Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV A Randomized Clinical Trial

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dc.contributor.authorVargas, Jose Ignacio
dc.contributor.authorJensen, Daniela
dc.contributor.authorMartinez, Felipe
dc.contributor.authorSarmiento, Valeska
dc.contributor.authorPeirano, Felipe
dc.contributor.authorAcuna, Pedro
dc.contributor.authorProvoste, Felipe
dc.contributor.authorBustos, Valentina
dc.contributor.authorCornejo, Francisca
dc.contributor.authorFuster, Antonieta
dc.contributor.authorAcuna, Martin
dc.contributor.authorFuster, Felipe
dc.contributor.authorSoto, Sabrina
dc.contributor.authorEstay, Denisse
dc.contributor.authorJensen, Werner
dc.contributor.authorAhumada, Rodrigo
dc.contributor.authorArab, Juan Pablo
dc.contributor.authorSoza, Alejandro
dc.contributor.authorFuster, Francisco
dc.date.accessioned2025-01-20T22:09:43Z
dc.date.available2025-01-20T22:09:43Z
dc.date.issued2021
dc.description.abstractIMPORTANCE Active immunization for hepatitis B virus (HBV) infection is recommended in patients living with HIV. Limited evidence is available about the most appropriate regimen of HBV vaccination among those who have not responded to an initial schedule.
dc.description.abstractOBJECTIVE To determine the efficacy of a high-dose schedule compared with a standard dose of HBV vaccination.
dc.description.abstractDESIGN, SETTING, AND PARTICIPANTS This double-masked, parallel-group, randomized controlled trial included patients living with HIV at a single outpatient HIV and hepatology clinic in Chile for whom previous HBV vaccination had failed. Patients with hepatitis B surface antibody (anti-HBs) titers less than 10 IU/L after an initial HBV vaccination regimen were included. Consecutive patients were recruited between December 2013 and March 2018. Data were analyzed in June 2018 using intention-to-treat analysis.
dc.description.abstractINTERVENTION The high-dose HBV vaccination group consisted of 3 doses of 40 mu g recombinant hepatitis B vaccine at 0, 1, and 2 months. The standard-dose group received 3 doses 20 mu g each at 0, 1, and 2 months.
dc.description.abstractMAIN OUTCOMES AND MEASURES Primary outcome was the serologic response to HBV vaccination (anti-HBs greater than 10 IU/L) 4 to 8 weeks after completion of the schedule. Secondary outcomes were anti-HBs greater than 100 IU/L and seroprotective anti-HBs at 1 year follow up.
dc.description.abstractRESULTS A total of 107 patients underwent randomization (55 to the standard-dose group, 52 to the high-dose group); 81 (75.7%) were men, and the mean (SD) patient age was 47.0 (13.3) years. Nearly all patients were receiving antiretroviral therapy (105 patients [98%]) and 92 patients (86%) had an undetectable HIV viral load. Mean (SD) CD4 count was 418 (205) cells/mm(3). There were no differences in baseline characteristics between groups. Serological response in the high-dose group was found in 36 of 50 patients (72%; 95% CI, 56.9%-82.9%) compared with 28 of 55 patients in the standard-dose group (51%; 95% CI, 37.1%-64.6%) (odds ratio, 2.48; 95% CI, 1.02-6.10; P = .03). Mean (SD) anti-HB levels were 398.0 (433.4) IU/L in the high-dose group and 158.5 (301.4) IU/L in the standard-dose group (P < .001). Of patients with a serological response in the high-dose group, 29 of 36 (80.6%) had anti-HBs titers greater than 100 IU/L compared with 14 of 28 responders (50.0%) in the standard-dose group (P = .02). At 1-year follow-up, 20 of 25 patients (80.0%) with a serological response in the high-dose group had protective anti-HBs vs 9 of 23 patients (39.1%) in the standard-dose group (P = .01).
dc.description.abstractCONCLUSIONS AND RELEVANCE The results of this randomized clinical trial suggest that use of a high-dose regimen for HBV revaccination for patients with HIV achieves a higher and longer-lasting serological response as compared with a standard-dose regimen.
dc.fuente.origenWOS
dc.identifier.doi10.1001/jamanetworkopen.2021.20929
dc.identifier.issn2574-3805
dc.identifier.urihttps://doi.org/10.1001/jamanetworkopen.2021.20929
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/94344
dc.identifier.wosidWOS:000689729900002
dc.issue.numero8
dc.language.isoen
dc.revistaJama network open
dc.rightsacceso restringido
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleComparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV A Randomized Clinical Trial
dc.typeartículo
dc.volumen4
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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