primeri.
17 Nervous system disorders common
Bolezni živčevja pogosti
disturbance in attention, dizziness, headache, somnolence
motnje koncentracije, omotica, glavobol, zaspanost
uncommon
občasni Očesne bolezni
agitation, amnesia, ataxia, coordination abnormal, convulsions, thinking abnormal
vznemirjenost, amnezija, ataksija, motnje koordinacije, krči, nenormalne misli
Eye disorders uncommon
občasni
vision blurred
zamegljen vid
Gastrointestinal disorders common
Bolezni prebavil pogosti
Skin and subcutaneous tissue disorders very common
Bolezni kože in podkožja zelo pogosti
erythema multiforme, Stevens-Johnson syndrome
multiformni eritem, Stevens- Johnsonov sindrom
Immune system disorders
Bolezni imunskega sistema občasni
uncommon
preobčutljivost
hypersensitivity
Bolezni jeter, žolčnika in žolčevodov
Hepatobiliary disorders uncommon
občasni
Reproductive system and breast disorders
Motnje reprodukcije in dojk občasni
uncommon
ginekomastija
gynaecomastia
Psihiatrične motnje
abnormal dreams, anxiety, depression, insomnia
nenormalne sanje, anksioznost, depresija, nespečnost
affect lability, aggression, confusional state, euphoric mood, hallucination, mania, paranoia, suicide attempt, suicide ideation
čustvena labilnost, nasilno vedenje, zmedenost, evforično razpoloženje, halucinacije, manija, paranoja, poskus samomora, misli na samomor
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).
Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - “ combination antiretroviral therapy ”) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
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).
Prerazporeditev maščevja (lipodistrofija) pri bolnikih s HIV, vključno z izgubo perifernega in obraznega podkožnega maščevja, povečano intraabdominalno in visceralno maščevje, hipertrofijo prsi in akumulacijo dorzocervikalnega maščevja (bikovska grba) so povezali s kombiniranim protiretrovirusnim zdravljenjem.
18 Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
19 Kombinirano protiretrovirusno zdravljenje so povezali s pojavom metabolnih motenj, kot so hipertrigliceridemija, hiperholesterolemija, odpornost proti insulinu, hiperglikemija in povišana vrednost laktata v krvi (glejte poglavje 4. 4).
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).
Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali z dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
Laboratory test abnormalities:
Nenormalne vrednosti laboratorijskih testov:
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).
Povišanje aspartat aminotransferaze (AST) in alanin aminotransferaze (ALT) na več kot petkratno zgornjo mejo normalnih vrednosti (ZMN) so opazili pri 3% od 1. 008 bolnikov, zdravljenih s 600 mg efavirenza (5– 8% po dolgotrajnem zdravljenju v raziskavi 006).
Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Podobna povišanja so opazili tudi pri bolnikih na kontrolnem režimu (5% po dolgotrajnem zdravljenju).
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).
Povišanje gama glutamiltransferaze (GGT) na več kot petkratno ZMN so opazili pri 4% bolnikov, zdravljenih s 600 mg efavirenza in pri 1, 5– 2% bolnikov, zdravljenih s kontrolnim režimom (po dolgotrajnem zdravljenju pri 7% bolnikov, zdravljenih z efavirenzem, in 3% bolnikov, zdravljenih s kontrolnim režimom).
In the long-term study (006), 1% of patients in each treatment arm discontinued because of liver or biliary system disorders.
V dolgoročni raziskavi (006) je 1% bolnikov v vsakem kraku prekinilo zdravljenje zaradi motenj v delovanju jeter, žolčnika ali žolčevodov.
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).
V dolgoročnih podatkih iz raziskave 006 je bilo 137 bolnikov, zdravljenih s kombinacijami, ki so vsebovale efavirenz (povprečno trajanje zdravljenja 68 tednov), in 84 bolnikov, zdravljenih s kontrolnim režimom (povprečno trajanje 56 tednov), ob presejanju seropozitivnih na hepatitis B (pozitivnih na površinski antigen) in/ ali C (pozitivnih na protitelo proti hepatitisu C).
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.
