natgillin/translations-raw huggingface dataset:
Interactions between tenofovir disoproxil fumarate and protease inhibitors and antiretroviral agents other than protease inhibitors are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ b. i. d.”, and once daily as “ q. d.”).
Interakcije med tenofovirdizoproksil fumaratom in zaviralci proteaze in protiretrovirusnimi zdravili, ki niso zaviralci proteaze, so navedene v preglednici 1 spodaj (povečanje je označeno z znakom “ ↑ ”, zmanjšanje z “ ↓ ”, brez spremembe z “ ↔ ”, dvakrat na dan z “ bid. ”, enkrat na dan pa s “ q. d. ”).
Interactions between tenofovir disoproxil fumarate and other medicinal products
Interakcije med tenofovirdizoproksil fumaratom in drugimi zdravili
Medicinal product by
Zdravilne učinkovine po terapevtskih
Recommendation
Priporočilo glede
therapeutic areas
področjih
Mean percent change in AUC, Cmax, Cmin
učinkovin
concerning
sočasne uporabe s
(dose in mg)
(odmerek v mg)
co-administration with tenofovir disoproxil fumarate 300 mg
tenofovirdizoproksil fumaratom 300 mg)
ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/ Ritonavir (300 q. d. / 100 q. d. / 300 q. d.)
ZDRAVILA ZA PREPREČEVANJE IN ZDRAVLJENJE INFEKCIJ Protiretrovirusne učinkovine Zaviralci proteaze atazanavir/ ritonavir (300 q. d. / 100 q. d. / 300 q. d.)
Renal function should be closely monitored (see section 4.4).
Delovanje ledvic je treba skrbno nadzorovati (glejte poglavje 4. 4).
Tenofovir:
Brez pomembnega učinka na farmakokinetične parametre lopinavirja/ ritonavirja. tenofovir:
Renal function should be closely monitored (see section 4.4).
Delovanje ledvic je treba
Darunavir/ Ritonavir (300/ 100 b. i. d. / 300 q. d.) NRTIs
(300/ 100 b. i. d. / 300 q. d.)
Tenofovir:
Brez pomembnega učinka na farmakokinetične parametre darunavirja/ ritonavirja. tenofovir:
Co-administration of tenofovir disoproxil
NRTI- ji (Nukleozidni in nukleotidni zaviralci reverzne transkriptaze) didanozin
fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse events.
Sočasna uporaba tenofovirdizoproksil fumarata in didanozina povzroča povečanje sistemske izpostavljenosti didanozinu za 40- 60%, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom.
tenofovir disoproxil fumarate and didanosine is not recommended (see section 4.4).
Sočasna uporaba tenofovirdizoproksil fumarata in didanozina ni priporočena (glejte poglavje 4. 4).
Adefovir dipivoxil
adefovirdipivoksil
Tenofovir disoproxil fumarate should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Tenofovirdizoproksil fumarata se ne sme uporabljati skupaj z adefovirdipivoksilom (glejte poglavje 4. 4).
Entecavir
entecavir
No clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with entecavir.
Pri sočasni uporabi tenofovirdizoproksil fumarata in entecavirja ni bilo klinično pomembnih farmakokinetičnih interakcij.
Studies conducted with other medicinal products:
Študije, opravljene z drugimi zdravili:
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ ethinyl oestradiol.
Pri sočasni uporabi tenofovirdizoproksil fumarata in emtricitabina, lamivudina, indinavirja, efavirenza, nelfinavirja, sakinavirja (okrepljenega z ritonavirjem), metadona, ribavirina, rifampicina, takrolimusa ali hormonskega kontracepcijskega sredstva norgestimata/ etinilestradiola ni bilo klinično pomembnih farmakokinetičnih interakcij.
Tenofovir disoproxil fumarate must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Tenofovirdizoproksil fumarat se mora jemati s hrano, kajti hrana poviša biološko razpoložljivost tenofovirja (glejte poglavje 5. 2).
4.6 Pregnancy and lactation
9 4. 6 Nosečnost in dojenje
Pregnancy For tenofovir disoproxil fumarate limited clinical data on exposed pregnancies are available.
Nosečnost Za tenofovirdizoproksil fumarat so na voljo pomankljivi klinični podatki pri nosečnicah, ki so bile izpostavljene zdravilu.
Animal studies do not indicate direct or indirect harmful effects of tenofovir disoproxil fumarate with respect to pregnancy, foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive tenofovirdizoproksil fumarata na nosečnost, razvoj plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Tenofovir disoproxil fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Tenofovirdizoproksil fumarat smete uporabljati med nosečnosti samo v primeru, kadar pričakovana korist upravičuje možno tveganje za plod.
