natgillin/translations-raw huggingface dataset:
It is used in patients who have compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised liver enzymes or signs of damage when liver tissue is examined under a microscope).
Uporablja se pri bolnikih, ki imajo kompenzirano jetrno bolezen (jetra so poškodovana, vendar delujejo normalno), in izkazujejo tudi znake nadaljnjega razmnoževanja virusa in znake poškodb jeter (zvišano koncentracijo jetrnih encimov ali znake poškodb pri preiskavi tkiva jeter pod mikroskopom).
Treatment with Sebivo should be started by a doctor who has experience in the management of chronic hepatitis B.
Zdravljenje z zdravilom Sebivo mora začeti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
The recommended dose of Sebivo is one tablet once a day, with or without food.
Priporočeni odmerek zdravila Sebivo je ena tableta enkrat dnevno, ki se vzame s hrano ali brez nje.
Patients who have problems with their kidneys may need to take a lower daily dose using the oral solution.
Bolniki, ki imajo težave z ledvicami, bodo morda morali jemati manjši dnevni odmerek peroralne raztopine.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Podrobne informacije so na voljo v povzetku glavnih značilnosti zdravila, ki je prav tako del EPAR.
The active substance in Sebivo, telbivudine, is an antiviral medicine that belongs to the class ‘ nucleoside analogues’.
Zdravilna učinkovina zdravila Sebivo, telbivudin, je protivirusno zdravilo, ki spada v razred „ nukleozidnih analogov “.
Telbivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Telbivudin zavira delovanje virusnega encima, imenovanega DNK polimeraza, ki je udeležen pri tvorbi virusne DNK.
By stopping the virus making DNA, telbivudine prevents it from multiplying and spreading.
Telbivudin ustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
The effects of Sebivo were first tested in experimental models before being studied in humans.
Učinki zdravila Sebivo so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The patients were mainly of Asian origin and had an average age of 36 years.
V dvoletni študiji, ki je zajela 1 367 bolnikov, so primerjali učinkovitost tablet Sebivo z učinkovitostjo lamivudina (drugega zdravila za kronični hepatitis B).
None of the patients had been treated with nucleoside analogues before.
Bolniki so bili v glavnem azijskega porekla in v
Reproduction is authorised provided the source is acknowledged. measure of effectiveness was the number of patients who had responded to treatment after a year.
Noben izmed bolnikov predhodno ni bil zdravljen z nuklezoidnimi analogi.
A response was defined as low levels of viral DNA in the blood, together with either the levels of a liver enzyme called alanine aminotransferase (ALT) returning to normal or the marker for the hepatitis B virus disappearing from the blood.
Odziv je bil opredeljen kot nizka koncentracija virusne DNK v krvi skupaj z bodisi vzpostavitvijo normalnih koncentracij jetrnega encima, imenovanega alanin aminotransferaza (ALT), ali izginotjem pokazatelja virusa hepatitisa B v krvi.
The company also presented the results of a study showing that the oral solution produced the same levels of the active substance in the blood as the tablets.
Družba je predstavila tudi izide študije, ki kaže da so pri jemanju peroralne raztopine v krvi prisotne enake količine zdravilne učinkovine kot pri jemanju tablet.
Overall, Sebivo was as effective as lamivudine, with about three-quarters of the patients responding to treatment after a year.
Na splošno je bilo zdravilo Sebivo, pri katerem se je približno tri četrtine bolnikov odzvalo na zdravljenje po enem letu, tako učinkovito kot lamivudin.
The results were also calculated separately between ‘ HBeAg-positive’ patients (infected with the common hepatitis B virus) and ‘ HBeAg-negative ’ patients (infected with a virus that has mutated, leading to a form of chronic hepatitis B that is more difficult to treat).
Rezultati so bili izračunani tudi ločeno za „ HBeAG- pozitivne “ bolnike (okužene z običajnim virusom hepatitisa B) in za „ HBeAG- negativne “ bolnike (okužene z virusom, ki je mutiral, kar je privedlo do oblike kroničnega hepatitisa B, ki jo je teže zdraviti).
Sebivo was more effective than lamivudine in the HBeAg-positive patients, with 75% responding to Sebivo and 67% to lamivudine.
Zdravilo Sebivo je bilo bolj učinkovito od lamivudina v skupini HBeAG- pozitivnih bolnikov, v kateri se je na zdravljenje odzvalo 75, 3% bolnikov, ki so prejemali zdravilo Sebivo, in 67% bolnikov, ki so prejemali lamivudin.
