Vaccinare anti HV?

Hepatita viral B
n 2011, rile membre UE/EEA au raportat 17.276 cazuri

de infecii cu VHB (3,5 cazuri la 100.000 locuitori), dintre

care 2.832 acute (16,4%), 11.705 (67,8%) cronice i restul
clasificate cu statut necunoscut.
Incidena global a hepatitei acute B (0,8 la 100.000
locuitori) este mult mai redus versus rata cazurilor cronice
(8,1 la 100.000 locuitori). La cazurile acute, transmiterea
heterosexual s-a situat pe primul loc, urmat de cea
nosocomial i prin utilizare de droguri injectabile. Pentru
cazurile cronice, caile de transmitere au fost mai ales cea
materno-fetala si heterosexual. Declinul cazurilor acute
este legat probabil de implementarea vaccinrii antiVHB n
Europa, n timp ce creterea numrului cazurilor cronice
poate fi explicat prin lrgirea screening-ului populaiei cu
risc.
ECDC!) Annual!epidemiological!report 2013!) Reporting!on!2011!surveillance!data and!
2012!epidemic! intelligence!data,!
http://www.ecdc.europa.eu/en/publications/Publications/annual5epidemiological5

n 2012, Romnia a nregistrat 332 cazuri

de hepatit viral acut cu VHB i 30 cazuri

cronice, cele mai multe la grupa de vrst
25-34 ani. Doar 16 pacieni din cei cu
infecii acute aveau vaccinarea antihepatit
B complet, cu 3 doze. Transmiterea a fost
heterosexual
(n
26,2%
cazuri),
nosocomial (22,9%) pentru hepatita viral
acut, respectiv cea heterosexual (36,7%)
si contactul intrafamilial cu un bolnav de
hepatit B (10%), pentru cea cronic.
Centrul!Naional!de!Supraveghere!i!Control!al!Bolilor!Transmisibile!) Raport!
pentru!anul!2012!) Analiza! evoluiei!bolilor!transmisibile!aflate!n!supraveghere,!
http://www.insp.gov.ro/cnscbt/index.php?option=< com_docman&Itemid=11

We searched thetrialregisters ofThe Cochrane Hepato-Biliary

Group,The Cochrane Library,MEDLINE andEMBASEto February 2003.

Chen W, Gluud C, 21 January 2009

Main results:
We identified 21 randomised trials, all with one or more

methodological weaknesses.

Four
trials
demonstrated
that
PDV
versusplacebosignificantly decreased hepatitis B events
at maximum follow-up (RR0.51, 95%CI0.35 to 0.73).
RV did not differ significantly from PDV in eliciting a
protective hepatitis B surface antibody (anti-HBs) level in
two trials.
Both vaccines were well tolerated. Low-dose vaccine (1 or
2 g) by the intradermal route resulted in significantly
more participants without protective anti-HBs level
compared
with
high-dose
(10
or
20
g)
by
theintramuscularroute (RR1.41, 95%CI1.13 to 1.76).

Chen W, Gluud C, 21 January

2009
The intradermal route caused significantly more local

adverse events, while theintramuscularroute caused

significantly moresystemicadverse events.
The gluteal injection produced significantly more
participants without protective anti-HBs level than the
deltoid injection.
Theprevalenceof anti-HBs seroconversion by rapid
vaccination (0, 1, and 2 months) was significantly lower
than that by standard vaccination (0, 1, and 6 months).
Booster vaccinations with different RV doses (2.5, 5, 10,
20, or 40 g) produced similar prevalenceof anti-HBs
seroconversion in three trials assessing participants
who did not respond to previous HBV vaccination.

ENGERIX B/EUVAX B

20 g/mlsuspensie injectabila
Vaccin impotriva hepatitei B (ADNr)
(adsorbit) (VHB)

Irving GJ, Holden J, Yang R, Pope D11

July 2012 Hepato-Biliary Group
Main results:
We included a total of 11 clinical studies, of which only three

were considered to have lowriskofbias; two were quasirandomised studies in which we only addressed harms.
Nine randomised trials with 732,380 participants addressed
the primaryoutcomeof clinically confirmed hepatitis A. Of
these, four trials assessed the inactivated hepatitis A
vaccine (41,690 participants) and five trials assessed the
live attenuated hepatitis A vaccine (690,690 participants). In
the three randomised trials with lowriskofbias(all
assessing inactivated vaccine), clinically apparent hepatitis
A occurred in 9/20,684 (0.04%) versus 92/20,746 (0.44%)
participants in the HAV vaccine andcontrolgroups
respectively (RR0.09, 95%CI0.03 to 0.30).

Irving GJ, Holden J, Yang R, Pope D11

July 2012 Hepato-Biliary Group
In all nine randomised trials, clinically apparent hepatitis A occurred

in 31/375,726 (0.01%) versus 505/356,654 (0.18%) participants in

the HAV vaccine andcontrolgroups respectively (RR0.09,
95%CI0.05 to 0.17).
These results were supported bytrialsequential analyses. Subgroup
analyses confirmed the clinicaleffectivenessof both inactivated
hepatitis A vaccines (RR0.09, 95%CI0.03 to 0.30) and live
attenuated hepatitis A vaccines (RR0.07, 95%CI0.03 to 0.17) on
clinically confirmed hepatitis A.
Inactivated hepatitis A vaccines had a significant effect on reducing
the lack of sero-protection (less than 20 mIU/L) (RR0.01,
95%CI0.00 to 0.03). Notrial reported on a sero-protective
threshold less than 10 mIU/L. Theriskof both non-serious local
andsystemicadverse events was comparable toplacebofor the
inactivated HAV vaccines. There were insufficientdatato draw
conclusions on adverse events for the live attenuated HAV vaccine.

Havrix Adult 1440

Antigen de virus hepatitic A (VHA)

vaccin hepatitic A inactivat, adsorbit,
suspensie injectabila