natgillin/translations-raw huggingface dataset:
In the first study, 84% of the 244 patients taking Truvada achieved and maintained viral loads below 400 copies/ ml by 48 weeks, compared to 73% of the 243 taking the comparator medicines.
V prvi študiji je bila pri 84% od 244 bolnikov, ki so jemali zdravilo Truvada, dosežena in vzdrževana virusna obremenitev pod 400 kopij/ ml, v primerjavi s 73% od 243 bolnikov, ki so jemali primerjalna zdravila.
Around two thirds of the patients in the second study achieved and maintained viral loads below 50 copies/ ml after 48 weeks.
Pri okoli dveh tretjinah bolnikov so bile v drugi študiji dosežene in vzdrževane virusne obremenitve pod 50 kopijami/ ml po 48 tednih.
The combination tablet was absorbed in the body in the same way as the separate medicines.
Kombinirana tableta se je po tkivih telesa porazdelila na enak način kot ločeni zdravili.
The most common side effects with Truvada (seen in more than 1 patient in 10) are hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, diarrhoea, vomiting, nausea (feeling sick) and raised blood levels of creatine kinase (an enzyme found in muscles).
Najpogostejši neželeni učinki zdravila Truvada (opaženi pri več kot 1 od 10 bolnikov) so hipofosfatemija (nizke ravni fosfatov v krvi), glavobol, vrtoglavica, diareja, bruhanje, slabost in povišane ravni kreatin kinaze (encim, ki ga najdemo v mišičju) v krvi.
For the full list of all side effects reported with Truvada, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Truvada, glejte Navodilo za uporabo.
Truvada should not be used in patients who may be hypersensitive (allergic) to emtricitabine, tenofovir, tenofovir disoproxil fumarate or any of the other ingredients.
Zdravila Truvada ne smejo prejemati bolniki, ki utegnejo biti preobčutljivi za (alergični na) emtricitabin, tenofovir, tenofovir dizoproksil fumarat ali katerokoli drugo sestavino zdravila.
As with other anti-HIV medicines, patients taking Truvada may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Kot pri drugih zdravilih proti HIV, lahko pride tudi pri bolnikih, ki prejemajo zdravilo Truvada, do lipodistrofije (spremembe v porazdelitvi telesnega maščevja), osteonekroze (odmiranje kostnine) ali sindroma imunske reaktivacije (simptomi okužbe zaradi izboljšanja stanja imunskega sistema).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Truvada.
Bolniki, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C) in prejemajo zdravilo Truvada, imajo povišano tveganje za poškodbe jeter.
As with all other NRTIs, Truvada may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Truvada during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells than can cause problems in the blood).
Kot drugi NRTI- ji, lahko tudi zdravilo Truvada povzroči acidozo (povečana količina mlečne kisline v telesu), pri dojenčkih mater, ki med nosečnostjo prejemajo zdravilo Truvada pa tudi mitohondrijsko disfunkcijo (poškodbe delov celice, ki tvorijo energijo, kar lahko povzroči težave s krvjo).
The Committee for Medicinal products for Human Use (CHMP) concluded that Truvada’ s benefits are greater than its risks in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Truvada pri protiretrovirusnem kombinacijskem zdravljenju odraslih, okuženih s HIV- 1, večje od z njim povezanih tveganj.
It noted that the benefit of Truvada has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.
Odbor je ugotovil, da so koristi zdravila Truvada dokazali le pri bolnikih, ki prej niso prejemali zdravljenja za okužbo s HIV, vendar poenostavljen način odmerjanja kombinacijske tablete enkrat na dan lahko bolnikom pomaga pri vztrajanju pri zdravljenju.
The committee recommended that Truvada be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Truvada.
Other information about Truvada:
Druge informacije o zdravilu Truvada:
The European Commission granted a marketing authorisation valid throughout the EU for Truvada to Gilead Sciences International Limited on 21 February 2005.
Evropska Komisija je dovoljenje za promet z zdravilom Truvada, veljavno po vsej Evropski uniji, odobrila družbi Gilead Sciences International Limited dne 21. februarja 2005.
The full EPAR for Truvada is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Truvada je na voljo tukaj.
Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use
Peroralna uporaba Peroralna uporaba
Bottle (HDPE) Bottle (HDPE)
Plastenka (HDPE) Plastenka (HDPE)
30 tablets 3 x 30 tablets
30 tablet 3 x 30 tablet
Truvada 200 mg/ 245 mg film-coated tablets.
Truvada 200 mg/ 245 mg filmsko obložene tablete
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Ena filmsko obložena tableta vsebuje 200 mg emtricitabina in 245 mg tenofovirdizoproksilata (kar je ekvivalentno 300 mg tenofovirdizoproksil fumarata ali 136 mg tenofovirja).
Each tablet contains 80 mg lactose monohydrate.
Vsaka tableta vsebuje 80 mg laktoze monohidrata.
Blue, capsule-shaped, film-coated tablet, debossed on one side with “ GILEAD” and on the other side with “ 701”.
Modra, kapsulne oblike, filmsko obložena tableta z vtisnjenima znakoma “ GILEAD ” na eni strani in “ 701 ” na drugi strani.
Truvada is a fixed dose combination of emtricitabine and tenofovir disoproxil fumarate.
Zdravilo Truvada je fiksna kombinacija odmerkov emtricitabina in tenofovirdizoproksil fumarata.
It is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Indicirano je v kombinirani protiretrovirusni terapiji za zdravljenje odraslih oseb, okuženih s HIV- 1.
The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment-naïve patients (see section 5.1).
Dokaz uspešnosti kombinacije emtricitabina in tenofovirdizoproksil fumarata v protiretrovirusni terapiji temelji izključno na študijah, opravljenih na še nezdravljenih bolnikih (glejte poglavje 5. 1).
Posology Adults:
Odmerjanje Odrasli:
The recommended dose of Truvada is one tablet, taken orally, once daily.
Priporočeni odmerek zdravila Truvada je ena tableta, peroralno, enkrat dnevno.
In order to optimise the absorption of tenofovir, it is recommended that Truvada should be taken with food.
Za optimalno absorpcijo tenofovirja se priporoča zdravilo Truvada jemati s hrano.
Even a light meal improves absorption of tenofovir from the combination tablet (see section 5.2).
Celo lahek obrok izboljša absorpcijo tenofovirja iz kombinirane tablete (glejte poglavje 5. 2).
Where discontinuation of therapy with one of the components of Truvada is indicated or where dose modification is necessary, separate preparations of emtricitabine and tenofovir disoproxil fumarate are available.
Če se izkaže, da je potrebno prekiniti terapijo z eno od učinkovin zdravila Truvada, ali če je potrebno prilagoditi odmerek, so na voljo ločeni pripravki emtricitabina in tenofovirdizoproksil fumarata.
Truvada is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.2).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Truvada pri otrocih pod 18 let ni priporočljiva (glejte poglavje 5. 2).
No data are available on which to make a dose recommendation for patients over the age of 65 years.
Podatkov, na osnovi katerih bi lahko priporočili odmerke za bolnike starejše od 65 let, ni na voljo.
Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in patients with renal dysfunction.
Emtricitabin in tenofovir se izločata preko ledvic in pri bolnikih z ledvično disfunkcijo izpostavljenost emtricitabinu in tenofovirju naraste.
There are limited data on the safety and efficacy of Truvada in patients with moderate and severe renal impairment (creatinine clearance < 50 ml/ min) and long term safety data has not been evaluated for mild renal impairment
Podatki o varnosti in učinkovitosti zdravila Truvada pri bolnikih z zmernimi in hudimi motnjami v delovanju ledvic (očistek kreatinina
2 (creatinine clearance 50-80 ml/ min).
2 < 50 ml/ min) so nezadostni, dolgoročni podatki o varnosti pri bolnikih z blagimi motnjami v delovanju ledvic (očistek kreatinina 50- 80 ml/ min) niso bili ovrednoteni.
Therefore, in patients with renal impairment Truvada should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Zato se sme pri vseh bolnikih z motnjami v delovanju ledvic zdravilo Truvada uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
Patients with renal impairment may require close monitoring of renal function (see section 4.4).