In the HBeAg-negative patients, Sebivo was as effective as lamivudine (75 and 77% responding, respectively).
V skupini HBeAg- negativnih bolnikov je bilo zdravilo Sebivo učinkovitejše od lamivudina (na zdravljenje se je odzvalo 75, 2% bolnikov oziroma 77, 2% bolnikov).
The most common side effects with Sebivo (seen in between 1 and 10 patients in 100) are dizziness, headache, cough, increased levels of some enzymes in the blood (amylase, lipase, creatine phosphokinase and alanine aminotransferase), diarrhoea, nausea (feeling sick), abdominal (tummy) pain, skin rash and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Sebivo (opaženi pri 1 do 10 bolnikih od 100) so omotičnost, glavobol, kašelj, povečana koncentracija nekaterih encimov v krvi (amilaze, lipaze, kreatin fosfokinaze in alanin aminotransferaze), driska, slabost, bolečine v trebuhu, kožni izpuščaji in utrujenost.
Because creatine phosphokinase is an enzyme that is raised when muscles are damaged, doctors need to monitor all muscle-related side effects closely.
Ker je kreatin fosfokinaza encim, katerega koncentracija se poveča pri poškodbi mišic, mora zdravnik skrbno spremljati vse neželene učinke, ki so povezani z mišicami.
For the full list of all side effects reported with Sebivo, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sebivo, glejte navodilo za uporabo.
Sebivo should not be used in people who may be hypersensitive (allergic) to telbivudine or to any of the other ingredients.
Zdravila Sebivo ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telbivudin ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sebivo’ s benefits are greater than its risks for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/ or fibrosis.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Sebivo pri zdravljenju kroničnega hepatitisa B pri odraslih bolnikih s kompenzirano jetrno boleznijo in znaki virusne replikacije, stalno zvišanimi koncentracijami alanin aminotransferaze (ALT) in histološko dokazanim vnetjem in/ ali fibrozo večje od z njim povezanih tveganj.
As the studies were mainly carried out in Asia and included fewer Caucasian patients than the Committee would have liked to see, the Committee asked the company to carry out a further study in Europe.
Ker so bile vse študije večinoma izvedene v Aziji in so vključevale manj bolnikov bele rase, kot je bilo zaželeno s strani CHMP, je odbor družbo pozval, naj izvede dodatne študije v Evropi.
The Committee recommended that Sebivo be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Sebivo odobri dovoljenje za promet.
Other information about Sebivo:
Druge informacije o zdravilu Sebivo:
The European Commission granted a marketing authorisation valid throughout the European Union for Sebivo to Novartis Europharm Limited on 24 April 2007.
Evropska komisija je dovoljenje za promet z zdravilom Sebivo, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 24. aprila 2007.
The full EPAR for Sebivo can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sebivo je na voljo tukaj.
EU Number EU/ 1/ 07/ 388/ 001 EU/ 1/ 07/ 388/ 002
Številka EU EU/ 1/ 07/ 388/ 001 EU/ 1/ 07/ 388/ 002
Invented name Sebivo Sebivo
Izmišljeno ime Sebivo Sebivo
Strength 600 mg 600 mg
jakost 600 mg 600 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet
farmacevtska oblika filmsko obložena tableta filmsko obložena tableta
Route of Administration Oral use Oral use
pot uporabe peroralna uporaba peroralna uporaba
Packaging Blister (PVC/ alu) Blister (PVC/ alu)
ovojnina pretisni omot (PVC/ alu) pretisni omot (PVC/ alu)
Package size 28 tablets 98 tablets
velikost pakiranja 28 tablet 98 tablet
Bottle (glass)
steklenica (steklo)
1 bottle + 1 Cup
1 steklenica + 1 odmerna posodica
White to slightly yellowish, oval film-coated tablet, imprinted with “ LDT” on one side.
Bela do rahlo rumenkasta filmsko obložena tableta ovalne oblike, z vtisnjeno oznako “ LDT ” na eni strani.
Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Zdravilo Sebivo je indicirano za zdravljenje kroničnega hepatitisa B pri odraslih bolnikih s kompenzirano jetrno boleznijo in znaki virusne replikacije, stalno zvišanimi koncentracijami alanin - aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ ali fibrozo.
See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Glede podrobnosti študije in posebnih značilnosti bolnikov, na katerih temelji ta indikacija, glejte poglavje 5. 1.
Adults The recommended dose of Sebivo is 600 mg (one tablet) once daily, taken orally, with or without food.