Given that the potential risks to developing human foetuses are unknown, the use of tenofovir disoproxil fumarate in women of childbearing potential must be accompanied by the use of effective contraception.
Ker možno tveganje za razvoj človeškega ploda ni znano, morajo biti ženske v rodni dobi, ki jemljejo tenofovirdizoproksil fumarat zaščitene z učinkovito kontracepcijo.
Lactation In animal studies it has been shown that tenofovir is excreted into milk.
Dojenje Študijah na živalih so je pokazale, da tenofovir prehaja v mleko.
It is not known whether tenofovir is excreted in human milk.
Ni pa znano ali tenofovir prehaja v človeško mleko.
Therefore, it is recommended that mothers being treated with tenofovir disoproxil fumarate do not breast-feed their infants.
Zato se priporoča naj matere, ki se zdravijo s tenofovirdizoproksil fumaratom, ne dojijo.
9 As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Splošno priporočljivo je, naj s HIV in HBV okužene ženske ne dojijo, da se prepreči prenos HIV in HBV na dojenčka.
However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil fumarate.
Vendar je bolnike potrebno opozoriti, da se lahko v času zdravljenja s tenofovirdizoproksil fumaratom pojavi omotičnost.
Assessment of adverse reactions from clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil fumarate (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (as fumarate) (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
V drugi dvojno slepi kontrolirani primerjalni študiji je 600 še nezdravljenih bolnikov 144 tednov prejemalo tenofovirdizoproksil 245 mg (v obliki fumarata) (n=299) ali stavudin (n=301) v kombinaciji z lamivudinom in efavirenzom.
Approximately one third of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil fumarate in combination with other antiretroviral agents.
Neželeni učinki so za pričakovati pri približno 1/ 3 bolnikov zdravljenih s tenofovirdizoproksil fumaratom v kombinaciji z drugimi zdravili.
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and absolute frequency.
Spodaj so navedeni neželeni učinki, domnevno (vsaj možno) povezani z zdravljenjem, po organskih sistemih in absolutni pogostosti.
Frequencies are defined as very common (≥ 1/ 10) or common (≥ 1/ 100, < 1/ 10).
Pogostost je definirana kot zelo pogosti (≥ 1/ 10) ali pogosti (≥ 1/ 100, < 1/ 10).
See also Post-marketing experience below.
Glejte tudi razdelek Postmarketinške izkušnje spodaj.
Very common: hypophosphataemia
Zelo pogosto: hipofosfatemija
Very common: dizziness
Zelo pogosto: omotičnost
Very common: diarrhoea, vomiting, nausea Common: flatulence
Zelo pogosto: driska, bruhanje, navzea Pogosto: flatulenca (napihnjenost)
Approximately 1% of tenofovir disoproxil fumarate-treated patients discontinued treatment due to the gastrointestinal events.
10 Približno 1% bolnikov zdravljenih s tenofovirdizoproksil fumaratom je zdravljenje prekinilo zaradi neželenih učinkov v prebavnem traktu.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirana protiretrovirusna terapija je povezana z presnovnimi anomalijami, kot so hipertrigliceridemija, hiperholesterolemija, rezistenca na insulin, hiperglikemija in hiperlaktatemija (glejte poglavje 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).
Pri bolnikih s HIV je kombinirana protiretrovirusna terapija povezana s prerazporeditvijo telesnih maščob (lipodistrofija), vključno z izgubo periferne in obrazne podkožne maščobe, povečanjem količine intraabdominalne in visceralne maščobe, hipertrofijo prsi in dorzocervikalnim kopičenjem maščobe (bivolja grba).
In a 144-week controlled clinical study in antiretroviral-naïve patients that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz, patients who received tenofovir disoproxil had a significantly lower incidence of lipodystrophy compared with patients who received stavudine.
V 144 tednov trajajoči kontrolirani klinični študiji pri bolnikih, še nezdravljenih s protiretrovirusnimi zdravili, v kateri je bil tenofovirdizoproksil fumarat primerjan s stavudinom v kombinaciji z lamivudinom in efavirenzom, so imeli bolniki, ki so jemali tenofovirdizoproksil pomembno nižjo incidenco lipodistrofije v primerjavi z bolniki, ki so jemali stavudin.
The tenofovir disoproxil fumarate arm also had significantly smaller mean increases in fasting triglycerides and total cholesterol than the comparator arm.