Pri bolnikih z motnjami v delovanju ledvic je treba skrbno nadzorovati delovanje ledvic (glejte poglavje 4. 4).
Dose interval adjustments are recommended for patients with creatinine clearance between 30 and 49 ml/ min.
Intervale med odmerki je priporočljivo prilagoditi pri bolnikih, ki imajo očistek kreatinina med 30 in 49 ml/ min.
These dose adjustments have not been confirmed in clinical studies and the clinical response to treatment should be closely monitored in these patients (see sections 4.4 and 5.2).
Prilagoditve odmerkov niso bile potrjene s kliničnimi študijami in pri teh bolnikih je potrebno skrbno nadzorovati klinični odziv na zdravljenje (glejte poglavji 4. 4 in 5. 2).
Mild renal impairment (creatinine clearance 50-80 ml/ min):
Blage motnje v delovanju ledvic (očistek kreatinina 50- 80 ml/ min):
Limited data from clinical studies support once daily dosing of Truvada in patients with mild renal impairment (see section 4.4).
Majhno število podatkov iz kliničnih študij podpira odmerjanje zdravila Truvada enkrat dnevno pri bolnikih z blagimi motnjami v delovanju ledvic (glejte poglavje 4. 4).
Moderate renal impairment (creatinine clearance 30-49 ml/ min):
Zmerne motnje v delovanju ledvic (očistek kreatinina 30- 49 ml/ min):
Administration of Truvada every 48 hours is recommended, based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil fumarate in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4). Severe renal impairment (creatinine clearance < 30 ml/ min) and haemodialysis patients:
Priporočljiv je odmerek zdravila Truvada vsakih 48 ur, ki temelji na podatkih o farmakokinetiki enkratnih odmerkov za emtricitabin in tenofovirdizoproksil fumarat pri bolnikih, ki niso okuženi z virusom HIV, z različnimi stopnjami motenj v delovanju ledvic (glejte poglavje 4. 4).
Truvada is not recommended for patients with severe renal impairment (creatinine clearance < 30 ml/ min) and in patients who require haemodialysis because appropriate dose reductions cannot be achieved with the combination tablet.
Zdravila Truvada se ne priporoča dajati bolnikom s hudimi motnjami v delovanju ledvic (očistek kreatinina < 30 ml/ min) in bolnikom, ki potrebujejo hemodializo, ker ustreznih zmanjšanj odmerka ni mogoče doseči s kombinirano tableto.
The pharmacokinetics of Truvada and emtricitabine have not been studied in patients with hepatic impairment.
Farmakokinetičnih lastnosti zdravila Truvada in emtricitabina niso proučevali pri bolnikih z motnjami v delovanju jeter.
The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required for tenofovir disoproxil fumarate in these patients.
Farmakokinetične lastnosti tenofovirja so proučevali pri bolnikih z motnjami v delovanju jeter in pri teh bolnikih ni potrebno prilagoditi odmerka tenofovirdizoproksil fumarata.
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see sections 4.4 and 5.2).
Na osnovi minimalne jetrne presnove in izločanja emtricitabina preko ledvic je malo verjetno, da bi bila pri bolnikih z motnjami v delovanju jeter potrebna prilagoditev odmerka zdravila Truvada (glejte poglavji 4. 4 in 5. 2).
If Truvada is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Če se jemanje zdravila Truvada prekine pri bolnikih s hkratno HIV in HBV okužbo, je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4. 4).
Method of administration If patients have difficulty in swallowing, Truvada can be disintegrated in approximately 100 ml of water, orange juice or grape juice and taken immediately.
Način uporabe Če ima bolnik težave s požiranjem, lahko zdravilo Truvada razdrobi v približno 100 ml vode, pomarančnega ali grozdnega soka in jo nemudoma popije.
Hypersensitivity to the active substances emtricitabine, tenofovir, tenofovir disoproxil fumarate or to any of the excipients.
Preobčutljivost za zdravilne učinkovine emtricitabin, tenofovir, tenofovirdizoproksil fumarat ali katerokoli pomožno snov.
Truvada should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil (as fumarate) or other cytidine analogues, such as lamivudine and zalcitabine (see section 4.5).