Odrasli Priporočeni odmerek zdravila Sebivo je 600 mg (ena tableta) enkrat na dan, in sicer peroralno, s hrano ali brez nje.
Treatment discontinuation should be considered as follows: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is evidence of loss of efficacy.
Pri odločanju o prenehanju zdravljenja je treba upoštevati naslednje: • Pri HBeAg- pozitivnih bolnikih brez ciroze je treba zdravljenje izvajati vsaj 6- 12 mesecev po potrditvi serokonverzije HBe (izginitev HBeAg in HBV DNK s pojavom anti- HBe) ali do serokonverzije HBs ali do dokazanega prenehanja učinka zdravljenja.
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse. • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
Vrednosti ALT in HBV DNK v serumu je treba po prekinitvi zdravljenja redno spremljati, da bi zaznali morebiten pozen virološki relaps. • Pri HBeAg- negativnih bolnikih brez ciroze je treba zdravljenje izvajati vsaj do serokonverzije HBs ali do dokazanega prenehanja učinka zdravljenja.
On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1) and might be useful for driving the management of patients treated with telbivudine monotherapy.
Pokazalo se je, da odziv po 24 tednih zdravljenja lahko napove dolgoročen odziv (glejte preglednico 7 v poglavju 5. 1) in je lahko koristen podatek pri vodenju bolnikov, zdravljenih s telbivudinom v monoterapiji.
2 Renal impairment No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is ≥ 50 ml/ min.
2 Ledvična okvara Pri bolnikih z očistkom kreatinina ≥ 50 ml/ min ni potrebno prilagajati priporočenega odmerka telbivudina.
Adjustment of the dose is required in patients with creatinine clearance < 50 ml/ min, including those with end-stage renal disease (ESRD) on haemodialysis.
Pri bolnikih z očistkom kreatinina < 50 ml/ min, vključno s tistimi s končno ledvično odpovedjo, ki se zdravijo s hemodializo, je treba prilagoditi odmerjanje.
Dosing regimen adjustment of Sebivo in patients with renal impairment
Prilagajanje sheme odmerjanja zdravila Sebivo pri bolnikih z okvaro ledvic
Creatinine clearance (ml/ min)
očistek kreatinina (ml/ min)
Telbivudine 20 mg/ ml oral solution Daily dose adjustment
telbivudin 20 mg/ ml peroralna telbivudine 600 mg filmsko raztopina obložene tablete prilagajanje dnevnega odmerka druga možnost ** prilagajanja odmerka s podaljševanjem intervala med odmerki
≥ 50 30-49 < 30 (not requiring dialysis)
≥ 50 30- 49 < 30 (dializa ni potrebna)
600 mg (30 ml) once daily 400 mg (20 ml) once daily 200 mg (10 ml) once daily
600 mg (30 ml) enkrat dnevno 600 mg enkrat dnevno 400 mg (20 ml) enkrat dnevno 600 mg enkrat na 48 ur 200 mg (10 ml) enkrat dnevno 600 mg enkrat na 72 ur
ESRD*
KLO *
120 mg (6 ml) once daily
120 mg (6 ml) enkrat dnevno 600 mg enkrat na 96 ur
* End stage renal disease ** In case use of the oral solution is not possible
* končna ledvična odpoved ** če bolnik ne more uporabljati peroralne raztopine
End-stage renal disease patients For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2).
Bolniki s končno ledvično odpovedjo Bolnikom s končno ledvično odpovedjo je treba zdravilo Sebivo aplicirati po končanem postopku hemodialize (glejte poglavje 5. 2).
Hepatic impairment No adjustment to the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2).
Okvara jeter Pri bolnikih z okvaro jeter ni potrebno prilagajati priporočenega odmerka zdravila Sebivo (glejte poglavje 5. 2).
Children and adolescents Sebivo is not recommended for use in children and adolescents below 16 years of age due to a lack of data on safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Sebivo pri otrocih in mladostnikih pod 16 let ni priporočljiva.
Elderly patients (age above 65 years) No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
Starejši bolniki (starost nad 65 let) Ni razpoložljivih podatkov, na katerih bi temeljila posebna priporočila za odmerjanje pri bolnikih, starih več kot 65 let (glejte poglavje 4. 4).
Following initiation of antiviral treatment, serum ALT may rise in some patients while serum levels of HBV DNA fall (see section 4.8).
Po začetku protivirusnega zdravljenja se lahko pri nekaterih bolnikih ALT v serumu zviša, vrednosti HBV DNK v serumu pa znižajo (glejte poglavje 4. 8).