V skupini s tenofovirdizoproksil fumaratom je bilo tudi pomembno manjše srednje povišanje trigliceridov in skupnega holesterola na tešče kot v primerjalni skupini.
10 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 dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
Assessment of adverse reactions from clinical study data is based on experience in two double-blind comparative controlled studies in which 641 patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg (as fumarate) daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
Ocena neželenih učinkov v kliničnih študijah temelji na izkušnjah iz dveh dvojno slepih kontroliranih primerjalnih študij, v katerih je 641 bolnikov s kroničnim hepatitisom B in kompenzirano jetrno boleznijo 48 tednov prejemalo 245 mg tenofovirdizoproksila (v obliki fumarata) na dan (n = 426) ali 10 mg adforvirdipivoksila na dan (n = 215).
Frequencies are defined as common (≥ 1/ 100, < 1/ 10).
Pogostost je definirana kot pogosti (≥ 1/ 100, < 1/ 10).
Common: diarrhoea, vomiting, abdominal pain, nausea, abdominal distension, flatulence
Pogosto: driska, bruhanje, abdominalna bolečina, navzea, napenjanje, flatulenca
ALT increase
Pogosto: zvišanje ALT
Common: fatigue
Pogosto: utrujenost
Exacerbations during treatment:
Eksacerbacije med zdravljenjem:
In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil fumarate-treated patients versus 1.9% of adefovir dipivoxil-treated patients.
V študijah pri bolnikih, ki še niso bili zdravljeni z nukleozidi, so se zvišanja ALT med zdravljenjem za > 10- kratno vrednost ZMN (zgornja meja normalne vrednosti) in > 2- kratno vrednost izhodiščne vrednosti pojavila pri 2, 6% bolnikov, zdravljenih s tenofovirdizoproksil fumaratom, in pri 1, 9% bolnikov, zdravljenih z adefovirdipivoksilom.
Among tenofovir disoproxil fumarate-treated patients, on-treatment ALT elevations had a median time to onset of 8 weeks, resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10 copies/ ml reduction in viral load that preceded or coincided with the ALT elevation.
Med bolniki, ki so prejemali tenofovirdizoproksil fumarat, je bila mediana časa do zvišanja ALT med zdravljenjem 8 tednov, zvišanje se je ob nadaljevanju zdravljenja prenehalo, v večini primerov pa je bilo povezano z zmanjšanjem virusne obremenitve za ≥ 2 log10 kopij/ ml, ki se je zgodilo pred zvišanjem ALT ali pa je sovpadalo z njim.
Periodic monitoring of hepatic function is recommended during treatment.
Med zdravljenjem je priporočeno občasno spremljati delovanje jeter.
Post-marketing experience:
11 Postmarketinške izkušnje:
In addition to adverse reaction reports from clinical studies the following possible adverse reactions have also been identified during post-marketing safety surveillance of tenofovir disoproxil fumarate.
Poleg poročil o neželenih učinkih iz kliničnih študij, so v postmarketinškem nadzorovanju varnosti tenofovirdizoproksil fumarata odkrili tudi naslednje možne neželene učinke.
Frequencies are defined as rare (≥ 1/ 10,000, < 1/ 1,000) or very rare (< 1/ 10,000) including isolated reports.
Pogostnost je definirana kot redka (≥ 1/ 10. 000, < 1/ 1. 000) ali zelo redka (< 1/ 10. 000), vključno s posameznimi primeri.
Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot always be made.
O teh učinkih je prostovoljno poročala populacija neznane velikosti, zato pogostosti ni vedno mogoče oceniti.
Rare: lactic acidosis Not known: hypokalaemia
Redko: laktacidoza Pogostost ni znana: hipokaliemija
Rare: pancreatitis
Redko: pankreatitis
Rare: increased transaminases Very rare: hepatitis Not known: hepatic steatosis
Redko: povišane vrednosti transaminaz Zelo redko: hepatitis Pogostost ni znana: jetrna steatoza
Rare: rash
Redko: izpuščaj
11 Musculoskeletal and connective tissue disorders:
Bolezni mišično- skeletnega sistema in vezivnega tkiva:
Not known: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), muscular weakness, myopathy
Pogostost ni znana: rabdomioliza, osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom), mišična oslabelost, miopatija
Rare: acute renal failure, renal failure, proximal renal tubulopathy (including Fanconi syndrome), increased creatinine Very rare: acute tubular necrosis Not known: nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus
Redko: akutna ledvična odpoved, ledvična odpoved, proksimalna ledvična tubulopatija (vključno s Fanconijevim sindromom), povišan kreatinin Zelo redko: akutna tubularna nekroza Pogostost ni znana: nefritis (vključno z akutnim intersticijskim nefritisom), nefrogeni diabetes insipidus
Very rare: asthenia
Zelo redko: astenija
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.