Zdravila Truvada se ne sme dajati skupaj z drugimi zdravili, ki vsebujejo emtricitabin, tenofovirdizoproksilat (v obliki fumarata) ali druge analoge citidina, kot sta lamivudin in zalcitabin (glejte poglavje 4. 5).
Triple nucleoside therapy:
Tritirno zdravljenje z nukleozidom:
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil fumarate was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Obstajajo poročila o visoki stopnji virološke odpovedi in pojavu rezistence v obeh primerih v zgodnji fazi, kadar se je tenofovirdizoproksil fumarat kombiniral z lamivudinom in abakavirjem kakor tudi z lamivudinom in didanozinom kot režim zdravljenja enkrat na dan.
Appropriate precautions must continue to be used.
Pri bolnikih, ki se zdravijo z zdravilom Truvada ali s katerokoli drugo obliko protiretrovirusne terapije, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
3 Renal impairment:
3 Zato mora biti bolnik pod skrbnim kliničnim nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s HIV povezanimi obolenji.
Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion.
Bolniki morajo biti poučeni o tem, da nobeno protiretrovirusno zdravljenje, vključno z zdravilom Truvada, ne preprečuje tveganja za prenos HIV na druge preko spolnega stika ali okužbe s krvjo.
Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice (see section 4.8).
Pri klinični uporabi tenofovirdizoproksil fumarata so poročali o ledvični odpovedi, motnjah v delovanju ledvic, zvišanem kreatininu, hipofosfatemiji in proksimalni tubulopatiji (vključno s Fanconijevim sindromom) (glejte poglavje 4. 8).
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Truvada and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and then every three months.
Pred začetkom zdravljenja z zdravilom Truvada se priporoča izračun očistka kreatinina pri vseh bolnikih in nadzor delovanja ledvic (očistek kreatinina in vrednost serumskega fosfata) vsake štiri tedne v prvem letu zdravljenja in pozneje vsake tri mesece.
In patients at risk for renal impairment, including patients who have previously experienced renal events while receiving adefovir dipivoxil, consideration should be given to more frequent monitoring of renal function.
Pri bolnikih s tveganjem za motnje v delovanju ledvic, vključno z bolniki, pri katerih so se predhodno pojavile motnje delovanja ledvic pri jemanju adefovirdipivoksila, je treba pretehtati možnost pogostejšega nadzora delovanja ledvic.
Patients with renal impairment (creatinine clearance < 80 ml/ min), including haemodialysis patients:
Bolniki z motnjami v delovanju ledvic (očistek kreatinina < 80 ml/ min), vključno z bolniki na hemodializi:
Renal safety with Truvada has only been studied to a very limited degree in patients with impaired renal function (creatinine clearance < 80 ml/ min).
Varnost uporabe zdravila Truvada za ledvice je bila pri bolnikih z oslabljenim delovanjem ledvic (očistek kreatinina < 80 ml/ min) preučevana le v zelo omejenem obsegu.
Dose interval adjustments are recommended for patients with creatinine clearance 30-49 ml/ min (see section 4.2).
Intervale med odmerki je priporočljivo prilagoditi pri bolnikih, ki imajo očistek kreatinina med 30 in 49 ml/ min (glejte poglavje 4. 2).
Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 ml/ min who received tenofovir disoproxil fumarate in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal function (see section 5.2).
Nadalje je imela v majhni klinični študiji podskupina bolnikov z očistkom kreatinina med 50 in 60 ml/ min, ki je prejemala tenofovirdizoproksil fumarat v kombinaciji z emtricitabinom vsakih 24 ur 2- 4- krat večjo izpostavljenost tenofovirju in poslabšanje delovanja ledvic (glejte poglavje 5. 2).
Therefore, a careful benefit-risk assessment is needed when Truvada is used in patients with creatinine clearance < 60 ml/ min, and renal function should be closely monitored.
Zato je treba skrbno oceniti razmerje med koristmi in tveganjem pri uporabi zdravila Truvada pri bolnikih z očistkom kreatinina < 60 ml/ min in je potrebno skrbno nadzorovati delovanje ledvic.
In addition, the clinical response to treatment should be closely monitored in patients receiving Truvada at a prolonged dosing interval.