Med temi sočasno okuženimi bolniki je prišlo do povišanj AST, večjih od petkratne ZMN, pri 13% bolnikov, ki so jemali efavirenz, in pri 7% bolnikov v kontrolnem kraku, ter do zvišanj ALT, večjih od petkratne ZMN, pri 20% bolnikov, ki so jemali efavirenz, ter pri 7% bolnikov v kontrolnem kraku.
Among co-infected patients, 3% of those treated with efavirenz-containing regimens and 2% in the control arm discontinued from the study because of liver or biliary system disorders.
Med sočasno okuženimi bolniki je 3% tistih, ki so jemali kombinacije z efavirenzem, in 2% bolnikov iz kontrolnega kraka prekinilo raziskavo zaradi motenj v delovanju jeter, žolčnika ali žolčevodov.
Reasons for discontinuation among co-infected recipients of efavirenz included abnormalities in hepatic enzymes; there were no discontinuations reported in this study for cholestatic hepatitis, hepatic failure, or fatty liver (see section 4.4).
Med vzroki za prekinitev zdravljenja pri sočasno okuženih prejemnikih efavirenza so bile nenormalnosti jetrnih encimov; v tej raziskavi pa niso poročali o prekinitvah zaradi holestatskega hepatitisa, jetrne odpovedi ali jetrne steatoze (glejte poglavje 4. 4).
Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
V klinični raziskavi so v podskupini 1. 008 bolnikov asimptomatska zvišanja nivojev serumskih amilaz, večja kot 1, 5 kratna zgornja meja normalne vrednosti, opazili pri 10% bolnikov, zdravljenih z efavirenzem, in pri 6% bolnikov iz kontrolne skupine.
Lipids: increases in total cholesterol of 10 - 20% have been observed in some uninfected volunteers receiving efavirenz.
Pri nekaj neokuženih prostovoljcih, ki so prejemali efavirenz, so opazili 10 – 20% zvišanje skupnega holesterola.
In clinical trials of various efavirenz-containing regimens in treatment naive patients, total cholesterol, HDL-cholesterol, and triglycerides increased over 48 weeks of treatment (21 – 31%, 23 – 34%, and 23 – 49%, respectively).
V kliničnih raziskavah z različnimi režimi zdravljenja z efavirenzem so se pri za zdravljenje občutljivih bolnikih vrednosti skupnega holesterola, HDL- holesterola in trigliceridov po 48 tednih zdravljenja zvišale (21 – 31%, 23 – 34% oz.
The proportion of patients with a total cholesterol/ HDL-cholesterol ratio greater than 5 was unchanged.
Delež bolnikov, pri katerih je bilo razmerje skupni/ HDL- holesterol večje od 5, se ni spremenil.
The magnitude of changes in lipid levels may be influenced by factors such as duration of therapy and other components of the antiretroviral regimen.
Na obseg sprememb vrednosti lipidov lahko vplivajo dejavniki, kot so trajanje zdravljenja ter druge komponente protiterovirusnega režima zdravljenja.
Cannabinoid test interaction: efavirenz does not bind to cannabinoid receptors.
Efavirenz se ne veže na kanabinoidne receptorje.
False positive test results have only been observed with the CEDIA DAU Multi-Level THC assay, which is used for screening, and have not been observed with other cannabinoid assays tested including tests used for confirmation of positive results.
Lažno pozitiven izvid so opazili samo pri večnivojni THC analizi CEDIA DAU, ki se uporablja za presejalne teste, pri drugih kanabinoidnih testih, vključno s testom za potrditev pozitivnega rezultata, pa tega niso opazili.
Postmarketing experience with efavirenz has shown the following additional adverse reactions to occur in association with efavirenz-containing antiretroviral treatment regimens: cerebellar coordination and balance disturbances, delusion, hepatic failure, neurosis, photoallergic dermatitis, psychosis and completed suicide.
Izkušnje z efavirenzem na tržišču so pokazale še sledeče dodatne neželene učinke, ki se lahko pojavijo pri protiretrovirusnem zdravljenju, ki vključuje efevirenz: motnje cerebelarne koordinacije in ravnotežja, privid, odpoved jeter, nevroza, fotoalergični dematitis, psihoza in samomor.