Naslednji neželeni učinki, našteti pod zgoraj navedenimi organskimi sistemi, se lahko pojavijo kot posledica proksimalne ledvične tubulopatije: rabdomioliza, osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom), hipokaliemija, mišična oslabelost, miopatija in hipofosfatemija.
If overdose occurs the patient must be monitored for evidence of toxicity (see sections 4.8 and 5.3), and standard supportive treatment applied as necessary.
V primeru prevelikega odmerka je potrebno pri bolniku nadzorovati znake toksičnosti (glejte poglavji 4. 8 in 5. 3) in mu nuditi standardno podporno zdravljenje.
Tenofovir can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 ml/ min.
Tenofovir se lahko odstrani s hemodializo; vrednost mediane hemodializnega očistka za tenofovir je 134 ml/ min.
The elimination of tenofovir by peritoneal dialysis has not been studied.
5. 1 Farmakodinamične lastnosti
Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil.
Tenofovirdizoproksil fumarat je fumaratna sol predzdravila tenofovirdizoproksila.
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue.
Tenofovirdizoproksil se absorbira in pretvori v zdravilno učinkovino tenofovir, ki je analog nukleozid (nukleotid) monofosfata.
Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Tenofovir difosfat zavira reverzno transkriptazo virusa HIV- 1 in polimerazo virusa HBV z direktno kompeticijo za vezavo z naravnim dezoksiribonukleotidnim substratom in potem, ko je vključen v DNA, povzroči prekinitev njene sinteze.
At concentrations of up to 300 µmol/ l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
Tenofovir ni pokazal učinkov na sintezo mitohondrijske DNA ali na nastajanje mlečne kisline pri koncentracijah do 300 µmol/ l pri in vitro analizah.
Data pertaining to HIV:
Informacije, ki se nanašajo na virus HIV:
HIV antiviral activity in vitro:
Protivirusna aktivnost proti virusu HIV in vitro:
The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1-6 µmol/ l in lymphoid cell lines and 1.1 µmol/ l against primary HIV-1 subtype B isolates in PBMCs.
50% inhibitorna koncentracija (EC50) tenofovirja za divji tip laboratorijskega seva HIV- 1IIIB znaša 1- 6 µmol/ l v limfoidnih celičnih linijah in EC50 za primarne izolate HIV- 1 podtipa B je 1, 1 µmol/ l v PBMC.
Tenofovir is also active against HIV-1 subtypes A, C, D, E, F, G, and O and against HIVBaL in primary monocyte/ macrophage cells.
Tenofovir je prav tako aktiven proti podtipom HIV- 1 A, C, D, E, F, G in O in proti HIVBaL v primarnih monocitih/ makrofagih.
Tenofovir shows activity in vitro against HIV-2, with an EC50 of 4.9 µmol/ l in MT-4 cells.
Tenofovir kaže in vitro aktivnost proti HIV- 2 z EC50 4, 9 µmol/ l v MT- 4 celicah.
Strains of HIV-1 with reduced susceptibility to tenofovir and a K65R mutation in reverse transcriptase have been selected in vitro and in some patients (see Clinical results).
In vitro in pri nekaterih bolnikih so bili izbrani sevi HIV- 1 z zmanjšano občutljivostjo za tenofovir in z mutacijo reverzne transkriptaze K65R (glejte razdelek Klinični rezultati).
Tenofovir 12 disoproxil fumarate should be avoided in antiretroviral experienced patients with strains harbouring the K65R mutation (see section 4.4).
Uporabi tenofovirdizoproksil fumarata se je potrebno izogniti pri bolnikih s sevom nosilcem K65R mutacije, ki so že bili zdravljeni s protiretrovirusnimi zdravili (glejte poglavje 4. 4).
Clinical studies in treatment-experienced patients have assessed the anti-HIV activity of tenofovir disoproxil 245 mg (as fumarate) against strains of HIV-1 with resistance to nucleoside inhibitors.
V kliničnih študijah pri bolnikih, ki so se predhodno zdravili, so ocenili aktivnost 245 mg tenofovirdizoproksila (v obliki fumarata) proti sevom virusa HIV- 1, odpornim na nukleozidne zaviralce.