Poleg tega je potrebno skrbno nadzorovati klinični odziv na zdravljenje pri bolnikih, ki prejemajo zdravilo Truvada s podaljšanim intervalom med odmerki.
The use of Truvada is not recommended in patients with severe renal impairment (creatinine clearance < 30 ml/ min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Uporabo zdravila Truvada se ne priporoča pri bolnikih s hudimi motnjami v delovanju ledvic (očistek kreatinina < 30 ml/ min) in bolnikih, ki potrebujejo hemodializo, ker ustreznih zmanjšanj odmerka ni mogoče doseči s kombinirano tableto (glejte poglavji 4. 2 in 5. 2).
If serum phosphate is < 1.5 mg/ dl (0.48 mmol/ l) or creatinine clearance is decreased to < 50 ml/ min in any patient receiving Truvada, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Če je vrednost serumskega fosfata < 1, 5 mg/ dl (0, 48 mmol/ l) ali se očistek kreatinina zmanjša na < 50 ml/ min je pri vsakem bolniku, ki prejema zdravilo Truvada, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4. 8, proksimalna tubulopatija).
Consideration should also be given to interrupting treatment with Truvada in patients with creatinine clearance decreased to < 50 ml/ min or decreases in serum phosphate to < 1.0 mg/ dl (0.32 mmol/ l).
Pri bolnikih z zmanjšanjem očistka kreatinina na < 50 ml/ min ali z zmanjšanjem serumskega fosfata na < 1, 0 mg/ dl (0, 32 mmol/ l) je treba presoditi tudi o prekinitvi zdravljenja z zdravilom Truvada.
Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Zdravila Truvada naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil (glejte poglavje 4. 5).
Truvada should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Uporabi zdravila Truvada se je potrebno izogniti pri bolnikih, okuženih s HIV- 1, ki so nosilci mutacije K65R, in ki so že bili zdravljeni s protiretrovirusnimi zdravili (glejte poglavje 5. 1).
Bone effects:
Učinki na kosti:
In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
V 144 tednov trajajoči kontrolirani klinični študiji, v kateri sta bila primerjana tenofovirdizoproksil fumarat in stavudin v kombinaciji z lamivudinom in efavirenzom pri bolnikih, ki še niso bili zdravljeni s protiretrovirusnimi zdravili, so pri obeh zdravljenih skupinah opazili manjše zmanjšanje mineralne gostote kosti kolka in hrbtenice.
Decreases in bone mineral density of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks.
Zmanjšanje mineralne gostote kosti hrbtenice in spremembe kostnih biomarkerjev od začetne vrednosti so bile v 144 tednih pomembno večje v skupini, ki se je zdravila s tenofovirdizoproksil fumaratom.
Decreases in bone mineral density of hip were significantly greater in this group until 96 weeks.
Zmanjšanje mineralne gostote kosti v kolku je bilo do 96 tednov značilno večje v tej skupini.
Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
4 Anomalije na kosteh (redko prispevajo k zlomom) so lahko povezane s proksimalno ledvično tubulopatijo (glejte poglavje 4. 8).
4 Patients with HIV and hepatitis B or C virus co-infection:
Bolniki, hkrati okuženi z virusom HIV in virusom hepatitisa B ali C:
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusno terapijo, obstaja povečano tveganje za hude in potencialno usodne neželene reakcije v delovanju jeter.
The safety and efficacy of Truvada have not been established for the treatment of chronic HBV infection.
Varnost in učinkovitost zdravila Truvada nista bili ugotavljani pri zdravljenju kronične okužbe z virusom HBV.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Emtricitabin in tenofovir sta v študijah farmakodinamike posamično in v kombinaciji pokazala aktivnost proti virusu HBV (glejte poglavje 5. 1).
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil fumarate have anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Majhno število kliničnih izkušenj kaže, da imata emtricitabin in tenofovirdizoproksil fumarat anti- HBV aktivnost, če se ju uporabi v kombinirani protiretrovirusni terapiji za nadzor okužbe s HIV.
Discontinuation of Truvada therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Prekinitev zdravljenja z zdravilom Truvada pri bolnikih s hkratno HIV in HBV okužbo je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.