19 Paediatric patients: undesirable effects in children were generally similar to those of adult patients.
Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
Rash was reported more frequently in children (in a clinical study including 57 children who received efavirenz during a 48-week period, rash was reported in 46%) and was more often of higher grade than in adults (severe rash was reported in 5.3% of children).
Izpuščaj je bil pri otrocih bolj pogost (v 48- tedenski raziskavi, ki je vključevala 57 otrok, zdravljenih z efavirenzem, so o izpuščaju poročali pri 46%) in pogosteje bolj izražen kot pri odraslih (huda oblika izpuščaja se je pojavila pri 5, 3% otrok).
Although nervous system symptoms are difficult for young children to report, they appear to be less frequent in children and were generally mild.
Čeprav majhni otroci težko opišejo simptome živčnega sistema, se zdi, da so le- ti pri otrocih manj pogosti in večinoma blagi.
In the study of 57 children, 3.5% of patients experienced nervous system symptoms of moderate intensity, predominantly dizziness.
Hudih simptomov ni imel noben otrok.
No child had severe symptoms or had to discontinue because of nervous system symptoms.
Zaradi simptomov živčnega sistema zdravljenja ni bilo treba nikomur prekiniti.
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Nekaj bolnikov, ki so pomotoma jemali 600 mg dvakrat dnevno, je poročalo o večjem pojavljanju simptomov živčnega sistema.
Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient ’ s clinical status.
Zdravljenje prevelikega odmerjanja z efavirenzem naj vključuje splošne podporne ukrepe, vključno s spremljanjem življenjskih znakov in opazovanjem bolnikovega kliničnega stanja.
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Za odstranitev neabsorbirane učinkovine lahko uporabimo aktivno oglje.
Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Ker se efavirenz močno veže na proteine, je malo verjetno, da bi z dializo iz krvi lahko odstranili znatnejšo količino učinkovine.
Non-nucleoside reverse transcriptase inhibitors.
Nenukleozidni zaviralci reverzne transkriptaze.
Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).
Efavirenz je nekompetitivni zaviralec reverzne transkriptaze (RT) HIV- 1 in ne zavira pomembno RT HIV- 2 ali celičnih polimeraz DNA (α, β, γ ali δ).
Antiviral activity: the free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/ monocyte cultures.
Koncentracija prostega efavirenza, potrebna za 90% do 95% in vitro inhibicijo laboratorijskih in kliničnih izolatov divjega tipa ali tistih, ki so rezistentni na zidovudin, je bila v območju od 0, 46 do 6, 8 nM, in sicer v limfoblastoidnih celičnih linijah, perifernih krvnih enojedrnih celicah (PBMC) in v kulturah makrofagov/ monocitov.
Resistance: the potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild type viral strains.
Učinkovitost efavirenza proti virusnim različicam z aminokislinskimi substitucijami na mestih 48, 108, 179, 181 ali 236 na RT ali različicam z aminokislinskimi substitucijami na proteazi je bila v celičnih kulturah podobna njegovi učinkovitosti proti divjim tipom virusnih sevov.
The single substitutions which led to the highest resistance to efavirenz in cell culture correspond to a leucine-to-isoleucine change at position 100 (L100I, 17 to 22-fold resistance) and a lysine-to-asparagine at position 103 (K103N, 18 to 33-fold resistance).
Enkratne substitucije, ki so povzročile največjo rezistenco na efavirenz v celični kulturi, so ustrezale spremembi levcina v izolevcin na mestu 100 (L100I, 17 do 22- krat večja rezistenca) in spremembi lizina v asparagin na mestu 103 (K103N, 18 do 33- krat večja rezistenca).
Greater than 100-fold loss of susceptibility was observed against HIV variants expressing K103N in addition to other amino acid substitutions in RT.
Več kot 100- kratno izgubo dovzetnosti so opazili proti HIV različicam, ki so imele poleg drugih aminokislinskih substitucij na RT tudi substitucijo K103N.