The results indicate that patients whose HIV expressed 3 or more thymidine-analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced response to tenofovir disoproxil 245 mg (as fumarate) therapy.
Rezultati so pokazali, da so bolniki, katerih HIV je izražal tri ali več mutacij, povezanih z analogom timidina (TAM, thymidine- analogue associated mutations), ki so vsebovale ali M41L ali L210W mutacijo reverzne transkriptaze, kazali zmanjšan odziv na zdravljenje z 245 mg tenofovirdizoproksila (v obliki fumarata).
Clinical results:
Klinični rezultati:
The effects of tenofovir disoproxil fumarate in treatment-experienced and treatment-naïve HIV-1 infected adults have been demonstrated in trials of 48 weeks duration in treatment-experienced HIV-1 infected adults.
Učinkovitost tenofovirdizoproksil fumarata so dokazali pri že zdravljenih in še nezdravljenih odraslih, okuženih s HIV- 1, v 48 tednov trajajočih študijah.
In study GS-99-907, 550 treatment-experienced patients were treated with placebo or tenofovir disoproxil 245 mg (as fumarate) for 24 weeks.
Prejemali so placebo ali 245 mg tenofovirdizoproksil (v obliki fumarata) 24 tednov.
The mean baseline CD4 cell count was 427 cells/ mm3, the mean baseline plasma HIV-1 RNA was 3.4 log10 copies/ ml (78% of patients had a viral load of < 5,000 copies/ ml) and the mean duration of prior HIV treatment was 5.4 years.
Ob začetku študije je bilo srednje število CD4 celic 427 celic/ mm3, srednja plazemska koncentracija HIV- 1 RNA 3, 4 log10 kopij/ ml (78% bolnikov je imelo virusno obremenitev < 5. 000 kopij/ ml) in srednje trajanje predhodnega zdravljenja HIV je bilo 5, 4 let.
Baseline genotypic analysis of HIV isolates from 253 patients revealed that 94% of patients had HIV-1 resistance mutations associated with nucleoside reverse transcriptase inhibitors, 58% had mutations associated with protease inhibitors and 48% had mutations associated with non-nucleoside reverse transcriptase inhibitors.
Genotipska analiza HIV izolatov pri 253 bolnikih je ob začetku študije odkrila, da ima 94% bolnikov HIV- 1 mutacije za rezistenco povezane z nukleozidnimi zaviralci reverzne transkriptaze, 58% je imelo mutacije povezane s proteaznimi zaviralci in 48% je imelo mutacije povezane z nenukleozidnimi zaviralci reverzne transkriptaze.
At week 24 the time-weighted average change from baseline in log10 plasma HIV-1 RNA levels (DAVG24) was -0.03 log10 copies/ ml and -0.61 log10 copies/ ml for the placebo and tenofovir disoproxil 245 mg (as fumarate) recipients (p < 0.0001).
V 24. tednu je časovno vrednotena povprečna sprememba od začetne vrednosti izražena kot log10 plazemske koncentracije HIV- 1 RNA (DAVG24) znašala - 0, 03 log10 kopij/ ml pri bolnikih, ki so prejemali placebo in - 0, 61 log10 kopij/ ml pri prejemnikih 245 mg tenofovirdizoproksila (v obliki fumarata) (p < 0, 0001).
A statistically significant difference in favour of tenofovir disoproxil 245 mg (as fumarate) was seen in the time-weighted average change from baseline at week 24 (DAVG24) for CD4 count (+13 cells/ mm3 for tenofovir disoproxil 245 mg (as fumarate) versus -11 cells/ mm3 for placebo, p-value = 0.0008).
Protivirusni učinek tenofovirdizoproksil
The antiviral response to tenofovir disoproxil fumarate was durable through 48 weeks (DAVG48 was -0.57 log10 copies/ ml, proportion of patients with HIV-1 RNA below 400 or 50 copies/ ml was 41% and 18% respectively).
13 fumarata je bil izražen skozi 48 tednov (DAVG48 je bila - 0, 57 log10 kopij/ ml, delež pacientov z HIV- 1 RNA pod 400 kopij/ ml je bil 41%, s pod 50 kopij/ ml pa 18%).
Eight (2%) tenofovir disoproxil 245 mg (as fumarate) treated patients developed the K65R mutation within the first 48 weeks.
Osem (2%) bolnikov zdravljenih z 245 mg tenofovirdizoproksilom (v obliki fumarata) je razvilo K65R mutacijo v teku prvih 48 tednov.