Overall, ALT flares occurred more frequently in HBeAg-positive patients than in HBeAg-negative patients.
Do poslabšanja z zvišanjem ALT je prišlo pogosteje pri HBeAg- pozitivnih bolnikih kot pri HBeAg - negativnih.
In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
Pri bolnikih s kompenzirano jetrno boleznijo ob zvišanju ALT v serumu večinoma ne 3 pride do zvišanih vrednosti bilirubina v serumu ali do drugih znakov odpovedi jeter.
3 Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B.
O poslabšanjih hepatitisa so poročali tudi pri bolnikih, ki so zaključili zdravljenje hepatitisa B.
Post-treatment ALT flares are normally associated with increases in serum HBV DNA levels, and the majority of such cases have proven to be self-limiting.
Poslabšanja z zvišanjem ALT po zaključku zdravljenja so običajno povezana s porastom vrednosti HBV DNA v serumu in so v večini primerov spontano izzvenela.
Occurrence of lactic acidosis (in the absence of hypoxaemia) sometimes fatal, and usually associated with severe hepatomegaly with steatosis have been reported with the use of nucleoside/ nucleotide analogues.
Poročali so, da je ob uporabi nukleozidnih/ nukleotidnih analogov prišlo do laktacidoze (brez hipoksemije), včasih s smrtnim izidom, običajno pa v povezavi s hudo hepatomegalijo in steatozo.
Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/ lactic acidosis of unknown aetiology occur.
Zdravljenje z nukleozidnimi analogi je treba prekiniti, če pride do hitrega porasta koncentracij aminotransferaz, napredujoče hepatomegalije ali metabolične acidoze/ laktacidoze iz neznanega vzroka.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/ hepatic steatosis, renal failure and higher levels of serum lactate.
Hudi primeri, nekateri s smrtnim izidom, so bili povezani s pankreatitisom, odpovedjo/ steatozo jeter, odpovedjo ledvic in zvišanimi koncentracijami laktata v serumu.
Muscular effects Cases of myopathy and myalgia have been reported with telbivudine use several weeks to months after starting therapy (see section 4.8).
Vpliv na mišice Poročali so o primerih miopatije in bolečin v mišicah ob uporabi telbivudina, do katerih je prišlo več tednov do več mesecev po začetku zdravljenja (glejte poglavje 4. 8).
Myopathy, defined as persistent unexplained muscle aches and/ or muscle weakness regardless of the degree of increases in creatine kinase levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
Pri vsakem bolniku z difuznimi nepojasnjenimi bolečinami v mišicah, povečano občutljivostjo mišic, njihovo šibkostjo ali miozitisom (ki je opredeljen kot miopatija s histološko potrjeno poškodbo mišic) je treba pomisliti na miopatijo, opredeljeno kot perzistentne nepojasnjene bolečine v mišicah oziroma šibkost mišic ne glede na stopnjo zvišanja vrednosti kreatin kinaze.
It is not known whether the risk of myopathy during treatment with telbivudine is increased with concurrent administration of other medicinal products associated with myopathy (e. g. statins, fibrates, or ciclosporin).
Ni znano, ali je tveganje za miopatijo med zdravljenjem s telbivudinom povečano ob sočasni uporabi drugih zdravil, ki so povezana z miopatijo (npr. statinov, fibratov ali ciklosporina).
Peripheral neuropathy Peripheral neuropathy has been uncommonly reported in telbivudine-treated patients.
Periferna nevropatija O periferni nevropatiji so občasno poročali pri bolnikih, ki so prejemali telbivudin.
If peripheral neuropathy is suspected, treatment with telbivudine should be reconsidered (see section 4.8).
V primeru suma na periferno nevropatijo je treba ponovno pretehtati zdravljenje s telbivudinom (glejte poglavje 4. 8).
An increased risk of peripheral neuropathy has been observed when telbivudine and pegylated interferon alfa-2a are co-administered (see section 4.5).
Pri sočasni uporabi telbivudina in pegiliranega interferona alfa- 2a so opažali povečano tveganje za periferno nevropatijo (glejte poglavje 4. 5).
Such increased risk cannot be excluded for other interferons alfa (pegylated or standard).
Tudi pri drugih interferonih alfa (pri pegiliranih ali pri standardnih) takega povečanega tveganja ni mogoče izključiti.
Moreover, the benefit of this combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Razen tega tudi koristi zdravljenja s kombinacijo telbivudina in interferona alfa (pegiliranega ali standardnega) zaenkrat niso dokazane.
Renal function Telbivudine is eliminated primarily by renal excretion, therefore dose interval adjustment is recommended in patients with creatinine clearance < 50 ml/ min, including patients on haemodialysis.
4 Delovanje ledvic Telbivudin se večinoma izloča preko ledvic, zato je pri bolnikih z očistkom kreatinina < 50 ml/ min, vključno s tistimi na hemodializi, priporočljivo prilagoditi intervale med odmerki.
Therefore, virological response should be closely monitored in patients with increased dosage interval (see sections 4.2 and 5.2).
Zato je treba pri bolnikih s podaljšanimi intervali med odmerki pazljivo spremljati virološki odziv (glejte poglavji 4. 2 in 5. 2).
4 Patients with cirrhosis without decompensation Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Bolniki s cirozo brez dekompenzacije Zaradi majhnega števila razpoložljivih podatkov (približno 3% vključenih bolnikov je imelo cirozo) je pri uporabi telbivudina pri bolnikih s cirozo potrebna posebna previdnost.
Patients with cirrhosis with decompensation There are no efficacy and safety data in patients with decompensated cirrhosis.
Bolniki s cirozo z dekompenzacijo O varnosti in učinkovitosti pri bolnikih z dekompenzirano cirozo ni podatkov.
Patients with antiviral resistant HBV infection Available evidence does not support the use of telbivudine monotherapy in patients with established lamivudine-resistant hepatitis B virus infection.
Bolniki okuženi z virusom hepatitisa B, ki je rezistenten na protivirusna zdravila Razpoložljivi podatki ne podpirajo uporabe telbivudina kot edinega zdravila pri bolnikih z okužbo z virusom hepatitisa B, ki je rezistenten na lamivudin.
In vitro, telbivudine was not active against the HBV strains containing rtM204V/ rtL180M or rtM204I mutations (see section 5.1).
In vitro telbivudin ni bil učinkovit proti sevu HBV z mutacijama rtM204V/ rtL180M ali rtM204I (glejte poglavje 5. 1).
The efficacy of telbivudine against HBV harbouring the M204V mutation has not been established in clinical trials.
Učinkovitost telbivudina proti virusu hepatitisa B, ki nosi mutacijo M204V, v kliničnih preskušanjih ni bila ugotovljena.
The preliminary results from the cell-based assay showed that the adefovir resistance-associated substitution A181V had 3.7 fold reduced susceptibility to telbivudine.
Predhodni rezultati preskusa na celični osnovi so pokazali, da je substitucija A181V, povezana z rezistenco na adefovir, 3, 7- krat zmanjšala občutljivost za telbivudin.
The rate of genotypically confirmed telbivudine resistance in the pivotal study at 48 weeks was 2.7%.
Delež genotipično potrjene rezistence na telbivudin je bil po 48 tednih v ključni študiji 2, 7%.
Liver transplant recipients The safety and efficacy of telbivudine in liver transplant recipients are unknown.
Bolniki s presajenimi jetri Varnost in učinkovitost telbivudina pri bolnikih s presajenimi jetri nista znani.
Elderly patients Clinical studies of telbivudine did not include sufficient numbers of patients ≥ 65 years of age to determine whether they respond differently from younger subjects.
Starejši bolniki V klinične študije telbivudina ni bilo vključeno dovolj veliko število bolnikov, starih 65 let ali več, da bi lahko ugotovili, če se odzivajo drugače kot mlajše osebe.
In general, caution must be exercised when prescribing Sebivo to elderly patients in view of the greater frequency of decreased renal function due to concomitant disease or concomitant use of other medicinal products.
Na splošno je pri predpisovanju zdravila Sebivo starejšim bolnikom potrebna previdnost, predvsem zaradi večje pogostnosti zmanjšanega delovanja ledvic zaradi spremljajočih bolezni ali sočasne uporabe drugih zdravil.
Other special populations Sebivo has not been investigated in co-infected hepatitis B patients (e. g. patients co-infected with human immunodeficiency virus [HIV], hepatitis C virus [HCV] or hepatitis D virus [HDV]).
Druge posebne skupine Zdravila Sebivo niso raziskovali pri bolnikih, ki so sočasno z virusom hepatitisa B okuženi še z drugim virusom (npr. pri bolnikih, ki so sočasno okuženi še s humanim virusom imunske pomanjkljivosti [HIV], z virusom hepatitisa C [HCV] ali z virusom hepatitisa D [HDV]).